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Journal of Prosthodontic Research Jun 2024Marginal bone loss (MBL) occurs in the periapical cervical bone after dental implant placement and abutment connection. MBL may not result in peri-implantitis; however,...
PURPOSE
Marginal bone loss (MBL) occurs in the periapical cervical bone after dental implant placement and abutment connection. MBL may not result in peri-implantitis; however, it is always accompanied by MBL. Recent studies have demonstrated that early MBL is a predictor of peri-implantitis. In this narrative review, we aimed to provide an evidence base for recommended treatment strategies for clinicians to prevent MBL.
STUDY SELECTION
We reviewed the recent literature and performed a narrative synthesis of the evidence, focusing on available systematic reviews and meta-analyses of implant marginal bone resorption.
RESULTS
The available evidence indicates that certain biological, material, and technical factors can influence MBL and consequently dictate the risk of developing peri-implant disease in later years. The order of the impact of the strength of each factor is unknown. Current recommendations to prevent MBL include controlling patients' smoking and hemoglobin A1c levels to sufficiently low levels before surgery and throughout their lifetime. Regarding the material, a platform-switching, conical-connecting implant system, and an abutment with a height of at least 2 mm should be selected. Placement should be performed using techniques that ensure sufficient soft tissue (keratinized gingival width > 2 mm, supracrestal tissue height > 3 mm), and non-undersized preparations in the cortical bone should be made with connected concave abutments during primary or secondary surgery. Patients should receive supportive peri-implant therapy during maintenance.
CONCLUSIONS
MBL development is multifactorial and can be reduced by considering the biological, material, and technical factors.
PubMed: 38925986
DOI: 10.2186/jpr.JPR_D_23_00223 -
Ceska a Slovenska Oftalmologie :... 2024This article presents an overview of treatment regimens of drugs containing antivascular endothelial growth factor for the treatment of neovascular form of age-related... (Review)
Review
This article presents an overview of treatment regimens of drugs containing antivascular endothelial growth factor for the treatment of neovascular form of age-related macular degeneration. Currently, drugs containing antivascular endothelial growth factor are the only effective treatment for this chronic and progressive disease. The treatment regimens for this disease in the last two decades have seen a shift from a simple endeavor to stabilize the disease to achieving maximum improvement of visual acuity and its maintenance, with improvement of the patient's quality of life and a minimal treatment burden on patients and their families. Other goals of the alternative dosing regimens that have replaced the original fixed regimens were greater individualization of the dosing regimen, better patient cooperation, saving financial costs and reducing the burden on application centers. Age-related macular degeneration, whether dry form or wet form, represents a serious health and socioeconomic problem, as the disease is one of the most common causes of severe and irreversible central visual acuity disorders up to the degree of practical blindness of one or both eyes in people over 50 years of age in developed industrialized countries. The most important issue is to ensure early diagnosis of this disease, followed by prompt and continuous treatment with an individualized proactive treatment regimen, with the aim of stabilizing and improving anatomical and functional results.
Topics: Humans; Angiogenesis Inhibitors; Macular Degeneration; Vascular Endothelial Growth Factor A; Bevacizumab
PubMed: 38925899
DOI: 10.31348/2024/25 -
BMJ Open Jun 2024Patients with cirrhosis awaiting liver transplantation (LT) are often frail, and malnourished. The period of time on the waitlist provides an opportunity to improve...
INTRODUCTION
Patients with cirrhosis awaiting liver transplantation (LT) are often frail, and malnourished. The period of time on the waitlist provides an opportunity to improve their physical fitness. Prehabilitation appears to improve the physical fitness of patients before major surgery. Little is known about prehabilitation in patients with cirrhosis. The aim of this feasibility study will be to investigate the feasibility, safety, and effectiveness of a multimodal prehabilitation programme in this patient population.
