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Assessment of therapeutic clinical trials for proximal humeral fractures

  • Jonathan Koa;Mohamad Y. Fares;Mohammad Daher;Joseph A. Abboud
    • Clinics in Shoulder and Elbow
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    • v.27 no.2
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    • pp.237-246
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    • 2024
  • Proximal humeral fractures (PHFs) are a common injury among the older population. An ideal therapeutic protocol has yet to be developed, and numerous clinical trials are being conducted to find the best therapeutic approach. The purpose of this study is to evaluate the current body of knowledge available via interventional clinical trials. In December 2022, interventional clinical trials relating to PHFs on Clinicaltrials.gov were screened. Trial characteristics included duration, status, intervention, phase, outcomes, location, and study design. Publications associated with each trial were searched on PubMed/Medline using the ClinicalTrials.gov registry number. The final dataset comprised 64 trials. The most common trial status was completed (36%). The majority did not have a Food and Drug Administration-defined phase (67%), was randomized (81%), involved a single facility (72%), used a parallel assignment intervention model (80%), and used an open-label approach (45%). Eleven trials were associated with a publication, and the publication rate was 17%. Average enrollment was 86 participants, and mean trial duration was 51.4 months. Europe/UK/Russia/Turkey participated in the most trials (70%). Most of the trials were initiated after 2010 (87.5%). Procedure-related interventions (55%) were most common. Disability/function was the most common primary outcome assessed (61%). The low publication rate and the multitude of trials conducted after 2010 highlight the urgency and need for trial results to be published to establish an ideal therapeutic protocol. Since the majority of the trials involved a single institution and an open-label approach, reinforcing blinding and establishing multi-centered trials can improve the validity of the clinical trial results.

Acromioclavicular joint dislocation and concomitant labral lesions: a systematic review

  • Jad Mansour;Joseph E Nassar;Michel Estephan;Karl Boulos;Mohammad Daher
    • Clinics in Shoulder and Elbow
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    • v.27 no.2
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    • pp.247-253
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    • 2024
  • Acromioclavicular (AC) joint dislocations frequently co-occur with intra-articular glenohumeral pathologies. Few comprehensive studies have focused on labral tears specifically associated with AC joint trauma. This systematic review will address this gap. A comprehensive electronic search was conducted across PubMed, Cochrane Library, and Google Scholar (pages 1-20) spanning from 1976 to May 19, 2023. Seven studies met the inclusion criteria for this systematic review, consisting of three retrospective studies and four case series. These studies collectively involved 1,044 patients, of whom 282 had concomitant labral lesions. The pooled prevalence of intra-articular labral injuries associated with acute AC joint dislocation was 27%. The prevalence of these labral lesions varied significantly between studies, ranging from 13.9% to 84.0% of patients, depending on the study and the grade of AC joint dislocation. Various types of labral tears were reported, with superior labrum anterior to posterior (SLAP) lesions being the most common. The prevalence of SLAP lesions ranged from 7.2% to 77.4%, with higher grades of AC joint dislocations often associated with a higher prevalence of SLAP tears. Moreover, grade V dislocations exhibited a complete correlation with SLAP tears. The studies yielded contradictory findings regarding older age and higher grades of AC joint dislocation as risk factors for concurrent labral lesions. This review underscores the frequent association between labral lesions and AC joint dislocations, particularly in cases of lower-grade injuries. Notably, SLAP lesions emerged as the predominant type of labral tear.

Bilateral reverse shoulder arthroplasty versus bilateral anatomic shoulder arthroplasty: a meta-analysis and systematic review

  • Mohammad Daher;Mohamad Y. Fares;Jonathan Koa;Jaspal Singh;Joseph Abboud
    • Clinics in Shoulder and Elbow
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    • v.27 no.2
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    • pp.196-202
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    • 2024
  • Background: As the population is aging and indications are expanding, shoulder arthroplasty is becoming more frequent, especially bilateral staged replacement. However, surgeons are hesitant to use bilateral reverse prostheses due to potential limitations on activities of daily living. Methods: This meta-analysis was conducted to compare bilateral anatomic to bilateral reverse shoulder implants. PubMed, Cochrane, and Google Scholar (pages 1-20) were searched until April 2023. The clinical outcomes consisted of postoperative functional scores (American Shoulder and Elbow Surgeons [ASES], Single Assessment Numeric Evaluation [SANE], Physical Component Score [PCS], Mental Component Score, and Simple Shoulder Test), pain, and range of motion (external rotation and forward elevation). Three studies were included in this meta-analysis. Results: Bilateral anatomic implants had better postoperative functional outcomes and range of motion, but no significant difference was seen in postoperative pain when compared to the reverse prosthesis. Better ASES score, SANE score, and PCS as well as better external rotation and forward elevation were seen in the bilateral anatomic shoulder replacement group, but no significant difference in pain levels was seen between the two groups Conclusions: The results may be explained by the lower baseline seen in the reverse prosthesis group, which may be due to an older population and different indications. Nevertheless, more randomized controlled studies are needed to confirm these findings. Level of evidence: III.

