Adult Female Volunteers Research Articles

A structural modeling approach to determine the effects of orthorexia nervosa and social appearance anxiety on healthy lifestyle behaviors in young adults

Aims: The aim of this study is to examine the relationship between orthorexia nervosa (ON) and social appearance anxiety (SAA) and to investigate the effects of these variables on healthy lifestyle behaviors (HLB) in young adults aged 18-30 years. Methods: A total of 408 young adult male and female volunteers, with a mean age of 21.7±2.95 years, participated in this study. A structural model was proposed to examine the effects of SAA and ON on HLB. To assess how well the study variables represented the underlying components, we first evaluated a confirmatory measurement model. Subsequently, we analyzed a structural model that allowed for the examination of multiple regression equations involving several dependent variables. Results: SAA had a negative influence on HLB (std β=-0.673; t-value=-8.425), a significant negative relationship between ON, HLB was also promoted (std β=-0.554; t-value=-9.388). It was determined that there is a positive correlation between SAA, ON which is statistically significant (correlation coefficient=0.830; t-value=10.244). Conclusion: It is concluded that the individuals with high social appearance anxiety do not adopt healthy lifestyle behaviors and are more prone to orthorexia nervosa.

Clinical Assessment of Breast Cancer Resistance Protein (BCRP)-Mediated Drug-Drug Interactions of Sepiapterin with Curcumin and Rosuvastatin in Healthy Volunteers.

Sepiapterin, also known as PTC923 and CNSA-001, is a synthetic form of endogenous sepiapterin being developed as a novel oral treatment for phenylketonuria. Sepiapterin is a natural precursor of tetrahydrobiopterin (BH4) and, when orally administered, is converted to BH4 via the pterin salvage pathway. In vitro studies have demonstrated that both sepiapterin and BH4 are both substrates and inhibitors of the breast cancer resistance protein (BCRP) transporter. This phase I study investigated BCRP-mediated drug-drug interactions of sepiapterin as a victim and as a perpetrator. An open-label, fixed-sequence, four-period, crossover, single-dose study was conducted in adult male and female healthy volunteers (18-55 years of age). In a given treatment period, subjects received a single oral dose of sepiapterin (20 mg/kg), sepiapterin (20 mg/kg) plus curcumin (2 g), rosuvastatin (10 mg), or rosuvastatin (10 mg) plus sepiapterin (60 mg/kg). The pharmacokinetics of sepiapterin, its metabolite BH4, and rosuvastatin were studied, and geometric mean ratios of exposures in the presence and absence of the BCRP inhibitor curcumin or sepiapterin were estimated. The presence of the BCRP c.421C>A polymorphism was evaluated in all subjects. A total of 29 subjects were enrolled and included in the safety analysis. Among them, 26 subjects were included in the pharmacokinetic and drug-drug interaction analyses. Following oral administration20 mg/kg sepiapterin, sepiapterin was rapidly and extensively converted to BH4, and BH4 maximum observed concentration (415.0 ng/mL) was observed 4.95 h (time to maximum observed concentration) post-dose. Sepiapterin maximum observed concentration and area under the concentration-time curve from time 0 to time of the last quantifiable measurement or the last sample collection time (AUClast) were <1% of BH4 values. Coadministration of the BCRP inhibitor curcumin (2 g) increased BH4 maximum observed concentration, AUClast, and area under the concentration-time curve from time 0 extrapolated to infinity by 24%, 21%, and 20%, respectively. When sepiapterin was coadministered with the BCRP substrate rosuvastatin, there was no effect on the pharmacokinetics of rosuvastatin. BCRP c.421C/A carriers (n = 4) had higher plasma exposures of BH4 (1.39 × for AUClast) and rosuvastatin (1.61 × for AUClast) than c.421C/C carriers (n = 22). Greater increases in BH4 exposures (1.33 vs 1.18 for AUClast) were observed in c.421C/A carriers compared with c.421C/C carriers when sepiapterin was coadministered with curcumin. All treatments were well tolerated during the study. Oral coadministration of the BCRP inhibitor curcumin slightly increased the plasma exposure of sepiapterin and its metabolite BH4 in healthy volunteers. This modest increase was deemed not clinically meaningful. Sepiapterin did not alter the pharmacokinetics of the BCRP substrate rosuvastatin.

