bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinicopathologic correlations of superficial esophageal adenocarcinoma in endoscopic submucosal dissection specimens
Authors: Dhingra Sadhna , Bahdi Firas , May Sarah B. , Othman Mohamed O.
Published: November 2021

Background

Endoscopic submucosal dissection (ESD) is a novel endoscopic treatment for early esophageal adenocarcinoma (EAC). The western pathologists’ experience with ESD specimens remains limited. This study aimed to correlate histopathologic features of Barrett’s esophagus (BE)-associated adenocarcinoma in ESD resections with clinical outcomes to determine whether they aid future management decisions.

Methods

We retrospectively evaluated 49 consecutive ESD resection specimens from 42 patients with BE-associated adenocarcinoma (24 intramucosal and 18 submucosal EAC) at a single tertiary referral center. Pathologic evaluation included presence of dysplasia, invasive adenocarcinoma, peritumoral inflammation, desmoplasia, lymphovascular and perineural invasion; tumor differentiation, depth of invasion, morphology, and budding; and margin status for dysplasia or carcinoma. Follow up data included endoscopic biopsies in 35 patients and pathology reports of esophagectomies in 11 patients. Poor outcomes were defined as recurrence or residual invasive adenocarcinoma at esophagectomy, metastasis on imaging, or R1 resection in patients undergoing ESD for tumor debulking.

Results

Two patients (8%) with intramucosal adenocarcinoma and 9 patients (50%) with submucosal adenocarcinoma had poor outcomes. Histopathologic features associated with poor outcomes included poor differentiation, lymphovascular invasion, submucosal invasion > 500 μm, tumor budding, and tubuloinfiltrative histologic pattern. Four patients had positive deep margin away from the deepest tumor invasion and did not show residual tumor on follow up.

Conclusions

Our results validated European Society of Gastroenterology (ESGE) guidelines of high-risk pathologic features for additional therapy in esophageal adenocarcinoma and identified tumor budding frequently in association with other high-risk features. Positive deep margin distant from deepest tumor invasion could be procedural and warrants endoscopic correlation for management.
Positive breastfeeding experiences and facilitators in mothers of preterm and low birthweight infants: a meta-ethnographic review
Authors: Flacking Renée , Tandberg Bente Silnes , Niela-Vilén Hannakaisa , Jónsdóttir Rakel B. , Jonas Wibke , Ewald Uwe , Thomson Gill
Published: November 2021

Background

Most qualitative research on breastfeeding the preterm or low-birthweight (LBW) infant has focused on negative insights; there are no comprehensive insights into how, when and why mothers experience positive breastfeeding experiences. We aimed to address this knowledge gap by exploring what characterizes and facilitates a positive breastfeeding experience in mothers of preterm and/or LBW infants.

Methods

A systematic review using meta-ethnographic methods was conducted. Search strategies involved a comprehensive search strategy on six bibliographic databases, citation tracking and reference checking. The analysis involved a reciprocal level of translation and a line of argument synthesis.

Results

Searches identified 1774 hits and 17 articles from 14 studies were included, representing the views of 697 mothers. A positive breastfeeding experience was identified as being ‘attuned’. Three themes and eight sub-themes were developed to describe what characterizes attuned breastfeeding. ‘Trusting the body and what it can do’, concerned how attuned breastfeeding was facilitated through understanding the bodily responses and capacity and feeling comfortable with holding the infant and to breastfeed. ‘Being emotionally present – in the here and now’ described the importance of feeling relaxed and reassured. ‘Experiencing mutual positive responses’, illuminated how attunement was related to feelings of mutuality - when the mother recognises the infant’s cues, responds to these signals and receives a positive response from the infant. The key factors to facilitate attuned breastfeeding were opportunities for prolonged close physical contact with the infant, positive relationships with and support from staff and peers, and being facilitated to breastfeed when the infant showed feeding cues.

Conclusions

This study provides new insights into what characterizes a positive breastfeeding experience and how staff can facilitate and enable mothers to achieve attuned breastfeeding. Improvements in units’ design, such as for rooming-in and having prolonged skin-to-skin contact, and care provided by knowledgeable, supportive and encouraging staff and peers, are crucial. The mother’s physical and emotional states and the infant’s behavioural responses and physiological signals should guide the process towards positive breastfeeding practices.
Selectively recommend 18F-FDG PET/CT for patients with de novo nasopharyngeal carcinoma in endemic areas
Authors: Chen Chuanben , Xu Ting , Qiu Xiufang , Xie Shihan , You Ziqing , Hu Yixin , Zheng Yinghong , Liang Zewei , Huang Chaoxiong , Chen Taojun , Li Li , Liu Jing , Fei Zhaodong
Published: November 2021

Introduction

To identify the subset of patients with de novo nasopharyngeal carcinoma (NPC) for whom [18F] fluorodeoxyglucose positron emission tomography and computed tomography (18F-FDG PET/CT) should be recommended, and to determine whether PET/CT is a cost-effective decision for precise M staging in endemic areas.

