6-month Follow-up Research Articles

Engineered Tendon-Fibrocartilage-Bone Composite With Mechanical Stimulation for Augmentation of Rotator Cuff Repair: A Study Using an In Vivo Canine Model With a 6-Month Follow-up.

Rotator cuff repair augmentation using biological materials has become popular in clinical practice to reduce the high retear rates associated with traditional repair techniques. Tissue engineering approaches, such as engineered tendon-fibrocartilage-bone composite (TFBC), have shown promise in enhancing the biological healing of rotator cuff tears in animals. However, previous studies have provided limited long-term data on TFBC repair outcomes. The effect of mechanical stimulation on TFBC has not been explored extensively. To evaluate functional outcomes after rotator cuff repair with engineered TFBC subjected to mechanical stimulation in a 6-month follow-up using a canine in vivo model. Controlled laboratory study. A total of 40 canines with an acute infraspinatus (ISP) tendon transection model were randomly allocated to 4 groups (n =10): (1) unilateral ISP tendon undergoing suture repair only (control surgery); (2) augmentation with engineered TFBC alone (TFBC); (3) augmentation with engineered TFBC and bone marrow-derived stem cells (BMSCs) (TFBC+C); and (4) augmentation with engineered TFBC and BMSCs, as well as mechanical stimulation (TFBC+C+M). Outcome measures-including biomechanical evaluations such as failure strength, stiffness, failure mode, gross appearance, ISP tendon and muscle morphological assessment, and histological analysis-were performed 6 months after surgery. As shown in the mechanical test, the TFBC+C+M group exhibited higher failure strength compared with other repair techniques. The most common failure mode was avulsion fracture in the TFBC+C+M group, but tendon-bone junction rupture was observed predominantly in different groups. Engineered TFBC with mechanical stimulation showed over 70% relative failure strength compared with normal ISP, and the other groups showed about 50% relative failure strength. Histological analysis revealed less fat infiltration and closer-to-normal muscle fiber structure in the mechanical stimulation group. This study provides evidence that mechanical stimulation of engineered TFBC promotes rotator cuff regeneration, thus supporting its potential for rotator cuff repair augmentation. This study provides valuable evidence supporting the use of a novel tissue-engineered material (TFBC) in rotator cuff repair and paves the way for advancements in the field of rotator cuff regeneration.

Does scaffold enhancement show significant superiority over microfracture alone for treating knee chondral defects? A systematic review and meta-analysis of randomised clinical trials.

Chondral and osteochondral lesions in the knee are common conditions that significantly impair individuals' well-being and can lead to osteoarthritis, imposing substantial burdens on healthcare systems. The limited natural healing capacity of articular cartilage necessitates innovative treatment strategies. Microfracture (MF) is a widely used technique for knee chondral defects, but its long-term efficacy is often inadequate. Although recent randomised controlled trials have compared microfractures with scaffold-enhanced therapies, a comprehensive systematic review and meta-analysis are lacking. An extensive literature search was conducted in PubMed and EMBASE databases following PRISMA guidelines. Inclusion criteria focused on randomised controlled trials (RCTs) comparing microfractures alone to matrix-induced chondrogenesis for knee chondral defects with at least a 12-month follow-up. Ten randomised controlled trials conducted between 2013 and 2024, enroling 378 patients, were included. The meta-analysis showed no significant superiority of scaffolds over MF (p > 0.05) in International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome, Visual Analog Scale, and Magnetic Resonance Observation of Cartilage Repair Tissue scores at 12 and 24 months. However, individual studies suggested the potential benefits of scaffolds, especially in long-term outcomes. Clinical improvements from MF typically decline after 2-3 years, underscoring the need for long-term follow-up in future research. Our meta-analysis shows no significant difference between MF and MF with scaffold in treating knee cartilage defects, though some long-term RCTs demonstrate statistically significant differences. The absence of a universally accepted algorithm for analysing knee chondral defects limits this study. Establishing reliable guidelines and standardised study protocols is essential to improve long-term patient outcomes and the quality of future papers. Level I.

Plasma Proteomic Biomarkers in Alzheimer's Disease and Cardiovascular Disease: A Longitudinal Study.

