Whole Health Options and Pain Education (wHOPE): A Pragmatic Trial Comparing Whole Health Team vs Primary Care Group Education to Promote Nonpharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans-Rationale, Methods, and Implementation.

BACKGROUND: The Whole Health model of the U.S. Department of Veterans Affairs (VA) emphasizes holistic self-care and multimodal approaches to improve pain, functioning, and quality of life. wHOPE (Whole Health Options and Pain Education) seeks to be the first multisite pragmatic trial to establish evidence for the VA Whole Health model for chronic pain care. DESIGN: wHOPE is a pragmatic randomized controlled trial comparing a Whole Health Team (WHT) approach to Primary Care Group Education (PC-GE); both will be compared to Usual VA Primary Care (UPC). The WHT consists of a medical provider, a complementary and integrative health (CIH) provider, and a Whole Health coach, who collaborate with VA patients to create a Personalized Health Plan emphasizing CIH approaches to chronic pain management. The active comparator, PC-GE, is adapted group cognitive behavioral therapy for chronic pain. The first aim is to test whether the WHT approach is superior to PC-GE and whether both are superior to UPC in decreasing pain interference in functioning in 750 veterans with moderate to severe chronic pain (primary outcome). Secondary outcomes include changes in pain severity, quality of life, mental health symptoms, and use of nonpharmacological and pharmacological therapies for pain. Outcomes will be collected from the VA electronic health record and patient-reported data over 12 months of follow-up. Aim 2 consists of an implementation-focused process evaluation and budget impact analysis. SUMMARY: This trial is part of the Pain Management Collaboratory, which seeks to create national-level infrastructure to support evidence-based nonpharmacological pain management approaches for veterans and military service personnel.

A consensus introduction to serum replacements and serum-free media for cellular therapies.

The cell therapy industry is a fast-growing industry targeted toward a myriad of clinical indications. As the cell therapy industry matures and clinical trials hit their pivotal Phase 3 studies, there will be a significant need for scale-up, process validation, and critical raw material quality assurance. Part of the well discussed challenges of upscaling manufacturing processes there is a less discussed issue relating to the availability of raw materials in the needed quality and quantities. The FDA recently noted that over 80% of the 66 investigational new drug (IND) applications for mesenchymal stem cell (MSC) products analyzed described the use of FBS during manufacturing. Accumulated data from the past years show an acceleration in serum consumption by at least 10%-15% annually, which suggests that the global demand for serum may soon exceed the supply. Ongoing concerns of safety issues due to risks of various pathogen contaminations, as well as issues related to the aforementioned serum variability that can affect final product reproducibility, are strong motivators to search for serum substitutes or serum-free media. it is important to note that there are no accepted definitions for most of these terms which leads to misleading's and misunderstandings, where the same term might be defined differently by different vendors, manufacturer, and users. It is the drug developer's responsibility to clarify what the supplied labels mean and to identify the correct questions and audits to ensure quality. The paper reviews the available serum replacements, main components, basic strategies for replacement of serum and suggests definitions.

Post-transplantation primary central nervous system lymphoma in a patient with systemic lupus erythematosus and prolonged use of immunosuppressant.

Post-transplantation primary central nervous system lymphoma is an uncommon and fatal post-transplant lymphoproliferative disorder. Such lymphomas have been described in only a few case series in the literature. The incidence of this condition is rising with improved survival after organ transplantation. A case of post-transplantation primary central nervous system lymphoma in a young Chinese woman with systemic lupus erythematosus is described here. She presented with right-sided weakness and memory loss after tooth extraction 2 weeks before admission. Contrast computed tomography of the brain demonstrated a contrast rim-enhancing lesion over the left frontal lobe. With a history of recent dental procedure, long-term immunosuppressive therapy and computed tomography findings, cerebral abscess was highly suspected. Emergency operation was performed. Histopathology showed post-transplantation primary central nervous system lymphoma, with cells positive for B-cell marker CD20. Immunosuppressant was stopped and she was treated with radiotherapy and rituximab (anti-CD20 monoclonal antibody). She remained disease-free at 16 months. Post-transplantation primary central nervous system lymphoma is rare with variable presentation and radiological features. We believe rituximab may have a role in the treatment of such lymphomas.

Stand-off detection of solid targets with diffuse reflection spectroscopy using a high-power mid-infrared supercontinuum source.

