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Healthy Female Volunteers (healthy + female_volunteer)
Selected AbstractsRapid and sensitive determination of strychnine and brucine in human urine by capillary electrophoresis with field-amplified sample stackingBIOMEDICAL CHROMATOGRAPHY, Issue 2 2010Junmei Li Abstract A simple, rapid, sensitive and low-cost method using capillary electrophoresis (CE) coupled with field-amplified sample stacking (FASS) has been developed and validated for the simultaneous determination of strychnine and brucine residues in human urine. Before sample loading, a water plug (3.5 kPa, 3,s) was injected to contain sample cations and to permit FASS. Electrokinetic injection at a voltage (20 kV, 25,s) was then used to introduce cations. Separation was performed using 20,mM acetate buffer (pH 3.8) with an applied voltage of 20 kV. The calibration curves were linear over a range of 8.00,2.56 , 102,ng/mL (r = 0.9995) for strychnine and 10.0,3.20 × 102,ng/mL (r = 0.9999) for brucine. Extraction recoveries in urine were greater than 79.6 and 82.8% for strychnine and brucine, respectively, with an RSD of less than 4.9%. The detection limits (signal-to-noise ratio 3) for strychnine and brucine were 2.00 and 2.50,ng/mL, respectively. A urine sample from one healthy female volunteer (26 years old, 50,kg) was pretreated and analyzed. Strychnine and brucine levels in urine could be detected 24,h after administration. On these grounds, this method was feasible for application to preliminary screening of trace levels of abused drugs for both doping control and forensic analysis. Copyright © 2009 John Wiley & Sons, Ltd. [source] Topical ascorbic acid on photoaged skin.EXPERIMENTAL DERMATOLOGY, Issue 3 2003Clinical, topographical, ultrastructural evaluation: double-blind study vs. placebo Abstract:, Vitamin C is known for its antioxidant potential and activity in the collagen biosynthetic pathway. Photoprotective properties of topically applied vitamin C have also been demonstrated, placing this molecule as a potential candidate for use in the prevention and treatment of skin ageing. A topically applied cream containing 5% vitamin C and its excipient were tested on healthy female volunteers presenting with photoaged skin on their low-neck and arms in view to evaluate efficacy and safety of such treatment. A double-blind, randomized trial was performed over a 6-month period, comparing the action of the vitamin C cream vs. excipient on photoaged skin. Clinical assessments included evaluation at the beginning and after 3 and 6 months of daily treatment. They were performed by the investigator and compared with the volunteer self assessment. Skin relief parameters were determined on silicone rubber replicas performed at the same time-points. Cutaneous biopsies were obtained at the end of the trial and investigated using immunohistochemistry and electron microscopy. Clinical examination by a dermatologist as well as self-assessment by the volunteers disclosed a significant improvement, in terms of the ,global score', on the vitamin C-treated side compared with the control. A highly significant increase in the density of skin microrelief and a decrease of the deep furrows were demonstrated. Ultrastructural evidence of the elastic tissue repair was also obtained and well corroborated the favorable results of the clinical and skin surface examinations. Topical application of 5% vitamin C cream was an effective and well-tolerated treatment. It led to a clinically apparent improvement of the photodamaged skin and induced modifications of skin relief and ultrastructure, suggesting a positive influence of topical vitamin C on parameters characteristic for sun-induced skin ageing. [source] Clinical and instrumental evaluation of a food supplement in improving skin hydrationINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 4 2005G Primavera Synopsis Topically applied cosmetic products can be helpful in improving skin hydration. The study shows how oral supplementation could be helpful in improving and preventing the skin dehydration. A total of 32 healthy female volunteers entered the study. Of which, 16 were treated with a food supplement based on vegetable ceramides, amino acids, fish cartilage, antioxidants and essential fatty acids for 40 days and 16 with placebo. The results of the clinical and instrumental evaluations carried out in this study, have highlighted how the active treatment is effective in improving skin hydration and in reducing the cutaneous smoothness and roughness and the depth of furrows, in comparison to the placebo. In fact, concerning several important parameters, as stratum corneum hydration