The co-occurrence of Alzheimer's disease (AD) and cardiovascular diseases (CVDs) in older adults highlights the necessity for the exploration of potential shared risk factors. A total of 566 adults were selected from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database, including 111 individuals with AD, 383 with mild cognitive impairment (MCI), and 410 with CVD. The multivariable linear mixed model (LMM) was used to investigate the associations of AD and CVD with longitudinal changes in 146 plasma proteomic biomarkers (measured at baseline and the 12-month follow-up). The LMM showed that 48 biomarkers were linked to AD and 46 to CVD (p < 0.05). Both AD and CVD were associated with longitudinal changes in 14 biomarkers (α1Micro, ApoH, β2M, BNP, complement C3, cystatin C, KIM1, NGAL, PPP, TIM1, THP, TFF3, TM, and VEGF), and both MCI and CVD were associated with 12 biomarkers (ApoD, AXL, BNP, Calcitonin, CD40, C-peptide, pM, PPP, THP, TNFR2, TTR, and VEGF), suggesting intricate connections between cognitive decline and cardiovascular health. Among these, the Tamm Horsfall Protein (THP) was associated with AD, MCI, CVD, and APOE-ε4. This study provides valuable insights into shared and distinct biological markers and mechanisms underlying AD and CVD.

Salivary Antimicrobial Peptide in Patients With Dementia Before and After Clinical Oral Rehabilitation Programme: A Randomised Controlled Trial.

Emerging evidence suggests a link between salivary metabolite changes and neurodegenerative dementia, with antimicrobial peptides (AMPs) implicated in its pathogenesis. We investigated the effects of a clinical oral rehabilitation programme tailored for dementia patients on salivary flow rate, AMP levels and oral health-related quality of life (OHRQoL). Eligible patients were randomly assigned to either the experimental group (EG; n = 28) or the control group (CG; n = 27). Both groups received a leaflet on oral health. In addition, the EG received an oral care intervention that included individual lessons on oral muscle exercises and oral self-care practices. Saliva samples and OHRQoL data were collected at baseline and follow-up visits. Generalised estimating equation models were used to analyse the changes over time. At the 3-month follow-up, EG showed significantly lower histatin 5 (HTN-5) levels (β = -0.08; effect size [ES] = 0.72) than CG. At 6 months, EG exhibited improved salivary flow rate (β = 0.89; ES = 0.89) and OHRQoL (β = 6.99; ES = 1.31) compared to CG. Changes in salivary flow rate (β = 4.03), HTN-5 level (β = -0.78) and beta-defensin 2 level (BD-2) (β = -0.91) at 3 months predicted improved OHRQoL at 6 months (all p < 0.05). Our clinical oral rehabilitation programme reduced the level of salivary HTN-5, increased salivary flow rate and enhanced OHRQoL in dementia patients. Furthermore, changes in salivary flow rate, HTN-5 level and BD-2 level were associated with improvements in patients' OHRQoL.

Improvements in Safety Outcomes Following Brief Healthcare-Based Intimate Partner Violence Interventions among Women Who Screen Positive for Intimate Partner Violence-Related Traumatic Brain Injuries.

Background: Traumatic brain injuries (TBIs) are a common consequence of experiencing intimate partner violence (IPV). IPV-related TBI contributes to adverse health outcomes among women, but it is unknown whether a history of IPV-related TBI negatively impacts safety outcomes following healthcare-based interventions for IPV. Methods: Using data from a larger randomized clinical trial, we explored the impact of IPV-related TBI status on safety-related outcomes in two healthcare-based IPV interventions. At baseline, 35% (n = 21) of the sample screened positive for IPV-related TBI history. We used repeated measures ANOVAs to examine differences in safety outcomes at post-treatment and 1-month follow-up based on treatment condition and IPV-related TBI status. Results: Significant interaction effects were found for safety outcomes, such that women with IPV-related TBI history experienced larger reductions in the frequency of physical IPV and similar reductions in sexual IPV across both treatment conditions compared to women without IPV-TBI (F(2, 102) = 10.88, p < 0.001; F(2, 98) = 3.93, p = 0.036). Conclusions: Findings suggest that brief healthcare-based IPV interventions may result in improvements in safety outcomes for women with a history of IPV-TBI. This highlights the continued need for implementation of promising IPV-focused interventions to promote safety and protect women from experiencing further IPV.

DepActive: study protocol for a randomised controlled multicentre trial of telephone-delivered behavioural activation for the treatment of depression in older adults in primary care

