bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety Assessment of Streptococcus salivarius UBSS-01 in Rats and Double-Blind Placebo-Controlled Study in Healthy Individuals
Authors: Jatoth Bindhu S. , Rahman Ziaur , Dandekar Manoj P. , Venkataraman Rajesh , Shivalingegowda Ravi K. , Manuel Gloriya G. 
Published: April 2024

Streptococcus salivarius is a common, harmless, and prevalent member of the oral microbiota in humans. In the present study, the safety of S. salivarius UBSS-01 was evaluated using in silico methods and preclinical and clinical studies. In an acute toxicity study, rats were administered with 5 g/kg (500 × 109 CFU) S. salivarius UBSS-01. The changes in phenotypic behaviors and hematological, biochemical, electrolytes, and urine analyses were monitored. No toxicity was observed at 14 days post-treatment. The no observable effects limit (NOEL) of S. salivarius UBSS-01 was >5 g/kg in rats. In a 28-day repeat dose toxicity study, rats were administered S. salivarius UBSS-01 once daily at doses of 0.1, 0.5, and 1 g/kg (10, 50, and 100 billion CFU/kg, respectively) body weight. S. salivarius UBSS-01 did not influence any of the hematology parameters and clinical chemistry parameters in plasma and serum samples after 28-day repeated administration. No structural abnormality was observed in the histological examination of organs. Whole genome analysis revealed the absence of virulence factors or genes that may transmit antibiotic resistance. In the double-blind study with 60 human participants (aged 18–60 years), consumption of S. salivarius UBSS-01 for 30 days was found to be safe and results were comparable with placebo treatment These findings indicate that S. salivarius UBSS-01 may be safe for human consumption.
Combined superficial keratectomy, alcohol delamination and amniotic membrane patch with fibrin glue in Salzmann nodular degeneration
Authors: Messina Marco , Poddi Maria , De Santi Nicola , Bianchi Eduardo , Cagini Carlo 
Published: April 2024

Purpose To describe the outcomes of five Salzmann's Nodular Degeneration (SND) cases treated with a combination of alcohol delamination, superficial keratectomy and amniotic membrane patch with fibrin glue. Methods Five patients affected by SND with significant discomfort and decreased visual acuity were evaluated with refraction, best corrected visual acuity, Break-up time test, corneal topography, Anterior Segment of Optical Coherence Tomography and images of anterior segment with a full slit lamp examination. All the patients underwent alcohol delamination of the corneal epithelium followed by superficial keratectomy to remove the subepithelial nodules. A patch of amniotic membrane was applied to all of them with a ring shape and a banana shape in two patients due to the location of the disease. A bandage contact lens was inserted. The patch was kept in place for 14 days. Another bandage contact lens was inserted for 21 days until the corneal epithelium had completely healed. Results The surgical procedure was successful in removing the nodules in all patients. Vision was restored in all cases with a significant regularization of the corneal surface and reduction of ocular discomfort. After a 12-month follow-up, none of the patients showed recurrence of the disease. Conclusions Combining alcohol delamination with superficial keratectomy and amniotic membrane patch with fibrin glue is an effective procedure for the management of SND to regularize the corneal surface and avoid the recurrence of subsequent nodules. This report is the first description of the outcomes of SND cases treated with a combination of the aforementioned techniques.
Results of Palliative Stenting in Malignant Superior Vena Cava Syndrome Analyzing Self-Expanding Stainless Steel and Nitinol Venous Bare Metal Stents
Authors: Rioja Artal Sara , González Martínez Victor , Royo Serrando Josep , Delgado Daza Rafael , Moga Donadeu Lluis 
Published: April 2024