Pharmacokinetics and bioequivalence of the generic and original dabigatran etexilate after a single dose in healthy volunteers

Aim. To study the comparative pharmacokinetics and confirmation of bioequivalence of the generic (T) and original (R) dabigatran etexilate in healthy volunteers after a single oral dose under fasted conditions.Material and methods. To confirm bioequivalence, an open-label, randomized, replication, crossover, four-step study was conducted to compare the pharmacokinetics and bioequivalence of generic and original dabigatran with a single oral dose 150 mg dabigatran etexilate under fasted conditions in adult healthy male and female volunteers. Sixty-eight subjects participated in the study. During the study, blood plasma samples were taken from volunteers, in which the concentration of total and free dabigatran was determined. Based on the data obtained, pharmacokinetic and statistical analysis was carried out and 90% confidence intervals were calculated for the ratio of mean pharmacokinetic parameters (Сmax, Tmax, AUC0-t, AUC0-∞, AUCt-∞, T1/2, AUCt-∞/AUC0-∞) for total and free dabigatran.Results. The established 90% confidence intervals for the ratio of AUC0-t, AUC0-∞ and Cmax values for total dabigatran were 82,56-96,36% (mean ratio, 89,19%), 82,39-95,90% (mean ratio, 88,89%) and 85,98-99,17% (mean ratio, 92,34%), respectively. The established 90% confidence intervals for the ratio of AUC0-t, AUC0-∞ and Сmax values for free dabigatran were 83,37-98,29% (mean ratio, 90,53%), 82,98-97,33% (mean ratio, 89,87%) and 85,04-99,28% (mean ratio, 91,88%), respectively. For the estimated pharmacokinetic parameters of dabigatran etexilate, 90% confidence intervals ranged from 80-125% for AUC0-t, AUC0-∞ and Cmax. Additional safety analysis was carried out. Generic and original dabigatran were well tolerated by the volunteers. There were no significant differences in vital signs, paraclinical characteristics throughout the study compared with the initial data, as well as significant differences between the drugs in all studied parameters of adverse events.Conclusion. The study showed that generic and original dabigatran are bio­equivalent. In addition, the data obtained indicate that the agents have similar safety profiles.

Expanding the Frontiers of nail product evaluation: Novel application of differential scanning calorimetry (DSC) for assessing crosslinking density and predicting nail brittleness and flexibility.

While modern industry advancements have expanded nail beautification options, scientific literature primarily focuses on nail biology and medicine, with limited attention on cosmetic treatments. This study aimed to investigate human nail denaturation properties, including gender impact, blending nails to enlarge the sample pool, nail sensitization through bleaching, and active effectiveness testing. The objective was to understand the DSC and bending fatigue relationship, and define the consumer relevance of the DSC test. Nail clippings were collected from adult female and male volunteers. The wet DSC was employed to validate sample preparation, explore the effects of gender, and assess the potential of using blended nails for claims substantiation testing. Nails were sensitized through bleaching using hydrogen peroxide. The effects were confirmed through DSC and nail flexure tests. Furthermore, the ability of actives to address concerns related to nail softness and brittleness was assessed using these techniques. The results confirmed the viability of equilibrating nails in water for up to 14 h as a standardized testing method. The denaturation temperature results were independent of gender and suitable for claims substantiation testing. Blending nails from different sources did not yield significant variations in denaturation properties. A preliminary study suggested that cadaver nails should be used with caution because they exhibited differences in denaturation temperature, influenced by the sampling location. Bending fatigue tests highlighted the significance of humidity, with higher humidity conditions (80%) enhancing nail flexibility and providing better resolution for claims substantiation. Sensitizing the nails with hydrogen peroxide induced alterations in both DSC and bending fatigue results. Proof-of-principle studies demonstrated an elevation in denaturation temperature and a decrease in the number of cycles to break, indicating a nail-hardening effect when formaldehyde was applied. The use of a nail softener led to an enhancement in nail fatigue resistance due to a notable reduction in nail crosslinking density. The measurement of crosslinking density proved to be a sensitive tool for assessing the effects of cosmetic treatments on nails, particularly in predicting outcomes related to nail brittleness and flexibility.