METHODS AND ANALYSIS
This is an open-label single-arm feasibility trial recruiting 25 consecutive adult patients with cirrhosis active on the LT waiting list of the McGill University Health Centre (MUHC). Individuals will be excluded based on criteria developed for the safe exercise training in patients with cirrhosis. Enrolled individuals will participate in a multimodal prehabilitation programme conducted at the PeriOperative Programme complex of the MUHC. It includes exercise training with a certified kinesiologist (aerobic and resistance training), nutritional optimisation with a registered dietician and psychological support with a nurse specialist. The exercise training programme is divided into an induction phase with three sessions per week for 4 weeks followed by a maintenance phase with one session every other week for 20 weeks. Aerobic training will be individualised based on result from cardiopulmonary exercise testing (CPET) and will include a high-intensity interval training on a cycle ergometer. Feasibility, adherence and acceptability of the intervention will be assessed. Adverse events will be reviewed before each visit. Changes in exercise capacity (6-minute walk test, CPET, liver frailty index), nutritional status and health-related quality of life will be assessed during the study. Post-transplantation outcomes will be recorded.
ETHICS AND DISSEMINATION
The research ethics board of the MUHC has approved this study (2021-7646). Our findings will be submitted for presentation at national and international conferences, and for peer-reviewed publication.
TRIAL REGISTRATION NUMBER
NCT05237583.
Topics: Humans; Liver Transplantation; Feasibility Studies; Liver Cirrhosis; Preoperative Exercise; Waiting Lists; Quality of Life; Physical Fitness; Adult; Exercise Therapy; Male; Female
PubMed: 38925705
DOI: 10.1136/bmjopen-2023-081362 -
BMJ Open Jun 2024Insomnia is a common health problem and cognitive-behavioural therapy (CBT) is recommended as a treatment. As there is a critical shortage of CBT-trained therapists, we... (Comparative Study)
Comparative Study Randomized Controlled Trial
INTRODUCTION
Insomnia is a common health problem and cognitive-behavioural therapy (CBT) is recommended as a treatment. As there is a critical shortage of CBT-trained therapists, we developed a digital CBT application (IIIP MED: Sleepy Med) as Software as a Medical Device for insomnia. This paper describes the study protocol for an exploratory randomised controlled trial (RCT) to evaluate effectiveness and safety of our developed digital CBT (dCBT) for 5 weeks compared with zolpidem tartrate for patients with insomnia disorder.
METHODS AND ANALYSIS
This proposed multicentre exploratory RCT will be conducted at the outpatient clinic of Chiba University Hospital, Akita University Hospital and Yoyogi Sleep Disorder Center, Japan. The study population comprises two parallel groups (dCBT and zolpidem) consisting of 15 participants each (n=30 in total) diagnosed with insomnia disorder who remain symptomatic at 4 weeks after sleep hygiene education. We will evaluate the effectiveness at baseline, week 5 (post-intervention) and week 10 (follow-up). The primary outcome will be the change of subjective sleep onset latency at week 5 from baseline. Secondary outcomes include sleep-related outcomes, such as objective sleep onset latency measured by mobile electroencephalography, functional improvement during the daytime and quality of life.
ETHICS AND DISSEMINATION
Ethics approval was granted by the Institutional Review Board of Chiba University Hospital (K2023001). All participants will be required to provide written informed consent. Results will be published in international journals.
TRIAL REGISTRATION NUMBER
jRCT2032230353.
Topics: Humans; Sleep Initiation and Maintenance Disorders; Zolpidem; Cognitive Behavioral Therapy; Hypnotics and Sedatives; Adult; Randomized Controlled Trials as Topic; Female; Male; Treatment Outcome; Japan; Middle Aged
PubMed: 38925698
DOI: 10.1136/bmjopen-2023-081205 -
Cancer Medicine Jun 2024Avelumab first-line (1 L) maintenance is a standard of care for advanced urothelial carcinoma (aUC) based on the JAVELIN Bladder 100 phase 3 trial, which showed that... (Randomized Controlled Trial)
Randomized Controlled Trial
Avelumab first-line maintenance in advanced urothelial carcinoma: Complete screening for prognostic and predictive factors using machine learning in the JAVELIN Bladder 100 phase 3 trial.
BACKGROUND
Avelumab first-line (1 L) maintenance is a standard of care for advanced urothelial carcinoma (aUC) based on the JAVELIN Bladder 100 phase 3 trial, which showed that avelumab 1 L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) vs BSC alone in patients who were progression free after receiving 1 L platinum-containing chemotherapy. Here, we comprehensively screened JAVELIN Bladder 100 trial datasets to identify prognostic factors that define subpopulations of patients with longer or shorter OS irrespective of treatment, and predictive factors that select patients who could obtain a greater OS benefit from avelumab 1 L maintenance treatment.
