Registration Number Research Articles

The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Key Points Patients with IgA nephropathy and significant proteinuria are at high risk of progressive kidney function loss and kidney failure.We report the results of a clinical trial assessing the selective endothelin receptor antagonist SC0062 for the treatment of IgA nephropathy.SC0062 led to clinically meaningful improvements in proteinuria and did not increase risk of peripheral edema at higher doses. Background Endothelin receptor type A activation contributes to kidney injury in patients with IgA nephropathy. SC0062 is a novel selective endothelin receptor type A antagonist. We report the results of a phase 2 dose-finding trial to characterize the efficacy and safety of SC0062 in patients with IgA nephropathy. Methods We conducted a randomized, placebo-controlled, double-blind, clinical trial in adults with biopsy-proven IgA nephropathy and eGFR ≥30 ml/min per 1.73 m2 with urinary protein-creatinine ratio (UPCR) ≥0.75 g/g or proteinuria ≥1 g/24 hour despite using maximum tolerated doses of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Patients were randomized 1:1:1:1 to 24-week treatment with SC0062 5, 10, and 20 mg or matching placebo once daily. The primary efficacy outcome was percent change from baseline in UPCR in 24-hour urine samples after 12 weeks of treatment. Secondary end points included changes in eGFR. Safety outcomes including treatment emerging adverse events and serious adverse events were recorded. Results Overall, 131 patients (mean age 42 years [SD, 11]; mean eGFR 72 ml/min per 1.73 m2 [SD 24] and median 24-hour UPCR 1.2 g/g [25th–75th percentile, 0.9–1.5 g/g]) were randomized to placebo (n=34) or SC0062 5 mg (n=33), 10 mg (n=32), or 20 mg (n=32). All SC0062 doses reduced UPCR versus placebo throughout treatment. At week 12, placebo-corrected geometric mean changes (95% confidence interval) from baseline in UPCR with SC0062 5, 10, and 20 mg were−27.6% (−43.0 to −8.2), −20.5% (−37.4 to 1.0), and −38.1% (−51.4 to −21.0), respectively, and at week 24 they were−22.4% (−42.2 to 4.3), −30.9% (−48.6 to −7.0), and −51.6% (−64.2 to −34.6), respectively. No differences in eGFR were observed among treatment groups. The proportion of participants with treatment emerging adverse events or serious adverse events was balanced among treatment groups. Peripheral edema was reported by 2 (6%), 1 (3%), 1 (3%) participants in the 5, 10, and 20 mg SC0062-treated groups, respectively, compared with 5 (15%) in the placebo group. Conclusions In patients with IgA nephropathy, SC0062 reduced proteinuria and did not increase risk of peripheral edema. Clinical Trial registry name and registration number: A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of CKD, NCT05687890.

Preoperative Calcium or Vitamin D Supplement in Thyroidectomy: A Systematic Review and Meta-Analysis.

The objective of this systematic review and meta-analysis was to assess the role of preoperative calcium and vitamin D supplementation in patients who underwent total thyroidectomy. The search for randomized controlled trials was performed in the OVID Medline and Embase databases. The last search was made on September 16, 2024. Three independent reviewers evaluated full-text articles from relevant reports based on eligibility criteria. The quality of the included studies was assessed by two reviewers according to the ROB 2 tool. This systematic review and meta-analysis considered 13 studies with 1504 participants. There were positive results in treatment outcomes including the mean postoperative calcium level (MD, 0.30 mg/dL: 95% CI, 0.15 to 0.44); the 48 h of postoperative hypocalcemia (OR, 0.41; 95% CI, 0.27 to 0.62); the postoperative symptomatic hypocalcemia (OR, 0.38; 95% CI, 0.24 to 0.62); the IV calcium supplementation (OR, 0.32; 95% CI, 0.18 to 0.58); and length of hospital stays (MD, -0.29; 95% CI, -0.51 to -0.07) as compared to the control group. Readmission rates showed no significant differences between the groups (OR, 0.15; 95% CI, 0.01 to 3.08). Preoperative calcium and vitamin D supplementation in patients who underwent total thyroidectomy results in reduction of postoperative symptomatic hypocalcemia. The finding is critical because it offers a feasible and effective solution that could improve patient care while potentially reducing the burden of numerous blood tests during the postoperative period. This systematic review protocol was registered with PROSPERO (registration number CRD42021278859). Level 1 Laryngoscope, 2024.

