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Context: We previously reported positive behavioral effects of both daily mantra meditation and classical music listening interventions in breast cancer survivors with cancer related cognitive complaints. Objective: The objective of this pilot study was to compare the effects of the meditation intervention to a music listening intervention on biomarkers of inflammation and cellular aging (secondary outcomes) in breast cancer survivors. Design: Randomized control trial, baseline data collection (time 1), post intervention data collection (time 2) Setting: Community-based, Central Texas Participants: 25 breast cancer survivors (BCS) who were 3 months to 6 years post chemotherapy completion and reported cognitive decline Intervention(s): Kirtan Kriya meditation (KK) or music listening (ML), 8 weeks, 12 minutes a day Main Outcome: Telomerase activity [TA], c-reactive protein [CRP], soluble IL-2 receptor alpha [sIL-2Rα], soluble IL-4 receptor [sIL-4R], soluble IL-6 receptor [sIL-6R], soluble tumor necrosis factor receptor II [sTNF-RII], VEGF receptor 2 [sVEGF-R2], and VEGF receptor 3 [sVEGF-R3] Results: Repeated measures analysis of variance models were analyzed from time 1 to time 2 by group for each biomarker. A pattern of greater telomerase activity across time in both groups (F (1,15) = 3.98, p = .06, η²p = .21); significant decreases in sIL-4R across time for both groups (F (1,22)= 6.28, p = .02, η²p = .22); group*time effect was nominally different but not statistically different for sIL-4R (F(1,22)= 3.82, p = .06, η²p = .15); and a pattern for a group*time effect with ML group showing higher levels of sVEGF-R3 at time 2 (F (1,20)=, p = .12, η²p = .11). No significant effects were found for CRP, sIL-2Rα, sIL-6R, sTNF-RII, or sVEGF-R2.

TARAMAPUBMED TARAMASCOPUS Statement of problem: Sleeping without conventional complete dentures (CCDs) has been stated by some to induce negative effects on the cardiorespiratory functions of edentulous patients with obstructive sleep apnea (OSA), although others have reported the exact opposite. Therefore, a consensus on nocturnal CCD usage is lacking. Purpose: The purpose of this clinical study was to assess the effects of nocturnal denture usage on cardiorespiratory stability by using pulse oximetry (PO). Materials and methods: Thirty CCD wearers were enrolled in the study. The first nocturnal pulse oximetry (FNPO) recordings were made on 3 different nights while the participants were sleeping without dentures (WOD). Oxygen desaturation index (ODI) and other PO parameters of the participants, including total respiratory event (TRE), basal SpO2 (BSpO2), time≤88 (T88), average low SpO2 (ALSpO2), total pulse event (TPE), average pulse rate (APR), and heart rate variability index (HRVI), were processed and the obtained data were recorded as WOD condition values. According to the ODI scores, the OSA status of the participants was grouped as normal (ODI30). Complete dentures were fabricated by an experienced prosthodontist and a dental laboratory technician by following conventional procedures. At the end of the first month of the follow-up period, the second nocturnal PO recordings (SNPO) were made on 3 different nights while the participants slept wearing dentures (WID), and the data obtained were recorded as WID condition values. The comparison of mean PO values obtained from WOD and WID were analyzed with the Wilcoxon signed- rank test (α=.05). Results: Significant differences were found between WOD and WID values in terms of TRE (P=.01), ODI (P=.001), ALSpO2 (P=.006), TPE (P=.001), and HRVI (P=.001) parameters. The significance of the improvements in the WID condition increased with the severity of OSA. Conclusions: Improvements were observed in substantial cardiorespiratory parameters such as the ODI and HRVI of the participants wearing dentures nocturnally.

Contingency management is an effective treatment for cigarette smoking cessation but feasibility and acceptability concerns have been barriers to implementation. We conducted a pilot test of QuitBet, a commercial, digital (smartphone) social game for smoking cessation during which participants earned financial incentives for abstinence. QuitBet included a social feed for posting messages and entirely participant-funded incentives in the form of a deposit contract (the "bet"). QuitBet had a bet of $30 and lasted for 28 days. After a week to prepare for quitting, the quit day was Day 8. Between Day 9-28 (a 20-day period), participants earned back $1 of their $30 bet for each day of carbon monoxide (CO)-verified abstinence (≤ 6 ppm). Remaining bet money was pooled into a "grand prize" pot. Participants who were abstinent on at least 19 of the 20 days (1 "lapse" day allowed) were declared "winners" and split the grand prize pot equally. A game host posted a daily message containing evidence-based education about smoking cessation or a discussion topic. Recruitment goals were met. Among the players (N = 50 U.S. adults, 78% female), 17 (34%) were winners. Thirty-seven participants (74%) responded to a post-QuitBet survey, of whom 95% said they would be interested in playing another QuitBet and would recommend QuitBet to others. Overall, feedback was positive with some suggestions for improvement. In conclusion, a digital social game for smoking cessation with a deposit contract was feasible and acceptable. Next steps include conducting a randomized trial to establish efficacy and a sustainable business model. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

192 Background: Adequate surgical lymphadenectomy is integral to the staging and treatment of gastric cancer. A number of Asian studies have explored the utility of lymph node (LN) mapping in gastric cancer but this in not commonly performed in Western countries. We sought to evaluate the utility and safety of LN mapping in Western patients. Methods: We conducted a pilot study of 13 patients with histologically proven non-metastatic gastric adenocarcinoma that received endoscopic peri-tumoral indocyanine green fluorescence (ICG) injections immediately prior to surgical resection to facilitate LN mapping. Illumination with ICG around the primary tumor, in lymphatic basins, tracts, and lymph nodes were confirmed by the PINPOINT system on recorded videos. Descriptive statistical analysis was performed. Results: Among the 13 patients enrolled, median age was 75 years and 7 were men. On pathologic review, 15% were T1, 54% were T2, and 69% had were node negative. Tumours were located in the proximal third in 1 patient, middle third in 2 patients and distal third in 10 patients. All patients had a laparoscopic subtotal gastrectomy and 10 patients had a D2 lymphadenectomy. 5 patients received preoperative and 7 received postoperative chemotherapy. The median number of LNs harvested was 26 [IQR 24-34]. Video confirmation of ICG mapping of the primary tumor, lymphatic basins, tracts, and LNs were obtained in all patients. All LNs identified with ICG uptake were removed with surgical lymphadenectomy. ICG mapped LNs fell outside the D1 distribution in 100% and outside the D1-plus distribution in 54% of cases. ICG mapped LNs were within the D2 distribution in all cases. No ICG related allergic reactions or procedural complications were observed. Postoperative complications included 2 grade A pancreatic fistulas, 1 gastrointestinal bleed, and 1 NSTEMI. Peri-operative morality was zero. Conclusions: We demonstrate ICG lymph node mapping as a safe and useful technique for identifying regional draining lymph nodes and for primary tumor localization in Western patients. The majority of cases found LNs draining outside the D1 and D1+ distributions, highlighting the importance of appropriate lymphadenectomies in gastric cancer.

The present study aimed to explore the efficacy and safety of roxadustat in patients with renal anemia and erythropoietin (EPO) hyporesponsive who are receiving continuous ambulatory peritoneal dialysis (CAPD).This is a single center, before and after treatment, self-controlled study; 55 CAPD patients with renal anemia and EPO hyporesponsiveness were enrolled. The main follow-up parameters included routine blood, liver and kidney function, electrolyte, blood lipid, high-sensitivity C-reactive protein, and iron tests. Serum samples were used to determine interleukin-6 and tumor necrosis factor-α levels via enzyme linked immunosorbent assay. The Modified Quantitative Subjective Global Assessment Score and Malnutrition-Inflammation Score before and after treatment, and adverse events during treatment were recorded. The follow-up observation time was 12 weeks. Preliminary data 12-24 weeks before the enrollment as well as post-follow-up data at 36 weeks were also collected.Fifty patients completed the 12-week follow-up. The hemoglobin levels were 8.0 ± 1.2 g/dL at baseline and 11.2 ± 2.0 g/dL after 12 weeks of roxadustat treatment. The hemoglobin increases at all measured time points and was statistically significant compared with the baseline value (P .05). The overall hemoglobin response rate (hemoglobin increase ≥ 1.0 g/dL) was 80%, and 50% of the patients reached the hemoglobin target (hemoglobin ≥ 11.0 g/dL) at 12 weeks. Transferrin was higher at 12 weeks (2.2 ± 0.5 g/L) than at baseline (1.7 ± 0.5 g/L) (P .05), while serum ferritin levels slightly decreased compared with the baseline value (P .05). The median high-sensitivity C-reactive protein level and other inflammation-related indicators, such as white blood cell counts, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, interleukin-6, and tumor necrosis factor-α, were not significantly different from their baseline values. Nutrition-related biochemical indices such as albumin, creatinine, and blood lipids were also not significantly changed. The Modified Quantitative Subjective Global Assessment Score and Malnutrition-Inflammation Score were slightly lower at 12 weeks than at baseline. No serious adverse events were observed during the follow-up period. Post-follow-up data revealed a maintained hemoglobin level in patients who remained on roxadustat treatment while those switched back to EPO treatment after 12 weeks resulted in a decreased hemoglobin at 36 weeks.In patients with EPO hyporesponsiveness on CAPD, roxadustat can efficiently and safely improve anemia and nutritional status without promoting inflammation.

