Search For Trials Research Articles

Artículo traducido]Rivaroxaban frente a enoxaparina como tromboprofilaxis en cirugía ortopédica y traumatología: un metaanálisis.

Venous thromboembolism is highly associated with orthopedic surgery, so thromboprophylaxis is an important consideration for orthopedic surgeons. The new oral anticoagulants have clear advantages for clinical practice. To analyze the efficacy and safety of rivaroxaban versus enoxaparin for thromboprophylaxis in different orthopedic surgeries. Systematic electronic search of clinical trials was carried out. Data extraction of efficacy outcomes (deep venous thrombosis, pulmonary embolism and death) and safety outcomes (major bleeding and clinically relevant bleeding) was realized. Six randomized and controlled clinical trials were included in this meta-analysis. Compared with enoxaparin the risk of venous thromboembolism was lower with rivaroxaban both in different orthopedic surgeries (RR: 0.51; 95% CI: 0.36-0.73; P=.0002). This result was even better and more homogeneous in the analysis of symptomatic deep venous thrombosis outcome (RR: 0.43; 95% CI: 0.28-0.65; P<.0001; I2 = 0%; P=.49). The risk of bleeding was not significantly higher with rivaroxaban (RR: 1.20; 95% CI: 0.97-1.49; P=.09). Rivaroxaban should be considerate such as a more effective alternative for thromboprophylaxis in orthopedic surgery.

Efficacy of Photobiomodulation in Orthodontic Pain Management: A Systematic Review of Literature

Aim and Background: This systematic review aimed to investigate the efficacy of photobiomodulation (PBM) on alleviating orthodontic pain. Review Methods: An extensive electronic search for randomized control trials via Medline (via PubMed), The Cochrane Controlled Clinical Trials Register, and Science Direct up to October 15, 2023 was done. Hand searching was performed for relevant journals. Reference articles were retrieved and exported to Zotero software. The risk of bias was assessed using Version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). Results: A total of 8 articles were considered for systematic review. Most of the studies arrived at the consensus that photobiomodulation (PBM) indeed reduces the pain associated with orthodontic treatments. Conclusion: The synthesis of available evidence in our analysis reveals a substantial body of research suggesting a positive effect of PBM on reducing orthodontic pain. However, the existing variations in PBM parameters, and outcome measurements emphasize the necessity for more standardized approaches in future investigations.

Analysis of the Effectiveness and Safety of the Fentermine and Topiramate Association in Obesity: A Systematic Review of the Literature

Introduction: obesity is a chronic disease that can manifest itself at any stage of life, with an increasing incidence and prevalence, which contributes to other health problems.Objective: to determine the application of Phentermine and Topiramate in the treatment of obesity.Methods: a search for clinical trials and randomized controlled trials was conducted. The search was carried out exhaustively in the search engines/databases PubMed, Cachrane Library, Scopus, Google Scholar and Web of Science. Results: 21 studies were identified, of which 11 met the inclusion criteria. The evaluated research articles provided moderate evidence that the combination of Phentermine and Topiramate is effective and safe for the treatment of obesity. A gradual decrease in patients' body weight was observed from the start of treatment and up to 20 weeks thereafter. In addition, notable secondary outcomes, such as changes in blood pressure, triglyceride levels, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol and glycosylated hemoglobin (A1C) were found from the start of treatment.Conclusion: the doses of these drugs for chronic weight control in adults are 3,75 mg, 7,5 mg and 15 mg in the case of phentermine and 23 mg, 46 mg and 92 mg of topiramate, being the maximum recommended dose 15 mg/92 mg. If a 5 % weight loss is not achieved after 12 weeks with this dose, their use should be reconsidered

Facilitation of Enrollment onto Cancer Clinical Trials Using a Novel Navigator-Assisted Program: A Cross-Sectional Study.

