Standard Group Research Articles

The effect of arrowroot diet on pancreatic and kidney histomorphology of mice induced by D-Galactose

Arrowroot contains antioxidants that can potentially reduce d-galactose-induced aging in the pancreas and kidneys. This study aimed to determine the effect of arrowroot administration on the histomorphology of the pancreas and kidneys of mice induced by d-galactose. Experimental research that has been conducted in 2023 using Musculus Balb/C mice were divided into four groups as follows: a healthy control group (HC), negative control (NC) with d-galactose induction & standard feed, P1 and P2 groups with d-galactose inductions & 45% and 60% arrowroot feed. Histological slides were stained with haematoxylins-eosin. Data analysis was performed using a microscope at a magnification of 40 × 10. Severe signs of aging in pancreas (cell atrophy, cytoplasmic vacuolation, necrosis, congestion, and inflammation) were observed in NC and P1 groups and minimal signs in P2 compared to HC group. The damage mean (%) of tubular, glomerular kidney and inflammation scores were 52.46 ± 1.46, 76.66 ± 9.87, 67.99 ± 2.12, and 60.93 ± 0.55 (p=0.005); 62.64 ± 11.13, 70.48 ± 13.32, 71.25 ± 8.04, and 65.53 ±14.26, (p=0.707); 8.75 ± 2.5, 27.25 ± 4.57, 8 ± 7.25, and 13.5 ± 6.19, (p=0.001), respectively. In conclusion, administration of arrowroot affects the histomorphology features of the pancreas and kidneys of mice induced by aging using d-galactose.

Comments on standard EN-10371 and proposals for standard follow up

The small punch test technique was developed in the USA in the 1980 s, followed shortly by Japan and introduced to Europe in the 1990 s. CEN organized Workshop 21 to summarize more than ten years of research results and formulate the first technical guidelines CWA 15627. The specification work for European standard started in 2015 and the first European standard EN-10371 was published in 2022. The EN-10371 standardized the specimen size and test apparatus. It also specifies the test procedure and characteristic parameters for small punch test (SP) and small punch creep test (SPC). Nine annexes allows estimation of the values normally obtained using classical standard size uniaxial or fracture mechanics specimens. In order to make the standard perfect and usable, the standard working group proposed a five year “standard follow up” project in 2019. Responding to the proposed project, authors carefully re-examined the specification, and found some shortcomings in the standard. Proposals are put forward to improve the current methodology and extend the standard scope to include the latest development.

Treatment results of lymphoblastic lymphomas from progenitor cells according to ALL IC-BFM 2002/2009 protocols: monocenter clinical trial

Introduction. The acute lymphoblastic leukemia (ALL) therapy programs developed by the BFM group (Berlin-Frankfurt-Munster) are used to treat lymphoblastic lymphomas from precursor cells (LBL) and are the most effective treatment methods in the world.Aim. To assess the treatment results of LBL in children according to the ALL IC-BFM 2002/2009 protocols in a clinical trial of a single center.Materials and methods. From 2002 to 2022 a retrospective and prospective study included 70 patients aged 2 to 17 years with newly diagnosed LBL, with a median age of 9.4 years. There were 1.5 times more male patients than female (43:27). LBL from T-cells progenitor (T-LBL) was diagnosed in 61 patients (87 %), and LBL from B-cells progenitor (B-LBL) — in 9 (13 %). 59 (84.3 %) patients were included in the intermediate risk (IR) group and 11 (15.7 %) patients — in high-risk (HR) group. There were no patients in the study cohort who met the criteria of the standard risk group (SR).Results. The 10-year OS in the group of patients treated according to the ALL IC-BFM 2002/2009 protocols was 95.4 ± 2.6 %; the 10-year RFS — 91.9 ± 4.9 %; the 10-year EFS — 86.7 ± 5.6 %. When analyzing survival rates depending on the prognostic risk group, the 10-year OS for patients of the intermediate risk group was 96.6 ± 2.6 %, and for patients of the high-risk group — 90.9 ± 8.7 %.Conclusions. The obtained results confirm the high effectiveness of the ALL IC-BFM 2002/2009 protocols in the treatment of LBL.

Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial

Increased polyp detection during colonoscopy is associated with decreased post-colonoscopy colorectal cancer incidence and mortality. The COLO-DETECT trial aimed to assess the clinical effectiveness of the GI Genius intelligent endoscopy module for polyp detection, comparing colonoscopy assisted by GI Genius (computer-aided detection [CADe]-assisted colonoscopy) with standard colonoscopy in routine practice. We did a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial in 12 National Health Service (NHS) hospitals (ten NHS Trusts) in England, among adults (aged ≥18 years) undergoing planned colonoscopy for gastrointestinal symptoms or for surveillance due to personal or family history (ie, symptomatic indications), or colorectal cancer screening. Randomisation (1:1) to CADe-assisted colonoscopy or standard colonoscopy was done with a web-based dynamic adaptive algorithm, immediately before colonoscopy, with stratification by age group, sex, colonoscopy indication (screening or symptomatic), and NHS Trust. Recruiting staff, participants, and colonoscopists were unmasked to trial allocation; histopathologists, co-chief investigators, and trial statisticians were masked. CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal. The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures); the key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma). Analysis was by intention to treat (ITT), with outcomes compared between groups by mixed-effects regression modelling, in which effect estimates were adjusted for randomisation stratification variables. Data were imputed for outcome measures with more than 5% missing values. All participants who underwent colonoscopy were assessed for safety. The trial is registered on ISRCTN (ISRCTN10451355) and ClinicalTrials.gov (NCT04723758), and is complete. Between March 29, 2021, and April 6, 2023, 2032 participants (1132 [55·7%] male, 900 [44·3%] female; mean age 62·4 years [SD 10·8]) were recruited and randomly assigned: 1015 to CADe-assisted colonoscopy and 1017 to standard colonoscopy. 1231 (60·6%) participants were undergoing screening and 801 (39·4%) had symptomatic indications. Mean adenomas per procedure was 1·56 (SD 2·82; n=1001 participants with available data) in the CADe-assisted colonoscopy group versus 1·21 (1·91; n=1009) in the standard colonoscopy group, representing an adjusted mean difference of 0·36 (95% CI 0·14-0·57; adjusted incidence rate ratio 1·30 [95% CI 1·15-1·47], p<0·0001). Adenomas were detected in 555 (56·6%) of 980 participants in the CADe-assisted colonoscopy group versus 477 (48·4%) of 986 in the standard colonoscopy group, representing a proportion difference of 8·3% (95% CI 3·9-12·7; adjusted odds ratio 1·47 [95% CI 1·21-1·78], p<0·0001). Numbers of adverse events were similar between the CADe-assisted colonoscopy and standard colonoscopy groups (adverse events: 25 vs 19; serious adverse events: four vs six), and no adverse events in the CADe-assisted colonoscopy group were deemed to be related to GI Genius use on independent review. Results of the COLO-DETECT trial support the use of GI Genius to increase detection of premalignant colorectal polyps in routine colonoscopy practice. Medtronic.

Therapeutic efficacy of cold atmospheric plasma in four golden retrievers with acute otitis externa.

Cold atmospheric plasma (CAP) is a new therapeutic tool used to treat various skin diseases in humans and animals. To evaluate the effect of CAP in the treatment of canine acute otitis externa (AOE). Four client-owned golden retriever dogs with bilateral AOE. After cleaning with a commercial ear cleanser, right ears (STANDARD group) were treated with an antibiotic/antifungal/corticosteroid combination and left ears (CAP group) were treated with CAP every three days for a total of four treatments. Cytological score and otitis index score (OTIS)3 were recorded for each ear on Day (D)0, D10 and D15. At D10 and D15, owners and investigators recorded an overall assessment. In both groups, OTIS3 and cytological score decreased over the study period. The overall assessment scale ranged from moderate to excellent in both groups. Cold atmospheric plasma treatment showed equal therapeutic effect compared with a commercial topical anti-inflammatory and antimicrobial ear treatment.

Venous return physiology applied to post-cardiac arrest haemodynamic management: a post hoc analysis of the NEUROPROTECT trial

BackgroundThe European Resuscitation Council 2021 guidelines for haemodynamic monitoring and management during post-resuscitation care from cardiac arrest call for an individualised approach to therapeutic interventions. Combining the cardiac function and venous return curves with the inclusion of the mean systemic filling pressure enables a physiological illustration of intravascular volume, vasoconstriction and inotropy. An analogue mean systemic filling pressure (Pmsa) may be calculated once cardiac output, mean arterial and central venous pressure are known. The NEUROPROTECT trial compared targeting a mean arterial pressure of 65 mmHg (standard) versus an early goal directed haemodynamic optimisation targeting 85 mmHg (high) in ICU for 36 h after cardiac arrest. The trial data were used in this study to calculate post hoc Pmsa and its expanded variables to comprehensively describe venous return physiology during post-cardiac arrest management. A general estimating equation model was used to analyse continuous variables split by standard and high mean arterial pressure groups.ResultsData from 52 patients in each group were analysed. The driving pressure for venous return, and thus cardiac output, was higher in the high MAP group (p < 0.001) along with a numerically increased estimated stressed intravascular volume (mean difference 0.27 [− 0.014–0.55] L, p = 0.06). The heart efficiency was comparable (p = 0.43) in both the standard and high MAP target groups, suggesting that inotropy was similar despite increased arterial load in the high MAP group (p = 0.01). The efficiency of fluid boluses to increase cardiac output was increased in the higher MAP compared to standard MAP group (mean difference 0.26 [0.08–0.43] fraction units, p = 0.01).ConclusionsCalculation of the analogue mean systemic filling pressure and expanded variables using haemodynamic data from the NEUROPROTECT trial demonstrated an increased venous return, and thus cardiac output, as well as increased volume responsiveness associated with targeting a higher MAP. Further studies of the analogue mean systemic filling pressure and its derived variables are warranted to individualise post-resuscitation care and evaluate any clinical benefit associated with this monitoring approach.