Materials and methods

Retrospective analysis of data of 4469 patients diagnosed with de novo NPC between January 2014 and December 2019. The detection rate of distant metastasis was compared between different groups. Univariate and multiple logistic regression analysis was applied to identify the risk factors for distant metastasis. The cost-effectiveness of the diagnostic strategies was assessed.

Results

The detection rate of distant metastasis in the whole cohort was 5.46%. In multivariate analysis, male sex, T3-4 stage, N2-3 stage, and high plasma Epstein-Barr virus (EBV) DNA (≥ 14,650 copies/mL) were risk factors for distant metastases. NPC patients with T3-4 stage combined with N2-3 stage, high EBV DNA combined with male sex, or N2-3 stage combined with high EBV DNA were defined as recommended group with relatively higher tendency for metastasis. Distant metastasis incidence in recommended group and unrecommended group were 10.25% and 1.75%, respectively (P < 0.001). In the recommended group, PET/CT significantly improved the detection rate of distant metastasis (13.25% vs 9.02%, P = 0.005). Cost-effectiveness analysis revealed that additional cost for every one percent increase in distant metastasis detection rate was $22,785.58 in the recommended group (< Willingness-to-pay (WTP) threshold of $32,700.00) and $310,912.90 in the unrecommended group.

Conclusions

In patients with de novo NPC, the tendency for metastasis can be predicted based on clinical parameters. 18F-FDG PET/CT should be selectively recommended for the subset of patients with a relatively higher tendency for metastasis.
Lumbar degenerative disease treated by percutaneous endoscopic transforaminal lumbar interbody fusion or minimally invasive surgery-transforaminal lumbar interbody fusion: a case-matched comparative study
Authors: Xue You-Di , Diao Wen-Bo , Ma Chao , Li Jie
Published: November 2021

Purpose

This study aimed to evaluate the clinical efficacy and imaging results of percutaneous endoscopic transforaminal lumbar interbody fusion (PETLIF) through comparing it with minimally invasive surgery-transforaminal lumbar interbody fusion (MISTLIF).

Materials and methods

We performed a retrospective analysis on patients with lumbar degenerative disease treated by PETLIF or MISTLIF from September 2017 to January 2019, and the patients were divided into two groups: the PETLIF group and the MISTLIF group. The clinical and imaging parameters of the two groups were evaluated.

Results

There was no significant difference between the two groups in complication rate. The operative time in the PETLIF group was significantly less than that in the MISTLIF group. Compared with those before operation, the postoperative VAS-L and VAS-B scores were significantly improved after operation in the both groups. In addition, the postoperative VAS-B score of the PETLIF group was significantly lower than that of the MISTLIF group. At the last follow-up, there was no significant difference between the two groups in the VAS-L score, VAS-B score, ODI score, and bony fusion rate.

Conclusions

Both PETLIF and MISTLIF could achieve satisfactory clinical outcomes in the treatment of lumbar degenerative disease, but our study suggested that PETLIF had less damage, rapid recovery after operation, and short discharge time.
Application of an adjusted patient blood management protocol in patients undergoing elective total hip arthroplasty: towards a zero-percent transfusion rate in renal patients—results from an observational cohort study
Authors: Hourlier Hervé , Fennema Peter
Published: November 2021

Background

Renal patients are at high risk of blood transfusion following major orthopaedic surgery. A variety of patient blood management (PBM) policies have been proposed to reduce the rate of transfusions. The aim of this observational study was to assess the performance of an adjusted PBM protocol in patients with chronic kidney disease (CKD) undergoing elective total hip arthroplasty (THA).

Methods

A total of 1191 consecutive patients underwent elective unilateral THA and took part in an adjusted PBM protocol. The PBM protocol consisted of epoetin (EPO) alfa therapy prescribed by the surgeon, routine administration of tranexamic acid (TXA), an avascular approach to the hip and postoperative prophylaxis of thromboembolism. The performance of this PBM protocol was analysed in patients with a glomerular filtration rate (GFR) below or above 60 ml/min/1.73 m2at baseline. Haemoglobin levels were controlled at admission, on postoperative day (POD) 1 and on POD 7 ± 1. A bleeding index (BI) was used as a proxy for blood loss.

Results

In total, 153 patients (12.9%) presented with a modification of diet in renal disease value below 60 at baseline. Of these, 20 (13.1%) received EPO therapy and 120 (78.4%) received TXA. None of the patients received allogenic blood transfusions during the first perioperative week. The mean BI for the entire study population was 2.7 (95% CI 2.6, 2.8). CKD did not exert a significant impact on the BI (p = 0.287). However, it was found that both TXA and EPO therapy significantly lowered the BI (difference, − 0.3,p < 0.001). There were no thromboembolic complications in renal patients who received TXA and/or EPO therapy.