Purpose: The purpose was to analyze the technical, clinical, and survival outcomes of our patients with malignant superior cava vein syndrome (SVCS) treated with endovascular approach and analyze the efficacy of different stent types used. Material and Methods: It is an observational, retrospective, single-center study. From 2006 to 2023, 42 patients (32 male, 10 female, mean age 62 years, age range, 41-87 years) underwent percutaneous stent placement for malignant SVCS. One stainless steel stent (Wallstent) and 2 venous nitinol stent type (Sinus-XL, Venovo) were used. Follow-up mean was 276 days. Results: A total of 53 stents were deployed. Clinical success was 97.6% in less 24 hours. Technical success was achieved in 97.6%. No complications were found except 1 patient died during the procedure due to stent migration and atrial dissociation (2.3%). Overall intraprocedural stent migration rate was 11.9% (18.8% stainless steel stent, 9.6% nitinol stent, p>0.05). Overall survival rates were 87.8%, 41.99%, and 34.12%, and overall primary patency rates were 100%, 93.3%, 91.6% at 1, 6, and 12 months, respectively. Conclusions: Endovascular treatment is a safe and effective therapeutic option for SVCS with high technical and clinical success rates and low complication and recurrence rates. Clinical impact The malignant superior cava vein syndrome is a rare clinical entity treated classically with radiation and chemotherapy with a slower response, or surgical bypass, which is an aggressive surgical technique. Endovascular treatment offers a low-invasive technique with quick clinical resolution and good permeability results. However, further studies are lacking to deal with procedure technical characteristics, stent type used, technical complications, and medium- and long-term patency studies. This study aims to evaluate all these items, analysing self-expanding stainless steel and nitinol venous bare metal stents, and add value to endovascular treatment, confirming the good results of this technique.
Clinical efficacy of sodium aescinate administration following endovenous laser ablation for varicose veins
Authors: Yang Xinrui , Jin Jian , Huang Siyi , Qiu Peng , Wang Ruihua , Ye Kaichuang , Lu Xinwu 
Published: April 2024

Background Endovenous interventions and minimally invasive procedures are effective in the management of varicose veins. However, they can cause postoperative discomfort. Objective To evaluate the clinical efficacy of sodium aescinate (SA) in improving edema, pain, vein-specific symptoms, and quality of life in patients following endovenous laser ablation (EVLA) for varicose veins. Methods In this single-center randomized controlled trial (RCT), patients were allocated into two groups: in Group A, 60 mg SA was administered twice daily for 20 days, and in Group B (control), no venoactive drug was prescribed. The Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system for chronic venous disorders was used to assess the varicose veins. The circumferences of the calf and ankle were recorded for evaluating edema. The 10-point Visual Analog Scale (VAS), Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Veins Questionnaire (AVVQ) were used to measure the pain intensity, overall varicose vein severity, and patient’s quality of life, respectively. Results The study included 87 patients (mean age, 59.9 ± 10.7 years; 54 men) with CEAP class C2–C5 varicose veins who underwent EVLA and phlebectomy or foam sclerotherapy. The calf circumference recovered quicker in Group A than in Group B by days 10, 21, and 30 (difference from baseline was 1.04 ± 0.35 vs 2.39 ± 1.15 [ p < .001], 0.48 ± 0.42 vs1.73 ± 1.00 [ p < .001], and 0.18 ± 0.64 vs 0.82 ± 0.96 [ p < .001], respectively). The ankle circumference recovered quicker in Group A than in Group B by days 10 and 21 (the difference from baseline was 1.37 ± 0.52 vs 2.36 ± 0.93 [ p < .001] and 0.58 ± 0.60 vs 1.14 ± 0.88 [ p = .002], respectively). Pain relief was achieved quicker in Group A than in Group B (0.257 ± 1.097 [ p = .0863] vs 0.506 ± 1.250 [ p = .0168] by day 21). There were no significant differences in the VCSS and AVVQ scores between both groups. There were no drug-related adverse effects. Conclusions SA, in combination with compression therapy, can relieve edema and alleviate pain in patients following EVLA for varicose veins.
Temporal association between atrial fibrillation and ischemic stroke: Systematic review and meta-analysis
Authors: D’lima Jessica , Thijs Vincent , Lim Han S , Rodrigues Thalys Sampaio , Beaudoin Ann-Marie 
Published: April 2024