Effectiveness of low dose cyproterone acetate compared to standard dose in feminizing hormone treatment: a single institutional retrospective pilot study.

Data regarding the effectiveness of low-dose cyproterone acetate (CPA) in testosterone suppression as feminizing hormone therapy (FHT) in individuals assigned male at birth (AMAB) are sparse. To assess the effectiveness in testosterone suppression using low-dose CPA (<25mg/day) compared to standard-dose CPA (25-50mg/day) in FHT. A retrospective cohort study of 59 individuals AMAB using CPA was done at a tertiary care center in Bangkok, Thailand between January 2014 and July 2022. The main outcomes included a median time when the testosterone was suppressed (<50ng/dL), the proportion of individuals AMAB who achieved the targeted testosterone level at 3months, and the testosterone level at each follow-up. Changes in clinical data were assessed. Among 59 individuals AMAB, 37 initiated CPA with available testosterone levels at the 3-month follow-up. Twenty-two individuals AMAB started with low-dose CPA (12.5mg/day), and 15 individuals AMAB started with standard-dose CPA. The median time to reach targeted testosterone was 3months in both groups (adjusted hazard ratio 0.60, P = .489). At 3months, 72.7% of those on low-dose CPA and 86.7% of those on standard-dose CPA achieved targeted testosterone (adjusted relative risk 0.85, P = .606). Testosterone levels at all follow-up visits were not significantly different. The standard dose group had higher high-density lipoprotein cholesterol (HDL-C) but lower low-density lipoprotein cholesterol (LDL-C) and alanine aminotransferase (ALT). This study supports a paradigm shift toward using lower-dose CPA in FHT. This is one of a few studies showing the effectiveness of low-dose CPA in testosterone suppression within 3months. Limitations include a small sample size and missing data. Testosterone suppression is comparable between CPA 12.5mg/day and the standard dose in FHT.

Comparative Analysis of Duroplasty Techniques in Decompressive Craniectomy: The CANDID Study.

At present, there is no consensus regarding the most optimal dural substitute to use for duroplasty in primary decompressive craniectomy (PDC) for traumatic brain injury (TBI). The author's objective was to conduct a retrospective analysis comparing 2 techniques of PDC: duroplasty using anterior-based vascularized galea pericranium (VP group) with synthetic dural substitute duroplasty (SR group). From April 2015 to February 2022, 379 craniotomies were done for TBI. The outcome of eligible 97 consecutive patients receiving PDC treatment were examined. Out of 97, 60 received vascularized galea pericranium and 37 received synthetic dural graft for dural augmentation. Propensity matching generated 28 pairs (56 patients) for analysis. The primary outcome was extended Glasgow Outcome Scale (GOS-E) measured at 6 months after injury. Secondary outcomes included were incidence of surgical complications (neurosurgical site infections, and hemorrhagic and hydrodynamic complications), surgical time, days in intensive care unit, hospital length of stay, hospital mortality, and GOS-E at 1 year after injury. Patients in VP group, compared with those in SR group had better GOS-E score at 6 months (P = .011) and 1 year (P = .026). Hospital mortality (P = .342), days in intensive care unit (P = .574), hospital stay (P = .155), surgical time (P = .131), medical and surgical complications including neurosurgical infections, and hemorrhagic and hydrodynamic complications did not differ significantly in both groups. Complication of brain abscess was found exclusively in the SR group (P = .327). In this retrospective study, adults who underwent PDC for TBI using anterior-based vascularized galea pericranial graft were associated with better clinical outcomes at 6 months and 1 year compared with standard repair group using synthetic dural substitute (G patch).

