Healthy Female Volunteers Research Articles

Finite Element Analysis of Unilateral versus Bipedicular Bone-Filling Mesh Container for the Management of Osteoporotic Compression Fractures.

The effect of unilateral and bilateral bone-filling mesh containers (BFC) on osteoporotic vertebral compression fracture (OVCF) was analyzed by the finite element method. The CT scan data of the T12-L2 vertebral body were obtained from a healthy female volunteer with no history of lumbar spine injury or obvious abnormality of vertebral body morphology. The normal finite element model of the T12-L2 vertebral body and the finite element model of osteoporosis were established, and the models were validated. The L1 in the normal model of the vertebral body was used to simulate the vertebral compression fracture, after which the unilateral and bilateral BFC were simulated to establish models representing the two surgical approaches. We analyzed changes in the deformation and von Mises stress in vertebral bodies and intervertebral discs in the two models under seven working conditions (axial direction, anteflexion, rear protraction, left-side bending, right-side bending, left rotation, and right rotation) and found that the unilateral and bilateral approaches are biomechanically comparable, with no statistical difference between the two overall models.

Potential Molecular Biomarkers of Central Nervous System Damage in Breast Cancer Survivors.

Damage of the central nervous system (CNS), manifested by cognitive impairment, occurs in 80% of women with breast cancer (BC) as a complication of surgical treatment and radiochemotherapy. In this study, the levels of ICAM-1, PECAM-1, NSE, and anti-NR-2 antibodies which are associated with the damage of the CNS and the endothelium were measured in the blood by ELISA as potential biomarkers that might reflect pathogenetic mechanisms in these patients. A total of 102 patients enrolled in this single-center trial were divided into four groups: (1) 26 patients after breast cancer treatment, (2) 21 patients with chronic brain ischemia (CBI) and asymptomatic carotid stenosis (ICA stenosis) (CBI + ICA stenosis), (3) 35 patients with CBI but without asymptomatic carotid stenosis, and (4) 20 healthy female volunteers (control group). Intergroup analysis demonstrated that in the group of patients following BC treatment there was a significant increase of ICAM-1 (mean difference: −368.56, 95% CI −450.30 to −286.69, p < 0.001) and PECAM-1 (mean difference: −47.75, 95% CI −68.73 to −26.77, p < 0.001) molecules, as compared to the group of healthy volunteers. Additionally, a decrease of anti-NR-2 antibodies (mean difference: 0.89, 95% CI 0.41 to 1.48, p < 0.001) was detected. The intergroup comparison revealed comparable levels of ICAM-1 (mean difference: −33.58, 95% CI −58.10 to 125.26, p = 0.76), PECAM-1 (mean difference: −5.03, 95% CI −29.93 to 19.87, p = 0.95), as well as anti-NR-2 antibodies (mean difference: −0.05, 95% CI −0.26 to 0.16, p = 0.93) in patients after BC treatment and in patients with CBI + ICA stenosis. The NSE level in the group CBI + ICA stenosis was significantly higher than in women following BC treatment (mean difference: −43.64, 95% CI 3.31 to −83.99, p = 0.03). Comparable levels of ICAM-1 were also detected in patients after BC treatment and in the group of CBI (mean difference: −21.28, 95% CI −111.03 to 68.48, p = 0.92). The level of PECAM-1 molecules in patients after BC treatment was also comparable to group of CBI (mean difference: −13.68, 95% CI −35.51 to 8.15, p = 0.35). In conclusion, among other mechanisms, endothelial dysfunction might play a role in the damage of the CNS in breast cancer survivors.

BCG-induced trained immunity enhances acellular pertussis vaccination responses in an explorative randomized clinical trial

