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Female Volunteers (female + volunteer)

Distribution by Scientific Domains
Medical Sciences69%
Life Sciences19%
Chemistry11%

Kinds of Female Volunteers

  • healthy female volunteer
    		•

    Selected Abstracts

    Sensitive analysis of donepezil in plasma by capillary electrophoresis combining on-column field-amplified sample stacking and its application in Alzheimer's disease,

    ELECTROPHORESIS, Issue 17 2008
    Hsin-Hua Yeh
    Abstract Field-amplified sample stacking (FASS) in capillary electrophoresis (CE) was used to determine the concentration of donepezil, an acetylcholinesterase inhibitor, in human plasma. A sample pretreatment by liquid,liquid extraction with isopropanol/n -hexane (v/v 3:97) and subsequent quantification by FASS-CE was used. Before sample loading, a water plug (0.5,psi, 6,s) was injected to permit FASS. Electrokinetic injection (7,kV, 90,s) was used to introduce sample cations. The separation condition for donepezil was performed in electrolyte solutions containing Tris buffer (60,mM, pH 4.0) with sodium octanesulfonate 40,mM and 0.01% polyvinyl alcohol as a dynamic coating to reduce analytes' interaction with capillary wall. The separation was performed at 28,kV and detected at 200,nm. Using atenolol as an internal standard, the linear ranges of the method for the determination of donepezil in human plasma were over a range of 1,50,ng/mL. The limit of detection was 0.1,ng/mL (S/N=3, sampling 90,s at 7,kV). One female volunteer (54 years old) was orally administered a single dose of 10,mg donepezil (Aricept®, Eisai), and blood samples were drawn over a 60,h period for pharmacokinetic study. The method was also applied successfully to monitor donepezil in sixteen Alzheimer's disease patients' plasmas. [source]

    Rapid and sensitive determination of strychnine and brucine in human urine by capillary electrophoresis with field-amplified sample stacking

    BIOMEDICAL CHROMATOGRAPHY, Issue 2 2010
    Junmei 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]

    Naturally Occurring Female Hairline Patterns

    DERMATOLOGIC SURGERY, Issue 6 2009
    BERNARD P. NUSBAUM MD
    BACKGROUND Hair transplantation is gaining popularity in women. Although much has been written about hairline design in male patients, more information is needed about natural female hairlines. OBJECTIVE To determine the frequency, dimensions, and location of structures that compose the female hairline. METHODS Hairline characteristics were measured in 360 female volunteers at an informal hair salon setting. RESULTS A widow's peak was present in 81%. The mean distance from the mid-eyebrow to the frontal midpoint was 5.5 cm. Lateral mounds were observed in 98%. The mean distance from the frontal midpoint to the apex of the lateral mounds was 3.74 cm on the right and 3.97 cm on the left. The mean distance from the apex of the lateral mounds to the apex of the temporal points was 3.78 cm on the right and 3.51 cm on the left. The shape of the temporal recessions was concave triangular or concave oval in 87% of the subjects. CONCLUSION This study provides proposed guidelines for designing the hairline in women. [source]