Effectiveness of combined physical exercise and cognitive training in older adults with cognitive impairment: A systematic review and meta-analysis

Falls among cognitively impaired older adults are a global concern. The aim of this study was to assess the efficacy of combining physical exercise and cognitive training to improve balance among older adults. A systematic search of databases, including Embase, Medline-OVID, CINAHL-EBSCOhost, and Central-Cochrane Library, was conducted from March 9 to April 6, 2023. The search used keywords based on the PICO question, where the population was older adults with cognitive impairment. Compared to a single therapy, the intervention involved a combination of muscle strengthening and cognitive therapy, with the outcome of falls or balance. Inclusion criteria were randomized controlled trials (RCTs) in any setting. Studies with participants under 60 years old and lacking baseline clinical assessments were excluded. EndNote 20 was used as a reference manager tool, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 flow diagram was used to map out the number of identified records. Two investigators worked independently, and the Jadad scale was used for critical appraisal. The PROSPERO registration number is CRD42023454876. A fixed-effects meta-analysis was performed using an inverse-variance method. Four articles met the inclusion criteria, three of which were included in the meta-analysis. Studies were from Europe, New Zealand, and the Philippines, with a total sample of 255 participants and mean ages of 65.9–87.5 years. The studies used combined physical and cognitive training in one group. Results showed a significant moderate effect size (effect size (ES): 2.29; standardized mean difference (SMD): 0.41; p<0.05; heterogeneity (I2): 0%) indicating no heterogeneity. In conclusion, the combined intervention displayed the potential to improve balance for cognitively impaired older adults.

Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial.

Key Points This phase 2, double-blind, randomized controlled trial evaluated the complement C5 inhibitor, ravulizumab, in adults with IgA nephropathy.A 30.1% (90% confidence interval, 13.7% to 43.5%) relative reduction in proteinuria for ravulizumab versus placebo was observed at approximately 6 months.Treatment with ravulizumab was well tolerated. Background The complement system plays a central role in the pathogenesis of IgA nephropathy. We present findings from a phase 2 trial of ravulizumab, a complement C5 inhibitor. Methods The Study of Ravulizumab in Proliferative Lupus Nephritis or IgA Nephropathy (NCT04564339) was a randomized, double-blind, placebo-controlled trial of ravulizumab in addition to standard of care. Adults with IgA nephropathy, proteinuria ≥1 g/d, and eGFR ≥30 ml/min per 1.73 m2, and on stable renin-angiotensin blockade were randomized 2:1 to ravulizumab (intravenous every 8 weeks) or placebo for 26 weeks. From week 26–50, all participants received open-label ravulizumab. The primary end point was percentage change in proteinuria from baseline (BL) to week 26. Secondary end points included change in proteinuria at week 50 and eGFR. Safety, pharmacokinetics, and pharmacodynamics were evaluated. Results Forty-three patients were randomized to ravulizumab and 23 to placebo. At week 26, a statistically significant reduction in proteinuria was observed with ravulizumab versus placebo: −41.9% (95% confidence interval [CI], −50.2% to −32.0%) change in urine protein with ravulizumab and −16.8% (95% CI, −31.8% to 1.6%) change with placebo (30.1% treatment effect; P = 0.005). At week 50, there was a −44.8% (95% CI, −55.1% to −32.1%) change from BL in urine protein with ravulizumab, and in patients who crossed over from placebo to ravulizumab at week 26, the change from BL (week 0) to week 50 was −45.1% (−58.0% to −28.4%). The least squares mean change in eGFR from BL to week 26 with ravulizumab was 0.2 (95% CI, −2.3 to 2.7) ml/min per 1.73 m2 and with placebo was −4.5 (−7.9 to −1.1) ml/min per 1.73 m2. From BL to week 50, the least squares mean change in eGFR with ravulizumab was −3.9 (95% CI, −6.4 to−1.3) ml/min per 1.73 m2, and in patients who crossed over from placebo to ravulizumab at week 26, it was −6.3 (−9.7 to −2.9) ml/min per 1.73 m2. Ravulizumab was well tolerated, with an adverse event profile similar to that for placebo. Conclusions An early, sustained, and clinically meaningful reduction in proteinuria and trend toward stabilization of eGFR were observed with ravulizumab versus placebo. A phase 3 trial (NCT06291376) is enrolling. Clinical Trial registry name and registration number: Study of Ravulizumab in Proliferative Lupus Nephritis or IgA Nephropathy, NCT04564339.

