Reviews on recent clinical trials最新文献

Introduction: Gastric Diffuse Large B-Cell Lymphoma (DLBCL) is an aggressive type of non-Hodgkin lymphoma (NHL) that originates from B lymphocytes. It is the most common subtype among gastric lymphomas, accounting for approximately 30-40% of all lymphoma cases. The incidence of DLBCL varies depending on geographic region and age, with an annual incidence of approximately 5-7 cases per 100,000 people in Western countries. Patients with human immunodeficiency virus (HIV) infection have a significantly increased risk of developing lymphomas, including DLBCL, due to chronic immunosuppression. Before the advent of Highly Active Antiretroviral Therapy (HAART), the incidence of DLBCL in patients with HIV was estimated to be 60 to 200 times higher than in the general population. After the introduction of HAART, the incidence of DLBCL decreased to approximately 24 times higher than in the general population. CD4 lymphocyte count is a key factor. Studies have shown that patients with lower CD4 counts and higher viral loads had an increased risk of systemic NHL, while the use of HAART was associated with a reduced incidence of NHL. In HIV-positive patients, DLBCL is often associated with greater aggressiveness and a less favorable prognosis compared to immunocompetent patients.

Case presentation: This case report describes a 67-year-old woman with a known diagnosis of HIV infection who presented with abdominal pain, unintentional weight loss, melena, and severe anemia. After 3 weeks from symptoms onset, an esophagogastroduodenoscopy revealed numerous ulcerated areas in the stomach. Gastric biopsies confirmed the diagnosis of DLBCL, ABC-like subtype.

Conclusion: This case highlights the critical importance of early upper gastrointestinal endoscopy in the follow-up of gastric lesions in HIV-positive patients, demonstrating how timely endoscopic monitoring serves as an essential tool to accurately assess the therapeutic effectiveness of antiviral and antitumor treatments. Direct visualization of the lesions' response enables prompt adjustment of therapy, significantly improving clinical outcomes. Moreover, the optimal management of such complex cases necessitates close multidisciplinary collaboration among hematologists, gastroenterologists, and infectious disease specialists. This interdisciplinary synergy is key to ensuring an integrated approach that enhances diagnostic precision, therapeutic strategies, and follow-up protocols, ultimately aiming to optimize patient outcomes and quality of life.

Introduction: Controlling bleeding is one of the most closely monitored aspects of surgery and is considered both a potential complication and a possible source of malpractice, representing a significant risk for the surgeon. Floseal (Baxter Healthcare Corporation) is a hemostatic matrix composed of gelatin and thrombin, designed to control bleeding in surgical settings where standard techniques are ineffective or impractical. This study aimed to provide a comprehensive overview of the use of Floseal kits across a variety of surgical procedures. Particular attention was given to the ergonomic characteristics, usability, and effectiveness of the device in relation to procedural complexity and the associated risk of hemorrhage.

Methodology: Data from 95 clinical cases were collected through a survey of a sample of surgeons from three hospitals in the Tuscany Region (Italy). The survey gathered information on the use of Floseal kits across different types of surgeries, as well as the ergonomic aspects of their application. Additionally, a qualitative ergonomic analysis was performed through indirect observation of videos showing Floseal's use during surgical procedures. Based on these findings, potential medico-legal implications were also evaluated.

Results: The survey results indicated that 93% of procedures required only one Floseal kit, with the highest usage observed in open surgeries (76%). The device was rated as highly effective, receiving scores of 4-5 on a Likert scale, and demonstrated excellent ease of use in 73% of cases. In terms of ergonomics, Floseal showed outstanding ease of application without significant difficulties, even in complex procedures such as robotic and laparoscopic surgeries.

Discussion: Attention to proper usage is essential to avoid errors, such as application in non-expandable areas or the risk of intravascular thrombosis. Proper preparation of the device is necessary to ensure rapid intervention times. Additionally, some considerations are discussed regarding the potential role of AI in improving device ergonomics and its applications in surgical practice.

Conclusion: Floseal is a highly effective and user-friendly hemostatic device with broad applicability across various surgical specialties. The limited kit consumption per procedure (93% of surgeries required only one kit) contributes to waste reduction and optimal hemorrhage management. Moreover, the ergonomic design and usability of the device enhance its effectiveness in controlling bleeding during surgery.

Introduction: The COVID-19 pandemic significantly disrupted daily routines, including Contact Lens (CL) usage patterns. This study examines the factors influencing adherence to CL guidelines among residents in the northern West Bank, both before and during the pandemic.

Methods: A cross-sectional analysis was conducted using a questionnaire completed by 379 CL users aged 18-35 between April 25 and May 1, 2022. The survey covered demographic data, CL history, behavioral changes, and adherence practices. A validated seven-item Likert-scale tool (Cronbach's α = 0.9025) was used to assess adherence levels. Multivariable logistic regression was performed to identify predictors of adherence change.