Clinical trials are essential to the advancement of clinical therapies that improve the outcomes of people with cancer. However, enrollment in clinical trials remains a challenge. The Clinical Trial Navigator [CTN] Program was designed to address the current gap in the cancer care journey by assisting with the clinical trials search process. Between March 2019 and July 2024, applicants of the CTN program included people with cancer, their family members, and/or their care team. Applicants entered the CTN program through a REDCap® survey that collected the patient's medical history. A final curated list of potential clinical trials was provided to the applicant. Metrics of success included clinical trial referral and enrollment, and we examined the factors that impacted these outcomes. A total of 445 people with cancer applied to the CTN program during the study. Of the 262 patients with referral and enrollment information, a trial referral occurred in 27.5% [n = 72]. Of the 72 patients who were referred to a clinical trial, 13 [18.1%] were enrolled, 9 [12.5%] are pending enrollment, and 50 [69.4%] were not enrolled. We identified a potential trial for 88% of applicants, with a median of one potential trial per patient. Physicians were highly involved as applicants. The CTN program is successful in searching for clinical trials for people with cancer. Ongoing implementation into other Canadian sites, assessments of patient-reported outcomes, website and social media campaigns, and research into the factors that impact referral and enrollment are underway.

The Force Awakening in HbA1c Control: A Systematic Review and Meta-Analysis on the Efficacy of High-Intensity and Endurance Exercise in Patients With Type 2 Diabetes Mellitus.

The increase in the global prevalence of type 2 diabetes mellitus (DM2), driven mainly by obesity and physical inactivity, has increased interest in various nonpharmacological therapies. This systematic review aims to establish the effectiveness of high-intensity interval training (HIIT) and resistance exercise (RE) compared with continuous aerobic exercise in improving control in patients with DM2. We conducted a comprehensive search for clinical trials using databases such as MEDLINE (PubMed) and Web of Science. The search was performed using a controlled vocabulary (MeSH) together with Boolean operators, and the results were limited to English and Spanish. Secondary outcomes were improvements in VO2max and decreases in low-density lipoprotein (LDL). This study aims to explain evidence-based recommendations for primary care physicians on exercise therapies to improve glycemic management as well as cardiovascular health in people with DM2.

Efficacy of Photobiomodulation in Accelerating Orthodontic Tooth Movement: A Systematic Review of Literature

Aim and background: This systematic review aimed to investigate the efficacy of photobiomodulation (PBM) on the acceleration of orthodontic tooth movement (OTM). Review methods: An extensive electronic search for randomized control trials via Medline (via PubMed), The Cochrane Controlled Clinical Trials Register, and Science Direct up to October 15, 2023 was done. Hand searching was performed for relevant journals. Reference articles were retrieved and exported to Zotero software. The risk of bias was assessed using Version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). Results: A total of 14 articles were considered for systematic review. Most of the studies arrived at the consensus that photobiomodulation (PBM) indeed accelerates the pace of tooth movement and significantly diminishes the time required for achieving proper tooth alignment. Conclusion: The synthesis of available evidence in our analysis reveals a substantial body of research suggesting a positive effect of PBM on accelerating tooth movement. However, the existing variations in PBM parameters, and outcome measurements emphasize the necessity for more standardized approaches in future investigations.

Clinical Effectiveness of Bee Venom Acupuncture for Bone Fractures and Potential Mechanisms: A Narrative Overview.

Bee venom acupuncture, a type of herbal acupuncture, combines the pharmacological actions of bioactive compounds from bee venom with the mechanical stimulation of meridian points. Bee venom acupuncture is gaining popularity, particularly in the Republic of Korea, primarily for pain relief of various conditions. This study aimed to summarize and evaluate the available evidence on the use of bee venom acupuncture for recovery after bone fractures. Electronic literature searches for experimental studies and clinical trials were conducted using the PubMed, China Academic Journals (CAJ), and OASIS databases. The search revealed 31 studies, of which six met our criteria. These studies demonstrated that bee venom acupuncture can be effective in treating bone fractures, suggesting a promising area for future research. However, evidence supporting its efficacy in this context is limited. Rigorous trials with large sample sizes and robust designs are needed to clarify the role of bee venom acupuncture for these indications. In addition, future studies should explore the optimal dosage and concentration of bee venom acupuncture.

Acupuncture in the treatment of chemotherapy-induced peripheral neuropathy: a meta-analysis and data mining.

