Nonrandomized Trial Research Articles

Effects of Manual Therapy on Fascial Distortion Model in Adolescent Ankle Sprain: A Pilot Study

ObjectivesThe present study aimed to assess the feasibility of investigating the effects of manual therapy on ankle functional muscle strength, static balance, and disability in adolescent patients with an ankle sprain. MethodsThe study was a nonrandomized prepost clinical feasibility trial. From September 2021 to February 2022, 31 patients with ankle sprain received manual therapy. Functional muscle strength of plantar flexor muscles and static balance were evaluated using the standing heel-rise and unipedal stance tests on the injured and healthy legs before and after the first and second sessions. Foot and Ankle Disability Index (FADI) assessed the disability at baseline, after the first and second sessions, in the third and sixth weeks. ResultsWithin-group analysis of the unipedal stance test with open and closed eyes and the standing heel-rise test showed that injured legs significantly improved after the first and second sessions, compared to uninjured legs (P < .05). Furthermore, there were significant differences among all repeated FADI measures (P < .05). ConclusionsThis study demonstrated that a study was feasible to measure ankle functional muscle strength, static balance, and disability in adolescent patients with an ankle sprain.

Changes in Periodontal Tissues With Periodontally Accelerated Orthodontics: A Systematic Review and Meta-Analysis.

Periodontally accelerated orthodontic (PAO) therapy has been found to increase hard tissue, helping to decrease orthodontic relapse rates and improve retention capacity. The aim of this study was to synthesize available evidence on clinical and tomographic changes in periodontal tissues when using PAOtechniques. A systematic review with meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and registered in the International Prospective Register of Systematic Reviews (PROSPERO). The search was carried out in PubMed, Embase, Cochrane, Web of Science, Scopus, and Google Scholar. Randomized and non-randomized clinical trials comparing PAO versus conventional orthodontics were included. Quality assessment was performed using the Downs & Black scale, and the risk of bias was assessed using the revised Cochrane risk-of-bias tool. Mean differences and 95% confidence intervals (CIs) were calculated, and the mean difference was divided by a t-test. During the initial search, 465 studies were identified. Five articles studying 130 patients were included, which assessed both clinical and tomographic changes, along with treatment duration. PAO was administered to patients with skeletal class III in three studies, to class II patients in one study, and to individuals with dental crowding in another study. Two studies showed a moderate risk of bias, and the rest showed a low risk. The meta-analysis revealed a vestibular bone thickness increase of 0.32 mm (0.56-008; P = 0.008), a reduction of 3.12 mm (2.15-4.08; P= 0.001) in gingival retraction, and a treatment duration that was 7.07 months (8.79-5.36;P = 0.001) shorter in patients subjected to PAO compared to those undergoing conventional orthodontic treatment. Considering the limitations of the study and acknowledging that definitive conclusions cannot be drawn, the findings suggest that treatment time decreased in patients undergoing PAO, with an increase in vestibular bone thickness and less gingival retraction observed in those undergoing this intervention.

Serum neurofilament light release levels as marker of neurotoxicity in general anesthesia versus hypnosis: A prospective non-randomized trial

Background: Whether general anesthetics induce neurotoxicity is unclear. Objectives: We hypothesized that serum neurofilament light (NfL) release, a marker of neural injury, would not be different in patients receiving general anesthesia (GA) compared to hypnosis. Design: Prospective, non-randomized. Setting: Tertiary university hospital. Methods: Patients undergoing breast cancer or thyroid/parathyroid surgery were enrolled. Propofol and remifentanil were used for GA. For hypnosis, only low dose remifentanil was allowed. Main outcome measures: NfL was measured at baseline, at day 1 and at postoperative visit. At preoperative and postoperative visit, patients performed a Montreal Cognitive Assessment (MoCA) test. Primary outcome was absolute change in NfL at day 1 between groups. Results: Among 100 included patients, 51 were in GA and 49 in hypnosis group. There were 26/49 (53%) breast cancer patients in hypnosis group and 13/51 (26%) in GA arm, p = 0.005. Baseline NfL was higher in the hypnosis group (p = 0.050). We subtracted log-transformed baseline NfL from postoperative NfL to analyze normalized values as absolute change. The mean normalized value at day 1 (primary endpoint) was 0.02 (± 0.11) in the GA and 0.03 (± 0.20) in the hypnosis group; p = 0.979 [d = 0.16, 95% CI: -0.40 to 0.39]. In a linear mixed-effects model including variables that influenced baseline NfL (advanced age, higher creatinine values, breast cancer), mean difference (95 % CI) in absolute change of log NfL at day 1 between both groups was 0.007 (- 0.04 to 0.06); p = 0.791. A change in MoCA as compared to baseline was not different between groups (p = 0.761). Conclusions: Our results show that there was no statistical or clinical difference in postoperative NfL release between GA and hypnosis. GA with propofol was not associated with a different risk of neural injury compared to hypnosis. Trial registration: NCT04500236.