Background: Paroxysmal atrial fibrillation (PAF) is strongly associated with ischemic stroke. Continuous cardiac implantable electronic devices (CIEDs) can assess PAF episodes over prolonged periods. Studies that attempted to find a temporal association between PAF and ischemic stroke were inconclusive. Thus, we performed a systematic review and meta-analysis to assess this relationship. Aims: This study aimed to assess the temporal association between AF episodes and stroke within 30 days of the arrhythmic episode. The secondary outcome is a temporal association within a 90-day period. Summary of review: A total of 2804 studies that discussed the temporal relationship between PAF and ischemic stroke were screened, and 7 studies were included in the meta-analysis. Among the 4041 patients included in these studies, there were 138 patients with device detected PAF episodes and stroke. Four studies used a 30-day window for temporality and the pooled odds ratio (OR) showed a significant association (OR 4.11 (95% CI 1.03–16.40)). The three studies reporting on AF and stroke within a 90-day window did not find a significant temporal relationship (OR 0.43 (95% CI 0.13–1.41)). Finally, the pooled result of those seven studies did not show a significant association (OR 1.51 (95% CI 0.44–5.17)). Conclusion: This meta-analysis supports a temporal relationship between PAF and ischemic stroke within a 30-day window. Establishing this relationship is important for individualized risk prediction and targeted anticoagulation treatment. Data access statement: The data will be made available upon reasonable request.
A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke with Proven Occlusion (TEMPO-2): Rational and design of a multicenter, randomized open-label clinical trial
Authors: Singh Nishita , Kenney Carol C , Butcher Ken S , Buck Brian , Barber Philip A , Field Thalia S , Choi Philip M , Yu Amy YX , Kleinig Timothy , Appireddy Ramana , Molina Carlos A , Muir Keith W , Hill Michael D , Coutts Shelagh B 
Published: April 2024

Background: Almost half of acute ischemic stroke patients present with mild symptoms and there are large practice variations in their treatment globally. Individuals with an intracranial occlusion who present with minor stroke are at an increased risk of early neurological deterioration and poor outcomes. Individual patient data meta-analysis in the subgroup of patients with minor deficits showed benefit of alteplase in improving outcomes; however, this benefit has not been seen with intravenous alteplase in published randomized trials. Design: TEMPO-2 (A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion) is a prospective, open label with blinded outcome assessment, randomized controlled trial, designed to test the superiority of intravenous tenecteplase (0.25 mg/kg) over nonthrombolytic standard of care, with an estimated sample size of 1274 patients. Adult patients presenting with acute ischemic stroke with the National Institutes of Health Stroke Scale (NIHSS) ⩽ 5 and visible arterial occlusion or perfusion deficit within 12 h of onset are randomized to receive either tenecteplase (0.25 mg/kg) or standard of care. The primary outcome is return to baseline neurological functioning, measured by the modified Rankin scale (mRS) at 90 days. Safety outcomes include death and symptomatic hemorrhage (intra or extra-cranial). Other secondary outcomes include mRS 0–1, mRS 0–2, ordinal shift analysis of the mRS, partial, and full recanalization on follow-up computed tomography angiogram. Conclusion: Results of this trial will aid in determining whether there is benefit of using tenecteplase (0.25 mg/kg) in treating patients presenting with minor stroke who are at high risk of developing poor outcomes due to presence of an intracranial occlusion. Data access statement: Data will be available upon reasonable request.
Variability in Surgical Case Volume Performed During ACGME-Accredited Orthopaedic Foot and Ankle Fellowship Training
Authors: Silvestre Jason , Reid Jared J. , Scott Daniel J. , Aiyer Amiethab A. , Gross Christopher E. 
Published: April 2024

Introduction Previous studies have demonstrated a positive correlation between case volume and outcomes in foot and ankle surgery. This study elucidates surgical case volume benchmarks for Accreditation Council for Graduate Medical Education (ACGME)–accredited orthopaedic foot and ankle fellowship training in the United States. Methods The ACGME provided case logs for orthopaedic residents and foot and ankle fellows (2018-2021). Variabilities in reported fellowship case volumes were defined as the fold-difference between 90th and 10th percentiles. Reported case volumes were compared between training cohorts with parametric tests. Results Case logs from 65 orthopaedic foot and ankle fellows and 3146 orthopaedic residents were included. Fellows reported 1.3- to 1.5-fold more foot and ankle cases during fellowship training than during residency training (P < .001). On average, orthopaedic foot and ankle fellows reported 405.4 cases and most were arthrodesis (17%), forefoot reconstruction (17%), mid/hindfoot reconstruction (13%), tendon repair/transfer (12%), and trauma ankle hindfoot (11%). Case categories with the highest variabilities were amputation (14.8-fold difference), infection/tumor (11.6-fold difference), arthroscopy (9.2-fold difference), and calcaneus (8.7-fold difference). Discussion Case volume benchmarks can assist trainees and faculty during orthopaedic foot and ankle training. More research is needed to determine case minimum requirements needed for autonomous practice in foot and ankle surgery. Level of Evidence: Level III
Comparing Rates of Radiographic Baseplate Loosening Between Cement and Cementless INFINITY Total Ankle Prostheses
Authors: Millstein Ian Daniel , Koneru Manisha , Dibato John Epoh , Gentile Pietro , Mahjoub Adel , Freeland Erik 
Published: April 2024