Conclusions

A zero-percent transfusion rate during the first perioperative week is attainable in patients with stage 3 or stage 4 CKD undergoing contemporary elective THA. With the use of a pragmatic blood-sparing protocol, patients with renal dysfunction did not have an increased risk of bleeding and did not have an increased incidence in the rate of perioperative blood transfusions.
A case report of fractured guidewire removal by rotational atherectomy
Authors: Wang Xu , Ye Jian , Gao Jun-Qing , Liu Zong-Jun
Published: November 2021

Background

Fractures occur in association with manipulation and because of the complexity of the coronary artery, and they can cause a series of serious complications, such as myocardial infarction and secondary thrombosis. Common treatments for fractured guidewires include conservative, interventional and surgical methods.

Case presentations

A 67-year-old male was admitted to our institute. He had recurrent chest tightness and chest pain for half a month, which worsened in one day. He was diagnosed with acute non-ST-segment elevation myocardial infarction. Guidewire fracture was caused by improper manipulation during percutaneous coronary intervention. We successfully performed rotational atherectomy to remove the fractured guidewire. His symptoms, and condition improved 6 weeks after the removal of fractured guidewire.

Conclusion

Physicians should have higher requirements for the quality of the guidewires and operation techniques.
Low frequency of HPV positivity in breast tumors among patients from south-central Poland
Authors: Biesaga Beata , Janecka-Widła Anna , Kołodziej-Rzepa Marta , Mucha-Małecka Anna , Słonina Dorota , Ziobro Marek , Wysocka Joanna , Adamczyk Agnieszka , Majchrzyk Kaja , Niemiec Joanna , Ambicka Aleksandra , Grela-Wojewoda Aleksandra , Harazin-Lechowska Agnieszka
Published: November 2021

Background

Some studies suggest that Human Papilloma Virus (HPV) infection is important factor in carcinogenesis of breast tumors. This study’ objective was to analyze HPV prevalence in breast cancers of patients from south-central Poland.

Materials and methods

The study was performed based on archival paraffin embebbed and formalin fixed blocks in the group of 383 patients with breast cancer. HPV prevalence and its genotype were assessed, respectively by: nested PCR (with two groups of primers: PGMY09/PGMY11 and GP5+/GP6+), quantitative PCR (qPCR). Tumors were classified as HPV positive in case of at least one positive result in nested PCR and positive results in genotyping procedure. For all HPV positive tissues P16 immunostaining was applied in order to confirm active viral infection.

Results

In the group of 383 breast cancers, HPV positivity was found in 17 samples (4.4%) in nested PCR. All these samples were subjected to HPV genotyping. This analysis revealed presence of HPV type 16 into two tumors (0.5%). In these two cancers, P16 overexpression was reported.

Conclusion

In breast tumors of patients from south-central Poland in Poland, HPV positivity is demonstrated in very low percentage of cases.
Antinociceptive and analgesic effect of continuous intravenous infusion of maropitant, lidocaine and ketamine alone or in combination in cats undergoing ovariohysterectomy
Authors: Corrêa Janaina Maria Xavier , Niella Raquel Vieira , Oliveira Jéssica Natália Silva de , Silva Junior Alex Costa , Marques Claire Souza da Costa , Pinto Taísa Miranda , Silva Elisângela Barboza da , Beier Suzane Lilian , Silva Fabiana Lessa , Lavor Mário Sérgio Lima de
Published: November 2021

Background

Multimodal analgesia consists of the combination of analgesic drugs at low doses to act in different places along the path of pain. Studies with continuous infusion of analgesic drugs in cats are not common. This study aimed to evaluate the analgesic effect of maropitant, lidocaine and ketamine alone or in combination (intravenous bolus + subsequent continuous intravenous infusion) in the management of acute postoperative pain in cats undergoing ovariohysterectomy. Seventy healthy cats undergoing an ovariohysterectomy received a standard anesthetic protocol consisting of acepromazine and morphine, propofol (anesthesia induction), and isoflurane (anesthesia maintenance). The animals were stratified into seven groups (n = 10 in each group): control (CG), maropitant (MG), lidocaine (LG), ketamine (KG), maropitant + lidocaine (LMG), maropitant + ketamine (KMG), and maropitant + lidocaine + ketamine (LKMG). All drugs were injected first as an intravenous bolus and then by continuous intravenous infusion. During surgery, esophageal temperature, respiratory rate, heart rate, oxygen saturation, expired isoflurane concentration, and partial pressure of carbon dioxide at the end of expiration were evaluated at 7 time points. Postoperative pain was evaluated for 6 h after extubation using the visual analogue scale and the UNESP-Botucatu multidimensional composite pain scale for assessing postoperative pain in cats.