Effect of Comprehensive HIV Prevention Information Package on Syphilis Infection Levels Among Youths in Kakamega and Kericho Counties, Kenya

The world&amp;apos;s biggest threat to development and public health is HIV. Youth in sub-Saharan Africa are primarily affected by the HIV epidemic. Despite the availability of HIV prevention options, new infections among youth in Kenya only reduced by 56% between 2015 and 2021. Various HIV prevention interventions have been implemented among youth with little or no assessment of their effectiveness in reducing new HIV infections. The objective of the study was to evaluate the effect comprehensive HIV prevention information package of the package on syphilis infections levels among the youths in Kakamega and Kericho counties, Kenya. A non-randomized control trial was conducted with Kakamega as intervention and Kericho as Comparison County. The pretest questionnaire was administered in both intervention and control counties in December 2001. The posttest questionnaire was administered in both intervention and control counties after nine months of providing HIV prevention information package. Quantitative data was analyzed using descriptive and inferential statistics. Qualitative data was transcribed and analyzed thematically. There was significant increase in knowledge of sexually transmitted infections in intervention county (t = 3.340, P = 0.021). There was significant number of youth in Kakamega county who reported unusual sores in genital area at endline (t = 2.035, P = 0.043). Similarly, more youths sought treatment after experiencing the syphilis symptoms (t = 1.931, P = 0.054) at endline in Kakamega county. There were no significant differences in the number of youths in Kericho county at endline who experienced unusual symptoms, sought treatment and informed their sexual partners (P &amp;gt; 0.05). The findings from the study will inform national rollout of the intervention to contribute to safer sexual behaviors among youth.

Beyond the smile: a systematic review of diagnostic tools for peripheral facial paralysis.

Effective rehabilitation of peripheral facial paralysis (PFP) requires reliable assessment tools. This systematic review aimed to identify and validate instruments used in PFP rehabilitation, categorizing them according to the ICF framework. A comprehensive search was conducted across PubMed, Cinahl, Web of Science, and Scopus up to April 2024. Observational analytical studies and one non-randomized controlled trial that validated tools for assessing PFP were included. Thirty-three studies were included, covering twenty different tools. Seventeen tools were related to the "Structure and Function" domain, while three addressed "Activity and Participation." The Sunnybrook and House-Brackmann scales were the most extensively studied. The Sunnybrook scale exhibited excellent intra- and inter-rater reproducibility and internal validity, making it suitable for clinical use. The House-Brackmann scale was user-friendly but had limitations in reproducibility and sensitivity to subtle differences, which newer versions like the FNGS 2.0 aimed to address. The FAME scale showed promise by reducing subjective scoring. Computerized tools, such as eFACE and A-FPG, and instruments for lip asymmetry and ocular involvement demonstrated potential but require further validation. The Facial Disability Index and the FaCE Scale were validated for assessing disability and participation restrictions. This review identified several validated tools for PFP assessment, with the Sunnybrook and House-Brackmann scales being the most reliable. While emerging tools and computerized programs show promise, they need further validation for routine clinical use. Integrating validated tools into clinical practice is essential for comprehensive assessment and effective rehabilitation of PFP.