Exploratory study of cold hypersensitivity in Japanese women: genetic associations and somatic symptom burden

Temperature perception is essential for humans to discern the environment and maintain homeostasis. However, some individuals experience cold hypersensitivity, characterized by a subjective feeling of coldness despite ambient environmental temperatures being normal, the underlying mechanisms of which are unknown. In this study, we aimed to investigate the relationship between subjective cold symptoms and somatic burden or single nucleotide polymorphisms to understand the causes of cold hypersensitivity. We conducted an online questionnaire survey [comprising 30 questions, including past medical history, subjective symptoms of cold hypersensitivity, and the Somatic Symptom Scale-8 (SSS-8)]. Respondents were 1200 Japanese adult female volunteers (age: 20–59 years), recruited between April 21 and May 25, 2022, who were customers of MYCODE, a personal genome service in Japan. Among the 1111 participants, 599 (54%) reported cold hypersensitivity. Higher cold hypersensitivity severity was positively associated with the SSS-8 scores. Additionally, a genome-wide association study for cold hypersensitivity was conducted using array-based genomic data obtained from genetic testing. We identified 11 lead variants showing suggestive associations (P < 1 × 10–5) with cold hypersensitivity, some of which showed a reasonable change in expression in specific tissues in the Genotype-Tissue Expression database. The study findings shed light on the underlying causes of cold hypersensitivity.

Application of Machine Learning to Ultrasonography in Identifying Anatomical Landmarks for Cricothyroidotomy Among Female Adults: A Multi-center Prospective Observational Study

We aimed to develop machine learning (ML)-based algorithms to assist physicians in ultrasound-guided localization of cricoid cartilage (CC) and thyroid cartilage (TC) in cricothyroidotomy. Adult female volunteers were prospectively recruited from two hospitals between September and December, 2020. Ultrasonographic images were collected via a modified longitudinal technique. You Only Look Once (YOLOv5s), Faster Regions with Convolutional Neural Network features (Faster R-CNN), and Single Shot Detector (SSD) were selected as the model architectures. A total of 488 women (mean age: 36.0 years) participated in the study, contributing to a total of 292,053 frames of ultrasonographic images. The derived ML-based algorithms demonstrated excellent discriminative performance for the presence of CC (area under the receiver operating characteristic curve [AUC]: YOLOv5s, 0.989, 95% confidence interval [CI]: 0.982–0.994; Faster R-CNN, 0.986, 95% CI: 0.980–0.991; SSD, 0.968, 95% CI: 0.956–0.977) and TC (AUC: YOLOv5s, 0.989, 95% CI: 0.977–0.997; Faster R-CNN, 0.981, 95% CI: 0.965–0.991; SSD, 0.982, 95% CI: 0.973–0.990). Furthermore, in the frames where the model could correctly indicate the presence of CC or TC, it also accurately localized CC (intersection-over-union: YOLOv5s, 0.753, 95% CI: 0.739–0.765; Faster R-CNN, 0.720, 95% CI: 0.709–0.732; SSD, 0.739, 95% CI: 0.726–0.751) or TC (intersection-over-union: YOLOv5s, 0.739, 95% CI: 0.722–0.755; Faster R-CNN, 0.709, 95% CI: 0.687–0.730; SSD, 0.713, 95% CI: 0.695–0.730). The ML-based algorithms could identify anatomical landmarks for cricothyroidotomy in adult females with favorable discriminative and localization performance. Further studies are warranted to transfer this algorithm to hand-held portable ultrasound devices for clinical use.

The effects of endurance physical exercise with fat-free milk intake as a therapy for metabolic syndrome and/or sarcopenia

