A Bayesian approach for evaluating equivalence over multiple groups, and comparison with frequentist tost.

Manufacturing and testing of pharmaceutical products frequently occur in multiple facilities within a company's network. It is of interest to demonstrate equivalence among the alternative testing/manufacturing facilities to ensure product consistency and quality regardless of the facility where it was manufactured/tested. In the Frequentist framework, equivalence testing is well established when comparing two labs or manufacturing facilities; however, when considering more than two labs or production sites, the Frequentist approach may not always offer appropriate or interpretable estimates for demonstrating equivalence among all of them simultaneously.

Development and qualification of 3 L scale-down model for large scale vaccine process on Vero cell culture using microcarriers.

Scale-down models (SDM) are pivotal tools for process understanding and improvement to accelerate the development of vaccines from laboratory research to global commercialization. In this study, a 3 L SDM representing a 50 L scale Vero cell culture process of a live-attenuated virus vaccine using microcarriers was developed and qualified based on the constant impeller power per volume principle. Both multivariate data analysis (MVDA) and the traditional univariate data analysis showed comparable and equivalent cell growth, metabolic activity, and product quality results across scales.

O-Annealing Effect on the Etching Resilience of a TiO/AlO filter Prepared by Atomic Layer Deposition.

This research investigates the improvements of ozone (O) annealing on the optical and etching characteristics of TiO/AlO multilayer band-pass filters designed for potential optoelectronic applications. The band-pass filters were fabricated using atomic layer deposition (ALD), and their performance was systematically analyzed after the addition of O annealing at moderate temperatures (up to 300 °C). Results reveal that O annealing improves the optical transmittance of the multilayers by approximately 40% without significant spectral changes (∼6 nm).

Nephro-urological outcomes of a proactive management of children with spina bifida in their first 5 Years of life.

Introduction: The proactive management of spina bifida (SB), especially of its severe form, myelomeningocele (MMC), has contributed to decreasing chronic kidney disease (CKD). The objective of this study is to present the evolution of 5-year-old patient with MMC followed from birth with a proactive approach.

Material And Methods: This retrospective study included 55 cases with MMC of up to 5 years of age.

Ameliorative Effects of Oral Glucosamine on Insulin Resistance and Pancreatic Tissue Damage in Experimental Wistar rats on a High-fat Diet.

Hyperlipidemia due to a high-fat diet (HFD) is a risk factor for inducing insulin resistance (IR) and adverse effects on pancreatic β-cells in obesity and type 2 diabetes mellitus. This relationship may be due to activation of the hexosaminebiosynthesis pathway. Administration of exogenous glucosamine (GlcN) can increase the end product of this pathway (uridine-5'-diphosphate-N-acetyl-glucosamine), which can mediate IR and protein glycosylation.

Dear enemy effect in the Mexican volcano mouse Neotomodon alstoni: Implications of sex in the agonistic behaviour among neighbours.

Two opposite phenomena have been found in territorial animals, the "dear enemy'' and the "nasty neighbour'', which refer to individuals that show less aggression toward neighbours than toward strangers and vice versa. However, the need to maintain territory should differ for males and females because sexual reproduction is the result of the different adaptive strategies of the sexes. In this study, we explore territorial behaviour in the context of dear-enemy and nasty neighbour effects in the Mexican volcano mouse (Neotomodon alstoni).

Design of the β3-Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure Trial.

Combined pre-and post-capillary hypertension (CpcPH) is a relatively common complication of heart failure (HF) associated with a poor prognosis. Currently, there is no specific therapy approved for this entity. Recently, treatment with beta-3 adrenergic receptor (β3AR) agonists was able to improve pulmonary hemodynamics and right ventricular (RV) performance in a translational, large animal model of chronic PH.

Sex Differences Among Participants in the Latin American Stroke Registry.

Background Reports on sex differences in stroke outcome and risk factors are scarce in Latin America. Our objective was to analyze clinical and prognostic differences according to sex among participants in the LASE (Latin American Stroke Registry). Methods and Results Nineteen centers across Central and South America compiled data on demographics, vascular risk factors, clinical stroke description, ancillary tests, and functional outcomes at short-term follow-up of patients included from January 2012 to January 2017.

Safety Evaluation and Whole-Genome Annotation of Lactobacillus plantarum Strains from Different Sources with Special Focus on Isolates from Green Tea.