Acellular pertussis (aP) booster vaccines are central to pertussis immunization programs, although their effectiveness varies. The Bacille Calmette-Guérin (BCG) vaccine is a prototype inducer of trained immunity, which enhances immune responses to subsequent infections or vaccinations. While previous clinical studies have demonstrated that trained immunity can protect against heterologous infections, its effect on aP vaccines in humans is unknown. We conducted a clinical study in order to determine the immunological effects of trained immunity on pertussis vaccination. Healthy female volunteers were randomly assigned to either receive BCG followed by a booster dose of tetanus-diphteria-pertussis inactivated polio vaccine (Tdap-IPV) 3 months later (BCG-trained), BCG + Tdap-IPV concurrently, or Tdap-IPV followed by BCG 3 months later. Primary outcomes were pertussis-specific humoral, T- and B-cell responses and were quantified at baseline of Tdap-IPV vaccination and 2 weeks thereafter. As a secondary outcome in the BCG-trained cohort, ex vivo leukocyte responses were measured in response to unrelated stimuli before and after BCG vaccination. BCG vaccination 3 months prior to, but not concurrent with, Tdap-IPV improves pertussis-specific Th1-cell and humoral responses, and also increases total memory B cell responses. These responses were correlated with enhanced IL-6 and IL-1β production at the baseline of Tdap-IPV vaccination in the BCG-trained cohort. Our study demonstrates that prior BCG vaccination potentiates immune responses to pertussis vaccines and that biomarkers of trained immunity are the most reliable correlates of those responses.

Adhesion Molecules ICAM-1 and PECAM-1 as Potential Biomarkers of Central Nervous System Damage in Women Breast Cancer Survivors.

Breast cancer (BC) is the most common tumor in women worldwide with high mortality rates. Surgical methods followed by radio–chemotherapy are used to treat these tumors. Such treatment can lead to various side effects, including neurological complications. The development of a reliable biomarker to predict the onset of CNS complications could improve clinical outcomes. In the current study, ICAM-1 and PECAM-1 serum levels were measured as potential biomarkers in 45 female patients in a long-term follow-up period after breast cancer treatment, and compared to 25 age-matched female healthy volunteers. Serum levels of both biomarkers, ICAM-1 and PECAM-1 were significantly higher in patients after breast cancer treatment and could be associated with cognitive dysfunction, depression, and vestibulocerebellar ataxia. In conclusion, our results provide a first hint that elevated serum levels of ICAM-1 and PECAM-1 could serve as early predictive biomarkers in breast cancer survivors that might help to improve the management of these patients.

Opioid-blunted cortisol response to stress is associated with increased negative mood and wanting of social reward

Animal research suggests a central role of the μ-opioid receptor (MOR) system in regulating affiliative behaviors and in mediating the stress-buffering function of social contact. However, the neurochemistry of stress-related social contact seeking in humans is still poorly understood. In a randomized, double-blind, between-subjects design, healthy female volunteers (N = 80) received either 10 mg of the µ-opioid agonist morphine sulfate, or a placebo. Following a standardized psychosocial stress induction, participants engaged in a social reward task, in which the motivation to obtain skin-to-skin social touch and the hedonic reactions elicited by such touch were assessed. Morphine prevented the increase of salivary cortisol typically observed following acute stress exposure. Notably, this altered HPA axis responsivity was associated with increased negative affect in response to psychosocial stress, and with enhanced subjective wanting of highly rewarding social contact. These findings provide novel evidence on the effect of exogenous opioids administration on the reactions to psychosocial stress and point to a state-dependent regulation of social motivation.

Bioequivalence Trial of Two Piracetam 800 Mg ImmediateRelease Oral Tablets in Mexicans: Insights in the Use and Abuse of Nootropics

Objective: To share pharmacokinetic data and a bio-analytical method for the conduction of a bioequivalence trial of Piracetam 800-mg immediate release tablets in Mexicans. Methods: Twelve male and 18 female healthy volunteers were administered with a single oral dose of one 800-mg Piracetam tablet under fasting conditions, in a cross-over design study, with blood sampling up to 24 h post-dose. Piracetam was measured by tandem Mass Spectrometry coupled to Ultra-Performance Liquid Chromatography (UPLC-MS/MS) using metronidazole as internal standard. Logarithmic ratios of maximal plasma concentration (Cmax ) and Area Under the Curve (AUC) were used to establish 90% Confidence Intervals [CI] for bioequivalence. Results: Both formulations (Nootropil™ as reference product, and PIRACETAM generic formulation as test product) were safe and well tolerated. The analytical method proved to be linear with accuracy and precision within a range of 1-60 µg/mL; 90% CI for and were [82.62–94.68] and [95.22–102.06]. Cmax was reached at approximately 1 h, and plasma elimination half-life (t1/2) was around 5.1 h for both products. Conclusion: Assayed products met the criteria established by the Mexican regulatory agency (COFEPRIS) to be declared bioequivalent. Mexican population appears to be a high absorber of Piracetam, exhibiting a 300% higher and an ABC0-inf 60% greater than other populations previously reported.

