Search Results (2,189)

Background/Objectives: Obesity is a major risk factor for knee osteoarthritis (OA), and weight loss is crucial for its management. This pilot study explores the effects of a Very Low-Calorie Ketogenic Diet (VLCKD) in women with obesity and symptomatic knee OA. Methods: Women with symptomatic knee OA and obesity, defined as a body mass index (BMI) ≥ 30 kg/m², were eligible for the VLCKD protocol. The intervention included a ketogenic phase from baseline (T0) to the 8th week (T8), followed by a progressive reintroduction of carbohydrates over the next 12 weeks, ending at the 20th week (T20). Body mass index (BMI), the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the EuroQol 5D (EQ-5D), and the 36-item Short Form Health Survey (SF-36) were assessed at all time points. Generalized estimating equations were used to analyze the association between BMI and patient-reported outcomes across the study period. Results: Twenty participants started the study, but four discontinued the intervention, with two of these being due to adverse effects. The mean age of the 16 patients who completed the 20-week program was 57.3 ± 5.5 years, and their mean BMI was 40.0 ± 4.8 kg/m². The mean BMI significantly decreased to 37.5 ± 4.5 at T4, 36.3 ± 4.6 at T8, and 34.8 ± 4.8 at T20 (all p < 0.001 compared to baseline). The total WOMAC score improved from a mean of 43.6 ± 16.9 at T0 to 30.2 ± 12.8 at T4 (p = 0.005) and further to 24.7 ± 10.6 at T8 (p = 0.001) and to 24.8 ± 15.9 at T20 (p = 0.005). The reduction in BMI was significantly correlated with the improvements in WOMAC, EQ-5D, and SF-36 over time. No major adverse effects were observed. Conclusions: A 20-week VLCKD in women with obesity and knee OA significantly reduced their weight and improved their outcomes, warranting further research. This trial is registered with number NCT05848544 on ClinicalTrials.gov. Full article

Chronic obstructive pulmonary disease (COPD) is a condition that significantly impacts both patients and healthcare systems. The management of COPD involves various pharmacological intervention strategies, and addressing the issue of low adherence to these strategies has become a subject of significant interest. In response to this concern, there has been a shift toward utilizing telemedicine and mobile applications. The primary objective of this scoping review is to delineate the usage of mobile applications to enhance medication adherence in adult patients with COPD. This study involved a search of databases such as Medline, Google Scholar, Cochrane, and ClinicalTrial.gov, focusing on the literature published in English and Spanish over the last decade. The selected studies assessed interventions involving mobile applications (mobile apps) designed to improve medication adherence. Four digital aids were identified and available on online platforms, mobile apps, or both: m-PAC, myCOPD, Wellinks mHealth, and Propeller Health. Propeller Health, in particular, is an app that directly measures medication adherence through electronic medication monitors attached to participants’ inhalers. Opening the app was associated with higher odds of using control medications compared to participants who did not open the app. The findings suggest that these digital interventions serve as valuable tools to enhance patient adherence to treatment. Future research should focus on evaluating the effectiveness of different digital devices, such as digital inhalers and mobile applications, that directly measure medication adherence. Full article

When collecting marker-based motion capture data from clinical populations, speed of collection and comfort for the participant is a priority. This could be achieved by attaching markers to motion capture Velcro suits, as opposed to the skin. This study aimed to ascertain the reliability of sagittal-plane gait parameters estimated using Plug-in Gait (PiG) and Conventional Gait Model 2 (CGM2) marker sets from data collected in Suited and Non-suited (markers placed onto skin) conditions. For ten participants, markers were placed based on PiG and CGM2 models and data captured during a 2-min treadmill walk. Trials were repeated in suited and non-suited conditions. PiG ankle flexion/extension measurements had poor/moderate reliability (Non-suited ICC = 0.531, Suited ICC = 0.435). CGM2 ankle flexion/extension measurements had good/excellent reliability (Non-suited ICC = 0.916, Suited ICC = 0.900). There were significant differences in minimal detectable change (MDC) between conditions at the ankle for PiG (Non-suited MDC = 2.32°, Suited MDC = 18.90°), but not for CGM2 (Non-suited MDC = 0.63°, Suited MDC = 0.95°). When using CGM2, knee (Non-suited ICC = 0.878, Suited ICC = 0.855) and hip (Non-suited ICC = 0.897, Suited ICC = 0.948) showed good/excellent reliability in both conditions. A motion capture suit is not a reliable solution when collecting joint angle data using the PiG model but is reliable enough to consider when using the CGM2 model. Full article

