bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized, active-controlled, parallel, open-label, multicenter, phase 4 study to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain
Authors: Kang Seon Mee , Hong Jun Hwa , Ku Bon Jeong 
Published: April 2023

Background:
Diabetic peripheral polyneuropathy is the most common chronic complication of type 2 diabetes. Neuropathic pain is challenging to manage, and various drugs are required to control it, decreasing treatment adherence. Pregabalin, a ligand that binds to alpha-2-delta subunits of the presynaptic calcium channel, has been approved by the Food and Drug Administration for the treatment of diabetic neuropathic pain. In this study, we will compare the efficacy, safety, treatment satisfaction, and compliance between pregabalin sustained-release (SR) tablets and pregabalin immediate-release (IR) capsules in type 2 diabetic patients with peripheral neuropathic pain.

Methods:
This study is a randomized, active-controlled, parallel, open-label, multicenter, phase 4 clinical trial (trial registration NCT05624853). Type 2 diabetic patients with glycosylated hemoglobin below 10% and peripheral neuropathic pain who have been taking pregabalin 150 mg/d or more for more than 4 weeks will be randomly assigned to pregabalin SR tablet (150 mg once a day, n = 65) or pregabalin IR capsule (75 mg twice a day, n = 65) therapy for 8 weeks. The primary outcome will be the efficacy of SR pregabalin after 8 weeks of treatment, which will be assessed by visual analog scale measurements. The secondary outcomes will include changes in several parameters, such as quality of life, treatment satisfaction, quality of sleep, and drug compliance.

Discussion:
In thus study, we aim to demonstrate that pregabalin SR tablets are associated with better compliance and satisfaction compared with pregabalin IR capsules, despite similar efficacy.
Non-alcoholic fatty liver disease is associated with an increased risk of type 2 diabetes
Authors: Loosen Sven H. , Krieg Sarah , Krieg Andreas , Qvartskhava Natalia , Luedde Tom , Kostev Karel , Roderburg Christoph 
Published: April 2023

Objective
Non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease worldwide and represents the leading cause of liver-related morbidity and mortality. Its all-cause mortality is often driven by co-existing metabolic diseases such as type 2 diabetes (T2DM), which share many pathophysiological characteristics. The risk of developing T2DM among NAFLD patients in Germany is only poorly described.

Methods
A cohort of 17 245 NAFLD patients and a propensity score-matched cohort of equal size were identified from the Disease Analyzer database (IQVIA) between 2005 and 2020. The incidence of T2DM was evaluated as a function of NAFLD during a 5-year study period using Cox-regression models.

Results
Within 5 years of the index date, 18.8% and 11.7% of individuals with and without NAFLD were diagnosed with T2DM (P < 0.001). Regression analysis revealed a hazard ratio of 1.77 [95% confidence interval (CI), 1.68–1.88] for the development of T2DM among NAFLD patients. Subgroup analyses confirmed this association for all age groups (18–50, 51–60, 61–70 and >70 years), male and female patients, as well as normal weight (BMI < 25 kg/m2), overweighted (BMI 25–30 kg/m2) and obese (BMI > 30 kg/m2) patients.

Conclusion
Our data revealed a significantly increased incidence of T2DM among NAFLD patients in Germany. Given the dramatically increasing global relevance of NAFLD, we believe that prevention and regular screening programs for T2DM in NAFLD patients could help to reduce its high mortality and morbidity in the future.
Successful nonoperative treatment of a closed posteromedial ankle dislocation without associated fractures – a case report
Authors: Almotlaqem Nahar , Altammar Abdulaziz , Hassan Adnan , Lari Ali 
Published: April 2023

Introduction:
Pure ankle dislocations occurring in the absence of malleolus fractures are extremely rare injuries. These injuries often present with high-energy trauma and ligamentous injury. Comprehensive research is not available due to the rarity of the injury. However, recent literature has supported treatment by nonoperative means. This case report aims to discuss a similar case and offer insight into the prognosis of such injuries.

Case presentation:
A previously healthy 26-year-old male was diagnosed with a closed posteromedial ankle dislocation without associated fractures. Reduction was performed under procedural sedation and confirmed with postreduction radiographs. The patient was immobilized and scheduled for serial follow-up in the outpatient department. Weight bearing was gradually introduced at 6 weeks along with physiotherapy. The American Orthopedic Foot and Ankle Score was 90 and 100 at 6 months and 1 year follow-up, respectively. Return to sports was possible at 1 year postinjury. Range of motion was normal apart from a 5–8° ankle dorsiflexion deficit. Radiographs, computed tomography, and MRI were unremarkable with longer term follow-up.