Rifaximin and Metronidazole Fixed Dose Combination: New Treatment Option in the Management of Diarrhea

Background: Endemic infectious diarrhea is a widespread problem around the world, caused by a combination of viruses, bacteria, and parasites. While commonly used fluoroquinolone antibiotics are effective for specific types of acute diarrhea, they carry potential side effects. Aim: To assess the effectiveness and tolerability of a fixed-dose combination of rifaximin and metronidazole as an alternative treatment approach for the management of acute diarrhea. Study Design: A multicentre, open-label, non-comparative and non-randomized trial was conducted in 370 patients suffering from acute diarrhea due to various factors. Methodology: Patients were given a tablet containing fixed-dose combination of 200 mg of rifaximin and 400 mg of metronidazole twice daily for 5 days. The primary outcomes evaluated were changes in the number of loose/watery stools, the presence of fever, nausea, vomiting, abdominal pain and gas/flatulence from baseline to day 5. A global assessment using a 3-point scale (Excellent/Good/Poor) was done by the investigators for efficacy and tolerability evaluation. Adverse drug reactions were monitored throughout the study period. Results: After 5-day therapy, the average number of watery stools per day decreased significantly from 7.853 ± 3.773 to 0.766 ± 0.949 (P &lt; .001). None of the patients experienced fever and vomiting, while few patients experienced nausea (0.31%), abdominal pain (0.31%), and gas/flatulence (0.93%) at the end of the study. According to the evaluation by the investigators, all patients reported good to excellent efficacy and tolerability. Conclusions: The combination therapy of rifaximin and metronidazole is clinically effective and safe to treat acute diarrhea caused by different factors and can serve as a new treatment option for managing acute diarrhea.

Contribution of kelp dashi liquid to sustainable maintenance of taste sensation and promotion of healthy eating in older adults throughout the umami-taste salivary reflex.

Taste decline, including taste loss in older adults, leads to malnutrition and frailty. In a super-aging society, improving taste decline and maintaining taste sensation are crucial for the wellbeing of older adults. Hyposalivation frequently affects older individuals and is the leading cause of taste decline in older adults. Treating taste decline, including taste loss, in older adults presents challenges due to the limited sustainable methods for increasing saliva production, except for drug therapy, which may lead to adverse effects. Umami-taste stimulation results in a prolonged increase in both the whole salivary flow rate (WF), more than 90% of which is secreted from the major salivary glands, and the minor salivary gland flow rate (MF) in healthy volunteers through the umami-taste salivary reflex. We hypothesized that umami-rich kelp dashi liquid (KDL), commonly used in Japanese cuisine, may alleviate taste decline and sustain normal taste sensation in older adults with hyposalivation. This study investigated whether KDL stimulation could improve taste decline. A non-randomized controlled trial was conducted at the dental department of a university hospital, involving those who presented with dry mouth between May 2017 and December 2021. Before and after repeated KDL stimulation, characteristics like changes in WF and MF, the recognition thresholds (RTs) for five basic tastes, and subjective eating and swallowing difficulties were assessed. Statistical comparisons were performed between the values measured before and after KDL stimulation. A total of 35 older patients were included. Patients with reduced MF and with or without reduced WF exhibited umami-taste loss. Repeated stimulation with KDL increased MF and WF and improved taste loss, including umami, decreased RTs, and normalized each taste. Furthermore, subjective taste impairment, subjective eating and swallowing difficulties, and burning sensations in the oral mucosa were alleviated. These findings indicate that KDL stimulation improved umami-taste loss and normalized each taste sensation, further alleviating eating difficulties via the umami-taste salivary reflex. Importantly, umami-taste loss was also observed in patients with normal WF but decreased MF, who are typically not diagnosed with hyposalivation. Therefore, KDL has the potential to sustain taste sensations and promote healthy eating habits in older individuals.

Does mental fatigue affect performance in racket sports? A systematic review

Mental fatigue impairs performance across several sports domains. However, a systematic review on its effects on racket sports performance has been lacking due to the previous scarcity of studies. This review aims to provide a comprehensive review the effects of mental fatigue on racket players’ performance, with a discussion of the underlying mechanisms. A thorough search was conducted across five databases, including Web of Science, PubMed, SCOPUS, SPORTDiscus (via EBSCOhost), and the Psychological and Behavioral Science Collection (via EBSCOhost). The PICOS framework established the inclusion criteria: (1) healthy racket sports players; (2) induction of mental fatigue in both field and laboratory settings; (3) comparison of mental fatigue interventions with a control group (e.g., watching a movie or reading a magazine); (4) assessment of performance outcomes, including physical performance, skilled performance, and perceptual-cognitive performance; and (5) randomized controlled trials (RCTs), non-randomized controlled trials (non-RCTs), and non-randomized non-controlled trials. Mental fatigue manipulation, subjective evaluation, and (neuro)physiological markers were synthesized to support the successful induction of mental fatigue. Performance was categorized into tennis, table tennis, badminton, and padel based on the characteristics of specific racket sports domains. Secondary outcomes, such as the rate perception of effort (RPE) and motivation, were synthesized to explain the mechanisms based on the prominent theory of the Psychobiological model of endurance performance. Six studies revealed that mental fatigue impacts stroke performance in table tennis, affecting speed, accuracy, faults, and only second-serve accuracy in tennis. The response time of psychomotor performance increased in table tennis, padel, and badminton. Meanwhile, mental fatigue increased the RPE and remained unchanged in heart rate, blood glucose, and lactate, consistent with the Psychobiological model of endurance performance. Additionally, attention is suggested as a significant underlying psychobiological factor.