Endometrial Regenerative Cell-Derived Conditioned Medium Alleviates Experimental Colitis.

Background Traditional interventions can play a certain role in attenuating ulcerative colitis (UC), known as one type of inflammatory bowel diseases, but sometimes are not effective. Endometrial regenerative cells (ERCs) have been shown to exert immunosuppressive effects in different models of inflammation, and stem cell-derived conditioned media (CM) have advantages over cell therapy in terms of easy access and direct action. However, whether ERC-CM could alleviate colitis remains unclear and will be explored in this study. Methods Menstrual blood was collected from healthy female volunteers to obtain ERCs and ERC-CM. Acute colitis was induced by 3% dextran sodium sulfate (DSS), and ERC-CM was injected on days 4, 6, and 8, respectively, after induction. The disease activity index was calculated through the record of weight change, bleeding, and fecal viscosity during the treatment process. Histological features, macrophage and CD4+ T cell in the spleen and colon, and cytokine profiles in the sera and colon were measured. In addition, an in vitro lymphocyte proliferation assay was measured by using a CCK-8 kit in this study. Results ERC-CM treatment significantly improved the symptoms and histological changes in colitis mice. ERC-CM increased the percentage of Tregs in the spleen and colon but decreased the percentages of M1 macrophages and Th1 and Th17 cells in the spleen and decreased the population of Th17 cells in the colon. In addition, ERC-CM treatment decreased the local expression of TNF-α, IL-6, and iNOS in the colon. Furthermore, ERC-CM increased the levels of anti-inflammatory cytokines IL-10 and IL-27 but decreased proinflammatory cytokines IL-6 and IL-17 in the sera. In addition, ERC-CM significantly inhibited ConA-induced mouse lymphocyte proliferation in vitro. Conclusion The results suggest that ERC-CM can exert similar therapeutic effects as ERCs and could be explored for future application of cell-free therapy in the treatment of colitis.

Skin occlusive performance: Sustainable alternatives for petrolatum in skincare formulations.

The emollients are important ingredients used in skincare formulations that can act as moisturizing agents through their occlusive potential, preventing skin water loss. Consumer interest in natural and sustainable products has grown considerably in the last few years, requiring efforts from the cosmetic industry to design products with raw materials of natural, organic, and sustainable origin. Thus, it is essential to improve the knowledge about the behavior of cosmetic raw materials that can be used as sustainable alternatives to synthetic ingredients. This work aimed to evaluate the occlusive performance of different vegetable oils used as emollients in skincare cosmetics, through comparative analysis with petrolatum, a synthetic emollient with a high occlusive skin potential. The study included 80 healthy female adult volunteers. TEWL measurements were performed before and after 15min, 2 and 6h of emollients application on the forearms of the research participants. All research participants provided written informed consent. The results obtained showed that the vegetable oils were effective in providing an occlusive effect on the skin. When compared to the petrolatum, the vegetable oils did not provide a high immediate skin occlusion effect. However, most of them showed a skin occlusion performance comparable to petrolatum throughout the 6h time course. Vegetable oils can be used as a sustainable alternative to synthetic emollients, and they are promising in replacing petrolatum in skincare formulations with respect to the occlusion effect of the skin. The vegetable oils did not provide a high immediate skin occlusion effect (15min post-application) as the petrolatum, which is known to have increased occlusion properties. However, most of them showed a skin occlusion performance comparable to petrolatum throughout the 6-hour time course.

Selenium nutritional status and its association with SLEDAI-2K, HOMA-IR and lipid profile in Juvenile Systemic Lupus Erythematosus patients.