Background: Nutrition and exercise are important factors for addressing metabolic syndrome and sarcopenia as they are related to insulin secretion. Proteins, particularly branched-chain amino acids (BCAAs), have insulinotropic effects, while exercise reduces insulin secretion. It is thus important to investigate the effects of protein intake and exercise alone and in combination to determine suitable dietary and exercise therapies for treating metabolic syndrome and sarcopenia. Methods: Eight healthy young adult female volunteers participated in a crossover trial consisting of two 5-day experiments. Days 1 and 2 comprised a body-weight-maintained adjustment period during which the participants consumed control diets (energy, 2,010 kcal; protein, 51.9 g). Days 3 to 5 comprised the treatment period during which the participants consumed experimental diets (energy, 2,010 kcal; protein 82.3 g) containing 402 kcal of fat-free milk, and either performed only normal daily activities (non-Ex) or performed normal daily activities and exercised on a bicycle with an ergometer at a target intensity of about 50% of the maximal oxygen intake, expending 402 kcal of additional energy (Ex). Total urine samples were collected during the daytime (6:45 to 18:45) and nighttime (18:45 to 6:45 the next morning). Fasting blood samples were collected early in the morning before and after the treatment period. Results: Plasma valine, leucine, and BCAA levels were significantly elevated after both the non-Ex and Ex periods. Serum insulin levels were significantly elevated only after the non-Ex period. Urinary C-peptide immunoreactivity excretion levels increased significantly during the non-Ex period, but they decreased significantly during the Ex period. After the Ex period, the serum triglyceride and remnant lipoprotein-cholesterol (RLP-C) levels were significantly decreased. Homeostatic model assessment for insulin resistance (HOMA-IR) and atherosclerosis index (AI) values were slightly, yet significantly, increased after the non-Ex period, but were unchanged after the Ex period. The degree of change (Δ) in the RLP-C level significantly and positively correlated with the Δ HOMA-IR and Δ AI.

Identification and Analysis of Human-Exoskeleton Coupling Parameters in Lower Extremities.

This paper proposed linear and non-linear models for predicting human-exoskeleton coupling forces to enhance the studies of human-exoskeleton coupling dynamics. Then the parameters of these models were identified with a newly designed platform and the help of ten adult male and ten adult female volunteers (Age: 23.65 ±4.03 years, Height: 165.60 ±8.32 mm, Weight: 62.35 ±14.09 kg). Comparing the coupling force error predicted by the models with experimental measurements, one obtained a more accurate and robust prediction of the coupling forces with the non-linear model. Moreover, statistical analysis of the experimental data was performed to reveal the correlation between the coupling parameters and coupling positions and looseness. Finally, backpropagation (BP) neural network and Gaussian Process Regression (GPR) were used to predict the human-exoskeleton coupling parameters. The significance of each input parameter to the human-exoskeleton coupling parameters was assessed by analyzing the sensitivity of GPR performance to its inputs. The novelty and contribution are the establishment of the non-linear coupling model, the design of the coupling experimental platform and a regression model which provides a possibility to obtain human-exoskeleton without experimental measurement and identification. Based on this work, one can optimize control algorithm and design comfortable human-exoskeleton interaction.

Investigation of the Validity and Reliability of Two Smart Bands Selected That Count Steps at Different Walking Speed

Whether activity monitor smart wristbands that have become widespread can accurately estimate the step count while walking is a matter of curiosity. The current study aims to analyze the validity and reliability of step count (SC) estimation at normal walking and fast walking pace under controlled conditions of two selected smart wristbands of the leading wearable device vendors, Xiaomi (Mi4) and Huawei (H4). Twenty healthy adult male and twenty healthy adult female were included in the study and analyzed separately. The mean age of male and female participants was 22.25 and 21.62 years, with BMI values of 24.22 kg/m2 and 21.42 kg/m2, respectively. The above-ground walking protocol consisted of four separate five-minute tests: Normal Walking Test, Normal Walking Retest, Fast Walking Test, and Fast Walking Retest. In the study, the analyses were performed by using activity monitor measurements and criterion measurements (the number of steps determined from video recordings), compatibility of test-retest measurement values, error indicators (MPE and MAPE), Intraclass Correlation Coefficients (ICC), and Bland-Altman limits of agreement. According to the current study results, it was revealed that the MAPE values recorded for Mi4 and H4 smart wristbands for both normal and fast walking pace in male and female participants were &amp;lt;5%, which was deemed excellent. According to all analyses, the H4 device was found to be valid and reliable, but according to ICC and Pearson Correlation analyses, the Mi4 device was not found to be valid and reliable at fast walking pace.