METHODS
We performed machine learning analyses to screen a large set of baseline covariates, including patient demographics, disease characteristics, laboratory values, molecular biomarkers, and patient-reported outcomes. Covariates were identified from previously reported analyses and established prognostic and predictive markers. Variables selected from random survival forest models were processed further in univariate Cox models with treatment interaction and visually inspected using correlation analysis and Kaplan-Meier curves. Results were summarized in a multivariable Cox model.
RESULTS
Prognostic baseline covariates associated with OS included in the final model were assignment to avelumab 1 L maintenance treatment, Eastern Cooperative Oncology Group performance status, site of metastasis, sum of longest target lesion diameters, levels of C-reactive protein and alkaline phosphatase in blood, lymphocyte proportion in intratumoral stroma, tumor mutational burden, and tumor CD8+ T-cell infiltration. Potential predictive factors included site of metastasis, tumor mutation burden, and tumor CD8+ T-cell infiltration. An analysis in patients with PD-L1+ tumors had similar findings to those in the overall population.
CONCLUSIONS
Machine learning analyses of data from the JAVELIN Bladder 100 trial identified potential prognostic and predictive factors for avelumab 1 L maintenance treatment in patients with aUC, which warrant further evaluation in other clinical datasets.
Topics: Humans; Antibodies, Monoclonal, Humanized; Male; Female; Machine Learning; Prognosis; Aged; Urinary Bladder Neoplasms; Middle Aged; Carcinoma, Transitional Cell; Maintenance Chemotherapy; Antineoplastic Agents, Immunological; Progression-Free Survival; Biomarkers, Tumor
PubMed: 38924353
DOI: 10.1002/cam4.7411 -
PloS One 2024Postoperative patients with ostomies experience significant changes in their lives as a result of the device implantation. Self-care is important to improve their health... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Postoperative patients with ostomies experience significant changes in their lives as a result of the device implantation. Self-care is important to improve their health outcomes. Telehealth provides an opportunity to expand access to self-care education.
AIM
This is a multicenter, non-inferiority randomized, open-label, controlled trial to evaluate the non-inferiority of a telehealth intervention to the standard in-person approach in improving self-care behaviors.
METHODS AND ANALYSIS
Three hundred and eighty-four patients aged ≥ 18 years, with a recently placed ostomy, no stomal/peristomal complications, and documented cognitive integrity will be randomly assigned (1:1) to receive either a telehealth intervention (four remote educational sessions) or a standard educational approach (four in-person sessions) delivered in outpatient settings. Every session (remote and in-person) will occur on Days 25, 32, 40, and 60 after discharge. Follow-ups will occur 1, 3, and 6 months after the last intervention session. Primary outcome is self-care maintenance measured using the Ostomy Self-care Index (OSCI). Secondary outcomes include self-care monitoring, self-care management, self-efficacy (OSCI), quality of life (Stoma specific quality of Life), depression (Patient Health Questionnaire-9), adjustment (Ostomy Adjustment Inventory-23), stomal and peristomal complication rates, healthcare services utilization, mobility, and number of working days lost. Analyses will be performed per intention-to-treat and per protocol.
ETHICS AND DISSEMINATION
This study has been approved by the Institutional Review Board of the main center (registration number: 119/22). Following completion of the trial, dissemination meetings will be held to share the results of the study with the participants and the health-care team. Adoption of telehealth technologies for ostomy patients can improve service organization by ensuring better integration and continuity of care. If the remote intervention produces comparable effects to the in-person intervention, it would be wise to make telehealth education an alternative treatment for addressing the educational needs of uncomplicated postoperative ostomy patients.
TRIAL REGISTRATION
ClinicalTrials.gov (identifier number: NCT05796544).
Topics: Humans; Telemedicine; Self Care; Ostomy; Patient Education as Topic; Quality of Life; Female; Male; Adult
PubMed: 38924038
DOI: 10.1371/journal.pone.0303015 -
PloS One 2024The introduction of antiretroviral therapy (ART) has successfully changed the clinical course of people with HIV, leading to a significant decline in the incidence of...