Results

Adverse effects related to maropitant, lidocaine and ketamine infusion were not observed. Pain scores were lower in the MG, KG and LG groups when compared to the CG group using both scales. Although pain scores were also lower in all combination groups than CG, more animals in these groups required rescue analgesia compared to MG. This indicates that the postoperative analgesic effect of all drugs, either alone or in combination, confers analgesia, although the combinations did not promote greater analgesia.

Conclusions

Continuous intravenous infusion of maropitant, lidocaine, and ketamine alone induces postoperative analgesic effect in cats undergoing ovariohysterectomy, but combinations of these drugs did not increase the analgesic effect. No adverse effect was observed with any drug or their combination.
Reversible infertility in male dog following prolonged treatment of Malassezia dermatitis with ketoconazole
Authors: Domosławska Anna , Zduńczyk Sławomir
Published: November 2021

Background

Ketoconazole, an antifungal agent, adversely affects spermatogenesis in rodents, but knowledge on adverse effects of prolonged administration of ketoconazole on the fertility of male dogs is lacking. A case of reversible infertility with azoospermia in a male American Staffordshire terrier treated with ketoconazole is reported here.

Case presentation

A seven-year old male American Staffordshire terrier treated for 3 months with ketoconazole for a persistentMalasseziadermatitis displayed reduced libido and mating of 3 bitches had been unsuccessful. The dog was presented at the clinic 40 days after the treatment had been stopped.At first presentation, low libido and complete absence of sperm in the ejaculate (azoospermia) associated with low testosterone level were found. Repeated examinations revealed that sperm quality and testosterone level had restored 100 days after ketoconazole had been withdrawn. Thereafter, the dog successfully mated 2 bitches.

Conclusion

The treatment with ketoconazole for 3 months may have led to reversible infertility characterized by azoospermia. Therefore, owners of stud dogs should be informed of this risk prior to initiating such treatment and in case of infertility, previous treatment with ketoconazole should be considered as a possible cause.
Effects of short-term existential group therapy for breast Cancer patients
Authors: Nakamura Chizu , Kawase Masatoshi
Published: November 2021

Objectives

Cancer patients who suffer from existential difficulties, including fear of death, isolation, or loss of human relationships, try to accept these fears by exploring the meaning of their life. In particular, early psychological intervention for patients prevents them from psychosocial maladjustment afterwards. Therefore, we have developed the Short-term Existential Group Therapy Program (Short-term EGP) for cancer patients, focusing on relief of existential or spiritual suffering and/or pain. This study aims to statistically evaluate the effects of this program on breast cancer patients within the first year after cancer diagnosis.

Methods

Thirty-one patients completed our research program. A ninety-minute therapeutic group session was held once a week for 5 weeks. We performed the above assessments three times: just before and after the intervention, as well as a month after the end of intervention. Outcome assessment included measures of spiritual well-being (SELT-M), Mental Adjustment to Cancer (MAC) and Profile of Mood States (POMS).

Results

The SELT-M “Overall QOL” scores were significantly increased after intervention, and these scores were maintained a month after intervention, particularly in those with high MAC “Hopelessness” scores. Subscales of the SELT-M scores were significantly increased after intervention, and these scores were maintained up to a month after intervention.

Conclusion

Short-term EGP intervention could be effective in helping patients relieve their existential distress. Some of the treatment effects were maintained a month after the end of the intervention. In addition, Short-term EGP could be particularly effective for those patients who feel hopelessness after cancer diagnosis.

Trial registration

Retrospectively registered. University Hospital Medical Information Network (UMIN CTR) UMIN000040651. Registered June 4, 2020.
Cognitive behavioral treatment for irritable bowel syndrome: a recent literature review
Authors: Sugaya Nagisa , Shirotsuki Kentaro , Nakao Mutsuhiro
Published: November 2021

Irritable bowel syndrome (IBS) is a gastrointestinal psychosomatic disorder that often develops and worsens with stress. Hence, it is important to treat it from both, its physical and mental aspects. We reviewed recent research on cognitive-behavioral therapy (CBT)—one of the most widely studied psychological treatments for IBS—since it focuses on addressing the cognitions and behaviors associated with IBS symptoms, and combines diverse content, such as cognitive techniques, exposure, stress management, and mindfulness, whose effects have been widely studied. Research on CBT for IBS varies not only in terms of content of the interventions, but also in terms of implementation (individual or group, face-to-face or online). Internet-delivered CBT has recently shown the possibility of providing more accessible and cost-effective psychological intervention to IBS patients in formats, other than face-to-face. In recent years, many standardized scales that allow for IBS-specific psychological assessments have been used in clinical studies of CBT for IBS. Tools that competently deliver effective interventions and properly measure their effectiveness are expected to spread to many people suffering from IBS.
Nutritional iodine status and obesity
Authors: Moleti Mariacarla , Di Mauro Maria , Paola Giuseppe , Olivieri Antonella , Vermiglio Francesco
Published: November 2021

Iodine is an essential component of the thyroid hormones, thyroxine and triiodothyronine. Its availability strictly depends on iodine content of foods, which may vary from very low to very high. Inadequate iodine intake (deficiency or excess) may affect thyroid function resulting in hypothyroidism or hyperthyroidism. Based on median urinary iodine concentrations, epidemiological criteria have been established for the categorization and monitoring of nutritional iodine status of a population (or subgroups of populations). Additional methods for iodine intake assessment include measurement of thyroid size (by thyroid palpation or ultrasonography) and of biochemical parameters, such as neonatal thyroid stimulating hormone, thyroglobulin and thyroid hormones.