A two-week exercise intervention improves cold symptoms and sleep condition in cold-sensitive women

BackgroundWe examined whether an aerobic exercise intervention in young women with cold sensitivity symptoms improves sleep quality and decreases cold complaints. Furthermore, we examined the association with increased foot skin temperature (Tsk) before falling asleep and decrease in sensitivity to cold in the brain.MethodsWe recruited 16 female adult volunteers who had cold sensitivity and were not engaged in daily exercise training, and they were divided into an exercise group (EXE) and a control group (CON). EXE was given a 2-week exercise intervention that consisted mainly of walking and jogging. Before and after the intervention, temperature sensation and body temperature parameters were measured just before bedtime; electroencephalogram measurements were taken during sleep; and subjective sleep surveys, including Oguri-Shirakawa-Azumi (OSA) sleep inventory (middle-aged and aged version) and visual analogue scale (VAS), were conducted immediately after waking up. All experiments were performed in the winter season.ResultsIn EXE, overall and foot warmth and comfort increased (p < 0.05) after the 2-week exercise intervention. The exercise intervention also decreased (p < 0.05) the scores for cold feeling in the fingertips, feet, and toes. In the OSA sleep inventory, factor IV (refreshing) and factor V (sleep length) were increased (p < 0.05) by the exercise intervention. Subjective sleep quality evaluated by VAS increased (p < 0.05) with exercise intervention. The exercise intervention in EXE shortened middle awake time after sleep onset (p < 0.05) and prolonged deep sleep length (p < 0.05). The exercise intervention increased (p < 0.05) alpha-wave power before sleep. In CON, all variables remained unchanged throughout the 2-week control period.ConclusionShort-term aerobic exercise alleviated peripheral extremity cold sensitivity symptoms and improved subjective sleep quality. Our findings suggest that these improvements were not due to increased Tsk at rest before bedtime but to decreased sensitivity to cold in the brain that was expressed as increased alpha activity.

A Study of Parasympathetic Autonomic Function in Different Phases of the Menstrual Cycle among Young Adult Females

Background: The sex hormones, estrogen, and progesterone, as well as the gonadotropins, luteinizing hormone, and follicle-stimulating hormone produced from the anterior pituitary, govern the three stages of the menstrual cycle: menstrual, follicular, and luteal. Hormone fluctuations cause changes in autonomic function. There have been relatively few studies that show autonomic function modification throughout various periods of the menstrual cycle. Aim and Objectives: The current study was undertaken to investigate the difference in mean parasympathetic autonomic characteristics between the proliferative and secretory stages of the menstrual cycle. Materials and Methods: A total of 120 healthy young adult female volunteers were recruited among Kalinga Institute of Medical Sciences, Kalinga Institute of Nursing Sciences, and Kalinga Institute of Dental Sciences students. The study eliminated 20 students who were in the bleeding phase of their cycle. The electrocardiogram was captured, and parasympathetic parameters were determined using the fully automated CANWin instrument in the Department of Physiology. The data of the abovementioned parameters were compiled, tabulated, and entered into Microsoft Excel 2013 and statistically analyzed using STATA software 15.1. Results: The subjects’ mean ages, heights, and weights were 18.9 ± 0.70 years, 156.6 ± 5.25 cm, and 53.7 ± 8.63 kg, respectively. The mean resting heart rate in the secretory phase was substantially greater than in the proliferative phase, indicating sympathetic dominance. The 30:15 ratio between proliferative and secretory stages. The mean E: I ratio calculated from the slow deep breathing maneuver reveals a statistically significant difference between the proliferative and secretory phases. Conclusion: During the secretory phase, there is a considerable rise in parasympathetic activity among the individuals in the current study. Changes in parasympathetic activity throughout the follicular and secretory stages of the menstrual cycle may be caused by fluctuations in estrogen and progesterone levels.

The Comparative Bioavailability of Fluticasone and Azelastine Delivered as a Single Fixed Dose Combination (MP-AzeFlu) in Comparison to Two Different Formulations of Azelastine and Fluticasone Propionate Following Intranasal Administration in Healthy Chinese Volunteers.

Two studies (Study I and Study II) were conducted in healthy Chinese volunteers to confirm that there was no pharmacokinetic drug interaction between AZE and FLU in MP-AzeFlu. The secondary objective was to evaluate the pharmacokinetic parameters of MP-AzeFlu compared with the commercially available mono-components. Both studies were a randomized, open-label, three-period, six-sequence, single-dose cross-over trial (William's design) conducted at Beijing Hospital (Beijing, China) in September and October of 2019 in 30 healthy adult male and female volunteers. The natural log transformed parameters: AUC0-tlast, AUC0-∞ and Cmax were analyzed. The comparison of PK parameters between MP-AzeFlu and Aze (commercially available) showed that the LS mean ratios (90% CI) values for, AUC0-tlast, AUC 0-∞ and Cmax were 100.29% (94.31-106.66%), 100.76% (94.60-107.32%) and 93.14% (81.47-106.48%). The comparison of PK parameters between MP-AzeFlu and Flu (commercially available) for the bioavailability evaluation showed that the LS mean ratios (90% CI) values for, AUC0-tlast, AUC 0-∞ and Cmax were 83.48% (69.81-99.82%), 100.19% (87.34-114.94%) and 81.91% (68.50-97.95%). The study results confirm that neither the FLU or the AZE component in the combination product (MP-AzeFlu), nor the existing qualitative and quantitative differences in the formulation between the currently marketed AZE and FLU mono-product, display significant potential to impact the systemic exposure of AZE or FLU in Chinese subjects.

