Science.gov

Sample records for 14-day range-finding study

  1. Trichloromelamine 14-Day Range Finding and 90-Day Subchronic Studies in Rats. 3 August 1988 - 17 January 1989. Phase 2

    DTIC Science & Technology

    1992-11-13

    COSATI CODES 10. SUBJECT TERMS (Continue on reverne if necessary and identify by block number) FIELD GROUP SUB-GROUP Trichloroemelamine, toxicity , 14-Day...90-Day 19, ABSTRACT (Conamnue on revers if necessary and identify by block number) The subchronic study examined the toxicity of the food service...observed adverse effect level in the 90-day study was 30 mg/kg/day. Trichloromelamine should be considered moderately toxic when ingested acutely

  2. Range Finding 14-Day and 90-Day Subchronic Feeding Studies with N,N-Dipropylcyclohexanecarboxamide in Rats. Phase 4.

    DTIC Science & Technology

    1986-12-01

    clinical chemistry values. Significant increases occurred in male rat liver organ-to-body weight ratios in all three dose levels at the 45 and 90 day necropsies during the 90-day feeding study. A no effect dose was not achieved during this study. Additional testing would be required to confirm a no effect dose level. It is concluded that a toxic hazard may exist from a prolonged significant oral exposure to N,N-Dopropylcyclohexanecarboxamide. It is recommended that further evaluation of this compound as a candidate insect repellent be discontinued due to the deleterious

  3. Toxicological Study No. 75-51-YJ81-93, 4-Amino-2-Nitrotoluene (4A2NT) Oral Approximate Lethal Dose 14-day Range Finding 90-Day Subchronic Feeding Studies in Rats, August 1991-November 1993

    DTIC Science & Technology

    1994-07-01

    NOVEMBER 1993 1. PURPOSE. The oral approximate lethal dose study was conducted todetennine an approximate dosage range at which to begin the 14-day...5000 mg/Kg. The 14-day range fmding study suggested a probable compound related effect in the薘~m (high dose ) exposure groups of both sexes and a...possible compound related effect mIlle 1000 ppm (middle dose ) exposure groups of both sexes. An NOAEL was not established for the 90-day subchronic

  4. A 14-day ground-based hypokinesia study in nonhuman primates: A compilation of results

    NASA Technical Reports Server (NTRS)

    Kazarian, L.; Cann, C. E.; Parfitt, M.; Simmons, D.; Morey-Holton, E.

    1981-01-01

    A 14 day ground based hypokinesia study with rhesus monkeys was conducted to determine if a spaceflight of similar duration might affect bone remodeling and calcium homeostatis. The monkeys were placed in total body casts and sacrificed either immediately upon decasting or 14 days after decasting. Changes in vertebral strength were noted and further deterioration of bone strength continued during the recovery phase. Resorption in the vertebrae increased dramatically while formation decreased. Cortical bone formation was impaired in the long bones. The immobilized animals showed a progressive decrease in total serum calcium which rebounded upon remobilization. Most mandibular parameters remained unchanged during casting except for retardation of osteon birth or maturation rate and density distribution of matrix and mineral moieties.

  5. Dose Dense Cyclophosphamide, Methotrexate, Fluorouracil is Feasible at 14-Day Intervals: A Pilot Study of Every-14-Day Dosing as Adjuvant Therapy for Breast Cancer

    PubMed Central

    Drullinsky, Pamela; Sugarman, Steven M.; Fornier, Monica N.; D’Andrea, Gabriella; Gilewski, Teresa; Lake, Diana; Traina, Tiffany; Wasserheit-Lieblich, Carolyn; Sklarin, Nancy; Atieh-Graham, Deena; Mills, Nancy; Troso-Sandoval, Tiffany; Seidman, Andrew D.; Yuan, Jeffrey; Patel, Hamangi; Patil, Sujata; Norton, Larry; Hudis, Clifford

    2012-01-01

    Purpose Cyclophosphamide/methotrexate/fluorouracil (CMF) is a proven adjuvant option for patients with early-stage breast cancer. Randomized trials with other regimens demonstrate that dose-dense (DD) scheduling can offer greater efficacy. We investigated the feasibility of administering CMF using a DD schedule. Patients and Methods Thirty-eight patients with early-stage breast cancer were accrued from March 2008 through June 2008. They were treated every 14 days with C 600, M 40, F 600 (all mg/m2) with PEG-filgrastim (Neulasta®) support on day 2 of each cycle. The primary endpoint was tolerability using a Simon’s 2-stage optimal design. The design would effectively discriminate between true tolerability (as protocol-defined) rates of ≤ 60% and ≥ 80%. Results The median age was 52-years-old (range, 38–78 years of age). Twenty-nine of the 38 patients completed 8 cycles of CMF at 14-day intervals. Conclusion Dose-dense adjuvant CMF is tolerable and feasible at 14-day intervals with PEG-filgrastim support. PMID:21147686

  6. Repeated dose (14 days) rat intramuscular toxicology study of Her1 vaccine.

    PubMed

    Mancebo, A; Casacó, A; Sánchez, B; González, B; Gómez, D; León, A; Bada, A M; Arteaga, M E; González, Y; González, C; Pupo, M; Fuentes, Dasha

    2012-12-01

    Our goal was to assess the toxicity of two strengths (200 and 400 μg) of HER1 cancer vaccine (Center of Molecular Immunology, Cuba), presented in two different formulations, in Sprague Dawley rats after repeated intramuscular administration (14 days). Four groups (5 animals/sex) were established: Control, Placebo (adjuvant), and two Treated groups receiving a dose representing ten times of human total dose (10×), 28.6 and 57.1 μg/kg. Clinical observations, body weight and rectal temperature were measured during the study. Clinical pathology analysis was performed, besides gross necropsy and histological examination of tissues on animals at the end of the assay. The assay ended with a 100% survival. Injection site damage, with the presence of cysts and granulomas, was observed in adjuvant and vaccine treated groups, with most severe cases predominating at higher strength. Administration of Placebo and Her1 vaccine induced increase in polymorphonuclear cells, with relative lymphopenia conditioned by primary neutrophilia. In summary, results suggest that Her1 immunization was capable of inducing an inflammatory effect at the injection site, leading to systemic alterations, more significant at higher strength (400 μg, 57.1 μg/kg), probably affected by the immunizations' schedule used. The vaccine was shown to be well tolerated without any obvious signs of systemic toxicity, with findings largely attributable to the adjuvant used.

  7. Comparison of Ocular Outcomes in Two 14-Day Bed Rest Studies

    NASA Technical Reports Server (NTRS)

    Cromwell, R. L.; Zanello, S. B.; Yarbough, P. O.; Taibbi, G.; Vizzeri, G.

    2011-01-01

    /D) ratio. For all measures, there was no significant difference between subject groups for pre-bed rest testing. Post bed rest values also remained similar between groups. Comparison of pre- to post bed rest testing within each group did not demonstrate any statistical differences. These preliminary results from 14-day bed rest studies suggest that the combination of exercise and horizontal bed rest as compared to 6 degrees HDT bed rest did not produce differences in the ocular response with regard to IOP and optic disc parameters. The ocular measures reported here only included pre- and post bed rest time points. Further investigation is needed to examine both the acute response and long term adaptation of structural and functional ocular parameters in the bed rest platform and determine its usefulness for studying spaceflight phenomena. From a clinical perspective, the ability to study ocular responses in the controlled environment of the bed rest platform can provide valuable information for the care of patients restricted to bed rest.

  8. A case-control study to identify predictors of 14-day mortality following carbapenem-resistant Acinetobacter baumannii bacteraemia.

    PubMed

    Nutman, A; Glick, R; Temkin, E; Hoshen, M; Edgar, R; Braun, T; Carmeli, Y

    2014-12-01

    Carbapenem-resistant Acinetobacter baumannii (CRAB) is an increasingly common nosocomial pathogen. We sought to identify clinical and microbiological predictors of 14-day mortality among patients with CRAB bacteraemia. This case-control study included all adult patients in one Israeli hospital with CRAB on blood culture between July 2008 and June 2011. Cases were defined as patients who died within 14 days of bacteraemia onset and controls as patients who survived over 14 days. Sequence-typing of the blaOXA-51-like gene and REP-PCR identified CRAB clone groups. Logistic regression was performed to analyze predictors of 14-day all-cause mortality. To correct for differences in treatment onset, Cox regression was used to examine the effect of receiving an active antibiotic. Eighty-three cases and 89 controls were included. Six major CRAB clone groups were identified, with 14-day mortality ranging from 17 to 66%. Independent predictors of 14-day mortality were severity of illness (OR = 1.38 for each 1-point increase in Sequential Organ Failure Assessment (SOFA) score; 95% CI, 1.21, 1.56), independence in activities of daily living (ADL) on admission (OR = 3.40; 95% CI, 1.20, 9.67, for fully dependent vs. independent), surgery before bacteraemia (OR = 0.25; 95% CI, 0.11, 0.59) and clone group (OR = 7.76; 95% CI, 2.52, 23.85, for the most virulent group vs. the reference group). In the multivariate Cox model using a propensity score to adjust for SOFA, clone, ADL and surgery, active antibiotic treatment was protective (HR = 0.30; 95% CI, 0.15, 0.60). Differences in virulence between CRAB clones may partly explain heterogeneous results in previous studies of mortality following CRAB infection.

  9. Comparison of Ocular Outcomes in Two 14-Day Bed Rest Studies

    NASA Technical Reports Server (NTRS)

    Cromwell, Ronita L.; Zanello, S. B.; Yarbough, P. O.; Tabbi, G.; Vizzeri, G.