Protocol for a randomized controlled trial of moderate intensity interval training in individuals with chronic obstructive pulmonary disease and obstructive sleep apnea overlap syndrome who have excessive daytime sleepiness

BackgroundThe term “Overlap Syndrome” (OS) describes the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single individual. Excessive daytime sleepiness (EDS) is a common symptom of OS shown to be associated with an increased risk of cardiovascular disease (CVD) that could be reduced through exercise. Thus, we propose to investigate a novel exercise intervention in individuals with the EDS-OS phenotype as they are at highest risk of CVD yet have the greatest barriers to exercise. MethodsWe will conduct a single-site, randomized, two-arm, parallel group-controlled exercise trial in individuals with EDS-OS. The Epworth Sleepiness Scale (ESS) will be assessed at baseline. Individuals with OS and the EDS-OS phenotype (ESS >10) (n = 46) will be randomized to a moderate intensity interval training (MIIT, i.e. intervals of 5 min at 50% VO2peak followed by 3 min of active recovery at 10% VO2peak) or a control group of standard of care. We will investigate if MIIT intervention decreases the risk of CVD in EDS-OS, which will be assessed by: 1) quality of life, measured by the 36-Item Short Form Health Survey; 2) physical activity, measured by daily step counts; and 3) cardiovascular health, assessed as VO2peak, flow-mediated dilation and serum high sensitivity C-reactive protein, lipids, and glucose. ConclusionOur findings will guide future development and implementation of exercise interventions that could reduce the risk of CVD in the understudied EDS-OS phenotype.

Adaptive radiotherapy (up to 74 Gy) or standard radiotherapy (66 Gy) for patients with stage III non-small-cell lung cancer, according to [18F]FDG-PET tumour residual uptake at 42 Gy (RTEP7–IFCT-1402): a multicentre, randomised, controlled phase 2 trial

Thoracic radiation intensification is debated in patients with stage III non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of a boost radiotherapy dose up to 74 Gy in a functional sub-volume given according to on-treatment [18F]fluorodeoxyglucose ([18F]FDG)-PET results. In this multicentre, randomised, controlled non-comparative phase 2 trial, we recruited patients aged 18 years or older with inoperable stage III NSCLC without EGFR mutation or ALK rearrangement with an Eastern Cooperative Oncology Group performance status of 0-1, and who were affiliated with or a beneficiary of a social benefit system, with evaluable tumour or node lesions, preserved lung function, and who were amenable to curative-intent radiochemotherapy. Patients were randomly allocated using a central interactive web-response system in a non-masked method (1:1; minimisation method used [random factor of 0·8]; stratified by radiotherapy technique [intensity-modulated radiotherapy vs three-dimensional conformal radiotherapy] and by centre at which patients were treated) either to the experimental adaptive radiotherapy group A, in which only patients with positive residual metabolism on [18F]FDG-PET at 42 Gy received a boost radiotherapy (up to 74 Gy in 33 fractions), with all other patients receiving standard radiotherapy dosing (66 Gy in 33 fractions over 6·5 weeks), or to the standard radiotherapy group B (66 Gy in 33 fractions) over 6·5 weeks. All patients received two cycles of induction platinum-based chemotherapy cycles (paclitaxel 175 mg/m2 intravenously once every 3 weeks and carboplatin area under the curve [AUC]=6 once every 3 weeks, or cisplatin 80 mg/m2 intravenously once every 3 weeks and vinorelbine 30 mg/m2 intravenously on day 1 and 60 mg/m2 orally [or 30 mg/m2 intravenously] on day 8 once every 3 weeks). Then they concomitantly received radiochemotherapy with platinum-based chemotherapy (three cycles for 8 weeks, with once per week paclitaxel 40 mg/m2 intravenously and carboplatin AUC=2 or cisplatin 80 mg/m2 intravenously and vinorelbine 20 mg/m2 intravenously on day 1 and 40 mg/m2 orally (or 20 mg/m2 intravenously) on day 8 in 21-day cycles). The primary endpoint was the 15-month local control rate in the eligible patients who received at least one dose of concomitant radiochemotherapy. This RTEP7-IFCT-1402 trial is registered with ClinicalTrials.gov (NCT02473133), and is ongoing. From Nov 12, 2015, to July 7, 2021, we randomly assigned 158 patients (47 [30%] women and 111 [70%] men) to either the boosted radiotherapy group A (81 [51%]) or to the standard radiotherapy group B (77 [49%)]. In group A, 80 (99%) patients received induction chemotherapy and 68 (84%) received radiochemotherapy, of whom 48 (71%) with residual uptake on [18F]FDG-PET after 42 Gy received a radiotherapy boost. In group B, all 77 patients received induction chemotherapy and 73 (95%) received radiochemotherapy. At the final analysis, the median follow-up for eligible patients who received radiochemotherapy (n=140) was 45·1 months (95% CI 39·3-48·3). The 15-month local control rate was 77·6% (95% CI 67·6-87·6%) in group A and 71·2% (95% CI 60·8-81·6%) in group B. Acute (within 90 days from radiochemotherapy initiation) grade 3-4 adverse events were observed in 20 (29%) of 68 patients in group A and 33 (45%) of 73 patients in group B, including serious adverse events in five (7%) patients in group A and ten (14%) patients in group B. The most common grade 3-4 adverse events were febrile neutropenia (seven [10%] of 68 in group A vs 16 [22%] of 73 in group B), and anaemia (five [7%] vs nine [12%]). In the acute phase, two deaths (3%) occurred in group B (one due to a septic shock related to chemotherapy, and the other due to haemotypsia not related to study treatment), and no deaths occurred in group A. After 90 days, one additional treatment-unrelated death occurred in group A and two deaths events occurred in group B (one radiation pneumonitis and one pneumonia unrelated to treatment). A thoracic radiotherapy boost, based on interim [18F]FDG-PET, led to a meaningful local control rate with no difference in adverse events between the two groups in organs at risk, in contrast with previous attempts at thoracic radiation intensification, warranting a randomised phase 3 evaluation of such [18F]FDG-PET-guided radiotherapy dose adaptation in patients with stage III NSCLC. Programme Hospitalier de Recherche Clinique National 2014.