To assess nutritional status regarding selenium in adolescents with Juvenile Systemic Lupus Erythematosus (jSLE) and analyze possible associations with disease activity, insulin resistance and lipid profile. This was an observational, cross-sectional study of 31 female adolescents with jSLE and 31 healthy female volunteers as a comparison group. We obtained demographic, anthropometric (weight, stature, waist, and neck circumferences), and clinical data (disease activity measured by SLEDAI-2K) from both groups; laboratory data including: lipid profile, plasma selenium, erythrocyte glutathione peroxidase activity (GPx), plasma malondialdehyde (MDA), ultrasensitive C-reactive protein (usCRP), insulin levels, and glycemia (Homeostasis Model Assessment for Insulin Resistance-HOMA-IR). Mean age at diagnosis of jSLE group was 15.9±1.7years, with mean disease duration of 3.6±2.6years. 48% of patients and controls had below-reference Se levels (≤46mcg/L). GPx was more frequently below reference levels (<4.171U/L) in the jSLE group, compared to controls. A ROC curve was used to assess the power of the variables to discriminate between both groups; insulin (AUC = 0.712; CI 95% 0.584-0.840), waist-to-height ratio (AUC = 0.704; CI 95% 0.572-0.837), and HOMA-IR (AUC = 0.689; CI 95% 0.556-0.822) were the variables with the greatest discriminatory power. Linear regression showed an independent inverse association between Se levels and c-LDL; no such correlation was found for GPx activity. SLEDAI-2K and HOMA-IR showed no association with levels of Se and GPx activity. Approximately, 50% of jSLE adolescents had below reference Se levels. The frequency of inadequate GPx values was higher in patients, compared to controls. There was an independent inverse association between Se and c-LDL levels in both groups; this was not the case for HOMA-IR and SLEDAI-2K. The data show the importance of assessing Se nutritional status in jSLE patients.

P562 A Phase 1 Study Evaluating the Effect of Coadministration of Etrasimod on the Pharmacokinetics and Pharmacodynamics of a Monophasic Oral Contraceptive in Healthy Female Volunteers

Abstract Background Etrasimod (ETR) is a once-daily (QD), oral, selective sphingosine 1-phosphate receptor modulator in clinical development for immune-mediated inflammatory disorders including inflammatory bowel disease (IBD) and atopic dermatitis. At diagnosis, ~50% of patients with IBD are &amp;lt;35 years old. Oral contraceptives (OC) are the most common birth control among women in the US. It’s important to ensure an IBD therapy does not impact the pharmacokinetic (PK)/pharmacodynamic (PD) performance of the OC. This study evaluated the effect of coadministration of ETR on the PK/PD performance of a monophasic OC. Methods This open-label Phase 1 study enrolled 21 premenopausal healthy female adults (18–40 years). On Days 1–21 of Period 1 (Days 1–28), participants received OC containing 30mcg ethinylestradiol (EE) and 50mcg levonorgestrel (LVG). On Day 23, participants initiated ETR 2mg QD such that steady-state concentrations were achieved by Day 28 and thereafter. On Days 29–49 of Period 2 (Days 29–50), the OC was coadministered with ETR 2mg QD. Samples for measuring the pharmacologically active components of the OC (EE and LVG) were collected over 24 hours on Days 21 and 49. Log-transformed primary PK parameters were calculated and compared using analysis of variance with treatment as fixed effect and participant as random effect. PD markers (follicle-stimulating hormone [FSH], luteinizing hormone [LH], estradiol, progesterone) were measured at baseline (Days 1 and 29) and throughout Periods 1 and 2. Largest ovarian follicle size measured by transvaginal ultrasound (TVUS), sex hormone–binding globulin (SHBG) levels, and Hoogland score were measured on Days 1 (before OC dosing), 11, 29 (before OC+ETR dosing), and 39. Safety and tolerability were also evaluated. Results Only minor-to-mild increases in EE and LVG Cmax,ss and AUCtau,ss exposure measures were observed when the OC was coadministered with ETR vs when the OC was administered alone (Table). These changes were not considered clinically relevant. Markers of ovarian activity (FSH, LH, estradiol, progesterone, SHBG, TVUS/Hoogland score) demonstrated no clinically relevant impact of coadministration of ETR on the PD performance of the OC. All treatments were generally well tolerated. Most treatment-emergent adverse events (AEs) were mild or moderate; 2 participants had severe AEs. No abnormalities in laboratory parameters, vital signs, or 12-lead electrocardiogram assessments were noted. Conclusion The PK/PD performance of the monophasic OC was not altered to a clinically relevant extent; thus contraceptive efficacy was maintained during coadministration with ETR. ETR and the monophasic OC, administered alone or in combination, were generally well tolerated.

