bluuebunny/crossref_metadata_2025_split huggingface dataset:
Low-Molecular-Weight Heparin and Fondaparinux Use in Pediatric Patients With Obesity
Authors: Garner Michael P. , Onuoha Chimnonso P. , Fenn Norman E. 
Published: August 2020

Objective: The objective of this study is to comprehensively review the efficacy and safety data of low-molecular-weight heparins (LMWHs) and fondaparinux in pediatric patients with obesity. Data Sources: A comprehensive literature search of PubMed, SCOPUS, CINAHL, Academic Search Complete, PsycInfo, Cochrane Library, and Web of Science databases was conducted (1900 to July 2020). Search terms utilized included LMWH, low-molecular-weight heparin, enoxaparin, dalteparin, tinzaparin, fondaparinux, pediatric, child, children, obese, obesity, overweight. No limits or timeline restrictions were imposed. Study Selection and Data Extraction: Studies that reported pediatric patients with described overweight or obesity and utilized LMWHs or fondaparinux were considered. Data Synthesis: Of 207 studies screened, 12 were included. Average dose reductions of 12.9% to 37.3% from the starting dose were observed with treatment indications of enoxaparin and increased up to 27.3% for prophylactic indications. Trends could not be concluded in the dalteparin and fondaparinux studies. Four thrombotic and 15 bleeding events were reported in the studies. Relevance to Patient Care and Clinical Practice: Pediatric patients with obesity may initially be underdosed or overdosed with enoxaparin compared with children with healthy body weight, depending on the indication. Conclusion: Pediatric patients with obesity may benefit from proactively adjusting enoxaparin dosing on initiation of therapy. Further studies are needed for dalteparin and fondaparinux in these populations. Clinical controversy exists with the relevance of monitoring these high-risk medications for therapeutic and prophylactic indications. Thrombotic and hemorrhagic events were similar to reported adult outcomes.
Safety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma in Patients With Severe or Moderately Severe Hemophilia B: A Continuation Study
Authors: Windyga Jerzy , Stasyshyn Oleksandra , Lissitchkov Toshko , Mamonov Vasily , Serban Margit , Rusen Luminita , Ploder Bettina , Tangada Srilatha 
Published: August 2020

This phase 3, prospective, open-label, multicenter, continuation study (NCT01286779) investigated the use of a recombinant factor IX (FIX), nonacog gamma (BAX 326, RIXUBIS®) in patients with severe or moderately severe hemophilia B. The study population included 85 patients transitioning from a phase 1/3 pivotal study (NCT01174446), a pediatric study (NCT01488994), and 30 newly recruited patients, naïve to nonacog gamma. Patients received nonacog gamma as prophylaxis treatment (standard, modified or PK-tailored) or on-demand, as determined by the investigator. Treatment was assessed for safety, immunogenicity, hemostatic efficacy and consumption. In this study, after ≥100 exposure days, nonacog gamma resulted in no treatment-related serious adverse events, and no patients developed inhibitory antibodies to FIX. Nonacog gamma was efficacious at controlling bleeding episodes, with an 89.1% overall hemostatic efficacy rating of excellent or good, and 56% of bleeds resolved with one infusion. The annualized bleeding rate was considerably lower during prophylactic treatment (median ABR of 1.3 in 108 patients) than during on-demand treatment (median ABR of 16.5 in 13 patients). These results show that in previously treated patients and nonacog gamma-naïve patients, long-term use of nonacog gamma had acceptable safety and tolerability, and was efficacious as a prophylactic treatment for the management of bleeding episodes. NCT01286779, EudraCT: 2010-022726-33
Safety of ninety-minute daratumumab infusion
Authors: Lombardi Jeffrey , Boulin Mathieu , Devaux Madeline , Cransac Amélie , Pistre Pauline , Pernot Corinne , Payssot Alexandre , Lafon Ingrid , Caillot Denis , Gueneau Pauline 
Published: August 2020