Effects of Yi Jin Jing on enhancing muscle strength and physical performance in older individuals: a systematic review and meta-analysis

BackgroundThe aging population is rapidly increasing, leading to physical decline and higher risks of chronic diseases, including sarcopenia, which adversely affects muscle quality and strength. Yi Jin Jing (YJJ), a traditional Chinese exercise method, can enhance flexibility and strength, but evidence regarding its effectiveness in older adults is conflicting. This meta-analysis aims to systematically evaluate the effects of YJJ on muscle strength and physical performance in this demographic.MethodsWe searched seven electronic databases: China National Knowledge Infrastructure, Wanfang Data, Sinomed, Web of Science, PubMed, Cochrane Library, and EMBASE to identify randomized controlled trials (RCTs). Following PRISMA guidelines, we quantified the effects of YJJ on muscle strength (grip strength, isokinetic strength) and physical performance (chair sit-to-stand, squatting-to-standing, shoulder flexibility, sit-and-reach tests). Treatment effects were calculated using Hedges’g. The Cochrane tool assessed risk of bias, the PEDro scale evaluated methodological quality, and the GRADE method assessed evidence quality. Data analysis was conducted using Stata 17.0 software, utilizing standardized mean differences (SMD) and 95% confidence intervals (CIs).ResultsThis meta-analysis included 10 RCTs involving 590 participants. The overall risk of bias was assessed to be low. The methodological quality of these studies was generally moderate, and the quality of the main results varied from low to moderate. The findings revealed that YJJ had considerable effects on the chair sit-to-stand test (Hedges’g = 1.06), squatting-to-standing test (Hedges’g = 1.08), and small to moderate effects on handgrip strength (Hedges’g = 0.25), 60°/s extensor peak torque (Hedges’g = 0.47), 60°/s extensor average power (Hedges’g = 0.31), 60°/s extensor total work (Hedges’g = 0.29), 60°/s flexor peak torque (Hedges’g = 0.42), 60°/s flexor average power (Hedges’g = 0.37), and 180°/s extensor peak torque (Hedges’g = 0.29), and left shoulder flexibility (Hedges’g = 0.4). However, there were no significant improvement effects in 180°/s extensor average power (Hedges’g = 0.19), 180°/s extensor total work (Hedges’g = 0.11), 180°/s flexor peak torque (Hedges’g = 0.01), 180°/s flexor average power (Hedges’g = −0.08), right shoulder flexibility (Hedges’g = 0.09), and sit-and-reach test (Hedges’g = 0.15).ConclusionYJJ significantly enhances specific aspects of physical performance, particularly chair sit-to-stand and squatting-to-standing tests, while showing small and moderate improvements in handgrip strength and knee muscle strength. However, it had no significant effects on other metrics, including shoulder flexibility and sit-and-reach tests.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024530487, Registration number: CRD42024530487.

Plasma and breast milk adipokines in women across the first year postpartum and their association with maternal depressive symptoms and infant neurodevelopment: Protocol for the APPLE prospective cohort study.

Adiponectin and leptin play important roles in the central nervous system. During the postpartum period, there is a need for a better understanding of the relationship between these cytokines and the neurological development of the infant, as well as their influence on preventing maternal depressive symptoms. To assess the correlation between adiponectin and leptin in maternal plasma and breast milk and their association with: infant neurodevelopment at 6 and 12 months of age; and maternal mental health over the first year postpartum. Prospective cohort study with four follow-up. Mothers and their newborns are recruited within the first 15 days postpartum (baseline). Follow-up visits occur at 2, 6, and 12 months postpartum. Visits include blood and breast milk collection, application of the Edinburgh Postnatal Depression Scale and Beck Depression Inventory to assess maternal mental health, application of the Bayley-III scale for infant developmental assessment, maternal and infant anthropometry and body composition, evaluation of reproductive history, mother-infant bonding, breastfeeding, consumption of ultra-processed foods, sleep quality, and socio-economic and demographic data. The research received funds in August 2022, and participant recruitment began in September 2022. The sample size will consist of 95 mother-child pairs. As of September 2023, 68 participants have been recruited. The project will provide insights into the association between adiponectin and leptin with postpartum depression and infant neurodevelopment, ultimately promoting improved care and quality of life for these groups. Additionally, it will provide data on the type of delivery, infant physical growth, maternal and infant body composition changes, sleep quality, consumption of ultra-processed foods, and maternal metabolic health, including vitamin D metabolites, oxidized polyunsaturated fatty acid metabolites, phospholipid species and triacylglycerols, which are of significant relevance to public health and, when interconnected, may yield important results and contribute to the existing literature. Name of the registry: Brazilian Clinical Trials Registry (ReBec). Registration number: RBR-9hcby8c.

O REGISTRO DE MARCA COMO VANTAGEM COMPETITIVA: UM PANORAMA DO SERTÃO SERGIPANO NO ANO DE 2021

The study explores the importance of registering trademarks as a tool for protection and competitive advantage for companies in the Sergipano Hinterland. It highlights how registered trademarks differentiate themselves in the market, creating identity and avoiding legal conflicts. The research identifies the risks that small and medium-sized companies face when operating without registration, such as losing their name and rebranding costs. Despite the increase in trademark registration in Brazil, many businesses in the region have yet to register their trademarks, which makes them vulnerable. The objectives include identifying the benefits of registration, assessing the risks of not registering and understanding the reasons for the low number of registrations. The methodology involves a bibliographic and documentary survey. The results show that the lack of registration compromises competitiveness and the need to raise awareness of its importance.

