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Biosensors May 2024One of the most common problems many babies encounter is neonatal jaundice. The symptoms are yellowing of the skin or eyes because of bilirubin (from above 2.0 to 2.5... (Review)
Review
One of the most common problems many babies encounter is neonatal jaundice. The symptoms are yellowing of the skin or eyes because of bilirubin (from above 2.0 to 2.5 mg/dL in the blood). If left untreated, it can lead to serious neurological complications. Traditionally, jaundice detection has relied on invasive blood tests, but developing non-invasive biosensors has provided an alternative approach. This systematic review aims to assess the advancement of these biosensors. This review discusses the many known invasive and non-invasive diagnostic modalities for detecting neonatal jaundice and their limitations. It also notes that the recent research and development on non-invasive biosensors for neonatal jaundice diagnosis is still in its early stages, with the majority of investigations being in vitro or at the pre-clinical level. Non-invasive biosensors could revolutionize neonatal jaundice detection; however, a number of issues still need to be solved before this can happen. These consist of in-depth validation studies, affordable and user-friendly gadgets, and regulatory authority approval. To create biosensors that meet regulatory requirements, additional research is required to make them more precise and affordable.
Topics: Biosensing Techniques; Humans; Jaundice, Neonatal; Infant, Newborn; Bilirubin
PubMed: 38785728
DOI: 10.3390/bios14050254 -
Trials May 2024Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has... (Review)
Review
INTRODUCTION
Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice.
METHODS
PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary.
RESULTS
Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'.
CONCLUSION
Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.
Topics: Humans; Informed Consent; Pamphlets; Randomized Controlled Trials as Topic; Surgical Procedures, Operative; Patient Education as Topic; Placebo Effect; Research Design; Placebos; Comprehension
PubMed: 38778336
DOI: 10.1186/s13063-024-08166-x -
Journal of Controlled Release :... Jul 2024Ultrasound is widely used in the diagnosis and therapy of cancer. Tumors can be treated by thermal or mechanical tissue ablation. Furthermore, tumors can be manipulated... (Meta-Analysis)
Meta-Analysis
Ultrasound is widely used in the diagnosis and therapy of cancer. Tumors can be treated by thermal or mechanical tissue ablation. Furthermore, tumors can be manipulated by hyperthermia, sonodynamic therapy and sonoporation, e.g., by increasing tumor perfusion or the permeability of biological barriers to enhance drug delivery. These treatments induce various immune responses in tumors. However, conflicting data and high heterogeneity between experimental settings make it difficult to generalize the effects of ultrasound on tumor immunity. Therefore, we performed a systematic review to answer the question: "Does ultrasound alter the immune reaction of peripheral solid tumors in humans and animals compared to control conditions without ultrasound?" A systematic literature search was performed in PubMed, EMBASE, and Web of Science and 24,401 potentially relevant publications were identified. Of these, 96 publications were eligible for inclusion in the systematic review. Experiments were performed in humans, rats, and mice and focused on different tumor types, primarily breast and melanoma. We collected data on thermal and non-thermal ultrasound settings, the use of sono-sensitizers or sono-enhancers, and anti-tumor therapies. Six meta-analyses were performed to quantify the effect of ultrasound on tumor infiltration by T cells (cytotoxic, helper, and regulatory T cells) and on blood cytokines (interleukin-6, interferon-γ, tumor necrosis factor-α). We provide robust scientific evidence that ultrasound alters T cell infiltration into tumors and increases blood cytokine concentrations. Furthermore, we identified significant differences in immune cell infiltration based on tumor type, ultrasound settings, and mouse age. Stronger effects were observed using hyperthermia in combination with sono-sensitizers and in young mice. The latter may impair the translational impact of study results as most cancer patients are older. Thus, our results may help refining ultrasound parameters to enhance anti-tumor immune responses for therapeutic use and to minimize immune effects in diagnostic applications.
Topics: Animals; Neoplasms; Humans; Ultrasonic Therapy
PubMed: 38777126
DOI: 10.1016/j.jconrel.2024.05.030 -
Investigational New Drugs Jun 2024In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted therapy (TT) and...