Purpose Daratumumab is the first anti-CD38 monoclonal antibody of the class approved for recurrent and refractory multiple myeloma. Grade 3 and 4 Infusion-Related Reactions (IRRs) are frequent during the first and second infusions. Due to the risks associated with severe IRRs, daratumumab is systematically administered over a period of 3.5 hours. The main objective of this study was to evaluate the safety of a 90-minute daratumumab infusion from the third infusion. Patients and methods All patients who had received two or more doses of daratumumab in monotherapy or in combination with standard infusion rates were included. We excluded patients enrolled in clinical trials. For the rapid infusion protocol, 20% of the dose was administered over 30 minutes and the remaining 80% over 60 minutes. Results From April 1 to May 31, 2019, 25 patients received 53 90-minute infusions of daratumumab. Premedication included corticosteroids, antipyretics, antihistamines, and if necessary a leukotriene receptor antagonist. No grade 3 or grade 4 IRRs were observed. Conclusion From the third infusion, we found that a rapid administration of daratumumab (90 vs 210 minutes) was well tolerated and safe. It would be interesting to test this regimen from the second infusion.
Short single-wedge stems have higher risk of periprosthetic fracture than other cementless stem designs in Dorr type A femurs: a finite element analysis
Authors: Nandi Sumon , Shah Anoli , Joukar Amin , Becker Kevin , Crutchfield Cody , Goel Vijay 
Published: August 2020

Background: The use of total hip arthroplasty (THA) femoral stems that transmit force in a favourable manner to the femur may minimise periprosthetic fractures. Finite element analysis (FEA) is a computerised method that analyses the effect of forces applied to a structure with complex shape. Our aim was to apply FEA to compare primary THA cementless stem designs and their association with periprosthetic fracture risk. Methods: 3-dimensional (3D) models of a Dorr Type A femur and 5 commonly used primary THA cementless stem designs (short single wedge, standard-length single wedge, modular, double-wedge metaphyseal filling, and cylindrical fully coated) were developed using computed tomography (CT) imaging. Implant insertion, single-leg stance, and twisting with a planted foot were simulated. FEA was performed, and maximum femoral strain along the implant-bone interface recorded. Results: Femoral strain was highest with short single-wedge stem design (0.3850) and lowest with standard-length single-wedge design (0.0520). Location of maximum femoral strain varied by stem design, but not with implant insertion, single-leg stance, or twisting with a planted foot. Strain was as high during implant insertion as with single-leg stance or twisting with a planted foot. Conclusions: Our results suggest the risk of intraoperative and postoperative periprosthetic fracture with THA in a Dorr A femur is highest with short single-wedge stems and lowest with standard-length single-wedge stems. Consideration may be given to minimising the use of short single-wedge stems in THA. Implant-specific sites of highest strain should be carefully inspected for fracture.
Preemptive analgesia in hip arthroscopy: intra-articular bupivacaine does not improve pain control after preoperative peri-acetabular blockade
Authors: Kazum Efi , Rath Ehud , Shlaifer Amir , Sharfman Zachary T , Martin Hal D , Eizenberg Gilad , Reider Evgeny , Amar Eyal 
Published: August 2020

Introduction: Literature addressing postoperative pain management after hip arthroscopy is relatively scarce. This study aimed to assess if there was added analgesic benefit associated with postoperative intra-articular bupivacaine blockade for patients who received preoperative peri-acetabular blockade for hip arthroscopy procedures. Methods: 52 patients were included in this comparative cohort study. Group 1 consisted of 20 patients who received preoperative peri-acetabular blockade and postoperative intra-articular blockade. The control group (Group 2), consisted of 32 patients who received only preoperative peri-acetabular blockade. Postoperative pain was recorded via visual analogue scale (VAS) pain scores, analgesic consumption, and pain diaries for 2 weeks postoperatively. Results: Postoperative VAS pain scores were significantly lower in the experimental group at the 30-minute recovery room assessment (VAS scores Group 1: 1.1; Group 2: 3.00, p = 0.034). Other than the 30-minute recovery room assessment, VAS pain scores, narcotic medication consumption, and non-narcotic analgesic consumption did not differ between the 2 groups at any time point in the study period. Conclusions: This study did not demonstrate significant clinical benefit for patients who receive postoperative intra-articular blockade in addition to preoperative peri-acetabular blockade with bupivacaine 0.5%. We recommend the use of preoperative peri-acetabular bupivacaine blockade without intra-articular blockade postoperatively for pain control in the setting of hip arthroscopy surgery.
Primary hip arthroscopy and conversion to total hip arthroplasty: trends and survival analysis in the Medicare population
Authors: Malik Azeem T , Jain Nikhil , Scharschmidt Thomas J , Glassman Andrew H , Khan Safdar N 
Published: August 2020