Background: Chronic lateral epicondylitis (LE), also known as tennis elbow, affects 1–3% of the population, primarily those over 40 years old. Most cases resolve with conservative treatments, but some require more advanced interventions. Extracorporeal shockwave therapy (ESWT) has emerged as a non-surgical treatment option, utilizing either low- or high-energy levels to alleviate pain and improve function. Objective: This study aimed to compare the efficacy of low-energy versus high-energy ESWT in the treatment of chronic LE, focusing on pain relief and functional improvement. Methods: A retrospective observational study was conducted including patients treated for chronic LE between 2021 and 2024. Participants were divided into two groups: low-energy ESWT (0.10 mJ/mm²) and high-energy ESWT (0.20 mJ/mm²). Both groups received 2400 pulses at a frequency of 6 Hz once a week for three weeks. Pain and functional outcomes were measured using a visual analog scale (VAS) and the Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE) at the baseline, three months (T1), and six months (T2) post-treatment. Results: Forty-six patients participated, with 24 in the low-energy group and 22 in the high-energy group. Baseline demographics and clinical characteristics were similar across groups. At T1 and T2, the low-energy group showed significantly greater reductions in the VAS scores (T1: 4.45 ± 0.8 vs. 3.6 ± 1.7, p = 0.04; T2: 3.2 ± 1.2 vs. 2.1 ± 1.1, p = 0.004) and PRTEE scores (T1: 34.3 ± 6.9 vs. 26.8 ± 11.9, p = 0.03; T2: 25.3 ± 6 vs. 17.6 ± 9, p = 0.005). Significant treatment–time interactions were observed for both the VAS and PRTEE scores, indicating sustained improvements in the low-energy group. Conclusions: Low-energy ESWT was more effective than high-energy ESWT in treating chronic LE, providing greater and longer-lasting pain relief and functional improvement. These findings suggest that low-energy ESWT should be preferred in clinical practice for managing this condition. Future research should focus on larger sample sizes and randomized controlled trials to confirm these results and explore the underlying mechanisms of differential efficacy between energy levels. Full article

Background: Gingival diseases, encompassing a spectrum of oral health concerns, represent a prevalent issue within the global population. Despite their widespread occurrence, the research landscape concerning effective interventions, particularly those rooted in herbal products, remains somewhat limited. Addressing this knowledge gap, the current study undertook a comprehensive evaluation aimed at assessing the clinical efficacy of a novel intervention: a 5% thymoquinone (TQ) gel. This investigation specifically focused on the application of TQ gel as an adjunctive measure to the standard protocol of scaling (SC) in individuals afflicted with plaque-induced gingivitis. Through rigorous examination and analysis, this study seeks to provide valuable insights into the potential utility and therapeutic benefits of this herbal-based intervention in managing gingival diseases. Objective: To evaluate the efficacy of 5% TQ gel using a novel liposome drug delivery as a topical application following SC in gingivitis patients. Methods: A double-blinded, parallel, randomized controlled clinical trial. The study was performed at the Faculty of Dentistry, King Abdulaziz University, and Qassim University, Saudi Arabia. This trial enrolled 63 participants in an age group between 18 and 40 years attending the outpatient clinics of the Faculty of Dentistry, Qassim University, Saudi Arabia, and a clinical diagnosis of gingivitis was made. The enrolled subjects were categorized into three groups: Group I—TQ gel with SC, Group II—Placebo with SC, and Group III—SC alone, and clinical outcomes were measured at baseline and two-week follow-up visits. Plaque index (PI), papillary bleeding index (PBI), and any adverse events with TQ gel are categorized as mild, moderate, and severe. 63 patients. Group I (n = 21); Group II (n = 21); Group III (n = 21). Results: The paired t-test compared the mean differences in PI and PBI at two time points and it was observed that there were significant differences in Group I with p-values of 0.04 and 0.05, respectively. A one-way ANOVA test was performed and it showed significant differences in the mean scores between the three groups for PI (p-value—0.01) and PBI (p-value—0.05). The post hoc Tukey’s test compared the mean differences in PI and PBI between the groups and the results were in favor of Group I which used TQ gel with SC. Conclusions: The clinical trial concluded that the plaque and gingival bleeding scores were significantly reduced in the group of patients who intervened with TQ gel following SC when compared to SC-alone and placebo groups. Also, there were significant reductions in the scores from the baseline to the two-week follow-up visit in patients treated with TQ gel and SC. Full article