Lactobacillus plantarum shows high intraspecies diversity species, and has one of the largest genome sizes among the lactobacilli. It is adapted to diverse environments and provides a promising potential for various applications. The aim of the study was to investigate the safety and probiotic properties of 18 L.

Host species influence on flea (Siphonaptera) infection parameters of terrestrial micromammals in a temperate forest of Mexico.

Studies of abundance and distribution of organisms are fundamental to ecology. The identity of host species is known to be one of the major factors influencing ectoparasitic flea abundance, but explanations are still needed regarding how host taxa influence abundance parameters of different flea species. This study was carried out at La Malinche National Park (LMNP), Tlaxcala, Mexico, where previously 11 flea species had been recorded on 8 host species.

Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study.

Purpose: Current reports on acute kidney injury (AKI) in the intensive care unit (ICU) show wide variation in occurrence rate and are limited by study biases such as use of incomplete AKI definition, selected cohorts, or retrospective design. Our aim was to prospectively investigate the occurrence and outcomes of AKI in ICU patients.

Methods: The Acute Kidney Injury-Epidemiologic Prospective Investigation (AKI-EPI) study was an international cross-sectional study performed in 97 centers on patients during the first week of ICU admission.

Landscape of genomic alterations in cervical carcinomas.

Cervical cancer is responsible for 10-15% of cancer-related deaths in women worldwide. The aetiological role of infection with high-risk human papilloma viruses (HPVs) in cervical carcinomas is well established. Previous studies have also implicated somatic mutations in PIK3CA, PTEN, TP53, STK11 and KRAS as well as several copy-number alterations in the pathogenesis of cervical carcinomas.

Species distribution and antifungal susceptibility of bloodstream fungal isolates in paediatric patients in Mexico: a nationwide surveillance study.

Objectives: To establish the species distribution and in vitro susceptibilities of 358 bloodstream fungal isolates from paediatric patients in Mexico.

Methods: Isolates were collected during a 2 year surveillance programme in 14 medical centres in 10 Mexican states. A molecular approach was used to determine the Candida parapsilosis species complex.

Oral thromboprophylaxis in pelvic trauma: a standardized protocol.

Background: Thromboprophylaxis for deep vein thrombosis (DVT) after lower-extremity trauma could include rivaroxaban, an oral medication that does not need laboratory monitoring.

Objective: To assess rivaroxaban's efficacy in preventing DVTs after pelvic trauma compared to its historical incidence.

Materials And Methods: All patients admitted with pelvic fractures in a 12-month period followed a standardized thromboprophylaxis protocol: 1) rivaroxaban 10 mg/day within 24 h of injury or upon hemodynamic stability; 2) pre-operative, post-operative, and 30-day extremity ultrasound; 3) ventilation-perfusion scintigraphy for clinical signs of pulmonary embolus; and 4) a 45-, 90-, and 120-day re-evaluation.

Acute meningitis prognosis using cerebrospinal fluid interleukin-6 levels.

Background: Improved diagnostic tests would aid in diagnosing and treating community-acquired meningitis.

Objective: To analyze the diagnostic value of interleukin-6 (IL-6) in the cerebrospinal fluid (CSF) of patients presenting with symptoms of acute meningitis.

Material And Methods: In a 6-month prospective, observational, cross-sectional emergency department (ED) study, serum and CSF samples were obtained from all patients with a headache and fever in whom the physician suspected meningitis.

Measuring intrabladder pressure with the head of the bed elevated 30°: evidence to support a change in practice.

Background: A 30° head-of-bed elevation is recommended for most critically ill patients. Measuring intrabladder pressure with the patient in this position is controversial.

Objective: To assess the feasibility of measuring intrabladder pressure with a 30° head-of-bed elevation.

Reliability of intrabladder pressure measurement in intensive care.

Background: The reliability of intrabladder pressure measurements obtained in nonsupine patients is unknown.

Objectives: To investigate the reliability of measurements of intrabladder pressure obtained with 30 degrees head-of-bed elevation.

Methods: With patients supine, 30 degrees head-of-bed elevation, and instillation of 0 and 25 mL physiological saline, intrabladder pressure was measured in 10 patients: twice by one nurse to assess intraobserver reliability and once by a different nurse to assess interobserver reliability.

Pain treatment in post-traumatic hip fracture in the elderly: regional block vs. systemic non-steroidal analgesics.

Background: This prospective, randomized double-blind study, conducted over 19 months in a tertiary care ED, sought to determine if a fascia-iliaca regional anesthetic block provides better and safer pain relief than does parenteral analgesia.

