Comparison of Aesthetic and Functional Rhinoplasty Outcomes Between Patients with Body Dysmorphic Disorder and Normal Individuals.

BACKGROUND: Rhinoplasty is among the top five most popular cosmetic surgical procedures worldwide. Among rhinoplasty candidates, the most common mental health disorder is body dysmorphic disorder. (BDD). The present study aimed to assess the prevalence of BDD among rhinoplasty candidates, its association with the patient's self-assessment of aesthetic outcome and nasal functional, post-rhinoplasty compared to applicants with negative screening for BDD. METHODS: The following study is a cross-sectional, comparative study. Out of the 209 rhinoplasty candidates screened by the BDDQ questionnaire, 39 were positive for BDD. From the remaining 170 patients who screened negative for BDD, 39 participants were randomly selected as the control group for the comparative analysis. Rhinoplasty outcome evaluation (ROE) and standardized cosmesis and health nasal outcomes survey-cosmetic (SCHNOS-C) questionnaires were used for assessment of patient satisfaction with the cosmetic outcome of rhinoplasty. Nasal obstruction symptom evaluation (NOSE) and standardized cosmesis and health nasal outcomes survey-obstruction (SCHNOS-O) were used for the assessment of satisfaction with functional outcomes between groups of patients screened positive and negative for BDD. RESULTS: The prevalence of BDD was 18.66% among rhinoplasty candidates. The average age of patients screened positive for BDD was 31.41. The mean ROE score was significantly lower (i.e. lower satisfaction) in patients screened positive for BDD (15.69 versus 19.08, P = 0.001), regardless of confounding variables, such as age, sex, and marital status. SCHNOS-C score was higher (i.e. less satisfaction) among patients with BDD (47.01 versus 34.96, P = 0.021) and was significantly associated with higher odds of severe aesthetic concern post-rhinoplasty (OR (95%CI) = 5.000 (1.135-22.022), P = 0.033). Patients screened positive for BDD had significantly higher NOSE scores (i.e. less satisfaction with functional outcome) compared to participants negative for BDD (49.74 versus 37.82, P = 0.012). SCHNOS-O score had no significant association with BDD (P = 0.053). Furthermore, there was no significant association between BDD and NOSE or SCHNOS-O score after adjustment for the confounders. CONCLUSION: Patients screened positive for BDD were significantly less satisfied with the cosmetic outcome of the rhinoplasty compared to those screened negative for BDD. Assessment of BDD among rhinoplasty candidates before surgery, could potentially be beneficial for both patients and surgeons. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Role of Cortico-Cancellous Heterologous Bone in Human Periodontal Ligament Stem Cell Xeno-Free Culture Studied by Synchrotron Radiation Phase-Contrast Microtomography.

This study was designed to quantitatively demonstrate via three-dimensional (3D) images, through the Synchrotron Radiation Phase-Contrast Microtomography (SR-PhC-MicroCT), the osteoinductive properties of a cortico-cancellous scaffold (Osteobiol Dual Block-DB) cultured with human Periodontal Ligament Stem Cells (hPDLSCs) in xeno-free media. In vitro cultures of hPDLSCs, obtained from alveolar crest and horizontal fibers of the periodontal ligament, were seeded onto DB scaffolds and cultured in xeno-free media for three weeks. 3D images were obtained by SR-PhC-microCT after one and three weeks from culture beginning. MicroCT data were successively processed with a phase-retrieval algorithm based on the Transport of Intensity Equation (TIE). The chosen experimental method, previously demonstratively applied for the 3D characterization of the same constructs in not xeno-free media, quantitatively monitored also in this case the early stages of bone formation in basal and differentiating conditions. Interestingly, it quantitatively showed in the xeno-free environment a significant acceleration of the mineralization process, regardless of the culture (basal/differentiating) medium. This work showed in 3D that the DB guides the osteogenic differentiation of hPDLSCs in xeno-free cultures, in agreement with 2D observations and functional studies previously performed by some of the authors. Indeed, here we fully proved in 3D that expanded hPDLSCs, using xeno-free media formulation, not only provide the basis for Good Manufacturing Practice (preserving the stem cells' morphological features and their ability to differentiate into mesenchymal lineage) but have to be considered, combined to DB scaffolds, as interesting candidates for potential clinical use in new custom made tissue-engineered constructs.