Introduction: With limited evidence on national incidences of hip arthroscopy in the elderly population, the current study aims to investigate trends of primary hip arthroscopies being performed in the elderly population, using the US Medicare database, and determine risk factors for conversion to total hip arthroplasty (THA). Methods: Medicare Standard Analytic Files were queried using CPT codes to retrieve records of primary hip arthroscopies done for degenerative pathology during 2005–2014. Overall and age-stratified trends in the incidence of hip arthroscopy over time were analysed. Kaplan Meier survival curves were used to assess the overall 2-year conversion rate to a THA. Cox regression analysis was implemented to study risk factors for conversion. Results: 8100 primary hip arthroscopies for degenerative pathology were performed during 2005–2014. There was a 280% increase in overall incidence of arthroscopy. The most commonly performed arthroscopic procedure was for chondroplasty and/or resection of labrum, with 4712 (58.1%) procedures. Around 18.5% patients underwent arthroplasty within 2 years after primary arthroscopy. Following Cox regression an existing diagnosis of osteoarthritis, ages 65–69, ages 70–74, and arthroscopies done in the West were associated with higher risk of conversion to THA within 2 years. Undergoing a repeat arthroscopy was not significantly associated with a higher risk of conversion. Conclusions: Despite inconclusive clinical evidence, hip arthroscopies are being increasingly used in patients older than 65 in the Medicare population. We conclude that patients in the age bracket of 65–74 years and with a pre-existing diagnosis of osteoarthritis, arthroscopy should be approached with caution.
Venous catheter at alternate exit site in a 2-year-old requiring long-term antibiotics for osteomyelitis: A case report
Authors: Ostroff Matthew D , Goldberg David , Bauhman Greg , Korb and Cheri 
Published: August 2020

In the pediatric population, vascular access is often challenging to secure and to maintain, especially for long-term intravenous (IV) treatment. The traditional approach for patients who require long-term IV antibiotics is placement of a peripherally inserted central catheter (PICC). The challenge in the pediatric population is the high risk of dislodgement after PICC placement, as these patients tend to pull their line out accidentally or purposefully. Current bedside options to prevent catheter dislodgement include adhesive securement devices, subcutaneous securement devices, sutures, and wrapping the site in gauze. However, these modalities often fail, leading to delay in administration of IV therapies, including life-saving antibiotics. A novel approach to this very common and serious issue is to tunnel the catheter subcutaneously, thereby placing the exit site in a location difficult for the patient to reach. Tunneled catheters generally are placed in children for long-term vascular access and insertion has primarily been reserved for surgeons in the operating room or by interventional radiologists. The following case report describes a central venous access catheter placed in the internal jugular vein and tunneled to the medial dorsal thoracic region successfully at the bedside, using intracavitary electrocardiogram (ECG) navigation under moderate sedation. Although a novel exit site, the technique of tunneling and use of the jugular vein is no different than traditional tunneling techniques therefore it was not deemed necessary to seek internal review board approval.
Utility of Inferior Lead Q-waveforms in diagnosing Ventricular Tachycardia
Authors: Subramany Swathi , Kattoor Ajoe John , Kovelamudi Swathi , Devabhaktuni Subodh , Mehta Jawahar L , Vallurupalli Srikanth , Paydak Hakan , Pothineni Naga Venkata K 
Published: August 2020

