Tag: nevin manimala

CNS Neurol Disord Drug Targets. 2023 Apr 4. doi: 10.2174/1871527322666230404114911. Online ahead of print.

ABSTRACT

BACKGROUND: Autism Spectrum Disorder (ASD) is a common child neurodevelopmental disorder, whose pathogenesis is not completely understood. Until now, there is no proven treatment for the core symptoms of ASD. However, some evidence indicates a crucial link between this disorder and GABAergic signals which are altered in ASD. Bumetanide is a diuretic that reduces chloride, shifts gamma-amino-butyric acid (GABA) from excitation to inhibition, and may play a significant role in the treatment of ASD.

OBJECTIVE: The objective of this study is to assess the safety and efficacy of bumetanide as a treatment for ASD.

METHODS: Eighty children, aged 3-12 years, with ASD diagnosed by Childhood Autism Rating Scale (CARS), ⩾30 were included in this double-blind, randomized, and controlled study. Group 1 received Bumetanide, Group 2 received a placebo for 6 months. Follow-up by CARS rating scale was performed before and after 1, 3, and 6 months of treatment.

RESULTS: The use of bumetanide in group 1 improved the core symptoms of ASD in a shorter time with minimal and tolerable adverse effects. There was a statistically significant decrease in CARS and most of its fifteen items in group 1 versus group 2 after 6 months of treatment (p-value <0.001).

CONCLUSION: Bumetanide has an important role in the treatment of core symptoms of ASD.

PMID:37021422 | DOI:10.2174/1871527322666230404114911

Nutr Health. 2023 Apr 6:2601060231166036. doi: 10.1177/02601060231166036. Online ahead of print.

ABSTRACT

AIM: To evaluate the association between sociodemographic factors and screen exposure during meals with the consumption of dietary markers in children treated at a university hospital in Rio de Janeiro.

METHODS: Cross-sectional study with children of both sexes between 2 and 9 years of age. Food consumption and screen exposure were assessed using specific forms. The socio-demographic data evaluated were age, maternal education, household composition, receipt of government benefits, and household food and nutrition security. The statistical analysis included simple and multivariate logistic regression with a confidence interval of 95%.

RESULTS: Among the 129 children evaluated, most of them were of preschool age (57.4%), 71.3% received some type of government benefit, and 69.8% ate meals in front of screens. Among the markers of a healthy diet, beans (86.0%) and fresh fruits (69.8%) were the most consumed, while among the markers of an unhealthy diet, the most common components were sweetened beverages (61.7%) and cookies, candies, or other sweets (54.7%). There was a higher consumption of sweetened beverages among the children whose families received a government benefit (OR 2.63; 95% CI: 1.13-6.13) and who were exposed to a screen during meals (2.27; 95% CI: 1.01-5, 14).

CONCLUSION: This study showed that in view of the high frequency of consumption of unhealthy foods and screen exposure during meals, it is imperative that food and nutrition education actions are taken to promote an adequate and healthy food environment in childhood.

PMID:37021415 | DOI:10.1177/02601060231166036

J Gerontol A Biol Sci Med Sci. 2023 Apr 6:glad099. doi: 10.1093/gerona/glad099. Online ahead of print.

ABSTRACT

BACKGROUND: Almost 60% of adults with amnestic mild cognitive impairment (aMCI) have obstructive sleep apnea (OSA). Treatment with continuous positive airway pressure (CPAP) may delay cognitive decline, but CPAP adherence is often suboptimal. In this study we report predictors of CPAP adherence in older adults with aMCI who have increased odds of progressing to dementia, particularly due to Alzheimer’s disease.

METHODS: The data are from Memories 2, “Changing the Trajectory of Mild Cognitive Impairment with CPAP Treatment of Obstructive Sleep Apnea”. Participants had moderate to severe OSA, were CPAP naïve, and received a telehealth CPAP adherence intervention. Linear and logistic regression models examined predictors.

RESULTS: The 174 participants (mean age 67.08 years, 80 Female, 38 Black persons) had a mean apnea-hypopnea index of 34.78, and 73.6% were adherent, defined as an average of ≥ 4 hours of CPAP use per night. Only 18 (47.4%) Black persons were CPAP adherent. In linear models, White race, moderate OSA, and participation in the tailored CPAP adherence intervention were significantly associated with higher CPAP use at 3 months. In logistic models, White persons had 9.94 times the odds of adhering to CPAP compared to Black persons. Age, sex, ethnicity, education, body mass index, nighttime sleep duration, daytime sleepiness, and cognitive status were not significant predictors.