Will repeated Intense Pulsed Light (IPL) treatment sessions affect facial skin sensitivity? Results of a twelve-Month, prospective, randomized split-face study.

Despite the widespread use of intense pulsed light (IPL) technology in cosmetic dermatology, the effects of its repeated use on facial skin sensitivity in healthy individuals remains unknown. Seventeen healthy female volunteers were included in the study. We measured objective biophysical parameters of the skin, including transepidermal water loss (TEWL), skin glossiness, thickness and density of the epidermis and dermis, sensory nerve current perception threshold (CPT), and regional blood flow before and after treatment at different time points. Sixteen volunteers completed a follow-up of 12months. The treated side of the face showed a decreased TEWL on D1 and D3, which reverted to normal on D7. Epidermal thickness increased and skin glossiness decreased on the treated side on D1, but returned to normal on D3. We found no statistically significant differences in CPT values or in regional blood flow volume and velocity, with the exception of D1, which exhibited a higher regional blood flow volume on the treated side. Repeated IPL treatments had no effects on facial skin barrier function, skin nerve sensitivity, or local microcirculation among healthy individuals. IPL is a safe skin care procedure that does not affect skin sensitivity.

Changes in the microcirculatory bed in patients with post-mastectomy syndrome

The purpose of the study: to determine the features of the state of the microcirculatory bed in women with post-mastectomy syndrome as a cause of fibrosis.Material and methods. The study involved 76 women, of whom two groups were formed. The first group consisted of 46 patients aged 25 to 49 years (mean age – (43.8 ± 3.8) years old) with post-mastectomy syndrome (PMES), the average period after radicle treatment of breast cancer was (4.3 ± 2.1) years. All patients underwent mastectomy, radiation and chemotherapy for the treatment of breast cancer, followed by a comprehensive examination to exclude metastasis and continued tumor growth, as well as to exclude hemodynamically significant violations of venous and arterial blood flow of the upper extremities. The second group was formed of 30 healthy female volunteers aged 25 to 43 years, whose average age was (33.75 ± 10.70) years old. Clinical and instrumental methods of examination were used: anthropometric method, lymphoscintigraphy of the upper extremities, laser Doppler flowmetry, determination of the expression level of intercellular adhesion molecules sICAM-1, sPECAM-1.The results. Gross violations of the function of the microcirculatory bed were revealed: endothelial dysfunction, spasm of precapillary sphincters, decrease in the intensity of blood flow in the metabolic capillaries, the predominance of passive mechanisms of blood flow regulation. These changes lead to tissue hypoxia, which may be the trigger for the development of fibrosis and lymphedema. Endothelial dysfunction, which is confirmed by increased expression of specific biomarkers, may be the basis of these disorders. A complex, long-term change in the work of microvessels leads to a breakdown of compensatory mechanisms.Conclusion. The study of the pathogenetic mechanisms of the development of post-mastectomy syndrome will allow forming preventive strategies in patients after treatment of breast cancer, improving the quality of life of these patients. Further search for promising predictors of the development of fibrosis, the study of changes in the microcirculatory bed will provide additional information about the pathogenesis of PMES, to identify changes in the soft tissues of the upper extremities at an early stage of post-mastectomy syndrome, may be important for the development of more effective methods of treatment of PMES.

Microalgae as a Sustainable, Natural-Oriented and Vegan Dermocosmetic Bioactive Ingredient: The Case of Neochloris oleoabundans