Efficacy of continuous glucose monitoring in people living with diabetes and end stage kidney disease on dialysis: a systematic review

BackgroundPatients with diabetes on dialysis experience wide variations in glucose levels and an increased risk of hypoglycaemia. Due to the inaccuracies of HbA1c in dialysis patients, JBDS-IP and KDIGO recommend the use of continuous glucose monitoring (CGM). We conducted a systematic review to examine the current evidence for CGM use and its impact on clinical outcomes in patients with diabetes on dialysis.MethodsA search of MEDLINE(R) ALL, Ovid Emcare, Journals@Ovid Full Text and Embase databases were conducted. Clinical or observational trials in adults with Type 1(T1D) or Type 2 (T2D) diabetes on dialysis and CGM intervention reporting on glycaemic outcomes were included.ResultsOf the 936 citations identified, 49 duplicates were removed. 887 citations were screened by title and abstract. 9 full texts were reviewed and a further 7 excluded due to duplications or failure to meet to selection criteria. Data was extracted for 2 studies, both prospective before-and-after interventional studies with no control group. Joubert et al. (2015) showed results for 15 participants with T1D. Mean CGM glucose level decreased from 8.37mmol/L at baseline to 7.7mmol/L at the end of the CGM period (p < 0.05) while HbA1c decreased from 6.9 to 6.5% (p < 0.05) during the same period. Mean CGM was lower on dialysis days (7.68mmol/L vs. 7.8mmol/L, p < 0.05). Képénékian et al. (2014) reported on data from 29 T2D patients. Following a 3 month CGM-adapted insulin regimen, HbA1c decreased from 8.4% at baseline to 7.6% (p < 0.01) by the end of study. Mean CGM values decreased from 9.9mmol/L to 8.9mmol/L (p = 0.05) and the frequency of glucose values > 10mmol/L decreased from 41 to 30% (p < 0.05), without a significant increase in hypoglycaemia frequency. Both studies were deemed to be of ‘good’ quality.ConclusionEvidence demonstrating the benefits of CGM in patients with diabetes receiving dialysis is lacking. There is a need for well-designed randomised controlled trials to ascertain the benefits of this technology in this patient group.Trail registrationPROSPERO registration number: CRD42023371635, https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=371635.

A systematic review protocol of injuries and illness across all the competitive cycling disciplines, including track cycling, mountain biking, road cycling, time trial, cyclocross, gravel cycling, BMX freestyle, BMX racing, e-sport, para-cycling and artistic cycling

IntroductionThe sport of cycling has witnessed phenomenal growth over the past decade. Globally, over 200 million television hours across five continents watched the recent inaugural World Championships in Glasgow, in 2023. The Union Cycliste Internationale (UCI), the world cycling governing body, has highlighted its mission to “promote and support research in cycling epidemiology and medicine, especially for the benefit of lesser-known disciplines” within its 2030 Agenda. This paper outlines a proposed protocol to conduct a systematic review that comprehensively analyses and synthesises the existing literature about cycling-related injuries and illness across all competitive disciplines.MethodsThe Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines will be followed through each stage of this systematic review. Cycling is an umbrella term used for many individual disciplines. Investigation of all types of injuries and/or illnesses sustained during training and/or competition among competitive athletes across all disciplines will be included in this review. A computerised, systematic literature search will be conducted in electronic databases MEDLINE, Scopus, Embase, and Cochrane Library. Independent screening by two reviewers in a two-step process: title/abstract screening followed by full-text review. The reference lists of included articles will be searched to identify any other potentially relevant articles. Narrative synthesis and tabular/charted presentation of the extracted data will be included.DiscussionThis protocol paper outlines the methodology to conduct a systematic review of injuries and illness across all competitive cycling disciplines. The aims of outlining this systematic review protocol are to aid research transparency, help reduce publication bias, prevent selective publication, and prevent the selective reporting of results. Future systematic reviews based on the proposed protocol will summarise the known prevalence, incidences, locations and burden of injury and illness across the sport of cycling.Trial RegistrationThis study has been registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number CRD42024502703).

Guidelines for the prescription of standard hematology and biochemistry clinical laboratory tests in the intensive care unit: A scoping review protocol.