and skin roughness, the improvement measured exceeded 25%. We therefore suggest that a combination of treatments (oral and topical) can be more effective in improving skin hydration. Resume L'application topique de produits cosmétiques peut aider à l'hydratation de la peau. L'étude montre comment une supplémentation orale peut améliorer et empêcher la déshydratation de la peau. Trente deux femmes volontaires en bonne santé ont participéà cette étude. Seize ont été traitées pendant quarante jours avec un supplément alimentaire contenant des céramides végétaux, des aminoacides, du cartilage de poisson, des antioxydants et des acides gras essentiels, seize autres ont reçu un placebo. Les résultats des évaluations cliniques et expérimentales menées dans cette étude ont montré comment le traitement actif est efficace pour améliorer, par rapport au placebo, l'hydratation de la peau et réduire la douceur, la rugosité cutanée et la profondeur des rides. En fait, si l'on considère des paramètres importants comme l'hydratation du stratum corneum et la rugosité de la peau, l'amélioration mesurée dépasse 25%. Nous suggérons également qu'une combinaison de traitements (oral et topique) peut être encore plus efficace. [source] The penetration enhancement and the lipolytic effects of TAT,GKH, both in in vitro, ex vivo, and in vivoINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 5 2004J. Lim It was demonstrated that the trans-activating transcriptional activator (TAT) protein from HIV-1 could enter cells when added to the surrounding media. TAT peptide chemically attached to various proteins was able to deliver these proteins to various cells and even at high levels in heart and spleen tissues in mice. In this study, the tri-peptide GKH (glycine,lysine,histidine) derived from the parathyroid hormone, which is known as a lipolytic peptide, was attached to 9-poly lysine (TAT) to be used as a cosmetic ingredient for eye-bag care product. When glycerol is released, expressed as the extracellular glycerol concentration (the so-called lipolysis index), TAT,GKH at 10,5m induces a maximal lipolytic effect of approximately 41.5% in epididymal adipocytes isolated from rats, compared with basal lipolysis. In a microdialysis study, TAT,GKH was perfused into epididymal adipose tissues of anaesthetized rats in increasing concentrations in a Ringer solution. The glycerol concentration in each dialysate was measured using an ultra-sensitive radiometric method. The perfusion of TAT,GKH induced a lipolytic effect. A penetration study showed that TAT,GKH resulted in a sevenfold higher penetration into excised hairless mice skin than GKH. An in vivo study showed that a TAT,GKH containing emulsion had a better effect upon the relative volume reduction of eye bag after 28 days of application on 22 healthy female volunteers than the placebo. It was therefore concluded that TAT,GKH increased skin penetration, which resulted in enhanced lipolytic effects in in vitro, ex vivo and in volume reduction of eye-bags in in vivo studies. [source] Importance of Pelvic Muscle Tenderness Evaluation in Women with Chronic Pelvic PainPAIN MEDICINE, Issue 2 2010Mary Lourdes Lima De Souza Montenegro MD Abstract Objective., To determine the prevalence of pelvic muscle tenderness in women with chronic pelvic pain (CPP) and to assess the importance of evaluating muscle tenderness in such women. Design., Observational study of 48 healthy female volunteers and 108 women with CPP, who were clinically evaluated for pelvic muscle tenderness by two researchers blinded to all clinical data. Results., The frequency of clinically detected pelvic muscle tenderness was significantly higher in women with CPP than in healthy volunteers (58.3% vs 4.2%, P < 0.001). Among women with CPP, those with pelvic muscle tenderness had higher Beck Depression Index scores (22 [6,42] vs 13 [3,39], P = 0.02) and higher rates of dyspareunia (63.5% [40/63] vs 28.9% [13/45], P < 0.004) and constipation (46.0% [29/63] vs 26.7% [12/45], P = 0.05) than those without pelvic muscle tenderness. Conclusion., Tenderness of pelvic muscles was highly prevalent among women with CPP and was associated with higher BDI scores and higher rates of dyspareunia and constipation. Determination of pelvic muscle tenderness may help in identifying women who require more intense treatment for CPP. [source] Cognitive effects of hormonal therapy in early stage breast cancer patients: a prospective studyPSYCHO-ONCOLOGY, Issue 8 2009Barbara Collins Abstract Objective: The primary purpose of this study was to evaluate the cognitive effects of adjuvant hormonal therapies in breast cancer patients. Participants and Methods: Post-menopausal