Conclusion:
Patients who sustain pure ankle dislocations with an intact distal tibiofibular syndesmosis can expect favorable outcomes with immobilization, splinting, and gradual rehabilitation, as evident by the high American Orthopedic Foot and Ankle Score and the time to return to sports. This case report serves to provide prognostic information and anticipate outcomes in patients with similar injuries.
Late recurrence of chromophobe renal cell carcinoma to unusual sites after 12 years of radical nephrectomy and radiotherapy: a rare case report from Syria
Authors: Zahlout Jaafar , Shmayyes Haidar , Zahlout Batoul , Salloum Mariam , Kassab Yahya , Zahlouk Nadim , Alshehabi Zuheir 
Published: April 2023

Introduction and Importance:In 2020, renal cell carcinoma (RCC) had an incidence of 73 750 new cases. This cancer is well known for its ability to give early and late metastases to some usual and unusual sites. The term ‘late recurrence’ is widely used to indicate a period exceeding 10 years from curative nephrectomy. This not-understood behaviour is almost specific to RCC, and it happens in a range between 4.3 and 11% of cases of RCC.Case Presentation:We report a case of a 67-year-old nonalcoholic smoker Syrian male presented with a 2-month painful mass located at the left upper posterolateral abdominal wall’s region. He has had a history of left chromophobe cell RCC treated with radical nephrectomy with adjuvant radiotherapy for 12 years. In light of computed tomography’s findings, a surgical biopsy was performed, and a pathological and immunohistochemical examination confirmed the diagnosis of chromophobe RCC.Clinical Discussion:Malignant cells seeding the surgical cut path and staying dormant for 12 years is the best theory of many to explain our case.Conclusion:We reported evidence for the potential of a relatively indolent histologic type of RCC (i.e. chromophobe cell carcinoma) to cause late recurrence after 12 years to a very rare site (i.e. abdominal wall’s superficial muscles). Research should focus on addressing late recurrence to determine the best surveillance protocols; investigating malignant cells seeding during surgery to improve surgical oncology’s outcomes; and studying late recurrence’s genetics to boost our targeted therapy options.
Risk factors of Helicobacter pylori infection in Bukavu, Democratic Republic of the Congo: a case–control study
Authors: Birato Yannick C. , Armand Masimango Bahati , Katabana Delphin M. , Shindano Tony A. 
Published: April 2023

Background:Helicobacter pylori(H. pylori) is the common etiology of gastric tumors. This study aimed to evaluate the risk factors associated withH. pyloriinfection in the eastern part of the Democratic Republic of the Congo (DR Congo), where these tumors seem to be more frequent than in its western part.Patients and Methods:Between January and December 2021, the authors conducted a multicenter case–control study in three hospitals in Bukavu City involving 90 individuals with dyspeptic complaints. Risk factors forH. pyloriinfection were assessed in a participant interview andH. pyloristatus from stool antigen detection.Results:Among the risk factors assessed, only history ofH. pyloriin the family and the habit of adding salt to already-seasoned food were found positively associated with the risk ofH. pyloriinfection (adjusted odds ratio: 7, 95 CI: 2.742–17.867;P<0.0001 and 2.911, 95% CI: 1.010–8.526;P=0.048, respectively). On the other hand, low-temperature food storage seems to be protective with a negative association (adjusted odds ratio: 0.044, 95% CI: 0.009–0.206;P=0.0001).Conclusion:This study demonstrated again the importance of lifestyle-related factors on the risk of acquisition ofH. pylori. These findings call for preventive interventions for this group of individuals.
Bilateral choanal atresia diagnosed in a 3-month-old female baby: a case report
Authors: Abraham Zephania S. , Kahinga Aveline A. 
Published: April 2023

Introduction and Importance:
Bilateral choanal atresia is a congenital anomaly where a newborn baby is born with bilateral imperforate posterior nares. In most cases, the diagnosis is established immediately after birth due to respiratory distress since newborn babies are obligate nasal breathers till 6 weeks of life. Establishing the diagnosis requires a high index of suspicion as it is characterized by paradoxical cyclical cyanosis. Delayed diagnosis of bilateral choanal atresia is a rare encounter in clinical practice. We are hereby reporting a 3-month-old baby with bilateral choanal atresia, and perhaps it is the third latest diagnosed case of bilateral choanal atresia in Tanzania.