    Bifidobacterium longum lysate, a new ingredient for reactive skin

    EXPERIMENTAL DERMATOLOGY, Issue 8 2010
    Audrey Guéniche
    Please cite this paper as: Bifidobacterium longum lysate, a new ingredient for reactive skin. Experimental Dermatology 2010; 19: e1,e8. Abstract:, Reactive skin is characterized by marked sensitivity to physical (heat, cold, wind) or chemical (topically applied products) stimuli and by the impairment of the skin barrier's ability to repair itself. Several lines of evidence suggest that beyond their capacity to positively influence the composition of intestinal microbiota, some probiotic bacteria can modulate the immune system both at local and systemic levels, thereby improving immune defense mechanisms and/or down-regulating immune disorders such as allergies and intestinal inflammation. Several recent human clinical trials clearly suggest that probiotic supplementation might be beneficial to the skin. Using a probiotic lysate, Bifidobacterium longum sp. extract (BL), we demonstrated first in vitro, and then in a clinical trial, that this non-replicating bacteria form applied to the skin was able to improve sensitive skin. The effect of BL were evaluated first on two different models. Using ex vivo human skin explant model we found a statistically significant improvement versus placebo in various parameters associated with inflammation such as a decrease in vasodilation, oedema, mast cell degranulation and TNF-alpha release. Moreover, using nerve cell cultures in vitro, we showed that after 6 h of incubation in culture medium (0.3,1%), the probiotic lysate significantly inhibited capsaicin-induced CGRP release by neurones. Then, a topical cream containing the active extract was tested in a randomized, double-blind, placebo-controlled trial. Sixty-six female volunteers with reactive skin were randomly given either the cream with the bacterial extract at 10% (n = 33) or the control cream (n = 33). The volunteers applied the cream to the face, arms and legs twice a day for two months. Skin sensitivity was assessed by stinging test (lactic acid) and skin barrier recovery was evaluated by measuring trans-epidermal water loss following barrier disruption induced by repeated tape-stripping at D1, D29 and D57. The results demonstrated that the volunteers who applied the cream with bacterial extract had a significant decrease in skin sensitivity at the end of the treatment. Moreover, the treatment led to increase skin resistance against physical and chemical aggression compared to the group of volunteers who applied the control cream. Notably, the number of strippings required to disrupt skin barrier function was significantly increased for volunteers treated with the active cream. Clinical and self-assessment scores revealed a significant decrease in skin dryness after 29 days for volunteers treated with the cream containing the 10% bacterial extract. Since in vitro studies demonstrated that, on one hand, isolate sensitive neurones release less CGRP under capsaicin stimulation in the presence of the bacterial extract and, on the other hand, increased skin resistance in volunteers applying the test cream, we speculate that this new ingredient may decrease skin sensitivity by reducing neurone reactivity and neurone accessibility. The results of this studies demonstrate that this specific bacterial extract has a beneficial effect on reactive skin. These findings suggest that new approaches, based on a bacteria lysate, could be developed for the treatment and/or prevention of symptoms related to reactive skin. [source]

    Topical ascorbic acid on photoaged skin.

    EXPERIMENTAL DERMATOLOGY, Issue 3 2003
    Clinical, 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]

    Efficacy of four insect repellents against mosquito bites: a double-blind randomized placebo-controlled field study in Senegal

    FUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2009
    Bernard Uzzan
    Abstract Insect-borne diseases represent a worldwide threat. In addition to fight against vectors (insecticides) and disease prevention (vaccination against yellow fever, chemoprophylaxis against malaria), insect repellents applied on the skin could help reduce the heavy burden related to these diseases. In a field study performed in Senegal, we compared the efficacy of one skin application between 3 and 4 p.m. of four spray repellents [icaridine 20%, para-menthane-diol (PMD) 20% and 50% and DEET 50%] against placebo, among 100 healthy male and female volunteers experienced with mosquito capture. Double-blind randomized cross-over placebo-controlled study (Latin-square design) during five consecutive nights (7 p.m. to midnight) in two villages was conducted. To avoid residual effect, right or left leg was alternately exposed during consecutive nights and the exposed leg was washed before next night. The statistical model was random and mixed effects anova. All four active repellents provided a significant and similar protection compared with placebo, lasting 8 h. However, there was a non-significant trend for a higher protection by DEET 50% than by PMD 20% (P = 0.07). Duration of protection was similar for all repellents. Their effects were similar among men and women, and against Anopheles or other species. No serious adverse drug reaction was noticed. Using a rigorous methodology and a large number of volunteers, our well-controlled study demonstrated an important and similar protective effect of all four repellents compared with placebo. Such field studies should be required before approval of any newly developed repellent. [source]