Background: Inhibition of human carcinomas has previously been linked to vitamin D due to its effects on cancer cell proliferation, migration, angiogenesis, and apoptosis induction. The anticancer activity of vitamin D has been confirmed by several studies, which have shown that increased cancer incidence is associated with decreased vitamin D and that dietary supplementation of vitamin D slows down the growth of xenografted tumors in mice. Vitamin D inhibits the growth of cancer cells by the induction of apoptosis as well as by arresting the cells at the G0/G1 (or) G2/M phase of the cell cycle. Aim and Key Scientific Concepts of the Review: The purpose of this article is to thoroughly review the existing information and discuss and debate to conclude whether vitamin D could be used as an agent to prevent/treat cancers. The existing empirical data have demonstrated that vitamin D can also work in the absence of vitamin D receptors (VDRs), indicating the presence of multiple mechanisms of action for this sunshine vitamin. Polymorphism in the VDR is known to play a key role in tumor cell metastasis and drug resistance. Although there is evidence that vitamin D has both therapeutic and cancer-preventive properties, numerous uncertainties and concerns regarding its use in cancer treatment still exist. These include (a) increased calcium levels in individuals receiving therapeutic doses of vitamin D to suppress the growth of cancer cells; (b) hyperglycemia induction in certain vitamin D-treated study participants; (c) a dearth of evidence showing preventive or therapeutic benefits of cancer in clinical trials; (d) very weak support from proof-of-principle studies; and (e) the inability of vitamin D alone to treat advanced cancers. Addressing these concerns, more potent and less toxic vitamin D analogs have been created, and these are presently undergoing clinical trial evaluation. To provide key information regarding the functions of vitamin D and VDRs, this review provided details of significant advancements in the functional analysis of vitamin D and its analogs and VDR polymorphisms associated with cancers. Full article

Telemedicine is now being used more frequently to evaluate patients with myasthenia gravis (MG). Assessing this condition involves clinical outcome measures, such as the standardized MG-ADL scale or the more complex MG-CE score obtained during clinical exams. However, human subjectivity limits the reliability of these examinations. We propose a set of AI-powered digital tools to improve scoring efficiency and quality using computer vision, deep learning, and natural language processing. This paper focuses on automating a standard telemedicine video by segmenting it into clips corresponding to the MG-CE assessment. This AI-powered solution offers a quantitative assessment of neurological deficits, improving upon subjective evaluations prone to examiner variability. It has the potential to enhance efficiency, patient participation in MG clinical trials, and broader applicability to various neurological diseases. Full article

A recent review proposed a role for multi-functional food or supplement products in priming the gut to support both digestive and systemic health. Accordingly, we designed and eva-luated the effect of a multi-functional gastrointestinal (GI) primer supplement on participant-reported measures for digestive health, quality-of-life (e.g., energy/vitality and general health), and reasons for satiation (e.g., attitudes towards food and eating). In this single-arm clinical trial, 68 participants with mild digestive symptoms consumed the GI primer supplement daily for 14 days. Digestive symptoms were evaluated daily from baseline (Day 0) through Day 14. At baseline and Day 14, participants reported their stool consistency, reasons for satiation, and quality-of-life measures using validated questionnaires. At Day 14, participants reported significant improvements in all (13/13) digestive symptom parameters (p-values < 0.05) and an increase in % of stools with normal consistencies. There were significant improvements (p-values < 0.05) in energy/vitality and general health, and in specific attitudes towards food and eating (e.g., physical satisfaction, planned amount, decreased eating priority, decreased food appeal, and self-consciousness). Results suggest the GI primer supplement promotes digestive health, improves quality of life, and impacts attitudes towards food/eating. This study provides preliminary support for the gut priming hypothesis through which multi-functional digestive products may improve GI health. Full article

