bluuebunny/crossref_metadata_2025_split huggingface dataset:
Covid 19 – Impact and new normal for pharmaceutical industry (Part – I)
Authors: Barshikar Ranjit 
Published: July 2020

This review article shares New Normal as part of impact of Covid 19, on Pharmaceutical Industry globally as whole & Manufacturing Operations as preventive measures or cure of Covid 19. Based on known transmissions & spreading routes, the Pharmaceutical Industry Manufacturing Operations needs to learn to avoid such impacts of transmissions & spreads. The pharmaceutical and healthcare operations need to take care to protect personnel As such The Pharmaceutical Industry does take very good care to avoid cross contaminations as part of Good Manufacturing Practices (GMP). But now keeping in mind seriousness of virus spread, the Pharmaceutical Industry has to take precautions to avoid transmission & spread during travel in buses, entry & exit procedures, change rooms, avoid hand touch to doors, handles etc. at office work places & throughout the manufacturing operations at site This article looks at various stages the Pharmaceutical Manufacturing Operation sites has to take care depending types of products & human involvement in such operations As per WHO, key major steps to protect against the infection are:  • Social distancing  • Use of Masks/Face- Shields  • Frequent Washing of Hands with soap & water or Sanitisation with proper sanitisers containing min. 70% Alcohol.  • Segregation of staff in essential & non-essential at manufacturing site.  • Non-essential staff to work from home Essential staff are the ones who are required to work in person at manufacturing site The Pharmaceutical Industry is moving forward very confidently by amending concerned SOP’s to meet Covid – 19 impact & challenges. This article describes “New Normal – impacts” of Covid-19 & basic requirements like Personal hygiene, Entry/Exit procedures to Protect the Workplace & Safety of the Workforce.
Clinical and radiographic outcomes of total shoulder arthroplasty with a partially cemented all-polyethylene pegged bone-ingrowth glenoid component: a systematic review
Authors: Malahias Michael-Alexander , Kostretzis Lazaros , Gkiatas Ioannis , Chronopoulos Efstathios , Brilakis Emmanouil , Antonogiannakis Emmanouil 
Published: July 2020

Background Several articles have been published reporting on the clinical performance of a novel pegged, all-polyethylene glenoid component design which features a central peg, circumferentially fluted, interference-fit peg for tissue integration and three small peripheral pegs for cementing. However, no systematic review exists to this date. Methods The US National Library of Medicine (PubMed/MEDLINE), EMBASE, and the Cochrane Database of Systematic Reviews were queried for publications up to May 2020. Results Overall, 13 articles were included for analysis (560 operated shoulders, range of mean follow-up: 2–6 years). The survival rate was 98.2% (550 out of 560 cases), while the rate of aseptic loosening was 0.2% (1 out of 560 cases). There were 139 cases (out of 399 reported; 34.1%) with peri-glenoid radiolucency, and 35 cases (out of 223 reported; 15.7%) of asymptomatic central peg osteolysis, with 1 of them undergoing revision. Conclusions There was fair quality of evidence to show that partially cemented all-polyethylene pegged bone-ingrowth glenoid components produce promising results, with a low revision rate in the short- to medium-term follow-up. Nevertheless, this analysis showed high rates of both radiolucency of the glenoid component and osteolysis around the central peg which raise concern for potential failure of this glenoid component in the long-term follow-up. Level of evidence Systematic review, IV.
The management of the shoulder skin microbiome (Cutibacterium acnes) in the context of shoulder surgery: a review of the current literature
Authors: Moore Nathan FE , Batten Timothy J , Hutton Christopher EJ , White William James , Smith Christopher D 
Published: July 2020

Background This review aims to establish current knowledge of the shoulder skin microbiome and how to manage the bacteria that reside within it. Methods A review was undertaken of the current literature through OvidSP. All abstracts were reviewed by three independent researchers. Results Thirty-five studies met the inclusion criteria. With forward referencing an additional 14 were included. None commented on organisms specific to the shoulder microbiome other than Cutibacterium acnes. Therefore, this review is focussed on the current knowledge of C. acnes. Discussion C. acnes is a skin commensal within the pilo-sebaceous glands reported to be the primary pathogen in up to 86% of shoulder joint infections. Pre-operative culture of unprepared skin can be indicative of underlying joint infection in shoulder arthroplasty revision. Intra-articular biopsies may have a high false positive due to skin contamination. Correlating the number of positive samples and certain associated signs can give a greater than 90% probability of a true infection. Standard surgical skin preparation, peri-surgical intravenous antibiotics and oral pre-operative antibiotics do not reduce bacterial load within the skin. However, topical benzoyl peroxide and clindamycin have both demonstrated significantly reduced bacteria load. Phylogenetically there are six main types. Patients may have more than one phenotype present during infection.
Next-generation sequencing to confirm clinical familial hypercholesterolemia
Authors: Reeskamp Laurens F , Tromp Tycho R , Defesche Joep C , Grefhorst Aldo , Stroes Erik SG , Hovingh G Kees , Zuurbier Linda 
Published: July 2020