The efficacy and acupoint selection of acupuncture in treating chemotherapy-induced peripheral neuropathy (CIPN) remain controversial. This study aims to explore the specific efficacy and acupoint selection of acupuncture in treating CIPN through a meta-analysis and data mining. Searching for clinical trials on acupuncture treatment for CIPN in 8 databases, evaluating its efficacy and safety through a meta-analysis, and exploring its acupoint selection through data mining. The meta-analysis included 21 studies and 2,121 patients, showing that compared with the control group, the acupuncture group could significantly improve neuropathic pain intensity (SMD = -0.66, 95% CI [-1.07, -0.25], p = 0.002), significantly reduce the NCI-CTCAE (MD = -0.29, 95%CI [-0.50, -0.08], p < 0.01), significantly reduce the FACT-NXT score (MD = 2.09, 95% CI [0.73,3.45], p < 0.05), significantly increase the motor conduction velocities (MCV) of median nerve (MD = 2.38, 95% CI [2.10, 2.67], p < 0.001), the sensory conduction velocities (SCV) of the median nerve (MD = 0.56, 95 %CI [-1.45, 2.57], p = 0.58), the SCV of the tibial nerve (MD = 1.78, 95% CI [0.50, 3.05], p < 0.01), and the SCV of sural nerves (MD = 4.60, 95% CI [0.17, 9.02], p < 0.05), as well as improving the quality of life score (MD =7.35, 95% CI [1.53, 13.18], p = 0.01). Data mining showed that the core acupoints for acupuncture treatment of CIPN were LI4, ST36, LI11, LR3, and SP6. Acupuncture can improve the neuropathic pain intensity, the intensity of the CIPN, MCV of the median nerve, SCV of the tibial nerve and peroneal nerve, quality of life, and has good safety in CIPN patients. LI4 (Hegu), ST36 (Zusanli), LI11 (Quchi), LR3 (Taichong), and SP6 (Sanyinjiao) are the core acupuncture points for treating CIPN, and this protocol has the potential to become a supplementary treatment for CIPN. https://www.crd.york.ac.uk/prospero, identifier CRD42024551137.

The Fragility of Statistical Significance in the Use of Aspirin in Prevention of Venous Thromboembolism Events Following Total Joint Arthroplasty: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background/Objectives: Comparative studies often use the p value to convey statistical significance, but fragility indices (FI) and fragility quotients (FQ) may better signify statistical strength. The use of aspirin as venous thromboembolism (VTE) chemoprophylaxis following elective arthroplasty has been debated between the orthopedic and cardiac fields. The purpose of this study was to apply both the FI and FQ to evaluate the degree of statistical fragility in the total joint arthroplasty (TJA) literature regarding aspirin (ASA) use for VTE prevention. Methods: We performed a systematic search for TJA clinical trials from 2004 to 2023 reporting comparisons between ASA and other chemoprophylaxis methods for VTE. The FI of each outcome was calculated through reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size and interquartile range (IQR) was calculated. SPSS Meta-analysis function was used to calculate the Mean Effect Size Estimate and 95% Confidence Intervals for each outcome. Results: Of 245 articles screened, 39 met search criteria, with 10 RCTs included for analysis (n = 11,481 patients). There were 38 outcome events reported, with three significant (p < 0.05) outcomes and 35 non-significant (p > 0.05) outcomes identified. The overall FI and FQ for all 38 outcomes were 6 (IQR: 5-7) and 0.059 (IQR: 0.044-0.064), respectively. Seven studies (70%) reported a loss-to-follow-up (LTF) greater than the overall FI. There was no increased risk of DVT, PE, or mortality with use of ASA (all p > 0.2). Conclusions: Despite showing non-inferiority in preventing venous thromboembolic events in TJA overall, the highest-level peer-reviewed literature concerning aspirin use following total joint arthroplasty is considered statistically fragile due to high loss-to-follow-up. In addition to the reporting of the p value, the fragility index and quotient can further provide insight into the strength and trustworthiness of outcome measures.

The Role of 5-Phosphodiesterase Inhibitors (PDE-5I) in Current Benign Prostatic Hyperplasia Treatment: A Narrative Review.