Quantitative Kinetics Evaluation of Blocks Versus Granules of Biphasic Calcium Phosphate Scaffolds (HA/ß-TCP 30/70) by Synchrotron Radiation X-ray Microtomography: A Human Study.

INTRODUCTION: Successful bone regeneration using both granules and blocks of biphasic calcium phosphate materials has been reported in the recent literature, in some clinical applications for maxillary sinus elevation, but the long-term kinetics of bone regeneration has still not been fully investigated. MATERIALS AND METHODS: Twenty-four bilateral sinus augmentation procedures were performed and grafted with hydroxyapatite/ß-tricalcium phosphate 30/70, 12 with granules and 12 with blocks. The samples were retrieved at different time points and were evaluated for bone regeneration, graft resorption, neovascularization, and morphometric parameters by computed microtomography and histology. RESULTS: A large amount of newly formed bone was detected in the retrieved specimens, together with a good rate of biomaterial resorption and the formation of a homogeneous and rich net of new vessels. The morphometric values were comparable at 5/6 months from grafting but, 9 months after grafting, revealed that the block-based specimens mimicked slightly better than granule-based samples the healthy native bone of the maxillary site. CONCLUSION: The scaffold morphology was confirmed to influence the long-term kinetics of bone regeneration.

Functionalized synchrotron in-line phase-contrast computed tomography: a novel approach for simultaneous quantification of structural alterations and localization of barium-labelled alveolar macrophages within mouse lung samples.

Functionalized computed tomography (CT) in combination with labelled cells is virtually non-existent due to the limited sensitivity of X-ray-absorption-based imaging, but would be highly desirable to realise cell tracking studies in entire organisms. In this study we applied in-line free propagation X-ray phase-contrast CT (XPCT) in an allergic asthma mouse model to assess structural changes as well as the biodistribution of barium-labelled macrophages in lung tissue. Alveolar macrophages that were barium-sulfate-loaded and fluorescent-labelled were instilled intratracheally into asthmatic and control mice. Mice were sacrificed after 24 h, lungs were kept in situ, inflated with air and scanned utilizing XPCT at the SYRMEP beamline (Elettra Synchrotron Light Source, Italy). Single-distance phase retrieval was used to generate data sets with ten times greater contrast-to-noise ratio than absorption-based CT (in our setup), thus allowing to depict and quantify structural hallmarks of asthmatic lungs such as reduced air volume, obstruction of airways and increased soft-tissue content. Furthermore, we found a higher concentration as well as a specific accumulation of the barium-labelled macrophages in asthmatic lung tissue. It is believe that XPCT will be beneficial in preclinical asthma research for both the assessment of therapeutic response as well as the analysis of the role of the recruitment of macrophages to inflammatory sites.

Quantitative evaluation of a single-distance phase-retrieval method applied on in-line phase-contrast images of a mouse lung.

Propagation-based X-ray phase-contrast computed tomography (PBI) has already proven its potential in a great variety of soft-tissue-related applications including lung imaging. However, the strong edge enhancement, caused by the phase effects, often hampers image segmentation and therefore the quantitative analysis of data sets. Here, the benefits of applying single-distance phase retrieval prior to the three-dimensional reconstruction (PhR) are discussed and quantified compared with three-dimensional reconstructions of conventional PBI data sets in terms of contrast-to-noise ratio (CNR) and preservation of image features. The PhR data sets show more than a tenfold higher CNR and only minor blurring of the edges when compared with PBI in a predominately absorption-based set-up. Accordingly, phase retrieval increases the sensitivity and provides more functionality in computed tomography imaging.

Duality between noise and spatial resolution in linear systems.

It is shown that in a broad class of linear systems, including general linear shift-invariant systems, the spatial resolution and the noise satisfy a duality relationship, resembling the uncertainty principle in quantum mechanics. The product of the spatial resolution and the standard deviation of output noise in such systems represents a type of phase-space volume that is invariant with respect to linear scaling of the point-spread function, and it cannot be made smaller than a certain positive absolute lower limit. A corresponding intrinsic "quality" characteristic is introduced and then evaluated for the cases of some popular imaging systems, including computed tomography, generic image convolution and phase-contrast imaging. It is shown that in the latter case the spatial resolution and the noise can sometimes be decoupled, potentially leading to a substantial increase in the imaging quality.