Background Familial hypercholesterolemia is characterised by high low-density lipoprotein-cholesterol levels and is caused by a pathogenic variant in LDLR, APOB or PCSK9. We investigated which proportion of suspected familial hypercholesterolemia patients was genetically confirmed, and whether this has changed over the past 20 years in The Netherlands. Methods Targeted next-generation sequencing of 27 genes involved in lipid metabolism was performed in patients with low-density lipoprotein-cholesterol levels greater than 5 mmol/L who were referred to our centre between May 2016 and July 2018. The proportion of patients carrying likely pathogenic or pathogenic variants in LDLR, APOB or PCSK9, or the minor familial hypercholesterolemia genes LDLRAP1, ABCG5, ABCG8, LIPA and APOE were investigated. This was compared with the yield of Sanger sequencing between 1999 and 2016. Results A total of 227 out of the 1528 referred patients (14.9%) were heterozygous carriers of a pathogenic variant in LDLR (80.2%), APOB (14.5%) or PCSK9 (5.3%). More than 50% of patients with a Dutch Lipid Clinic Network score of ‘probable’ or ‘definite’ familial hypercholesterolemia were familial hypercholesterolemia mutation-positive; 4.8% of the familial hypercholesterolemia mutation-negative patients carried a variant in one of the minor familial hypercholesterolemia genes. The mutation detection rate has decreased over the past two decades, especially in younger patients in which it dropped from 45% in 1999 to 30% in 2018. Conclusions A rare pathogenic variant in LDLR, APOB or PCSK9 was identified in 14.9% of suspected familial hypercholesterolemia patients and this rate has decreased in the past two decades. Stringent use of clinical criteria algorithms is warranted to increase this yield. Variants in the minor familial hypercholesterolemia genes provide a possible explanation for the familial hypercholesterolemia phenotype in a minority of patients.
Persistence of oncogenic and non-oncogenic human papillomavirus is associated with human immunodeficiency virus infection in Kenyan women
Authors: Tong Yan , Tonui Philip , Ermel Aaron , Orang’o Omenge , Wong Nelson , Titus Maina , Kiptoo Stephen , Muthoka Kapten , Loehrer Patrick J , Brown Darron R 
Published: July 2020

Objectives: Cervical cancer is caused by persistent infection with oncogenic, or “high-risk” types of human papillomaviruses, and is the most common malignancy in Kenyan women. A longitudinal study was initiated to investigate factors associated with persistent human papillomavirus detection among HIV-infected and HIV-uninfected Kenyan women without evidence of cervical dysplasia. Methods: Demographic/behavioral data and cervical swabs were collected from HIV-uninfected women (n = 82) and HIV-infected women (n = 101) at enrollment and annually for 2 years. Human papillomavirus typing was performed on swabs (Roche Linear Array). Logistic regression models of human papillomavirus persistence were adjusted for demographic and behavioral characteristics. Results: HIV-infected women were older and less likely to be married and to own a home and had more lifetime sexual partners than HIV-uninfected women. All HIV-infected women were receiving anti-retroviral therapy at enrollment and had satisfactory CD4 cell counts and HIV viral loads. One- and two-year persistent human papillomavirus detection was significantly associated with HIV infection for any human papillomavirus, high-risk human papillomavirus, International Agency for the Research on Cancer-classified high-risk human papillomavirus, and non-oncogenic “low-risk” human papillomavirus. Conclusion: Persistent detection of oncogenic and non-oncogenic human papillomavirus was strongly associated with HIV infection in Kenyan women with re-constituted immune systems based on satisfactory CD4 cell counts. In addition to HIV infection, factors associated with an increased risk of human papillomavirus persistence included a higher number of lifetime sex partners. Factors associated with decreased risk of human papillomavirus persistence included older age and being married. Further studies are needed to identify the immunological defects in HIV-infected women that allow human papillomavirus persistence, even in women receiving effective anti-retroviral therapy. Further studies are also needed to determine the significance of low-risk human papillomavirus persistence in HIV-infected women.
Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial
Authors: Nagpal A. Dave , Cowan Andrea , Li Linna , Nusca Graeme , Guo Linrui , Novick Richard J. , Harle Chris C. , House Andrew A. , Fox Stephanie , Jones Philip M. 
Published: July 2020