Recent studies carried out in overweight/obese children and adults provide evidence that body mass index (BMI) may significantly influence the above indicators, thus theoretically affecting the epidemiological evaluation of nutritional iodine status in populations.

In this short review, we analyze current knowledge on the effects of overweight and obesity on indicators of adequacy and monitoring of iodine status, namely urinary iodine excretion and thyroid volume and echogenicity.

Data on urinary iodine excretion in overweight/obese children are divergent, as both increased and reduced levels have been reported in overweight/obese children compared to normal-weight controls.

Whether gastrointestinal surgery may affect iodine absorption and lead to iodine deficiency in patients undergoing bariatric surgery has been evaluated in a limited number of studies, which excluded iodine deficiency, thus suggesting that supplements usually recommended after bariatric surgery do not need to include iodine.

Albeit limited, evidence on thyroid volume and obesity is consistent with a direct relationship between thyroid volume and BMI, irrespective of nutritional iodine status. Finally, a higher frequency of thyroid hypoechoic pattern has been described in overweight/obese children. This finding has been recently related to an increased adipocyte infiltration and thyroid parenchyma imbibition mediated by inflammatory cytokines and should be considered when the frequency of thyroid hypoechoic pattern is used as non-invasive marker to indirectly assess thyroid autoimmunity in monitoring Universal Salt Iodization programs. Further studies, specifically addressing the role of schoolchildren body mass index as a factor potentially influencing iodine intake indicators are needed.
Quantitative multiparametric MRI predicts response to neoadjuvant therapy in the community setting
Authors: Virostko John , Sorace Anna G. , Slavkova Kalina P. , Kazerouni Anum S. , Jarrett Angela M. , DiCarlo Julie C. , Woodard Stefanie , Avery Sarah , Goodgame Boone , Patt Debra , Yankeelov Thomas E.
Published: November 2021

Background

The purpose of this study was to determine whether advanced quantitative magnetic resonance imaging (MRI) can be deployed outside of large, research-oriented academic hospitals and into community care settings to predict eventual pathological complete response (pCR) to neoadjuvant therapy (NAT) in patients with locally advanced breast cancer.

Methods

Patients with stage II/III breast cancer (N = 28) were enrolled in a multicenter study performed in community radiology settings. Dynamic contrast-enhanced (DCE) and diffusion-weighted (DW)-MRI data were acquired at four time points during the course of NAT. Estimates of the vascular perfusion and permeability, as assessed by the volume transfer rate (Ktrans) using the Patlak model, were generated from the DCE-MRI data while estimates of cell density, as assessed by the apparent diffusion coefficient (ADC), were calculated from DW-MRI data. Tumor volume was calculated using semi-automatic segmentation and combined with Ktrans and ADC to yield bulk tumor blood flow and cellularity, respectively. The percent change in quantitative parameters at each MRI scan was calculated and compared to pathological response at the time of surgery. The predictive accuracy of each MRI parameter at different time points was quantified using receiver operating characteristic curves.

Results

Tumor size and quantitative MRI parameters were similar at baseline between groups that achieved pCR (n = 8) and those that did not (n = 20). Patients achieving a pCR had a larger decline in volume and cellularity than those who did not achieve pCR after one cycle of NAT (p < 0.05). At the third and fourth MRI, changes in tumor volume, Ktrans, ADC, cellularity, and bulk tumor flow from baseline (pre-treatment) were all significantly greater (p < 0.05) in the cohort who achieved pCR compared to those patients with non-pCR.

Conclusions

Quantitative analysis of DCE-MRI and DW-MRI can be implemented in the community care setting to accurately predict the response of breast cancer to NAT. Dissemination of quantitative MRI into the community setting allows for the incorporation of these parameters into the standard of care and increases the number of clinical community sites able to participate in novel drug trials that require quantitative MRI.
The effect of twice-weekly versus once-weekly sessions of either imagery rescripting or eye movement desensitization and reprocessing for adults with PTSD from childhood trauma (IREM-Freq): a study protocol for an international randomized clinical trial
Authors: Wibbelink Carlijn J. M. , Lee Christopher W. , Bachrach Nathan , Dominguez Sarah K. , Ehring Thomas , van Es Saskia M. , Fassbinder Eva , Köhne Sandra , Mascini Magda , Meewisse Marie-Louise , Menninga Simone , Morina Nexhmedin , Rameckers Sophie A. , Thomaes Kathleen , Walton Carla J. , Wigard Ingrid G. , Arntz Arnoud
Published: November 2021

Background

Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few trials have investigated the effect of session frequency. The present study’s aim is to compare treatment outcomes of twice-weekly versus once-weekly sessions of two treatments for PTSD related to childhood trauma, imagery rescripting (ImRs) and eye movement desensitization and reprocessing (EMDR). We hypothesize that both treatments will be more effective when delivered twice than once a week. How session frequency impacts treatment response, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for whom will also be investigated.