Introduction: 5-phosphodiesterase inhibitors (PDE-5I) have been investigated as a treatment for urinary dysfunction for almost a decade. The general perception is that they play a significant role in managing lower urinary tract symptoms (LUTS), particularly those associated with benign prostatic hyperplasia (BPH). However, the specific biochemical processes by which PDE-5I repairs urinary function are still poorly understood and there is little instrumental evidence of significant improvement in urinary symptoms. Therefore, we explore the role of 5-phosphodiesterase inhibitors (PDE-5I) as complementary to the conventional treatment of symptomatic BPH; we provide the suggested biological procedures involved in the association between PDE-5 inhibitor use and improvement in LUTS; and we propose new approaches to this topic. Material and Methods: A systematic search for clinical trials, experimental studies, and systematic reviews was performed in electronic libraries (PubMed, EMBASE, Scopus) using the terms "benign prostate hypertrophy", "benign prostate hyperplasia", "lower urinary tract symptoms", "storage symptoms", "voiding symptoms", "bladder outlet obstruction" and the keywords "mechanism of action", "synergy", "PDE-5 inhibitor", "alpha1-adrenergic antagonist", "5-alpha-reductase inhibitors" in various combinations. There was no restriction on publication date. Results: To date, only a few randomized studies have been published in which the effect of the combination of a conventional drug for the treatment of symptomatic BPH and a PDE-5I was investigated. Almost all showed significant improvement in IPSS and QoL. Some studies showed significant improvements in maximum urine flow (Qmax) and postvoiding residual volume (PVR) with combination therapy compared with a single agent alone. Conclusions: PDE-5I seems effective in relieving symptoms of some BPH patients when administered as complementary to agents currently used to treat BPH. However, the mechanism of action of PDE-5 inhibitors in LUTS remains poorly understood and it is difficult to determine the specific subset of BPH patients who will benefit from the combination of PDE-5 inhibitors with the current treatment. Well-designed, sufficiently informative comparative studies focusing on specific target group profiles (age, urogenital parameters) are needed to define new therapeutic options.

Breast cancer radiobiology: The renaissance of whole breast radiation fractionation (Review).

Breast cancer radiotherapy has evolved significantly, driven by decades of research into fractionation schedules aimed at optimizing treatment efficacy and minimizing toxicity. Initial trials such as NSABP B-06 and EBCTCG meta-analyses established the benefits of adjuvant whole-breast irradiation in reducing local recurrence and improving survival rates. The linear-quadratic (LQ) model provided a framework to understand tissue response to radiation, highlighting the importance of the α/β ratio in determining fractionation sensitivity. The present scoping review aimed to identify and describe hypofractionation regimens for whole breast radiotherapy and evaluate dose differences using the LQ model across proposed α/β ratios. A comprehensive PubMed search for clinical trials published since 2010 on hypo-fractionated regimens was performed. Studies discussing α/β ratios for breast cancer have been also searched. Data on dose, fractions and α/β ratios were collected, and biologically effective dose (BED) and equivalent dose in 2 Gy fractions were calculated. The coefficient of variation for BED varied with α/β ratios, showing the lowest variability for an α/β ratio of ~3 without tumor repopulation and increased with repopulation (BED-kT; k is a constant that depends on the repopulation rate of the tumor, and T is the total treatment time in days). Significant differences in BED variances were observed across α/β ratios (F-statistic 219.6, P<0.0001). START trials (P, A, and B) established α/β ratios of 3-4 Gy for breast cancer and normal tissues, confirming that hypofractionation is as effective as standard fractionation with potentially fewer late toxicities. Subsequent trials, such as FAST and FAST-Forward, demonstrated that ultra-hypofractionation is equivalent in tumor compared with conventional regimens. Further research is needed to gain a stronger understanding of radiobiological properties of breast cancer cells. Advances in radiotherapy technologies and the integration of biomarkers, radiomics and genomics are transforming treatment, moving towards precision medicine.

Cardioprotective strategies in the management of chemotherapy-induced cardiotoxicity: current approaches and future directions.