Purpose: Most young adult cancer survivors (YACS) do not meet physical activity (PA) guidelines. Although PA can improve health and quality of life (QOL), few randomized controlled trials (RCTs) of PA interventions for YACS exist. We conducted a pilot RCT to test feasibility of a PA intervention among YACS. Methods: We recruited 18-39-year-olds (≥1 and

Objective Post operative cognitive dysfunction (POCD) has been widely observed after major surgery, particularly in elderly patients with general anesthesia (GA). However, a specific unanswered question is whether different approaches to anesthetic managements are associated with different cognitive outcomes after endovascular treatments for unruptured intracranial aneurysms (UIAs). The purpose of this study is to assess the correlation of POCD with GA versus monitored anesthesia care (MAC). Methods We performed a pragmatic, prospective study to assess the association between different anesthetic approaches and POCD. We compared the pre- and post-procedural Montreal Cognitive Assessment (MoCA) scores in patients with normal cognition who underwent treatments of UIAs with various endovascular methods, using either GA or MAC. Results A total of 23 patients with UIAs were enrolled in the study. Seven (30.4%) and sixteen (69.6%) UIAs were treated without perioperative complications under GA or MAC, respectively. There was a significant decline in the post-procedural MoCA score under GA (mean difference = 1.14; 95% confidence interval = [0.42–1.87], P Conclusions Treating UIAs using MAC was associated with a decrease in POCD as compared to GA in patients undergoing endovascular treatments for UIAs with normal cognition. Larger randomized studies are needed to confirm these findings.

Spatial neglect is a syndrome due to impaired neural networks critical for spatial attention and related cognitive and motor functions. Affected individuals also have impaired self-awareness of their own neglect symptoms. The present randomized controlled study was the first proof-of-concept pilot examining the multi-context treatment approach using a protocol of spatial exploration strategy training in one brief session (20-30 minutes). The therapist provided supportive feedback and semi-structured guidance to promote strategy learning and self-discovery of omission errors. 40 patients with left-sided neglect after right brain stroke were included. The results showed that the treatment reduced lateralized bias toward the ipsilesional side of space but did not improve overall detection performance. Impaired general self-awareness of daily-life spatial difficulties was found independent of treatment outcome. This implies that judgment regarding responsiveness to treatment should not be made based on an awareness interview or the severity of neglect symptoms. Lastly, the treatment showed the potential of improving online contextual self-awareness of spatial abilities. A collaborative and interactive approach that focuses on helping the patient self-discover, monitor and self-manage their errors, appears to have a potential for decreasing neglect symptoms. Future studies are required to examine additional aspects of the multi-context treatment approach.

Integrating animals into therapy is applied increasingly in patients in a minimally conscious state (MCS). This pilot study investigates the effect of animal presence on frontal brain activity in MCS patients compared to healthy subjects. O; 2; HB, HHb and tHb of two MCS patients and two healthy adults was measured in frontal cortex using functional near-infrared spectroscopy during three sessions with a live animal and three sessions with a mechanical toy animal present. Each session had five phases: (1) baseline, (2) watching animal, (3) passive contact, (4) active contact, (5) neutral. Data were descriptively analysed. All participants showed the largest hemodynamic response during direct contact with the live or toy animal compared to "baseline" and "watching." During active contact, three of the four participants showed a stronger response when stroking the live compared to the toy animal. All participants showed an inverted signal with higher HHb than O; 2; Hb concentrations while stroking the live or toy animal. Animal contact leads to a neurovascular reaction in both MCS patients and healthy subjects, indicating elevated neural activity in the frontal cortex. We conclude that while a toy animal can elicit attention processes, active contact to a living animal is combined with emotional processes.

Background Theta burst stimulation (TBS), a patterned repetitive transcranial magnetic stimulation (rTMS) protocol with shorter simulation duration and lower stimulus intensity, could be a better protocol for individuals with autism spectrum disorder (ASD). Our study aimed to explore the impacts of intermittent TBS (iTBS) over the bilateral posterior superior temporal sulcus (pSTS) on intellectually able adults with ASD. Material and methods In this randomized, single-blinded, sham-controlled crossover trial, 13 adults with ASD completed iTBS for 5 consecutive days over the bilateral pSTS and inion (as a sham control) in a 16-weeks interval and in a randomly assigned order. The neuropsychological function was measured with the Wisconsin Card Sorting Test (WCST) for cognitive flexibility while the clinical outcomes were measured with both self-rate and parents-rate Autism Spectrum Quotient (AQ) before and after 5-day iTBS interventions. Results The results revealed significantly immediate effects of multi-session iTBS over the bilateral pSTS on parent-rate autistic symptoms in adults with ASD. The post-hoc analysis revealed the impacts of multi-session iTBS on cognitive flexibility were affected by baseline social-communicative impairment and baseline cognitive performance. Besides, the impacts of multi-session iTBS on clinical symptoms was affected by the concurrent psychotropic medication use and baseline autistic symptoms. Conclusions Given the caveat of the small sample size and discrepancy of multiple informants, this pilot study suggests the therapeutic potential of 5-day multi-session iTBS over the pSTS in adults with ASD. Individual factors modulating the response to rTMS should be explicitly considered in the future trial.

Objective The objective of the present study was to evaluate morphine consumption and pain scores 24 hours postoperatively to compare the effects of a bilateral pectointercostal fascial block (PIFB) with those of a transversus thoracic muscle plane block (TTMPB) on acute poststernotomy pain in cardiac surgery patients who have undergone median sternotomy. Design Prospective, randomized, double-blinded. Setting The operating room, intensive care unit, and patient ward at a university hospital. Participants Thirty-nine American Society of Anesthesiologists II-to-III patients aged 18- to-80 years, scheduled for elective cardiac surgery via median sternotomy. Interventions Patients randomly were allocated to groups scheduled to receive bilateral ultrasound–guided PIFB or TTMPB. Measurements and Main Results The primary outcome was postoperative morphine use within the first 24 hours. Secondary outcomes were the numerical pain rating scale (NRS) scores at rest and during coughing, time of first analgesic demand from the patient-controlled analgesia (PCA) device, and rescue analgesia use. The nausea/vomiting scores, time to extubation, length of stays in intensive care and the hospital, patient satisfaction scores, and complications were also recorded. The first 24-hour morphine use did not significantly differ between the PIFB and TTMPB groups (mean ± standard deviation [95% CI], 13.89 ± 6.80 [10.83-16.95] mg/24 h and 15.08 ± 7.42 [11.83-18.33] mg/24 h, respectively, p = 0.608). No significant difference between the two groups in the NRS scores at rest and during coughing was observed; the groups had similar requirements for rescue analgesia in the first 24 hours (n [%], three [15.8] and seven [35], p = 0.273, respectively). The time from PCA to the first analgesia request was longer in the PIFB than in the TTMPB group (median [interquartile range], 660 [540-900] minutes, and 240 [161-525] minutes, respectively, p = 0.002). Conclusions PIFB and TTMPB showed similar effectiveness for morphine consumption within 24 hours postoperatively and in pain scores in cardiac surgery patients.

Suicide is a considerable public health concern, particularly among U.S. veterans. Despite inpatient psychiatric hospitalization being a primary recommended treatment for acute suicidality, available inpatient group treatments remain limited. The current quality improvement project (QIP) aimed to examine the feasibility and acceptability of a newly developed single-session suicide-focused psychoeducation for veterans during psychiatric hospitalization. This project was conducted in two phases among veterans hospitalized for suicidal thoughts or behaviors. The first phase (

BACKGROUND: Functional stability of the shoulder requires a balance of active forces, passive forces, and control subsystems of the joint complex. Although whole-body vibration enhances shoulder muscle function and proprioception, the impact of vibration on the sensorimotor control of the shoulder joint remains unclear. OBJECTIVE: To investigate the acute effect of vibratory stimuli on the sensorimotor control of the shoulder joint. METHODS: Fifteen male participants (age, 22.7 ± 2.3 years) were included and performed the exercise in a modified push-up position with partial weight-bearing on a vibration platform with and without vibratory stimuli. The vibration protocol included six sets lasting for 30 s each with a 30-s rest between sets. The main outcome measures included the upper limb static stability test, Upper Quarter Y Balance Test (UQYBT), and electromyography data of the upper limb. RESULTS: Vibratory stimuli resulted in an increased UQYBT score (all directions; P< 0.01) and infraspinatus, serratus anterior, and lower trapezius muscle activity (P< 0.05) between pre- and post-exercise versus the control condition. Stabilometric parameters showed no significant interaction between condition and time. CONCLUSIONS: Vibratory stimuli could maximize training benefits while limiting injury risk for athletes. Our findings could guide the development of rehabilitation programs for patients with shoulder instability.