CONCLUSIONS: Older patients with aMCI have high CPAP adherence, suggesting that age and cognitive impairment should not be a barrier to prescribing CPAP. Research is needed to improve adherence in Black patients, perhaps through culturally tailored interventions.

PMID:37021413 | DOI:10.1093/gerona/glad099

Europace. 2023 Apr 6:euad086. doi: 10.1093/europace/euad086. Online ahead of print.

ABSTRACT

AIMS: The development of intracardiac echocardiography (ICE) has enabled fluoroless atrial fibrillation (AF) ablation using three-dimensional electroanatomical mapping systems. However, fluoroless cryoballoon ablation (CBA) remains challenging, mainly because of the lack of a visual mapping system. Hence, this study aimed to investigate the safety and efficacy of fluoroless CBA for AF under ICE guidance.

METHODS AND RESULTS: Patients (n = 100) who underwent CBA for paroxysmal AF were randomly assigned to zero-fluoroscopic (Zero-X) and conventional groups. Intracardiac echocardiography was used to guide the transseptal puncture and catheter and balloon manipulation in all enrolled patients. The patients were prospectively followed for 12 months after CBA. The mean age was 60.4 years, and the left atrial (LA) size was 39.4 mm. Pulmonary vein isolation (PVI) was achieved in all patients. In the Zero-X group, fluoroscopy was used in only one patient because of unstable phrenic nerve capture during right-sided PVI. The procedure time and LA indwelling time in the Zero-X group were not statistically different compared with that in the conventional group. Fluoroscopic time (9.0 vs. 0.008 min) and radiation exposure (29.4 vs. 0.02 mGy) were significantly shorter in the Zero-X group than in the conventional group (P < 0.001). The complication rate did not differ between the two groups. During a mean follow-up of 663.3 ± 172.3 days, the recurrence rate was similar (16.0 vs. 18.0%; P = 0.841) between the groups. Multivariate analysis revealed that LA size was the only independent predictor of clinical recurrence.

CONCLUSION: Intracardiac echocardiography-guided fluoroless CBA for AF was a feasible strategy without compromising acute and long-term success or complication rates.

PMID:37021403 | DOI:10.1093/europace/euad086

Foot Ankle Spec. 2023 Apr 5:19386400231162409. doi: 10.1177/19386400231162409. Online ahead of print.

ABSTRACT

BACKGROUND: Given the lack of objective data on opioid use and the difficulty of addressing a patient’s postoperative pain, we sought to quantify patient’s narcotic use after hallux valgus surgery. The purpose of our study was to determine the average quantity and type of postoperative opioids consumed after hallux valgus surgery and to assess potential predictive factors for increased opioid consumption.

METHODS: At the preoperative visit, patients were consented and completed a demographical questionnaire. Data were collected from the operative record, 2, 6, and 12-week postoperative visits. Type and number of pills prescribed were recorded as well as number of pills consumed at each postoperative visit. A logistic regression was performed to determine the average quantity consumed postoperatively and any statistically significant correlations.

RESULTS: The average number of opioid pills collectively consumed at the 2-week and 12-week postoperative visit was 20 and 23, respectively. At the 2-week postoperative visit, only patient body mass index (BMI) showed a correlation with increased opioid use.

CONCLUSION: Patients consumed an average of 23 of 40 (57.5%) narcotic pain pills prescribed after hallux valgus reconstruction surgery through the 12-week postoperative period. Owing to the opioid epidemic and potential for narcotic diversion, surgeons should counsel their patients on proper nonopioid postoperative pain management.

LEVEL OF EVIDENCE: II Therapeutic.

PMID:37021374 | DOI:10.1177/19386400231162409

Global Spine J. 2023 Apr 5:21925682231166324. doi: 10.1177/21925682231166324. Online ahead of print.

ABSTRACT

STUDY DESIGN: A retrospective case-control study.

OBJECTIVE: This study aimed to compare the effects of the Wiltse approach of pedicle screw fixation (PSF) either in combination with or without vertebroplasty (VP) in the treatment of Genant III degree osteoporotic thoracolumbar fractures (Genant III-OTLFs).

METHODS: A retrospective study of Genant III-OTLFs was performed from January 2018 to December 2019, including 54 cases of PSF + VP and 56 cases of PSF. Clinical indicators [visual analog scale (VAS) score, Oswestry disability index (ODI)], radiographic parameters [local kyphosis angle (LKA), percentage of anterior, central, and posterior vertebral heights (AVH%, CVH%, and PVH%, respectively)] and follow-up complications [adjacent vertebral fracture (AVF), residual pain (RP), vertebral height loss (VHL), and internal fixation failure (IFF)] were compared between the 2 groups.