Efficacy, immunogenicity, and safety of COVID-19 vaccines in individuals with liver cirrhosis: a rapid review and meta-analysis

  • Faranak Salajegheh;Mohammad Rezaei Zadeh Rukerd;Mohsen Nakhaie;Zohreh-Al-Sadat Ghoreshi;Javad Charostad;Nasir Arefinia
    • Clinical and Experimental Vaccine Research
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    • v.13 no.2
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    • pp.83-90
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    • 2024
  • The emergence of coronavirus disease 2019 (COVID-19) vaccines has been a remarkable advancement. However, the efficacy, immunogenicity, and safety of these vaccines in individuals with liver cirrhosis require careful evaluation due to their compromised immune status and potential interactions with underlying liver disease. The present study aimed to evaluate the safety and efficacy of COVID-19 vaccines in liver cirrhosis patients. In the present study, we searched international databases, including Google Scholar, PubMed, Scopus, Embase, and Web of Science. The search strategy was carried out by using keywords and MeSH (Medical Subject Headings) terms. STATA ver. 15.0 (Stata Corp., USA) was used to analyze the data statistically. The analysis was performed using the randomeffects model. We also used the chi-square test and I2 index to calculate heterogeneity among studies. For evaluating publication bias, Begg's funnel plots and Egger's tests were used. A total of 4,831 liver cirrhosis patients with COVID-19 were examined from 11 studies. The rate of hospitalization in the patients with liver cirrhosis was 17.6% (95% confidence interval [CI], 9%-44%). The rate of fever in the patients with liver cirrhosis was 4.5% (95% CI, 0.9%-8.1%). The rate of positive neutralizing antibodies in the patients with liver cirrhosis was 82.5% (95% CI, 69.8%-95.1%). Also, the rates of seroconversion after the second vaccination in patients with liver cirrhosis and the control group were 96.6% (95% CI, 92.0%-99.0%), and 99.7% (95% CI, 99.0%-100.0%), respectively. COVID-19 vaccines have demonstrated promising efficacy, immunogenicity, and safety profiles in individuals with liver cirrhosis, providing crucial protection against COVID-19-related complications.

Acute abdomen following COVID-19 vaccination: a systematic review

  • Nelson Luis Cahuapaza-Gutierrez;Renzo Pajuelo-Vasquez;Cristina Quiroz-Narvaez;Flavia Rioja-Torres;Maria Quispe-Andahua;Fernando M. Runzer-Colmenares
    • Clinical and Experimental Vaccine Research
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    • v.13 no.1
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    • pp.42-53
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    • 2024
  • Purpose: Conduct a systematic review of case reports and case series regarding the development of acute abdomen following coronavirus disease 2019 (COVID-19) vaccination, to describe the possible association and the clinical and demographic characteristics in detail. Materials and Methods: This study included case report studies and case series that focused on the development of acute abdomen following COVID-19 vaccination. Systematic review studies, literature, letters to the editor, brief comments, and so forth were excluded. PubMed, Scopus, EMBASE, and Web of Science databases were searched until June 15, 2023. The Joanna Briggs Institute tool was used to assess the risk of bias and the quality of the study. Descriptive data were presented as frequency, median, mean, and standard deviation. Results: Seventeen clinical case studies were identified, evaluating 17 patients with acute abdomen associated with COVID-19 vaccination, which included acute appendicitis (n=3), acute pancreatitis (n=9), diverticulitis (n=1), cholecystitis (n=2), and colitis (n=2). The COVID-19 vaccine most commonly linked to acute abdomen was Pfizer-BioNTech (messenger RNA), accounting for 64.71% of cases. Acute abdomen predominantly occurred after the first vaccine dose (52.94%). All patients responded objectively to medical (88.34%) and surgical (11.76%) treatment and were discharged within a few weeks. No cases of death were reported. Conclusion: Acute abdomen is a rare complication of great interest in the medical and surgical practice of COVID-19 vaccination. Our study is based on a small sample of patients; therefore, it is recommended to conduct future observational studies to fully elucidate the underlying mechanisms of this association.