This scoping review protocol describes the strategy for a scoping review that aims to provide a comprehensive overview of published guidelines for the prescription of standard laboratory tests performed in intensive care unit (ICU) patients. The use of clinical laboratories is constantly increasing. However, there is evidence of inappropriate use. Inappropriate laboratory testing has the potential to harm patients, increase costs, burden staff, and has an environmental impact. Effective management can be achieved through demand managing strategies, such as providing guidelines on performing the appropriate test, for the right patient, at the right time. Although national and international guidelines exist for individual tests, a comprehensive summary of available recommendations for laboratory testing in the ICU is currently unavailable. This scoping review will incorporate documents that provide explicit advice on which test to perform in ICU patients. We selected 34 tests routinely ordered in the ICU. This review will consider any document type that matches our concept and context. We will consider gray literature with appropriate adherence to guidelines methodology. We will not limit the review by geographical location, but will only include articles published in English. Our scoping review will follow the Joanna Brigg Institute (JBI) methodology. We will search Medline (PubMed), Embase, Scopus, Google Scholar, and Google. Our search strategy adheres to the JBI 3-step construction approach for systematic reviews. We will search for keywords related to guidelines, laboratory testing, and the 34 selected tests. We will report our study using the S1 Checklist. Review registration number: osf.io/yfs9z.

Effectiveness of gait analysis in management of osteoarthritis knee at primary care settings in Asia: a systematic review and meta-analysis protocol

Background: This systematic review will focus on the effectiveness of gait analysis on osteoarthritis knee management. The objectives of this systematic review and meta-analysis are to synthesize the clinical effectiveness and to compare the effectiveness of gait analysis in the osteoarthritis knee management in Asian population. Methods: This review will be conducted and reported according to PRISMA guidelines. To discover relevant papers, the search technique will use MeSH terms such as osteoarthritis knee, gait analysis, osteoarthritis knee management, primary healthcare, effectiveness, and Asia. Other synonymous words will be searched using the Boolean operator "and"/"or" on PubMed, Embase, Scopus, and Cochrane. Randomized controlled trials assessing the efficacy of gait analysis in the therapy of osteoarthritis knee patients in primary care settings in Asia will be considered. A random effects meta-analysis will be carried out using the REVMAN software version 5.3.5. The STATA software version SE16 will be used for both cumulative and comparative meta-analysis. Conclusions: This review and meta-analysis will be among the first to give an extensive purview on the effectiveness of gait analysis in osteoarthritis knee management at primary care settings in Asian population. This study will also acknowledge the effects of different gait analysis strategies with an attempt to compare the same. Trial Registration: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO registration number: CRD42024540444).

The role of neutrophils in pain: systematic review and meta-analysis of animal studies.

The peripheral inflammatory response is an attractive therapeutic target for pain treatment. Neutrophils are the first circulating inflammatory cells recruited to sites of injury, but their contribution to pain outcomes is unclear. We performed a systematic review and meta-analysis of original preclinical studies, which evaluated the effect of preemptive neutrophil depletion on pain outcomes (PROSPERO registration number: CRD42022364004). Literature search (PubMed, January 19, 2023) identified 49 articles, which were meta-analyzed using a random-effects model. The risk of bias was evaluated using SYRCLE's tool. The pooled effect considering all studies showed that neutrophil depletion induced a consistent pain reduction. Inflammatory, joint, neuropathic, and visceral pain showed significant pain alleviation by neutrophil depletion with medium-large effect sizes. However, muscle and postoperative pain were not significantly alleviated by neutrophil depletion. Further analysis showed a differential contribution of neutrophils to pain outcomes. Neutrophils had a higher impact on mechanical hyperalgesia, followed by nociceptive behaviors and mechanical allodynia, with a smaller contribution to thermal hyperalgesia. Interspecies (mice or rats) differences were not appreciated. Analyses regarding intervention unveiled a lower pain reduction for some commonly used methods for neutrophil depletion, such as injection of antineutrophil serum or an anti-Gr-1 antibody, than for other agents such as administration of an anti-Ly6G antibody, fucoidan, vinblastine, CXCR1/2 inhibitors, and etanercept. In conclusion, the contribution of neutrophils to pain depends on pain etiology (experimental model), pain outcome, and the neutrophil depletion strategy. Further research is needed to improve our understanding on the mechanisms of these differences.

A Cross-Sectional Study of the Current and Future Dental Hygiene and Dental Therapy Student Workforce in the UK and Ireland During 2022-2025: Considering Facilitators and Barriers to the Growth of This Workforce.