Case Presentation:
We present a 3-month-old female baby who was attended to at our department with a history of difficulty in breathing characterized by bilateral nasal obstruction since birth. The baby was admitted for 3 weeks due to episodes of respiratory distress after birth. She was thereafter discharged from the hospital and attended various hospitals without relief since the baby was managed as a case of adenoid hypertrophy.

Clinical Discussion:
The patient underwent bilateral transnasal endoscopic choanal atresia release with stenting under general anesthesia in the operating room. Postoperatively, she was kept on a nasal decongestant, a broad-spectrum antibiotic, and an analgesic. Regular suctioning was done during routine follow-up.

Conclusion:
Clinicians must have a high index of suspicion to establish the diagnosis of bilateral choanal atresia in newborn babies. Immediate surgical perforation of the atretic choanae with or without stenting remains to be the treatment of choice.
Inappropriate Shock Delivery Is Common During Pediatric In-Hospital Cardiac Arrest
Authors: Gray James M. , Raymond Tia T. , Atkins Dianne L. , Tegtmeyer Ken , Niles Dana E. , Nadkarni Vinay M. , Pandit Sandeep V. , Dewan Maya ,   for the pediRES-Q Investigators
Published: April 2023

OBJECTIVES:
To characterize inappropriate shock delivery during pediatric in-hospital cardiac arrest (IHCA).

DESIGN:
Retrospective cohort study.

SETTING:
An international pediatric cardiac arrest quality improvement collaborative Pediatric Resuscitation Quality [pediRES-Q].

PATIENTS:
All IHCA events from 2015 to 2020 from the pediRES-Q Collaborative for which shock and electrocardiogram waveform data were available.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
We analyzed 418 shocks delivered during 159 cardiac arrest events, with 381 shocks during 158 events at 28 sites remaining after excluding undecipherable rhythms. We classified shocks as: 1) appropriate (ventricular fibrillation [VF] or wide complex ≥ 150/min); 2) indeterminate (narrow complex ≥ 150/min or wide complex 100–149/min); or 3) inappropriate (asystole, sinus, narrow complex < 150/min, or wide complex < 100/min) based on the rhythm immediately preceding shock delivery. Of delivered shocks, 57% were delivered appropriately for VF or wide complex rhythms with a rate greater than or equal to 150/min. Thirteen percent were classified as indeterminate. Thirty percent were delivered inappropriately for asystole (6.8%), sinus (3.1%), narrow complex less than 150/min (11%), or wide complex less than 100/min (8.9%) rhythms. Eighty-eight percent of all shocks were delivered in ICUs or emergency departments, and 30% of those were delivered inappropriately.

CONCLUSIONS:
The rate of inappropriate shock delivery for pediatric IHCA in this international cohort is at least 30%, with 23% delivered to an organized electrical rhythm, identifying opportunity for improvement in rhythm identification training.
Country of birth is associated with antiretroviral therapy choice in treatment-naive persons living with HIV in France
Authors: Palich Romain , Hentzien Maxime , Hocqueloux Laurent , Duvivier Claudine , Allavena Clotilde , Huleux Thomas , Delobel Pierre , Makinson Alain , Rey David , Cuzin Lise 
Published: April 2023

Objectives:
We aimed to describe factors associated with the choice of first ART in PLHIV in France, included the country of birth, as well as the time to undetectable viral load and treatment discontinuation.

Design:
Observational study conducted from the national Dat’AIDS prospectively collected database.

Methods:
We included all adults who started their first ART between 01/01/2014 and 12/31/2020, with a pretherapeutic plasma viral load (pVL)≥400 copies/mL. Uni- and multivariable logistic regressions were used to analyze PLHIV characteristics driving to an INSTI-based first prescribed regimen. We also analyzed time to first line discontinuation, and to a first undetectable pVL, using Kaplan-Meier and Cox models.

Results:
We analyzed data from 9094 PLHIV: 45% men who have sex with men, 27% women and 27% heterosexual men; 48% born abroad; 4.7% and 2.8% with concomitant hepatitis B and tuberculosis, respectively. INSTIs were prescribed as first line therapy in 50% of PLHIV, which increased over time. Native French PLHIV were more likely to receive an INSTI-based regimen than PLHIV born abroad PLHIV (adjusted prevalence ratio 1.47, 95%CI 1.33–1.60), as were high pVL at diagnosis, hepatitis B or concomitant tuberculosis. Time before discontinuation the first ART and reaching a first undetectable pVL was not different according to the place of birth.