BackgroundDepression is common in older adults and is related to reduced quality of life and functional ability as well as increased mortality and morbidity. Current guidelines recommend psychological treatments for the treatment of depression in adults. Studies show that about 30% of older adults with depression in Sweden receive pharmacological treatment and about 3% receive psychological treatment. However, a majority receive no treatment at all. There is a need for effective and scalable psychological treatment options for older adults with depression in primary care. Behavioural activation is an extensively evaluated, effective, and relatively simple treatment for depression that can be delivered by health care professionals without comprehensive training in psychological treatment.MethodsWe will conduct a randomised controlled 2-armed parallel group multicentre trial comparing treatment as usual in primary care to a five-session telephone-delivered behavioural activation treatment as add on to treatment as usual. The current trial is open labelled. In all, 250 older adults (≥ 65 years) with depression will be recruited from primary healthcare centres in three Swedish regions. The primary outcome is depressive symptoms measured with the Montgomery Åsberg Depression Rating Scale – Self rating version (MADRS-S) after treatment and at 3- and 6-month follow-up. Secondary outcomes include depression diagnoses, activity level (self-rated and measured with accelerometer), and self-rated anxiety, daily functioning, quality of life, self-efficacy, and loneliness.DiscussionThere is a need for fully powered studies of brief behavioural activation for older adults with depression delivered by telephone in a primary care context. This study has the potential to improve first-line treatment of depression in older adults in primary care, consequently reducing morbidity and mortality within this population. Increasing the availability and accessibility to effective psychological treatment for depression in older adults is needed to meet future demographic changes.Trial registrationClinicalTrials.gov: NCT06284889. Registered February 28, 2024.

Feasibility and Safety of Post-Transcatheter Aortic Valve Replacement Coronary Revascularization Guided by Stress Cardiac Imaging

Background: Systematic revascularization of asymptomatic coronary artery stenosis before transcatheter aortic valve replacement (TAVR) is controversial. Purpose: The purpose of this study was to evaluate the feasibility and safety of functional evaluation of coronary artery disease (CAD) followed by selective ischemia-guided percutaneous coronary revascularization following TAVR. Methods: This prospective, bi-centric, single-arm, open-label trial included all patients with severe aortic stenosis (AS) eligible for TAVR and with significant CAD defined as ≥1 coronary stenosis ≥ 70%. Patients with left main stenosis ≥ 50%, proximal left anterior descending artery (LAD) stenosis ≥ 90% or &gt; class 2 Canadian Classification Society (CCS) angina were excluded. Myocardial ischemia was evaluated by stress cardiac imaging one month after TAVR. The primary endpoint was a composite of all-cause death, stroke, major bleeding (Bleeding Academic Research Consotium ≥ 3), major vascular complication (Valve Academic Research Consortium 3 criteria), acute coronary syndrome (ACS) and hospitalization for cardiac causes within 6 months of receiving TAVR. Results: Between June 2020 and June 2022, 64 patients were included in this study. The mean age was 84 ± 5.2 years. CAD mostly involved LAD (n = 27, 42%) with frequent multivessel disease (n = 30, 47%) and calcified lesions (n = 39, 61%). Stress cardiac imaging could be achieved in 70% (n = 46) of the patients, while 30% (n = 18) did not attend the stress test. Significant myocardial ischemia was observed in only three patients (4.5%). At 6-month follow-up, fifteen patients (23%) reached the primary endpoint, including death in six patients (9%), stroke in three patients (5%) and major bleeding in three patients (5%). ACS was observed in only two patients (3%) but both had severe coronary stenosis (≥90%) and did not refer for stress imaging for personal reasons. Hospital readmission (n = 27, 41%) was mostly related to non-cardiac causes (n = 17, 27%). Conclusions: In patients with asymptomatic CAD scheduled to undergo TAVR, a selective ischemia-guided coronary revascularization after TAVR seems to be safe, with a very low rate of ACS and few cases of myocardial ischemia requiring revascularization, despite low adherence to medical follow-up in this elderly population. This strategy could be evaluated in a randomized study.

Effects of orthokeratology and spectacle lenses with highly aspherical lenslets on unilateral myopic anisometropia control.

To evaluate the 1-year effects of orthokeratology (OK) lenses and spectacle lenses with highly aspherical lenslets (HALs) on axial length (AL) elongation in children with unilateral myopic anisometropia. This ambispective cohort study recruited 81 children aged 8-14 years with unilateral myopic anisometropia. Of these, 42 participants (mean age 11.07 ± 1.54 years; 23 males) were treated with monocular OK lenses (OK group), and 39 (mean age 10.64 ± 1.72 years; 22 males) with binocular HALs (HAL group). Changes in AL and spherical equivalent refraction (SER) from baseline at 3, 6 and 12 months were compared between eyes and groups. Kaplan-Meier estimation and Cox proportional hazard regression were performed to analyse the risk of myopia onset in the initially non-myopic eyes. Mean axial elongation in the myopic and non-myopic eyes at the 12-month follow-up visit were 0.17 ± 0.20 and 0.41 ± 0.26 mm in the OK group (p < 0.001) and 0.10 ± 0.15 and 0.12 ± 0.12 mm in the HAL group (p = 0.32), respectively. Compared with the OK group, the non-myopic eyes in the HAL group had less axial elongation, lower cumulative myopia incidence and percentage of participants with rapid myopic shift at the 6- and 12 month follow-up (all p < 0.05). Cox regression analysis showed that a higher initial SER decreased the risk of myopia onset significantly in the initially non-myopic eyes (B = -2.06; 95% CI, 0.03-0.49; p = 0.003). Monocular OK lenses suppressed axial elongation in the myopic eye and minimised anisometropia; however, the non-treated contralateral eye may experience faster myopia onset and myopic shift. Binocular HALs can effectively reduce axial elongation in both eyes of children with unilateral myopic anisometropia.

