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Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension

Drugs. 2023 Dec 7. doi: 10.1007/s40265-023-01973-7. Online ahead of print.

ABSTRACT

PURPOSE: A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication.

METHODS: Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (n = 49). IOP was measured at baseline, day 1-2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters.

RESULTS: Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months.

CONCLUSION: The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months.

TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.

PMID:38060092 | DOI:10.1007/s40265-023-01973-7

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Evaluating the Effect of Lactobacillus casei FEGY 9973 and Curcumin on Experimental Giardiasis

Acta Parasitol. 2023 Dec 7. doi: 10.1007/s11686-023-00744-4. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Giardia is a parasitic hard protozoan that causes a variety of parasitological and pathological changes in gastrointestinal epithelial cells and is resistant to a variety of disinfectants and treatments. This study used experimental animals infected with Giardia Lamblia to assess the potential therapeutic effect of Lactobacillus casei, Lactobacillus bulgaricus (Lactobacillus in yoghurt) and curcumin in comparison to one of the commonly used drugs (metronidazole).

METHODS: The study included 54 Syrian hamsters (Mesocricetus auratus) that ranged in weight from 80 to 100 g and were divided into six groups: The effect of the used preparations was assessed in terms of parasitological and histopathological aspects in Group I non-infected healthy control, Group II infected non-treated, Group III infected treated with metronidazole MTZ, Group IV infected treated with Lactobacillus casei, Group V infected treated with curcumin, and Group VI infected treated with, Lactobacillus bulgaricus (Lactobacillus in yoghurt). The number of G. lamblia cysts per gram of stool was counted during the parasitological examination.

RESULTS: The difference between the infected non-treated group and all the treated groups was statistically significant (P0.05). When compared to the infected untreated group, Lactobacillus casei and, Lactobacillus bulgaricus (Lactobacillus in yoghurt) produced a 100% reduction in G. lamblia cyst shedding, curcumin produced an 87.80% reduction in number of cysts, and metronidazole produced a 78.4% reduction in number of cysts.

CONCLUSION: Our results highlight the potentially effective therapeutic effect of different preparations of probiotics and curcumin against Giardiasis.

PMID:38060086 | DOI:10.1007/s11686-023-00744-4

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Association between prediabetes and breast cancer: a comprehensive meta-analysis

Breast Cancer Res Treat. 2023 Dec 7. doi: 10.1007/s10549-023-07181-x. Online ahead of print.

ABSTRACT

BACKGROUND: Breast cancer accounts for up to 30% of cancer cases in women in the US. Diabetes mellitus has been recognized as a risk factor for breast cancer. Some studies have suggested that prediabetes may also be associated with breast cancer whereas other studies have shown no or an inverse association; thus, we conducted a meta-analysis to assess the risk of breast cancer in prediabetes.

METHODS: We searched PubMed/Medline, EMBASE, Google Scholar, and Scopus to identify studies that reported breast cancer risks in patients having prediabetes compared to normoglycemic patients. Binary random-effects model was used to calculate a pooled odds ratio (OR) with 95% confidence intervals. I2 statistics were used to assess heterogeneity. Leave-one-out sensitivity analysis and subgroup analyses were performed.

RESULTS: We analyzed 7 studies with 24,586 prediabetic and 224,314 normoglycemic individuals (783 and 5739 breast cancer cases, respectively). Unadjusted odds ratio (OR) for breast cancer was 1.45 (95% CI = 1.14, 1.83); adjusted OR was 1.19 (95% CI = 1.07, 1.34) in prediabetes. Subgroup analysis revealed a higher breast cancer risk in individuals aged less than 60 years (OR = 1.86, 95% CI = 1.39, 2.49) than in those aged 60 years or more (OR = 1.07, 95% CI = 0.97, 1.18). Subgroup analysis by median follow-up length indicated a higher risk of breast cancer for follow-ups of less than or equal to 2 years (OR = 2.34, 95% CI = 1.85, 2.95) than in those of over 10 years (OR = 1.1, 95% CI = 0.99, 1.23) and 6 to 10 years (OR = 1.03, 95% CI = 0.88, 1.21).

CONCLUSIONS: In conclusion, individuals with prediabetes have higher risk of developing breast cancer than those with normoglycemia, especially younger prediabetes patients. These individuals may benefit from early identification, monitoring, and interventions to reverse prediabetes.