Economic Burden of Chronic Obstructive Pulmonary Disease: A Systematic Review

  • Hai Quang Pham;Kiet Huy Tuan Pham;Giang Hai Ha;Tin Trung Pham;Hien Thi Nguyen;Trang Huyen Thi Nguyen;Jin-Kyoung Oh
    • Tuberculosis and Respiratory Diseases
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    • v.87 no.3
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    • pp.234-251
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    • 2024
  • Globally, providing evidence on the economic burden of chronic obstructive pulmonary disease (COPD) is becoming essential as it assists the health authorities to efficiently allocate resources. This study aimed to summarize the literature on economic burden evidence for COPD from 1990 to 2019. This study examined the economic burden of COPD through a systematic review of studies from 1990 to 2019. A search was done in online databases, including Web of Science, PubMed/Medline, Scopus, and the Cochrane Library. After screening 12,734 studies, 43 articles that met the inclusion criteria were identified. General study information and data on direct, indirect, and intangible costs were extracted and converted to 2018 international dollars (Int$). Findings revealed that the total direct costs ranged from Int$ 52.08 (India) to Int$ 13,776.33 (Canada) across 16 studies, with drug costs rannging from Int$ 70.07 (Vietnam) to Int$ 8,706.9 (China) in 11 studies. Eight studies explored indirect costs, while one highlighted caregivers' direct costs at approximately Int$ 1,207.8 (Greece). This study underscores the limited research on COPD caregivers' economic burdens, particularly in developing countries, emphasizing the importance of increased research support, particularly in high-resource settings. This study provides information about the demographics and economic burden of COPD from 1990 to 2019. More strategies to reduce the frequency of hospital admissions and acute care services should be implemented to improve the quality of COPD patients' lives and reduce the disease's rising economic burden.

Review on Prevalence, Risk Factors, and Research Advancements on the Use of Medical Gloves Concerning Hand Dermatitis Among Health Care Workers

  • Jeevasunthari Gunasegaran;Ying-Ying Teh;Chin-Keong Lim;Shiow-Fern Ng
    • Safety and Health at Work
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    • v.15 no.2
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    • pp.129-138
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    • 2024
  • The COVID-19 pandemic has led to a significant surge in glove usage, as recommended by the World Health Organization. Despite efforts to ensure the quality and safety of gloves, glove-associated skin diseases such as hand dermatitis have become ubiquitous, particularly among health care workers. This review discusses the prevalence, causes, and risk factors of hand dermatitis, as well as research efforts in medical gloves in the past decade to overcome glove-related hand dermatitis. Research papers from 2013 to 2022 were reviewed, selecting only 49 relevant papers from the Ovid, PubMed, and Scopus databases. The average prevalence of hand dermatitis among health care workers increased from 21.08% to 37.24% upon the impact of the COVID-19 pandemic. The cases are likely due to allergies to latex proteins, rubber additives, and accelerators commonly found in gloves. Using alternatives to latex gloves, such as accelerator-free and latex-free glove options, can help reduce allergy-induced hand dermatitis. Strict hand hygiene practices, such as frequent hand washing and the use of sanitizers, are also contributing factors in contracting hand dermatitis. Over the past decade, glove research advancements have focused mainly on reducing or immobilizing latex proteins. These include the use of biodegradable dialdehyde, sodium alginate, arctigenin, bromelain, papain, UV-LED, prototype photoreactors, and structure-modified nanosilica with silane A174. Two effective hand dermatitis preventive measures, i.e. an additional layer of glove liners and the use of gentle alcohol-based hand sanitizer, were recommended. These advancements represent promising steps towards mitigating hand dermatitis risks associated with glove usage.

Evaluation of deep learning and convolutional neural network algorithms for mandibular fracture detection using radiographic images: A systematic review and meta-analysis