    2012-01-01

    Reports of astronauts' visual changes have raised concern about ocular health during long-duration spaceflight. Some of these findings include globe flattening with hyperopic shifts, choroidal folds, optic disc edema, retinal nerve fiber layer (RNFL) thickening, and cotton wool spots. While the etiology remains unknown, it is hypothesized that, in predisposed individuals, hypertension in the brain may follow cephalad fluid shifts during spaceflight. This possible mechanism of ocular changes may also apply to analogous cases of idiopathic intracranial hypertension (IIH) or pseudotumor cerebri on Earth patients. Head-down t ilt (HDT) bed rest is a spaceflight analog that induces cephalad fluid shifts. Previous studies of the HDT position demonstrated body fluid shifts associated with changes in intraocular pressure (IOP) but the conditions of bed rest varied among experiments, making it difficult to compare data and draw conclusions. For these reasons, vision evaluation of bed rest subjects was implemented for NASA bed rest studies since 2010, in an attempt to monitor vision health in subjects subjected to bed rest. Vision monitoring is thus currently performed in all NASA-conducted bed rest campaigns

  10. Randomized dose-ranging study of the 14-day early bactericidal activity of bedaquiline (TMC207) in patients with sputum microscopy smear-positive pulmonary tuberculosis.

    PubMed

    Diacon, Andreas H; Dawson, Rodney; Von Groote-Bidlingmaier, Florian; Symons, Gregory; Venter, Amour; Donald, Peter R; Conradie, Almari; Erondu, Ngozi; Ginsberg, Ann M; Egizi, Erica; Winter, Helen; Becker, Piet; Mendel, Carl M

    2013-05-01

    Bedaquiline is a new antituberculosis agent targeting ATP synthase. This randomized, double-blinded study enrolling 68 sputum smear-positive pulmonary tuberculosis patients evaluated the 14-day early bactericidal activity of daily doses of 100 mg, 200 mg, 300 mg, and 400 mg bedaquiline, preceded by loading doses of 200 mg, 400 mg, 500 mg, and 700 mg, respectively, on the first treatment day and 100 mg, 300 mg, 400 mg, and 500 mg on the second treatment day. All groups showed activity with a mean (standard deviation) daily fall in log10 CFU over 14 days of 0.040 (0.068), 0.056 (0.051), 0.077 (0.064), and 0.104 (0.077) in the 100-mg, 200-mg, 300-mg, and 400-mg groups, respectively. The linear trend for dose was significant (P = 0.001), and activity in the 400-mg dose group was greater than that in the 100-mg group (P = 0.014). All of the bedaquiline groups showed significant bactericidal activity that was continued to the end of the 14-day evaluation period. The finding of a linear trend for dose suggests that the highest dose compatible with safety considerations should be taken forward to longer-term clinical studies.

  11. Association Between Cardiovascular and Intraocular Pressure Changes in a 14-Day 6 deg Head Down Tilt (HDT) Bed Rest Study: Possible Implications in Retinal Anatomy

    NASA Technical Reports Server (NTRS)

    Cromwell, Ronita; Zanello, Susana; Yarbough, Patrice; Ploutz-Snyder, Robert; Taibbi, Giovanni; Vizzeri, Gianmarco

    2013-01-01

    Visual symptoms and intracranial pressure increase reported in astronauts returning from long duration missions in low Earth-orbit are thought to be related to fluid shifts within the body due to microgravity exposure. Because of this possible relation to fluid shifts, studies conducted in head-down tilt (HDT) bed rest are being monitored for potential changes in ocular health. These measures will also serve to determine whether HDT is a suitable ground-based analog to model subclinical cardiovascular and ocular changes that could shed light on the etiology of the VIIP syndrome observed in spaceflight. Sixteen healthy normotensive (12M, 4F, age range 29-54 years), non-smoker and normal weight subjects, volunteered to participate in a 14 day 6 deg head HDT study conducted at the NASA Flight Analogs Research Unit (FARU). This facility provides standard bed rest conditions (diet, wake/sleep time, time allowed in sunlight) during the time that the subjects stay at the FARU. Cardiovascular parameters were obtained in supine posture at BR-5, BR+0, and BR+3 and ocular monitoring was performed weekly. Intraocular pressure (IOP) increased from pre-bed rest BR-3) to the third day into bed rest (BR+3). Values reached a plateau towards the end of the bed rest phase (BR10) and decreased within the first three days of recovery (BR+2) returning to levels comparable to baseline at BR-3. As expected, most cardiovascular parameters were affected by 14 days of HDT bed rest. Plasma volume decreased as a result of bed rest but recovered to baseline levels by BR+3. Indications of cardiovascular deconditioning included increase in both systolic and diastolic blood pressure and heart rate, and a decrease in stroke volume and cardiac output between BR-5 and BR+3. Due to the experimental design of this study, we were not able to test the hypothesis that fluid shifts might be involved in the IOP increase during the bed rest phase, since cardiovascular measures were not available for those

  12. Miniaturization of cytotoxicity tests for concentration range-finding studies prior to conducting the pH 6.7 Syrian hamster embryo cell-transformation assay.

    PubMed

    Plöttner, Sabine; Käfferlein, Heiko U; Brüning, Thomas

    2013-08-15

    The Syrian hamster embryo (SHE) cell-transformation assay (SHE assay) is a promising alternative method to animal testing for the identification of potential carcinogens in vitro. Prior to conducting the SHE assay the appropriate concentration range for each test chemical must be established, with a maximum concentration causing approximately 50% cytotoxicity. Concentration range-finding is done in separate experiments, which are similar to the final SHE assay but with less replicates and more concentrations. Here we present an alternative for the cytotoxicity testing by miniaturization of the test procedure by use of 24-well plates and surpluses from feeder-cell preparations as target cells. In addition, we integrated the photometry-based neutral red (NR) assay. For validation of the assay, incubations with dimethyl sulf-oxide, p-phenylenediamine-2HCl, aniline, o-toluidine-HCl, 2,4-diaminotoluene, and 2-naphthylamine were carried out in the miniaturized approach and compared with the standard procedure in terms of calculating the relative plating efficiencies (RPEs). To directly compare both methods, concentrations that produced 50% cytotoxicity (IC50) were calculated. Excellent associations were observed between the number of colonies and NR uptake. For all test substances a concentration-dependent, concomitant decrease of NR uptake in the miniaturized approach and RPEs in the standard test was observed after a 7-day incubation. The results from both test setups showed a comparable order of magnitude and the IC50 values differed by a factor <2 (1.4-1.9), depending on the substance in question. Overall, the miniaturized approach should be considered an improved alternative for cytotoxicity testing in the SHE assay, as it saves valuable SHE cells and speeds-up the time, to obtain test results more rapidly.

  13. 14 Days to Have Your Say

    ERIC Educational Resources Information Center

    Peterson, Andrea; Haulgren, Frank

    2010-01-01

    During spring quarter 2008, the Western Washington University (WWU) Libraries established an interactive bloglike environment called "14 Days to Have Your Say" with the intention of gathering new ideas and feedback about the libraries from the university community. The environment was developed as a fairly simple Drupal site. The project…

  14. Nutrition Composition and Single, 14-Day and 13-Week Repeated Oral Dose Toxicity Studies of the Leaves and Stems of Rubus coreanus Miquel.

    PubMed

    Om, Ae-Son; Song, Yu-Na; Noh, GeonMin; Kim, HaengRan; Choe, JeongSook

    2016-01-08

    The leaves and stems of the plant Rubus coreanus Miquel (RCMLS) are rich in vitamins, minerals and phytochemicals which have antioxidant, anti-hemolytic, anti-inflammatory, anti-fatigue and anti-cancer effects. However, RCMLS is not included in the Korean Food Standards Codex due to the lack of safety assurance concerning RCMLS. We evaluated single and repeated oral dose toxicity of RCMLS in Sprague-Dawley rats. RCMLS did not induce any significant toxicological changes in both male and female rats at a single doses of 2500 mg/kg/day. Repeated oral dose toxicity studies showed no adverse effects in clinical signs, body weight, food consumption, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weight, and histopathology at doses of 625, 1250, and 2500 mg/kg/day. The LD50 and LOAEL of RCMLS might be over 2500 mg/kg body weight/day and no target organs were identified. Therefore, this study revealed that single and repeated oral doses of RCMLS are safe.

  15. HMX: 14 Day Toxicity in Mice by Dietary Administration

    DTIC Science & Technology

    1985-07-30

    i Nitrite LT 0.01 Non-carbonate 15 Ammoniacal Nitrogen 0.10 Alkalinity as CaCO3 60 Albuminod Nitrogen LT .01 Permanganate value -..... 21 C 0.55 Free...study is not indi- vidually inspected. The processes involved are inspected at K 1 intervals according to a pre-determined schedule. This report has...water effluent from the manufacturing processes for RDX and HMX. This report describes a 14 day dietary study in mice conducted "to set dose levels

  16. Excretory/secretory proteome of 14-day schistosomula, Schistosoma japonicum.

    PubMed

    Cao, Xiaodan; Fu, Zhiqiang; Zhang, Min; Han, Yanhui; Han, Qian; Lu, Ke; Li, Hao; Zhu, Chuangang; Hong, Yang; Lin, Jiaojiao

    2016-01-01

    Schistosomiasis remains a serious public health problem, with 200 million people infected and 779 million people at risk worldwide. The schistosomulum is the early stage of the complex lifecycle of Schistosoma japonicum in their vertebrate hosts, and is the main target of vaccine-induced protective immunity. Excretory/secretory (ES) proteins play a major role in host-parasite interactions and ES protein compositions of schistosomula of S. japonicum have not been characterized to date. In the present study, the proteome of ES proteins from 14 day schistosomula of S. japonicum was analyzed by liquid chromatography/tandem mass spectrometry and 713 unique proteins were finally identified. Gene ontology and pathway analysis revealed that identified proteins were mainly involved in carbohydrate metabolism, degradation, response to stimulus, oxidation-reduction, biological regulation and binding. Flow cytometry analysis demonstrated that thioredoxin peroxidase identified in this study had the effect on inhibiting MHCII and CD86 expression on LPS-activated macrophages. The present study provides insight into the growth and development of the schistosome in the final host and valuable information for screening vaccine candidates for schistosomiasis.

  17. An automatic 14-day paste diet feeder for animals

    NASA Technical Reports Server (NTRS)

    Vasques, Marilyn; Mulenburg, Jerry; Gundo, Dan; Griffith, Jon

    1994-01-01

    During a centrifuge experiment, any interruption that requires stopping the centrifuge may influence the results. Centrifuges often must be stopped for animal maintenance (food, water and waste removal), especially in cases of timed feedings. To eliminate the need for stopping the centrifuge while still providing timed feeding, an automatic paste diet feeder was developed. The feeder is based on a constant volume concept and can deliver a predetermined amount of paste diet at specified time intervals. This unit was supported by water delivery and waste collection systems. The entire system performed reliably and maintained the animals well for a continuous centrifugation experiment of 14 days.