Chronic wounds result from the body’s inability to heal, causing pain, pathogen entry, limited treatment options, and societal burden. Diabetic foot ulcers are particularly challenging, often leading to severe complications like leg amputation. A clinical study tested AMNIODERM+^®, a new device with a lyophilized human amniotic membrane (HAM), on chronic diabetic foot ulcers. Participants had diabetic neuropathic or neuroischemic leg wounds (2–16 cm²) unhealed by 20% after six weeks of standard care. This study showed significant wound healing improvements with AMNIODERM+^®. The median wound size reduction after 12 weeks was 95.5%, far exceeding the null hypothesis of 20% change. Additionally, 65% of patients achieved complete ulceration healing, surpassing the 50% efficacy requirement. The median time to full closure was 11.4 weeks, with the proportion of completely healed patients rising progressively, reaching 55% by week 11. These findings, from the clinical trial “Freeze-dried amniotic membrane in the treatment of nonhealing wounds”, suggest AMNIODERM+^® as a promising future treatment for chronic diabetic foot ulcers. The published results were obtained as part of a clinical trial entitled “Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial”, EUDAMED Nr. CIV-SK-22-10-041146. Full article

This review evaluates the reporting of demographic characteristics and the diversity of participants of phase III lung cancer clinical trials with Canadian research sites. A literature search was conducted using the ClinicalTrials.gov registry to identify clinical trials conducted between 1 January 2013, and 31 December 2023. The demographic reporting practices and the representation of sex/gender, racial, and ethnic groups were assessed. The location of Canadian research sites was also examined for trends in reporting and representation. Associated publications were reviewed for demographic data collection methods. Of the 25 clinical trials, 24 reported race and 18 also reported ethnicity. All clinical trials reported sex/gender, and the city and province of the participating Canadian sites. Most participants were White (66.1%), identified as not Hispanic or Latino (81.4%), and were male (57.8%). The provinces with the most clinical trial sites were Ontario (43.6%) and Quebec (34.2%). Lung cancer clinical trials lack adequate demographic reporting and representation of females, diverse patient groups, and geographical locations in Canada with high lung cancer incidence rates. Specifically, the Indigenous Peoples of Canada and Nunavut require better representation in lung cancer clinical trials conducted in Canada. These findings highlight the need to improve diversity and demographic representation in clinical research. Full article

Conditioned pain modulation (CPM) and temporal summation (TS) tests can measure the ability to inhibit pain in fibromyalgia syndrome (FMS) patients and its level of pain sensitization, respectively. However, their clinical validity is still unclear. We studied the association between changes in the CPM and TS tests and the clinical improvement of FMS patients who received therapeutic intervention. We systematically searched for FMS randomized clinical trials with data on therapeutic interventions comparing clinical improvement (pain intensity and symptom severity reduction), CPM, and TS changes relative to control interventions. To study the relationship between TS/CPM and clinical measures, we performed a meta-regression analysis to calculate odds ratios. We included nine studies (484 participants). We found no significant changes in TS or CPM by studying all the interventions together. Our findings show that this lack of difference is likely because pharmacological and non-pharmacological interventions resulted in contrary effects. Non-pharmacological interventions, such as non-invasive neuromodulation, showed the largest effects normalizing CPM/TS. Meta-regression was significantly associated with pain reduction and symptom severity improvement with normalization of TS and CPM. We demonstrate an association between clinical improvement and TS/CPM normalization in FMS patients. Thus, the TS and CPM tests could be surrogate biomarkers in FMS management. Recovering defective endogenous pain modulation mechanisms by targeted non-pharmacological interventions may help establish long-term clinical recovery in FMS patients. Full article