  • Mahmood Dashti;Sahar Ghaedsharaf;Shohreh Ghasemi;Niusha Zare;Elena-Florentina Constantin;Amir Fahimipour;Neda Tajbakhsh;Niloofar Ghadimi
    • Imaging Science in Dentistry
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    • v.54 no.3
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    • pp.232-239
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    • 2024
  • Purpose: The use of artificial intelligence (AI) and deep learning algorithms in dentistry, especially for processing radiographic images, has markedly increased. However, detailed information remains limited regarding the accuracy of these algorithms in detecting mandibular fractures. Materials and Methods: This meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Specific keywords were generated regarding the accuracy of AI algorithms in detecting mandibular fractures on radiographic images. Then, the PubMed/Medline, Scopus, Embase, and Web of Science databases were searched. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was employed to evaluate potential bias in the selected studies. A pooled analysis of the relevant parameters was conducted using STATA version 17 (StataCorp, College Station, TX, USA), utilizing the metandi command. Results: Of the 49 studies reviewed, 5 met the inclusion criteria. All of the selected studies utilized convolutional neural network algorithms, albeit with varying backbone structures, and all evaluated panoramic radiography images. The pooled analysis yielded a sensitivity of 0.971 (95% confidence interval [CI]: 0.881-0.949), a specificity of 0.813 (95% CI: 0.797-0.824), and a diagnostic odds ratio of 7.109 (95% CI: 5.27-8.913). Conclusion: This review suggests that deep learning algorithms show potential for detecting mandibular fractures on panoramic radiography images. However, their effectiveness is currently limited by the small size and narrow scope of available datasets. Further research with larger and more diverse datasets is crucial to verify the accuracy of these tools in in practical dental settings.

The Effect of Walnut (Juglans regia) Leaf Extract on Glycemic Control and Lipid Profile in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

  • Atieh Mirzababaei;Mojtaba Daneshvar;Faezeh Abaj;Elnaz Daneshzad;Dorsa Hosseininasab;Cain C. T. Clark;Khadijeh Mirzaei
    • Clinical Nutrition Research
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    • v.11 no.2
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    • pp.120-132
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    • 2022
  • Numerous clinical trials have examined the beneficial effects of Juglans regia leaf extract (JRLE) in patients with type 2 diabetes mellitus (T2DM); however, the results of these studies are inconsistent. Therefore, we conducted the current systematic review and meta-analysis to evaluate the effect of JRLE on glycemic control and lipid profile in T2DM patients. We searched online databases including PubMed, Scopus, EMBASE, and Web of Science for randomized controlled clinical trials that examined the effect of JRLE on glycemic and lipid indices in T2DM patients. Data were pooled using both fixed and random-effect models and weighted mean difference (WMD) was considered as the overall effect size. Of the total records, 4 eligible studies, with a total sample size of 195 subjects, were included. The meta-analysis revealed that JRLE supplementation significantly reduces fasting blood glucose (WMD, -18.04; 95% confidence interval [CI], -32.88 mg/dL, -3.21 mg/dL; p = 0.017) and significantly increases fasting insulin level (WMD, 1.93; 95% CI, 0.40 U/L, 3.45 U/L; p = 0.014). Although the overall effect of JRLE supplementation on hemoglobin A1c was not significant, a significant reduction was seen in studies with an intervention duration of > 8 weeks (WMD, -0.64; 95% CI, -1.16%, -0.11%; p = 0.018). Moreover, we also found no significant change in lipid parameters. Our findings revealed a beneficial effect of JRLE supplementation on glycemic indices in T2DM patients, but no significant improvement was found for lipid profile parameters.

The Effects of Magnesium Supplementation on Serum Magnesium and Calcium Concentration in Patients With Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Mohammad Zamani;Neda Haghighat
    • Clinical Nutrition Research
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    • v.11 no.2
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    • pp.133-145
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    • 2022
  • The aim of this systematic review and meta-analysis was to summarize all the existing randomized controlled trials (RCTs) evidence and to evaluate the effects of magnesium supplementation on serum magnesium, calcium and urinary magnesium concentrations in patients with type 2 diabetes compared with the control. Two independent authors systematically searched online databases including Embase, Scopus, PubMed, and Web of Science from inception until 30th January 2022. RCTs complying with the inclusion criteria were included in this meta-analysis. The heterogeneity among the included studies was assessed using Cochrane's Q test and I-square (I2) statistic. Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size. Sixteen trials were included in this meta-analysis. Serum magnesium (mean difference, 0.15 mg/dL; 95% confidence interval [CI], 0.06 to 0.23; p = 0.001) and urinary magnesium (WMD, 1.99 mg/dL; 95% CI, 0.36 to 3.62; p = 0.017) concentrations were significantly increased after magnesium supplementation when compared with the control group. However, magnesium supplementation did not have any significant effect on serum calcium (WMD, -0.09 mg/dL; 95% CI, -0.27 to 0.08; p = 0.294) level when compared with the control group. This meta-analysis demonstrated that magnesium supplementation significantly increased Serum magnesium levels which may have played an indirect role in improved clinical symptoms in patients with type 2 diabetes.