  18. EPO modulation in a 14-days undersea scuba dive.

    PubMed

    Revelli, L; Vagnoni, S; D'Amore, A; Di Stasio, E; Lombardi, C P; Storti, G; Proietti, R; Balestra, C; Ricerca, B M

    2013-10-01

    Erythropoiesis is affected during deep saturation dives. The mechanism should be related to a downregulation of serum Erythropoietin (s-EPO) concentration or to a toxic effect of the hyperbaric hyperoxia. We evaluated s-EPO and other haematological parameters in 6 scuba divers before, during and after a 14-days guinness saturation dive (8-10 m). Athletes were breathing air at 1.8-2 ATA, under the control of a team of physicians. Serum parameters were measured before diving (T0) and: 7 days (T1), 14 days (T2) after the beginning of the dive and 2 h (T3) and 24 h (T4) after resurfacing. Hgb, and many other haematological parameters did not change whereas Ht, s-EPO, the ratio between s-EPO predicted and that observed and reticulocytes (absolute, percent) declined progressively from T0 to T3. At T4 a significant rise in s-EPO was observed. Hgb did not vary but erythropoiesis seemed to be affected as s-EPO and reticulocyte counts showed. All these changes were statistically significant. The experiment, conducted in realistic conditions of dive length, oxygen concentration and pressure, allows us to formulate some hypotheses about the role of prolonged hyperbarism on erythropoiesis. The s-EPO rise, 24 h after resurfacing, is clearly documented and related to the "Normobaric Oxygen Paradox". This evidence suggests interesting hypotheses for new clinical applications such as modulation of s-EPO production and Hgb content triggered by appropriate O₂ administration in pre-surgical patients or in some anemic disease.

  19. NASA 14 Day Undersea Missions: A Short-Duration Spaceflight Analog for Immune System Dysregulation?

    NASA Technical Reports Server (NTRS)

    Crucian, B. E.; Stowe, R. P.; Mehta, S. K.; Chouker, A.; Feuerecker, M.; Quiriarte, H.; Pierson, D. L.; Sams, C. F.

    2011-01-01

    This poster paper reviews the use of 14 day undersea missions as a possible analog for short duration spaceflight for the study of immune system dysregulation. Sixteen subjects from the the NASA Extreme Enviro nment Mission Operations (NEEMO) 12, 13 and 14 missions were studied for immune system dysregulation. The assays that are presented in this poster are the Virleukocyte subsets, the T Cell functions, and the intracellular/secreted cytokine profiles. Other assays were performed, but are not included in this presntation.

  20. [A 14-day-old boy with jaundice and apnoea].

    PubMed

    Smerud, Ole-Jørgen Olsøy; Solevåg, Anne Lee; Hansen, Thor Willy Ruud; Grønn, Morten

    2015-12-15

    We describe an infant who was readmitted from home at 14 days of age with jaundice and a history of apnoea and episodes of retrocollis/opisthotonos. He had been only mildly jaundiced on discharge from the maternity clinic at 2 days of age. The total serum bilirubin (TSB) on admission was 542 µmol/L, and the infant was treated intensively with triple phototherapy and exchange transfusion. In contrast to what is recommended in Norwegian national guidelines for management of neonatal jaundice, the parents had apparently neither received oral nor written information about jaundice and its follow-up at the time of discharge from maternity. They therefore contacted their child healthcare centre when they had questions about jaundice, though the national guidelines specifically state that follow-up for neonatal jaundice during the first 2 weeks of life is the responsibility of the birth hospital. Inappropriate advice resulted in delayed referral, and the child has been diagnosed with chronic kernicterus, probably the first such case in Norway since national guidelines were formalised in 2006. Genetic work-up disclosed compound heterozygosity for Crigler-Najjar syndrome type I, to the best of our knowledge the first instance of this disorder ever to have been diagnosed in Norway. The incidence of kernicterus is Norway is much lower than in other industrialised countries. This is most likely due to national guidelines for management of neonatal jaundice, which place the responsibility for management and follow-up of jaundice with the birth hospital during the crucial first 2 weeks of life. This case report reminds us that tragedies may occur when guidelines are disregarded.

  1. 4 CFR 7.5 - Adverse actions: Suspensions for 14 days or less.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 4 Accounts 1 2012-01-01 2012-01-01 false Adverse actions: Suspensions for 14 days or less. 7.5... § 7.5 Adverse actions: Suspensions for 14 days or less. (a) Policy. A GAO employee may be suspended for 14 days or less for such cause as will promote the efficiency of GAO (including...

  2. 4 CFR 7.5 - Adverse actions: Suspensions for 14 days or less.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 4 Accounts 1 2014-01-01 2013-01-01 true Adverse actions: Suspensions for 14 days or less. 7.5... § 7.5 Adverse actions: Suspensions for 14 days or less. (a) Policy. A GAO employee may be suspended for 14 days or less for such cause as will promote the efficiency of GAO (including...

  3. Human Habitation in a Lunar Electric Rover During a 14-Day Field Trial

    NASA Technical Reports Server (NTRS)

    Litaker, Harry, Jr.; Thompson, Shelby; Howard, Robert, Jr.

    2010-01-01

    Various military and commercial entities, as well as the National Aeronautics and Space Administration (NASA), have conducted space cabin confinement studies. However, after an extensive literature search, only one study was found using a simulated lunar rover (LUNEX II), under laboratory conditions, with a crew of two for an eighteen day lunar mission. Forty-three years later, NASA human factors engineers conducted a similar study using the Lunar Electric Rover (LER) in a dynamic real-world lunar simulation at the Black Point Lava Flow in Arizona. The objective of the study was to obtain human-in-the-loop performance data on the vehicle s interior volume with respect to human-system interfaces, crew accommodations, and habitation over a 14-day mission. Though part of a larger study including 212 overall operational elements, this paper will discuss only the performance of fifty different daily habitational elements within the confines of the vehicle carried out by two male subjects. Objective timing data and subjective questionnaire data were collected. Results indicate, much like the LUNEX II study, the LER field study suggest that a crew of two was able to maintain a satisfactory performance of tasks throughout the 14-day field trail within a relative small vehicle volume.

  4. Comparison of 7 versus 14 days wrist actigraphy monitoring in a sleep disorders clinic population.

    PubMed

    Briscoe, Samantha; Hardy, Emma; Pengo, Martino F; Kosky, Christopher; Williams, Adrian J; Hart, Nicholas; Steier, Joerg

    2014-04-01

    Wrist actigraphy is a valid measure to assess sleep and circadian rhythm abnormalities. It is listed in the diagnostic criteria for sleep disorders where single night polysomnography is insufficient (ICSD-2). However, an optimal recording time remains unclear. We hypothesised that seven days would provide sufficient data for analysis, similar to recordings for 14 days. We analysed three consecutive years of actigraphy data obtained within a tertiary sleep referral centre. Data were recorded continuously for two weeks using an AW4 actiwatch (Cambridge NeuroTechnology, Cambridge, UK; Mini Mitter Co, Sunriver, OR). Parameters, including sleep efficiency (SE), sleep latency (SL), sleep fragmentation index (SFI), total sleep time (TST) and wake after sleep onset (WASO) were analysed using GraphPad Prism (Version 5.02, GraphPad Software Inc, San Diego, CA) and classified into week one, week two and an overall average for the duration of 14 days. In addition, two experienced consultants working in the sleep laboratory compared the results of week one versus week two independently, visually analysing the data for circadian rhythmicity and fragmentation of the pattern, allowing calculation of the intraclass correlation coefficient (ICC), κ. The actigraphies of 239 patients (51.9% male; age 42 (16) years) were analysed. There was no difference in SE, SL, SFI or WASO between week one, week two and 14 days average recording. A small difference was found between TST week one (399.9 minutes, 95% CI 389.9-409.9 minutes) and TST week two (388.7 minutes, 95% CI 378.3-399.1 minutes), but not between TST for 14 days average recording (394.3 minutes, 95% CI 384.7-403.9 minutes) and either week. Independent scorers achieved a good agreement in the rhythmicity of the sleep pattern (ICC κ 0.734, p < 0.001) and a low agreement for the fragmentation of the pattern (ICC κ 0.380, p < 0.001). One week of wrist actigraphy recording provides similar data to two week actigraphies, despite

  5. Report of 14-day bedrest simulation of Skylab

    NASA Technical Reports Server (NTRS)

    Johnson, P. C. (Compiler); Mitchell, C. (Compiler)

    1976-01-01

    Part one of a two-phase bedrest project in which the physiological effects of weightlessness were simulated is presented. The project was designed to approximate the medical testing and dietary control of Skylab. The test period included a three week pre-flight period, a two week bedrest period and a two week post-flight period. The test subjects ate measured amounts of the Skylab diet and drank deionized water to recreate the metabolic balance studies of Skylab. The medical testing program, pre- and postbedrest, was similar to that of Skylab including: lower body negative pressure testing the orthostatic intolerance noted after both spaceflights and bedrest, bicycle ergometry testing the cardiovascular response to graded exercise, postural equilibrium, vestibular studies and electromyograms. Fluid and electrolyte shifts and balance were documented with intake and output records and radionuclide studies. The subjects were observed by a psychiatrist who watched for signs of mental stress in the test environment and changes in mental status.