“Vegan” and “sustainable” characteristics are strong claim trends behind the development of innovative skincare, fragrances, and makeup products. This created a need in the market for compliant ingredients. To date, there have been no records evidencing the use of the microalgae Neochloris oleoabundans (NA) in dermocosmetics. Therefore, we studied the applicability of such a natural compound in this context. NA was cultivated, and the scavenging activity (SA) of the NA extracts was evaluated. The highest SA was from the aqueous extract (54.8% ± 2.1%), being higher than that of the positive control. Two hydrogels were prepared with 1.0% ammonium acryloyldimethyltaurate/VP copolymer: (1) control gel; and (2) gel with a 1.0% NA aqueous extract. In vivo experiments were performed in healthy male and female volunteers with skin phototypes of II–IV. The stratum corneum (SC) hydration and the transepidermal water loss (TEWL) were measured in the forearm of participants to determine their biocompatibility. This parameter was determined by skin bioengineering measurements, confirming that SC hydration and TEWL were not affected by the samples. The laser Doppler measurements results showed a delayed erythema onset in the sites, where the NA hydrogel was applied. The results confirmed the biocompatibility and the anti-inflammatory activity of an innovative ingredient derived from microalgae suitable for a natural and vegan lifestyle.

The dual role of interleukin-17 in the growth of human papillomavirus-negative cervical cancer cells

To explore the relationship between IL-17 mediated immune response and HPV-negative cervical cancer, we established the co-culture system of cervical cancer C-33A cells and PBMC, and treated with different concentrations of rhIL-17. PBMC were extracted from 10ml anticoagulant blood provided by healthy female volunteers and colleagues in our hospital, which were co-cultured with cervical cancer C-33A cells. After treatment with different concentrations of rhIL-17, the proliferation, apoptosis, invasion behavior and VEGF expression level of cancer cells in each group, were determined by CCK-8, flow cytometry, transwell invasion assay and ELISA, respectively. The proliferation rate of C-33A cells slightly increased with the ascending of IL-17 concentration, but no statistical significance was found among each group ( P &gt; 0.05). When at low concentration of IL-17, the cell apoptosis rate seems to slightly decline. With the increase of concentration, the decrease of apoptosis rate became more obvious ( P &lt; 0.05). However, differing from those shown above, we found that IL-17 slightly inhibited the cancer cell invasion at high concentration, while it was more obvious at low concentration ( P &lt; 0.05). Furthermore, we found that there was no significant correlation between IL-17 and VEGF ( P &gt; 0.05). In summary, there is a close correlation between IL-17 mediated immune response and HPV-negative cervical cancer. Also, we think that IL-17 may play a dual role in tumor progression and could be a possible significant influence on tumor proliferation, apoptosis, and metastasis, which provides a basic theoretical basis for the further study of immunotherapy measures for cervical cancer.

Immediate and Long Term Clinical Benefits of a Novel Topical Micronized Collagen Face Cream

Collagen has been a component of skin care formulations for many years, and over this time, there have been numerous claims of its efficiency. Collagen protein is responsible for firm strong skin, but since collagen fibers are too large to penetrate the stratum corneum (SC), topical creams containing collagen fibers remain on the skin surface without affecting skin quality. To overcome the poor penetration of collagen fibers, we prepared in the past micronized collagen fibers that were proven to reach the epidermis layer while inserted in a cream. In the present paper, we have performed a clinical study that analyzes the effect of the micronized fibrillar collagen containing cream on skin. Fifty five healthy female volunteers were enrolled and completed the study. The anti-ageing, firming, elasticity and moisturization efficacy of the cream were measured using Profilometer, Cutometer and Corneometer respectively. The results showed a significant improvement in skin hydration firmness and elasticity, a significant reduction in fine lines and wrinkles was also observed.

Patients with Chronic Constipation Experience Psychological Stress as Measured By the POMS2 Test and Salivary Stress Markers