Background: Electrocardiogram (ECG) differentiation of wide complex tachycardia (WCT) into ventricular tachycardia (VT) and supraventricular tachycardia with aberration (SVT-A) is often challenging. Objective: To determine if the presence of Q-waveforms (QS, Qr, QRs) in the inferior leads (II, III, aVF) can differentiate VT from SVT-A in a WCT compared to Brugada algorithm. We studied 2 inferior lead criteria namely QWC-A where all the inferior leads had a similar Q wave pattern and QWC-B where only lead aVF had a Q-waveform. Methods: A total of 181 consecutive cases of WCT were identified, digitally separated into precordial leads and inferior leads and independently reviewed by 2 electrophysiologists. An electrocardiographic diagnosis of VT or SVT-A was assigned based on Brugada and inferior lead algorithms. Results were compared to the final clinical diagnosis. Results: VT was the final clinical diagnosis in 24.9% of ECG cohort (45/181); 75.1% (136/181) were SVT-A. QWC-A and QWC-B had a high specificity (93.3% and 82.8%) and accuracy (78.2% and 71.0%), but low sensitivity (33.3% and 35.6%) in differentiating VT from SVT-A. The Brugada algorithm yielded a sensitivity of 82.2% and specificity of 68.4%. Area under the curve in ROC analysis was highest with Brugada algorithm (0.75, 95% CI 0.69-0.81) followed by QWC-A (0.63, 95% CI 0.56-0.70) and QWC-B (0.59, 95% CI 0.52-0.67). Conclusion: QWC-A and QWC-B criteria had poor sensitivity but high specificity in diagnosing VT in patients presenting with WCT. Further research combining this simple criterion with other newer diagnostic algorithms can potentially improve the accuracy of the overall diagnostic algorithm.
Development of Professional Care Program for Nurses in Dementia Wards and Its Educational Effects
Authors: Takeuchi Yoko , Kato Mayumi , Kitamura Tatsuru , Toda Daisuke , Taniguchi Yoshimi , Shogenji Miho , Tsujiguchi Hiromasa 
Published: August 2020

Purpose: To develop an education program for nurses specializing in dementia care, and to investigate its effects. Methods: An intervention study of nurses was conducted using a quasi-experiment with 3 randomly assigned groups. Participants were 51 nurses from a psychiatric hospital dementia ward, divided into an intervention program group (17 nurses), a knowledge-acquisition-only group (16 nurses), and a usual-care group (18 nurses) as controls. The program group intervention comprised 3 frameworks: motivation for achieving the task, acquisition of professional knowledge required for dementia care, and sharing of successful experiences based on professional knowledge. The knowledge-acquisition-only group received only the acquisition of professional knowledge framework, and the usual-care group received only the usual-care framework. The intervention period was 3 months. Results: Post-intervention, the program group had a significantly greater sense of self-efficacy associated with professional knowledge and significantly greater self-efficacy associated with practice compared with the knowledge-acquisition-only and the usual-care groups. Professional knowledge was acquired by 80% of the program group, compared with 70% of the knowledge-acquisition-only group. A co-occurrence network diagram of the multivariate analysis results produced by text mining of the descriptive data indicated that nurses provided care for symptoms specific to different diseases based on their pathological mechanisms. Conclusion: Program implementation led to the acquisition of deeper knowledge and greater self-efficacy by sharing expertise-based practices and successful experiences, compared with desk-based learning in a single workshop lecture, suggesting the program’s usefulness in clinical practice.
Prefrontal Cortex Activity During Walking: Effects of Aging and Associations With Gait and Executive Function
Authors: Nóbrega-Sousa Priscila , Gobbi Lilian Teresa Bucken , Orcioli-Silva Diego , Conceição Núbia Ribeiro da , Beretta Victor Spiandor , Vitório Rodrigo 
Published: August 2020

