Marfan’s syndrome is a systemic disorder of connective tissue typically involving cardiovascular, musculoskeletal and ocular systems. Given the relative rarity of neurovascular complications in Marfan’s syndrome, there is currently little published data on the use of thrombolysis in patients with Marfan’s syndrome and acute ischaemic stroke. Of concern is the possibility of underlying cerebral artery dissection in patients with Marfan’s syndrome presenting with stroke and the risk of haemorrhagic complications with thrombolysis. We report the third known case of a patient with Marfan’s syndrome with an acute ischaemic stroke without evidence of cerebral artery dissection who received thrombolysis successfully with neurological improvement. A 47-year-old woman with a history of Marfan’s syndrome and previous left middle cerebral artery (MCA) territory infarct presented to our emergency department with sudden onset of right facial, arm and leg weakness with a NIHSS score of 15 and clinical examination findings of a right upper motor neurone facial palsy and right hemiparesis. CT brain revealed a dense right MCA sign and no evidence of haemorrhage. She received 0.9mg/kg of alteplase without complications. There was a suspicion for cerebral artery dissection but this was not evident on both CT angiography and MRI angiogram with black blood sequences. She recovered well with a NIHSS score of 1 and mild residual dysphasia. This case demonstrates that thrombolysis may be given safely in a patient with Marfan’s syndrome and acute ischaemic stroke and exclusion of underlying cerebral artery dissection should always be a consideration.

BACKGROUNDThis study examined the prevalence of depressive symptoms among elderly immigrants from Mainland China to Canada and the impact of various psychosocial factors as predictors of the number of depressive symptoms reported by the elderly Chinese immigrants.

METHODSThe participants were 444 elderly immigrants who migrated from Mainland China to Canada. They were a part of a random sample of 2272 elderly Chinese living in the communities and took part in a face-to-face interview to answer questions in an orally administrated questionnaire. The depressive symptoms of the participants were measured by a Chinese version of the Geriatric Depression Scale. Data obtained from the 444 elderly Chinese immigrants was analyzed to assess the impact of various psychosocial factors on the number of depressive symptoms that they reported.

RESULTSThe findings indicated that 23.2% of the elderly immigrants were assessed to have some depressive symptoms. When other predicting variables were adjusted, elderly immigrants with more chronic illnesses, less positive attitude towards ageing, poorer physical health, less adequate financial situation, lower level of ethnic identification as Chinese, more service barriers, lower level of life satisfaction, shorter length of residency in Canada and those who lived alone tended to have more depressive symptoms.

CONCLUSIONSThe findings indicate that the prevalence rate of depressive symptoms among our elderly immigrant sample is higher than the one reported in a general elderly population. While further research is recommended to examine the reasons for such a difference, culturally appropriate health services, including health promotion programs, should be promoted to reduce mental health disparities.

Aged ; Canada ; epidemiology ; China ; ethnology ; Depression ; epidemiology ; Emigration and Immigration ; Female ; Humans ; Male ; Middle Aged ; Prevalence

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards ; Software Validation

OBJECTIVEAnalyses of bladder cancer mortality in the Black Foot Disease (BFD) endemic area of southwest Taiwan conducted by Morales et al. showed a discontinuity in risk at 400 microg/L arsenic in the drinking water in a stratified analysis and no discontinuity in a continuous analysis. As the continuous analysis presentation had been used by both the NRC and the EPA to assess the carcinogenic risk from arsenic ingestion, an explanation of the discontinuity was sought.

METHODSReview of 40 years of published health studies of the BFD-endemic area of SW Taiwan showed that earlier publications had limited their cancer associations with arsenic levels in artesian well waters and that the reports of Morales et al., NRC, and EPA failed to do so. Underlying data for the Morales et al. study were obtained from the appendix to the NRC report. Bladder cancer mortality rates were calculated from case counts and person-years of observation for each study village. Villages were categorized by water source according to the descriptions from the underlying study. Graphic and regression analyses were conducted of the bladder cancer mortality rates using exposure as a continuous variable and simultaneously stratifying by water source.

RESULTSThe median village well arsenic levels ranged from 350 to 934 microg/L for villages solely dependent on artesian well water and from 10 to 717 microg/L for villages not solely dependent on artesian well water. Bladder cancer mortality rates were found to be dependent upon the arsenic level only for those villages that were solely dependent on artesian well water for their water source. Bladder cancer mortality rates were found to be independent of arsenic level for villages with non-artesian well water sources.

CONCLUSIONSThe data indicate that arsenic exposure levels do not explain the bladder cancer mortality risk in SW Taiwan among villages not dependent upon artesian well water. The association for villages dependent upon artesian well water may be explained either by arsenic acting as a high-dose carcinogen or in artesian well water as a co-carcinogen with some other aspect of artesian well water (possibly humic acid). Arsenic exposure level alone appears to be an insufficient exposure measure to describe the risk of bladder cancer mortality in the BFD-endemic area. Risk analyses that fail to take water source into account are likely to misrepresent the risk characterization, particularly at low arsenic levels.