A Bioequivalence Study of Allergostin® Compared to Administration of Kestin® in Healthy Volunteers

Relevance. International non-proprietary name (INN) Ebastin is widely used in medical practice in the treatment of urticaria and allergic rhinitis. It is an antiallergic drug, which belongs to the second generation of H1-histamine receptor blocker, it is necessary to emphasize that Ebastin is effective when taken orally. As part of the registration of trade name Allergostin, a clinical study of its bioequivalence with Kestin was conducted with the participation of 26 healthy volunteers.&#x0D; Aim. The aim of this publication is summarize results of the clinical study of the comparative pharmacokinetics and bioequivalence, safety and tolerability of Allergostin, film-coated tablets, 20 mg (NTFF POLYSAN LLC, Russia), and Kestin, film-coated tablets, 20 mg (Almiral S.A., Spain), in healthy volunteers after a single oral dose on an empty stomach.&#x0D; Materials and methods. To confirm bioequivalence, an open, randomized, two-period, cross-over study of comparative pharmacokinetics and bioequivalence of drugs with a single oral intake on an empty stomach in adult healthy male and female volunteers was conducted. During the study, blood plasma samples were taken from volunteers. Each sample was tested by using a validated high performance liquid chromatography with tandem mass spectrometry method, the concentrations of ebastine and the active metabolite carabastin were determined. Based on obtained data , pharmacokinetic and statistical analysis was carried out, 90% confidence intervals (CI) were calculated for the ratio of the geometric mean values of the pharmacokinetic parameters Cmax and AUC0-72 for carabastin.&#x0D; Results. Based on results of statistical analysis, it was shown that the pharmacokinetic parameters of the test (Allergostin) and reference (Kestin) drug are characterized by high similarity. For the estimated pharmacokinetic parameters of carabastin, 90% CI ranged from 80-125% for AUC0-t and Cmax.&#x0D; Conclusion. Thus, according to the applied criteria, the drugs are recognized as bioequivalent.

A phase-I, open label clinical trial to assess the safety & tolerability of qHPV vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults

BackgroundThis first in human study was designed as an open label clinical trial to assess safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) quadrivalent HPV (qHPV) vaccine. MethodsA total of 48 healthy male and female (24 each) adult volunteers were administered a 0.5 ml single dose of SIIPL qHPV vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events. Results47 subjects completed the study in compliance with protocol. One subject had pain immediately after immunization which was recovered without treatment. None of the participants experienced any other local or systemic solicited AEs and serious AE. ConclusionqHPV vaccine manufactured by SIIPL was found to be safe and well tolerable in adults. Further clinical development should continue to assess safety and immunogenicity, in the target population following recommended 2 and 3-dose schedule.Clinical Trial Registration – CTRI/2017/02/007785.

Differences between brain responses to peroneal electrical transcutaneous neuromodulation and transcutaneous tibial nerve stimulation, two treatments for overactive bladder.