Decompressive craniectomy in trauma: What you need to know.

Decompressive craniectomy (DC) is a surgical procedure in which a large section of the skull is removed, and the underlying dura mater is opened widely. After evacuating a traumatic acute subdural hematoma, a primary DC is typically performed if the brain is bulging or if brain swelling is expected over the next several days. However, a recent randomized trial found similar 12-month outcomes when primary DC was compared with craniotomy for acute subdural hematoma. Secondary removal of the bone flap was performed in 9% of the craniotomy group, but more wound complications occurred in the craniectomy group. Two further multicenter trials found that, whereas early neuroprotective bifrontal DC for mild to moderate intracranial hypertension is not superior to medical management, DC as a last-tier therapy for refractory intracranial hypertension leads to reduced mortality. Patients undergoing secondary last-tier DC are more likely to improve over time than those in the standard medical management group. The overall conclusion from the most up-to-date evidence is that secondary DC has a role in the management of intracranial hypertension following traumatic brain injury but is not a panacea. Therefore, the decision to offer this operation should be made on a case-by-case basis. Following DC, cranioplasty is warranted but not always feasible, especially in low- and middle-income countries. Consequently, a decompressive craniotomy, where the bone flap is allowed to "hinge" or "float," is sometimes used. Decompressive craniotomy is also an option in a subgroup of traumatic brain injury patients undergoing primary surgical evacuation when the brain is neither bulging nor relaxed. However, a high-quality randomized controlled trial is needed to delineate the specific indications and the type of decompressive craniotomy in appropriate patients.

Fit comparison of interim crowns manufactured with open and proprietary 3D printing modes versus milling technology: An in vitro study.

This study aimed to assess the fit of interim crowns produced using DLP-based 3D printing with different manufacturing workflows-open and proprietary-versus milling technology. A total of 120 crowns were evaluated using the replica technique. The control group (Mill, n = 30) was manufactured via subtractive technology. Experimental groups were printed using a DLP printer (SprintRay Pro95). In the proprietary mode (SR100, n = 30), manufacturer resin was used with a 100-μm layer thickness (LT) and a splashing cleaning postprocessing. In the open mode, validated resin was used. Group B100 (n = 30) had a 100-μm LT, and group B50 (n = 30) had a 50-μm followed by postprocessing in an ultrasonic bath with full immersion in isopropyl alcohol. Kruskal-Wallis tests with Bonferroni correction was applied after normal analysis (α = 0.05). Group B50 exhibited the best overall fit (123.87 ± 67.42 μm), which was comparable to the gold standard Milling group, which demonstrated the lowest marginal fit (p = 0.760). SR100 showed significantly poorer performance compared to Mill, B50, and B100 (p < 0.001). 3D printed and milled interim crowns generally demonstrated clinically acceptable fit, with the exception of the SR100 group. Postprocessing notably influenced crown fit, with the open mode with total immersion in isopropyl alcohol being superior. The present study demonstrates that the selection of an optimal manufacturing and postprocessing workflow results in superior fit for interim crowns. This enables dental professionals to evaluate protocols and ensure reliable outcomes with improved clinical outcomes in interim crown fabrication.

Conventional ultrasonography enabled with augmented reality needle guidance for percutaneous kidney access: An innovative methodologies randomized controlled trial.