Iptacopan Efficacy and Safety to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH): A Systematic Review and Meta-Analysis.

Paroxysmal nocturnal hemoglobinuria (PNH) is an uncommon blood condition caused by complement-mediated hemolysis. In early clinical studies, iptacopan, an oral factor B inhibitor, showed promise in treating PNH. This systematic review aimed to compile information on the effectiveness and safety of iptacopan for PNH.A systematic review was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. The Medline, Embase, PubMed, and Cochrane Central databases were searched for randomized controlled trials (RCTs) and observational studies that evaluated iptacopan for PNH. The primary efficacy outcomes were hemoglobin and lactate dehydrogenase (LDH) changes. A fixed-effects model was used for the meta-analysis. Six studies (three prospective cohorts, two RCTs, and one non-randomized trial) were included, comprising 197 patients. Iptacopan therapy significantly increased hemoglobin levels (mean differences (MD) = 12.98 g/L; 95% CI: 11.82-14.13; p < 0.0001) and decreased LDH (MD = -83.55 IU/L; 95% CI: -83.77 to -83.34; p < 0.0001). Subgroup analyses revealed more significant hemoglobin increases in European vs. Asian populations, studies with baseline Hb > 10 g/dL vs. < 10 g/dL, and studies lasting > 24 weeks vs. ≤ 24 weeks. LDH decreases were more pronounced in studies with baseline LDH > 500 IU/L vs. < 500 IU/L. The incidence of adverse events ranged from 66% to 90%, with the most common being headache, nasopharyngitis, and diarrhea. Serious adverse events occurred in 0-20% of patients across studies. Only one patient withdrew because adverse effects were reported across all studies.Preliminary data support iptacopan's effectiveness in improving hemoglobin levels and lowering hemolysis in PNH, both as a monotherapy and in combination with usual treatment. The safety profile appears to be excellent, with a minimal incidence of major adverse events and treatment discontinuation. Further studies are needed to validate the effectiveness and safety of larger, longer-term trials. Iptacopan is a viable oral therapy option for PNH.

Are educational tools in oral health programs for pregnant women effective in improving the oral status of mothers and babies? A systematic review.

To analyze, through a systematic review, the effectiveness of educational tools (ETs) in Oral Health Programs (OHPs) for pregnant women in improving their oral status and thatof their babies. Searches were carried out in 5 electronic databases. Randomized (RCTs) and non-randomized clinical trials (CTs) were selected that included pregnant women exposed or not to ETs in OHPs, whose oral health status, in the pre- or postnatal period, or of their babies were verified. The types of ETs, outcomes, and results were extracted. Bias risk was assessed by ROBINS-I and RoB 2.0; and the certainty of the evidence (CE) by GRADE. A total of nine studies were included. Most used more than one ET (n = 8), with verbal guidance used in all (n = 9). Mothers showed a reduction in biofilm (n = 3), caries (n = 4) and periodontitis (n = 4). All studies with babies (n = 3) were successful in preventing caries. RCTs (n = 3) were classified as low risk of bias (n = 1), with concerns (n = 1) and high risk of bias (n = 1). CTs (n = 6) presented risk of bias as low (n = 2), serious (n = 1) and critical (n = 3). Studies about caries in babies showed high CE, and those who evaluated caries and periodontal parameters/biofilm in the mother had moderate and low CE, respectively. ETs as a strategy of OHPs for pregnant women can be effective in preventing caries in themselves and in their babies. However, despite the improvement of the mothers' oral hygiene and gingival condition, the CE was low considering this parameter.