To compare brain responses to peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) and transcutaneous tibial nerve stimulation (TTNS), two methods for treating overactive bladder (OAB), using functional magnetic resonance imaging (fMRI). The present study was not designed to compare their clinical efficacy. This study included 32 healthy adult female volunteers (average age 38.3 years (range 22-73)). Brain MRI using 3 T scanner was performed during three 8-min blocks of alternating sequences. During each 8-min block, the protocol alternated between sham stimulation (30 s) and rest (30 s) for 8 repeats; then peroneal eTNM® stimulation (30 s) and rest (30 s) for 8 repeats; then, TTNS stimulation (30 s) and rest (30 s) for 8 repeats. Statistical analysis was performed at the individual level with a threshold of p = 0.05, family-wise error (FWE)-corrected. The resulting individual statistical maps were analyzed in group statistics using a one-sample t-test, p = 0.05 threshold, false discovery rate (FDR)-corrected. During peroneal eTNM®, TTNS, and sham stimulations, we recorded activation in the brainstem, bilateral posterior insula, bilateral precentral gyrus, bilateral postcentral gyrus, left transverse temporal gyrus, and right supramarginal gyrus. During both peroneal eTNM® and TTNS stimulations, but not sham stimulations, we recorded activation in the left cerebellum, right transverse temporal gyrus, right middle frontal gyrus, and right inferior frontal gyrus. Exclusively during peroneal eTNM® stimulation, we observed activation in the right cerebellum, right thalamus, bilateral basal ganglia, bilateral cingulate gyrus, right anterior insula, right central operculum, bilateral supplementary motor cortex, bilateral superior temporal gyrus, and left inferior frontal gyrus. Peroneal eTNM®, but not TTNS, induces the activation of brain structures that were previously implicated in neural control of the of bladder filling and play an important role in the ability to cope with urgency. The therapeutic effect of peroneal eTNM® could be exerted, at least in part, at the supraspinal level of neural control.

The Relationship Between Health-Related Quality of Life and Lower-Extremity Visuomotor Reaction Time in Young Adult Women Following Ankle Sprain.

Many individuals who sustain a lateral ankle sprain (LAS) fail to return to prior activity due to residual symptoms; and report elevated levels of injury-related fear, decreased function, and decreased health-related quality of life (HRQOL). Additionally, individuals with history of LAS exhibit deficits in neurocognitive functional measures like visuomotor reaction time (VMRT), which contributes to worse patient-reported outcome scores. The aim of this study was to examine the relationship between HRQOL and lower-extremity (LE) VMRT in individuals with LAS history. Cross-sectional. Young adult female volunteers with history of LAS (n = 22; age = 24 [3.5]y; height = 163.1 [9.8]cm; mass = 65.1 [11.5]kg; and time since last LAS = 67.8 [50.5]mo) completed HRQOL outcomes including the following: (1)Tampa Scale of Kinesiophobia-11, (2)Fear-Avoidance Beliefs Questionnaire, (3)Penn State Worry Questionnaire, (4)modified Disablement in the Physically Active Scale, and (5)Foot and Ankle Disability Index (FADI). Additionally, participants completed a LE-VMRT task by responding to a visual stimulus using their foot to deactivate light sensors. Participants completed trials bilaterally. Separate Spearman rho correlations were performed to assess the relationship between patient-reported outcomes assessing constructs of HRQOL and LE-VRMT bilaterally. Significance was set at P < .05. There was a strong, significant negative correlation between FADI-Activities of Daily Living (ρ = -.68; P = .002) and FADI-Sport (ρ = -.76; P = .001) scores and injured limb LE-VMRT; moderate, significant negative correlations between the uninjured limb LE-VMRT and FADI-Activities of Daily Living (ρ = -.60; P = .01) and FADI-Sport (ρ = -.60; P = .01) scores; and moderate, significant positive correlations between the injured limb LE-VMRT and modified Disablement in the Physically Active Scale-Physical Summary Component (ρ = .52; P = .01) and modified Disablement in the Physically Active Scale-Total (ρ = .54; P = .02) scores. All other correlations were not statistically significant. Young adult women with history of LAS demonstrated an association between self-reported constructs of HRQOL and LE-VMRT. As LE-VMRT is a modifiable injury risk factor, future studies should examine the effectiveness of interventions designed to improve LE-VMRT and the impact on self-reported HRQOL.

GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers.