With evidence suggesting that dental hygienists (DH) and dental therapists (DThs) can undertake a significant proportion of routine clinical work, this paper explores the number of recent graduates and students currently in training in the UK and Ireland and considers whether there are sufficient DH and DTh registrants to positively impact on population needs. An online questionnaire survey was distributed by the Directors of Dental Hygiene and Therapy Group to all programme leads of dental hygiene and dental therapy programmes during December 2023. There was a 100% response rate. The majority of programmes award a Bachelor's degree, with a minority offering a Diploma or Foundation degree; one programme awards an MSc level qualification. The number of graduates in the 2022-2023 academic year was 429, registered with both the General Dental Council (GDC) and Dental Council of Ireland (DCI). The numbers of DH students expected to graduate in 2023-2024 academic year is likely to increase by 44% and in 2024-2025 this will increase by a further 12% compared to the previous year. The anticipated numbers of DTh graduates registering across the UK in 2023-2024 academic year is 312, representing in a slight decrease of 3% from the previous year; in 2024-2025 this figure is expected to remain static at 313. The results of this study demonstrate the numbers of students recently graduated and in training in the UK and Ireland, during 2022-2025. The numbers of registrants is slightly increasing, but there is a need for detailed information regarding working practices to inform future workforce planning; this will inform the need for increasing training numbers.

Advancing Community Care and Access to Follow-Up after Acute Kidney Injury Hospitalization: A Randomized Clinical Trial.

Key Points A risk-guided intervention improved adherence to processes of care for AKI survivors.Further supports are necessary to improve uptake of processes of care for AKI survivors in primary care. Background AKI is associated with development and progression of CKD. Gaps in recommended care for CKD are common after AKI. Methods In this randomized controlled trial conducted in Alberta, Canada, we allocated adults hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or greater AKI to a risk-guided, transition of care intervention versus usual practices at the time of hospital discharge. For people in the intervention group, we used a validated risk index to predict risk of severe CKD after AKI. People at low risk (&lt;1%) received patient education alone. People at medium risk received additional clinical guidance, provided to their primary care physician. People at high risk (&gt;10%) were referred to nephrology. The primary outcome was the proportion of patients who received treatment with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin II receptor blocker (ARB), statin, and nephrology specialist follow-up within 90 days of discharge. Results One hundred fifty-five patients were recruited; the mean (SD) age was 60 (15) years, 91 (60%) were male, and 96 (62%) had eGFR &lt;60 ml/min per 1.73 m2 or urine albumin-creatinine ratio &gt;30 mg/g at discharge. The proportion of participants who received ACE-I/ARB, statin treatment, and nephrologist follow-up was 28% in the intervention group versus 3% in the usual care group (absolute risk difference [RD], 25%; 95% confidence interval [CI], 15% to 36%). The use of ACE-I or ARB in participants with urine albumin-creatinine ratio &gt;300 mg/g or diabetes was greater in the high-risk group with the intervention versus usual care (RD, 37%; 95% CI, 6% to 67%), as was statin use among those with CKD (RD, 30%; 95% CI, 5% to 56%) and nephrologist follow-up for those with sustained eGFR &lt;30 ml/min per 1.73 m2 at discharge (RD, 78%; 95% CI, 56% to 100%). Hyperkalemia was more frequent in the intervention group (RD, 10%; 95% CI, 9% to 19%). Conclusions A risk-guided intervention for patients hospitalized with AKI increased recommended processes of care for CKD for high-risk patients after hospital discharge. Clinical Trial registry name and registration number: Improving Post Discharge Care after Acute Kidney Injury (AFTER AKI), NCT02915575.

Preliminary study on the effects of boysenberry juice intake on brown adipose tissue activity in healthy adults

Brown adipose tissue (BAT) plays an important role in energy metabolism because it uses fatty acids for thermogenesis during cold exposure. Preclinical studies found that boysenberry anthocyanins (BoyACs) activate BAT. Therefore, the aim of this preliminary study was to evaluate how BoyAC intake affects BAT in humans. We performed an open-label single-arm nonrandomized study in healthy volunteers. Before and after 4 weeks of daily consumption of 100 ml boysenberry juice (BoyJ) containing 61 mg of BoyACs, participants were assessed at 24 °C and then after 1 h of mild cold exposure (18 °C). An infrared thermography camera was used to measure skin surface temperatures in the supraclavicular BAT region (Tscv) and the non-BAT region of the upper chest (Tch). Energy metabolism was measured by indirect calorimetry. For each endpoint, we calculated Δ as the difference between values before and after cold exposure and compared the values before and after BoyJ intake. 10 volunteers participated (age: 36.1 ± 4.1, body mass index (BMI): 20.9 ± 0.6). After BoyJ intake, ΔTscv-ch was significantly higher (p = 0.029), but Δ energy expenditure, Δ fat oxidation, and Δ carbohydrate oxidation were not significantly different. We found a significant positive correlation between BMI and Δfat oxidation with BoyJ intake. The results indicate that 4 weeks of BoyJ intake activates cold-induced thermogenesis in the scv-BAT but does not have a significant effect on energy metabolism. BoyJ intake may increase fat oxidation during cold exposure in individuals with higher BMI.Trial registry number: UMIN000043476, 05/03/2021.