Background: Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a “real-world” trial in cardiac surgery. Objective: We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design: A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting: A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants: Patients undergoing planned, isolated coronary revascularization. Measurements: Serum creatinine and patient weight were measured daily postoperatively. Methods: Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results: The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, “risk” occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas “injury” occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations: The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions: This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.
Early Surgical Fixation for Hip Fractures in Patients Taking Direct Oral Anticoagulation: A Retrospective Cohort Study
Authors: King Kieran , Polischuk Michael , Lynch Genni , Gergis Anthony , Rajesh Ashwin , Shelfoon Christopher , Kattar Nrusheel , Sriselvakumar Sajan , Cooke Cameron 
Published: July 2020

Introduction: Currently, evidence-based guidelines regarding delay to theatre for urgent surgical intervention in patients taking direct oral anticoagulants (DOACs) are lacking. Therefore, this study aims to investigate the effect of DOACs on patient outcomes receiving early (<48 hours) versus delayed (>48 hours) surgery for neck of femur fractures. Methods: A retrospective cohort study was conducted at a tertiary teaching hospital. Treatment groups were hip fracture patients taking DOACs on admission and receiving surgery in <48 hours (n = 17) and >48 hours (n = 11). A control cohort of hip fracture patients not taking DOACs (n = 56) was matched to the <48 hours treatment group for comparison. Patient demographics were recorded and key outcome measures included perioperative hemoglobin levels, transfusion rates, time to surgery, 90-day mortality, hematoma rates, and length of stay in hospital. Results: There was no significant difference in perioperative hemoglobin levels, transfusion rates, or hematoma between groups. Patients taking DOACs and receiving early surgery had significantly longer time to surgery compared to the non-DOAC control (32.21 ± 7.83 vs 25.98 ± 11.4, P = .01). No deaths were recorded in the early DOAC group at 90 days, compared to 4 (36%) in the late DOAC group ( P = .04). Discussion and Conclusions: Our study suggests hip fracture patients taking DOACs on admission is not a reason to delay surgery. However, given the lack of literature in this area, further prospective research with larger patient numbers is required to definitively guide clinical practice.
Does Anterior Cruciate Ligament Reconstruction Protect the Meniscus and Its Repair? A Systematic Review
Authors: Korpershoek Jasmijn V. , de Windt Tommy S. , Vonk Lucienne A. , Krych Aaron J. , Saris Daniel B.F. 
Published: July 2020

Background: Anterior cruciate ligament (ACL) tear and meniscal injury often co-occur. The protective effect of early ACL reconstruction (ACLR) on meniscal injury and its repair is not clear. Critical literature review can support or change clinical strategies and identify gaps in the available evidence. Purpose: To assess the protective effect of ACLR on the meniscus and provide clinical guidelines for managing ACL tears and subsequent meniscal injury. We aimed to answer the following questions: (1) Does ACLR protect the meniscus from subsequent injury? (2) Does early ACLR reduce secondary meniscal injury compared with delayed ACLR? (3) Does ACLR protect the repaired meniscus? Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review was performed through use of MEDLINE and Embase electronic databases according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms included ACL, reconstruction, and meniscus. Studies describing primary ACLR and nonoperative treatment in adult patients were included, as well as studies indicating timing of ACLR. The included articles were assessed individually for risk of bias through use of the modified Cochrane Risk of Bias and MINORS (Methodological Index for Nonrandomized Studies) tools. Results: One level 2 randomized controlled trial and several level 3 and 4 studies indicated a protective effect of ACLR on meniscal injury compared with nonoperative treatment. There was weak (level 3) evidence of the protective effect of early ACLR on the meniscus. Meniscal repair failure was less frequent in patients with ACL reconstruction than in patients with ACL deficiency (level 4). Conclusion: The evidence collected in this review suggests a protective effect of ACLR for subsequent meniscal injury (level 2 evidence). ACLR should be performed within 3 months of injury (level 3 evidence). Meniscal injury requiring surgical repair in the ACL-deficient knee should be treated with repair accompanied by ACLR (level 3 evidence). The paucity of level 2 studies prevents the formation of guidelines based on level 1 evidence. There is a strong clinical need for randomized or prospective trials to provide guidelines on timing of ACLR and meniscal repair.
Gingival Thickness and Outcome of Periodontal Plastic Surgery Procedures: A Meta-regression Analysis
Authors: Holtzman L. Paternò , Blasi G. , Rivera E. , Herrero F. , Downton K. , Oates T. 
Published: July 2020