Introduction Total ankle replacement is indicated for end-stage ankle osteoarthritis. Periprosthetic radiolucency, from separation between the bone and implant, is suggested to be indicative of potential prosthesis failure risk. Anchoring implants with cement may mitigate this. This study aimed to compare rates of periprosthetic radiolucency between patients with cement-affixed and cementless implants. Methods A retrospective analysis was performed on 28 patients who underwent total ankle replacement with the INFINITY Total Ankle System (Wright Medical, Memphis, Tennessee) implant between January 2016 and May 2022. Anteroposterior, mortise, and lateral ankle X-rays were reviewed by 2 independent reviewers for tibiotalar angle, talar tilt, and periprosthetic radiolucency. The Wilcoxon rank-sum test and chi-square test were performed. Results The incidence of periprosthetic radiolucency at the most recent follow-up did not significantly differ between cement and cementless groups (57.1% in both groups, P = 1.0). Follow-up tibiotalar and talar tilt angles were not significantly different (P > .51 for all comparisons) Conclusions Patients with cemented implants had a similar incidence of periprosthetic radiolucency compared with patients with cementless prostheses. Understanding of long-term clinical outcomes will help inform optimal operative approaches for ankle prostheses. Levels of Evidence: Therapeutic, Level III, Retrospective cohort study
Fixing a Hole: a retrospective cohort study evaluating HAV, HBV, tetanus screening, and vaccination during hospitalization in persons who use substances
Authors: Streifel Amber C. , Rivera Sarti Jose Eduardo , Sikka Monica K. , Conte Michael , Winders Bradie , Varley Cara D. 
Published: April 2024

Background: Rates of serious injection-related infections in persons who use drugs have increased. Resulting admissions are an opportunity for screening and vaccination of preventable infections such as hepatitis A virus (HAV), hepatitis B virus (HBV), and tetanus. Design and methods: We conducted a retrospective review of adults with documented substance use admitted for bacterial infection between July 2015 and March 2020. We evaluated HAV, HBV, and tetanus vaccination status at admission, along with screening for HAV and HBV infection and immunity. We identified the proportion of patients at risk for infection who received HAV, HBV, and tetanus vaccines during admission and patient-level factors associated with vaccination. Results: We identified 280 patients who met our inclusion criteria. Of the 198 (70.7%) patients at risk for HAV, infectious disease providers recommended vaccination for 21 (10.6%) and 15 (7.6%) received HAV vaccine. Of the 174 (62.1%) patients at risk for HBV, infectious disease providers recommended vaccination for 32 (18.3%) and 25 (14.4%) received HBV vaccine. A large proportion of patients (31.4%, 88) had no documentation of prior tetanus vaccination, and infectious disease providers recommended tetanus vaccination for three (1.1%) and five patients (1.8%) received a tetanus booster. Infectious disease consult vaccine recommendations were statistically significantly associated with HAV or HBV vaccination prior to discharge. Conclusion: Over 70% of our population is at risk for one or more of these preventable infections. Efforts are needed to maximize inpatient screening and vaccination for HAV, HBV, and tetanus in patients with barriers to care.
Three cycles of mobile app design to improve HIV self-management: A development and evaluation study
Authors: Kim Gwang Suk , Kim Layoung , Baek Seoyoung , Shim Mi-So , Lee SangA , Kim Ji Min , Yoon Jong Yae , Kim Jin , Choi JunYong , Choi Jae-Phil 
Published: April 2024