Effectiveness of immersive technologies in oral health promotion and education: A systematic review

ObjectiveTo evaluate the effectiveness of immersive technologies in oral health promotion and education. MethodsAn extensive literature review was conducted using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) method. This study was systematically performed in six electronic databases (PubMed, Google Scholar, Web of Science, Cochrane, Scopus, and EBSCO). The risk of bias was assessed with the Cochrane tools using RoB 2.0 and ROBINS-I. ResultsPICOS criteria were formulated for study inclusion. The bibliographical search identified 10,074 articles, which were filtered subsequently. Finally, the most pertinent nine articles were included and scrutinized for data synthesis and analysis. This includes five randomized controlled trials and four non-randomized controlled trials in different countries that focused on children (33.3%), adolescents (11.1%), and adults (55.6%). The interventions used virtual reality (VR) and augmented reality (AR) to promote knowledge and attitudes towards oral care, improve toothbrushing performance, and smoking cessation, and reduce anxiety levels in oral health education. ConclusionThis systematic review demonstrates that immersive technologies, including VR and AR, significantly enhance oral health knowledge, attitudes, and self-efficacy, leading to improved health outcomes. Clinical significanceImmersive technologies such as VR and AR have the potential to provide innovative and effective methods for enhancing oral health promotion and education, while promoting positive health behaviours, which are crucial for improving overall oral health outcomes.

Comparative Analysis of Nutritional Advice and a Combined Approach for Addressing Impending Stunting in Infants: A Clinical Trial.

Weight faltering (WF) has been associated with stunting and with long-term adverse consequences for health and development. Nutritional care for managing WF may consist of giving nutritional advice (NA) and/or provision of oral nutrition supplements (ONSs). In this study, we aimed to evaluate practical management options in the community for infants with WF aged 6-12 months. This nonrandomized clinical trial was conducted in the community of Makassar, South Sulawesi, from March 2022 to March 2023. A total of 1013 infants were enrolled for screening. Anthropometric measures were performed in 913 infants, of which 170 showed WF below the 15th percentile of the WHO weight increment table without stunting. Infants with a weight increment below P5th were assigned to receive NA plus ONS, while infants between P5th and below P15th were assigned to receive only NA. At the second and third months, ONSs were administered to WF infants who were below P15th. One month after the intervention, 87/105 infants in the NA-plus-ONS group (82.8%) and 52/65 infants in the NA-only group (80%) were no longer WF. After 3 months, infants in the NA-plus-ONS group achieved greater weight gain than infants in the NA group (264.1 g vs. 137.4 g, p < 0.001) as well as greater length gain (2.35 cm vs. 2.14 cm, p < 0.001). WF management should be started at below P15th to achieve a better result. Infants with greater nutritional deficits should be assigned to receive the combination of NA plus ONSs to achieve a higher rate of resolution of growth.

Olaparib Without Androgen Deprivation for High-Risk Biochemically Recurrent Prostate Cancer Following Prostatectomy

Olaparib is a poly(adenosine diphosphate-ribose) polymerase inhibitor that provides benefit in combination with hormonal therapies in patients with metastatic prostate cancer who harbor homologous recombination repair (HRR) alterations. Its efficacy in the absence of androgen deprivation therapy has not been tested. To determine the activity of olaparib monotherapy among patients with high-risk biochemically recurrent (BCR) prostate cancer after radical prostatectomy. This phase 2, single-arm nonrandomized controlled trial enrolled genetically unselected patients across 4 sites in the US from May 2017 to November 2022. Eligible patients had BCR disease following radical prostatectomy, a prostate-specific antigen (PSA) doubling time of 6 months or shorter, an absolute PSA value of 1.0 ng/mL or higher, and a testosterone level of 150 ng/dL or higher. Treatment was with olaparib, 300 mg, by mouth twice daily until doubling of the baseline PSA, clinical or radiographic progression, or unacceptable toxic effects. The primary end point was a confirmed 50% or higher decline in PSA from baseline (PSA50). Key secondary end points were outcomes by HRR alteration status, as well as safety and tolerability. Of the 51 male patients enrolled (mean [SD] age, 63.8 [6.8] years), 13 participants (26%) had a PSA50 response, all within the HRR-positive group (13 of 27 participants [48%]). All 11 participants with BRCA2 alterations experienced a PSA50 response. Common adverse events were fatigue in 32 participants (63%), nausea in 28 (55%), and leukopenia in 22 (43%), and were consistent with known adverse effects of olaparib. In this nonrandomized controlled trial, olaparib monotherapy led to high and durable PSA50 response rates in patients with BRCA2 alterations. Olaparib warrants further study as a treatment strategy for some patients with BCR prostate cancer but does not have sufficient activity in those without HRR alterations and should not be considered for those patients. ClinicalTrials.gov Identifier: NCT03047135.