  6. Human embryos cultured in vitro to 14 days

    PubMed Central

    2017-01-01

    We know a great deal about the development of the mammalian embryo until the time that the blastocyst implants into the uterus. With model organisms such as the mouse, we have also developed a considerable understanding of development immediately around gastrulation as embryos can be recovered at this stage for short-term in vitro culture. However, the intervening period of development remained a ‘black box’ because it takes place as the blastocyst is implanting into the uterus. Over the past 6 years, techniques pioneered and developed in Magdalena Zernicka-Goetz's laboratory for the in vitro culture of embryos through these implantation stages have opened up this box, affording the first glimpse of embryonic development through these previously hidden stages. Remarkably, the techniques developed with mouse embryos are equally applicable to human embryos, ushering the very first opportunities for studying our own development throughout this time. Here, I outline how the culture methods were developed, paving the way to culture of the human embryo to the point of gastrulation, an accomplishment recognized as the People's Choice for the Scientific Breakthrough of 2016 in Science magazine. I also discuss the new ethical challenges raised by the possibility of extending the time limits for human embryo culture. PMID:28123056

  7. The 14-day repeated dose liver micronucleus test with methapyrilene hydrochloride using young adult rats.

    PubMed

    Inoue, Kenji; Ochi, Akimu; Koda, Akira; Wako, Yumi; Kawasako, Kazufumi; Doi, Takaaki

    2015-03-01

    The repeated dose liver micronucleus (RDLMN) assay using young adult rats has the potential to detect genotoxic hepatocarcinogens that can be integrated into a general toxicity study. The assay methods were thoroughly validated by 19 Japanese facilities. Methapyrilene hydrochloride (MP), known to be a non-genotoxic hepatocarcinogen, was examined in the present study. MP was dosed orally at 10, 30 and 100mg/kg/day to 6-week-old male Crl:CD (SD) rats daily for 14 days. Treatment with MP resulted in an increase in micronucleated hepatocytes (MNHEPs) with a dosage of only 100mg/kg/day. At this dose level, cytotoxicity followed by regenerative cell growth was noted in the liver. These findings suggest that MP may induce clastogenic effects indirectly on the liver or hepatotoxicity of MP followed by regeneration may cause increase in spontaneous incidence of MNHEPs.

  8. Effect of 14 days of bed rest on urine metabolite excretion and plasma enzyme levels

    NASA Technical Reports Server (NTRS)

    Pace, N.; Grunbaum, B. W.; Kodama, A. M.; Rahlmann, D. F.; Newsom, B. D.

    1974-01-01

    After 1 week of ambulatory base-line measurement, a group of 8 men 19-26 years of age remained continuously recumbent for 14 days. Studies were continued for 1 week following the prolonged recumbency. Urine excretion rates for a number of constituents were determined 2 days before bed rest, on day 14 of bed rest, and day 6 after bed rest. Blood plasma samples were also obtained at these times, and analyzed for several enzymes. On day 14 of bed rest significant increases were observed in urine excretion of total osmotically-active substances, magnesium, calcium, phosphate, creatinine, hydroxyproline, and 17-OH corticosteroids. A decrease occurred in urinary glucose excretion. Plasma levels of alkaline phosphatase and LDH-3 were depressed, while plasma GPT was elevated. Many of these changes persisted on day 6 after bed rest, and are interpreted as concomitants of the disuse atrophy of the musculoskeletal system that characterizes prolonged bed rest and weightlessness.

  9. Evaluation of persistence of terbinafine in the hair of normal cats after 14 days of daily therapy.

    PubMed

    Foust, Abby L; Marsella, Rosanna; Akucewich, Lisa H; Kunkle, Gail; Stern, Amy; Moattari, Syamak; Szabo, Nancy J

    2007-08-01

    This study determined the residual concentration of terbinafine in cat hair after 14 days of oral treatment. Ten clinically normal cats were administered terbinafine orally at a daily dose of 34-45.7 mg kg(-1) for a total of 14 days. Areas of 15 cm(2) were shaved on the lateral thorax at day 0 and weekly for 8 weeks after the last dose of terbinafine. The hair samples were analysed by high-pressure liquid chromatography to determine the persistence of terbinafine over time. The mean terbinafine concentration in hair was 2.30 ng mg(-1) after 14 days of therapy. The half life was 1.84 weeks after the last dose of terbinafine. With a 99% confidence interval, the concentration of terbinafine remained in the cat hair at or above 0.03 ng mg(-1) (minimal inhibitory concentration (MIC)(90) = 0.03 microg mL(-1)) for 5.3 weeks. Slight deviations in the complete blood cell count and serum chemistry values were not attributed to terbinafine. Four cats experienced vomiting during the terbinafine treatment; two of these cats also experienced intense facial pruritus followed by a macular to papular skin reaction 7-14 days after the discontinuation of terbinafine. In summary, terbinafine persists in hair at concentrations above the MIC for several weeks after stopping medication, even after short-term therapy (14 days). These results suggest that pulse therapy of terbinafine should be further researched and potentially considered as a treatment modality for feline dermatophytosis, an approach that would decrease treatment duration while maintaining effectiveness.

  10. Local versus whole-body sweating adaptations following 14 days of traditional heat acclimation.

    PubMed

    Poirier, Martin P; Gagnon, Daniel; Kenny, Glen P

    2016-08-01

    The purpose of this study was to examine if local changes in sweat rate following 14 days of heat acclimation reflect those that occur at the whole-body level. Both prior to and following a 14-day traditional heat acclimation protocol, 10 males exercised in the heat (35 °C, ∼20% relative humidity) at increasing rates of heat production equal to 300 (Ex1), 350 (Ex2), and 400 (Ex3) W·m(-2). A 10-min recovery period followed Ex1, while a 20-min recovery period separated Ex2 and Ex3. The exercise protocol was performed in a direct calorimeter to measure whole-body sweat rate and, on a separate day, in a thermal chamber to measure local sweat rate (LSR), sweat gland activation (SGA), and sweat gland output (SGO) on the upper back, chest, and mid-anterior forearm. Post-acclimation, whole-body sweat rate was greater during each exercise bout (Ex1: 14.3 ± 0.9; Ex2: 17.3 ± 1.2; Ex3: 19.4 ± 1.3 g·min(-1), all p ≤ 0.05) relative to pre-acclimation (Ex1: 13.1 ± 0.6; Ex2: 15.4 ± 0.8; Ex3: 16.5 ± 1.3 g·min(-1)). In contrast, only LSR on the forearm increased with acclimation, and this increase was only observed during Ex2 (Post: 1.32 ± 0.33 vs. Pre: 1.06 ± 0.22 mg·min(-1)·cm(-2), p = 0.03) and Ex3 (Post: 1.47 ± 0.41 vs. Pre: 1.17 ± 0.23 mg·min(-1)·cm(-2), p = 0.05). The greater forearm LSR post-acclimation was due to an increase in SGO, as no changes in SGA were observed. Overall, these data demonstrate marked regional variability in the effect of heat acclimation on LSR, such that not all local measurements of sweat rate reflect the improvements observed at the whole-body level.

  11. Evidence for increased beta-adrenoreceptor responsiveness induced by 14 days of simulated microgravity in humans

    NASA Technical Reports Server (NTRS)

    Convertino, V. A.; Polet, J. L.; Engelke, K. A.; Hoffler, G. W.; Lane, L. D.; Blomqvist, C. G.; Eckberg, D. L. (Principal Investigator)

    1997-01-01

    We studied hemodynamic responses to alpha- and beta-receptor agonists in eight healthy men before and after 14 days of 6 degrees head-down tilt (HDT) to test the hypothesis that increased adrenoreceptor responsiveness is induced by prolonged exposure to simulated microgravity. Steady-state infusions of isoproterenol (Iso) at rates of 0.005, 0.01, and 0.02 microgram.kg-1.min-1 were used to assess beta 1- and beta 2-adrenoreceptor responsiveness. Infusions of phenylephrine (PE) at rates of 0.25, 0.50, and 1.00 microgram.kg-1.min-1 were used to assess responsiveness of alpha 1-vascular adrenoreceptors. Slopes calculated from linear regressions between Iso and PE doses and changes in beat-to-beat heart rate, blood pressure, and leg vascular resistance (occlusion plethysmography) for each subject were used as an index of alpha- and beta-adrenoreceptor responsiveness. HDT increased the slopes of heart rate (1,056 +/- 107 to 1,553 +/- 83 beats micrograms-1.kg-1.min-1; P = 0.014) and vasodilation (-469 +/- 111 to -1,446 +/- 309 peripheral resistance units.microgram-1.kg-1.min-1; P = 0.0224) to Iso infusion. There was no alteration in blood pressure or vascular resistance responses to PE infusion after HDT. Our results provide evidence that simulated microgravity causes selective increases in beta 1- and beta 2-adrenoreceptor responsiveness without affecting alpha 1-vascular adrenoreceptor responses.

  12. Influence of 14-day hind limb unloading on isolated muscle spindle activity in rats.

    PubMed

    Zhao, Xue Hong; Fan, Xiao Li; Song, Xin Ai; Wu, Su Di; Ren, Jun Chan; Chen, Ming Xia

    2010-09-01

    During hind limb unloading (HU), the soleus is often in a shortened position and the natural physiological stimulus of muscle spindles is altered, such that muscle spindle activity also changes. Using isolated spindle conditions, the present study investigates the electrophysiological activity and ultrastructure of muscle spindles following HU. Results show that muscle spindle discharges fall into either of two main patterns, single spikes or spike clusters in shortened positions, with a steady frequency of 18-38 spikes/s (mean 29.08 +/- 2.45) in an extended position. Following 14-day HU, afferent discharge activity was significantly altered in soleus muscle spindles. Duration of individual spikes was significantly prolonged, from 0.54 +/- 0.05 ms for control rats to 1.53 +/- 0.25 ms for rats in the HU group. In a shortened position, regular rhythm afferent discharges were obviously depressed, and the majority of muscle spindles became silent, while in an extended position, the discharges remained continuous but with decreased frequency. Results also show that the ultrastructure of muscle spindles experience degenerative changes during HU. Altered muscle spindle afference could possibly modify the activity of motor neurons and further affect the activity of extrafusal fibers.

  13. Changes in prevalence of subjective fatigue during 14-day 6° head-down bed rest

    NASA Astrophysics Data System (ADS)

    Hirayanagi, Kaname; Natsuno, Toyoki; Shiozawa, Tomoki; Yamaguchi, Nobuhisa; Watanabe, Yoriko; Suzuki, Satomi; Iwase, Satoshi; Mano, Tadaaki; Yajima, Kazuyoshi

    2009-06-01

    The present study examines the prevalence of subjective fatigue in young healthy males during 14 days of 6° head-down bed rest (HDBR) by using a multidimensional questionnaire. Forty-one subjects completed the Subjective Fatigue Scale questionnaire to assess the fatigue-related complaints and symptoms. The questionnaire is composed of three sections, with 10 items each. The sections measured drowsiness and dullness (Section 1), difficulty in concentration (Section 2), and the projection of physical disintegration (Section 3). The subjects answered simple questions between 1400 and 1700 on 6 measurement days before and during the HDBR period. The prevalence rate of low back pain was markedly high (80.5%) on the second day and more than 50% in the first half of the HDBR period, and any complaints related to either a lack of sleep or a deterioration in the quality of sleep continued until the end of the HDBR period. Our findings may be useful in developing preventive strategies against physical and mental fatigue associated with prolonged HDBR, horizontal bed rest, and microgravity environments.