The introduction of antiretroviral therapy (ART) has successfully changed the clinical course of people with HIV, leading to a significant decline in the incidence of HIV-related neurocognitive disorders. Integrase strand transferase inhibitors (INSTI) are recommended and preferred first-line ART for the treatment of HIV-1 infection in ART-naïve subjects. This type of therapy regimen is expected to have higher CNS penetration, which may bring more cognitive stability or even make significant cognitive improvement in people with HIV. The study aimed to follow up on neurocognitive performance in HIV subjects on two types of INSTI therapy regimens at two-time points, one year apart. The study sample consisted of 61 ART naïve male participants, of which 32 were prescribed raltegravir (RAL) and 29 dolutegravir (DTG). There was no significant difference between subsamples according to the main sociodemographic (age, education level) and clinical characteristics (duration of therapy, nadir CD4 cells level, CD4 cells count, CD8 cells, CD4/CD8 ratio). For neurocognitive assessment, six measures were used: general cognitive ability (MoCA test), verbal fluency (total sum score for phonemic and category fluency), verbal working memory (digit span forward), cognitive capacity (digit span backwards), sustained attention (Color Trail Test 1), and divided attention (Color Trail Test 2). In both therapy groups (RAL and DTG), there was no significant decrease in neurocognitive achievement on all used measures over a one-year follow-up in both therapy groups. A statistically significant interactive effect of time and type of therapy was found on the measure of divided attention-DTG group showed slight improvement, whereas RAL group showed slight decrease in performance. During the one-year follow-up of persons on INSTI-based regimen, no significant changes in cognitive achievement were recorded, which suggests that the existing therapy can have a potentially positive effect on the maintenance of neurocognitive achievement.
Topics: Humans; Male; HIV Infections; Adult; Follow-Up Studies; Cognition; Raltegravir Potassium; HIV Integrase Inhibitors; Middle Aged; Pyridones; Piperazines; Heterocyclic Compounds, 3-Ring; Oxazines; Neuropsychological Tests; HIV-1
PubMed: 38923982
DOI: 10.1371/journal.pone.0306278 -
Clinical and Translational Science Jun 2024The recommended immunosuppressive treatment after kidney transplantation consists of tacrolimus, mycophenolate mofetil, and low-dose corticosteroids. Drug concentrations...
Immune responsiveness in stable kidney transplantation patients: Complete inhibition of T-cell proliferation but residual T-cell activity during maintenance immunosuppressive treatment.
The recommended immunosuppressive treatment after kidney transplantation consists of tacrolimus, mycophenolate mofetil, and low-dose corticosteroids. Drug concentrations are monitored using therapeutic drug monitoring (TDM), which does not necessarily correlate with pharmacodynamic activity. To find the balance between optimal efficacy and minimal toxicity, it might be more informative to monitor patients' immunological status rather than drug concentrations. We selected a panel of T-cell-based immune assays, which were used for immunomonitoring of 14 stable kidney transplantation patients. Whole blood was incubated with a T-cell stimulus, after which T-cell proliferation, T-cell activation marker expression and cytokine production were measured to study residual immune activity in vitro (before drug intake; drug added to the incubation) and ex vivo (after drug intake). T-cell proliferation was completely suppressed in all patients over the full day, while IL-2, IFN-γ, CD71, and CD154 showed fluctuations over the day with a strong inhibition (75%-25%) at 2 h post-dose. The level of inhibition was variable between patients and could not be related to pharmacokinetic parameters or the presence of regulatory or senescence immune cells. Moreover, the level of inhibition did not correlate with the in vitro tacrolimus drug effect as studied by incubating pre-dose blood samples with additional tacrolimus. Overall, IL-2, IFN-γ, CD71, and CD154 seem to be good markers to monitor residual immune activity of transplantation patients. To evaluate the correlation between these pharmacodynamic biomarkers and clinical outcome, prospective observational studies are needed.