Current Status of Barriers to mHealth Access Among Patients With Stroke and Steps Toward the Digital Health Era: Systematic Review.

Mobile health (mHealth) offers significant benefits for patients with stroke, facilitating remote monitoring and personalized health care solutions beyond traditional settings. However, there is a dearth of comprehensive data, particularly qualitative insights, on the barriers to mHealth access. Understanding these barriers is crucial for devising strategies to enhance mHealth use among patients with stroke. This study aims to examine the recent literature focusing on barriers to mHealth access among patients with stroke. A systematic search of PubMed, MEDLINE, Web of Science, and CINAHL Plus Full Text was conducted for literature published between 2017 and 2023. Abstracts and full texts were independently screened based on predetermined inclusion and exclusion criteria. Data synthesis was performed using the convergent integrated analysis framework recommended by the Joanna Briggs Institute. A total of 12 studies met the inclusion criteria. The majority were qualitative studies (about 42%), followed by mixed methods (25%), pilot studies (about 17%), nonrandomized controlled trials (about 8%), and observational studies (about 8%). Participants included patients with stroke, caregivers, and various health care professionals. The most common mHealth practices were home-based telerehabilitation (30%) and poststroke mHealth and telecare services (20%). Identified barriers were categorized into two primary themes: (1) at the patient level and (2) at the health provider-patient-device interaction level. The first theme includes 2 subthemes: health-related issues and patient acceptability. The second theme encompassed 3 subthemes: infrastructure challenges (including software, networking, and hardware), support system deficiencies, and time constraints. This systematic review underscores significant barriers to mHealth adoption among patients with stroke. Addressing these barriers in future research is imperative to ensure that mHealth solutions effectively meet patients' needs.

The effect of surface treatments on the bond strength of polyetheretherketone posts: a systematic review protocol

Abstract* Background Polyetheretherketone (PEEK) is widely used in the biomedical field due to its outstanding biological and mechanical properties. Originally employed as a temporary abutment in implantology, recent research has expanded its indications for more definitive applications, such as frameworks and dental post and core. This shift requires a thorough assessment of PEEK’s adhesion and mechanical characteristics. However, PEEK’s inert properties and intricate chemistry create difficulties in surface treatment, resulting in reduced surface energy and inadequate adhesion. Inducing specific physical and chemical changes aims to overcome these challenges and enhance adhesion for PEEK. Despite its numerous clinical trials, standardized protocols remain lacking. This systematic review aims to assess the impact of surface treatments on the bonding performance of PEEK posts. Methods A detailed search of the literature will be conducted across several databases including PubMed, Scopus and clinical trial registries. Additional databases such as Cochrane Central, EMBASE, Web of Science and EBSCO will also be included. The search strategy will target controlled randomized studies and non-randomized clinical trials evaluating the impact of surface treatments on PEEK post adhesion strength. The Newcastle-Ottawa Scale (NOS) will be used to assess bias in non-randomized studies, while the Cochrane Risk of Bias (ROB II) tool will be employed for evaluating randomized controlled trials. Data extraction will focus on study design, treatment methods, outcomes and results. This systematic review protocol will adhere to the guidelines for systematic reviews outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Discussion The discussion will explore the implications of findings on clinical practice, highlighting the importance of enhancing PEEK’s bioactivity and surface energy to improve bonding efficacy in dental procedures. Moreover, it will suggest areas for future research to advance dental materials science, aiming to optimize the utilization of PEEK in dental applications Systematic review registration PROSPERO: CRD42024529783 (Registered on 08/04/2024).