PMID:38060076 | DOI:10.1007/s10549-023-07181-x

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Increased Delta and Theta Power Density in Sickle Cell Disease Individuals with Chronic Pain Secondary to Hip Osteonecrosis: A Resting-State Eeg Study

Brain Topogr. 2023 Dec 7. doi: 10.1007/s10548-023-01027-x. Online ahead of print.

ABSTRACT

PURPOSE: Identify the presence of a dysfunctional electroencephalographic (EEG) pattern in individuals with sickle cell disease (SCD) and hip osteonecrosis, and assess its potential associations with depression, anxiety, pain severity, and serum levels of brain-derived neurotrophic factor (BDNF).

METHODS: In this cross-sectional investigation, 24 SCD patients with hip osteonecrosis and chronic pain were matched by age and sex with 19 healthy controls. Resting-state EEG data were recorded using 32 electrodes for both groups. Power spectral density (PSD) and peak alpha frequency (PAF) were computed for each electrode across Delta, Theta, Alpha, and Beta frequency bands. Current Source Density (CSD) measures were performed utilizing the built-in Statistical nonparametric Mapping Method of the LORETA-KEY software.

RESULTS: Our findings demonstrated that SCD individuals exhibited higher PSD in delta and theta frequency bands when compared to healthy controls. Moreover, SCD individuals displayed increased CSD in delta and theta frequencies, coupled with decreased CSD in the alpha frequency within brain regions linked to pain processing, motor function, emotion, and attention. In comparison to the control group, depression symptoms, and pain intensity during hip abduction were positively correlated with PSD and CSD in the delta frequency within the parietal region. Depression symptoms also exhibited a positive association with PSD and CSD in the theta frequency within the same region, while serum BDNF levels showed a negative correlation with CSD in the alpha frequency within the left insula.

CONCLUSION: This study indicates that individuals with SCD experiencing hip osteonecrosis and chronic pain manifest a dysfunctional EEG pattern characterized by the persistence of low-frequency PSD during a resting state. This dysfunctional EEG pattern may be linked to clinical and biochemical outcomes, including depression symptoms, pain severity during movement, and serum BDNF levels.

PMID:38060074 | DOI:10.1007/s10548-023-01027-x

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Assessment of seasonal warming trends at the Nile Delta: a paradigm for human-induced climate change

Environ Monit Assess. 2023 Dec 7;196(1):20. doi: 10.1007/s10661-023-12204-7.

ABSTRACT

Given its modern geographical and geomorphological characteristics, along with rapid socio-economic changes, the Nile Delta stands out as one of the world’s most dynamic landscapes. The key drivers of the land use change in this region have been the reclamation of delta margins, changes in agricultural practices, and urban expansion. The present study aims to explore the variations in the seasonal daytime and nighttime trends of the land surface temperatures (LST) at this active agronomic system in response to the seasonal variations of vegetation cover as revealed by the normalized difference vegetation index (NDVI) during the past two decades. The data were exclusively acquired from the Moderate Resolution Imaging Spectroradiometer (MODIS) instrument for the period from January 2001 to December 2021, where geospatial and statistical analyses were accomplished to construct a LST/NDVI spatio-temporal pattern throughout the Nile Delta. Results revealed a robust negative and a significant relationship between the NDVI and the diurnal LST with high regression coefficients (R2) ranging from 0.78 to 0.97 (p value < 0.05). Maximal seasonal warming trends occurred during harvesting seasons (springs and falls), while the least warming was recorded during winters (the growing seasons). It was also observed that the nocturnal warming (0.72°C/decade) was almost as double as the corresponding value of the daytime trend (0.33°C/decade). The study recognized a seasonal climatic warming throughout the Nile Delta influenced by the human-induced land use change and agricultural practices.

PMID:38060061 | DOI:10.1007/s10661-023-12204-7

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Effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer: a systematic review and meta-analysis

Support Care Cancer. 2023 Dec 7;32(1):15. doi: 10.1007/s00520-023-08229-w.

ABSTRACT

PURPOSE: To evaluate the effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer.

METHODS: We conducted a systematic search of the PubMed, Embase, CINAHL, Web of Science, and Cochrane Library (CENTRAL) databases from database inception to May 5, 2023, for randomized controlled trials (RCTs) and cohort studies that investigated prehabilitation in the context of esophagogastric cancer. A random-effects model was used for meta-analysis.