We measure the diffuse reflection spectrum of solid samples such as explosives (TNT, RDX, PETN), fertilizers (ammonium nitrate, urea), and paints (automotive and military grade) at a stand-off distance of 5 m using a mid-infrared supercontinuum light source with 3.9 W average output power. The output spectrum extends from 750-4300 nm, and it is generated by nonlinear spectral broadening in a 9 m long fluoride fiber pumped by high peak power pulses from a dual-stage erbium-ytterbium fiber amplifier operating at 1543 nm. The samples are distinguished using unique spectral signatures that are attributed to the molecular vibrations of the constituents. Signal-to-noise ratio (SNR) calculations demonstrate the feasibility of increasing the stand-off distance from 5 to ~150 m, with a corresponding drop in SNR from 28 to 10 dB.

Computed Tomographic Morphometric Analysis of C1 and C2 for Lamina Cross Screw Placement in Malay Ethnicity.

STUDY DESIGN: This is an observational study of computed tomography (CT) data. PURPOSE: The C1 and C2 laminas in the Malaysian Malay population were analyzed for the feasibility of fitting 3.5-mm laminar screws in a cross configuration. OVERVIEW OF LITERATURE: Morphometric analysis of the C1 and C2 laminas has been performed for various populations but not for the Malaysian Malay population. METHODS: A total of 330 CT cervical images were measured to establish the bicortical diameter of the C1 and C2 laminas as well as their height and length. The C1 posterior tubercle bicortical diameter and height were also determined from these images. All parameters were measured up to 0.1 mm, and statistical analysis was performed using IBM SPSS Statistics ver. 24.0 (IBM Corp., Armonk, NY, USA). An independent t -test and the Pearson chi-square test were used to determine the mean difference and screw acceptance. RESULTS: The means of the C1 lamina measurements were 5.79±1.19 mm in diameter, 9.76±1.51 mm in height, and 20.70±1.86 mm in length. The means of the measurements of the posterior tubercle were 7.20±1.88 mm in diameter and 10.51±1.68 mm in height. The means of the C2 lamina measurements were 5.74±1.31 mm in diameter, 11.76±1.69 mm in height, and 24.96±2.56 mm in length. Overall 65.5% of C1 and 80.3% of C2 laminas are able to accept 3.5-mm screws in a cross configuration. Screw acceptability is similar between the right and left sides (p >0.05). However, males have a higher screw acceptability compared with females (p <0.05), except for the C2 left lamina. CONCLUSIONS: It is feasible to insert a 3.5-mm screw in a cross configuration in the C1 and C2 laminas of the Malaysian Malay population, especially in males. However, a CT scan should be performed prior to the operation to determine screw acceptability and to estimate screw sizes.

Glutaraldehyde-chitosan and poly (vinyl alcohol) blends, and fluorescence of their nano-silica composite films.

In this study, a commercial chitosan cross-linked with glutaraldehyde (GA-chitosan) having the autofluorescent property was effectively blended with a poly (vinyl alcohol) (PVA) matrix, in the formation of a transparent and fluorescent blend film. The fluorescent efficiency of the film was enhanced with red-shifted emission band by increasing the concentrations of the GA-chitosan and decreasing the PVA crystallinity. It was found that the incorporation of silica nanoparticles could further decrease the PVA crystallinity, enhance the fluorescent efficiency, and largely redshift the emission band, as compared with the neat GA-chitosan-PVA blend film. This fluorescent property could be finely tuned by careful doping of the silica nanoparticles and change of the PVA crystallinity. These phenomena could be reasonably explained by high extent of isolation of the fluorophores, increase of the stiffness of the fluorescent conjugated planar structure, and further decrease of the PVA crystallinity. In addition, the introduction of the nano-silica could improve the water and heat resistances of the GA-chitosan-PVA based silica nanocomposites.

Alternate pathways involving Sgs1/Top3, Mus81/ Mms4, and Srs2 prevent formation of toxic recombination intermediates from single-stranded gaps created by DNA replication.

Toxic recombination events are detected in vegetative Saccharomyces cerevisiae cells through negative growth interactions between certain combinations of mutations. For example, mutations affecting both the Srs2 and Sgs1 helicases result in extremely poor growth, a phenotype suppressed by mutations in genes that govern early stages of recombination. Here, we identify a similar interaction involving double mutations affecting Sgs1 or Top3 and Mus81 or Mms4. We also find that the primary DNA structures that initiate these toxic recombination events cannot be double-strand breaks and thus are likely to be single-stranded DNA. We interpret our results in the context of the idea that replication stalling leaves single-stranded DNA, which can then be processed by two competing mechanisms: recombination and nonrecombination gap-filling. Functions involved in preventing toxic recombination would either avoid replicative defects or act on recombination intermediates. Our results suggest that Srs2 channels recombination intermediates back into the gap-filling route, whereas Sgs1Top3 and Mus81Mms4 are involved in recombination andor in replication to allow replication restart.