  14. Fiber size and myosin phenotypes of selected rhesus lower limb muscles after a 14-day spaceflight

    NASA Technical Reports Server (NTRS)

    Roy, R. R.; Zhong, H.; Bodine, S. C.; Pierotti, D. J.; Talmadge, R. J.; Barkhoudarian, G.; Kim, J.; Fanton, J. W.; Kozlovskaya, I. B.; Edgerton, V. R.

    2000-01-01

    Muscle biopsies were taken from the rhesus (Macaca mulatta) soleus (Sol, a slow ankle extensor), medial gastrocnemius (MG, a fast ankle extensor), tibialis anterior (TA, a fast ankle flexor), and vastus lateralis (VL, a fast knee extensor) muscles in vivarium controls (n=5) before and after either a 14-day spaceflight (Bion 11, n=2) or a 14-day ground-based flight simulation (n=3). Myosin heavy chain (MHC) composition (gel electrophoresis), fiber type distribution (immunohistochemistry), and fiber size were determined. Although there were no significant changes, each muscle showed trends towards adaptation.

  15. 4 CFR 7.5 - Adverse actions: Suspensions for 14 days or less.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... therefor, and any order effecting the suspension, together with any supporting material, shall be... 4 Accounts 1 2010-01-01 2010-01-01 false Adverse actions: Suspensions for 14 days or less. 7.5 Section 7.5 Accounts GOVERNMENT ACCOUNTABILITY OFFICE PERSONNEL SYSTEM PERSONNEL RELATIONS AND...

  16. Evidence for Increased Beta-Adrenoreceptor Responsiveness Induced by 14 Days of Simulated Microgravity in Humans

    NASA Technical Reports Server (NTRS)

    Convertino, Victor A.; Polet, Jill L.; Engelke, Keith A.; Hoffler, G. W.; Lane, Lynda D.

    1996-01-01

    We studied hemodynamic responses to alpha and beta receptor agonists in 8 healthy men ( 38+- 2 yrs) before and after 14 days of 6 degree head-down tilt (HDT) to test the hypothesis that increased adrenergic responsiveness is induced by prolonged exposure to microgravity. Immediately following a 30-min baseline period, a steady-state infusion of isoproterenol (ISO) was used to assess beta 1- and beta 2-adrenergic responsiveness. ISO was infused at three graded constant rates of 0.005, 0.01 and 0.02 ug/kg/min. After heart rate and blood pressure had been allowed to return to baseline levels following ISO infusion graded infusion of phenylephrine (PE) was used to assess responsiveness of alpha I-vascular receptors. PE was infused at three graded constant rates of 0.25, 0.50 and 1.00 ug/kg/min. Each infusion interval for both drugs was 9 min. During the infusions, constant monitoring of beat-to-beat blood pressure and heart rate was performed and leg blood flow was measured with occlusion plethysmography at each infusion level. The slopes calculated from linear regressions between ISO and PE doses and changes in heart rate, blood pressure, and leg vascular resistance for each subject were used to represent alpha- and beta- adrenoreceptor responsiveness. Fourteen days HDT increased the slopes of heart rate (1056 +- 107 to 1553 +- 83 beats/ug/kg/min; P= 0.014) and vasodilation (-469ft +- 111 to -l446 +- 309 PRU/ug/kg/min; P =0.0224) to ISO infusion. There was no alteration in blood pressure or vascular resistance responses to PE infusion after HDT. Our results provide evidence that microgravity causes selective increases in beta 1- and beta 2-adrenergic responsiveness without affecting alpha 1-vascular responses.

  17. Biomedical analysis of rat body hair after hindlimb suspension for 14 days

    NASA Astrophysics Data System (ADS)

    Terada, Masahiro; Kawano, Fuminori; Ishioka, Noriaki; Higashibata, Akira; Majima, Hideyuki J.; Yamazaki, Takashi; Watanabe-Asaka, Tomomi; Niihori, Maki; Nakao, Reiko; Yamada, Shin; Mukai, Chiaki; Ohira, Yoshinobu

    2012-04-01

    The levels of 26 minerals in rat body hair were analyzed in control and hindlimb-suspended Wistar Hannover rats (n=5 each). We quantified the levels of 22 minerals in this experiment. However, we were unable to measure the levels of 4 minerals (Be, V, Cd, and Hg) quantitatively because they were below the limit of detection. Of the 22 quantified, the levels of 19 minerals were not significantly different between control and hindlimb-suspended groups. The levels of 3 minerals (Pb, Cr, and Al) tended to be higher in the hindlimb-suspended group than in the control group; however, this difference was not significant. The concentrations of 3 other minerals (I, K, and Mg) were significantly different between the 2 groups. The iodine (I) level was 58.2% higher in the hindlimb-suspended group than in the control group (P<0.05). Potassium (K) and magnesium (Mg) levels were 55.2% and 20.4% lower, respectively, in the experimental group (P<0.05 in both cases). These results indicate that a physiological change in mineral metabolism resulting from physical or mental stress, such as hindlimb suspension, is reflected in body hair. The Japan Aerospace Exploration Agency (JAXA) has initiated a human research study to investigate the effects of long-term space flight on gene expression and mineral metabolism by analyzing hair samples of astronauts who stayed in the International Space Station (ISS) for 6 months. We believe that hindlimb suspension for 14 days can simulate the effects of an extremely severe environment, such as space flight, because the hindlimb suspension model elicits a rapid physiological change in skeletal muscle, bone, and fluid shift even in the short term. These results also suggest that we can detect various effects on the body by analyzing the human scalp hair shaft.

  18. Short term (14 days) consumption of insoluble wheat bran fibre-containing breakfast cereals improves subjective digestive feelings, general wellbeing and bowel function in a dose dependent manner.

    PubMed

    Lawton, Clare L; Walton, Jenny; Hoyland, Alexa; Howarth, Elaine; Allan, Peter; Chesters, David; Dye, Louise

    2013-04-22

    This study investigated whether increasing insoluble (predominantly wheat bran) fibre over 14 days improves subjective digestive feelings, general wellbeing and bowel function. A single centre, multi-site, open, within subjects design with a 14 day non-intervention (baseline) monitoring period followed by a 14 day fibre consumption (intervention) period was performed. 153 low fibre consumers (<15 g/day AOAC 985.29) completed a daily symptom diary for 14 days after which they consumed one bowl of ready-to-eat breakfast cereal containing at least 5.4 g fibre (3.5 g from wheat bran) for 14 days and completed a daily symptom diary. Significant improvements were demonstrated in subjective perception of bowel function (e.g., ease of defecation) and digestive feelings (bloating, constipation, feeling sluggish and digestive discomfort). Significant improvements were also found in subjective perception of general wellbeing (feeling less fat, more mentally alert, slim, happy and energetic whilst experiencing less stress, mental and physical tiredness, difficulty concentrating and fewer headaches). In general, improvements in study outcomes increased with increasing cereal/fibre consumption. However, consuming an additional minimum 5.4 g of fibre (3.5 g wheat bran) per day was shown to deliver measurable and significant benefits for digestive health, comfort and wellbeing. Encouraging consumption of relatively small amounts of wheat bran could also provide an effective method of increasing overall fibre consumption.

  19. Detecting laser-range-finding signals in surveying converter lining based on wavelet transform

    NASA Astrophysics Data System (ADS)

    Li, Hongsheng; Yang, Xiaofei; Shi, Tielin; Yang, Shuzi

    1998-08-01

    The precision of the laser range finding subsystem has important influences on the performances of the whole measurement system applied to survey the steelmaking converter lining erosion state. In the system, the object of laser beams is some rough lighting surfaces in high temperature. the laser range finding signals to reach the microcomputer system would be submerged in intense disturb environments. Common laser range finding devices could not work normally. This paper presents a method based on the wavelet transform to test solving the problem. The idea of this method includes encoding the measuring signals, decomposing the encoded received signals of components in different frequency scales and time domains by the wavelet transform method, extracting the features of encoded signals according to queer points to confirm the arrival of signals, and accurately calculating out the measured distances. In addition, the method is also helpful to adopt some digital filter algorithms in time. It could make further in improvement on the precision.

  20. Design and simulation of a mixer and phase difference measuring circuitry for laser range finding systems

    NASA Astrophysics Data System (ADS)

    Liu, Guili; Wang, Yanlin; Liu, Gang

    2006-11-01

    This article focuses on the circuit implementation of a mixer and phase difference measurement for laser range finding systems. It will introduce simply the principle of the laser range finding system, which is the basis of the electronic circuitry design. The modulated laser lights of two different frequencies are mixed and the phase difference is detected in order to measure the range. The method of measuring the range is to use the mixer and the phase difference detector. The new and high precision IC that has a high quality makes the circuit simple and reliable. The circuit of the mixer and the phase difference detector for laser range finding systems is designed using AD608 and AD8302 chips.

  1. Adaptations of young adult rat cortical bone to 14 days of spaceflight

    NASA Technical Reports Server (NTRS)

    Vailas, A. C.; Vanderby, R., Jr.; Martinez, D. A.; Ashman, R. B.; Ulm, M. J.; Grindeland, R. E.; Durnova, G. N.; Kaplanskii, A.