Chemotherapy-induced cardiotoxicity (CIC) is a significant challenge in cancer treatment, leading to heart failure and myocardial infarction. With rising cancer survival rates, the long-term cardiovascular health of survivors has gained importance. While several cardioprotective medications have been studied to mitigate chemotherapy's harmful effects on the heart, more research is needed to confirm their effectiveness and optimal use. This review synthesizes evidence on cardioprotective drugs in managing CIC. The authors conducted a comprehensive literature search of peer-reviewed articles, clinical trials, and meta-analyses published between January 2000 and May 2024. Studies were selected based on relevance, quality, and focus on mechanisms, efficacy, and clinical outcomes of cardioprotective agents such as beta-blockers, ACE inhibitors, ARBs, statins, and dexrazoxane. Cardioprotective medications show potential in alleviating the impact of chemotherapy on heart function. Beta-blockers and ACE inhibitors effectively reduce heart failure incidence and improve cardiac outcomes. Statins, with their anti-inflammatory and antioxidative properties, and dexrazoxane, which reduces anthracycline-induced cardiotoxicity, also show promise. However, variability in study designs, patient groups, and chemotherapy treatments complicates the establishment of standardized treatment protocols. Cardioprotective drugs hold significant promise in managing CIC and improving cardiac outcomes for cancer patients. Current evidence supports the efficacy of beta-blockers, ACE inhibitors, statins, and dexrazoxane. Further research is needed to establish standardized protocols, evaluate long-term safety, and optimize treatment timing. Integrating cardioprotective strategies into oncological care can enhance the quality of life and prognosis for cancer survivors.

Implementation of a rule-based algorithm to find patients eligible for cancer clinical trials.

To explore implementing regular expressions (RegEx) to streamline patient identification and classification for matching to clinical trials. To prepare approaches needed to match patients to relevant cancer clinical trials, we combined NCI's Clinical Trials Search API to extract high-level eligibility criteria, including cancer type, stage, receptor/biomarker status, with similar data of patients with appointments in the upcoming week. Using RegEx, we prospectively identified all patients with breast, liver, or lung cancers at treatment decision points at 2 Cancer Centers' and 2 community hospitals', classified their cancer type, stage, and receptor/biomarker status. We evaluated accuracy using RegEx against manual reviews. Algorithm accuracy to identify patients at treatment decision points revealed 92% True Negative and 53% True Positive rate. Staging accuracy varied from 67% to 95%, and receptor/biomarker status accuracy from 76% to 86%. Using RegEx significantly reduced the number of patients requiring manual review, demonstrating a reduction in manual labor and potential biases, which can improve efficiency and inclusivity of clinical trial enrollment processes, especially in resource limited or data sensitive environments. NCT05146297.

Assessing the cost-effectiveness of replacing antimetabolites with mTOR inhibitors in heart transplant immunosuppression in China: a network meta-analysis-based economic evaluation.

Although several pharmacoeconomic studies have assessed the cost-effectiveness of maintenance immunosuppressive regimens for heart transplant recipients, economic comparisons between various combination drug therapies remain sparse. This study used an economic evaluation based on network meta-analysis to assess the cost-effectiveness of four immunosuppressive regimens for adult heart transplant recipients in China. We conducted a systematic search for clinical trials in PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP database. A validated Markov model was adapted to reflect the Chinese medical landscape. Four maintenance immunosuppression regimens were considered: tacrolimus/mycophenolate mofetil (TAC/MMF), cyclosporine/mycophenolate mofetil (CSA/MMF), everolimus/cyclosporine (EVL/CSA), and sirolimus/tacrolimus (SRL/TAC). The probabilities of health events were derived from a comprehensive literature review. Direct medical costs, adjusted for 2022 values, were from public documents and websites, while utilities for quality-adjusted life-years (QALYs) were taken from previous studies. Primary outcomes were mean lifetime cost, QALYs, and cost-effectiveness, with a willingness-to-pay (WTP) threshold set at three times China's GDP per capita in 2022. Sensitivity analyses were conducted to test the robustness of the results. The base case analysis identified TAC/MMF as the most cost-effective regimen, producing a mean of 6.31 QALYs per patient at a cost of Chinese Yuan (CNY) 534,182.89. Sensitivity analyses consistently reinforced TAC/MMF as the most cost-effective and robust choice. TAC/MMF is the most cost-effective maintenance immunosuppressive regimen for heart transplant recipients within the Chinese health system. The study findings are reinforced by sensitivity analyses, affirming their robustness amid various uncertainties.

Diagnostic accuracy of cytology and urine methylation test in patients with non-muscle invasive bladder cancer: a systematic review and meta-analysis.