Background: Psychological stress is known to lead to the pathogenesis and exacerbation of constipation. Therefore, it is important to understand the stress status in patients with constipation to treat constipation and prevent its exacerbation. Until now, the stress status of patients has been subjectively evaluated mainly by questionnaires, but in recent years it has become possible to objectively evaluate it by measuring stress markers in saliva. This study evaluated the stress status in patients with chronic constipation from both subjective and objective perspectives. Methods: Eighty-four adult females with chronic constipation and 20 healthy adult female volunteers as controls were enrolled in this study. All subjects were subjectively evaluated for their mood using the shortened Profile of Mood StatesSecond Edition (POMS2) and objectively evaluated by measuring salivary stress markers, such as cortisol, chromogen A, oxytocin, and secretory immunoglobulin A (s-IgA) using Enzyme-Linked Immuno Sorbent Assay. Results: In the POMS2 analysis, the T-scores of negative mood subscales, such as Anger–Hostility, Confusion–Bewilderment, Depression–Dejection, Fatigue–Inertia, and Tension–Anxiety were significantly higher in the constipation group than in the control group. In contrast, positive mood subscale scores, such as Vigor–Activity and Friendliness were not significantly different between the two groups. These results significantly increased the total mood disorder score, which comprehensively reflects a negative mood in the constipation group compared to the control group. In the stress marker analyses, cortisol, chromogranin A, and s-IgA concentrations in the constipation group were significantly higher than those in the control group. In contrast, the oxytocin concentration in the constipation group tended to be lower than in the control group. Conclusion: These results suggest that patients with constipation have more stressful negative emotions, such as anxiety, depression, tension, and fatigue than healthy individuals. This study will be important and useful when considering the treatment, exacerbation, or prevention of constipation.

Differences in total lung capacity among Indians and Europeans

Background: Total lung capacity (TLC) is the volume of air in the lungs at the end of a maximal inhalation. TLC mainly depends on various factors/predictors such as height, age, gender, and ethnicity, and therefore, population-specific reference equations should be used. Currently, in India, we use the (European committee for coal and steel [ECCS], published in the year 1993) reference equation with no correction factor for TLC. It is recommended that the reference equation should be tested on a sample of local healthy participants, differences between the measured values and the predicted values are determined to see if the reference equation is a suitable/good fit for the population. Aim: The aim of this study was to compare the actual values of TLC from the healthy male and female volunteers from Pune city with the reference values obtained from the ECCS equations in these participants and determine the correction factor/percent differences between the mean values for different age and height groups. Design and Setting: A prospective, cross-sectional study of lung function measurements (TLC) by body plethysmography was carried out in a research center. Methodology: TLC was measured by Jaeger's Body Plethysmograph (model: Master scope) according to the recommendation of the American Thoracic Society's/European Respiratory Society's standards 2005 in a sample of 241 healthy nonsmoking volunteers (150 men and 82 women) aged 20–70 years, living in Pune city of Maharashtra, India. Statistical Analysis: The mean of actual TLC and the reference TLC were plotted against the different age groups and height groups and percentage difference was determined. Multiple linear regression was carried out to find the predictive equations for TLC parameter measured by the body plethysmography. Age, height, and weight were used as the predictors (independent variables) in the multiple regression analysis. Since sex is also a predictor of TLC, separate models were run for men and women. Results: There were statistically significant differences between the measured TLC and the reference TLC obtained from the ECCS equation in both males (5.05 L ± 0.69 vs. 6.3 L ± 0.50) and females (3.69 L ± 0.54 vs. 4.39 L ± 0.36), respectively. Males have higher TLC as compared to females of the same age and height. The mean of actual TLC and the reference TLC was plotted against different age groups and height groups, and percentage difference was determined. The percentage differences ranged from 17% to 21% in males and 13%–17% in females. Conclusion: The ECCS equation is not suitable for Pune population and may lead to misinterpretation of restrictive lung diseases and hyperinflation. A correction factor of 18.5% in males and 15% in females may be used for the ECCS equation for TLC in Pune population.

Evaluation of the Effect of Radiotherapy on CCL5/miR-214 -3p/MALAT1 Genes Expression in Blood Samples of Breast Cancer Patients.