Predicting Risk of Post-Operative Morbidity and Mortality following Gynaecological Oncology Surgery (PROMEGO): A Global Gynaecological Oncology Surgical Outcomes Collaborative Led Study.

The medical complexity of surgical patients is increasing, and surgical risk calculators are crucial in providing high-value, patient-centered surgical care. However, pre-existing models are not validated to accurately predict risk for major gynecological oncology surgeries, and many are not generalizable to low- and middle-income country settings (LMICs). The international GO SOAR database dataset was used to develop a novel predictive surgical risk calculator for post-operative morbidity and mortality following gynecological surgery. Fifteen candidate features readily available pre-operatively across both high-income countries (HICs) and LMICs were selected. Predictive modeling analyses using machine learning methods and linear regression were performed. The area-under-the-receiver-operating characteristic curve (AUROC) was calculated to assess overall discriminatory performance. Neural networks (AUROC 0.94) significantly outperformed other models (p < 0.001) for evaluating the accuracy of prediction across three groups, i.e., minor morbidity (Clavien-Dindo I-II), major morbidity (Clavien-Dindo III-V), and no morbidity. Logistic-regression modeling outperformed the clinically established SORT model in predicting mortality (AUROC 0.66 versus 0.61, p < 0.001). The GO SOAR surgical risk prediction model is the first that is validated for use in patients undergoing gynecological surgery. Accurate surgical risk predictions are vital within the context of major cytoreduction surgery, where surgery and its associated complications can diminish quality-of-life and affect long-term cancer survival. A model that requires readily available pre-operative data, irrespective of resource setting, is crucial to reducing global surgical disparities.

New Perspective on the Interaction Behavior Between Riboflavin and ß Lactoglobulin-ß Casein Complex by Biophysical Techniques.

Riboflavin (RF) is a vitamin that only exists in plants and microorganisms and must be procured externally by humans. On the other hand, there are two major allergic factors in cow's milk, including ß-lactoglobulin (ßLG) and ß-casein (ßCN), while their allergic properties can be eliminated by binding to micronutrients. In this regard, we examined the binding process of RF to ßLG and ßCN in the binary and ternary systems by different spectroscopies such as zeta potential, electric conductivity, and molecular modeling. According to the result of the fluorescence spectrum regarding the interaction of RF with ßLG and ßCN in binary and ternary systems, an increase in RF concentration declined the fluorescence intensity of three systems and also caused the quenching of proteins. Static quenching plays a pivotal role in the formation of stable interactions. The obtained thermodynamic parameters by Van't Hoff equation ascertained the predominance of hydrogen bonds and van der Waals interaction in all the systems. Considering how the negative value of ΔH0 resulted in the negative value of ΔG0, the systems were assumed to be enthalpy driven. The outcomes of circular dichroism (CD) disclosed that the attachment of RF to the targets of systems increased their a-helix content, which particularly included the binding of RF to ßLG that led to the conversion of ß-sheet to α-helix content. As indicated by the results of zeta potential, the low concentration of RF contained the dominance of hydrophobic forces in the interactions, whereas the enlargement of this concentration prevailed electrostatic forces. Moreover, conductometry measurements showed an extension in the rate of ionizable groups due to the addition of RF to the systems, which may increase the probability of an interaction between RF, ßCN, and ßLG in binary and ternary systems. In consistency with the outcomes of molecular dynamics simulation, the data of molecular docking approved the capability of RF in forming strong and stable interactions with ßCN and ßLG.

A Protocol for Evaluating Digital Technology for Monitoring Sleep and Circadian Rhythms in Older People and People Living with Dementia in the Community.