Multiple clinical studies have demonstrated the numerous advantages of urine methylation test over cytology for monitoring patients with non-muscle invasive bladder cancer (NMIBC) following surgery. This research aims to provide a systematic review and meta-analysis to evaluate the efficacy and limits of urine methylation test in the clinical management of NMIBC. This research was carried out by conducting a comprehensive search of clinical trials comparing cytology and urine methylation test for NMIBC follow-up using databases such as PubMed, Embase, Web of Science, and the Cochrane Library up until May 2023, including references from relevant articles. The study is registered on PROSPERO with ID CRD42023398969. This study comprised six studies with a total of 1676 patients. The analysis revealed that the AUC of urine methylation test had a greater AUC than that of the cytology examination (0.89 vs 0.71). In post-operative follow-up of patients with NMIBC, the urine methylation test demonstrated a significant sensitivity (0.69 vs 0.52), but with lower specificity (0.87 vs 0.93) than cytology examination. The urine methylation test and cytology examination have both shown strong diagnostic performance in screening for NMIBC patients. However, urine methylation test outperforms cytology examination in terms of accuracy and sensitivity. PROSPERO, identifier CRD42023398969.

Prognostic and post-surgical updates in the treatment of non-syndromic craniosynostosis: a systematic review

Introduction: Craniosynostosis represents a rare congenital condition characterized by the premature fusion of one or more cranial sutures. The majority of cases of this disorder are non-syndromic in nature. Objective: This study aims to conduct an analysis and comparison of available surgical techniques, evaluating their respective postoperative outcomes in the treatment of non-syndromic craniosynostosis. The focus lies on assessing functional, aesthetic, and neurological outcomes. Methods: A systematic review was undertaken, encompassing the search for clinical trials (including randomized trials), systematic reviews, and meta-analyses available online in both Portuguese and English languages. The search terms "prognosis" and "non-syndromic craniosynostosis" were utilized along with the boolean operator "AND". Articles published between 2018 and 2023 were filtered through the Virtual Health Library (VHL) and PubMed platforms, specifically targeting studies presenting prognostic data related to craniosynostosis in pediatric patients up to 12 months of age. Results: The most favorable prognostic outcomes identified in this investigation were associated with conventional cranioplasty and minimally invasive endoscopic craniectomy techniques. Notably, conventional cranioplasty demonstrated superior intellectual outcomes among patients undergoing this procedure, with an average intelligence quotient of 111.7 ± 13 and academic performance aligning closely with national averages across various domains. Conversely, minimally invasive endoscopic craniectomy exhibited low rates of blood transfusion, complications, and reoperations. Conclusion: The findings underscore the superior cognitive prognosis associated with conventional cranioplasty, positioning it as a highly applicable surgical option for addressing craniosynostosis, supported by robust evidence.

Outcomes of Outpatient Versus Inpatient Induction of Labor: A Systematic Review and Meta-Analysis.

Induction of labor (IOL) has become a common practice in obstetrics, leading to an increase in antenatal admissions and workload. This review aims to explore the available options for outpatient IOL and their effectiveness. We conducted an electronic search for trials on Cochrane, PubMed, Google Scholar, and Web of Science databases for randomized control trials (RCTs) comparing inpatient and outpatient labor induction and covering the period until 2024. We selected randomized trials that compared IOL in outpatient vs. inpatient settings and involved mechanical or hormonal agents. The participants were pregnant women with singleton fetuses who were more than 37 weeks and low risk for IOL with a Bishopscore <6. When comparing outpatient and inpatient induction methods, we found no significant differences in cesarean section rates and vaginal delivery. Outpatient induction generally resulted in shorter hospital stays. Using a Foley catheter for outpatient induction reduced the cesarean section rate and total hospital stay. There were no safety concerns with this approach. IOL in this analysis was shown to be similar to inpatient IOL in most of the measured outcomes. Implementation of IOL in an outpatient setting proved to be safe with similar outcomes to inpatient IOL.

Changing landscape of geriatric clinical trials: Analysis of Clinical Trials Registry of India.