Results: CL usage significantly declined during the pandemic from 5.2 to 3.4 days per week (p < 0.01). Approximately 35% of participants reported reduced adherence to CL safety guidelines. Guidance from optometrists or ophthalmologists was associated with improved adherence (aOR = 0.54, 95% CI: 0.33- 0.88, p = 0.013). While city residents showed better adherence compared to those in villages or camps, this was not statistically significant (aOR = 1.14, 95% CI: 0.72-1.80, p = 0.585).

Discussion: Lifestyle shifts during lockdowns contributed to decreased adherence, with professional eye care guidance emerging as a key protective factor.

Conclusion: The pandemic negatively impacted CL hygiene behaviors, but professional support mitigated this effect. Strengthening patient education may improve adherence during future public health crises.

Introduction: Premenstrual syndrome (PMS) significantly affects women's quality of life. This study compares the effects of propolis and fennelin capsules on PMS symptoms in students.

Methods: A double-blind, randomized controlled trial (2024) was conducted with 90 students at Hamadan University of Medical Sciences, who were randomized into propolis (500 mg), fennelin (30 mg extract), or placebo groups (30 participants each). Interventions were administered over two menstrual cycles. PMS symptom severity and frequency were assessed using validated questionnaires and analyzed with SPSS-21.

Results: Propolis and fennelin reduced PMS symptom severity by 78.9% and 79.3%, respectively (p = 0.016), whereas no significant change was observed in the placebo group (p = 0.206). No side effects were reported.

Conclusion: Propolis and fennelin may serve as complementary options for short-term PMS symptom relief in young women. However, the small sample size and short duration limit the generalizability of the findings, highlighting the need for future studies with larger, more diverse populations and longer follow-up periods.

Clinical trial no: IRCT20120215009014N525.

Drug repurposing is an emerging strategy in the drug discovery arena, shedding light on new therapeutic uses for already known drugs. This strategy enormously reduces the time and cost of drug development because it utilizes existing data on safety and efficacy of drugs. This review provides basic mechanisms, strategies, and challenges related to drug repurposing. Here we discuss the role of polypharmacology, potential off-target effects in the use of computational and experimental methods for identifying repurposing opportunities, and regulatory and ethical considerations in drug repurposing. Completed cases demonstrate that this approach works effectively across various therapeutic areas, from oncology to rare diseases. Challenges include the need for regulatory and clinical data. Drug repurposing is extremely promising for the rapid delivery of new treatments to patients while cooperating in the development of a more sustainable healthcare system. In-depth knowledge of biological systems and disease mechanisms will allow for drug repurposing to potentially revolutionize new treatments and patients' outcomes.

Introduction: Urinary tract infections (UTIs) caused by multidrug-resistant, biofilmforming Klebsiella pneumoniae represent a serious global health concern. Conventional antibiotics often fail due to resistance and biofilm-associated tolerance, necessitating novel diagnostic and therapeutic strategies. This study investigated interleukin-8 (IL-8) as a diagnostic marker and evaluated the anti-virulence potential of ellagic acid against extended-spectrum β-lactamase (ESBL)-producing K. pneumoniae.

Methods: This study was a cross-sectional, experimental, and analytical investigation conducted from August 2023 to March 2024. Serum IL-8 levels were quantified in patients and healthy controls using ELISA. The antibiotic susceptibility of K. pneumoniae isolates was assessed according to CLSI guidelines, and ESBL activity was determined by the nitrocefin hydrolysis test. Biofilm formation was quantified using the crystal violet assay, with and without ellagic acid treatment. In silico docking studies were conducted using AutoDock Vina to predict interactions between ellagic acid and the CTX-M-15 β-lactamase, Wza, FabH, and SdiA proteins.

Results: IL-8 levels were significantly higher in patients (223.8 ± 43.5 pg/mL) compared with controls (47.9 ± 17.3 pg/mL; p < 0.0001). All isolates were resistant to ampicillin and showed broad resistance to other antibiotics. Ellagic acid significantly reduced biofilm biomass (p = 0.0002) but concurrently increased ESBL activity (p = 0.0001). Docking demonstrated that ellagic acid was strongly bound to CTX-M-15 (-8.3 kcal/mol), had moderate interactions with Wza and SdiA, whereas the interaction with FabH was relatively low.

Discussion: The high concentration of IL-8 supports its use as a biomarker to detect K. pneumoniae infections. The elevated resistance profile of K. pneumoniae to antibiotics highlights the urgent need for alternative treatment approaches. Though ellagic acid increased ESBL activity, it showed distinct antibiofilm activity and responses with virulence-related proteins, indicating a modulatory action that may reduce bacterial pathogenicity. Limitations include the lack of in vivo validation and the need to mechanistically elucidate the modulation of ESBL.