Methods

The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, Germany, and the Netherlands. We aim to recruit 220 participants, who will be randomized to one of four conditions: (1) EMDR once a week, (2) EMDR twice a week, (3) ImRs once a week, or (4) ImRs twice a week. Treatment consists of 12 sessions. Data are collected at baseline until one-year follow-up. The primary outcome measure is clinician-rated PTSD symptom severity. Secondary outcome measures include self-reported PTSD symptom severity, complex PTSD symptoms, trauma-related cognitions and emotions, depressive symptoms, dissociation, quality of life, and functioning. Process measures include memory, learning, therapeutic alliance, motivation, reluctance, and avoidance. Additional investigations will focus on predictors of treatment outcome and PTSD severity, change mechanisms of EMDR and ImRs, the role of emotions, cognitions, and memory, the optimization of treatment selection, learned helplessness, perspectives of patients and therapists, the network structure of PTSD symptoms, and sudden treatment gains.

Discussion

This study will extend our knowledge on trauma-focused treatments for PTSD related to childhood trauma and, more specifically, the importance of session frequency. More insight into the optimal session frequency could lead to improved treatment outcomes and less dropout, and in turn, to a reduction of healthcare costs. Moreover, the additional investigations will broaden our understanding of how the treatments work and variables that affect treatment outcome.

Trial registration

Netherlands Trial Register NL6965, registered 25/04/2018.
Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
Authors: Ku Yong Ho , Lee Hyun , Ryu Hwa Yeon , Kang Jae Hui
Published: November 2021

Background

As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured from the PL KCTC0399BP strain, can increase immune function, as measured using blood-test indicators. This clinical trial protocol is designed as the main trial and is based on the results of a pilot study.

Methods

This clinical trial is a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants are enrolled and randomly divided into two groups: the experimental group (PL 1000 mg) and the control group (placebo). Participants are administered with experimental food or placebo for eight weeks. Blood tests are performed before trial initiation and 8 weeks later, at trial completion. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis dataset to statistically analyze the effectiveness of the treatment.

Discussion

This study evaluates the effects of PL extract on immune function and will contribute to knowledge on the value of PL as an immune-function–boosting functional food.

Trial registration

Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460. Registered on 12 October 2020
The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
Authors: Léger Maxime , Pessiot-Royer Solène , Perrault Tristan , Parot-Schinkel Elsa , Costerousse Fabienne , Rineau Emmanuel , Lasocki Sigismond
Published: November 2021

Background

Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries.

Methods

The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview.

Discussion

This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life.

Trial registration

ClinicalTrials.gov NCT04797312. Registered on 15 March 2021
Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
Authors: Fu Qinwei , Xie Hui , Zhou Li , Li Xinrong , Liu Yang , Liu Min , Wang Chaoyu , Wang Xiaocen , Wang Zhiqiao , Tang Jinfan , Xiao Huan , Xiao Zhiyong , Zhou Jing , Feng Chengzhi , Wang Li , Ao Zhimin , Chen Xi , Su Chang , Wu Xuanyu , Zhao Maolan , Hu Sihan , Lin Hanwen , Huang Jiali , Xu Guo , Zhang Qinxiu , Jiang Luyun
Published: November 2021

Background

Some pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the efficacy of auricular acupressure (AA) therapy in preventing and relieving AEFI after injection of COVID-19 vaccine.

Methods

The study design is a randomized, multicentre, three-arm controlled, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled and assigned in the medical institutions randomly for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group, and wait-list group. Interventions will be performed immediately and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline and 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%.

Discussion

Results of this trial will help to clarify the value of auricular acupressure therapy in preventing and relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine.

Trial registration

China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210). Registered on 8 February, 2021.
The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
Authors: Giordano Nicholas A. , Seilern und Aspang Jesse , Baker J‘Lynn , Rice Cammie Wolf , Barrell Bailey , Kirk Lauren , Ortega Erika , Wallace Michelle , Steck Alaina , Schenker Mara L.
Published: November 2021

Background

Orthopedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed little emphasis on individualized risk assessments for misuse and systematically implementing non-pharmacologic pain management strategies. Therefore, a community-academic partnership was formed to design a novel position in the healthcare field (Life Care Specialist (LCS)), who will educate patients on the risks of opioids, tapering usage, safe disposal practices, and harm reduction strategies. In addition, the LCS teaches patients behavior-based strategies for pain management, utilizing well-described techniques for coping and resilience. This study aims to determine the effects of LCS intervention on opioid utilization, pain control, and patient satisfaction in the aftermath of orthopedic trauma.