CYRAD: a translational study assessing immune response to radiotherapy by photons or protons in postoperative head and neck cancer patients through circulating leukocyte subpopulations and cytokine levels

BackgroundRadiotherapy has both immunostimulant and immunosuppressive effects, particularly in radiation-induced lymphopenia. Proton therapy has demonstrated potential in mitigating this lymphopenia, yet the mechanisms by which different types of radiation affect the immune system function are not fully characterized. The Circulating Immunes Cells, Cytokines and Brain Radiotherapy (CYRAD) trial aims to compare the effects of postoperative X-ray and proton radiotherapy on circulating leukocyte subpopulations and cytokine levels in patients with head and neck (CNS and ear nose throat) cancer.MethodsCYRAD is a prospective, non-randomized, single-center non interventional study assessing changes in the circulating leukocyte subpopulations and cytokine levels in head and neck cancer patients receiving X-ray or proton radiotherapy following tumor resection. Dosimetry parameters, including dose deposited to organs-at-risk such as the blood and cervical lymph nodes, are computed. Participants undergo 29 to 35 radiotherapy sessions over 40 to 50 days, followed by a 3-month follow-up. Blood samples are collected before starting radiotherapy (baseline), before the 11th (D15) and 30th sessions (D40), and three months after completing radiotherapy. The study will be conducted with 40 patients, in 2 groups of 20 patients per modality of radiotherapy (proton therapy and photon therapy). Statistical analyses will assess the absolute and relative relationship between variations (depletion, recovery) in immune cells, biomarkers, dosimetry parameters and early outcomes.DiscussionPrevious research has primarily focused on radiation-induced lymphopenia, paying less attention to the specific impacts of radiation on different lymphoid and myeloid cell types. Early studies indicate that X-ray and proton irradiation may lead to divergent outcomes in leukocyte subpopulations within the bloodstream. Based on these preliminary findings, this study aims to refine our understanding of how proton therapy can better preserve immune function in postoperative (macroscopic tumor-free) head and neck cancer patients, potentially improving treatment outcomes.Protocol versionVersion 2.1 dated from January 18, 2023.Trial registrationThe CYRAD trial is registered from October 19, 2021, at the US National Library of Medicine, ClinicalTrials.gov ID NCT05082961.

12314 Effectiveness Of Continuous Glucose Monitors In Patients With Type 2 Diabetes On Washington Medicaid Or Financial Assistance

Abstract Disclosure: A. Deng: None. A. Thirumalai: None. J. Lin: None. M. Weber: None. S. Zuo: None. Continuous glucose monitors (CGMs) have become more accessible for patients with type 2 diabetes mellitus (T2DM) on one insulin injection per day who have either commercial or Medicare plans. However, there are still strict requirements for patients with Washington State Medicaid, creating disparities in diabetes care for vulnerable populations. The aim of this study is to assess the effectiveness and adherence of CGMs in patients with T2DM on Washington State Medicaid plans or institutional financial assistance who are prescribed at least one insulin injection daily, similar to Medicare requirements. This ongoing prospective cohort study enrolled 40 adult patients with T2DM, baseline A1C greater than 7%, and prescribed at least one insulin injection per day from three Harborview Medical Center clinics. Through grant funding, patients were provided with Freestyle Libre 2 CGMs for 6 months. Since this is an ongoing study, we present preliminary results of patients who completed 3 months of CGM use. Effectiveness was measured by the change in A1C from baseline to 3 months after initiation of the CGM (primary outcome) and change in CGM glycemic metrics on ambulatory glucose profile (AGP) from baseline to 3 months after initiation of CGM (secondary outcomes). Assessment of adherence to the CGMs involved tracking the percentage of CGM data captured from the AGP reports recorded at each visit and monitoring dispense history. Twenty patients reached the 3-month follow-up with a median age of 59 years; 60% female, 70% non-English speaking; 45% with Medicaid, and 55% with Harborview Financial Assistance as insurance coverage. Median baseline A1C was 9.2%, duration of diabetes was 10 years, number of diabetes medications was 3, daily insulin injections of 2, and number of blood glucose checks per day was 1. At first CGM download (2 weeks), the median time in range (TIR, glucose 70-180 mg/dL) was 53.5%, coefficient of variation was 35.3% and percent of data captured was 80%. At 3-month follow-up, the median reduction in A1c was –1.2% (IQR -1.8, -0.5). On CGM, the median TIR had increased to 60.5%, coefficient of variation had improved to 31.5% and percent of data captured was 79%. In this ongoing study, preliminary findings show encouraging early evidence of improved glycemic control after CGMs were initiated and patients sustained greater than 70% CGM data captured at 3 months. These results should be interpreted with caution given the small number of participants with results at 3 months. Nonetheless, once the study is complete, the outcomes may be used to inform eligibility requirements for continuous glucose monitors in patients with Washington Medicaid or Harborview Financial Assistance. Presentation: 6/3/2024