Conclusion:
Despite unrestricted access to INSTIs in France, independently from HIV disease parameters, PLHIV born abroad received INSTIs less frequently as a first regimen than those born in France. Qualitative data are needed to better understand physicians’ prescribing practices.
Evaluation of 11C-Choline PET/CT for T Staging and Tumor Volume Delineation in Nasopharyngeal Cancer Patients in Comparison to 18F-FDG PET/CT
Authors: Li Chunyan , Yang Yuhui , Hu Fan , Xu Yuanyuan , Wu Bian , Huang Jing , Yang Kunyu , Lan Xiaoli 
Published: April 2023

Purpose
Accurate determination of the primary tumor extension of nasopharyngeal carcinoma (NPC) by 18F-FDG PET/CT is limited by the high physiological 18F-FDG uptake in the surrounding area, especially in the brain tissue. We aimed to assess whether 11C-choline PET/CT could improve the accuracy of T staging and tumor volume delineation for NPC patients.

Methods
Patients with pathologically confirmed diagnosis of NPC were enrolled. The primary tumor extension of each patient was evaluated by 11C-choline PET/CT, 18F-FDG PET/CT, and contrast-enhanced MRI. The PET/CT-based tumor volume (V
PET) was measured by 3 threshold methods, including the threshold of SUV 2.5 (Th2.5), 40% of maximal SUV (Th40%), and the relative background-dependent threshold (Thbgd). Tumor volume and Dice similarity coefficient were compared among V
PET with different segmentation methods and V
MR.

Results
Thirty-three patients with treatment-naive NPC and 6 patients with suspicious recurrent disease were enrolled. The NPC lesions were avid for both 11C-choline and 18F-FDG. Visual analysis showed that 11C-choline PET/CT had better contrast and higher discernability than 18F-FDG PET/CT for intracranial, skull base, and orbital involvement. 11C-choline PET/CT also exhibited advantage over MRI for differentiation between local recurrence and radiation-induced alterations. For the tumor delineated, the V
MR was larger than V
PET in general, except for 18F-FDG PET/CT with Th2.5 threshold. For all 3 threshold methods applied, 11C-choline PET/CT produced more consistent and comparable tumor volume to MRI than 18F-FDG PET/CT. 11C-choline PET/CT with Thbgd threshold showed the closest tumor volume and highest similarity to MRI.

Conclusions

11C-choline PET/CT provides a higher accuracy than 18F-FDG PET/CT in mapping tumor extension in locally advanced NPC and may be a promising complement to MRI in delineating the primary tumor.
Organ Donation Organization Architecture: Recommendations From an International Consensus Forum
Authors: Williment Claire , Beaulieu Louis , Clarkson Anthony , Gunderson Susan , Hartell David , Escoto Manuel , Ippersiel Richard , Powell Linda , Kirste Gunter , Nathan Howard M. , Opdam Helen , Weiss Matthew J. 
Published: April 2023

Background.
This report contains recommendations from 1 of 7 domains of the International Donation and Transplantation Legislative and Policy Forum (the Forum). The purpose is to provide expert guidance on the structure and function of Organ and Tissue Donation and Transplantation (OTDT) systems. The intended audience is OTDT stakeholders working to establish or improve existing systems.

Methods.
The Forum was initiated by Transplant Québec and co-hosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This domain group included administrative, clinical, and academic experts in OTDT systems and 3 patient, family, and donor partners. We identified topic areas and recommendations through consensus, using the nominal group technique. Selected topics were informed by narrative literature reviews and vetted by the Forum’s scientific committee. We presented these recommendations publicly, with delegate feedback being incorporated into the final report.

Results.
This report has 33 recommendations grouped into 10 topic areas. Topic areas include the need for public and professional education, processes to assure timely referral of patients who are potential donors, and processes to ensure that standards are properly enforced.