Methods

In total, 200 orthopedic trauma patients will be randomized to receive an intervention (LCS) or a standard-of-care control at an urban level 1 trauma center. All patients will be assessed with comprehensive social determinants of health and substance use surveys immediately after surgery (baseline). Follow-up assessments will be performed at 2, 6, and 12 weeks postoperatively, and will include pain medication utilization (morphine milligram equivalents), pain scores, and other substance use. In addition, overall patient wellness will be evaluated with objective actigraphy measures and patient-reported outcomes. Finally, a survey of patient understanding of risks of opioid use and misuse will be collected, to assess the influence of LCS opioid education.

Discussion

There is limited data on the role of individualized, multimodal, non-pharmacologic, behavioral-based pain management intervention in opioid-related risk-mitigation in high-risk populations, including the orthopedic trauma patients. The findings from this randomized controlled trial will provide scientific and clinical evidence on the efficacy and feasibility of the LCS intervention. Moreover, the final aim will provide early evidence into which patients benefit most from LCS intervention.

Trial registration

ClinicalTrials.govNCT04154384. Registered on 11/6/2019 (last updated on 6/10/2021).
Valorization of Chinese hickory shell as novel sources for the efficient production of xylooligosaccharides
Authors: Wang Zhi-Kun , Huang Caoxing , Zhong Jun-Lei , Wang Yi , Tang Lv , Li Bing , Sheng Jian-Jun , Chen Liang , Sun Shaolong , Shen XiaoJun
Published: November 2021

Chinese hickory shell, a by-product of the food industry, is still not utilized and urgent to develop sustainable technologies for its valorization. This research focuses on the systematical evaluation of degraded products and xylooligosaccharide production with high yield from the shell via hydrothermal process. The pretreatment was carried out in a bath pressurized reactor at 140–220 °C for 0.5–2 h. The results indicated that the pretreatment condition strongly affected the chemical structures and compositions of the liquid fraction. The maximum yield of XOS (55.3 wt%) with limitation of by-products formation was achieved at 160 °C for 2 h. High temperature (220 °C) and short time (0.5 h) contributed to hydrolysis of xylooligosaccharide with high DP to yield 37.5 wt% xylooligosaccharide with DP from 2 to 6. Xylooligosaccharide obtained mainly consisted of xylan with branches according to the HSQC NMR analysis. Overall, the production of XOS with a high yield from food waste will facilitate the valorization of food waste in the biorefinery industry.

Graphical Abstract
Efficient lactic acid production from dilute acid-pretreated lignocellulosic biomass by a synthetic consortium of engineered Pseudomonas putida and Bacillus coagulans
Authors: Zou Lihua , Ouyang Shuiping , Hu Yueli , Zheng Zhaojuan , Ouyang Jia
Published: November 2021

Background

Lignocellulosic biomass is an attractive and sustainable alternative to petroleum-based feedstock for the production of a range of biochemicals, and pretreatment is generally regarded as indispensable for its biorefinery. However, various inhibitors that severely hinder the growth and fermentation of microorganisms are inevitably produced during the pretreatment of lignocellulose. Presently, there are few reports on a single microorganism that can detoxify or tolerate toxic mixtures of pretreated lignocellulose hydrolysate while effectively transforming sugar components into valuable compounds. Alternatively, microbial coculture provides a simpler and more efficacious way to realize this goal by distributing metabolic functions among different specialized strains.

Results

In this study, a novel synthetic microbial consortium, which is composed of a responsible for detoxification bacterium engineered Pseudomonas putida KT2440 and a lactic acid production specialist Bacillus coagulans NL01, was developed to directly produce lactic acid from highly toxic lignocellulosic hydrolysate. The engineered P. putida with deletion of the sugar metabolism pathway was unable to consume the major fermentable sugars of lignocellulosic hydrolysate but exhibited great tolerance to 10 g/L sodium acetate, 5 g/L levulinic acid, 10 mM furfural and HMF as well as 2 g/L monophenol compound. In addition, the engineered strain rapidly removed diverse inhibitors of real hydrolysate. The degradation rate of organic acids (acetate, levulinic acid) and the conversion rate of furan aldehyde were both 100%, and the removal rate of most monoaromatic compounds remained at approximately 90%. With detoxification using engineered P. putida for 24 h, the 30% (v/v) hydrolysate was fermented to 35.8 g/L lactic acid by B. coagulans with a lactic acid yield of 0.8 g/g total sugars. Compared with that of the single culture of B. coagulans without lactic acid production, the fermentation performance of microbial coculture was significantly improved.