Background The thrice weekly dosing regimen of DOTS has shown low rifampicin plasma concentrations as an independent risk factor for unfavourable tuberculosis (TB) outcome. With introduction of daily regimen using fixed dose combinations (FDC) under National Tuberculosis Elimination Programme (NTEP) the existence of suboptimal plasma levels of first-line antitubercular drugs and its clinical significance remain poorly understood. Method We included a prospective cohort of newly diagnosed pulmonary tuberculosis (PTB) patients receiving 4-FDC daily regimen under NTEP. Plasma concentration at 2 hours (C2h) of each drug was determined after two weeks of treatment using liquid chromatography (LCMS/MS) developed by us. TB card and laboratory reports were reviewed for baseline characteristics and clinical status at 2, 4 and 6 months after the initiation of treatment. At a 1 year follow-up, therapy failure was defined as death or a relapse of tuberculosis. Results Among 40 PTB patients, the C2h post dose plasma concentrations of H, R and E were suboptimal in 25%, 60% and 10% respectively. The C2h of H, R, Z and E were respectively 4.2 ± 2.0, 7.3 ± 2.8, 39.2 ± 8.8 and 3.5 ± 1.2 μg/ml; 60% of the patients had suboptimal plasma concentrations and commonly it was observed with H and R. C2h were lower than expected for at least two drugs i.e. H and R in 25% (10/40) of the patients. Plasma concentration of isoniazid and rifampicin has always been considered important for microbiological response and treatment outcome and low concentrations has been associated with poor treatment response. These patients may require a two year follow up and critical evaluation for prevention of MDR-TB. However, all the TB patients were cured and none of them had recurrence within one year follow up. Conclusions All the pulmonary TB patients administering 4-FDC daily regimen under programmatic settings were cured despite the suboptimal levels of isoniaizd and rifampicin. All the patients achieved pyrazinamide plasma levels and probably this could be the reason behind favourable outcome. Further study is required on large sample size with various subset of population to understand the need of therapeutic drug monitoring.

Background The COVID-19 pandemic has caused changes that disrupted the status quo of society. As a result, the level of conflict in community pharmacy has increased significantly. With existing conflict research more focused on the management of conflict, it is important to direct attention towards understanding the nature of conflict. This understanding will allow for informed resources to be developed to guide practice, decreasing the occurrence of and negative effects of conflict. Objective This research explored experiences of pharmacists working in community pharmacies, to identify the occurrence and nature of conflicts which may have been motivated by changes resulting directly or indirectly from the COVID-19 pandemic, to provide directions for future research into the nature of conflict. Method Person-to-person semi-structured telephone interviews were conducted. Transcripts were analysed using inductive reasoning to identify themes. Results Thirteen pharmacists agreed to participate in this study and 9 were interviewed. Analysis revealed 7 themes that described the causes, contributors, management, outcome, and essence of experienced conflict. A model that incorporated existing theory and themes derived from this study was developed to facilitate understanding of the nature of conflict in community pharmacy during the COVID-19 pandemic. Conclusion Conflict in community pharmacy settings follows a defined model with multiple interrelated themes. Guidance from this model may assist pharmacists in reducing occurrences of dysfunctional conflicts during their practice.

Background : Non-routine events (NRE) are defined as any suboptimal occurrences in a process being measured in the opinion of the reporter and comes from the field of human factors engineering. These typically occur well up-stream of an adverse event and NRE measurement has not been applied to the complex context of neonatal surgery. We sought to apply this novel safety event measurement methodology to neonates in the NICU undergoing gastrostomy tube placement. Methods : A prospective pilot study was conducted between November 2016 and August 2020 in the Level IV NICU and the pediatric operating rooms of an urban academic children's hospital to determine the incidence, severity, impact, and contributory factors of clinician-reported non-routine events (NREs, i.e., deviations from optimal care) and 30-day NSQIP occurrences in neonates receiving a G-tube. Results : Clinicians reported at least one NRE in 32 of 36 (89%) G-tube cases, averaging 3.0 (Standard deviation: 2.5) NRE reports per case. NSQIP-P review identified 7 cases (19%) with NSQIP-P occurrences and each of these cases had multiple reported NREs. One case in which NREs were not reported was without NSQIP-P occurrences. The odds ratio of having a NSQIP-P occurrence with the presence of an NRE was 0.695 (95% CI 0.06 – 17.04). Conclusion : Despite being considered a "simple" operation, >80% of neonatal G-tube placement operations had at least one reported NRE by an operative team member. In this pilot study, NRE occurrence was not significantly associated with the subsequent reporting of an NSQIP-P occurrence. Understanding contributory factors of NREs that occur in neonatal surgery may promote surgical safety efforts and should be evaluated in larger and more diverse populations. Level of evidence : IV

Background Scientists have been facing numerous challenges in the development of an effective therapeutic strategy for the treatment of COVID-19 pneumonia. Several studies have suggested that improving patient immunity and reducing lung injury induced by SARS-CoV-2 may be effective for treating patients with COVID-19. Methods A pilot trial of nebulization therapy with exosomes of mesenchymal stem cells (MSCs) was performed on seven patients with COVID-19 pneumonia. Exosomes secreted from MSCs were collected and purified using multiple ultrafiltration steps. All patients were treated with nebulization of MSC-derived exosomes, and primary safety and efficacy outcomes were evaluated. Results Our clinical study demonstrated that nebulization of MSC-derived exosomes is a novel method that might be utilized in the treatment of COVID-19 pneumonia. Nebulization of MSC-derived exosomes did not induce acute allergic or secondary allergic reactions but did promote the absorption of pulmonary lesions and reduce the duration of hospitalization for mild cases of COVID-19 pneumonia. Conclusions Nebulization of MSC-derived exosomes is a safe, effective, and simple method, and their application at the beginning of treatment may be more beneficial. Trial Registration Chinese Clinical Trial Registry, ChiCTR2000030261. Registered on 26 February 2020. Graphical Abstract

Funding Information: Source(s) of financial support: The study was supported by State funding for University‐level health research (TYH 2013311, Y122417012, and Y102218018), the Signe and Ane Gyllenberg Foundation, the Emil Aaltonen Foundation, and the Finnish Medical Foundation. Funding Information: Eija Kalso has received personal fees for participation in advisory board meetings of Pfizer and Orion Pharma, unrelated to this work. Dr. Juhani Ojala reports grants from Suomen Lääketieteen säätiö, outside the submitted work. Dr. Jukka Vanhanen reports grants from The Emil Aaltonen Foundation, grants from State funding for university‐level health research, during the conduct of the study. Part of Dr. Mari A. Kaunisto's salary is covered by a large Finnish biobank study FinnGen, funded by 12 international pharmaceutical companies (Abbvie, AstraZeneca, Biogen, Celgene, Genentech, a member of the Roche Group, GSK, Janssen, Maze Therapeutics, Merck/MSD, Novartis, Pfizer, and Sanofi) and Business Finland. Pantelis Lioumis has been consulting Nexstim Ltd. for issues not related to this study, such as motor and speech functional mapping until 2016. Dr. Jukka Putaala reports personal fees from Boehringer‐Ingelheim, personal fees and other from Bayer, grants and personal fees from BMS‐Pfizer, grants and personal fees from Abbott/St. Jude Medical, other from Vital Signum, other from Nokia Technologies, other from Bittium, other from BcB Medical, personal fees from Portola, personal fees from Terve Media, grants from Business Finland, grants from Amgen, personal fees from Herantis Pharma, other from Medixine, outside the submitted work; and he has participated in the European Stroke Organisation's guideline working groups on 1) poststroke hyperglycemia and 2) secondary prevention in patients with AF. He also has participated in the Finnish Duodecim Society's guideline working group on Ischemic stroke and TIA. The remaining authors have no potential conflicts to disclose. Conflict of Interest: Publisher Copyright: ©2021 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals LLC on behalf of International Neuromodulation Society. Objectives: Central poststroke pain (CPSP), a neuropathic pain condition, is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) targeted to the primary motor cortex (M1) can alleviate the condition, but not all patients respond. We aimed to assess a promising alternative rTMS target, the secondary somatosensory cortex (S2), for CPSP treatment. Materials and Methods: This prospective, randomized, double-blind, Sham-controlled three-arm crossover trial assessed navigated rTMS (nrTMS) targeted to M1 and S2 (10 sessions, 5050 pulses per session at 10 Hz). Participants were evaluated for pain, depression, anxiety, health-related quality of life, upper limb function, and three plasticity-related gene polymorphisms including Dopamine D2 Receptor (DRD2). We monitored pain intensity and interference before and during stimulations, and at one month. A conditioned pain modulation test was performed using the cold pressor test. This assessed the efficacy of the descending inhibitory system, which maytransmit TMS effects in pain control. Results: We prescreened 73 patients, screened 29, and included 21, of whom 17 completed the trial. NrTMS targeted to S2 resulted in long-term (from baseline to one-month follow-up) pain intensity reduction of ≥30% in 18% (3/17) of participants. All stimulations showed a short-term effect on pain (17–20% pain relief), with no difference between M1, S2, or Sham stimulations, indicating a strong placebo effect. Only nrTMS targeted to S2 resulted in a significant long-term pain intensity reduction (15% pain relief). The cold pressor test reduced CPSP pain intensity significantly (p = 0.001), indicating functioning descending inhibitory controls. The homozygous DRD2 T/T genotype is associated with the M1 stimulation response. Conclusions: S2 is a promising nrTMS target in the treatment of CPSP. The DRD2 T/T genotype might be a biomarker for M1 nrTMS response, but this needs confirmation from a larger study.