Successful needle puncture of the renal collecting system is a critical but difficult procedure in percutaneous nephrolithotomy (PCNL). Although fluoroscopy and ultrasound are the standard imaging techniques to guide puncture during PCNL, both have known limitations. To assess the feasibility and safety of a new navigation system for needle puncture in ultrasound-guided PCNL. This study employed a single-center randomized controlled trial (RCT) design to assess the feasibility and safety of a new navigation system for needle puncture in ultrasound-guided PCNL. Conducted between May 2021 and November 2021, the trial utilized computer-generated random numbers for participant allocation to control for selection bias. The trial was executed at the *********, which serves as an academic medical center. All patients who met the inclusion criteria were randomly divided into two groups, with 29 patients in each group. One group underwent PCNL procedures using the new navigation system, while the control group underwent standard ultrasound-guided PCNL procedures. Included patients had renal pelvis or caliceal calculi larger than 2.0cm in diameter or had multiple or staghorn stones. The puncture procedure was performed with the support of real-time ultrasound imaging and visual guidance displayed on the screen. The primary outcome was system feasibility and puncture success rate. Secondary outcomes included puncture time, total surgical time, number of attempts, post-procedure complications, and one-year and three-year stone recurrence rates. Stone clearance was defined by postoperative CT. Descriptive statistics summarized patient demographics, stone size, and location. Independent samples t-tests analyzed puncture time and total surgical time. Chi-square or Fisher's exact tests compared stone clearance, complications, socioeconomic status, renal hydronephrosis, stone location, race, and medical history. Linear regression examined the correlation between BMI and puncture time. Significance was set at P<0.05. For all 58 patients undergoing PCNL, needle punctures of the renal collecting system were completed with a success rate of 100%. The average time from planning the puncture protocol to successful puncture was significantly shorter in the AcuSee guidance system group (3.12min, range 0.2-6.88min) compared to the standard ultrasound-guided group (7.58min, range 5.41-10.68min), representing a reduction of approximately 59%. The total surgical time was also shorter in the AcuSee group for patients with no and mild hydronephrosis (P<0.05). Complication rates were lower in the AcuSee group, with no major complications observed. However, 3 patients in the standard ultrasound-guided group have adverse effects after the PCNL procedure. The one-year stone recurrence rate was significantly lower in the AcuSee group (3.4%) compared to the standard group (24.1%), and the three-year recurrence rate was also lower (6.9% vs. 41.4%). Patient-specific factors such as BMI, renal morphology, and prior surgical history did not significantly affect the performance of the AcuSee system. We report the first clinical application of a new navigation system for needle puncture in ultrasound-guided PCNL. It has been demonstrated that it is feasible and safe compared to the standard ultrasound-guided group in percutaneous renal puncture. This technology provides intuitive and easy-to-use visual guidance, which may facilitate safe, accurate and fast needle puncture of the kidney.

Correction of Trauma-induced Coagulopathy by Goal-directed Therapy: A Secondary Analysis of the ITACTIC Trial.

Trauma hemorrhage induces a coagulopathy with a high associated mortality rate. The Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy (ITACTIC) randomized trial tested two goal-directed treatment algorithms for coagulation management: one guided by conventional coagulation tests and one by viscoelastic hemostatic assays (viscoelastic). The lack of a difference in 28-day mortality led the authors to hypothesize that coagulopathic patients received insufficient treatment to correct coagulopathy. During ITACTIC, two sites were coenrolling patients into an ongoing prospective observational study, which included serial blood sampling at the same intervals as in ITACTIC. The subgroup in both studies had conventional and viscoelastic test results for each patient available for analysis. A goal-directed treatment was defined as one triggered by an ITACTIC algorithm. Coagulopathy was defined as rotational thromboelastometry EXTEM A5 less than 40 mm. The primary outcome was correction of coagulopathy by the 12th unit of erythrocyte transfusion during resuscitation. Full viscoelastic and conventional coagulation test results were available for 133 patients. Of these patients, 71% were coagulopathic on admission, and 16% developed a coagulopathy during resuscitation. ITACTIC viscoelastic hemostatic assay group patients were more likely to receive goal-directed treatment than the standard group (76% vs. 47%; odds ratio, 3.73; 95% CI, 1.64 to 8.49; P = 0.002). However, only 54% of patients received goal-directed treatment, and only 20% corrected their coagulopathy (vs. 0% with empiric treatment alone; not significant). Median time to first goal-directed treatment was 68 (53 to 88) min for viscoelastic and 110 (77 to 123) min for standard (P = 0.005). In ITACTIC, many bleeding trauma patients did not receive an indicated goal-directed treatment. Interventions arrived late during resuscitation and were only partially effective at correcting coagulopathy.

No differences in clinical and radiographic outcomes between standard versus high offset collared stems for primary total hip arthroplasty at fiveyears follow-up.