Long-term Results of Hypofractionated Radiotherapy With Intra-prostatic Boosts in Men With Intermediate- and High-risk Prostate Cancer: A Phase II Trial

AimsIn the conventionally fractionated phase III FLAME prostate trial, focal boosts improved local control and biochemical disease-free survival (bDFS). We explored the toxicity and effectiveness of a moderately hypofractionated schedule with focal boosts. Material and methodsBIOPROP20 is a phase II single-arm non-randomised trial for intermediate- to very high-risk localised prostate cancer patients with bulky tumour volumes. Multi-parametric magnetic resonance imaging (MRI) and 18F-choline positron emission tomography-computed tomography (PET-CT) scans were used for staging and boost volume definition. Patients were treated with 60Gy in 20 fractions with a boost dose up to 68Gy. Five patients with positive lymph nodes on the PET-CT scan received radiotherapy to pelvic lymph nodes (45Gy to elective nodes, boosted up to 50Gy to involved nodes). Primary outcomes were acute (≤18 weeks) and late urinary and gastrointestinal toxicity, prospectively recorded up to 5 years with Common Terminology Criteria for Adverse Events v4 (CTCAE). Secondary outcomes were biochemical or clinical progression, metastasis-free survival (MFS), and overall survival (OS). Results61 patients completed radiotherapy with hormone therapy (range: 6–36 months). Cumulative acute and late gastrointestinal toxicity was low at 6.6% and 5.0%, respectively. Cumulative acute and late urinary toxicity was 49.2% and 30.1%, respectively; the prevalence reduced to 5.9% at 5 years. At 5 years: 6 patients had biochemical progression (bDFS: 88.5%; 95% CI: 80.2–97.6%), the MFS was 82.4% (95% CI: 73.0–92.9%), 5 patients died (OS: 91.2%; 95% CI: 84.1–98.9%), one with prostate cancer. The prostate, boost, nodal planning volumes, and the organs at risk (rectum, bowel, urethra, and bladder) met the optimal protocol dose constraints. There was a trend to increased urinary toxicity with increasing urethral (RR: 1.95, 95% CI: 0.73–5.22, p = 0.18), but not bladder dose. ConclusionFocal boosts with a 20 fraction hypofractionated prostate radiotherapy schedule are associated with an acceptable risk of gastrointestinal and urinary toxicity and achieve good cancer control. ClinicalTrials.gov identifierNCT02125175.

Efficacy and Safety of Metronomic Capecitabine in Hepatocellular Carcinoma: ASystematic Review and Meta-analysis.

Metronomic capecitabine has been found to be useful in several types of cancers such as pancreatic cancer, breast cancer, gastrointestinal cancers, nasopharyngeal carcinoma, and metastatic colorectal cancer. This unique systematic literature review and meta-analysis was undertaken to assess the effectiveness and safety of metronomic capecitabine as a treatment regimen for hepatocellular carcinoma. A systematic search of major databases was performed. Eight studies that dealt with the use of metronomic capecitabine for hepatocellular carcinoma (HCC) were selected, seven were non-randomized control trials (n-RCTs), and one was a randomized control trial (RCT). Meta-analysis of these studies was performed using Review Manager v5.3 and STATA 15.1 software. The pooled prevalence of overall survival (OS), progression-free survival (PFS), overall response rate (ORR), grade 1-2 adverse events (grade 1-2 AEs), grade 3-4 adverse events (grade 3-4 AEs) was determined, including publication bias and sensitivity analysis. Eight studies met the inclusion criteria, combining the pooled data of 476 patients from safety and efficacy studies. The pooled prevalence of disease control rate (DCR) and overall response rate (ORR) achieved with metronomic capecitabine was 36% (95% CI 32-41) and 7% (95% CI 5-9) respectively. The median progression-free survival (PFS) and median overall survival (OS) were 3.57months (95% CI 3.29-3.85) and 11.75months (95% CI 10.56-12.95) respectively. The incidence of grade 3-4 adverse events (grade 3-4 AEs) and grade 1-2 adverse events (grade 1-2 AEs) was 38% (95% CI 32-44) and 73% (95% CI 67-79) respectively. This meta-analysis highlights metronomic capecitabine as a potential treatment for hepatocellular carcinoma (HCC) in the advanced stage. However, effective management of capecitabine's side effects is essential.

Washed microbiota transplantation improved the level of serum vitamin D in ulcerative colitis.