Primary dysmenorrhea is considered one of the main causes of pelvic pain during a woman’s childbearing years, resulting in poor quality of life. The objective was to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in painful symptomatology improvement and non-steroidal anti-inflammatory drug (NSAID) intake reduction in women with primary dysmenorrhea (PD) compared with a control group in the short, medium, and long terms. A single-blind, controlled clinical trial was developed. Participants were randomized to the experimental (TTNS) and control group (sham TTNS). Both groups received 12-weekly 30-min sessions with a NeuroTrac^TM PelviTone electrostimulation device. The intensity and severity of pain and non-steroidal anti-inflammatory drug (NSAID) intake were evaluated in the short-term (after treatment), medium-term (1–3 months), and long-term (6 months). A total of 61 participants were randomized, with a split of 31 (experimental group) and 30 (control group), but 55 participants completed the study and were analyzed. Statistically significant differences between both groups in the maximum pain intensity decrease (F = 4.88, p = 0.0043) measured with the visual analogue scale, as well as NSAID intake decrease (F = 4.68, p = 0.011) and days of their ingestion (F = 4.57, p = 0.012) occurred in the short term. Furthermore, significant decreases in the total number of NSAIDs ingested during the cycle (F = 3.82, p = 0.011) and the number of days on which patients ingested NSAIDs (F = 3.59, p = 0.015) in the medium–long term occurred. TTNS could be an effective and safe strategy to reduce pain caused by PD, which could reduce or complement the use of pharmacological techniques and other more invasive methods. Full article

Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system with unknown etiology, resulting in various impairments that necessitate continuous rehabilitation to enhance functionality, quality of life, and motor function, including through Virtual Reality (VR) therapy. Comparing tasks in virtual environments and their potential skill transfer to real-world settings could aid in optimizing treatment programs to improve motor performance in individuals with MS. This study aimed to determine whether practicing acquisition and retention phases using two distinct interfaces (concrete—Touch Screen or abstract—Kinect system) affects performance in a subsequent task using a different interface (transfer phase). A randomized clinical trial was conducted with 56 volunteers with MS and 41 controls. Participants engaged in a computer game where they burst as many bubbles as possible within 10 s per attempt. After the acquisition and retention phases, all participants switched interfaces (e.g., those using Kinect switched to Touchscreen and vice versa). Significant performance improvements were observed in both groups during the acquisition phase, which were maintained in the retention phase. Although the abstract interface was more challenging for both groups, only the MS group that practiced with the abstract interface successfully transferred their improvements to the concrete interface. Thus, despite the increased difficulty of the abstract task during practice, it led to better performance transfer when required to complete a subsequent concrete task, suggesting that abstract devices may be beneficial in clinical practice for improving motor function in people with MS. Full article

Research conducted on homogenous populations can lead to biased and misleading findings, impeding the development of effective interventions and treatments for diverse populations. Low participation among minority groups further leads to disparities in access to innovative cancer care and treatment outcomes associated with trial participation. To better understand cancer patients’ attitudes and willingness to participate in clinical trials, solid tumor patients attending their clinic visits were invited to complete a survey. The survey included questions on demographics, previous trial participation, and future trial interest. Responses were analyzed with frequency tables and chi-square tests. Of 300 participants, only 96 (32%) were asked to participate in a clinical trial. Of these, 81 (84%) chose to participate and 15 (16%) did not. There were notable differences by race but not gender or education level. Of the 204 who had never been asked to participate, 70% indicated that they would be willing to participate in future, and there was a strong sex–race interaction. Non-White males were the most hesitant group. Of 204, 99% indicated that they would participate to access new treatments, and 57% would participate to contribute to research overall. This study shows that many solid tumor patients undergoing treatment are not offered clinical trials. Racial differences in attitudes toward trial participation are evident. Nonetheless, many patients are willing to participate in trials to access innovative treatments and to support research. Culturally relevant outreach to build trust with minority groups is needed to increase overall participation in clinical trials. Full article

Arginases are key enzymes that hydrolyze L-arginine to urea and L-ornithine in the urea cycle. The two arginase isoforms, arginase 1 (ARG1) and arginase 2 (ARG2), regulate the proliferation of cancer cells, migration, and apoptosis; affect immunosuppression; and promote the synthesis of polyamines, leading to the development of cancer. Arginases also compete with nitric oxide synthase (NOS) for L-arginine, and their participation has also been confirmed in cardiovascular diseases, stroke, and inflammation. Due to the fact that arginases play a crucial role in the development of various types of diseases, finding an appropriate candidate to inhibit the activity of these enzymes would be beneficial for the therapy of many human diseases. In this review, based on numerous experimental, preclinical, and clinical studies, we provide a comprehensive overview of the biological and physiological functions of ARG1 and ARG2, their molecular mechanisms of action, and affected metabolic pathways. We summarize the recent clinical trials’ advances in targeting arginases and describe potential future drugs. Full article