Objective: To evaluate the impact of soft tissue thickness (STT) on root coverage achieved with different periodontal plastic surgery procedures. Background: Gingival recession has been managed successfully through various surgical approaches, with great variability in outcomes. Anatomic characteristics of the recipient site and selected technique account in part for this variability. Gingival flap thickness is one of the most critical site-related characteristics. Methods: An electronic search was conducted on the major databases (PubMed, Embase, Web of Science). Human prospective studies with at least 6 mo of follow-up and with a numeric baseline measurement for gingival thickness were eligible. Only studies including nonsmoking patients were considered. Variables included surgical approach, participant characteristics, local anatomic factors, and follow-up time. Primary outcome was mean percentage root coverage (%RC) achieved, and complete root coverage was a secondary outcome. Results: A total of 42 studies were included (35 randomized controlled trials, 5 case series, 1 prospective cohort study, and 1 controlled clinical trial). Across studies, the pooled %RC was 81.9% (95% CI, 79.1% to 84.7%). The %RC was not significantly associated ( P = 0.267) with baseline soft tissue thickness; however there was a significant ( P = 0.031) inverse relationship between STT and %RC after 12-mo follow-up. Subgroup analysis showed that for no graft, there was a significant ( P = 0.025) positive relationship between STT and %RC with the exclusion of the single outlier study based on STT. Conclusions: STT plays a limited role in predicting root coverage across all approaches; when flaps are performed with no graft, the effect of STT is most critical. The length of time following surgery appears to influence outcomes, with 12-mo follow-up offering greater insight. Knowledge Transfer Statement: The results of this study can suggest to clinicians which periodontal plastic surgery technique to employ when treating challenging cases. In particular, it can be helpful when selecting the treatment approach to treat thin phenotype sites. This study could help clinicians provide a more appropriate treatment decision in such cases.
Intra-articular Calcaneus Fractures: Current Concepts Review
Authors: Allegra Paul R. , Rivera Sebastian , Desai Sohil S. , Aiyer Amiethab , Kaplan Jonathan , Gross Christopher Edward 
Published: July 2020

Calcaneal fractures are the most common fracture of the tarsal bones and represent 1% to 2% of all fractures. Roughly 75% of these fractures include intra-articular involvement of the posterior facet of the calcaneus. Intra-articular calcaneal fractures are challenging injuries to manage for both patients and surgeons given their association with both early and late complications. This article aims to review the management, classification systems, surgical approaches, and care regarding intra-articular calcaneal fractures. A review of the current literature yielded treatment strategies that aim to reduce complications such as soft tissue injury or loss of articular reduction while maintaining satisfactory clinical outcomes. The purpose of this article is to review these current concepts in the management of intra-articular calcaneal fractures. Level of Evidence: Level V, expert opinion.
Trends in Publication and Levels of Evidence in Foot & Ankle International From 2000 to 2015
Authors: Griffith Matthew , Han Edward , Hattaway Joshua , Huh Jeannie 
Published: July 2020

Background: As the movement toward evidence-based medicine grows and publication rates rise each year, critical analysis of the orthopedic literature has become increasingly important. To aid readers in assessing the scientific quality of published research, Foot & Ankle International ( FAI) began assigning levels of evidence to all clinical articles in 2008. The purpose of this study was to analyze trends in the characteristics and levels of evidence of articles published in FAI between 2000 and 2015. Methods: All articles published in FAI from the years 2000, 2005, 2010, and 2015 were reviewed and categorized into article type (clinical, basic science, review, or technical tip). Each clinical article was assigned a level of evidence (I-V) and study type (prognostic, therapeutic, economic, or diagnostic). Descriptive information was gathered pertaining to country of origin, author credentials, and funding. Statistical analysis was performed using chi-squared tests to detect any trends in levels of evidence and publication characteristics. Results: A total of 647 articles were reviewed. From 2000 to 2015, there was a statistically significant increase in the publication of clinical research articles (70% to 83%; P = .013), while the number of basic science articles decreased (29% to 17%; P = .013). Of the clinical articles, there was a significant increase in therapeutic studies (41% to 58%; P = .003). During the study period, the publication of Level I and II evidence significantly increased (2% to 14%; P = .002). Although Level III and V evidence also increased (65% to 71%, P > .99), this was not found to be statistically significant. Publications originated from a total of 39 countries, with a significant increase in the proportion of international papers (33% to 48%; P = .007) over the study period. The proportion of articles authored by Doctors of Podiatric Medicine (DPMs) during the study period significantly decreased (4% to 2%, P = .035). Finally, the percentage of studies that disclosed the use of outside funding increased during the study period, with reported funding from grants or professional groups rising from 3% to 16% ( P < .001) and reported funding from commercial sources rising from 0% to 9% ( P = .002). Conclusion: The proportion of Level I and II studies published in FAI significantly increased from 2000 to 2015. The publication of clinical research rose, with a majority being therapeutic studies. There was a significant increase in articles published by international authors and a significant decrease in articles published by DPMs. During the same time period, there was a rise in the proportion of articles reporting the use of outside funding, both professional and commercial.