7008 Challenges in the Management of Thyroid Lymphoma - Case Report

Abstract Disclosure: F. Toloza Bonilla: None. P. Veeraraghavan: None. R. Lakhotia: None. M. Roschewski: None. N. Nilubol: None. S. Gubbi: None. J. Klubo-Gwiezdzinska: None. Introduction: Primary thyroid lymphoma is an extremely rare thyroid malignancy accounting for less than 5% thyroid malignancies. The management depends on the histological subtype and tumor staging, typically involving chemotherapy alone or combined with radiotherapy. Although, surgical intervention is generally not recommended, given the potential surgical risks and the absence of additional benefits compared to chemoradiation therapy, it is reserved to obtain tissue diagnosis and to treat compressive symptoms. Clinical Case: A 66-year-old Caucasian female presented with dysphagia to solid food and acute neck swelling for a few weeks. History was negative for fever, weight loss or nocturnal diaphoresis. The patient had a history of primary hypertension, pre-diabetes, and Hashimoto’s hypothyroidism. A neck computed tomography (CT) scan showed a thyromegaly (8.3 x 5.8 cm) and bilateral cervical lymphadenopathy. Thyroid ultrasound showed sub centimeter nodules in the right mid-gland and a heterogeneous and irregular left thyroid lobe. TSH was normal (0.87 mcIU/mL [0.27-4.2]). She was treated for suspected subacute thyroiditis with prednisone for two weeks, showing initial clinical improvement, but symptoms recurred after steroids were stopped. Subsequently, a CT neck and fludeoxyglucose F18 (FDG) positron emission tomography (PET) scan demonstrated FDG avid thyroid enlargement with local adenopathy and rightward tracheal deviation. Lymph node, FNA, core biopsies and molecular testing were consistent with stage IIE MYC/BCL6 rearranged diffuse large B-cell lymphoma as she had no bone marrow or central nervous system (CNS) involvement. The patient’s treatments included four cycles of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab with ibrutinib added after the first cycle and intrathecal methotrexate with cycles 3-6, to reduce the risk of CNS involvement. A 6-month post-therapy follow-up showed complete response (CR) on imaging with symptoms resolution. Four months later, she experienced worsening symptoms, including dysphagia with solids and liquids, and hoarseness despite CR to therapy and stable CT imaging. Laryngoscopic evaluation noted left vocal cord paralysis and extrinsic compression of the tracheoesophageal groove. Patient opted for a left hemithyroidectomy, experiencing excellent symptom relief. Surgical pathology showed findings consistent with a necrotic tumor and residual areas of lymphocytic thyroiditis. No active DLBCL was appreciated. The patient remains in remission and continues to be symptoms-free 24 months post-thyroid lymphoma treatment. Conclusion: While thyroidectomy is not typically recommended as the initial treatment for primary thyroid lymphoma, it emerges as a potentially effective option to manage recurrent or persistent compression symptoms following the completion of medical therapy. Presentation: 6/3/2024

Evaluating an early social communication intervention for young children with Down syndrome (ASCEND): results from a feasibility randomised control trial