    Lyonization pattern of normal human nails

    GENES TO CELLS, Issue 5 2008
    Mariko Okada
    To examine the X-inactivation patterns of normal human nails, we performed the human androgen receptor gene assay of DNA samples extracted separately from each finger and toe nail plates of nine female volunteers. The X-inactivation pattern of each nail was unique and constant for at least 2 years. The frequency of nails with one of the two X-chromosomes exclusively inactivated was 25.9%. In the nails composed of two types of cells with either one X-chromosome inactivated, the two cell types were distributed in patchy mosaics. These findings suggest that the composition of precursor cells of each nail is maintained at each site at least through several cycles of regeneration time, and that the nail plate has a longitudinal band pattern, each band consisting of cells with only one of the two X-chromosomes inactivated. Using the frequency of nails with one of two X-chromosomes exclusively inactivated, we estimated the number of progenitor cells that gave rise to the nail plate during development to be about 3, under the assumption that the process follows the binominal distribution model. A strong correlation observed among the big, index and little fingers, and among the corresponding toes suggests an interesting interpretation concerning their morphogenetic process. [source]

    Use of image analysis techniques for objective quantification of the efficacy of different hair removal methods

    INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 2 2007
    S. Bielfeldt
    In the field of consumer-used cosmetics for hair removal and hair growth reduction, there is a need for improved quantitative methods to enable the evaluation of efficacy and claim support. Optimized study designs and investigated endpoints are lacking to compare the efficacy of standard methods, like shaving or plucking, with new methods and products, such as depilating instruments or hair-growth-reducing cosmetics. Non-invasive image analysis, using a high-performance microscope combined with an optimized image analysis tool, was investigated to assess hair growth. In one step, high-resolution macrophotographs of the legs of female volunteers after shaving and plucking with cold wax were compared to observe short-term hair regrowth. In a second step, images obtained after plucking with cold wax were taken over a long-term period to assess the time, after which depilated hairs reappeared on the skin surface. Using image analysis, parameters like hair length, hair width, and hair projection area were investigated. The projection area was found to be the parameter most independent of possible image artifacts such as irregularities in skin or low contrast due to hair color. Therefore, the hair projection area was the most appropriate parameter to determine the time of hair regrowth. This point of time is suitable to assess the efficacy of different hair removal methods or hair growth reduction treatments by comparing the endpoint after use of the hair removal method to be investigated to the endpoint after simple shaving. The closeness of hair removal and visible signs of skin irritation can be assessed as additional quantitative parameters from the same images. Discomfort and pain rating by the volunteers complete the set of parameters, which are required to benchmark a new hair removal method or hair-growth-reduction treatment. Image analysis combined with high-resolution imaging techniques is a powerful tool to objectively assess parameters like hair length, hair width, and projection area. To achieve reliable data and to reduce well known image-analysis artifacts, it was important to optimize the technical equipment for use on human skin and to improve image analysis by adaptation of the image-processing procedure to the different skin characteristics of individuals, like skin color, hair color, and skin structure. [source]

    Clinical and instrumental evaluation of a food supplement in improving skin hydration

    INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 4 2005
    G 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 vivo

    INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 5 2004
    J. 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]

    Visual Field Loss and Risk of Fractures in Older Women

    JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2009
    Anne L. Coleman MD
    OBJECTIVES: To evaluate the associations between visual field loss and nonspine fractures. DESIGN: Prospective cohort study. SETTING: Community. PARTICIPANTS: Four thousand seven hundred seventy-three community-dwelling white and African-American women aged 65 and older with no previous history of hip fracture at the time of recruitment. MEASUREMENTS: Radiographically confirmed hip and nonspine, nonhip fractures identified from September 1997 to April 2008. Visual field loss was measured using a Humphrey Field Analyzer suprathreshold screening test of the peripheral and central vision of each eye and was classified into an ordinal rating of no, mild, moderate, or severe binocular visual field (BVF) loss. RESULTS: For hip and nonspine, nonhip fractures and in unadjusted and covariate-adjusted analyses, the highest incidence of fractures was seen in women with the most-severe BVF loss. In covariate-adjusted analysis, women with mild, moderate, and severe BVF loss had a 49% (hazard ratio (HR)=1.49, 95% confidence interval (CI)=1.18,1.88), 25% (HR=1.25, 95% CI=0.87,1.80), and 66% (HR=1.66, 95% CI=1.19,2.32) greater risk, respectively, for hip fractures than women without BVF loss. Similarly, women with mild visual field loss had a 12% (HR=0.88, 95% CI=0.75,1.04) lower risk for nonspine, nonhip fractures, whereas women with moderate and severe visual field loss had a 18% (HR=1.18, 95% CI=0.92,1.52) and 59% (HR=1.59, 95% CI=1.24,2.03) greater risk of nonspine, nonhip fractures than women without BVF loss. CONCLUSION: BVF loss is independently associated with hip and nonspine, nonhip fractures in older female volunteers. [source]