breast cancer patients scheduled to receive tamoxifen (n=31) or anastrozole (n=14) completed neuropsychological testing around the time of commencement of treatment (T1), and again 5,6 months later (T2). A sample of healthy female volunteers (n=28) was tested at comparable intervals. A standardized regression-based approach was used to assess cognitive change. This method uses test/retest scores of the healthy control group to generate an equation that predicts T2 scores from T1 scores. The difference between the predicted and obtained T2 scores divided by the standard error of the estimate produces a deviation score that reflects the discrepancy from the T1,T2 difference scores that would be expected on the basis of practice and error alone. Results: Analysis of individual deviation scores revealed that both the patients taking tamoxifen and those taking anastrozole were more likely than healthy controls to show reliable cognitive decline from T1 to T2 (39, 64, and 7%, respectively). Processing speed and verbal memory were the cognitive domains most affected. Conclusion: These data suggest that hormonal therapies exert a subtle negative influence on cognition in breast cancer patients. Further analyses indicated that this effect was not fully accounted for by demographic factors or fatigue. Methodological limitations of the current study are addressed, along with recommendations for future studies in this area. Copyright © 2008 John Wiley & Sons, Ltd. [source] Simultaneous determination of mifepristone and monodemethyl-mifepristone in human plasma by liquid chromatography,tandem mass spectrometry method using levonorgestrel as an internal standard: application to a pharmacokinetic studyBIOMEDICAL CHROMATOGRAPHY, Issue 1 2009Cheng Tang Abstract A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated to simultaneously determine mifepristone and monodemethyl-mifepristone in human plasma using levonorgestrel as the internal standard (IS). After solid-phase extraction of the plasma samples, mifepristone, monodemethyl-mifepristone and the IS were subjected to LC-MS/MS analysis using electro-spray ionization (ESI) in the multiple reaction monitoring (MRM) mode. Chromatographic separation was performed on an XTERRA MS C18 column (150 × 2.1 mm i.d., 5 µm). The method had a chromatographic run time of 4.5 min and linear calibration curves over the concentration ranges of 5,2000 ng/mL for mifepristone and monodemethyl-mifepristone. The recoveries of the method were found to be 94.5,103.7% for mifepristone and 70.7,77.3% for monodemethyl-mifepristone. The method had a lower limit of quantification (LLOQ) of 5.0 ng/mL and a lower limit of detection (LOD) of 1.0 ng/mL for both mifepristone and monodemethyl-mifepristone. The intra- and inter-batch precision was less than 15% for all quality control samples at concentrations of 10, 100 and 1000 ng/mL. These results indicate that the method was efficient with a short run time (4.5 min) and acceptable accuracy, precision and sensitivity. The validated LC-MS/MS method was successfully used in a pharmacokinetic study in healthy female volunteers after oral administration of 25 mg mifepristone tablet. Copyright © 2008 John Wiley & Sons, Ltd. [source] Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K® and Nizoral®) in a healthy female Mexican populationBIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 5 2004G. Marcelín-Jiménez Abstract A randomized, crossover study was conducted in 24 healthy female volunteers to compare the bioavailability of two brands of ketoconazole (200 mg) tablets; Onofin-K® (Farmacéuticos Rayere S.A., México) as the test and NIZORAL® (Janssen-Cilag, México) as the reference products. The study was performed at the Clinical Pharmacology Research Center of the Hospital General de México in Mexico City. Two tablets (400 mg) were administered as a single dose with 250 ml of water after a 12 h overnight fast on two treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested was analysed for ketoconazole by a modified and validated HPLC method with UV detection in the range 400,14000 ng/ml, using 200 µl of plasma in a full-run time of 2.5 min. The pharmacokinetic parameters AUC0,t, AUC0,,, Cmax, Tmax and t1/2 were determined from plasma concentrations of both formulations and the results discussed. AUC0,t, AUC0,, and Cmax were tested for bioequivalence after log transformation of data, and no significant differences were found either in 90% classic confidence interval or in the Anderson and Hauck test (p<0.05). Based on statistical analysis, it is concluded that Onofin-K® is bioequivalent to Nizoral®. Copyright © 2004 John Wiley & Sons, Ltd. [source] | ||||||||||