Introduction: Gut-lymph in animal models of acute disease is altered by intestinal ischemia and contributes to the development of systemic inflammation and organ dysfunction. Investigating gut-lymp...

Background Restless legs syndrome (RLS), a neurological disorder, often affects sleep quality in hemodialysis patients. This study aimed to evaluate acupressure's effect on the severity of RLS symptoms and sleep quality in hemodialysis patients with RLS. Material and methods This study is a cluster-randomized crossover pilot study. Patients were randomized to two sequences: acupressure for one month and observation for another month (AC); and observation for one month and acupressure for another month (CA). For the four-week acupressure intervention, patients received 36 min of acupressure three times weekly during their hemodialysis sessions. The acupoints were on the bilateral lower limbs, including Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), Xuanzhong (GB39), Chengshan (BL57), and Taichong (LR3). RLS severity and sleep quality (measured with the Pittsburgh sleep quality index, PSQI) were measured at baseline, month 1, and month 2. Results AC sequence (n = 14) was similar to the CA sequence (n = 9) in terms of gender, age, education, employment, marital status, comorbid disease, BMI, duration of dialysis, medication for RLS and insomnia, RLS severity, and PSQI. The general linear mixed model revealed no significant carryover effect on RLS severity, PSQI, and the seven subscales of PSQI. A significant treatment effect (acupressure) was only observed in RLS severity (p = 0.0013) but not in PSQI and the seven subscales. The significant period effect was observed in RLS severity (p = 0.0250) and the subscale of sleep disturbance (p = 0.0021). Conclusion In hemodialysis patients with RLS, acupressure can alleviate the severity of RLS but cannot improve sleep quality.

BACKGROUND High levels of inflammation pre- and post-percutaneous coronary intervention (PCI) are associated with worse outcomes. Recent trials have suggested a benefit from treating inflammation with colchicine in coronary artery disease. In this randomised pilot COPE-PCI sub-study, we aimed to determine if administration of colchicine pre-PCI, would attenuate the inflammatory effect of PCI. METHODS PCI patients were randomised to colchicine or placebo, 6 to 24-hours pre-procedure. Study blood samples were taken immediately pre-PCI, and 24-hours post-procedure. Samples were tested for a broad array of inflammatory biomarkers including high-sensitive(hs)-CRP, leucocyte counts, and hs-troponin-. Periprocedural Myocardial Injury (PM-Injury) was defined as per the ESC Third Universal Definitions of Myocardial Infarction. RESULTS Thirty-six were randomised to colchicine and 39 to placebo. Treatment groups were similar for baseline variables. The median time from drug administration to pre-PCI blood sampling was 18-hours. Overall inflammation was low across the patient population, pre- & post-PCI hsCRP was

Background This study explores live and recorded music listening in the outpatient pain clinic. There is evidence demonstrating the effectiveness of live and recorded music in a hospital setting but a comparison study of this kind has yet to be conducted. Methods A multimethod survey study design was used. A questionnaire utilizing rating scales was self-administered across two outpatient pain clinic waiting rooms. Patients were included through convenience sampling. In one clinic, a playlist of recorded music curated by two of the authors was provided. In the second clinic, a music therapy student played live music using guitar, flute, and voice. The questionnaire gathered data on music's impact on pain and emotional states, as well as attitudes toward music in the waiting room. Quantitative data was analyzed using descriptive statistics and qualitative data, gathered in the questionnaires open ended question, was analyzed using thematic analysis. Results The questionnaire was completed by 200 adult patients. Patients reported lowered levels of anxiety, stress, and pain in both clinics, as well as a shorter waiting time and more caring experience. Patients in the live music clinic reported that music lowered levels of stress, nervousness, agitation, and pain more than in the recorded music clinic. Conclusions Participants in this study identified that music is a useful tool in the pain clinic waiting room. This study contributes to evidence that music should be considered as a complimentary treatment for people living with pain and in the wider hospital setting. Additional research is warranted with a control group, pre- and posttesting, and studies of music in hospitals in a range of cultural contexts.

Objective Immunizing pharmacists can administer vaccines; however, they are less likely to administer adolescent vaccines such as vaccines that protect against human papillomavirus (HPV). Although past research has recommended incorporating pharmacists to increase adolescent vaccination, few intervention studies have tested healthcare delivery models that incorporate pharmacists to aid in vaccine series completion. This research explored the feasibility and acceptability of an intervention in which pharmacists administered booster doses of the HPV vaccine series. Methods Between April 2019 and February 2020, the research team recruited participants for a pilot randomized controlled trial hosted in one federally qualified health center (FQHC) clinic. Researchers asked intervention group participants to complete the HPV vaccine series with their community pharmacists and control group participants to complete the series at their FQHC. We conducted a pre- and post-intervention surveys and in-depth interviews with both intervention and control group participants. Results A total of 33 parents of children who received the first dose of the HPV vaccine enrolled in the study of whom 8 intervention and 11 control group participants completed post-intervention data collection. Although there were no statistically significant changes in vaccine completion and in psychometric variables, we did find that pharmacist-delivered HPV vaccination was acceptable, due, primarily, to convenience. Barriers to receiving pharmacist-administered vaccines included pharmacies’ lack of stocking the vaccine and insurance-related barriers to care. Conclusion Although a promising and acceptable healthcare delivery approach, there are still barriers for caregivers to have their children vaccinated against HPV at their community pharmacies.

OBJECTIVE We examined users' preferences for and engagement with text messages delivered as part of an emergency department (ED)-based intervention to improve antihypertensive medication adherence. METHODS We recruited ED patients with elevated blood pressure for a pilot randomized trial evaluating a medication adherence intervention with text messages. Intervention participants chose text content and frequency, received texts for 45 days, and completed a feedback survey. We defined engagement via responses to texts. We examined participant characteristics associated with text preferences, engagement, and feedback. RESULTS Participants (N = 101) were 57% female and 46% non-White. Most participants (71%) chose to receive both reminder and informational texts; 94% chose reminder texts once per day and 97% chose informational texts three times per week. Median text message response rate was 56% (IQR 26-80%). Participants who were Black (p

Background Gait abnormalities from neuromuscular conditions like cerebral palsy (CP) limit mobility and negatively affect quality of life. Increasing walking speed and stride length are essential clinical goals in the treatment of gait disorders from CP. Research question. How does over-ground gait training with an untethered ankle exoskeleton providing adaptive assistance affect mobility-related spatiotemporal outcomes and lower-extremity muscle activity in people with CP? Methods A diverse cohort of individuals with CP (n = 6, age 9–31, Gross Motor Function Classification System Level I – III) completed four over-ground training sessions (98 ± 17 min of assisted walking) and received pre- and post-training assessments. On both assessments, participants walked over-ground with and without the exoskeleton while we recorded spatiotemporal outcomes and muscle activity. We used two-tailed paired t-tests to compare all parameters pre- and post-training, and between assisted and unassisted conditions. Results Following training, walking speed increased 0.24 m/s (p = 0.006) and stride length increased 0.17 m (p = 0.013) during unassisted walking, while walking speed increased 0.28 m/s (p = 0.023) and stride length increased 0.15 m (p = 0.002) during exoskeleton-assisted walking. Exoskeleton training improved stride-to-stride repeatability of soleus and vastus lateralis muscle activation by up to 51 % (p ≤ 0.046), while the amount of integrated stance-phase muscle activity was similar across visits and conditions. Relative to baseline, post-training walking with the exoskeleton resulted in a soleus activity pattern that was 39 % more similar to the typical pattern from unimpaired individuals (p Significance This study demonstrates acute spatiotemporal and neuromuscular benefits from over-ground training with adaptive ankle exoskeleton assistance, and provides rationale for completion of a longer randomized controlled training protocol.