    1992-01-01

    To determine whether mature humeral cortical bone would be modified significantly by an acute exposure to weightlessness, adult rats (110 days old) were subjected to 14 days of microgravity on the COSMOS 2044 biosatellite. There were no significant changes in peak force, stiffness, energy to failure, and displacement at failure in the flight rats compared with ground-based controls. Concentrations and contents of hydroxyproline, calcium, and mature stable hydroxylysylpyridinoline and lysylpyridinoline collagen cross-links remained unchanged after spaceflight. Bone lengths, cortical and endosteal areas, and regionl thicknesses showed no significant differences between flight animals and ground controls. The findings suggest that responsiveness of cortical bone to microgravity is less pronounced in adult rats than in previous spaceflight experiments in which young growing animals were used. It is hypothesized that 14 days of spaceflight may not be sufficient to impact the biochemical and biomechanical properties of cortical bone in the mature rat skeleton.

  2. Integrated Resistance and Aerobic Training Maintains Cardiovascular and Skeletal Muscle Fitness During 14 Days of Bed Rest

    NASA Technical Reports Server (NTRS)

    Ploutz-Snyder, Lori; Goetchius, Elizabeth; Crowell, Brent; Hackney, Kyle; Wickwire, Jason; Ploutz-Snyder, Robert; Snyder, Scott

    2012-01-01

    Background: Known incompatibilities exist between resistance and aerobic training. Of particular importance are findings that concurrent resistance and aerobic training reduces the effectiveness of the resistance training and limits skeletal muscle adaptations (example: Dudley & Djamil, 1985). Numerous unloading studies have documented the effectiveness of resistance training alone for the maintenance of skeletal muscle size and strength. However the practical applications of those studies are limited because long ]duration crew members perform both aerobic and resistance exercise throughout missions/spaceflight. To date, such integrated training on the International Space Station (ISS) has not been fully effective in the maintenance of skeletal muscle function. Purpose: The purpose of this study was to evaluate the efficacy of high intensity concurrent resistance and aerobic training for the maintenance of cardiovascular fitness and skeletal muscle strength, power and endurance over 14 days of strict bed rest. Methods: 9 subjects (8 male and 1 female; 34.5 +/- 8.2 years) underwent 14 days of bed rest with concurrent training. Resistance and aerobic training were integrated as shown in table 1. Days that included 2 exercise sessions had a 4-8 hour rest between exercise bouts. The resistance training consisted of 3 sets of 12 repetitions of squat, heel raise, leg press and hamstring curl exercise. Aerobic exercise consisted of periodized interval training that included 30 sec, 2 min and 4 min intervals alternating by day with continuous aerobic exercise.

  3. NASA 14 Day Undersea Missions: A Short-Duration Spaceflight Analog for Immune System Dysregulation

    NASA Technical Reports Server (NTRS)

    Crucian, B. E.; Stowe, R. P.; Mehta, S. K.; Quiriarte, H.; Pierson, D. L.; Sams, C. F.

    2010-01-01

    BACKGROUND Spaceflight-associated immune dysregulation (SAID) occurs during spaceflight and may represent specific clinical risks for exploration-class missions. An appropriate ground analog for spaceflight-associated immune dysregulation would offer a platform for ground-evaluation of various potential countermeasures. This study evaluated the NASA Undersea Mission Operations ( NEEMO ), consisting of 14 day undersea deployment at the Aquarius station, as an analog for SAID. Sixteen Aquanauts from missions NEEMO-12, 13 and 14 participated in the study. RESULTS Mid-mission alterations leukocyte distribution occurred, including granulocytosis and elevations in central-memory CD8+ T-cells. General T cell function was reduced during NEEMO missions in roughly 50% of subjects. Secreted cytokines profiles were evaluated following whole blood stimulation with CD3/CD28 (T cells) or LPS (monocytes). T cell production of IFNg, IL-5, IL-10, IL-2, TNFa and IL-6 were all reduced before and during the mission. Conversely, monocyte production of TNFa, IL-10, IL-6, IL-1b and IL-8 were elevated during mission, moreso at the MD-14 timepoint. Antibodies to Epstein-Barr virus (EBV) viral capsid antigen and early antigen were increased in approximately 40% of the subjects. Changes in EBV tetramer-positive CD8+ T-cells exhibited a variable pattern. Antibodies against Cytomegalovirus (CMV) were marginally increased during the mission. Herpesvirus reactivation was determined by PCR. EBV viral load was generally elevated at L-6. Higher levels of salivary EBV were found during the NEEMO mission than before and after as well as than the healthy controls. No VZV or CMV was found in any pre, during and after NEEMO mission or control samples. Plasma cortisol was elevated at L-6. CONCLUSION Unfortunately, L-6 may be too near to mission start to be an appropriate baseline measurement. The general immune changes in leukocyte distribution, T cell function, cytokine production, virus specific

  4. Comparison of soleus muscles from rats exposed to microgravity for 10 versus 14 days

    NASA Technical Reports Server (NTRS)

    Staron, R. S.; Kraemer, W. J.; Hikida, R. S.; Reed, D. W.; Murray, J. D.; Campos, G. E.; Gordon, S. E.

    1998-01-01

    The effects of two different duration space-flights on the extent of atrophy, fiber type composition, and myosin heavy chain (MHC) content of rat soleus muscles were compared. Adult male Fisher rats (n=12) were aboard flight STS-57 and exposed to 10 days of microgravity and adult ovariectomized female Spraque-Dawley rats (n=12) were aboard flight STS-62 for 14 days. Soleus muscles were bilaterally removed from the flight and control animals and frozen for subsequent analyses. Muscle wet weights, fiber types (I, IC, IIC, and IIA), cross-sectional area, and MHC content were determined. Although a significant difference was found between the soleus wet weights of the two ground-based control groups, they were similar with regard to MHC content (ca 90% MHCI and ca 10% MHCIIa) and fiber type composition. Unloading of the muscles caused slow-to-fast transformations which included a decrease in the percentage of type I fibers and MHCI, an increase in fibers classified as type IC, and the expression of two fast myosin heavy chains not found in the control rat soleus muscles (MHCIId and MHCIIb). Although the amount of atrophy (ca 26%) and the extent of slow-to-fast transformation (decrease in the percentage of MHCI from 90% to 82.5%) in the soleus muscles were similar between the two spaceflights, the percentages of the fast MHCs differed. After 14 days of spaceflight, the percentage of MHCIIa was significantly lower and the percentages of MHCIId and MHCIIb were significantly higher than the corresponding MHC content of the soleus muscles from the 10-day animals. Indeed, MHCIId became the predominant fast MHC after 14 days in space. These data suggest fast-to-faster transformations continued during the longer spaceflight.

  5. Changes in recruitment of Rhesus soleus and gastrocnemius muscles following a 14 day spaceflight

    NASA Technical Reports Server (NTRS)

    Hodgson, J. A.; Bodine-Fowler, S. C.; Roy, R. R.; De Leon, R. D.; De Guzman, C. P.; Koslovskaia, I.; Sirota, M.; Edgerton, V. R.

    1991-01-01

    The effect of microgravity on the recruitment patterns of the soleus, gastrocnemius, and tibialis-anterior muscles was investigated by comparing electromyograms (EMGs) of these muscles of Rhesus monkeys implanted with EMG electrodes, taken before and after a 14-day flight on board Cosmos 2044. It was found that the EMG amplitude values in the soleus muscle decreased after the spaceflight but returned to normal values over the 2-wk recovery period. The medial amplitudes of gastrocnemius and tibialis anterior were not changed by flight. Joint probability density distributions displayed changes after flight in both the soleus and gastrocnemius muscles, but not in tibialis anterior.

  6. Effect of high sodium intake during 14 days of bed-rest on acid-base balance

    NASA Astrophysics Data System (ADS)

    Frings, P.; Baecker, N.; Heer, M.

    Lowering mechanical load like in microgravity is the dominant stimulus leading to bone loss However high dietary sodium intake is also considered as a risk factor for osteoporosis and thereby might exacerbate the microgravity induced bone loss In a metabolic balance non bed-rest study we have recently shown that a very high sodium intake leads to an increased bone resorption most likely because of a mild metabolic acidosis Frings et al FASEB J 19 5 A1345 2005 To test if mild metabolic acidosis also occurs during immobilization we examined the effect of increased dietary sodium on bone metabolism and acid-base balance in eight healthy male test subjects mean age 26 25 pm 3 49 years body weight 77 98 pm 4 34 kg in our metabolic ward during a 14-day head-down tilt HDT bed-rest study The study was designed as a randomized crossover study with two study periods Each period was divided into three parts 4 ambulatory days with 200 mmol sodium intake 14 days of bed-rest with either 550 mmol or 50 mmol sodium intake and 3 recovery days with 200 mmol sodium intake The sodium intake was altered by variations in dietary sodium chloride content Blood pH P CO2 and P O2 were analyzed in fasting morning fingertip blood samples several times during the entire study Bicarbonate HCO 3 - and base excess BE were calculated according to the Henderson-Hasselbach equation Preliminary results in the acid-base balance from the first study period 4 subjects with 550 mmol and 4 subjects with 50 mmol sodium intake strongly

  7. Efficacy of 7-Day and 14-Day Bismuth-Containing Quadruple Therapy and 7-Day and 14-Day Moxifloxacin-Based Triple Therapy as Second-Line Eradication for Helicobacter pylori Infection

    PubMed Central

    Lee, Seong tae; Lee, Dong Ho; Lim, Ji Hyun; Kim, Nayoung; Park, Young Soo; Shin, Cheol Min; Jo, Hyun Jin; Song, In sung

    2015-01-01

    Background/Aims Bismuth-containing quadruple and moxifloxacin-based triple regimens are recommended as second-line therapy for Helicobacter pylori infection. The aim of this study was to compare the efficacy of each regimen. Methods From August 2004 to October 2012, a total of 949 patients (mean age, 54.32±12.08 years; male, 49.4%) who failed H. pylori eradication with a standard triple regimen were included. Patients treated with a bismuth-containing quadruple regimen for 7 and 14 days were designated as 7-BMT and 14-BMT, respectively, and those treated with a moxifloxacin-based triple regimen for 7 and 14 days were designated as 7-MA and 14-MA, respectively. H. pylori eradication was confirmed using the 13C-urea breath test, rapid urease test or histology. Results The eradication rates by 7-BMT, 14-BMT, 7-MA, and 14-MA were 66.4% (290/437), 71.1% (113/159), 53.1% (51/96), and 73.5% (189/257), respectively, by intention-to-treat analysis (ITT) and 76.5% (284/371), 83.8% (109/130), 55.6% (50/90), and 80.6% (187/232), respectively, by per-protocol analysis (PP). The eradication rates were higher in 14-BMT than 7-BMT by the ITT and PP analyses (p=0.277 and p=0.082, respectively). The 14-BMT and 14-MA treatments showed similar efficacies by ITT and PP (p=0.583 and p=0.443, respectively). Conclusions The 7-BMT, 14-BMT, and 14-MA treatments showed similar and suboptimal efficacies. In both regimens, extending the duration of treatment may be reasonable considering the high level of antibiotic resistance in Korea. PMID:25071068

  8. Hemodynamics, renal function, plasma renin, and aldosterone in man after 5 to 14 days of bedrest

    NASA Technical Reports Server (NTRS)

    Melada, G. A.; Goldman, R. H.; Luetscher, J. A.; Zager, P. G.