Conclusions

The microbial coculture system constructed in this study demonstrated the strong potential of the process for the biosynthesis of valuable products from lignocellulosic hydrolysates containing high concentrations of complex inhibitors by specifically recruiting consortia of robust microorganisms with desirable characteristics and also provided a feasible and attractive method for the bioconversion of lignocellulosic biomass to other value-added biochemicals.
Bacterial composition of midgut and entire body of laboratory colonies of Aedes aegypti and Aedes albopictus from Southern China
Authors: Lin Datao , Zheng Xiaoying , Sanogo Benjamin , Ding Tao , Sun Xi , Wu Zhongdao
Published: November 2021

Background

Aedes aegypti and Aedes albopictus are invasive mosquito species and significantly impact human health in southern China. Microbiota are confirmed to affect the development and immunity of mosquitoes. However, scientists have focused more on midgut microbiota of female mosquitoes and bacterial differences between female and male Aedes mosquitoes. The relationship between the midgut and entire body microbiota of Aedes is unclear. In this study, we collected mosquito samples reared under the same laboratory conditions and compared the microbial composition of midgut and entire bodies of Aedes aegypti and Aedes albopictus using 16S rRNA gene sequencing.

Methods

In this study, we collected mosquito samples reared under the same laboratory conditions and compared the microbial composition of midgut and entire bodies of Aedes aegypti and Aedes albopictus using 16S rRNA gene sequencing.

Results

A total of 341 OTUs were identified, showing that Proteobacteria was the dominant phylum and Methylobacterium the dominant genus in both Aedes aegypti and Aedes albopictus. The bacterial diversity and community structures of the entire bodies were similar between males and females in both Aedes aegypti and Aedes albopictus. Conversely, the bacterial compositions of male and female Aedes aegypti and Aedes albopictus were significantly different. NMDS analysis, UPGMA analysis, diversity indices and OTU distribution demonstrated that compositions and structures in midgut microbiota were similar but significantly different in the entire bodies of Aedes aegypti and Aedes albopictus. Functional prediction analysis showed that metabolism and environmental information processing were the dominant KEGG pathways at level 1. Our study showed that there were significantly different level 2 and 3 KEGG pathways in the midgut microbiota (16 level 2 and 24 level 3) and the entire bodies (33 level 2 and 248 level 3) between female Aedes albopictus and Aedes Aegypti.

Conclusions

Our findings that Aedes aegypti and Aedes albopictus reared in the same laboratory harbor a similar gut bacterial microbiome but different entire body microbiota imply that the gut microbiota of adult mosquitoes is environmentally determined regardless of the host genotype, but the entire body microbiota is more genetically determined. Our findings improved the understanding of the microbiota in the entire and partial tissues of Aedes mosquitoes.

Graphical abstract
Molecular and MALDI-TOF MS identification of swallow bugs Cimex hirundinis (Heteroptera: Cimicidae) and endosymbionts in France
Authors: Hamlili Fatima Zohra , Bérenger Jean-Michel , Diarra Adama Zan , Parola Philippe
Published: November 2021

Background

The Cimicidae are obligatory blood-feeding ectoparasites of medical and veterinary importance. We aim in the current study to assess the ability of MALDI-TOF MS to identifyCimex hirundinisswallow bugs collected in house martin nests.

Methods

Swallow bugs were picked out from abandoned nests of house martin swallows and identified morphologically to the species level. The bugs were randomly selected, dissected and then subjected to MALDI-TOF MS and molecular analyses.

Results

A total of 65 adults and 50 nymphs were used in the attempt to determine whether this tool could identify the bug species and discriminate their developmental stages. Five adults and four nymphs ofC. hirundinisspecimens were molecularly identified to update our MS homemade arthropod database. BLAST analysis ofCOIgene sequences from theseC. hirundinisrevealed 98.66–99.12% identity with the corresponding sequences ofC. hirundinisof the GenBank. The blind test against the database supplemented with MS reference spectra showed 100% (57/57)C. hirundinisadults and 100% (46/46)C. hirundinisnymphs were reliably identified and in agreement with morphological identification with logarithmic score values between 1.922 and 2.665. Ninety-nine percent ofC. hirundinisspecimens tested were positive forWolbachiaspp. The sequencing results revealed that they were identical toWolbachia massiliensis, belonging to the new T-supergroup strain and previously isolated fromC. hemipterus.

Conclusions

We report for the first time to our knowledge a case of human infestation by swallow bugs (C. hirundinis) in France. We also show the usefulness of MALDI-TOF MS in the rapid identification ofC. hirundinisspecimens and nymphs with minimal sample requirements. We phylogenetically characterized the novelWolbachiastrain (W. massiliensis) infectingC. hirundinisand compared it to other recognizedWolbachiaclades.

Graphical Abstract