BackgroundThis paper reports the results from a feasibility trial of an early parent-delivered social communication intervention for young children with Down syndrome (‘ASCEND’). The intervention focuses on developing children’s early social communication skills, in particular responding to shared attention. The aim was to inform the feasibility of running a full-scale trial through National Health Service (NHS) Speech and Language Therapy (SaLT) services, to assess whether the intervention is effective in improving language skills before children with Down syndrome start school.MethodsThis was a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, comparing the intervention plus standard NHS SaLT provision with standard NHS SaLT alone. We recruited 20 children with Down syndrome aged between 11 and 36 months through 3 NHS SaLT services, 19 of whom were randomised (10 — intervention group, 9 —control group). Pre- and post-intervention and 6-month follow-up assessments included language, social communication skills, adaptive behaviour, quality of life (parents and children), parental anxiety and depression. The intervention was parent delivered with parents having access to SaLT services and the research team during the intervention. Data were collected on recruitment and retention, standard care, treatment fidelity, acceptability of the intervention by the parents and speech and language therapists, feasibility of collecting health economic measures and suitability of the primary outcome measure.ResultsThe sample was sufficient for a feasibility study. The intervention (manual, support, materials) was positively received by the participating parents. Speech and language therapists also evaluated the acceptability of the intervention positively. Treatment fidelity which was measured by completion of weekly parent diaries and two adherence phone call was acceptable as 100% of the parent diaries were returned, over 90% of the parental diaries were completed correctly and 100% of adherence phone calls were completed. Retention was acceptable at 84% overall. The preliminary health economic data suggest that this intervention will be low cost. The sample size calculation suggests that 290 participants would need to be recruited, with 228 having a complete data set, for a full RCT.ConclusionBased on recruitment, retention and treatment fidelity, as well as the acceptability of the intervention to parents and speech and language therapists, a full-scale trial would be feasible in order to assess the effectiveness of the intervention.Trial registrationISRCTN13902755, registered on 25th August 2020, http://www.isrctn.com/ISRCTN13902755

Marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser melted cobalt chromium bar: a randomized clinical trial

BackgroundTo assess marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser-melted cobalt chromium (Co-Cr) bars.MethodThis research was set to be a parallel, triple-blinded, randomised controlled trial. Twenty completely edentulous patients received new conventional complete dentures according to conventional techniques. Two implants were placed at mandibular canine areas bilaterally, and patients were randomly allocated into two equal groups: the milled Co-Cr bar group and the selective laser melted (SLM) Co-Cr bar group. Marginal bone loss (MBL), modified plaque index (mPI), modified gingival index (mGI), and probing depth (PD) were evaluated at 0-month (baseline), 6-month, and 12-month follow-up visits. Repeated measures ANOVA test and Bonferroni’s post-hoc test were used for parametric data as PD, while for non-parametric data as MBL, mGI, and mPI, Mann-Whitney U test and Friedman’s test were used. A P-value ≤ 0.05 was set as the statistical level of significance. The study protocol was approved by the Faculty Research Ethics Committee at Minia University (636 4/10/2022). Registration for the clinical trial was made retrospectively on clinicaltrials.gov with ID NCT06401200 at 04/30/2024.ResultsThe follow-up period (one year) was completed without a dropout. Regarding MBL, no statistically significant difference was found between the two groups throughout the study. However, the milled group showed significantly increased MBL from 0- to 6-month follow up period. In both groups, mPI increased significantly from 0- to 6-months post-loading. On the other hand, no statistically significant difference between the two groups was found regarding mPI and mGI throughout the study follow-up periods. The PD was significantly lower in the milled compared to the SLM group at the 6- and 12-month follow up period.ConclusionTwo-implant mandibular overdenture retained with milled or SLM Co-Cr bar can provide an acceptable treatment option for completely edentulous patients regarding marginal bone loss and soft tissue outcomes.

Differences in the Impact of Intensive Rehabilitation on Hereditary Ataxias and the Cerebellar Subtype of Multiple System Atrophy.

Multiple system atrophy-cerebellar type (MSA-C) exhibits faster disease progression than does hereditary spinocerebellar degeneration (hSCD). In this study, we aimed to investigate the differences in the treatment effects and sustainability of intensive rehabilitation between patients with hSCD and those with MSA-C. Forty-nine patients (hSCD = 30, MSA-C = 19) underwent a 2- or 4-week intensive rehabilitation program. Balance function was evaluated using the scale for the assessment and rating of ataxia (SARA) and the balance evaluation systems test (BESTest) at pre-intervention, post-intervention, and 6-month follow-up. Notably, both groups demonstrated beneficial effects from the rehabilitation intervention. However, differences were observed in the magnitude and duration of these effects. In the hSCD group, the SARA scores at follow-up remained similar to those at baseline, indicating sustained benefits. However, the MSA-C group showed some deterioration in SARA scores compared with baseline scores but maintained improvements on the BESTest, demonstrating partial sustainability. Differences, mainly in sustainability, were observed between the hSCD and MSA-C groups. This may be due to varying rates of symptom progression. The findings of this study are significant when considering the frequency of follow-ups based on disease type.