Is the transection of the hernia sac during laparoscopic inguinal hernioplasty safe and feasible? An updated systematic review and meta-analysis.

There is a debate over whether to transect or completely reduce the hernia sac during laparoscopic tension-free repair of inguinal hernia. This study endeavors to systematically assess the efficacy and safety of two approaches, namely transected sac (TS) and completely reduced sac (RS), in laparoscopic tension-free repair of inguinal hernia. Utilizing a meta-analysis methodology, we aim to provide a comprehensive analysis of these techniques. A comprehensive search was conducted across PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases to identify comparative studies focusing on laparoscopic tension-free repair of inguinal hernia, specifically comparing TS and RS techniques. The selected studies were subjected to meta-analysis using RevMan 5.3 software. A total of 8 studies, involving 2995 patients with inguinal hernia, were included in the analysis. The meta-analysis results revealed that the TS group had a higher incidence of seroma compared to the RS group [OR = 1.74, 95% CI (1.35, 2.25), P < 0.0001], and a prolonged time to return to normal activity postoperatively [MD = 0.99, 95% CI (0.85, 1.14), P < 0.00001]. However, no statistically significant differences were observed between the two groups in terms of operation time [MD = -1.75, 95% CI (- 8.72, 5.22), P = 0.62], incidence of postoperative pain [OR = 1.00, 95% CI (0.41, 2.44), P = 1.00], overall postoperative complication rate [OR = 0.98, 95% CI (0.43, 2.20), P = 0.95], and recurrence rate fOR = 2.53, 95% CI (0.61, 10.39), P = 0.20]. Transected sac in laparoscopic inguinal hernia repair is associated with an increased incidence of seroma and a longer recovery time for patients to return to normal activity. Clinical trial registration Registration number is INPLASY20223110070.

Use and impact of clinical pathways across various healthcare settings: A protocol for an umbrella review of global evidence.

The proposed umbrella review aims to assess the use and impact of clinical pathways on professional practice, patient outcomes, length of hospital stay, hospital costs, patient satisfaction, and hospital staff satisfaction through a synthesis of existing systematic reviews and meta-analyses. Following PRIOR guidelines, a systematic search will be conducted in MEDLINE, Epistemonikos, and the Cochrane Library to identify relevant systematic reviews and meta-analyses, from inception till March 2024. Two reviewers will independently screen titles and abstracts, with a third resolving any disagreements. Full-text articles considered potentially relevant will be assessed for eligibility by the same process. The data extraction form will cover information about the review methods, characteristics of the included primary studies, the types of interventions evaluated, and the reported outcomes. This standardized data extraction form will be piloted by the review team on five to ten articles to ensure all relevant information is recorded. The quality of included systematic reviews and meta-analyses will be evaluated using AMSTAR 2. PROSPERO registration number is CRD42024529371. The study will present a narrative synthesis of the findings, addressing the clinical and methodological heterogeneity and assessing the impact of clinical pathways on various healthcare outcomes. This umbrella review will provide evidence-based insights into the effectiveness, challenges, and best practices of clinical pathways, guiding healthcare decision-making and identifying areas for future research. Results will be disseminated widely to inform policy and improve healthcare service delivery. No patient or public contribution, as this paper is a protocol of an umbrella review.

Clinicopathological characteristics and outcomes of patients with unexplained renal impairment: a single center study

Background: Chronic kidney disease (CKD) is a growing health problem. About 20% of CKD patients have undetermined causes. Data describing histopathological patterns of unexplained impaired kidney functions in Egypt are lacking. We aimed to identify the clinicopathological characteristics and short-term outcomes of adult cases with unexplained impaired kidney functions.Methods: We conducted a prospective study in Assiut University Hospital from August 2018 to May 2022. It included patients with unexplained elevated serum creatinine (serum creatinine > 115 µmol/L) who underwent renal biopsies. Descriptive statistics were used to summarize data on patient demographics, histopathological patterns, and outcomes after three months. Clinical trial registration number: NCT03586531.Results: Overall, 210 native renal biopsies were included in the analysis. Glomerular diseases were the most common pathological finding (n=88, 44.9 %), amyloidosis and FSGS were the most prevalent glomerular pathology (15.2%, 14.3%, respectively). Chronic kidney disease of unknown etiology (CKDu) was diagnosed in 8.1% of the cases; histology suggestive of genetic origin was found in 2.5%, and LECT amyloidosis was found in 3.8% of the cases. Poor outcomes were observed in 43.6% of the patients i.e., renal replacement therapy or death. Treatment strategies were changed based on the biopsy findings in 86 patients (40%).Conclusion: Amyloidosis and FSGS were the most common causes of unexplained renal impairment. CKDu is not uncommon in Egypt, and more preventive measures are needed. This study supports the irreplaceable role of renal biopsy in disease diagnosis, treatment decisions, and predicting prognosis even in advanced stages.