Abstract Background: Approximately 13% of the world’s population is more than 65 years old, and they consume major proportion of all medicinal products. Geriatric population constitute the majority of patients for chronic conditions including cardiac disease, malignancies, metabolic disorders, neurodegenerative disorders among others. However, in clinical trials, the elderly population is not adequately represented. In clinical studies, age-related physiological changes that impact the drug’s pharmacokinetics and pharmacodynamics in the elderly are not adequately assessed. Additionally, concomitant medications and comorbid conditions make elderly individuals more vulnerable to side effects. Objective: To analyse the trends of clinical trials involving the geriatric population in India over the past 16 years registered under Clinical Trial Registry of India. Materials and Methods: All clinical trials registered under CTRI from July 2007 to December 2023 were reviewed and analyzed using the key words “geriatrics”, “elderly”, “old age” in the ‘trial search’ section. Data was extracted for the year of study, type of trial, therapeutic area and sites of study. Results: Out of a total of 63,063 studies were registered in CTRI, 254 studies (0.37%) had geriatric population in their inclusion criteria. Of these studies 157 studies (61.8%) were interventional in nature. 29.9% of the studies were related to improvement in quality of life in the elderly. Regulatory clinical trials which included geriatrics to evaluate the efficacy and safety of drugs were only 5.5%. A gradual increase in the number of trials including elderly population was noted over the last 5 years. Conclusion: There is a major dearth of clinical trials that evaluate the geriatric population. However, there is an increasing trend of inclusion of geriatric population in clinical trials over the recent years.

Physiotherapeutic Assessment in Oncological Post-Mastectomy Patients

Introduction: Breast cancer is one of the most prevalent forms of cancer among women, and the medical treatment protocols are highly aggressive. In the case of mastectomy, a number of different sequelae are generated, including pain, functional limitation of the shoulder, dehiscence of the wound, decrease in joint range, decrease in muscle strength, lymphedema, and so forth. Such consequences directly impact the functionality and quality of life of the individual. Physiotherapy represents a potential avenue for addressing the sequelae resulting from the surgical procedure. Objective: The objective is to conduct a bibliographic research on the early physiotherapeutic treatment of post-mastectomy cancer patients. Methodology: A search for clinical trials from 2016 to 2023 was conducted in multiple languages, including English, Portuguese, and Spanish, across several databases: PEDro, PubMed, ScienceDirect, Cochrane, and Google Scholar. The inclusion and exclusion criteria facilitated an appropriate selection process for clinical trials, in conjunction with the PRISMA method. The selected clinical trials included a total sample of 644 individuals, in which various physiotherapeutic modalities were evaluated for the purpose of combating the various sequelae generated by mastectomy. Conclusions: Physiotherapy offers a range of beneficial therapeutic modalities, which, when applied early in post-mastectomy cancer patients, have a positive impact on these individuals. These include therapeutic exercise, hydrotherapy, and resistance aerobic exercise. Conversely, there are modalities such as manual lymphatic drainage and extracorporeal shock wave therapy that have uncertain benefits, given the lack of consensus on their evidence base.

Smart systems for real-time bearing faults diagnosis by using vibro-acoustics sensor fusion with Bayesian optimised 1-D CNNs

ABSTRACT Diagnosis of bearing faults in real-time is challenging when healthy bearing conditions are mixed with faulty ones, affecting the overall system of rotating machinery. Deep Learning provides an effective approach for condition-based maintenance of bearing faults, bypassing traditional signal processing complexity. Convolutional Neural Networks (CNNs) excel in real-time fault detection in bearings, leveraging their feature extraction capabilities from heterogeneous sensors. Usually, selecting optimal hyperparameters for CNNs is time-consuming and impacts model performance. Recent literature demonstrates that CNNs-based models for detecting bearing faults typically undergo trial searches to select optimal hyperparameters, leading to time-intensive procedures. To fill this research gap, our study proposes a Bayesian optimised 1-D CNNs method to address hyperparameter tuning challenges. Using Machinery Fault Simulator®, we demonstrate the effectiveness of our approach in identifying various bearing fault conditions through vibro-acoustics sensors. Bayesian optimisation efficiently partitions datasets for parallel computation, optimises hyperparameters, and minimises loss functions to enhance validation accuracy. The proposed method achieved a test accuracy of 99.62%, surpassing the benchmark’s 99.27%. Its effectiveness for bearing fault diagnosis is evident, compared to 96.76% without optimisation. Therefore, this study presents technical innovations, showcasing the diagnosis of diverse bearing faults with limited data through the integration of vibro-acoustics sensors.