Conclusion: IL-8 is a valuable biomarker for ESBL-producing K. pneumoniae infection. Ellagic acid reduces biofilm formation and targets bacterial resistance and virulence proteins, supporting its potential as a natural anti-virulence agent against multidrug-resistant K. pneumoniae.

The primary function of a vaccine is to trigger a series of immune responses that are targeted at a specific pathogen. The present vaccine administration methods need to be improved, even though currently available immunisations are a remarkable success story in modern medicine and have significantly reduced global morbidity and mortality rates. Multiple immunisations were recently integrated into a single injection. This strategy is the most effective way to expedite immunisation administration and lessen the psychological burden associated with receiving multiple doses. However, safety is crucial for their widespread acceptance. Pharmacokinetics and pharmacodynamics of combination vaccination entail coordinated antigen delivery, immune activation, and effectiveness and safety. These vaccine combinations face regulatory approval of consistent manufacture, immunogenicity, and safety in various populations. Clinical studies and real-world research determine their safety and efficacy, guiding regulatory approval and post-launch monitoring. This review article discusses the pharmacokinetics and pharmacodynamics, regulatory concerns, and clinical evidence on the safety and effectiveness of combination vaccines.

Green tea contains a bioactive polyphenol called epigallocatechin gallate (EGCG), which may be used as a therapeutic agent for breast cancer (BC). This review examines the pharmacological and chemical properties of EGCG, which may make it a valuable therapeutic agent for treating breast cancer. The distinctive physicochemical characteristics of EGCG, such as its solubility, stability, and bioavailability, are based on its molecular structure, which is also crucial for its medicinal uses. Furthermore, the availability of EGCG as a naturally occurring substance, its production in "Camellia sinensis," and the use of sophisticated extraction methods are also covered. Apoptosis is induced via caspase activation and mitochondrial failure. Metastasis-related enzymes are inhibited, and key signaling pathways, including PI3k, Akt, and MAPK, are modulated as part of EGCG's multifaceted anti-cancer actions. The synergistic benefits of EGCG with traditional chemotherapies, in combating drug resistance and enhancing their effectiveness, significantly improve the therapeutic value of these treatments. Limited bioavailability is addressed via liposomal delivery, nanoparticle encapsulation, and structural optimisation. Pharmacokinetics, toxicology, and clinical studies all support its safety and effectiveness. This study highlights the promise of EGCG as a therapeutic agent for breast cancer, exploring its molecular interactions, new formulations, and the integration of chemistry and molecular mechanisms to enhance EGCG's therapeutic applicability in clinical settings.

Introduction: Disinfection of the root canal system is crucial for the effectiveness of root canal treatment. Lasers and photoactivated disinfection (PAD) have emerged as preferred methods for eliminating pathogens from the root canal.

Method: Sixty intact, freshly extracted adult human uniradicular mature teeth with a single root canal were collected. The crowns were removed, resulting in canals measuring 14 mm in length. The root canals were prepared, sterilized, and then inoculated with broth containing Enterococcus faecalis (E. faecalis), followed by incubation for 30 days in an aerobic environment at 37°C. Biofilm formation was verified using a scanning electron microscope. The samples were randomly divided into six experimental groups (n = 10). Group 1 consisted of teeth treated only with distilled water. Group 2 teeth received 3% NaOCl and 17% EDTA as part of Conventional Chemomechanical Debridement (CCMD) but no additional treatment. Groups 3-6 also received CCMD followed by additional laser disinfection as follows: Group 3 underwent photoactivated disinfection (PAD) using riboflavin with a 450 nm laser; Group 4 underwent PAD using toluidine blue O (TBO) with a 635 nm laser; Group 5 underwent conventional laser endodontics (CLE) with an 808 nm laser; and Group 6 underwent CLE using triple wavelengths of 450 nm, 635 nm, and 808 nm.

Results: The Kruskal-Wallis test revealed significant differences in colony-forming units (CFUs) among the groups after treatment (p < 0.001). Subsequent analysis showed that the difference in mean CFUs between the PAD groups and the CLE groups was not statistically significant. The group treated with the triple laser wavelength exhibited the lowest average CFUs/mL, while the distilled water group had the highest mean value.

Discussion: The study confirms that diode laser-assisted disinfection significantly enhances bacterial reduction compared with conventional irrigation alone. Although PAD methods reduced E. faecalis, their effect was not statistically superior to conventional laser endodontics (CLE). The triplewavelength diode laser group achieved the greatest bacterial reduction, likely due to the synergistic effects of thermal and photochemical interactions. These findings support the adjunctive use of laser disinfection to improve root canal decontamination, particularly when combined with chemomechanical preparation.

Conclusion: This study demonstrates that combining an irrigating solution with a diode laser enhances the effectiveness of reducing pathogenic numbers.