Growth hormone (GH) is an essential regulator of growth, body composition and fuel metabolism and, consequently, GH secretion is under the feedback control of numerous nutritional and endocrine mediators. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) have been shown to exert pleiotropic effects, including stimulation of the activity of the hypothalamic-pituitary-adrenal axis. As GLP-1RAs exert multiple metabolic effects, we hypothesised that they may also affect the secretion of GH and examined the effect of a short-acting and a long-acting GLP-1 RA on GH secretion. This is a post hoc analysis of data from clinical trials. Two separate single-group open-label clinical trials were carried out in the ambulatory care setting with a duration of 1 and 21days, respectively. Healthy adult male and female volunteers with no chronic illnesses or use of daily medicines were recruited for the study. The two interventions were: study 1, single dose of 10µg exenatide administered subcutaneously (s.c.); study 2, 0.6mg liraglutide administered s.c. once daily for 21days. Administration of a single dose of exenatide (study 1) caused a clear increase in GH levels, peaking between 60 and 120min post-administration. There was also a small but statistically significant decrease in luteinising hormone and testosterone levels 120min after exenatide dosing. Administration of the long-acting GLP-1RA liraglutide daily for 21 days (study 2) elicited an increase in GH levels with no change in insulin-like growth factor-1 (IGF-1) concentrations after 3weeks of treatment. The results show that the administration of GLP-1RAs may elicit an increase in growth hormone levels. GLP-1 signalling may be a novel mechanism of regulation of GH secretion. This finding needs to be replicated in the placebo-controlled trial. NCT02089256 and NCT03160261.

Pharmacokinetic Study of Intranasal Dexamethasone and Methylprednisolone Compared with Intravenous Administration: Two Open-Label, Single-Dose, Two-Period, Two-Sequence, Cross-Over Study in Healthy Volunteers

Dexamethasone (DXM) and methylprednisolone (MEP) are potent glucocorticoids used to control several inflammatory conditions. Evidence of delayed DXM reaching the central nervous system (CNS) as well as tachyphylaxis and systemic, undesirable side effects are the main limitations of peripheral delivery. Intranasal administration offers direct access to the brain as it bypasses the blood-brain barrier. The Mucosal Atomization Device is an optimal tool that can achieve rapid absorption into the CNS and the bloodstream across mucosal membranes. This study was designed to evaluate and compare the bioavailability of DXM and MEP after intranasal versus intravenous administration. Two open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover studies were conducted, which involved healthy male and female adult volunteers. After intranasal administration, DXM and MEP were detected in plasma after the first sampling time. Mean peak concentrations of DXM and MEP were 86.61 ng/mL at 60 min and 843.2 ng/mL at 1.5 h post-administration, respectively. DXM and MEP showed high absolute bioavailability, with values of 80% and 95%, respectively. No adverse effects were observed. DXM and MEP systemic bioavailability by intranasal administration was comparable with the intravenous one, suggesting that the intranasal route can be used as a non-invasive and appropriate alternative for systemic drug delivery.

The Experimental Study Effects of Coconut Milk and Egg White as A Pack to Enhance the Hair Health Among Adult Male and Female Volunteers

The Experimental Study Effects of Coconut Milk and Egg White as A Pack to Enhance the Hair Health Among Adult Male and Female Volunteers

A six-month study of anti-SARS-CoV-2 BNT162b2 mRNA vaccination: A comparative analysis of essential trace elements and anti-RBD IgG sera levels

BackgroundAlthough essential trace elements (ETEs) play pivotal roles in life-supporting biochemical processes, their function in innate and adaptive immunity has not been fully elucidated, particularly during immunization. Furthermore, the association between anti-SARS-CoV-2 specific IgG antibodies and ETE levels with vaccine responsiveness has not been investigated. MethodsThe present study explored the status of ETEs (Mn, Cu, Zn, and Se) in sera of healthy women before and after vaccination with the anti-SARS-CoV-2 BNT162b2 mRNA vaccine in a follow-up period of six months. The main aim was to explore links between ETE levels and IgG antibodies produced against Spike glycoprotein's Receptor-Binding Domain (RBD). ResultsA recombinant protein of SARS-CoV-2 comprising the receptor binding domain was successfully expressed in HEK-293 T cells. The purified protein was suitable for producing a sensitive antibody detection assay for human serum and monitored seropositivity, indicating a transient response with peak anti-SARS-CoV-2 IgG levels 2 months after vaccination. In parallel to increasing antibody titers, serum concentrations of Cu, Mn, and Se were not affected by vaccination, and concentrations remained relatively constant at the different sampling times during the 6-month observation period. Total serum Zn concentrations were slightly elevated when compared between the first and last sampling dates. Overall, no consistent effects of vaccination on any of the three trace elements analyzed in our study were observed. ConclusionVaccination of adult healthy female volunteers with an mRNA vaccine was not associated with consistent changes in serum trace element concentrations over a six-month observation period.