Discogenic chronic low back pain management: intradiscal radiofrequency biacuplasty versus conservative treatment

BackgroundThis prospective bicentric study aims to evaluate and compare the efficacy of intradiscal radiofrequency biacuplasty (IDB) versus conservative management (CM) in treating chronic discogenic low back pain (CDLBP).MethodsForty-four patients with CDLBP were randomly assigned to either the biacuplasty group or the conservative management group. The biacuplasty group received treatment with two radiofrequency (RF) needles, positioned bilaterally on the annulus fibrosus under fluoroscopic guidance and local anaesthesia, to administer bipolar RF. Patients were monitored for 6 months, with the allowance of pain medication as needed. In the conservative management group, patients who continued to experience low back pain after three months were permitted to switch to the biacuplasty group. The study was conducted over two years, starting on July 1, 2020.ResultsThe studied groups had comparable age and gender distributions, with no significant difference in BMI. The Oswestry Disability Index (ODI) was assessed at baseline, 1 month, 3 months, and 6 months. At baseline, no significant difference was observed between the groups (p = 0.263). However, at the 1-month, 3-month, and 6-month follow-up, the biacuplasty group exhibited significantly lower ODI scores compared to the conservative management group (all p < 0.001), indicating that biacuplasty was more effective in reducing disability caused by chronic low back pain.ConclusionsIntradiscal radiofrequency biacuplasty is a minimally invasive interventional technique that has proven effective for patients with CDLBP who do not respond to conservative management.

Safety and efficacy assessment of the Inno-Xmart venous stent system in managing symptomatic iliofemoral venous obstruction: a 12-month outcome analysis.

This study aims to evaluate the safety and efficacy of the dedicated Inno-Xmart braided venous stent system (Suzhou Innomed Medical Device Co., Ltd., Jiangsu, China) in treating symptomatic iliofemoral venous obstruction. This clinical study followed a prospective, multicentre, single-arm design with the application of an objective performance goal. Patients diagnosed with symptomatic iliofemoral venous obstruction who met the eligibility criteria of this study were enrolled and treated with the Inno-Xmart venous stent system. The safety endpoints included the assessment of stent fracture, satisfaction of delivery system and 12-month incidence rate of major adverse events (MAEs). The primary efficacy endpoint focused on evaluating the 12-month primary patency rate through venography as determined by core laboratory. Secondary efficacy endpoints included surgical success rate, 6-month primary patency rate and the changes in quality of life from baseline to 6- and 12-month follow-up intervals. Between September 18, 2019, and April 26, 2021, 193 patients were successfully enrolled across 18 research institutions. The surgical success rate was 95.3% (184/193), the 12-month MAE rate was 5.1% (9/178) with no stent fractures or migrations. The 12-month primary patency rate for the participants was 96.1%, significantly surpassing the literature-derived objective performance of 80% (95% confidence interval [CI], 92.1-98.4; P < 0.0001). In addition, the mean venous clinical severity score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores at the 6- and 12-month follow-ups were significantly lower than the preoperative scores (P < 0.001). The innovative, dedicated braided venous stent designed to address symptomatic iliofemoral venous obstruction demonstrates a high technical success rate, low complication rates, and impressive mid-term (12-month) patency. It effectively enhanced the quality of life for patients and holds promising prospects for a wide range of applications. The clinical study was officially registered in the "Chinese Clinical Trial Registry" (Registration number: ChiCTR2000040216, date of registration: November 25th, 2020).

Effect of Pulmonary Vein Isolation with Left Atrial Wall Isolation Plus Selective CFAE Ablation in Patients with Persistent Atrial Fibrillation.

Pulmonary vein isolation (PVI) is a foundational treatment for persistent atrial fibrillation (PeAF), but the effectiveness of adding posterior wall isolation (PWI) and selective complex fractionated atrial electrogram (CFAE) ablation in the roof and anterior wall remains debated. The potential of these additional ablation techniques to improve long-term outcomes for PeAF patients is still uncertain. This retrospective study included 151 PeAF patients who underwent first-time catheter ablation at our center. The choice of ablation strategy was based on the operator's clinical judgment, taking into account the patient's specific condition and anatomical features. Patients were divided into two groups: the PVI group, which received PVI alone, and the modified PWI (MPWI) group, which received PVI along with additional PWI and selective CFAEs ablation in the roof and anterior wall. The primary endpoint was the absence of atrial arrhythmia lasting more than 30 s, without antiarrhythmic drugs, at 12 months. At the 12-month follow-up, 77.3% of the patients in the MPWI group and 52.1% of the patients in the PVI group remained in sinus rhythm without an atrial arrhythmia recurrence (p = 0.001). The BIC-based Cox regression analysis identified the ablation strategy and atrial fibrillation (AF) duration as independent predictors of recurrence across the cohort. It was found that MPWI significantly reduced the risk of recurrence, while a longer AF duration increased it. In the MPWI group, AF duration, left ventricular internal diameter in systole (LVIDs), and moderate or greater tricuspid regurgitation were independent predictors of recurrence. In the PVI group, only the left atrial low voltage area (LVA) index was a significant predictor. The addition of PWI and selective CFAE ablation to PVI significantly improves 12-month arrhythmia-free survival compared to PVI alone, demonstrating the superiority of this combined approach in improving long-term outcomes for patients with persistent AF.