To compare clinical and radiographic outcomes of propensity-matched patients undergoing THA using standard versus high offset stems at fiveyears. The authors retrospectively reviewed a consecutive series of primary THAs performed between 01/09/2015-31/12/2017 using a fully-hydroxyapatite coated collared stem, with either a standard (n = 365) or high (n = 110) offset. Outcomes collected included: modified Harris Hip Score (mHHS), Oxford Hip Score (OHS), Forgotten Joint Score (FJS), and radiographic measurements including limb length discrepancy (LLD), stem subsidence, and stem radiolucencies. Propensity score matching resulted in 80 hips per group. Preoperatively there were no significant differences in patient demographics, surgical data and radiographic measurements, except the standard offset group had significantly smaller femoral (40.0 ± 7.5 vs 48.4 ± 6.2, p < 0.001), acetabular (92. ± 6.3 vs 94.8 ± 7.3, p = 0.011) and global (132.0 ± 10.3 vs 143.2 ± 8.2, p < 0.001) offsets compared to the high offset group. At a minimum fiveyears follow-up, there were no significant differences in mHHS (93.2 ± 11.0 vs 93.1 ± 10.6, p = 0.553), OHS (45.1 ± 4.1 vs 45.3 ± 4.6, p = 0.623), and FJS (85.1 ± 19.3 vs 82.7 ± 23.0, p = 0.910). There were also no differences in radiographic measurements, including LLD (1.5 ± 4.8 vs 1.1 ± 3.5, p = 0.537), stem subsidence (0% vs 0%, p = 1.000), and stem radiolucencies (severe: 6% vs 1%, p = 0.152). The present matched-cohort study found no significant differences between standard versus high offset straight fully-hydroxyapatite coated collared stems for primary THA in terms of clinical and radiographic outcomes at fiveyears. These findings may suggest that uncemented collared high offset stems are not associated with an increased risk of radiolucencies and loosening compared to uncemented collared standard offset stems.

Plain language summary of the CARTITUDE-4 study of ciltacabtagene autoleucel for the treatment of people with relapsed or refractory multiple myeloma.

This is a summary of a phase 3 clinical trial called CARTITUDE-4. This trial compared the anti-cancer therapy ciltacabtagene autoleucel (or cilta-cel) with standard therapies in people who have multiple myeloma, a cancer that affects specific kinds of blood cells called plasma cells. The people in the study had been treated with 1 to 3 previous treatments for multiple myeloma, including a common anti-myeloma treatment called lenalidomide, but their multiple myeloma did not get better. About half of the 419 participants in this study received cilta-cel, while the other half received standard therapies, or therapies that are commonly used to treat multiple myeloma. Participants who received cilta-cel had a type of immune cell called T cells collected from their blood and genetically modified to recognize a specific protein found on myeloma cells. These modified T cells, which comprise cilta-cel, were then infused back into the bloodstream. After approximately 1year in the study, more participants were alive without their cancer getting worse in the cilta-cel group (76%) than in the standard therapies group (49%). The most common side effects in both groups were infections and low blood cell counts. Cytokine release syndrome (a potentially serious side effect caused by overactivation of the immune system) was common but mostly mild. Neurotoxicities (including immune effector cell-associated neurotoxicity syndrome, which can cause symptoms such as headaches, changes in consciousness, and difficulty with memory, attention, speaking, or understanding others) were less common and were reported in 20.5% of participants treated with cilta-cel. In CARTITUDE-4, more participants treated with cilta-cel showed improvements and were alive with control of their disease 12months after receiving cilta-cel compared with participants who received standard therapies.Clinical Trial Registration: NCT04181827 (CARTITUDE-4) (ClinicalTrials.gov).

A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy

IntroductionChildren with Cerebral Palsy (CP) encounter substantial nutritional challenges that impair their health and quality of life. Despite the importance of nutrition in managing CP and the recognition of physiological, behavioral, and social causes of malnutrition, research on the effectiveness of individualized nutritional interventions developed and supported by multidisciplinary teams is scarce. AimThe study will evaluate the impact of an individualized nutritional intervention developed and supported by a multidisciplinary team on the anthropometric outcomes and overall health of children with CP. MethodsA single-center, randomized controlled trial, conducted at the Medical University of Varna, Bulgaria, will enroll 100 children aged 2–12 years and diagnosed with CP. Participants will be randomly assigned to either an intervention group, receiving comprehensive structured dietary assessment and individualized nutrition plan developed by a multidisciplinary team of experts, or to a standard care group. Outcomes assessed will focus on anthropometric measures of nutritional status, but also include health outcomes, child development and clinical assessments, and quality of life indicators. EthicsEthical approval for this study has been obtained from the Medical Ethics Committee at the Medical University of Varna (Protocol No. 134 dated 20.07.2023). ConclusionThis study will assess the benefits of a multidisciplinary, individualized nutritional intervention for children with CP. The findings will have implications for clinical guidelines and interventions aiming to improve their care and quality of life.