Current cancer therapies include chemotherapy, radiation therapy, immunotherapy, and surgery. Despite these treatment methods, a major point in cancer treatment is early detection. RNAs (mRNA, miRNAs, and LncRNA) can be used as markers to improve cancer diagnosis and treatment. This research examined how radiotherapy affected CCL5, miR-214, and MALAT-1 gene expression in the immune pathway in peripheral blood samples from radiation therapy-treated breast cancer patients. Before and after radiotherapy, peripheral blood was collected from 15 patients in four steps. Blood samples were collected in an outpatient facility from 20 healthy female volunteers with no history of malignant or inflammatory conditions. RNA was extracted from the blood samples and cDNA was synthesized. CCL5, miR-214, and MALAT-1 gene expression were determined by real-time polymerase chain reaction (RT-PCR). CCL5 protein levels in the serum were determined in 80 samples (60 BC and 20 healthy controls) using Quantikine Enzyme-Linked Immunosorbent Assay (ELISA) kits (R&D Systems). The data were then statistically evaluated. There was a significant difference between CCL5 levels in tumoral and adjacent normal blood samples (p < 0.05). The results also show that the level of gene expression and serum concentration of CCL5 protein in different phases of radiotherapy is significantly different. On the other hand, the expression level of the miR-214 gene was significantly decreased in patients compared to the control group, but this decrease was not significant for the MALAT-1 gene (p< 0.05). Also, after each stage of radiotherapy, the expression level of these two genes showed a decrease, but in the fourth week after radiotherapy, this decrease was significant (p< 0.05). Radiotherapy is associated with a decrease in the expression of miR-214 and MALAT-1, as a result, an increase in the expression of CCL5. An increase in the concentration of CCL5 protein is accompanied by an increase in the level of monocytes, which ultimately causes the infiltration of macrophages and can ultimately cause cancer recurrence. It is suggested that these genes can probably be used as diagnostic and therapeutic radiotherapy markers in breast cancer.

Development and Evaluation of a Hydrogel containing Momordica cochinchinensis Spreng Extract for Topical Applications

The purpose of this research was to develop a hydrogel containing the extract of Gac fruit (Momordica cochinchinensis Spreng) with appropriate physicochemical properties and good dermatological efficacy. The Gac aril fruit was extracted by maceration in dichloromethane, and its antioxidant activity was determined through a DPPH assay. The very low water-solubility of the Gac extract is responsible for its incompatibility with the hydrogel. To overcome this drawback, LabrafacTM PG and Tween 60 were used to develop the hydrogel due to their potent potential for solubilizing the Gac extract. The prepared hydrogels displayed good physical properties, a homogenous orange gel, appropriate pH, and viscosity. After storage in an accelerated condition for six months, the hydrogels of the Gac extract had physical stability and high remaining amounts of beta-carotene and lycopene within the range of 90.25 - 94.61%. The skin efficacy of hydrogel containing the Gac fruit extract was found using 14 healthy female volunteers over a 30-day period of daily application. Topical application of the hydrogel containing the Gac fruit extract, which contains antioxidants, significantly moisturizes the skin and enhanced its elasticity (p ≤ 0.05; ANOVA). This makes it suitable for use as a skin care product.

Assessment of Heart Rate Variability in Patients with Fibroid Uterus

Background &amp; Aims Uterine leiomyoma's represent 29.4% and 41.4% of the hysterectomies in women aged 18–44 and 45–64, respectively. They are characterized by an increase in smooth muscle cell proliferation and excessive deposition of extracellular matrix proteins, collagens type I and III. The reactive oxygen species (ROS) has been shown to be involved in the signaling pathways of several growth factors that stimulate proliferation of a variety of cell types. The underlying inflammation leads to the genesis of benign tumors and cardiac autonomic dysfunction. The cumulative effect of oxidative stress, inflammation and ageing make these patients more vulnerable for cardiovascular autonomic imbalance. Therefore, the study was conducted to assess the heart rate variability as a non-invasive tool for assessing cardiac autonomic function in these patients. Method Thirty four female patients in the age group of 25–50 yrs with newly diagnosed uterine fibroid were recruited from the department of Obstetrics and Gynaecology of JIPMER. Thirty four female healthy volunteers aged between 25–50 years were recruited as controls. The parameters measured were Basal Heart rate (BHR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Heart rate variability parameters (time and frequency domain indices). Results SBP and diastolic BP were elevated in fibroid patients compared to controls. SBP was statistically significant (P value &lt;0.001). Time domain indices were significantly reduced (SDNN: P &lt; 0.001, RMSSD: P &lt;0.001, PNN50: 0.001) in fibroid patients. Among frequency indices, Total power was significantly reduced (P&lt;0.001), LFnu was significantly high (P&lt;0.001), HFnu was significantly decreased (P&lt;0.001) and LF-HF ratio was significantly increased (P&lt;0.001) in fibroid patients. Conclusion We conclude that fibroid patients have altered autonomic tone in the form of increased sympathetic tone and decreased parasympathetic tone.