In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted therapy (TT) and immunotherapy (IO). This systematic survey describes features of trials enrolling between 2010 and 2020, focusing on inclusion criteria, type of dose escalation scheme (DES) utilized, and use of expansion cohorts (ECs). A literature search identified phase I studies in adults with solid tumors published January 1, 2000- December 31, 2020 from 12 journals. We included only studies enrolling between 2010 and 2020 to better capture the PO era. Two reviewers abstracted data; a third established concordance. Of 10,744 studies, 10,195 were non-topical or enrolled prior to 2010; 437 studies were included. The most common drug classes were TT (47.6%), IO (22%), and CT (6.9%). In studies which reported race, patients were predominantly white (61.7%) or Asian (25.7%), followed by black (6.5%) or other (6.1%). Heterogeneity was observed in the reporting and specification of study inclusion criteria. Only 40.1% of studies utilized ECs, and among the studies which used ECS, 46.6% were defined by genomic selection. Rule-based DES were used in 89% of trials; a 3+3 design was used in 80.5%. Of all drugs tested, 37.5% advanced to phase II, while 10.3% garnered regulatory licensure (for an indication tested in phase I). In the era of PO, TT and IO have emerged as the most studied agents in phase I trials. Rule-based DES, which are more relevant for escalating CT, are still chiefly utilized.
Topics: Humans; Neoplasms; Precision Medicine; Clinical Trials, Phase I as Topic; Antineoplastic Agents; Molecular Targeted Therapy; Immunotherapy; Medical Oncology
PubMed: 38775890
DOI: 10.1007/s10637-024-01445-z -
BMC Public Health May 2024For healthcare delivery to be optimally effective, health systems must possess adequate levels and we must ensure a fair distribution of human resources aimed at...
BACKGROUND
For healthcare delivery to be optimally effective, health systems must possess adequate levels and we must ensure a fair distribution of human resources aimed at healthcare facilities. We conducted a scoping review to map the current state of human resources for health (HRH) in India and the reasons behind its shortage.
METHODS
A systematic search was conducted in various electronic databases, from the earliest available date till February 2024. We applied a uniform analytical framework to all the primary research reports and adopted the "descriptive-analytical" method from the narrative paradigm. Inductive thematic analysis was conducted to arrange the retrieved data into categories based on related themes after creating a chart of HRH problems.
RESULTS
A total of 9675 articles were retrieved for this review. 88 full texts were included for the final data analysis. The shortage was addressed in 30.6% studies (n = 27) whereas 69.3% of studies (n = 61) addressed reasons for the shortage. The thematic analysis of data regarding reasons for the shortage yielded five kinds of HRH-related problems such as inadequate HRH production, job dissatisfaction, brain drain, regulatory issues, and lack of training, monitoring, and evaluation that were causing a scarcity of HRH in India.
CONCLUSION
There has been a persistent shortage and inequitable distribution of human resources in India with the rural expert cadres experiencing the most severe shortage. The health department needs to establish a productive recruitment system if long-term solutions are to be achieved. It is important to address the slow and sporadic nature of the recruitment system and the issue of job insecurity among medical officers, which in turn affects their other employment benefits, such as salary, pension, and recognition for the years of service.