Vitamin D (VD) deficiency was reported to correlate with ulcerative colitis (UC) activity, which might be closely related to gut microbiota dysbiosis. This study aims to investigate the effects of washed microbiota transplantation (WMT) on VD metabolism in UC. The serum levels of 25-hdroxyvitamin D [25(OH)D] in 121 patients with UC and 53 healthy controls (HC) were detected. Subsequently, a non-randomized control trial (non-RCT) was conducted. Patients with UC were non-randomly assigned to undergo WMT (n=28) vs. conventional treatment (5-aminosalicylic acid, 5-ASA, n=10). Serum levels of 25(OH)D, fecal microbiota, and the expression of vitamin D receptor (VDR) in patients with UC were evaluated with a 3-month follow-up. Serum VD levels collected in the clinic practice indicated that patients with UC had significantly lower VD levels than HC (P<0.001). In the non-RCT, serum 25(OH)D level and VDR expression significantly increased (P=0.011, 0.026, respectively) in the WMT group, while no noticeable changes were observed in the non-WMT group. Microbiome profiling revealed that the increase in VD levels after WMT was positively associated with the abundances of Adlercreutzia_equolifaciens, Ruminococcus_obeum, and Dorea but negatively correlated with Escherichia. The study suggested that WMT increases the levels of VD with characteristic changes of specific microbiota, which indicated the association between the VD and the activity of UC might be regulated by gut microbiota.

Paper-based and mobile application-based self-monitoring tool for healthy dietary intake, development and applicability: a non-randomized trial

BackgroundUnhealthy diet is a key risk factor for Non-Communicable Diseases (NCDs) that contribute to increased morbidity and premature mortality. With increased computer literacy and mobile phone penetration, there is a high opportunity for mobile application-based interventions. The current study was conducted to develop a mobile application to monitor dietary intake and to assess its acceptability and effectiveness in diet control compared to a similar paper-based intervention.A mobile application was developed based on research evidence and opinions of local experts. The mobile application was introduced to a selected group of office workers who were in preparation, action, and maintenance stages of the Trans Theoretical Model (TTM) and a paper-based intervention was used as the comparator. Socio-demographic data were collected through a self-administered questionnaire. Participants were followed up for three months for adherence. The effectiveness of interventions was assessed at the end of three months by comparing the progressive change in the stage of change and the change from unhealthy to healthy dietary intake between two groups as primary and secondary outcomes respectively.ResultsAmong 123 office workers who participated in the study, 19.5% preferred the mobile intervention over the paper-based intervention. Younger, unmarried office workers and those who do not have children, had a higher acceptance for the mobile intervention (p < 0.05). There was no difference in adherence (in all three months) or outcomes between the two groups of intervention.Conclusion and recommendationsMobile application-based interventions are better accepted among the young age group and further studies are recommended to explore their applicability.Trial registrationThe study was registered in the Sri Lankan Clinical Trial Registry (Registration No. SLCTR/2020/025; Date 15th December 2020).

Efficacy and safety of mesenchymal stem cell therapies for ischemic stroke: a systematic review and meta-analysis.

The efficacy and safety of mesenchymal stem cells (MSCs) in the treatment of ischemic stroke (IS) remains controversial. Therefore, this study aimed to evaluate the efficacy and safety of MSCs for IS. A literature search until May 23, 2023, was conducted using PubMed, EMBASE, the Cochrane Library, and the Web of Science to identify studies on stem cell therapy for IS. Interventional and observational clinical studies of MSCs in patients with IS were included, and the safety and efficacy were assessed. Two reviewers extracted data and assessed the quality independently. The meta-analysis was performed using RevMan5.4. Fifteen randomized controlled trials (RCTs) and 15 non-randomized trials, including 1217 patients (624 and 593 in the intervention and control arms, respectively), were analyzed. MSCs significantly improved patients' activities of daily living according to the modified Rankin scale (mean difference [MD]: -0.26; 95% confidence interval [CI]: -0.50 to -0.01; P = .04) and National Institutes of Health Stroke Scale score (MD: -1.69; 95% CI: -2.66 to -0.73; P < .001) in RCTs. MSC treatment was associated with lower mortality rates in RCTs (risk ratio: 0.44; 95% CI: 0.28-0.69; P < .001). Fever and headache were among the most reported adverse effects. Based on our review, MSC transplantation improves neurological deficits and daily activities in patients with IS. In the future, prospective studies with large sample sizes are needed for stem cell studies in ischemic stroke. This meta-analysis has been registered at PROSPERO with CRD42022347156.