Objective Employing three cycles of Design Science Research (DSR) to develop a mobile app ‘ESSC (Excellent Self Supervised HIV Care)’ to improve self-management among people living with HIV (PLWH). Methods This study is based on the DSR framework comprising three iterative cycles. In the Relevance cycle, PLWH participated in a survey of mobile health (mHealth) experiences and needs. In the Rigor cycle, the information-motivation-behavioural skills (IMB) model was applied to foundations of the app, and HIV specialists verified the contents. Experts evaluated the heuristic system and the app quality with the Mobile Application Rating Scale (MARS). In the Design cycle, ESSC was built on the findings of the other two cycles, and end-users tested the usability using uMARS. Results The contents of the app were developed based on user requirements. The IMB model led ESSC to supplement motivational components for self-management, which built five functions: information contents; health life records including mental and sexual health; interactive counselling with healthcare providers; setting health goals after watching videos; and my page for self-reflection. To reduce social stigma and promote acceptance of the information-driven app, we created animated characters with neutral and bright features. The HIV specialists evaluated content validity as highly appropriate. The MARS score by the overall raters was between 3- acceptable and 4- good: functionality, 4.38; information, 4.12; aesthetics, 3.96; engagement, 3.37; and subjective quality, 3.25. Conclusions The DSR approach is effective for implementing usable and useful mHealth. The ESSC app would be feasible and contribute PLWH to retention in care.
Coronavirus disease 2019 infection among working-aged people with multiple sclerosis and the impact of disease-modifying therapies
Authors: Murley Chantelle , Pettersson Emma , Hillert Jan , Machado Alejandra , Friberg Emilie 
Published: April 2024

Background The risk of coronavirus disease 2019 among people with multiple sclerosis with different disease-modifying therapies is not well established. Objective To investigate the occurrence of coronavirus disease 2019 and the remaining symptoms among people with multiple sclerosis and the associations with different disease-modifying therapies. Methods Individuals aged 20–50 listed in the Swedish Multiple Sclerosis Registry were invited to participate in a survey in 2021. Information on reported coronavirus disease 2019 infection and remaining symptoms were linked to individual-level register data. The risks by disease-modifying therapy of having coronavirus disease 2019 or having remaining symptoms were estimated with logistic regression. Results Of the 4393 participants, 1030 (23.4%) self-reported coronavirus disease 2019 (749 confirmed and 281 suspected). The observed odds for coronavirus disease 2019 did not differ by disease-modifying therapy ( p-values <0.05). The majority reporting coronavirus disease 2019 had fully recovered (68.5%), 4.2% were currently/recently sick, and 27.0% had symptoms remaining after 2 months. The most frequently reported remaining symptoms involved one's sense of smell or taste (37.0%), fatigue (20.0%), and breathing (12.0%). No statistically significant associations were observed between having remaining symptoms and the disease-modifying therapy. Conclusion Despite the initial concerns of differing infection risks by MS treatments, we observed no differences in coronavirus disease 2019 occurrence or remaining symptoms among those who had coronavirus disease 2019. Nonetheless, exercising caution in interpreting our findings, it remains implicit that people with multiple sclerosis are particularly susceptible to infection and that lingering symptoms may persist beyond the initial infection.
Perispinal Etanercept to improve STroke Outcomes (PESTO): Protocol for a multicenter, international, randomized placebo-controlled trial
Authors: Thijs Vincent , Cloud Geoffrey C , Gilchrist Nigel , Parsons Brooke , Tilvawala Forum , Ho Jan , Ruthnam Lara , Stanislaus Vimal , Sprigg Nikola , Walker Marion , Bath Philip M , Churilov Leonid , Bernhardt Julie 
Published: April 2024

Rationale: A large proportion of stroke survivors will have long-lasting, debilitating neurological impairments, yet few efficacious medical treatment options are available. Etanercept inhibits binding of tumor necrosis factor to its receptor and is used in the treatment of inflammatory conditions. Perispinal subcutaneous injection followed by a supine, head down position may bypass the blood brain barrier. In observational studies and one small randomized controlled trial the majority of patients showed improvement in multiple post stroke impairments. Aim: Perispinal Etanercept to improve STroke Outcomes (PESTO) investigates whether perispinal subcutaneous injection of etanercept improves quality of life and is safe in patients with chronic, disabling, effects of stroke. Methods and design: PESTO is a multicenter, international, randomized placebo-controlled trial. Adult participants with a history of stroke between 1 and 15 years before enrollment and a current modified Rankin scale between 2 and 5 who are otherwise eligible for etanercept are randomized 1:1 to single dose injection of etanercept or placebo. Study outcomes: The primary efficacy outcome is quality of life as measured using the Short Form 36 Health Inventory at day 28 after first injection. Safety outcomes include serious adverse events. Sample size target: A total of 168 participants assuming an improvement of the SF-36 in 11% of participants in the control arm and in 30% of participants in the intervention arm, 80% power and 5% alpha. Discussion: PESTO aims to provide level 1 evidence on the safety and efficacy of perispinal etanercept in patients with long-term disabling effects of stroke.