    1975-01-01

    Continuous bedrest for 5 to 14 days had no significant effect on resting heart rate, blood pressure, or cardiac output in six normal men. Head-up tilt induced greater tachycardia in 5 of 6 patients after bed rest than in the control period. Propranolol diminished both tachycardia and the incidence of hypotension and faintness in upright posture. Plasma volume fell, extracellular fluid volume increased, and plasma renin activity was significantly elevated following bedrest. Unusually large increases in plasma renin followed head-up tilt or administration of isoproterenol during bedrest and after resuming normal activity. During bedrest, plasma aldosterone was often increased in the early morning. It is concluded that after bedrest, upright posture evokes strong beta-adrenergic activity as well as exaggerated metabolic and circulatory responses which can be reduced or abolished by the beta-adrenergic blocker, propranolol.

  9. Bone resorption starts at 14 days of treatment with gonadotropin-releasing hormone agonist in in vitro fertilization cycles.

    PubMed

    Yilmaz, H; Ozgur, K; Isikoglu, M; Sonmez, C; Uner, M

    2004-07-01

    The effect of gonadotropin-releasing hormone agonist (GnRH-a) use on bone turnover was investigated in a prospective cohort study of female patients undergoing in vitro fertilization (IVF) treatment. In 46 couples diagnosed with male-factor infertility, the women underwent a long step-down ovulation induction protocol. Urinary cross-linked N-telopeptide (uNTx) level was used to demonstrate bone turnover rate and was measured at the first day of GnRH-a administration, the first day of gonadotropin administration, the day after human chorionic gonadotropin injection and 12 days after embryo transfer. Urinary NTx levels (mean+/-standard deviation (SD)) were 71+/-34, 81+/-40, 81+/-50 and 83+/-47 nmol BCE/mmol creatinine (BCE, bone collagen equivalents), respectively. There was no statistically significant difference between the four measurements (p = 0.28). In 19 women GnRH-a was administered for > or = 14 days. Urinary NTx values of this group and the remaining 27 patients after GnRH-a treatment were 96.2+/-40.7 and 71.5+/-36.8 nmol BCE/mmol creatinine (mean+/-SD), respectively. The difference between these groups was statistically significant (p=0.038). These findings suggest that < 14 days' use of GnRH agonist in IVF patients has no effect on bone metabolism. To our knowledge, this is the first study demonstrating that the effect of agonists on bone metabolism starts as soon as estradiol suppression has started.

  10. Daily Supine LBNP Treadmill Exercise Maintains Upright Exercise Capacity During 14 Days of Bed Rest

    NASA Technical Reports Server (NTRS)

    Ertl, Andy C.; Watenpaugh, D. E.; Hargens, Alan R.; Fortney, S. M.; Lee, S. M. C.; Ballard, R. E.; William, J. M.

    1996-01-01

    Exposure to microgravity or bed rest reduces upright exercise capacity. Exercise modes, durations, and intensities which will effectively and efficiently counteract such deconditioning are presently unresolved. We that daily supine treadmill interval training with lower body negative pressure (LBNP) would prevent reduction in upright exercise capacity during 14 days of 6 deg. head-down bed rest (BR). Eight healthy male subjects underwent two 14 day BR protocols separated by 3 months. In a crossover design, subjects either remained at strict BR or performed 40 min of daily exercise consisting of supine walking and running at intensities varying from 40-80% of pre-BR upright peak oxygen uptake (VO2). LBNP during supine exercise was used to provide 1.0 to 1.2 times body weight of footward force. An incremental upright treadmill test to measure submaximal and peak exercise responses was given pre- and post-BR. In the non-exercise condition, peak VO2 and time to exhaustion were reduced 16 +/- 4% and 10 +/- 1% (p less than 0.05), respectively, from pre-BR. With LBNP exercise these variables were not significantly different (NS) from pre-BR. During submaximal treadmill speeds after BR, heart rate was higher (11 +/- 11 bpm, p less than 0.05) and respiratory exchange ratio was elevated (p less than 0.05) in the no exercise condition. Both were maintained at pre-BR levels in the LBNP exercise condition (NS from pre-BR). Since this supine treadmill interval training with addition of LBNP maintained upright exercise responses and capacity during BR, this countermeasure may also be effective during space flight.

  11. Two Week Oral Dose Range-Finding Toxicity Study of WR242511 in Rats

    DTIC Science & Technology

    1993-07-08

    oximeter (Instrumentation Laboratory Model 282). The assay was performed within one hour of sample collection. The specimens were kept on wet ice prior...were observed. Percent purity of initial WR242511 sample was found to be 99.51%, standard deviation - 0.02%, follow 99.59% ± 0.04%. The assay results...Ciba-Corning 550 Express Clinical Chemistry System Larsen. K. Clin. Chem. Acta, 41, 209, 1972 Total Protein Biuret technique Ciba-Corning 550

  12. Four Week Oral Dose Range-Finding Study of WR242511 in Dogs

    DTIC Science & Technology

    1994-03-09

    Laboratory, Model No. 282). The assay was performed within one-hour of sample collection. The specimens were kept on wet ice prior to analysis...this protein, which is synthesized by hepatocytes, is indicative of an inflammatory response, i.e. an acute phase reaction . Dose-dependent anemia, as...apparent decreases in the A/G ratio, and increases in serum haptoglobin levels, indicative of an acute phase reaction . In the lung, WR242511 resulted in

  13. Four Week Oral (Gavage) Dose Range-Finding Study of Halofantrine Hydrochloride in Mice

    DTIC Science & Technology

    1994-10-26

    Because marginal halofantrine- induced toxicity was seen in low dose females, the following dose level ranges are suggested: 1 - 2, 4 - 8 and 15-30 mg/kg...halofantrine- induced toxicity was seen in low dose females, the following dose level ranges are suggested: 1 - 2, 4 - 8 and 15-30 mg/kg/day. 2...selected on the basis of Sponsor-supplied subchronic toxicity data in rats and following discussions with the Sponsor. During the test animal selection

  14. Two Week Oral Dose Range-Finding Toxicity Study of WR269410 in Rats

    DTIC Science & Technology

    1993-07-09

    Clin. Chem. Acta, 4_L 209, 1972 Total Protein Biuret technique Ciba-Corning 550 Express Clinical Chemistry System Kingsley, G.J. Lab. Clin. Med. 27...Triglvcerides Methodology of Nagele, et al & a final Trinder reaction . Ciba-Corning 550 Express Clinical Chemistry System Nagele, U., Hagele, E. O., et al

  15. Changes in cold tolerance due to a 14-day stay in the Canadian Arctic

    NASA Astrophysics Data System (ADS)

    Livingstone, S. D.; Romet, T.; Keefe, A. A.; Nolan, R. W.

    1996-12-01

    Responses to cold exposure tests both locally and of the whole body were examined in subjects who stayed in the Arctic (average maximum and minimum temperatures -11 and -21° C respectively) for 14 days of skiing and sleeping in tents. These changes were compared to responses in subjects living working in Ottawa, Canada (average max. and min. temperatures -5 and -11° C respectively). The tests were done before the stay in the Arctic (Pre), immediately after the return (Post 1) and approximately 32 days after the return (Post 2). For the whole-body cold exposure each subject, wearing only shorts and lying on a rope mesh cot, was exposed to an ambient temperature of 10° C. There was no consistent response in the changes of metabolic or body temperature to this exposure in either of groups and, in addition, the changes over time were variable. Cold induced vasodilatation (CIVD) was determined by measuring temperature changes in the middle finger of the nondominant hand upon immersion in ice water for 30 min. CIVD was depressed after the Arctic exposure whilst during the Post 2 testing, although variable, did not return to the Pre values; the responses of the control group were similar. These results indicate that normal seasonal changes may be as important in adaptation as a stay in the Arctic. Caution is advised in the separation of seasonal effects when examining the changes in adaptation after exposure to a cold environment.