RESULTS: We identified 2,994 records and eventually included 12 studies (6 RCTs and 6 cohort studies) with a total of 910 patients. According to random-effects pooled estimates, prehabilitation reduced the incidence of all complications (RR = 0.79, 95% CI: 0.66 to 0.93, P = 0.006), pulmonary complications (RR = 0.61, 95% CI: 0.47 to 0.79, P = 0.0002), and severe complications (RR = 0.63, 95% CI: 0.47 to 0.84, P = 0.002), and shortened the length of stay (MD = -1.92, 95% CI: -3.11 to -0.73, P = 0.002) compared to usual care. However, there were no statistically significant differences in 30-day readmission rates or in-hospital mortality. Subgroup analysis showed that multimodal prehabilitation was effective in reducing the risk of all complications and severe complications, while unimodal prehabilitation was not.

CONCLUSIONS: Our findings suggested that prehabilitation may be beneficial in reducing postoperative complications and length of stay. We recommend preoperative prehabilitation to improve postoperative outcomes and hasten recovery following esophagogastric cancer surgery, and multimodal prehabilitation seems to be more advantageous in reducing complications. However, further studies are needed to confirm these results.

PMID:38060053 | DOI:10.1007/s00520-023-08229-w

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Integration of fruit fly and firefly optimization algorithm with support vector regression in estimating daily pan evaporation

Int J Biometeorol. 2023 Dec 7. doi: 10.1007/s00484-023-02586-1. Online ahead of print.

ABSTRACT

The purpose of the present study was to predict the pan evaporation values at four stations including Urmia, Makou, Mahabad, and Khoy, located in West Azerbaijan, Iran, using support vector regression (SVR), SVR coupled by fruit fly algorithm (SVR-FOA), and SVR coupled with firefly algorithm (SVR-FFA). Therefore, for the first time, this research has used the combined SVR-FOA to predict pan evaporation. For this purpose, meteorological parameters in the period of 1990-2020 were gathered and then using the Pearson’s correlation coefficient, significant inputs for pan evaporation estimation were determined. The correlation evaluation of the parameters showed that the two parameters of wind speed and sunshine hours had the highest correlation with the pan evaporation values, and in addition, these parameters, as input to the models, improved the results and increased the accuracy of the models. The obtained results indicated that at Urmia station, SVR-FFA with the lowest error was the best model. The SVR-FOA also had better performance than the SVR model. Additionally, the result showed that SVR-FOA with the lowest errors had the best capability in pan evaporation estimation at other studied stations. Therefore, it was concluded that FOA with advantages such as simplicity, fewer parameters, easy adjustment, and less calculation can significantly increase the capability of independent SVR models. Hence, based on the overall results, SVR-FOA may be recommended as the most accurate method for pan evaporation estimation.

PMID:38060013 | DOI:10.1007/s00484-023-02586-1

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The Hospitalist-Oncologist co-ManagemEnt (HOME) system improves hospitalization outcomes of patients with cancer

BMC Health Serv Res. 2023 Dec 6;23(1):1367. doi: 10.1186/s12913-023-10375-0.

ABSTRACT

BACKGROUND: The hospitalist system has been introduced to improve the quality and safety of inpatient care. As its effectiveness has been confirmed in previous studies, the hospitalist system is spreading in various fields. However, few studies have investigated the feasibility and value of hospitalist-led care of patients with cancer in terms of quality and safety measures. This study aimed to evaluate the efficacy of the Hospitalist-Oncologist co-ManagemEnt (HOME) system.

METHODS: Between January 1, 2019, and January 31, 2021, we analyzed 591 admissions before and 1068 admissions after the introduction of HOME system on January 1, 2020. We compared the length of stay and the types and frequencies of safety events between the conventional system and the HOME system, retrospectively. We also investigate rapid response system activation, cardiopulmonary resuscitation, unplanned intensive care unit transfer, all-cause in-hospital mortality, and 30-day re-admission or emergency department visits.

RESULTS: The average length of stay (15.9 days vs. 12.9 days, P < 0.001), frequency of safety events (5.6% vs. 2.8%, P = 0.006), rapid response system activation (7.3% vs. 2.2%, P < 0.001) were significantly reduced after the HOME system introduction. However, there was no statistical difference in frequencies of cardiopulomonary resuscitation and intensive care unit transfer, all-cause in-hospital morality, 30-day unplanned re-admission or emergency department visits.

CONCLUSIONS: The study suggests that the HOME system provides higher quality of care and safer environment compared to conventional oncologist-led team-based care, and the efficiency of the medical delivery system could be increased by reducing the hospitalization period without increase in 30-day unplanned re-admission.