Aims: This study also aimed to determine the effectiveness of parenteral NSAID analgesia for acute hip fractures.

Methods: Patients >65 years old presenting at an adult ED with acute hip fractures were randomized upon presentation to the ED into two groups (A and B) using numbers generated by the EPI-INFO™ (Atlanta, GA: Centers for Disease Control and Prevention) program.

Lactic dehydrogenase in cerebrospinal fluid may differentiate between structural and non-structural central nervous system lesions in patients with diminished levels of consciousness.

Background: Impaired consciousness without a history of trauma is a common reason for emergency department (ED) visits. Among critically ill patients with a history and physical findings suggestive of a cerebrovascular accident (CVA), it may be difficult to differentiate between a structural and a non-structural cause for their condition.

Objectives: This study was conducted to determine if lactic dehydrogenase (LDH) levels in the cerebrospinal fluid (CSF) of patients with acute non-traumatic neurological disorders could distinguish between structural and non-structural etiologies.

Negative blood culture infective endocarditis in the elderly: long-term follow-up.

Background And Aim: Since the appearance of transesophageal echocardiography, the long-term prognosis of patients with negative blood culture infective endocarditis (NBCIE) has been found to be similar to that of patients with positive blood culture infective endocarditis (PBCIE). Nevertheless, the prognostic implications of NBCIE in the elderly (>65 years) has not, to date, been well documented. Our aim was to study the long-term prognosis of elderly patients with NBCIE and compare it with that of elderly patients with PBCIE.

Single fascia iliaca compartment block for post-hip fracture pain relief.

Hip fractures can cause considerable pain when untreated or under-treated. To enhance pain relief and diminish the risk of delirium from typically administered parenteral analgesics and continued pain, we tested the efficacy of using fascia-iliaca blocks (FICB), administered by one of four attending physicians working in the emergency department (ED), with commonly available ED equipment. After informed consent, a physician administered one FICB to 63 sequential adult ED patients (43 women, 20 men; ages 37-96 years, mean 73.

Efferent projections of rat rostroventrolateral medulla C1 catecholamine neurons: Implications for the central control of cardiovascular regulation.

A replication-defective lentivirus vector that expresses enhanced green fluorescent protein (EGFP) under the control of a synthetic dopamine-beta-hydroxylase (DbetaH) promoter was used to define efferent projections of C1 catecholamine neurons in rat rostral ventrolateral medulla (RVLM). EGFP expression was restricted to C1 neurons and filled their somatodendritic compartments and efferent axons 7-28 days after vector injection. This included the descending projections to thoracic spinal cord and a network in brainstem, midbrain, and diencephalon.

ACE2 gene transfer attenuates hypertension-linked pathophysiological changes in the SHR.

Recently discovered, angiotensin-converting enzyme-2 (ACE2) is an important therapeutic target in the control of cardiovascular diseases as a result of its proposed central role in the control of angiotensin peptides. Thus our objective in the present study was to determine whether ACE2 gene transfer could decrease high blood pressure (BP) and would improve cardiac dysfunctions induced by hypertension in the spontaneously hypertensive rat (SHR) model. Five-day-old SHR and normotensive WKY rats received a single intracardiac bolus injection of lentiviral vector containing either murine ACE2 (ACE2) or control enhanced green fluorescent protein (EGFP) genes.

Protection from angiotensin II-induced cardiac hypertrophy and fibrosis by systemic lentiviral delivery of ACE2 in rats.

Angiotensin converting enzyme 2 (ACE2), a newly discovered member of the renin-angiotensin system (RAS), is a potential therapeutic target for the control of cardiovascular disease owing to its key role in the formation of vasoprotective peptides from angiotensin II. The aim of the present study was to evaluate whether overexpression of ACE2 could protect the heart from angiotensin II-induced hypertrophy and fibrosis. Lentiviral vector encoding mouse ACE2 (lenti-mACE2) or GFP was injected intracardially in 5-day-old Sprague-Dawley rats.

Nutritional concerns related to Roux-en-Y gastric bypass: what every clinician needs to know.

Weight loss surgery, particularly the Roux-en-Y gastric bypass (REYGB), has become a popular treatment strategy for obesity. Often the only measure of success is the amount of weight lost following surgery. Unfortunately the nutritional adequacy of the postoperative diet has frequently been overlooked, and in the months to years that follow, nutritional deficiencies have become apparent, including protein-calorie malnutrition and various vitamin and mineral deficiencies contributing to medical illnesses and limiting optimal health.