Introduction Traditional liver transplant strategies with cold preservation usually result in ischemia reperfusion injury (IRI) to the donor liver. Regular normothermic machine perfusion (NMP) donor livers suffer IRI twice. Here, we aimed to introduce a novel technique called continuous normothermic machine perfusion (NMP) without recooling to avoid a second IRI and its application in livers from extended criteria donors (ECDs). Materials and methods Seven donor livers transplanted following continuous NMP without recooling, 7 donor livers transplanted following standard NMP and 14 livers under static cold storage (SCS) were included in this study. Perioperative outcomes were recorded and analyzed between groups. Result During the NMP without a recooling procedure, all livers cleared lactate quickly to normal levels in a median time of 100 minutes (IQR 60~180) and remained stable until the end of perfusion. In the NMP without recooling and standard NMP groups, posttransplant peak aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were both significantly lower than those in the SCS group (P=0.0015 and 0.016, respectively). The occurrence rate of early allograft dysfunction (EAD) was significantly lower in the NMP without recooling group than in the SCS group (P=0.022), while there was no difference in the NMP group with or without recooling (P=0.462). Conclusion Our pilot study revealed a novel technique designed to avoid secondary IRI. This novel technique is shown to have at least a comparable effect to the standard NMP, though more data are needed to show its superiority in the future.

OBJECTIVES A histopathological tumor thickness of ≥1000 μm has been reported as one of many risk factors for recurrent lymph node metastasis in superficial pharyngeal cancer (SPC). However, methods for assessing this risk factor preoperatively have not yet been established. Hence, the current study aimed to evaluate the efficacy of endoscopic ultrasonography (EUS) in measuring tumor thickness preoperatively in patients with SPC. METHODS This single-center retrospective study included 44 consecutive patients with 47 lesions who underwent endoscopic submucosal dissection (ESD). Prior to surgery, EUS examination was performed while under general anesthesia. Further, microvascular irregularity in the target lesion was evaluated using the Japan Esophageal Society (JES) magnification endoscopic classification system. RESULTS A significant correlation was noted between histopathological and EUS tumor thickness (Spearman's correlation r == 0.879, p

A better assessment of prostate cancer (PrCa) risk is needed to improve screening. The PROFILE pilot study explored the feasibility of single nucleotide polymorphism profiling in men with a family history (FH) of PrCa to investigate the probability of detecting PrCa at prostate biopsy (PB). The results of the present pilot study have demonstrated that PB is a feasible and safe method of PrCa screening in men with a FH., Background. A better assessment of individualized prostate cancer (PrCa) risk is needed to improve screening. The use of the prostate-specific antigen (PSA) level for screening in the general population has limitations and is not currently advocated. Approximately 100 common single nucleotide polymorphisms (SNPs) have been identified that are associated with the risk of developing PrCa. The PROFILE pilot study explored the feasibility of using SNP profiling in men with a family history (FH) of PrCa to investigate the probability of detecting PrCa at prostate biopsy (PB). The primary aim of this pilot study was to determine the safety and feasibility of PrCa screening using transrectal ultrasound-guided PB with or without diffusion-weighted magnetic resonance imaging (DW-MRI) in men with a FH. A secondary aim was to evaluate the potential use of SNP profiling as a screening tool in this population. Patients and Methods. A total of 100 men aged 40–69 years with a FH of PrCa underwent PB, regardless of their baseline PSA level. Polygenic risk scores (PRSs) were calculated for each participant using 71 common PrCa susceptibility alleles. We treated the disease outcome at PB as the outcome variable and evaluated its associations with the PRS, PSA level, and DW-MRI findings using univariate logistic regression. Results. Of the 100 men, 25 were diagnosed with PrCa, of whom 12 (48%) had clinically significant disease. Four adverse events occurred and no deaths. The PSA level and age at study entry were associated with PrCa at PB (p = .00037 and p = .00004, respectively). Conclusion. The results of the present pilot study have demonstrated that PB is a feasible and safe method of PrCa screening in men with a FH, with a high proportion of PrCa identified requiring radical treatment. It is feasible to collect data on PrCa-risk SNPs to evaluate their combined effect as a potential screening tool. A larger prospective study powered to detect statistical associations is in progress. Implications for Practice: Prostate biopsy is a feasible and safe approach to prostate cancer screening in men with a family history and detects a high proportion of prostate cancer that needs radical treatment. Calculating a polygenic risk score using prostate cancer risk single nucleotide polymorphisms could be a potential future screening tool for prostate cancer.

Gastrointestinal (GI) symptoms often affect children with autism spectrum disorders (ASD) and GI symptoms have been associated with an abnormal fecal microbiome. There is limited evidence of Candida species being more prevalent in children with ASD. We enrolled 20 children with ASD and GI symptoms (ASD + GI), 10 children with ASD but no GI symptoms (ASD - GI), and 20 from typically developing (TD) children in this pilot study. Fecal mycobiome taxa were analyzed by Internal Transcribed Spacer sequencing. GI symptoms (GI Severity Index [GSI]), behavioral symptoms (Social Responsiveness Scale -2 [SRS-2]), inflammation and fungal immunity (fecal calprotectin and serum dectin-1 [ELISA]) were evaluated. We observed no changes in the abundance of total fungal species (alpha diversity) between groups. Samples with identifiable Candida spp. were present in 4 of 19 (21%) ASD + GI, in 5 of 9 (56%) ASD - GI, and in 4 of 16 (25%) TD children (overall P = 0.18). The presence of Candida spp. did not correlate with behavioral or GI symptoms (P = 0.38, P = 0.5, respectively). Fecal calprotectin was normal in all but one child. Finally, there was no significance in serum dectin-1 levels, suggesting no increased fungal immunity in children with ASD. Our data suggest that fungi are present at normal levels in the stool of children with ASD and are not associated with gut inflammation.

Objective We conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD). Methods We recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms. Results Two out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm. Conclusions This pilot trial provides important guidance for developing a larger scale trial of a modified intervention. Practice implications Overall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.

Evaluators of examinees in forensic contexts must consider the potential for falsified or exaggerated psychiatric symptoms and/or cognitive deficits. A number of validated assessment tools assist evaluators in identifying those examinees who feign impairment; however, no comprehensive method has been established for consolidating data from multiple tests, interviews, behavioral observations, and collateral sources. The current pilot study preliminarily examined the interrater reliability and validity of a new forensic assessment tool, the Feigning Evaluation INtegrating Sources (FEINS), developed to guide evaluators in the comprehensive assessment of feigning by adding structure to the collection of relevant data. Fifty-eight male pretrial defendants undergoing restoration of competency to stand trial at a state forensic psychiatric center participated in the study. Results provided preliminary support for reliability in scoring the FEINS, construct validity, and predictive validity. FEINS items that assessed clinical presentation, and those that guided the use of test data, were more useful than items capturing historical/demographic data. Structured professional judgments developed using the FEINS appeared to be more accurate in predicting competency evaluators' perceptions of feigning than both unstructured clinical judgment (i.e., referring psychologist's perception of feigning) alone and test data alone, using hierarchical multiple regressions. Findings suggest that the FEINS may have practical utility in guiding clinical opinions regarding feigning across psychiatric, cognitive, and psycholegal/functional domains. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

BACKGROUND Dying concerns are thoughts expressed by a person diagnosed with a terminal illness or by an individual coping with the impending death of a loved one. Little is known about the dying concerns of parents with advanced cancer (PWACs) with dependent children, and even less is known about the dying concerns of the coparent. Understanding the PWACs' dying concerns for the coparent can contribute to the overall health of the family when faced with the death of a loved one. OBJECTIVE The aim of this pilot descriptive study was to explore the PWACs' perspective of their dying concerns for their coparent. METHODS Four PWACs were recruited from 2 oncology inpatient units from an urban community hospital within the same hospital system. Semistructured interviews were conducted, audio-recorded, and transcribed with 4 participants. Data analysis used directed content analysis. RESULTS Parents with advanced cancer expressed concern about the repercussions of advanced cancer on family cohesiveness. Three subthemes within this general structure were "My Weakest Link," "If I'm Not There, Where Do They Go?" and "Putting Up a Front." CONCLUSIONS Parents with advanced cancer have concerns beyond their role as a parent could make a difference in the overall health of the PWACs, but also the family unit. The PWACs' concerns are present but may be covered over by use of protective mechanisms to maintain family cohesiveness. IMPLICATIONS FOR PRACTICE Understanding dying concerns may enhance nurse-initiated communications between family members and healthcare providers to improve psychological distress and enhance family functioning.