Expression of PGC-1α, PPAR-α and UCP1 genes, metabolic and anthropometric factors in response to sodium butyrate supplementation in patients with obesity: a triple-blind, randomized placebo-controlled clinical trial.

There is increasing evidence that gut metabolites have a role in the etiology of obesity. This study aimed to investigate the effects of sodium butyrate (NaB) supplementation on the expression of peroxisome proliferator-activated receptor (PPAR) gamma coactivator-1α (PGC-1α), PPAR-α, and uncoupling protein-1 (UCP-1) genes, as well as on the metabolic parameters and anthropometric indices in persons with obesity. In this triple-blind placebo-controlled randomized clinical trial, 50 individuals with obesity were randomly assigned to NaB (600 mg/day) + hypo-caloric diet or placebo group + hypo-caloric diet for 8 weeks. The study measured the participants' anthropometric characteristics, food consumption, and feelings of hunger in addition to the serum levels of metabolic indices and the mRNA expression of the PGC-1α, PPAR-α, and UCP-1 genes in peripheral blood mononuclear cells (PBMCs). PGC-1α and UCP-1 genes expression significantly increased in NaB group compared to the placebo at the endpoint. A significant decrease in weight, BMI, and waist circumference (WC) was observed in NaB group. Among the metabolic factors, NaB significantly decreased fasting blood sugar (FBS) (P = 0.04), low-density lipoprotein cholesterol (LDL-C) (P = 0.038) and increased high-density lipoprotein cholesterol (HDL-C) (P = 0.016). NaB could not significantly change serum GLP-1 level. This study unveiled NaB supplementation alone cannot have significant beneficial effects on anthropometric, and biochemical factors. NaB could affect anthropometric and metabolic risk variables associated with obesity only when prescribed, along with calorie restriction. This study was registered in the Iranian Registry of Clinical Trials ( https://en.irct.ir/trial/53968 ) on 31 January 2021 (registry number IRCT20190303042905N2).

Epidemiology of bronchiectasis at a single center in Japan: a retrospective cohort study

BackgroundThe characteristics of bronchiectasis (BE) in Asia, including Japan, remain largely unknown. We aimed to provide insights into the clinical characteristics and treatment outcomes of BE, especially regarding nontuberculous mycobacteria (NTM) infection and its poorly understood impact on prognosis. We also aimed to clarify the effect of long-term macrolide antibiotic use in patients with BE, who had no history of exacerbations.MethodsIn this single-center, retrospective study, the medical records of patients who satisfied the BE criteria between January 1, 2012, and August 31, 2023, were reviewed. Severe exacerbations and mortality during the observation period were recorded. Baseline characteristics and overall survival of patients with and without NTM infection, and factors influencing the time to the first exacerbation and death were analyzed. Additionally, the effects of long-term macrolide antibiotic use in patients without a history of severe exacerbations were estimated.ResultsIn a cohort of 1044 patients with BE, the rate of severe exacerbation was 22.3%, with mortality rates of 3.2% over 3 years. Notably, the high prevalence of NTM infection (n = 410, 39.3%) in this cohort was distinctive. NTM infection was not associated with either the time to first severe exacerbation (p = 0.5676, adjusted hazard ratio = 1.11) or mortality (p = 0.4139, adjusted hazard ratio = 0.78). Compared with the NTM group, the non-NTM group had a higher proportion of elevated inflammatory markers, with significant differences in C-reactive protein levels (p = 0.0301) and blood neutrophil counts (p = 0.0273). Pseudomonas aeruginosa colonization was more frequent in the non-NTM group (p = 0.0003). Among patients with non-NTM infection and without a history of exacerbation in the past 2 years, 38.2% received long-term macrolide antibiotics that did not invariably prolong the time to first severe exacerbation (p = 0.4517, IPW p = 0.3555).ConclusionsThis study highlights BE epidemiology in Japan, noting that the presence of NTM infection may not necessarily worsen the prognostic outcomes and advising caution in the casual use of macrolides for milder cases without a history of exacerbations.Clinical trial registrationUMIN Clinical Trials Registry Number: UMIN000054726 (Registered on 21 June 2024).