Topics: Humans; Kidney Transplantation; Male; Immunosuppressive Agents; Middle Aged; Female; T-Lymphocytes; Cell Proliferation; Adult; Tacrolimus; Lymphocyte Activation; Drug Monitoring; Aged; Mycophenolic Acid; Interferon-gamma
PubMed: 38923308
DOI: 10.1111/cts.13860 -
CoDAS 2024To analyze the performance of auditory speech perception (PF) after cochlear implant (CI) replacement surgery and associations with age, times of use of the first CI,...
PURPOSE
To analyze the performance of auditory speech perception (PF) after cochlear implant (CI) replacement surgery and associations with age, times of use of the first CI, deprivation, recovery and use of the second device.
METHODS
The retrospective study analyzed the medical records of 68 participants reimplanted from 1990 to 2016, and evaluated with PF performance tests, considering as a reference, the greater auditory capacity identified during the use of the first CI. Also analyzed were: Etiology of hearing loss; the reasons for the reimplantation; device brands; age range; sex; affected ear; age at first implant; time of use of the first CI, deprivation, recovery and use of the second device. The analyzes followed with the Chi-Square and Spearman, Mann-Whitney and Kruskal-Wallis tests (CI=95%; p≤0.05; Software SPSS®.v22).
RESULTS
Most were children with hearing loss due to idiopathic causes and meningitis. Abrupt stoppage of operation was the most common cause for device replacement. Most cases recovered and maintained or continued to progress in PF after reimplantation. Adults have the worst recovery capacity when compared to children and adolescents. The PF capacity showed a significant association (p≤0.05) with: age at first implant; time of use of the first and second CI.
CONCLUSION
Periodic programming and replacement of the device when indicated are fundamental for the maintenance of auditory functions. Being young and having longer use of implants represent advantages for the development of speech perception skills.
Topics: Humans; Speech Perception; Retrospective Studies; Female; Child; Male; Adolescent; Cochlear Implantation; Adult; Cochlear Implants; Child, Preschool; Young Adult; Middle Aged; Hearing Loss; Infant; Aged; Age Factors; Replantation
PubMed: 38922246
DOI: 10.1590/2317-1782/20242023220pt -
Journal of Functional Morphology and... May 2024The strength of the shoulder musculature involved with internal rotation and arm extension plays an important role in the overhead throwing motion for baseball athletes,...
The strength of the shoulder musculature involved with internal rotation and arm extension plays an important role in the overhead throwing motion for baseball athletes, both for throwing-related performance and injury risk. The maintenance of shoulder strength is a high priority for baseball athletes throughout a season; however, little is known in regards to the expected changes in strength throughout a season. To examine pre-post changes in shoulder strength, lower body power, and body composition among collegiate baseball players after the completion of a summer baseball league season. Amateur baseball players ( = 12; age: 20.9 ± 1.0 years.; height: 181.6 ± 5.6 cm; body mass: 86.4 ± 11.1 kg; BMI: 26.0 ± 2.6 kg/m) participated in the current study. Pre- and post-competitive season, the participants completed shoulder strength assessments and body composition and countermovement vertical jump (CMJ) tests. An upper-body isometric test (athletic shoulder [ASH] test) was used to evaluate shoulder strength for each arm. Each subject completed maximal isometric contractions for both the throwing and non-throwing arms at four separate angles of abduction (180°, 'I'; 135°, 'Y'; 90°, 'T'; and -180°, 'A') while lying in a prone position. For shoulder strength, the primary dependent variable of interest was a composite measure that represented the average of the forces produced across all four positions of the ASH test (I, Y, T, A). For the ASH test composite measure, there was a trend toward a significant arm-by-time interaction effect ( = 0.08), as shoulder strength decreased by 9.03% for the throwing arm (ES = 0.72; 95% CI = [-0.27, -0.01]), compared to only 2.03% for the non-throwing arm (ES = 0.15; 95% CI = [-0.16, 0.09]), over the course of the season. The main effects of time ( = 0.16) and arm ( = 0.58) were not significant for the ASH test composite measure. There was no relationship between lower body power and throwing arm strength at baseline (r = 0.20, = 0.56), and only a non-significant weak relationship at post-test (r = 0.28, = 0.41). Throughout a season, baseball players may experience reductions in shoulder strength of the throwing arm with minimal changes in shoulder strength in the non-throwing arm.
PubMed: 38921634
DOI: 10.3390/jfmk9020098