Constraining νSMEFT coefficients: The case of the extra U(1)′

We study the constraints on low-energy coefficients of the νSMEFT generalization of the Standard Model effective theory in the simple case of a U(1)′ enlargement of the Standard Model gauge group. In particular, we analyze the constraints imposed by the requirement that the extended theory remains free of gauge anomalies. We present the cases of explicit realizations, showing the obtained correlations among the coefficients of d=6 operators. Published by the American Physical Society 2024

Comparison of Conventionally Performed and Intracardiac Echocardiography Guided Catheter Ablation of Atrioventricular Node in Patients with Permanent Atrial Fibrillation-A Retrospective Single-Center Study.

Background: Atrioventricular node (AVN) ablation is an effective treatment for atrial fibrillation (AF) with uncontrolled ventricular rates despite maximal pharmacological treatment. Intracardiac echocardiography (ICE) can help with visualizing structures, positioning catheters, and guiding the ablation procedure. We compared only fluoroscopy-guided and ICE-guided AVN ablation regarding patients with permanent AF. Methods: Sixty-two consecutive patients underwent AVN ablation were enrolled in our retrospective single-center study (ICE group: 28 patients, Standard group: 34 patients). Procedural data, acute and long-term success rate, and complications were analyzed. Results: ICE guidance for AVN ablation significantly reduced fluoroscopy time (0.30 [0.06; 0.85] min vs. 7.95 [3.23; 6.59] min, p < 0.01), first-to-last ablation time (4 [2; 16.3] min vs. 26.5 [2.3; 72.5] min, p = 0.02), and in-procedure time (40 [34; 55] min vs. 60 [45; 110], p = 0.02). There was no difference in either the total ablation time (199 [91; 436] s vs. 294 [110; 659] s, p = 0.22) or in total ablation energy (8272 [4004; 14,651] J vs. 6065 [2708; 16,406] J, p = 0.28). The acute success rate was similar (ICE: 100% vs. Standard: 94%, p = 0.49) between the groups. Conclusions: In our retrospective trial, ICE-guided AVN ablation reduced fluoroscopy time, procedure time, and first-to-last ablation time. There was no difference in ablation time, total ablation energy, acute and long-term success, and complication rate.

Far Cortical Locking Versus Standard Constructs for Locked Plate Fixation in the Treatment of Acute, Displaced Fractures of the Distal Femur

Background: Fixation of distal femoral fractures remains a challenge, and nonunions are common with standard constructs. Far cortical locking (FCL) constructs have been purported to lead to improved fracture-healing as compared with that achieved with traditional locking bridge plates. We sought to test this hypothesis in a comparative effectiveness clinical trial. Methods: This randomized trial was performed across 16 centers and included adult patients with an AO/OTA type 33A or 33C distal femoral fracture that was suitable for bridging fixation. We excluded patients with periprosthetic fractures. Participants were randomly assigned to either FCL fixation or standard locking plate fixation. The primary outcome was a hierarchical composite of radiographic and clinical fracture-healing at 3 months after fixation. We estimated between-group differences with use of the win ratio approach. Secondary outcomes included radiographic healing, clinical fracture-healing, complications, reoperations, and health-related quality of life (Short Form-36 Health Survey Version 2 [SF-36] Physical Component Summary and Mental Component Summary scores) at 3, 6, and 12 months after fixation. Results: We randomly assigned 193 patients to treatment with either FCL screws (96 patients) or standard screws (97 patients). The study population had a mean age of 63.4 years, consisted predominantly of women (68%), and was well-balanced between AO/OTA 33A and 33C fractures. Based on 4,355 pairwise comparisons, the calculated win ratio was 1.18 (95% confidence interval [CI], 0.77 to 1.79; p = 0.45), indicating that patients assigned to FCL screws had better outcomes in 51% of the comparisons. Radiographic healing did not differ significantly between the groups (odds ratio, 1.36; 95% CI, 0.69 to 2.72; p = 0.38), nor did Function IndeX for Trauma (FIX-IT) scores (p = 0.41). There were no significant differences between the groups in terms of SF-36 Physical Component Summary scores at 3 months or in the change in scores at 12 months after fixation. Conclusions: In this multicenter randomized trial of adult patients with an AO/OTA type 33A or 33C distal femoral fracture, similar clinical and radiographic healing outcomes were observed in the FCL and standard fixation groups. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.