    Preliminary rapport on head posture and muscle activity in subjects with class I and II

    JOURNAL OF ORAL REHABILITATION, Issue 11 2005
    I. C. GADOTTI
    summary, Forward head posture may cause alterations in the stomatognathic system, including changes in the muscle activity of the masticatory muscles and dental occlusion alterations. Considering the need for further understanding of the relationship between the stomatognathic system and the cervical region, the purpose of this study was to analyse the head posture and the electromyographic (EMG) activity of the anterior portion of temporal and masseter muscles bilaterally among bruxist's subjects with different dental occlusion classifications using the Angle method. The study consisted of 20 female volunteers, between the ages of 17 and 27 years. They were separated into two groups (class I and class II occlusions) according to a dentist-performed evaluation. An assessment of forward head posture was conducted using a photographic technique (angular calculus) combined with a clinical analysis. In the EMG analyses, active differential surface electrodes (Ag) were utilized and were placed bilaterally on the belly of masseter and temporal muscles, perpendicular to the muscles fibres. The EMG signal recorded during bilateral isotonic mastication, was presented using the Root Mean Square and was processed by Matlab software. The results indicated that the EMG responses of temporal and masseter muscles tend to be modified by occlusion alteration class II. Subjects with class II occlusion tended to present more occurrence of forward head posture with alterations in the muscle activity pattern between masseter and temporal muscles. [source]

    Using real-time MRI to quantify altered joint kinematics in subjects with patellofemoral pain and to evaluate the effects of a patellar brace or sleeve on joint motion

    JOURNAL OF ORTHOPAEDIC RESEARCH, Issue 5 2009
    Christine E. Draper
    Abstract Abnormal patellofemoral joint motion is a possible cause of patellofemoral pain, and patellar braces are thought to alleviate pain by restoring normal joint kinematics. We evaluated whether females with patellofemoral pain exhibit abnormal patellofemoral joint kinematics during dynamic, weight-bearing knee extension and assessed the effects of knee braces on patellofemoral motion. Real-time magnetic resonance (MR) images of the patellofemoral joints of 36 female volunteers (13 pain-free controls, 23 patellofemoral pain) were acquired during weight-bearing knee extension. Pain subjects were also imaged while wearing a patellar-stabilizing brace and a patellar sleeve. We measured axial-plane kinematics from the images. Females with patellofemoral pain exhibited increased lateral translation of the patella for knee flexion angles between 0°and 50° (p,=,0.03), and increased lateral tilt for knee flexion angles between 0° and 20° (p,=,0.04). The brace and sleeve reduced the lateral translation of the patella; however, the brace reduced lateral displacement more than the sleeve (p,=,0.006). The brace reduced patellar tilt near full extension (p,=,0.001), while the sleeve had no effect on patellar tilt. Our results indicate that some subjects with patellofemoral pain exhibit abnormal weight-bearing joint kinematics and that braces may be effective in reducing patellar maltracking in these subjects. Published by Wiley Periodicals, Inc. J Orthop Res 27: 571,577, 2009 [source]

    Pharmacodynamic interaction of recombinant human interleukin-10 and prednisolone using in vitro whole blood lymphocyte proliferation

    JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 5 2002
    Abhijit Chakraborty
    Abstract Prednisolone, a commonly used synthetic corticosteroid, and IL-10, a cytokine under investigation for strong antiinflammatory properties, are being contemplated as a potential joint therapeutic regimen in immune disorders. Their pharmacodynamic interactions were examined in blood from healthy adult male and female volunteers using an in vitro phytohemagglutinin (PHA)-stimulated whole,blood lymphocyte proliferation technique. Isobolograms along with parametric competitive and noncompetitive interaction models were used to determine the nature and intensity of interactions. Single drug effects show prednisolone more efficacious in inhibiting lymphocyte proliferation with an IC50 of 3.3 ng/mL and Imax value of 1, signifying complete suppression. Analogous parameters for IL-10 were 16.2 ng/mL for IC50 and 0.89 for Imax. There were no significant differences in the single drug immunosuppressive effects among genders. Their joint effects showed additive interaction based on isobolographic analysis. Parametric analysis using the competitive interaction model described their interaction as slightly synergistic, while the noncompetitive interaction modeling indicate a small degree of antagonism. Also, the joint effects in females tend to be more antagonistic than males. Concomitant use of prednisolone and IL-10 should thus reflect the net additive responses to concentrations of each agent. © 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91:1334,1342, 2002 [source]

    The stable isotope ketoisocaproic acid breath test as a measure of hepatic decarboxylation capacity: a quantitative analysis in normal subjects after oral and intravenous administration

    LIVER INTERNATIONAL, Issue 9 2009
    Heiner K. Berthold
    Abstract Background and aims: There is no generally accepted kinetic evaluation method for the stable isotope [13C]ketoisocaproic acid (KIC) breath test. Differences found in the results between women and men are contradictory. Methods: Oral and intravenous breath tests using 1 mg/kg stable isotope-labelled KIC were performed in healthy male and female volunteers. A power exponential function was fitted to the mass spectrometric data of breath 13CO2 enrichment, allowing mathematical analysis of time-to-peak-excretion, half-excretion time, percent label recovery and parameters describing the shape of the curve. Body composition was determined using bioelectrical impedance analysis. Results: After oral administration, total label recovery after 3 h was about 22% and was not different between men (n=7) and women (n=8). The time to maximal label excretion was 0.67 ± 0.12 h in men and 0.9 ± 0.32 h in women (P=0.028) and the excretion curve showed an initially slower rise in women compared with men. Adjusting for lean body mass or body water abrogated the sex differences. Total label recovery after intravenous administration was about 9%, suggesting that the substrate was rapidly catabolized in the muscle compartment after intravenous administration. Conclusions: The modified power exponential function described allows standardized estimates of the KIC breath test results. When corrected for body composition, there are no differences in breath test results between men and women. The comparison between oral and intravenous results provides robust evidence that the KIC breath test measures predominantly hepatic and not muscle decarboxylation and is thus a highly specific liver function test. [source]

    Novel pharmacology: asimadoline, a ,-opioid agonist, and visceral sensation

    NEUROGASTROENTEROLOGY & MOTILITY, Issue 9 2008
    M. Camilleri
    Abstract, Asimadoline is a potent ,-opioid receptor agonist with a diaryl acetamide structure. It has high affinity for the , receptor, with IC50 of 5.6 nmol L,1 (guinea pig) and 1.2 nmol L,1 (human recombinant), and high selectively with , : , : , binding ratios of 1 : 501 : 498 in human recombinant receptors. It acts as a complete agonist in in vitro assay. Asimadoline reduced sensation in response to colonic distension at subnoxious pressures in healthy volunteers and in irritable bowel syndrome (IBS) patients without alteration of colonic compliance. Asimadoline reduced satiation and enhanced the postprandial gastric volume (in female volunteers). However, there were no significant effects on gastrointestinal transit, colonic compliance, fasting or postprandial colonic tone. In a clinical trial in 40 patients with functional dyspepsia (Rome II), asimadoline did not significantly alter satiation or symptoms over 8 weeks. However, asimadoline, 0.5 mg, significantly decreased satiation in patients with higher postprandial fullness scores, and daily postprandial fullness severity (over 8 weeks); the asimadoline 1.0 mg group was borderline significant. In a clinical trial in patients with IBS, average pain 2 h post- on-demand treatment with asimadoline was not significantly reduced. Post hoc analyses suggest that asimadoline was effective in mixed IBS. In a 12-week study in 596 patients, chronic treatment with 0.5 mg and 1.0 mg asimadoline was associated with adequate relief of pain and discomfort, improvement in pain score and number of pain-free days in patients with IBS-D. The 1.0 mg dose was also efficacious in IBS-alternating. There were also weeks with significant reduction in bowel frequency and urgency. Asimadoline has been well tolerated in human trials to date. [source]