PMID:38057800 | DOI:10.1186/s12913-023-10375-0

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Cancer patients’ behaviors and attitudes toward natural health products

BMC Complement Med Ther. 2023 Dec 6;23(1):442. doi: 10.1186/s12906-023-04278-0.

ABSTRACT

BACKGROUND: Natural health products (NHPs), including vitamins, minerals, and herbal supplements, are the most common complementary and alternative medicine (CAM) among cancer patients. Our survey determined the attitudes and behaviors of cancer patients toward natural complementary therapies that should be considered to implement an integrative approach in the future.

METHODS: Our survey was conducted in four hospitals in Belgium. Questionnaires were posted online from October 2020 to October 2021 for cancer patients. Descriptive statistics were used to analyze the data. A [Formula: see text] test was applied to study the type of NHP consumed according to diagnosis time. Fischer’s exact test compared patients who had changed their consumption since diagnosis and those who had not.

RESULTS: Out of 349 questionnaires collected, only 59 met all inclusion criteria. 83.1 % of the patients agreed that conventional medicine (CM) could benefit from complementary therapies, but they did not estimate (72.3 % of the patients) that those latter are more effective than conventional medicine. More than half of the patients used five or more NHPs. The most frequent NHPs consumed daily were vitamins (64.4 %), followed by other products (i.e., probiotics, gemmotherapy, birch sap and omega 3/6) (42.4 %) and herbs (40.7 %). Almost all patients started taking NHPs before their cancer diagnosis, but 72.7 % have changed their consumption significantly (p = 0.009) since their diagnosis. Boosting the immune system (79.7 %) and limiting conventional treatment side effects (76.9 %) were the most common reasons for NHPs’ use. 74.4 % of the patients did not take complementary therapies to delay or avoid conventional treatment.

CONCLUSIONS: The combination and high diversity of NHPs consumption highlight the importance of educating patients and healthcare providers (HCPs) about the risk of drug interactions associated with these natural products. Most cancer patients are more interested in using this non-mainstream medicine to complement their conventional treatment than as an alternative. Knowing the patients’ reasons and understanding patients’ attitudes toward NHPs will be essential for HCPs to address NHPs’ use.

PMID:38057795 | DOI:10.1186/s12906-023-04278-0

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Age and sex related change in tooth enamel thickness of maxillary incisors measured by cone beam computed tomography

BMC Oral Health. 2023 Dec 6;23(1):971. doi: 10.1186/s12903-023-03639-y.

ABSTRACT

BACKGROUND: To measure adequate enamel thickness of maxillary incisors in planning enamel reduction for a porcelain laminate veneer restoration in relation to chronological age and sex by using cone beam computed tomography (CBCT) in an Iraqi subpopulation.

METHODS: From 81 CBCT images, 324 maxillary incisors were examined. Enamel thickness was measured at both mesial and distal regions of the tooth in three different levels: cervical, middle, and incisal (occlusal) 1/3 at a sagittal section. Measurements were made for the following tooth areas using CBCT: facial enamel thickness at 1, 3, and 5 mm from the cementoenamel junction (CEJ), palatal enamel thickness at 5 mm from the CEJ (5 mm P), facial and palatal enamel thickness at the incisal edge (IFP), mid incisal enamel thickness (IET), and the incisal edge enamel-pulp distance (IEPD). Relationships of enamel thickness with age and sex were evaluated using Independent t-test, Mann-Whitney U-test and the Pearson correlation coefficient, a simple linear regression analysis used for statistical analysis.

RESULTS: Significant differences (P < 0.05) were found in terms of an inverse association between enamel thickness and chronological age at all measurements above the CEJ and the regression model for the mid-incisal enamel thickness was (R2 of 0.4). In contrast, there was an increase in IFP, palatal, and IPED enamel thickness with age. Also, significant differences were found in enamel thickness between males and females, the enamel being thicker in females in relation to facial enamel thickness, enamel palatal thickness above CEJ and IET, while for IEPD, the enamel thickness was greater in males compared to females.

CONCLUSION: The measurements for enamel thickness outcome variables in relation to chronological age revealed significant differences for each measured distance and there were statistically significant differences in enamel thickness between males and females at all measurements except at IFP. These results demonstrate that CBCT can be used for noninvasive, accurate measurements of enamel thickness in both sex.

PMID:38057794 | DOI:10.1186/s12903-023-03639-y