Topics: Humans; Health Care Sector; Health Personnel; Health Workforce; India; Job Satisfaction
PubMed: 38773422
DOI: 10.1186/s12889-024-18850-x -
Cureus Apr 2024The study of human cadavers is essential for teaching, advanced training, and research in medical and anatomical sciences. Medical institutions around the globe... (Review)
Review
The study of human cadavers is essential for teaching, advanced training, and research in medical and anatomical sciences. Medical institutions around the globe presently face a scarcity of cadaver supplies. For the majority of countries, unclaimed bodies are still the primary source of cadavers despite guidelines issued by the International Federation of Associations of Anatomists, which discourage the use of unclaimed bodies. This self-funded study aims to conduct a review of the existing national and international laws safeguarding the several rights of a deceased person. The study also reviewed the existing anatomy acts (and related acts) across various countries that facilitate cadaver supply for anatomy education and research. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, an online search for publications in four medical databases (PubMed, Scopus, Web of Sciences, and Google Scholar) was conducted from 1950 till 2022. A research review protocol was registered in PROSPERO prospectively (registration ID: CRD42023469534) using the Mesh terms like cadaver, anatomy education, dead person and rights, body donation program, unclaimed bodies, and anatomy acts. After the application of the eligibility criteria, 149 publications were shortlisted. After reviewing all the shortlisted articles, laws, and guidelines, using the data extraction checklist prepared by both authors, five international laws, three supreme court case decisions, two high court case decisions, four Indian penal Code Sections, and 22 anatomy acts were selected. Articles from other medical databases could not be reviewed, which was the limitation of this study. The anatomy/human tissue/tissue transplantation acts and advisories from regulatory bodies of individual African, Middle-Eastern, and European countries could not be retrieved. The review findings will emphasize the distinctions between India's anatomy acts and those of other developed nations, thereby broadening our perspective as we propose a model anatomy act for uniform implementation across the country to streamline the procurement of cadavers.
PubMed: 38765326
DOI: 10.7759/cureus.58473 -
Medicine May 2024To investigate the regulatory patterns of Chinese patent medicine (CPM) interventions on lipid metabolism disorders in patients with type 2 diabetes mellitus (T2DM)... (Meta-Analysis)
Meta-Analysis
Regulatory patterns of Chinese patent medicine for lipid metabolism disorders in patients with type 2 diabetes mellitus complicated by ischemic stroke: A systematic review and network meta-analysis.
BACKGROUND
To investigate the regulatory patterns of Chinese patent medicine (CPM) interventions on lipid metabolism disorders in patients with type 2 diabetes mellitus (T2DM) complicated by ischemic stroke.
METHODS
Two researchers independently searched 8 major databases and created a comprehensive database containing all randomized controlled trials (RCTs) that investigated the application of "blood-activating and stasis-removing" CPM in the treatment of stroke combined with T2DM until October 1, 2022. The collected data were compiled and organized in Excel. Quality assessment was performed using the Cochrane 5.3 bias risk assessment tool, and the network meta-analysis was conducted using R software.
RESULTS
A total of 12 articles were included in the final analysis, covering 4 types of CPM: Naoxintong Capsules (NXT), Tongmai Jiangtang Capsules, Tongxinluo Capsules (TXL), and Yindan Xinnaotong Soft Capsules. Among these, CPM formulations containing herbs with blood-activating and stasis-removing properties were the most commonly used. The results of the network meta-analysis are as follows: (1) the combination of 3 CPM formulations showed superior efficacy in improving total cholesterol levels compared to conventional Western medicine treatment (CT). In particular, Yindan Xinnaotong Soft Capsules + CT (surface under the cumulative ranking curve [SUCRA] = 97.24%) demonstrated the highest efficacy, followed by NXT + CT (SUCRA = 66.23%), and then TXL + CT (SUCRA = 55.16%). (2) TXL + CT treatment exhibited the most promising efficacy in improving triglyceride levels (P < .05), while the effects of the other 3 CPM formulations were not statistically significant. (3) In terms of improving low-density lipoprotein levels, NXT + CT (SUCRA = 82.27%) showed better efficacy than TXL + CT (SUCRA = 73.99%), while the effects of the other 2 CPM formulations were not statistically significant. (4) The combination of CPM formulations and CT resulted in a lower incidence of adverse reactions compared to CT (P < .05).
CONCLUSION
The treatment of patients with T2DM complicated by ischemic stroke commonly involved the use of "blood-activating and stasis-removing" herbal medicines. These herbal medicines have shown effectiveness in regulating patients' blood lipid levels. However, it is crucial to acknowledge that the analysis was influenced by variations in the number and quality of RCTs involving different CPM formulations. Therefore, additional validation through large-scale, high-quality RCT studies is required.
Topics: Diabetes Mellitus, Type 2; Humans; Drugs, Chinese Herbal; Ischemic Stroke; Network Meta-Analysis; Lipid Metabolism Disorders; Randomized Controlled Trials as Topic; Medicine, Chinese Traditional
PubMed: 38758863
DOI: 10.1097/MD.0000000000035050 -
Frontiers in Genetics 2024Human extrachromosomal circular DNA, or eccDNA, has been the topic of extensive investigation in the last decade due to its prominent regulatory role in the development...