Background Declines in gait parameters are common with aging and more pronounced in tasks with increased executive demand. However, the neural correlates of age-related gait impairments are not fully understood yet. Objectives To investigate ( a) the effects of aging on prefrontal cortex (PFC) activity and gait parameters during usual walking, obstacle crossing and dual-task walking and ( b) the association between PFC activity and measures of gait and executive function. Methods Eighty-eight healthy individuals were distributed into 6 age-groups: 20-25 (G20), 30-35 (G30), 40-45 (G40), 50-55 (G50), 60-65 (G60), and 70-75 years (G70). Participants walked overground under 3 conditions: usual walking, obstacle crossing, and dual-task walking. Changes in oxygenated and deoxygenated hemoglobin in the PFC were recorded using functional near-infrared spectroscopy. Gait spatiotemporal parameters were assessed using an electronic walkway. Executive function was assessed through validated tests. Results Between-group differences on PFC activity were observed for all conditions. Multiple groups (ie, G30, G50, G60, and G70) showed increased PFC activity in at least one of the walking conditions. Young adults (G20 and G30) had the lowest levels of PFC activity while G60 had the highest levels. Only G70 showed reduced executive function and gait impairments (which were more pronounced during obstacle crossing and dual-task walking). PFC activity was related to gait and executive function. Conclusions Aging causes a gradual increase in PFC activity during walking. This compensatory mechanism may reach the resource ceiling in the 70s, when reduced executive function limits its efficiency and gait impairments are observed.
Contralateral approach to transverse-sigmoid sinus stenting
Authors: Gordon Weston , Abraham Michael 
Published: August 2020

Introduction Endovascular dural venous sinus stenting (DVSS) has emerged as a safe and effective therapy for idiopathic intracranial hypertension (IIH) in patients with transverse-sinus stenosis associated with an elevated mean pressure gradient (MPG). The typical antegrade approach, jugular to sigmoid to transverse, is not always technically feasible due to the degree of stenosis and other anatomic factors. To this point, there has been no reported cases of contralateral DVSS. We describe four cases of DVSS from a contralateral transverse-sigmoid sinus approach. Methods We describe 4 patients presenting with symptoms of IIH between 2019 and 2020 who we treated with contralateral transverse-sigmoid sinus stenting. Cases were reviewed for clinical data including initial presenting symptoms, devices used, other attempted IIH treatments, and follow up symptoms. Results Four female patients were identified and treated under general endotracheal anesthesia. Stenoses measured 72%, 78%, 67%, and 70% with MPGs across the transverse-sigmoid sinus of 19, 16, 9 and 13 mmHg, respectively. Post-stenting MPGs were 1, 0, 1 and 1 mmHg, respectively. Three patients had complete resolution of symptoms and 1 had partial resolution. No complications occurred. Conclusions This case series demonstrates successful transverse-sigmoid sinus stenting from the contralateral dural sinus and provides an alternative approach to DVSS in patients with IIH.
Challenges and prospects in Chinese pharmaceutical regulatory environment
Authors: Tripathy Swagat , Murthy PN , Patra BP , Mehra Pooja , Dureja Harish 
Published: August 2020

Background China’s pharmaceutical market is growing at a healthy pace. This is due to potential rising per capita income, an increasing elderly population, urbanisation demographics and more access to health care. Methodology The methodology used is a comparative study on the basis of original empirical research. More specifically, the part of examination facts and regulation has been written by conducting empirical research on current international and national resource concerning the subject from books, various guidelines, rules and regulation, articles, published reports and internet. Results Generally the regulatory environment in China has been considered as an very challenging one. From regulatory perspective, CFDA regulations have not been stringent enough nor has it been robust enough to create a quality supply of medications, with (1) concerns in the subject matter, quality comparison between international regulatory standard and usually accepted local products and manufactures set standards; (2) a timeline for regulatory assessment and authorization of new drugs which is much longer in comparison to most countries; (3) less number of regulatory reviewer which has led to a backlog of earlier application. The journey to reshape China from ‘made-in-China’ to ‘discovered-in-China’ is highly challenging. (4) Complications with local protection, corruption and a lack of transparency. The directives from Government has recognized the need for significant system-level transformations for streamlining the pharmaceutical regulatory environment. Conclusion Continuing on the route of reform is promising that all Chinese citizens is eventually having access to safe, effective and high-quality medications in affordable price. These reformations are encouraging and promising not only for China’s health care system, but also for global Pharmaceutical industry and that’s the reason, now many big Pharma companies are considering China as a prime focus. The companies need to make use of the new opportunities, accessible to experience the benefit of faster time-to-market, and cause rewarding growth prospect for both domestic/ multinational companies.