Background The effects of integrated yoga programs on mental health outcomes in inflammatory bowel disease (IBD) have not been well explored. To explore the acceptability, implementation and effectiveness of an integrated eight-week yoga program plus aromatherapy massage in patients with IBD. Methods Nine participants with documented IBD were recruited from a gastroenterology clinic in Calgary, Alberta, Canada to participate in an integrated yoga program weekly for eight weeks with outcomes assessed at baseline and week 8. Primary outcomes were assessed using Theory of Planned Behaviour as a guiding theory to identify salient beliefs from qualitative analysis of a semi-structured interview, survey items measuring the strength of beliefs and a daily log was used to capture adherence and adverse events. Secondary outcomes were collected using validated survey tools examining anxiety, depression, stress, sleep quality, and physical and mental quality of life. Results Attitude, subjective norm and perceived behavioral control beliefs pertinent to the yoga intervention and daily practice were identified. Participants reported feeling the intervention was very helpful; however, felt guilt about not completing daily practices which decreased confidence and intention to continue with the practice. An average of 55.6% of in-person sessions were attended and decreased over time. Participants practiced on average of 5.4 days per week. Depression and mental health scores improved at week 8 from baseline. Conclusions We were able to identify key salient beliefs of IBD patients in regard to an integrated yoga plus aromatherapy massage intervention. This intervention appears to be acceptable and further research should explore its potential to improve mental and physical health outcomes including IBD symptoms.

No scholar has explored whether immunosuppressive treatments at different histopathological stages are different for idiopathic membranous nephropathy (IMN).From January 1, 2012, to January 1, 2018, all biopsy confirmed IMN cases treated with glucocorticoid (GC) plus cyclophosphamide (CTX) or GC were retrieved from the patients' medical records.The present study included 67 patients who received GC alone (31 with stage I, 30 with stage II and 6 with stage III) and 157 patients who received GC + CTX (77 with stage I, 66 with stage II and 14 with stage III). Primary efficacy assessments included achieving complete remission and remission. Secondary efficacy assessments included proteinuria, serum albumin and adverse events. GC + CTX group showed higher complete remission rates than the GC group after 6 and 12 months in patients with stage II IMN (22% vs 10%, P = 0.04 and 59% vs 17%, P 0.001, respectively). However, the two groups showed no difference in stages I and III (29% vs 26%, P = 0.61, 71% vs 52%, P = 0.09 and 14% vs 17%, P = 0.81, 21% vs 17%, P = 0.88, respectively). The GC + CTX group suffered a higher rate of gastrointestinal symptoms than the GC group in stage I and a higher rate of abnormal liver function in stage II.Treatment with GC + CTX was more effective than GC in treating patients with stage II IMN; however, the advantage of GC + CTX was not significant for patients with stage I and III IMN.

Current methods of evaluating essential tremor (ET) either rely on subjective ratings or use limited tremor metrics (i.e., severity/amplitude and frequency). In this study, we explored performance metrics from Fitts law tasks that replicate and expand existing tremor metrics, to enable low-cost, home-based tremor quantification and analyze the cursor movements of individuals using a 3D mouse while performing a collection of drawing tasks. We analyzed the 3D mouse cursor movements of 11 patients with ET and three controls, on three computer-based tasksa spiral navigation (SPN) task, a rectangular track navigation (RTN) task, and multi-directional tapping/clicking (MDT)with several performance metrics (i.e., outside area (OA), throughput (TP in Fitts law), path efficiency (PE), and completion time (CT)). Using an accelerometer and scores from the Essential Tremor Rating Assessment Scale (TETRAS), we correlated the proposed performance metrics with the baseline tremor metrics and found that the OA of the SPN and RTN tasks were strongly correlated with baseline tremor severity (R2=0.57 and R2=0.83). We also found that the TP in the MDT tasks were strongly correlated with tremor frequency (R2=0.70). In addition, as the OA of the SPN and RTN tasks was correlated with tremor severity and frequency, it may represent an independent metric that increases the dimensionality of the characterization of an individuals tremor. Thus, this pilot study of the analysis of those with ET-associated tremor performing Fitts law tasks demonstrates the feasibility of introducing a new tremor metric that can be expanded for repeatable multi-dimensional data analyses.

Insomnia is highly prevalent among military veterans but access to cognitive behavioral therapy for insomnia (CBT-I) is limited. Thus, this study examined the feasibility, acceptability, and potential efficacy of Insomnia Coach, a CBT-I-based, free, self-management mobile app. Fifty U.S. veterans, who were mostly male (58%) and mean age 44.5 (range = 28 to 55) years with moderate insomnia symptoms were randomized to Insomnia Coach (n = 25) or a waitlist control condition (n = 25) for 6 weeks. Participants completed self-report measures and sleep diaries at baseline, post-treatment, and follow-up (12 weeks post-randomization), and app participants (n = 15) completed a qualitative interview at post-treatment. Findings suggest that Insomnia Coach is feasible to use, with three-quarters of participants using the app through 6 weeks and engaging with active elements. For acceptability, perceptions of Insomnia Coach were very favorable based on both self-report and qualitative interview responses. Finally, for potential efficacy, at post-treatment, a larger proportion of Insomnia Coach (28%) than waitlist control participants (4%) achieved clinically significant improvement (p = .049) and there was a significant treatment effect on daytime sleep-related impairment (d = -0.6, p = .044). Additional treatment effects emerged at follow-up for insomnia severity (d = -1.1, p = .001), sleep onset latency (d = -0.6, p = .021), global sleep quality (d = -0.9, p = .002), and depression symptoms (d = -0.8, p =.012). These findings provide preliminary evidence that among veterans with moderate insomnia symptoms a CBT-I-based self-management app is feasible, acceptable, and promising for improving insomnia severity and other sleep-related outcomes. Given the vast unmet need for insomnia treatment in the population, Insomnia Coach may provide an easily accessible, convenient public health intervention for individuals not receiving care.

To assess intervention feasibility and acceptability, and compare the effectiveness of the CHOICES Decision Aid (DA) versus the National Cancer Institute (NCI) Cancer Clinical Trials (CCT) website to improve knowledge about CCTs and preparedness to make an informed decision.Oncology patients (n = 101) with a scheduled clinic visit were enrolled and randomized. Decision-making variables were collected at two timepoints. Post-intervention scores were examined via paired t-tests and multivariate regression analyses. Predictors of the magnitudes of the change in scores were examined in multivariable regression analyses.The interventions were feasible to implement and acceptable to participants. Both interventions increased objective and subjective knowledge, improved clarity of opinions, and reduced decisional conflict (p-values 0.01). Improvements in the belief that one could find out about CCTs were observed in the CHOICES DA arm (p 0.001). Multivariable analyses controlling for educational attainment showed no significant differences in the magnitude of change in outcome variables between intervention arms, but did find that improvements in some variables in the NCI arm - but not CHOICES DA arm - were associated with previous educational attainment.Interventions were feasible to implement and acceptable. Improvements in knowledge and decision-making outcomes were observed in both arms, supporting the view that interventions to improve CCT decision making are effective and feasible. Our results suggest that the CHOICES DA may be more effective than an informational website in improving decision-making outcomes regardless of participants' educational attainment.CCT resources should support informed decision-making among all cancer survivors, regardless of educational attainment.

Background Previous studies suggest that PAP-based CF protocols are suitable for newborn screening (NBS) for cystic fibrosis (CF) when newborns designated as CFSPID should not be detected. However, there are still discussions about the performance of IRT/PAP algorithms. We present the final results of a pilot study evaluating a IRT/PAP protocol with an IRT-dependent safety net (SN) conducted from 2008 to 2016 in southwestern Germany on nearly 500,000 newborns. Methods To achieve reliable data, all newborns were screened using both the PAP-based and a DNA-based CFNBS algorithm. PAP quantification and genetic analysis of the four most common CFTR mutations in Germany were performed in all newborns with IRT≥99.0 percentile. NBS was rated positive if either PAP was ≥1.6 µg/l and/or at least one CFTR mutation was detected. In addition, an IRT-dependent SN resulted in positive rating for both protocols if IRT was ≥99.9 percentile. To evaluate the IRT/PAP protocol, its performance was compared to that of the IRT/DNA protocol. Results The IRT/PAP protocol with IRT-based SN used in the study achieved a sensitivity of 94%, if false-negative detected neonates with meconium ileus and those designated as CFSPID were excluded from analysis. CF/CFSPID ratio was 92. However, PPV of the IRT/PAP+SN protocol was with 10.3% very low. Conclusions PAP-based CFNBS protocols can be used, if less detection of CFSPID is desired. The IRT/PAP protocol with IRT-dependent SN evaluated here achieved adequate sensitivity but should probably be used in combination with a third-tier test to also achieve an acceptable PPV.