Emotional competence self-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial.

Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people. This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16-22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 -1·18 [95% CI -2·01 to -0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [-0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (-0·54 [-1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths occurred. The CBT app delayed increases in depression symptoms in at-risk young people relative to the self-monitoring app, although this benefit faded by 12 months. Against hypotheses, the emotional competence app was not more effective at reducing depression symptoms than the self-monitoring app. CBT self-help apps might be valuable public mental health interventions for young people given their scalability, non-consumable nature, and affordability. European Commission.

Chyle leakage after laparoscopic cholecystectomy in a patient with duplicated cystic ducts: A case report and literature review.

Laparoscopic cholecystectomy (LC) is widely performed as a standard treatment for cholelithiasis, and chyle leakage after LC has rarely been reported. Duplicated cystic ducts draining a single gallbladder is an extraordinarily rare variation. We presented a case of chyle leakage after LC in a 53-year-old female with a rare variation of duplicated cystic ducts. Chyle leakage and duplicated cystic ducts. Conservative treatment including lipid intake and constant drainage. After 24 days of conservative treatment, the patient recovered and had no further troubles during the 3-month follow-up. There may be a potential relationship between anatomic variants of the extrahepatic bile ducts and those of the lymphatic system. When anatomic variations of the extrahepatic bile ducts are encountered, vigilance for lymphatic system injuries is as important as vigilance for bile duct injuries. Conservative therapy is the first choice for postoperative chyle leakage, and surgical intervention should be considered in cases with high-volume chyle leakage.

Emotional competence self-help mobile phone app versus cognitive behavioural self-help app versus self-monitoring app to promote mental wellbeing in healthy young adults (ECoWeB PROMOTE): an international, multicentre, parallel, open-label, randomised controlled trial.

Based on evidence that mental health is more than an absence of mental disorders, there have been calls to find ways to promote flourishing at a population level, especially in young people, which requires effective and scalable interventions. Despite their potential for scalability, few mental wellbeing apps have been rigorously tested in high-powered trials, derived from models of healthy emotional functioning, or tailored to individual profiles. We aimed to test a personalised emotional competence self-help app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to promote mental wellbeing in healthy young people. This international, multicentre, parallel, open-label, randomised controlled trial within a cohort multiple randomised trial (including a parallel trial of depression prevention) was done at four university trial sites in four countries (the UK, Germany, Spain, and Belgium). Participants were recruited from schools and universities and via social media from the four respective countries. Eligible participants were aged 16-22 years with well adjusted emotional competence profiles and no current or past diagnosis of major depression. Participants were randomised (1:1:1) to usual practice plus either the emotional competence app, the CBT app or the self-monitoring app, by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. The primary outcome was mental wellbeing (indexed by the Warwick-Edinburgh Mental Well Being Scale [WEMWBS]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. Outcome assessors were masked to group allocation. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Between Oct 15, 2020, and Aug 3, 2021, 2532 participants were enrolled, and 847 were randomly assigned to the emotional competence app, 841 to the CBT app, and 844 to the self-monitoring app. Mean age was 19·2 years (SD 1·8). Of 2532 participants self-reporting gender, 1896 (74·9%) were female, 613 (24·2%) were male, 16 (0·6%) were neither, and seven (0·3%) were both. 425 participants in the emotional competence app group, 443 in the CT app group, and 447 in the self-monitoring app group completed the follow-up assessment at 3 months. There was no difference in mental wellbeing between the groups at 3 months (global p=0·47). The emotional competence app did not differ from the CBT app (mean difference in WEMWBS -0·21 [95% CI -1·08 to 0·66]) or the self-monitoring app (0·32 [-0·54 to 1·19]) and the CBT app did not differ from the self-monitoring app (0·53 [-0·33 to 1·39]). 14 of 1315 participants were admitted to or treated in hospital (or both) for mental health-related reasons, which were considered unrelated to the interventions (five participants in the emotional competence app group, eight in the CBT app group, and one in the self-monitoring app group). No deaths occurred. The emotional competence app and the CBT app provided limited benefit in promoting mental wellbeing in healthy young people. This finding might reflect the low intensity of these interventions and the difficulty improving mental wellbeing via universal digital interventions implemented in low-risk populations. European Commission.