    Importance of Pelvic Muscle Tenderness Evaluation in Women with Chronic Pelvic Pain

    PAIN MEDICINE, Issue 2 2010
    Mary 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]

    UV Erythema Reducing Capacity of Mizolastine Compared to Acetyl-salicylic Acid or both Combined in Comparison to Indomethacin,,

    PHOTOCHEMISTRY & PHOTOBIOLOGY, Issue 4 2001
    Jens-Uwe Grundmann
    ABSTRACT UV light exerts hazardous effects such as induction of skin cancer and premature skin aging. In this study we evaluated an assumptive anti-inflammatory effect of the nonsedative histamine H1-receptor antagonist, mizolastine, on UV-induced acute sunburn reaction. Therefore, a clinical, randomized, double-blind, four-arm, crossover study was conducted in healthy young female volunteers (skin type II) comparing the UV sensitivity under mizolastine, acetyl-salicylic acid (ASA), indomethacin or a mizolastine/ASA combination. Moreover, HaCaT keratinocytes were incubated with mizolastine under various UV treatment modalities in vitro to study its effect on the release of inflammatory cytokines, i.e. interleukin (IL)-1,, IL-6 and tumor necrosis factor , (TNF-,). All three drugs were effective in suppressing the UVB-, UVA- and combined UVA/UVB-erythema. However, the strongest effects were observed using the combined treatment with both 250 mg ASA and 10 mg mizolastine. An inhibitory effect in vitro of 10 nM mizolastine upon UV-induced cytokine release from HaCaT keratinocytes was observed for IL-1, at 24 h after 10 J/cm2 UVA1, for IL-6 at 48 h after 10 J/cm2 UVA1 and 30 mJ/cm2 UVB, and also for TNF-, at 4 h after 10 J/cm2 UVA, 10 J/cm2 UVA1 and 30 mJ/cm2 UVB, respectively. The combination of mizolastine and ASA can be strongly recommended as a protective measure against UV erythema development with a lower unwanted side effect profile than that of the hitherto treatment modality, i.e. indomethacin. [source]

    Cognitive effects of hormonal therapy in early stage breast cancer patients: a prospective study

    PSYCHO-ONCOLOGY, Issue 8 2009
    Barbara 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 study

    BIOMEDICAL CHROMATOGRAPHY, Issue 1 2009
    Cheng 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]

    Comparative bioavailability of two oral formulations of ranitidine

    BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 1 2006
    Francisco J. Flores-Murrieta
    Abstract The current requirement of the Mexican Authorities to demonstrate the interchangeability of ranitidine formulations is to establish that the dissolution profile of the drug shows similarity. In order to establish if this requirement is adequate, the bioavailability of two formulations that did not meet this similarity were compared. Twenty-five female volunteers received 150 mg ranitidine (Azantac® or Midaven®) under fasting conditions in two separate sessions using a cross-over design. Plasma samples were obtained at selected times for a period of 12 h and stored frozen at ,80°C until analysed. Ranitidine plasma levels were determined and pharmacokinetic parameters were obtained. Values (mean ± SEM) were: Cmax 528.85 ± 25.34 and 563.03 ± 33.25 ng/ml, tmax 2.76 ± 0.19 and 2.79 ± 0.18 h, and AUC12 h 2694.94 ± 99.50 and 2648.51 ± 133.38 ng.h/ml, for Azantac® or Midaven®, respectively. No statistically significant difference was obtained in the parameters evaluated. Moreover, 90% confidence limits were 96.6%,116.2% and 90.7%,105.1% for Cmax and AUC12 h ratios, respectively, indicating that the formulations tested are bioequivalent, despite the dissimilarity in the dissolution profile of the formulations. These results suggest that the comparative dissolution profile is not an adequate test to demonstrate the interchangeability of ranitidine formulations. Copyright © 2005 John Wiley & Sons, Ltd. [source]

    Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K® and Nizoral®) in a healthy female Mexican population

    BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 5 2004
    G. 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]

    The absence of apoeccrine glands in the human axilla has disease pathogenetic implications, including axillary hyperhidrosis

    BRITISH JOURNAL OF DERMATOLOGY, Issue 6 2007
    D.L. Bovell
    Summary Background, The existence of a third type of sweat gland in human axillary skin, the apoeccrine gland, with a capacity to produce much higher sweat output than the eccrine gland, was proposed from examination of microdissected glands. However, previous studies of axillary skin glands did not examine the entire individual glandular structure via serial sections and the markers used to identify the different glands gave conflicting results and, hence, the existence of the apoeccrine gland remains controversial. Objectives, To investigate human axillary sweat glands by serial section histology and immunofluorescence. Methods, Human axillary sweat glands were investigated by serial sectioning of paraffin wax-embedded skin samples taken by biopsy from four male and six female volunteers (age range 20,35 years). Sections were examined by light microscopy and immunofluorescence, using antibodies to antigens reported to be markers for discriminating between eccrine and apocrine gland cells: CD15, CD44, S100 and human milk fat globulin. Results, Light microscopy demonstrated that there were hair follicles and a mean ± SD of 76 ± 14 sweat glands cm,2. Eccrine and apocrine glands were found to be present; however, no glands resembling the apoeccrine glands were detected. Both types of sweat gland exhibited signs of being active, with segments of the secretory coils displaying flattened cells and dilated glandular lumina; however, this dilation did not extend to obvious changes in the width of the gland. None of the eccrine glands exhibited evidence of the presence of apocrine cells or vice versa. Immunofluorescence markers were found not to be specific and did not discriminate between the different types of glands or demonstrate the presence of apoeccrine glands. Conclusions, This is the first time that serial sections of axillary skin have been examined by histology and immunofluorescence. The markers reported to discriminate between apocrine and eccrine glands were found to be nonspecific. No evidence of apoeccrine glands was found either by histology or by immunofluorescence. [source]

    Alterations in the epidermal,dermal melanin axis and factor XIIIa melanophages in senile lentigo and ageing skin

    BRITISH JOURNAL OF DERMATOLOGY, Issue 1 2006
    N. Ünver
    Summary Background, Senile lentigo (SL) is a pigmentation disorder that occurs predominantly on the dorsa of the hands, the forearms and the face; its incidence increases with age. Histological hallmarks of SL lesions are hyperpigmentation of the epidermis and elongation of the epidermal rete ridges. Various factors such as , -melanocyte-stimulating hormone, endothelin-1 or stem cell factor are involved in the onset and maintenance of the increased pigmentation. Alterations of the dermal compartment have not yet been analysed in detail in SL. Objectives, To study the occurrence and distribution of melanin in the dermis from SL and aged skin, biopsies from 12 subjects were morphologically analysed by light and electron microscopy in comparison with unaffected skin. Methods, Punch biopsies of SL and adjacent skin from 12 male or female volunteers aged 52,81 years were prepared for light and electron microscopy and samples were analysed by morphological, morphometric, histochemical and immunohistochemical methods. Results, The epidermis from SL revealed morphological features such as hyperpigmentation of basal keratinocytes and the formation of elongated rete ridges. S100+ melanocytes in the stratum basale were not markedly increased, indicating that the hyperpigmentation is predominantly due to changes in melanin synthesis, distribution or turnover. Quantification of epidermal cells expressing the proliferation marker Ki67 did not show an increase of this parameter in SL, indicating that at least in the established lesion cell proliferation is not enhanced. We further focused on the dermal compartment and observed granulated cells which were more abundant in SL. Electron microscopic and histochemical analysis revealed that the granulation of these cells is based on melanosomes, mostly present in large melanosomal complexes. Immunohistochemistry using antibodies to CD68 and factor XIIIa (FXIIIa) showed these melanophages to be predominantly FXIIIa+ dermal dendrocytes, which were about six times more abundant than CD68+ macrophages. Conclusions, In SL an increased number of melanophages was found compared with unaffected skin from the same subject. These melanophages were identified as FXIIIa+ dermal dendrocytes. Possible functional consequences of the massive melanin uptake by dermal dendrocytes are discussed. [source]