Human extrachromosomal circular DNA, or eccDNA, has been the topic of extensive investigation in the last decade due to its prominent regulatory role in the development of disorders including cancer. With the rapid advancement of experimental, sequencing and computational technology, millions of eccDNA records are now accessible. Unfortunately, the literature and databases only provide snippets of this information, preventing us from fully understanding eccDNAs. Researchers frequently struggle with the process of selecting algorithms and tools to examine eccDNAs of interest. To explain the underlying formation mechanisms of the five basic classes of eccDNAs, we categorized their characteristics and functions and summarized eight biogenesis theories. Most significantly, we created a clear procedure to help in the selection of suitable techniques and tools and thoroughly examined the most recent experimental and bioinformatics methodologies and data resources for identifying, measuring and analyzing eccDNA sequences. In conclusion, we highlighted the current obstacles and prospective paths for eccDNA research, specifically discussing their probable uses in molecular diagnostics and clinical prediction, with an emphasis on the potential contribution of novel computational strategies.
PubMed: 38746056
DOI: 10.3389/fgene.2024.1385150 -
Reproductive Biology and Endocrinology... May 2024The role of cytoplasmic fragmentation in human embryo development and reproductive potential is widely recognized, albeit without standard definition nor agreed upon... (Review)
Review
The role of cytoplasmic fragmentation in human embryo development and reproductive potential is widely recognized, albeit without standard definition nor agreed upon implication. While fragmentation is best understood to be a natural process across species, the origin of fragmentation remains incompletely understood and likely multifactorial. Several factors including embryo culture condition, gamete quality, aneuploidy, and abnormal cytokinesis seem to have important role in the etiology of cytoplasmic fragmentation. Fragmentation reduces the volume of cytoplasm and depletes embryo of essential organelles and regulatory proteins, compromising the developmental potential of the embryo. While it has been shown that degree of fragmentation and embryo implantation potential are inversely proportional, the degree, pattern, and distribution of fragmentation as it relates to pregnancy outcome is debated in the literature. This review highlights some of the challenges in analysis of fragmentation, while revealing trends in our evolving knowledge of how fragmentation may relate to functional development of the human embryos, implantation, and pregnancy outcome.
Topics: Humans; Female; Pregnancy; Embryonic Development; Pregnancy Outcome; Cytoplasm; Embryo Implantation
PubMed: 38745305
DOI: 10.1186/s12958-024-01217-7 -
BMC Psychology May 2024A growing number of studies have reported that problematic social networking use (PSNU) is strongly associated with anxiety symptoms. However, due to the presence of... (Meta-Analysis)
Meta-Analysis
A growing number of studies have reported that problematic social networking use (PSNU) is strongly associated with anxiety symptoms. However, due to the presence of multiple anxiety subtypes, existing research findings on the extent of this association vary widely, leading to a lack of consensus. The current meta-analysis aimed to summarize studies exploring the relationship between PSNU levels and anxiety symptoms, including generalized anxiety, social anxiety, attachment anxiety, and fear of missing out. 209 studies with a total of 172 articles were included in the meta-analysis, involving 252,337 participants from 28 countries. The results showed a moderately positive association between PSNU and generalized anxiety (GA), social anxiety (SA), attachment anxiety (AA), and fear of missing out (FoMO) respectively (GA: r = 0.388, 95% CI [0.362, 0.413]; SA: r = 0.437, 95% CI [0.395, 0.478]; AA: r = 0.345, 95% CI [0.286, 0.402]; FoMO: r = 0.496, 95% CI [0.461, 0.529]), and there were different regulatory factors between PSNU and different anxiety subtypes. This study provides the first comprehensive estimate of the association of PSNU with multiple anxiety subtypes, which vary by time of measurement, region, gender, and measurement tool.
Topics: Humans; Anxiety; Social Networking; Internet Addiction Disorder
PubMed: 38735963
DOI: 10.1186/s40359-024-01705-w