Sleep and circadian rhythm disturbance are predictors of poor physical and mental health, including dementia. Long-term digital technology-enabled monitoring of sleep and circadian rhythms in the community has great potential for early diagnosis, monitoring of disease progression, and assessing the effectiveness of interventions. Before novel digital technology-based monitoring can be implemented at scale, its performance and acceptability need to be evaluated and compared to gold-standard methodology in relevant populations. Here, we describe our protocol for the evaluation of novel sleep and circadian technology which we have applied in cognitively intact older adults and are currently using in people living with dementia (PLWD). In this protocol, we test a range of technologies simultaneously at home (7-14 days) and subsequently in a clinical research facility in which gold standard methodology for assessing sleep and circadian physiology is implemented. We emphasize the importance of assessing both nocturnal and diurnal sleep (naps), valid markers of circadian physiology, and that evaluation of technology is best achieved in protocols in which sleep is mildly disturbed and in populations that are relevant to the intended use-case. We provide details on the design, implementation, challenges, and advantages of this protocol, along with examples of datasets.

Analysis the Effect of Job Strain on Nurses' Quality of Work-Life: A Mediating and Moderating Model.

Background: One of the most important issues in all organizations is to improve performance of human resources to achieve goals. Therefore, it is necessary plans and solutions to reduce Job Strain (JS) and then increase Organizational Citizenship Behaviors (OCB), and Quality of Work-Life (QWL). The purpose of this study is to investigate the effect of JS on QWL with mediating role of OCB and moderator of employment status. Materials and Methods: This cross-sectional study was conducted on 300 nurses who were non-randomly voluntary selected among nurses working in seven educational hospitals in Ahvaz, Iran. Data were collected using demographic and occupational characteristics questionnaire and JS questionnaire with 12 items, OCB with 16 items & QWL with 26 items in the 5-point Likert scale. Data analysis was performed in SPSS22 using descriptive and inferential statistics, and structural equation modeling with SmartPLS3. Results: The results indicated the mean (SD) score of 49.56 (6.68) for JS (more than normal) and 58.84 (5.94) and 49.88 (7.69) for QWL and OCB, respectively. Spearman correlation coefficients show that JS has a negative relationship with QWL (r = -0.69, p < 0.001) and OCB (r = -0.54, p = 0.008). Also, nurses' employment status (Formal and Contractual) moderates the relationship between JS, QWL, and OCB. Conclusions: According to the results, job stress in nurses of Ahvaz hospitals was high and QWL was moderate (or less). Therefore, increased job stress leads to reduced QWL and OCBs of nurses. Also the employment Status and job security that it provides can modify this impact.

Ensemble learning from ensemble docking: revisiting the optimum ensemble size problem.

Despite considerable advances obtained by applying machine learning approaches in protein-ligand affinity predictions, the incorporation of receptor flexibility has remained an important bottleneck. While ensemble docking has been used widely as a solution to this problem, the optimum choice of receptor conformations is still an open question considering the issues related to the computational cost and false positive pose predictions. Here, a combination of ensemble learning and ensemble docking is suggested to rank different conformations of the target protein in light of their importance for the final accuracy of the model. Available X-ray structures of cyclin-dependent kinase 2 (CDK2) in complex with different ligands are used as an initial receptor ensemble, and its redundancy is removed through a graph-based redundancy removal, which is shown to be more efficient and less subjective than clustering-based representative selection methods. A set of ligands with available experimental affinity are docked to this nonredundant receptor ensemble, and the energetic features of the best scored poses are used in an ensemble learning procedure based on the random forest method. The importance of receptors is obtained through feature selection measures, and it is shown that a few of the most important conformations are sufficient to reach 1 kcal/mol accuracy in affinity prediction with considerable improvement of the early enrichment power of the models compared to the different ensemble docking without learning strategies. A clear strategy has been provided in which machine learning selects the most important experimental conformers of the receptor among a large set of protein-ligand complexes while simultaneously maintaining the final accuracy of affinity predictions at the highest level possible for available data. Our results could be informative for future attempts to design receptor-specific docking-rescoring strategies.

Geant4 Modeling of Cellular Dosimetry of 188Re: Comparison between Geant4 Predicted Surviving Fraction and Experimentally Surviving Fraction Determined by MTT Assay.