Adolescent ; Adult ; Aged ; Arsenic Poisoning ; complications ; epidemiology ; Child ; Child, Preschool ; Death Certificates ; Environmental Exposure ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Middle Aged ; Mortality ; trends ; Retrospective Studies ; Risk Assessment ; Taiwan ; epidemiology ; Urinary Bladder Neoplasms ; etiology ; mortality ; Water Supply

BACKGROUND AND PURPOSE: Intraoperative neurophysiological monitoring (IONM) using upper and lower somatosensory evoked potentials (SSEPs) is an established technique used to predict and prevent neurologic injury during intracranial tumor resections. Endoscopic port surgery (EPS) is a minimally-invasive approach to deep intraparenchymal and intraventricular brain tumors. The authors intended to evaluate the predictive value of SSEP monitoring during resection of intracranial brain tumors using a parallel endoscopic technique. METHODS: A retrospective review was conducted of patients operated on from 2007-2010 utilizing IONM in whom endoscopic ports were used to remove either intraparenchymal or intraventricular tumors. Cases were eligible for review if an endoscopic port was used to resect an intracranial tumor and the electronic chart included all intraoperative monitoring data as well as pre- and post-operative neurologic exams. RESULTS: 139 EPS cases met criteria for inclusion. Eighty five patients (61%) had intraparenchymal and fifty four (39%) had intraventricular tumors or colloid cysts. SSEP changes were seen in eleven cases (7.9%), being irreversible in three (2.2%) and reversible in eight cases (5.8%). Seven patients (5.0%) with intraparenchymal tumors had SSEP changes which met our criterea for significant changes while there were four (2.9%) with intraventricular (p-value=0.25). Five patients suffered post operative deficits, two reversible and two irreversible SSEP changes. Only one case exhibited post operative hemiparesis with no SSEP changes. The positive predictive value of SSEP was 45.4% and the negative predictive value was 99.2%. CONCLUSIONS: Based on the high negative and low positive predictive values, the utility of SSEP monitoring for cylindrical port resections may be limited. However, the use of SSEP monitoring can be helpful in reducing the impact of endoscopic port manipulation when the tumor is closer to the somatosensory pathway.
Brain Neoplasms ; Colloid Cysts ; Evoked Potentials ; Evoked Potentials, Somatosensory* ; Humans ; Monitoring, Intraoperative ; Paresis ; Retrospective Studies

Next-generation sequencing (NGS) is getting routinely used in the diagnosis of hereditary diseases, such as human cardiomyopathies. Hence, it is of utter importance to secure high quality sequencing data, enabling the identification of disease-relevant mutations or the conclusion of neg-ative test results. During the process of sample preparation, each protocol for target enrichment library preparation has its own requirements for quality control (QC); however, there is little evi-dence on the actual impact of these guidelines on resulting data quality. In this study, we analyzed the impact of QC during the diverse library preparation steps of Agilent SureSelect XT target enrichment and Illumina sequencing. We quantified the parameters for a cohort of around 600 sam-ples, which include starting amount of DNA, amount of sheared DNA, smallest and largest frag-ment size of the starting DNA; amount of DNA after the pre-PCR, and smallest and largest fragment size of the resulting DNA;as well as the amount of the final library, the corresponding smallest and largest fragment size, and the number of detected variants. Intriguingly, there is a high tolerance for variations in all QC steps, meaning that within the boundaries proposed in the current study, a considerable variance at each step of QC can be well tolerated without compromising NGS quality.

Aims: This study investigates the potential of porous polymethacrylate monoliths as enzyme support materials for large-scale enzyme commercialization. Methodology and results: It focuses on their preparation and various immobilization techniques, such as adsorption, covalent-binding and cross-linking, specifically applied to β-galactosidase for bioprocess applications. The research assesses immobilization performance, operational stability, reusability and optimization using response surface methodology (RSM). The results reveal that covalent-binding exhibited the highest enzyme activity recovery, while cross-linking showed superior performance at lower enzyme concentrations but decreased at higher concentrations. Covalent-bound enzymes demonstrated reusability for up to four cycles, with optimal pH ranging between 7 and 8 and optimal temperature ranging between 30 °C and 40 °C. Furthermore, RSM optimization highlighted the significant influence of substrate concentration on enzyme activity, with a reliable model (R2 = 0.9163) and adequate precision (S/N = 13.1409). Conclusion, significance and impact of study Overall, this study provides valuable guidelines for effectively employing porous monoliths in large-scale industrial bioprocessing, offering potential cost-saving benefits and enhanced efficiency in enzyme commercialization.