BACKGROUND Transcutaneous auricular vagus nerve stimulation (taVNS) may modulate cardiac autonomic function. However, the response rate of the traditional tonic paradigm is low, and the results remain inconsistent. A recent pilot study presented a novel burst paradigm to activate the cardiac parasympathetic system, which might offer a new approach to treat cardiac autonomic function. The present study reassessed the effect of burst taVNS on modulating heart rate variability and explored the difference between burst and traditional tonic paradigms. MATERIALS AND METHODS Forty-two young adults were recruited for this study. Each participant underwent three types of taVNS with sham (30 sec of stimulation), tonic (25 Hz, 500 μsec), and burst (five pulses at 500 Hz every 200 msec) paradigms, respectively, with simultaneous electrocardiogram recording. One-way analysis of variance, multivariate analysis of variance, and linear regression were used for analysis. Multiple testing was performed using Bonferroni correction. RESULTS Both burst and tonic paradigms induced a significant decrease in heart rate, which continued until poststimulation, and increased cardiac parasympathetic activity. Moreover, two parasympathetic system indicators showed significant increase only in burst taVNS. The response rates during burst (35.7%) and tonic (38.1%) stimulations were both higher than that during sham stimulation (11.9%). The response to taVNS showed parameter specificity with few nonresponders to the tonic paradigm responding to the burst paradigm. The overall response rate increased from 38.1% in tonic taVNS to 54.8% in taVNS using both burst and tonic paradigms. For both burst and tonic responders, baseline cardiac parasympathetic activity was found to be significantly negatively correlated with changes during stimulation. CONCLUSION The burst parameter could be used as an alternative strategy for regulating cardiac parasympathetic function by taVNS, which has the potential to be used as a complementary paradigm to traditional tonic taVNS for promoting clinical treatment efficacy.

Aim: To report the experience of chronic pain participants after a well-formulated ketogenic diet (WFKD) or whole-food diet (WFD). The quantitative outcomes for this trial have been published separately (clinical trial registration number ACTRN12620000946910). Patients & methods: The experience of 24 participants was evaluated after 12 and 24 weeks of dietary intervention using survey responses and open questions. Results & conclusion: Retention rates for the WFKD and WFD groups were 93 and 89%, respectively. Average adherence to the WFKD was 82% and to the WFD was 87%. The WFKD enjoyment was rated at 66 and 81% for the WFD group. The ease of adhering to the diet varied more widely for the WFKD group. Barriers included knowledge integration, time management, navigating social food environments and emotional attachment to eliminated foods. Facilitators included structured support and coaching, and comprehensive learning materials. The WFKD was shown to be a feasible and effective treatment option for chronic pain.

Objectives To examine the feasibility of performing ASL-MRI in paediatric patients with solid abdominal tumours. Methods Multi-delay ASL data sets were acquired in ten paediatric patients diagnosed with either a neuroblastoma (n = 4) or nephroblastoma (n = 6) during a diagnostic MRI examination at a single visit (n = 4 at initial staging, n = 2 neuroblastoma and n = 2 nephroblastoma patients; n = 6 during follow-up, n = 2 neuroblastoma and n = 4 nephroblastoma patients). Visual evaluation and region-of-interest (ROI) analyses were performed on the processed perfusion-weighted images to assess ASL perfusion signal dynamics in the whole tumour, contralateral kidney, and tumour sub-regions with/without contrast enhancement. Results The majority of the included abdominal tumours presented with relatively low perfusion-weighted signal (PWS), especially compared with the highly perfused kidneys. Within the tumours, regions with high PWS were observed which, at short PLD, are possibly related to labelled blood inside vessels and at long PLD, reflect labelled blood accumulating inside tumour tissue over time. Conversely, comparison of ASL perfusion-weighted image findings with T1w enhancement after contrast administration showed that regions lacking contrast enhancement also were void of PWS. Discussion This pilot study demonstrates the feasibility of utilizing ASL-MRI in paediatric patients with solid abdominal tumours and provides a basis for further research on non-invasive perfusion measurements in this study population.

A diagnosis of lymphedema comes with a lifetime requirement for careful self-care and treatment to control skin deterioration and the consequences of excessive fluid and protein buildup leading to abnormal limb volume and an increased risk of infection. The burden of care and psychosocial aspects of physical disfiguration and loss of function are associated with compromised quality of life (QoL). The current standard therapeutic intervention is complex decongestive therapy with manual lymph drainage and frequent wearing of compression garments. With insurance limitations on therapy visits and the time and travel required, additional home treatment options are needed. Pneumatic compression pumps that mimic the manual massage pressure and pattern are sometimes prescribed, but these are bulky, difficult to apply, and require immobility during treatment. An open-label pilot study in 40 subjects was performed to evaluate the QoL and limb volume maintenance efficacy of a novel wearable compression system (Dayspring™) that is low profile, easy to use, and allows for mobility during treatment. After 28 days of use, subjects had a statistically significant 18% (

Background: Sexual functions in women with lymphedema secondary to breast cancer surgery have not been investigated sufficiently. This study aimed to compare patients with and without lymphedema af...

Objective To address healthcare inequities, diversifying the physician workforce is an important step, and improved efforts to recruit Underrepresented in Medicine (URiM) students is vital. We aim to examine the current state of minority recruitment and provide solutions to increase diversity in urology residency training. Methods We conducted a retrospective analysis of self-reported race and ethnicity data for active urology trainees using the Data Resource Book by the Accreditation Council of Graduate Medical Education from 2011 to 2020. We also performed a longitudinal analysis comparing the number of urology applicants to urology trainees from 2016 to 2020 using the Electronic Residency Application Service statistics database. URiMs were designated in alignment with ACGME definitions. Categorical variables were summarized as frequencies and percentages and compared using chi-squared test between race and ethnicity. Results We identified 11,458 active urology trainees for analysis. Of these, 6638 (57.9%) identified as White, 1690 (14.7%) as Asian/Pacific Islander, 442 (3.9%) as Hispanic, 380 (3.3%) as Black, 11 (0.1%) as Native American, 608 (5.3%) as other race/ethnicity, and 1689 (14.7%) as unknown race or ethnicity. In 2011, 8.1% of trainees identified as URiM which remains the same at 8.2% in 2020. Conclusion As we strive to improve patient care and support our URiM colleagues, diversity, equity, and inclusion must be prioritized. Despite increases in students entering medical school and the expansion of urology training spots, the numbers of URiM in urologic training remain stubbornly unchanged. This work highlights an area of residency training that requires critical transformation.

Objective To evaluate the gustatory function before and after vestibular schwannoma (VS) surgery. Methods In this retrospective study, we evaluated the gustatory function of 12 patients who underwent VS surgery at Tsukuba University Hospital between 2012 and 2018. Gustatory function was examined using electrogustometry before VS surgery and 3 months, 6 months and 1 year after surgery. Electrogustometry was tested at the area mapped to the chorda tympani nerve, glossopharyngeal nerve and greater superficial petrosal nerve (GSPN). Intergroup mean comparisons of the threshold were performed using a one-way analysis of variance (ANOVA) followed by the Bonferroni post-hoc test. Results The gustatory function mapped to the chorda tympani nerve was significantly disturbed 6 months after the surgery as compared with the preoperative function (p = 0.033) and that the dysfunction recovered at 1 year. However, gustatory function mapped to the glossopharyngeal nerve and greater superficial petrosal nerve (GSPN) was not impaired. Conclusion The gustatory function mapped to the chorda tympani nerve is impaired after surgery for VS. The dysfunction peaked at 6 months after surgery, and recovered within 1 year.