BACKGROUND: The importance of cellular dosimetry in both diagnostic and radiation therapy is becoming increasingly recognized. OBJECTIVE: This study aims to compare surviving fractions, which were predicted using Geant4 and contained three types of cancer cell lines exposed to 188Re with the experimentally surviving fraction determined by MTT assay. MATERIAL AND METHODS: In this comparative study, Geant4 was used to simulate the transport of electrons emitted by 188Re from the cell surface, cytoplasm, nucleus or medium around the cells. The nucleus dose per decay (S-value) was computed for models of single cell and random monolayer cell. Geant4-computed survival fraction (SF) of cancer cells exposed to 188Re was compared with the experimental SF values of MTT assay. RESULTS: For single cell model, Geant4 S-values of nucleus-to-nucleus were consistent with values reported by Goddu et al. (ratio of S-values by analytical techniques vs. Geant4 = 0.811-0.975). Geant4 S-values of cytoplasm and cell surface to nucleus were relatively comparable to the reported values (ratio =0.914-1.21). For monolayer model, the values of SCy→N and SCS→N, were greater compared to those for model of single cell (2%-25% and 4%-38% were larger than single cell, respectively). The Geant4 predicted SF for monolayer MCF7, HeLa and A549 cells was in agreement with the experimental data in 10µCi activity (relative error of 2.29%, 2.69% and 2.99%, respectively). CONCLUSION: Geant4 simulation with monolayer cell model showed the highest accuracy in predicting the SF of cancer cells exposed to homogeneous distribution of 188Re in the medium.

Transfer Learning for Clinical Sleep Pose Detection Using a Single 2D IR Camera.

Sleep quality is an important determinant of human health and wellbeing. Novel technologies that can quantify sleep quality at scale are required to enable the diagnosis and epidemiology of poor sleep. One important indicator of sleep quality is body posture. In this paper, we present the design and implementation of a non-contact sleep monitoring system that analyses body posture and movement. Supervised machine learning strategies applied to noncontact vision-based infrared camera data using a transfer learning approach, successfully quantified sleep poses of participants covered by a blanket. This represents the first occasion that such a machine learning approach has been used to successfully detect four predefined poses and the empty bed state during 8-10 hour overnight sleep episodes representing a realistic domestic sleep situation. The methodology was evaluated against manually scored sleep poses and poses estimated using clinical polysomnography measurement technology. In a cohort of 12 healthy participants, we find that a ResNet-152 pre-trained network achieved the best performance compared with the standard de novo CNN network and other pre-trained networks. The performance of our approach was better than other video-based methods for sleep pose estimation and produced higher performance compared to the clinical standard for pose estimation using a polysomnography position sensor. It can be concluded that infrared video capture coupled with deep learning AI can be successfully used to quantify sleep poses as well as the transitions between poses in realistic nocturnal conditions, and that this non-contact approach provides superior pose estimation compared to currently accepted clinical methods.

Validating Consensus-Defined Severity Grading of Lymphatic Complications after Kidney Transplant.

Lymphatic complications after kidney transplantation (KTx) are associated with morbidities such as impaired wound healing, thrombosis, and organ failure. Recently, a consensus regarding the definition and severity grading of lymphoceles has been suggested. The aim of the present study was to validate this classification method. All adult patients who underwent KTx between December 2011 and September 2016 in our department were evaluated regarding lymphoceles that were diagnosed within 6 months after KTx based on the recent definition. Patients with lymphoceles were categorized according to the classification criteria, and clinical outcomes were compared between the groups. In our department, a total of 587 patients underwent KTx between 2011 and 2016. Lymphoceles were detected after KTx in 90 patients (15.3%). Among these patients, 24 (26.6%) had grade A lymphoceles, 14 (15.6%) had grade B, and 52 (57.8%) had grade C. The median duration times of intermediate care (IMC) and hospital stay were significantly higher among patients with grade C lymphoceles than they were among patients with grade A and B lymphoceles. Significantly more patients with grade C lymphoceles were readmitted to the hospital for treatment. The recently published definition and severity grading of lymphoceles after KTx is an easy-to-use and valid classification system, which may facilitate the comparison of results from different studies on lymphoceles after KTx.

A fast and easy-to-learn technique for liver resection in a porcine model.