RESULTS: No differences in surgical outcomes, clinical indicators, and radiographic parameters were observed between the 2 groups during the preoperation period and 7 days post-operatively (P > .05). However, the VAS score [2.0 (.6), 1.9 (.5)], ODI [23.7 (4.0), 22.6 (3.0)], LKA [9.5 (1.8), 10.6 (3.0)], AVH% [90.1 (2.7), 87.7 (6.0)], CVH% [92.5 (2.6), 91.3 (3.7)], and PVH% [93.4 (2.0), 92.7 (2.4)] at 1 year post-operatively and last follow-up of the PSF + VP group were better than those of the PSF group [2.5 (.8), 3.1 (1.1), 26.6 (3.8), 29.6 (4.6), 12.2 (1.6), 16.6 (3.2), 84.9 (4.0), 69.9 (6.6), 88.1 (3.1), 78.2 (5.1), 89.7 (2.3), 84.8 (4.6)], respectively (P < .001). During follow-up, the incidence of AVF had no difference (P > .05), while that of RP (32.1 vs 14.8%), VHL (33.9 vs 9.3%) and IFF (17.9 vs 5.6%) had statistical differences between them (P < .05).

CONCLUSION: The Wiltse approach of PSF combined with VP for Genant III-OTLFs can not only effectively relieve pain, restore vertebral height, and correcte kyphosis, but also better maintain vertebral height, delay kyphosis progression, and reduce complications during follow-up.

PMID:37021369 | DOI:10.1177/21925682231166324

Comput Methods Biomech Biomed Engin. 2023 Apr 5:1-17. doi: 10.1080/10255842.2023.2194474. Online ahead of print.

ABSTRACT

Recent research has shown that individuals suffering from COVID-19 are accommodating an elevated level of blood viscosity due to the morphological changes in blood cells. As viscosity is a major flow parameter influencing the flow across a stenosis or an aneurysm, the examination of the significance of hyperviscosity in COVID patients is imperative in arterial pathologies. In this research, we have considered a patient-specific case in which the aneurysm is located along the abdominal aortal walls. Recent research on the side effects of COVID-19 voiced out the various effects on the circulatory system of humans. Also, as abdominal aneurysms exist very often among individuals, causing the death of 150-200 million every year, the hyper-viscous effects of blood on the flow across the diseased aorta are explored by considering the elevated viscosity levels. In vitro explorations contribute considerably to the clinical methods and treatments to be regarded. The objective of the present inquest is to research the flow field in aneurysmatic-COVID-affected patients considering the elastic nature of vessel walls, using the arbitrary Lagrangian-Eulerian approach. The study supports the various clinical findings that voiced the detrimental effects associated with blood hyperviscosity. The simulation results obtained, by solving the fluid mechanics’ equations coupled with the solid mechanics’ equations, employing a FEM solver suggest that the elevated stress imparted by the hyper-viscous flows on the walls of the aneurysmal aorta can trigger the fastening of the aneurysmal sac enlargement or rupture.

PMID:37021363 | DOI:10.1080/10255842.2023.2194474

Stat Med. 2023 Apr 5. doi: 10.1002/sim.9734. Online ahead of print.

ABSTRACT

In adaptive clinical trials, the conventional end-of-trial point estimate of a treatment effect is prone to bias, that is, a systematic tendency to deviate from its true value. As stated in recent FDA guidance on adaptive designs, it is desirable to report estimates of treatment effects that reduce or remove this bias. However, it may be unclear which of the available estimators are preferable, and their use remains rare in practice. This article is the second in a two-part series that studies the issue of bias in point estimation for adaptive trials. Part I provided a methodological review of approaches to remove or reduce the potential bias in point estimation for adaptive designs. In part II, we discuss how bias can affect standard estimators and assess the negative impact this can have. We review current practice for reporting point estimates and illustrate the computation of different estimators using a real adaptive trial example (including code), which we use as a basis for a simulation study. We show that while on average the values of these estimators can be similar, for a particular trial realization they can give noticeably different values for the estimated treatment effect. Finally, we propose guidelines for researchers around the choice of estimators and the reporting of estimates following an adaptive design. The issue of bias should be considered throughout the whole lifecycle of an adaptive design, with the estimation strategy prespecified in the statistical analysis plan. When available, unbiased or bias-reduced estimates are to be preferred.

PMID:37021359 | DOI:10.1002/sim.9734

Radiat Oncol. 2023 Apr 5;18(1):63. doi: 10.1186/s13014-023-02247-y.

ABSTRACT

BACKGROUND: To analysis the clinical outcomes of concurrent chemoradiotherapy (CCRT) alone based on 10-year results for loco-regionally advanced nasopharyngeal carcinoma (LANPC), so as to provide evidence for individualized treatment strategy and designing appropriate clinical trial for different risk LANPC patients.