    High-dose squalene ingestion increases type I procollagen and decreases ultraviolet-induced DNA damage in human skin in vivo but is associated with transient adverse effects

    CLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 4 2009
    S. Cho
    Summary Background., Evidence for beneficial effects of squalene on ultraviolet (UV)-induced photoageing of the skin is lacking. Aim., To investigate whether squalene supplementation improves signs and molecular markers of photoageing in human skin in vivo. Methods., In total, 40 female volunteers aged > 50 years received two different doses [13.5 g/day (low-dose group) and 27 g/day (high-dose group)] of squalene for 90 days. At baseline and at the completion of the study, facial wrinkles were measured using skin replicas. Skin samples were taken to compare type I procollagen and matrix metalloproteinase 1 mRNA levels by real-time reverse-transcriptase PCR, and for type I procollagen immunostaining. Skin samples were also taken 24 h after 2 × minimal erythema dose (MED) of UV irradiation before and after squalene intake to assess UV-induced thymine dimer formation and keratinocytic apoptosis. Results., In total, 37 subjects completed the trial. Transient loose stool was experienced by 35% of volunteers in the low-dose group and 55% in the high-dose group. Facial wrinkles decreased significantly (P < 0.05) in the high-dose group, while procollagen type I mRNA levels and MED increased significantly in the low-dose group. Procollagen immunostaining tended to increase in both groups. Facial erythema decreased and pigmentation increased significantly in both groups. UV-induced keratinocytic apoptosis and thymine dimer staining were substantially reduced in both groups. Conclusions., Daily ingestion of 13.5 or 27 g of squalene per day resulted in antiageing effects in photoaged skin. However, in view of the frequent incidence of loose stool experienced by the subjects, the risk,benefit ratio of high-dose squalene supplementation is too high to recommend it for treating skin ageing. [source]

    Asymmetry of the active nonweightbearing foot and ankle range of motion for dorsiflexion-plantar flexion and its coupled movements in adults

    CLINICAL ANATOMY, Issue 7 2007
    Virgilio F. Ferrario
    Abstract Asymmetries in ankle range of motion (ROM) have been reported, but often the uninvolved limb is used as a reference in clinical practice. The study wanted to quantify the intraindividual asymmetries in dorsi-plantar flexion foot and ankle ROM and its coupled foot movements. Active triplanar nonweightbearing ROM of the foot and ankle was recorded in young healthy adults (30 male volunteers, mean age 22.8 years; 35 female volunteers, mean age 23.8 years) using an optoelectronic set-up. The sagittal plane movement (mean ROM female subjects right side 71.3°, left side 71.4°, P > 0.05; mean ROM male subjects right side 69°, left side 68.9°, P > 0.05; sex difference, P < 0.001) was coupled with frontal (mean ROM female subjects right side 16.6°, left side 14.8°, P > 0.05; male subjects right side 17°, left side 15.3°; P > 0.05; no sex difference) and horizontal (mean ROM female subjects right side 19.6°, left side 18.8°, P < 0.001; male subjects right side 17.6°, left side 16.2°, P < 0.001; sex < 0.001) plane motions. Individual fluctuating asymmetries up to 15° (principal movement), and up to 29° (associated movements) were measured. Overall, 20% of female and 34% of male subjects had principal plane asymmetries >5°, and 50% of the subjects had asymmetries >5° in the associated movements. In young adults, individual asymmetries in ankle joint complex dorsi-plantar flexion should be taken into account when using the uninvolved, contralateral limb as a reference for clinical examination. Clin. Anat. 20:834,842, 2007. © 2007 Wiley-Liss, Inc. [source]