Background: Mindfulness meditation has been shown to alleviate pain and may be an appealing adjunctive pain management option. Objective: To compare measures of pain, mindfulness, and opioid usage, and collect evaluative feedback among patients undergoing septorhinoplasty with and without guided meditation. Methods: Patients undergoing septorhinoplasty were randomized to online-guided meditation postoperative days 0-3 versus standard care; all received the same pain medications. Primary outcome measures included pain intensity, opioid consumption, mindfulness scores, and evaluative feedback. Results: Twenty-one patients received guided meditation and 24 received standard care. No significant difference in opioid consumption or pain scores was seen with the exception of higher opioid use in patients with intranasal splints in the standard care group. Twenty out of 21 patients provided evaluative feedback; all recommended mindfulness meditation to friends undergoing nasal surgery, 90% reported it was beneficial, 85% believed it eased pain/discomfort, and 80% believed it aided with sleep. Conclusion: Although no objective difference was found in opioid consumption or pain scores, most patients reported that guided mindfulness meditation was beneficial to their recovery following septorhinoplasty.

Objective Arthritis is a common condition, which frequently involves the hands. Patients with inflammatory arthritis have been shown to experience significant delays in diagnosis. We sought to develop and test a screening tool combining an image of a patient's hands, a short series of questions, and a single examination technique, to determine the most likely diagnosis in a patient presenting with hand arthritis. Machine learning techniques were used to develop separate algorithms for each component, which were combined to produce a diagnosis. Methods 280 consecutive new patients presenting to a Rheumatology practice with hand arthritis were enrolled. Each patient completed a 9-part questionnaire, had photographs taken of each hand, and had a single examination result recorded. The Rheumatologist diagnosis was recorded following a 45-minute consultation. The photograph algorithm was developed from 1000 previous hand images, and machine learning techniques were applied to the questionnaire results, training several models against the diagnosis from the Rheumatologist. Results The combined algorithms in this study were able to predict inflammatory arthritis with an accuracy, precision, recall and specificity of 96·8%, 97·2%, 98·6% and 90·5% respectively. Similar results were found when inflammatory arthritis was subclassified into rheumatoid arthritis and psoriatic arthritis. The corresponding figures for osteoarthritis were 79·6%, 85·9%, 61·9% and 92·6%. Conclusion This study demonstrates a novel application combining image-processing and a patient questionnaire with applied machine-learning methods, to facilitate the diagnosis of patients presenting with hand arthritis. Preliminary results are encouraging for the application of such techniques in clinical practice. This article is protected by copyright. All rights reserved.

BACKGROUND: Critically ill patients commonly suffer from infections that require antimicrobial therapy. In previous studies, liver dysfunction was shown to have an essential impact on the dose selection in these patients. This pilot study aims to assess the influence of liver dysfunction, measured by the novel LiMAx test, on clinical outcomes in critically ill patients treated with linezolid. METHODS: Twenty-nine critically ill patients were included and treated with linezolid. Indications for linezolid therapy were secondary or tertiary peritonitis (46.7%), bloodstream infection (6.7%) and 46.7% were other infections with gram-positive bacteria. Linezolid Cmin, maximal liver function capacity (LiMAx test) and plasma samples were collected while linezolid therapy was in a steady-state condition. Furthermore, potential factors for the clinical outcome were investigated using logistic regression analysis. Clinical cure was defined as the resolution or significant improvement of clinical symptoms without using additional antibiotic therapy or intervention. RESULTS: Cured patients presented lower median linezolid Cmin yet a significantly higher mean LiMAx-value compared to the clinical failure group (1.9 mg/L vs. 5.1 mg/L) (349 μg/kg/h vs. 131 μg/kg/h). In the logistic regression model, LiMAx < 178 μg/kg/h was the only independent predictor of clinical failure with a sensitivity of 77% and specificity of 93%. CONCLUSIONS: The LiMAx test predicts clinical failure more precisely than linezolid trough levels in critically ill surgical patients. Therefore liver failure may have a stronger impact on the outcome of critically ill surgical patients than low linezolid Cmin. While linezolid Cmin failed to predict patient’s outcome, LiMAx results were the only independent predictor of clinical failure.

Summary Background WHO recently approved a partially effective vaccine that reduces clinical malaria in children, but increased vaccine activity is required to pursue malaria elimination. A phase 1 clinical trial was done in Mali, west Africa, to assess the safety, immunogenicity, and protective efficacy of a three-dose regimen of Plasmodium falciparum sporozoite (PfSPZ) Vaccine (a metabolically active, non-replicating, whole malaria sporozoite vaccine) against homologous controlled human malaria infection (CHMI) and natural P falciparum infection. Methods We recruited healthy non-pregnant adults aged 18–50 years in Doneguebougou, Mali, and surrounding villages (Banambani, Toubana, Torodo, Sirababougou, Zorokoro) for an open-label, dose-escalation pilot study and, thereafter, a randomised, double-blind, placebo-controlled main trial. Pilot study participants were enrolled on an as-available basis to one group of CHMI infectivity controls and three staggered vaccine groups receiving: one dose of 4·5 × 105, one dose of 9 × 105, or three doses of 1·8 × 106 PfSPZ via direct venous inoculation at approximately 8 week intervals, followed by homologous CHMI 5 weeks later with infectious PfSPZ by direct venous inoculation (PfSPZ Challenge). Main cohort participants were stratified by village and randomly assigned (1:1) to receive three doses of 1·8 × 106 PfSPZ or normal saline at 1, 13, and 19 week intervals using permuted block design by the study statistician. The primary outcome was safety and tolerability of at least one vaccine dose; the secondary outcome was vaccine efficacy against homologous PfSPZ CHMI (pilot study) or against naturally transmitted P falciparum infection (main study) measured by thick blood smear. Combined artesunate and amodiaquine was administered to eliminate pre-existing parasitaemia. Outcomes were analysed by modified intention to treat (mITT; including all participants who received at least one dose of investigational product; safety and vaccine efficacy) and per protocol (vaccine efficacy). This trial is registered with ClinicalTrials.gov , number NCT02627456 . Findings Between Dec 20, 2015, and April 30, 2016, we enrolled 56 participants into the pilot study (five received the 4·5 × 105 dose, five received 9 × 105, 30 received 1·8 × 106, 15 were CHMI controls, and one withdrew before vaccination) and 120 participants into the main study cohort with 60 participants assigned PfSPZ Vaccine and 60 placebo in the main study. Adverse events and laboratory abnormalities post-vaccination in all dosing groups were few, mainly mild, and did not differ significantly between vaccine groups (all p>0·05). Unexpected severe transaminitis occured in four participants: one participant in pilot phase that received 1·8 × 106 PfSPZ Vaccine, one participant in main phase that received 1·8 × 106 PfSPZ Vaccine, and two participants in the main phase placebo group. During PfSPZ CHMI, approximately 5 weeks after the third dose of 1·8 × 106 PfSPZ, none of 29 vaccinees and one of 15 controls became positive on thick blood smear; subsequent post-hoc PCR analysis for submicroscopic blood stage infections detected P falciparum parasites in none of the 29 vaccine recipients and eight of 15 controls during CHMI. In the main trial, 32 (58%) of 55 vaccine recipients and 42 (78%) of 54 controls became positive on thick blood smear during 24-week surveillance after vaccination. Vaccine efficacy (1–hazard ratio) was 0·51 per protocol (95% CI 0·20–0·70; log-rank p=0·0042) and 0·39 by mITT (0·04–0·62; p=0·033); vaccine efficacy (1–risk ratio) was 0·24 per-protocol (0·02–0·41; p=0·031) and 0·22 mITT (0·01–0·39; p=0·041). Interpretation A three-dose regimen of PfSPZ Vaccine was safe, well tolerated, and conferred 51% vaccine efficacy against intense natural P falciparum transmission, similar to 52% vaccine efficacy reported for a five-dose regimen in a previous trial. Funding US National Institute of Allergy and Infectious Diseases, National Institutes of Health, Sanaria. Translation For the French translation of the abstract see Supplementary Materials section.

BACKGROUND Cardiotoxicity after cancer treatment is a potentially preventable life-threatening complication among women with breast cancer. There is no algorithm to identify women with breast cancer at risk of cardiotoxicity. OBJECTIVES We quantified signs and symptoms as well as selected laboratory values among women with breast cancer who developed cardiotoxicity. METHODS The clinical characteristics (n = 15) were collected from electronic health records. Spearman correlation coefficients and a nonparametric statistical test were used to analyze data. RESULTS Significant statistical differences were detected in the laboratory values comparing the first and second half of 6 months before cardiotoxicity including alanine aminotransferase (U/L) (30.67 ± 26.27 and 42.31 ± 35.65, respectively; P = .03, Cohen's d = 0.37). A negative correlation was found between estimated glomerular filtration rate and new onset of more than 1 sign or symptom (Spearman's ρ = -0.5, P = .06). CONCLUSIONS Investigating clinical characteristics before cardiotoxicity may determine the mechanism(s) and identify high-risk patients.