METHODS: Consecutive patients with stage III-IVa (AJCC/UICC 8th) were enrolled in this study. All patients received radical intensity-modulated radiotherapy (IMRT) and concurrent cisplatin chemotherapy (CDDP). The hazard ratios (HRs) of death risk in patients with T3N0 was used as baseline, relative HRs were calculated by a Cox proportional hazard model to classify different death risk patients. Survival curves for the time-to-event endpoints were analyzed by the Kaplan-Meier method and compared using the log-rank test. All statistical tests were conducted at a two-sided level of significance of 0.05.

RESULTS: A total of 456 eligible patients were included. With 12-year median follow-up, 10-year overall survival (OS) was 76%. 10-year loco-regionally failure-free survival (LR-FFS), distant failure-free survival (D-FFS) and failure-free survival (FFS) were 72%, 73% and 70%, respectively. Based on the relative hazard ratios (HRs) of death risk, LANPC patients were classified into 3 subgroups, low-risk group (T1-2N2 and T3N0-1) contained 244 patients with HR < 2; medium-risk group (T3N2 and T4N0-1) contained 140 patients with HR of 2 – 5; high-risk group (T4N2 and T1-4N3) contained 72 patients with HR > 5. The 10-year OS for patients in low-, medium-, and high-risk group were 86%, 71% and 52%, respectively. Significantly differences of OS rates were found between each of the two groups (low-risk group vs. medium-risk group, P < 0.001; low-risk group vs. high-risk group, P < 0.001; and medium-risk group vs. high-risk group, P = 0.002, respectively). Grade 3-4 late toxicities included deafness/otitis (9%), xerostomia (4%), temporal lobe injury (5%), cranial neuropathy (4%), peripheral neuropathy (2%), soft tissue damage (2%) and trismus (1%).

CONCLUSIONS: Our classification criteria demonstrated that significant heterogeneity in death risk among TN substages for LANPC patients. IMRT plus CDDP alone maybe suitable for low-risk LANPC (T1-2N2 or T3N0-1), but not for medium- and high-risk patients. These prognostic groupings provide a practicable anatomic foundation to guide individualized treatment and select optimal targeting in the future clinical trials.

PMID:37020312 | DOI:10.1186/s13014-023-02247-y

J Orthop Surg Res. 2023 Apr 5;18(1):276. doi: 10.1186/s13018-023-03726-4.

ABSTRACT

BACKGROUND: Anterior cervical discectomy and fusion has been considered standard management for cervical myelopathy and radiculopathy. However, the option of using self-locking stand-alone cages or cage-with-plate in three-level anterior cervical discectomy and fusion still remains controversial. The aim of this study was to evaluate the clinical and imaging outcomes of the two procedures in multilevel anterior cervical discectomy and fusion.

METHODS: Sixty-seven patients who underwent three-level anterior cervical discectomy and fusion were enrolled in this study, of which 31 patients underwent surgery using self-locking stand-alone cages (group cage) and 36 patients using cage-with-plate (group plate). For the evaluation of clinical outcomes, modified Japanese Orthopedic Association scores, visual analogue scale for neck pain, neck disability index, Odom’s criteria and dysphagia status were measured. Imaging outcomes were evaluated by cervical sagittal angle, fusion segmental Cobb’s angle, fusion segmental height, range of motion, cage subsidence rate, fusion rate and adjacent segment degeneration. Statistical analyses were performed using the SPSS software (version 19.0).

RESULTS: Both groups showed improvement in modified Japanese Orthopedic Association scores, visual analogue scale for neck pain and neck disability index, after surgery, and there was no significant difference between the groups. The occurrence rate of dysphagia is significantly lower in the group cage compared with the group plate (p < 0.05). The postoperative cervical sagittal angle, fusion segmental Cobb’s angle, fusion segmental height and cage subsidence rate in the group plate were significantly superior to that in the group cage (p < 0.05). However, the rate of adjacent segment degeneration was significantly lower in the group cage compared with the group plate (p < 0.05). Both groups showed no significant difference in terms of fusion rate (p > 0.05).

CONCLUSIONS: The self-locking stand-alone cages are effective, reliable and safe in anterior cervical discectomy and fusion for the treatment of cervical myelopathy and radiculopathy. Self-locking stand-alone cages showed a significantly lower rate of dysphagia and adjacent segment degeneration, while anterior cervical cage-with-plate could provide stronger postoperative stability and maintain better cervical spine alignment.

PMID:37020306 | DOI:10.1186/s13018-023-03726-4