Conclusions.
The recommendations encompass the multiple roles organ donation organizations play in the donation and transplantation process. We recognize the diversity of local conditions but believe that they could be adapted and applied by organ donation organizations across the world to accomplish their fundamental objectives of assuring that everyone who desires to become an organ donor is given that opportunity in a safe, equitable, and transparent manner.
Non-severe burns induce a prolonged systemic metabolic phenotype indicative of a persistent inflammatory response post-injury
Authors: Ryan Monique J. , Raby Edward , Whiley Luke , Masuda Reika , Lodge Samantha , Nitschke Philipp , Maker Garth L. , Wist Julien , Holmes Elaine , Wood Fiona M. , Nicholson Jeremy K. , Fear Mark W. , Gray Nicola 
Published: April 2023

AbstractGlobally, burns are a significant cause of injury that can cause substantial acute trauma as well as lead to increased incidence of chronic co-morbidity and disease. To date, research has primarily focused on the systemic response to severe injury, with little in the literature reported on impact of non-severe injuries (<15% total burn surface area; TBSA). To elucidate the metabolic consequences of non-severe burn injury, longitudinal plasma was collected from adults (n=35) who presented at hospital with a non-severe burn injury at admission, and at 6 week follow up. A cross-sectional baseline sample was also collected from non-burn control participants (n=14). Samples underwent multiplatform metabolic phenotyping using1H nuclear magnetic resonance spectroscopy and liquid chromatography-mass spectrometry to quantify 112 lipoprotein and glycoproteins signatures and 852 lipid species from across 20 subclasses.Multivariate data modelling (Orthogonal projection to latent structures-discriminate analysis) revealed alterations in lipoprotein and lipid metabolism when comparing baseline control to hospital admission samples, with the phenotypic signature found to be sustained at follow up. Univariate (Mann-Whitney U) testing and OPLS-DA indicated specific increases in GlycB (p-value <1.0e-4), low density lipoprotein-2 subfractions (Variable importance in projection score; VIP >6.83e-1) and monoacyglyceride (20:4)(p-value <1.0e-4) and decreases in circulating anti-inflammatory high-density lipoprotein-4 subfractions (VIP >7.75e-1), phosphatidylcholines, phosphatidylglycerols, phosphatidylinositols and phosphatidylserines.The results indicate a persistent systemic metabolic phenotype that occurs even in cases of non-severe burn injury. The phenotype is indicative of an acute inflammatory profile which continues to be sustained post-injury, suggesting an impact on systems health beyond the site of injury. The phenotypes contained metabolic signatures consistent with chronic inflammatory states reported to have elevated incidence post-burn injury. Such phenotypic signatures may provide patient stratification opportunities, to identify individual responses to injury, personalise intervention strategies and improve acute care, reducing risk of chronic co-morbidity.
FUME-TCRseq: Sensitive and accurate sequencing of the T-cell receptor from limited input of degraded RNA
Authors: Baker Ann-Marie , Nageswaran Gayathri , Nenclares Pablo , Ronel Tahel , Smith Kane , Kimberley Christopher , Lacle Miangela M , Bhide Shree , Harrington Kevin J , Melcher Alan , Rodriguez-Justo Manuel , Chain Benny , Graham Trevor A 
Published: April 2023

AbstractGenomic analysis of the T-cell receptor (TCR) reveals the strength, breadth and clonal dynamics of the adaptive immune response to pathogens or cancer. The diversity of the TCR repertoire, however, means that sequencing is technically challenging, particularly for samples with low quality, degraded nucleic acids. Here, we have developed and validated FUME-TCRseq, a robust and sensitive RNA-based TCR sequencing methodology that is suitable for formalin-fixed paraffin-embedded samples and low amounts of input material. FUME-TCRseq incorporates unique molecular identifiers into each molecule of cDNA, allowing correction for sequencing errors and PCR bias. We used RNA extracted from colorectal and head and neck cancers to benchmark the accuracy and sensitivity of FUME-TCRseq against existing methods, and found excellent concordance between the datasets. Furthermore, FUME-TCRseq detected more clonotypes than a commercial RNA-based alternative, with shorter library preparation time and significantly lower cost. The high sensitivity and the ability to sequence RNA of poor quality and limited amount enables quantitative analysis of small numbers of cells from archival tissue sections, which is not possible with other methods. To demonstrate this we performed spatially-resolved FUME-TCRseq of colorectal cancers using macrodissected archival samples, revealing the shifting T-cell landscapes at the transition to an invasive phenotype, and between tumour subclones containing distinct driver alterations. In summary, FUME-TCRseq represents an accurate, sensitive and low-cost tool for the characterisation of T-cell repertoires, particularly in samples with low quality RNA that have not been accessible using existing methodology.