OBJECTIVE: Despite the recent advances in surgical techniques and perioperative care, liver resection (especially extended hepatectomy) is still a high-risk procedure with considerable morbidity and mortality. Experimental large animal models are the best option for studies in this regard. The present study was performed to present an easy-to-learn, fast, and multipurpose model of liver resection in a porcine model. METHOD: Stepwise liver resections (resection of segments II/III, IVa/IVb, and VIII/IV) were performed in eight pigs with intraoperative monitoring of hemodynamic parameters. The technical aspects, tips, and tricks of this method are explained in detail. RESULTS: Based on the specific anatomical characteristics of the porcine liver, all resection types including segmental resection, hemihepatectomy, and extended hepatectomy could be performed in one animal in an easy-to-learn and fast technique. All animals were hemodynamically stable following stepwise liver resection. CONCLUSION: Stepwise liver resection using stapler in a porcine model is a fast and easy-to-learn method with which junior staff and research fellows can perform liver resection up to extended hepatectomy under stable conditions.

Prophylactic Peritoneal Fenestration during Kidney Transplantation Can Reduce the Type C Lymphocele Formation.

Lymphocele is a common complication following kidney transplantation (KTx). We aimed to evaluate the preventive effect of peritoneal fenestration during KTx in reducing lymphocele. From January 2001, the data of all KTx were prospectively gathered in our digital data bank. From 2008, preventive peritoneal fenestration was performed as a routine procedure for all patients with KTx. Between 2001 and 2008, 579 KTx were performed without preventive peritoneal fenestration. To compare the results between with and without peritoneal fenestration, the same number of patients after 2008 (579 patients) was included in this study. The pre-, intra-, and postoperative data of the patients in these two groups were analyzed and compared, especially regarding the postoperative different types of lymphocele formation. The mean recipient age was 52.6 ± 13.8, and 33.7% of the patients were female. Type C lymphocele was significantly lower in the group with preventive fenestration (5.3% vs. 8.8%, p = 0.014 for 31/579 vs. 51/579). Peritoneal dialysis and implantation of the kidney in the left fossa were independently associated with a higher rate of type C lymphocele (OR 2.842, 95% CI 1.354-5.967, p = 0.006 and OR 3.614, 95% CI 1.215-10.747, p = 0.021, respectively). The results of this study showed that intraoperative preventive peritoneal fenestration could significantly reduce type C lymphocele.

THERMAL AND FAST NEUTRON DOSE EQUIVALENT DISTRIBUTION MEASUREMENT OF 15-MV LINEAR ACCELERATOR USING A CR-39 NUCLEAR TRACK DETECTORS.

The main purpose of this study is to measure the contribution of the thermal and fast neutron dose along the central axis of the 15 MV Elekta Precise linac in a tissue equivalent phantom. In order to achieve this purpose, different points were selected in three field sizes of 5 × 5 cm2, 10 × 10 cm2 and 15 × 15 cm2. Fast and thermal neutrons were measured using CR-39 nuclear track detectors with and without thermal neutron converter of 10B, respectively. According to the results, the fast neutron dose equivalent was decreased as the depth increased (field size 5 × 5, 10 × 10 and 15 × 15 cm2 fall from 0.35 to 0.15, 0.5 to 0.3 and 0.5 to 0.3, respectively). Thermal dose equivalent was increased as the depth increased in the tissue equivalent phantom (field size 5 × 5, 10 × 10 and 15 × 15 cm2 rise from 0.1 to 0.4, 0.4 to 0.8 and 0.4 to 0.9, respectively). In conclusion, at depth <3 cm, most existing neutrons are fast and CR-39 films are sensitive to fast neutrons; therefore, they are more appropriate than thermoluminescent dosemeters in measuring neutron dose equivalent.

Infectious Complications Reporting in Common Variable Immunodeficiency: A Systematic Review and Meta-analysis.

OBJECTIVES: Common variable immunodeficiency (CVID) is a heterogeneous disorder characterized by hypogammaglobulinemia and increased susceptibility to recurrent infections. METHODS: We searched PubMed, Web of Science, and Scopus databases to find eligible studies from the earliest available date to January 2018 with standard keywords. Pooled estimates of the infection prevalence and the corresponding 95% confidence intervals were calculated using random-effects models. RESULTS: We found that pneumonia (67.7%) was the most prevalent infection followed by upper respiratory tract (59.0%) and gastrointestinal infections (36.3%). Furthermore, bacterial complications (41.7%) were higher in CVID patients compared to viral (25.4%), parasitic (18.8%), or fungal (3.4%) infections. Patients with longer age at diagnosis presented with fewer disease comorbidities. There was an inverse correlation between T lymphocyte count and viral infections. Moreover, we found that immunoglobulin M (IgM) serum level was inversely correlated with hepatitis C and gastrointestinal infections, and IgG serum level was inversely correlated with infectious arthritis. Higher numbers of CD4 and CD8 T cells were associated with the lower frequencies of otitis media. CVID patients with infections had significantly lower percentages of CD3 T cells. In contrast, higher percentages of CD19 lymphocytes were found in CVID patients who had a history of infections. CONCLUSIONS: Our findings demonstrated that in addition to hypogammaglobulinemia, patients with CVID have an imbalance in the frequency of T lymphocytes, which is in parallel with the higher frequency of infectious complications.

PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial.

INTRODUCTION: Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx). The size of the fenestration plays an important role in its effectiveness. A large peritoneal window is no longer indicated, due to herniation and difficulties in performing biopsies. Small preventive fenestration is effective but will be closed too early. The aim of this study is to evaluate whether metal clips around the edges of a small fenestration result in optimal effects with minimum fenestration size. METHODS AND ANALYSIS: This trial has been initiated in July 2019 and is expected to last for 2 and a half years. All patients older than 18 years, who receive kidneys from deceased donors, will be included. The kidney recipients will be randomly allocated to either a control arm (small fenestration alone) or an intervention arm (small fenestration with clipping). All fenestrations will be round, maximum 2 cm, and close to the kidney hilum. Clipping will be performed with eight metal clips around the peritoneal window (360°) in every 45° in an oblique position. The primary endpoint is the incidence of symptomatic post-KTx lymphatic complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms. ETHICS AND DISSEMINATION: This protocol study received approval from the Ethics Committee of the University of Heidelberg (Registration Number S-318/2017). A Standard Protocol Items: Recommendations for Interventional Trials checklist is available for this protocol. The results will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03682627).

Oral Preconditioning of Donors After Brain Death With Calcineurin Inhibitors vs. Inhibitors of Mammalian Target for Rapamycin in Pig Kidney Transplantation.

Background: The systemic inflammatory cascade triggered in donors after brain death enhances the ischemia-reperfusion injury after organ transplantation. Intravenous steroids are routinely used in the intensive care units for the donor preconditioning. Immunosuppressive medications could be potentially used for this purpose as well. Data regarding donor preconditioning with calcineurin inhibitors or inhibitors of mammalian target for Rapamycin is limited. The aim of this project is to investigate the effects of (oral) donor preconditioning with a calcineurin inhibitor (Cyclosporine) vs. an inhibitor of mammalian target for Rapamycin (Everolimus) compared to the conventional administration of steroid in the setting of donation after brain death in porcine renal transplantation. Methods: Six hours after the induction of brain death, German landrace donor pigs (33.2 ± 3.9 kg) were randomly preconditioned with either Cyclosporine (n = 9) or Everolimus (n = 9) administered via nasogastric tube with a repeated dose just before organ procurement. Control donors received intravenous Methylprednisolone (n = 8). Kidneys were procured, cold-stored in Histidine-Tryptophane-Ketoglutarate solution at 4°C and transplanted in nephrectomized recipients after a mean cold ischemia time of 18 h. No post-transplant immunosuppression was given to avoid confounding bias. Blood samples were obtained at 4 h post reperfusion and daily until postoperative day 5 for complete blood count, blood urea nitrogen, creatinine, and electrolytes. Graft protocol biopsies were performed 4 h after reperfusion to assess early histological and immunohistochemical changes. Results: There was no difference in the hemodynamic parameters, hemoglobin/hematocrit and electrolytes between the groups. Serum blood urea nitrogen and creatinine peaked on postoperative day 1 in all groups and went back to the preoperative levels at the conclusion of the study on postoperative day 5. Histological assessment of the kidney grafts revealed no significant differences between the groups. TNF-α expression was significantly lower in the study groups compared with Methylprednisolone group (p = 0.01) Immunohistochemistry staining for cytochrome c showed no difference between the groups. Conclusion: Oral preconditioning with Cyclosporine or Everolimus is feasible in donation after brain death pig kidney transplantation and reduces the expression of TNF-α. Future studies are needed to further delineate the role of oral donor preconditioning against ischemia-reperfusion injury.