  16. Validation of CRASH Model in Prediction of 14-day Mortality and 6-month Unfavorable Outcome of Head Trauma Patients

    PubMed Central

    Hashemi, Behrooz; Amanat, Mahnaz; Baratloo, Alireza; Forouzanfar, Mohammad Mehdi; Rahmati, Farhad; Motamedi, Maryam; Safari, Saeed

    2016-01-01

    Introduction: To date, many prognostic models have been proposed to predict the outcome of patients with traumatic brain injuries. External validation of these models in different populations is of great importance for their generalization. The present study was designed, aiming to determine the value of CRASH prognostic model in prediction of 14-day mortality (14-DM) and 6-month unfavorable outcome (6-MUO) of patients with traumatic brain injury. Methods: In the present prospective diagnostic test study, calibration and discrimination of CRASH model were evaluated in head trauma patients referred to the emergency department. Variables required for calculating CRASH expected risks (ER), and observed 14-DM and 6-MUO were gathered. Then ER of 14-DM and 6-MUO were calculated. The patients were followed for 6 months and their 14-DM and 6-MUO were recorded. Finally, the correlation of CRASH ER and the observed outcome of the patients was evaluated. The data were analyzed using STATA version 11.0. Results: In this study, 323 patients with the mean age of 34.0 ± 19.4 years were evaluated (87.3% male). Calibration of the basic and CT models in prediction of 14-day and 6-month outcome were in the desirable range (P < 0.05). Area under the curve in the basic model for prediction of 14-DM and 6-MUO were 0.92 (95% CI: 0.89-0.96) and 0.92 (95% CI: 0.90-0.95), respectively. In addition, area under the curve in the CT model for prediction of 14-DM and 6-MUO were 0.93 (95% CI: 0.91-0.97) and 0.93 (95% CI: 0.91-0.96), respectively. There was no significant difference between the discriminations of the two models in prediction of 14-DM (p = 0.11) and 6-MUO (p = 0.1). Conclusion: The results of the present study showed that CRASH prediction model has proper discrimination and calibration in predicting 14-DM and 6-MUO of head trauma patients. Since there was no difference between the values of the basic and CT models, using the basic model is recommended to simplify the risk

  17. Attenuated thermoregulatory sweating and cutaneous vasodilation after 14-day bed rest in humans.

    PubMed

    Michikami, Daisaku; Kamiya, Atsunori; Fu, Qi; Iwase, Satoshi; Mano, Tadaaki; Sunagawa, Kenji

    2004-01-01

    We investigated the effect of head-down bed rest (HDBR) for 14 days on thermoregulatory sweating and cutaneous vasodilation in humans. Fluid intake was ad libitum during HDBR. We induced whole body heating by increasing skin temperature for 1 h with a water-perfused blanket through which hot water (42 degrees C) was circulated. The experimental room was air-conditioned (27 degrees C, 30-40% relative humidity). We measured skin blood flow (chest and forearm), skin temperatures (chest, upper arm, forearm, thigh, and calf), and tympanic temperature. We also measured sweat rate by the ventilated capsule method in which the skin area for measurement was drained by dry air conditioned at 27 degrees C under similar skin temperatures in both trials. We calculated cutaneous vascular conductance (CVC) from the ratio of skin blood flow to mean blood pressure. From tympanic temperature-sweat rate and -CVC relationships, we assessed the threshold temperature and sensitivity as the slope response of variables to a given change in tympanic temperature. HDBR increased the threshold temperature for sweating by 0.31 degrees C at the chest and 0.32 degrees C at the forearm, whereas it reduced sensitivity by 40% at the chest and 31% at the forearm. HDBR increased the threshold temperature for cutaneous vasodilation, whereas it decreased sensitivity. HDBR reduced plasma volume by 11%, whereas it did not change plasma osmolarity. The increase in the threshold temperature for sweating correlated with that for cutaneous vasodilation. In conclusion, HDBR attenuated thermoregulatory sweating and cutaneous vasodilation by increasing the threshold temperature and decreasing sensitivity. HDBR increased the threshold temperature for sweating and cutaneous vasodilation by similar magnitudes, whereas it decreased their sensitivity by different magnitudes.

  18. 43 CFR 3715.2-3 - Under what circumstances will BLM allow me to temporarily occupy a site for more than 14 days?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... to temporarily occupy a site for more than 14 days? 3715.2-3 Section 3715.2-3 Public Lands: Interior... § 3715.2-3 Under what circumstances will BLM allow me to temporarily occupy a site for more than 14 days? BLM may allow temporary occupancy at a single site to extend beyond the 14-day period described...

  19. Effects of 14 days of head-down tilt bed rest on cutaneous vasoconstrictor responses in humans

    NASA Technical Reports Server (NTRS)

    Wilson, Thad E.; Shibasaki, Manabu; Cui, Jian; Levine, Benjamin D.; Crandall, Craig G.

    2003-01-01

    This study tested the hypothesis that head-down tilt bed rest (HDBR) reduces adrenergic and nonadrenergic cutaneous vasoconstrictor responsiveness. Additionally, an exercise countermeasure group was included to identify whether exercise during bed rest might counteract any vasoconstrictor deficits that arose during HDBR. Twenty-two subjects underwent 14 days of strict 6 degrees HDBR. Eight of these 22 subjects did not exercise during HDBR, while 14 of these subjects exercised on a supine cycle ergometer for 90 min a day at 75% of pre-bed rest heart rate maximum. To assess alpha-adrenergic vasoconstrictor responsiveness, intradermal microdialysis was used to locally administer norepinephrine (NE), while forearm skin blood flow (SkBF; laser-Doppler flowmetry) was monitored over microdialysis membranes. Nonlinear regression modeling was used to identify the effective drug concentration that caused 50% of the cutaneous vasoconstrictor response (EC(50)) and minimum values from the SkBF-NE dose-response curves. In addition, the effects of HDBR on nonadrenergic cutaneous vasoconstriction were assessed via the venoarteriolar response of the forearm and leg. HDBR did not alter EC(50) or the magnitude of cutaneous vasoconstriction to exogenous NE administration regardless of whether the subjects exercised during HDBR. Moreover, HDBR did not alter the forearm venoarteriolar response in either the control or exercise groups during HDBR. However, HDBR significantly reduced the magnitude of cutaneous vasoconstriction due to the venoarteriolar response in the leg, and this response was similarly reduced in the exercise group. These data suggest that HDBR does not alter cutaneous vasoconstrictor responses to exogenous NE administration, whereas cutaneous vasoconstriction of the leg due to the venoarteriolar response is reduced after HDBR. It remains unclear whether attenuated venoarteriolar responses in the lower limbs contribute to reduced orthostatic tolerance after bed rest and

  20. Randomized masked controlled clinical trial to compare 7-day and 14-day course length of doxycycline in the treatment of Mycoplasma felis infection in shelter cats.

    PubMed

    Kompare, B; Litster, A L; Leutenegger, C M; Weng, H-Y

    2013-03-01

    The aim of this study was to compare the clinical and microbial efficacy of a 7-day or a 14-day course of doxycycline for the treatment of Mycoplasma felis-infected cats with clinical signs of upper respiratory tract disease (URTD) assessed using clinical scoring criteria. Cats were randomly allocated to either the Doxy-7 group (N=20; 7-day course of oral doxycyline liquid followed by 7-days placebo); or the Doxy-14 group (N=20; 14-day course of oral doxycycline). There were no significant differences in Mycoplasma load between groups at Day 1 or Day 7 (P>0.05), but at Day 14 mean Mycoplasma load was lower in the Doxy-14 group (P=0.01). Mycoplasma load reduced over Days 1-7 in each group (P<0.01), but only the Doxy-14 group had a significantly reduced Mycoplasma load at Day 14 compared to Day 1 (P<0.01). On Day 14, 11 (55%) cats in the Doxy-7 group and 5 (25%) cats in the Doxy-14 group had positive PCR results for M. felis. There was a statistically significant reduction within each group across the Day 1-7 period for ocular discharge, nasal discharge, demeanor, and food intake scores (P<0.01 for each score category). Nasal discharge scores and sneezing scores were statistically lower in the Doxy-14 group than in the Doxy-7 group on individual days during the Day 8-14 period (P<0.05). We conclude that in M. felis-infected cats with clinical signs of URTD, a 14-day course of oral doxycycline produced superior microbial but not clinical results compared to a 7-day course of treatment.

  1. Range-Finding Risk Assessment of Inhalation Exposure to Nanodiamonds in a Laboratory Environment

    PubMed Central

    Koivisto, Antti J.; Palomäki, Jaana E.; Viitanen, Anna-Kaisa; Siivola, Kirsi M.; Koponen, Ismo K.; Yu, Mingzhou; Kanerva, Tomi S.; Norppa, Hannu; Alenius, Harri T.; Hussein, Tareq; Savolainen, Kai M.; Hämeri, Kaarle J.

    2014-01-01

    This study considers fundamental methods in occupational risk assessment of exposure to airborne engineered nanomaterials. We discuss characterization of particle emissions, exposure assessment, hazard assessment with in vitro studies, and risk range characterization using calculated inhaled doses and dose-response translated to humans from in vitro studies. Here, the methods were utilized to assess workers’ risk range of inhalation exposure to nanodiamonds (NDs) during handling and sieving of ND powder. NDs were agglomerated to over 500 nm particles, and mean exposure levels of different work tasks varied from 0.24 to 4.96 µg·m−3 (0.08 to 0.74 cm−3). In vitro-experiments suggested that ND exposure may cause a risk for activation of inflammatory cascade. However, risk range characterization based on in vitro dose-response was not performed because accurate assessment of delivered (settled) dose on the cells was not possible. Comparison of ND exposure with common pollutants revealed that ND exposure was below 5 μg·m−3, which is one of the proposed exposure limits for diesel particulate matter, and the workers’ calculated dose of NDs during the measurement day was 74 ng which corresponded to 0.02% of the modeled daily (24 h) dose of submicrometer urban air particles. PMID:24840353

  2. Evaluation of Arecoline Hydrobromide Toxicity after a 14-Day Repeated Oral Administration in Wistar Rats

    PubMed Central

    Niu, Jianrong; Zhou, Xuzheng; Li, Jianyong; Li, Bing

    2015-01-01

    A subchronic toxicity test was conducted in rats on the basis of a previous acute toxicity test to evaluate the safety of arecoline hydrobromide (Ah), to systematically study its pharmacological effects and to provide experimental support for a safe clinical dose. Eighty rats were randomly divided into four groups: a high-dose group (1000 mg/kg), medium-dose group (200 mg/kg), low-dose group (100mg/kg) and blank control group. The doses were administered daily via gastric lavage for 14 consecutive days. There were no significant differences in the low-dose Ah group compared to the control group (P>0.05) with regard to body weight, organ coefficients, hematological parameters and histopathological changes. The high-dose of Ah influenced some of these parameters, which requires further study. The results of this study indicated that a long-term, continuous high dose of Ah was toxic. However, it is safe to use Ah according to the clinically recommended dosing parameters. The level of Ah at which no adverse effects were observed was 100 mg/kg/day under the present study conditions. PMID:25880067

  3. Antiorthostatic suspension for 14 days does not diminish the oxidative response of neutrophils in mice

    NASA Technical Reports Server (NTRS)

    Smolen, J. E.; Fossett, M. C.; Joe, Y.; Prince, J. E.; Priest, E.; Kanwar, S.; Smith, C. W.

    2000-01-01

    The effects of long-term spaceflight on inflammatory responses have not been well-studied in either humans or animals. It is thus important to determine if the functions of immune and inflammatory cells are altered in models of spaceflight. One such animal model is antiorthostatic suspension (AOS), in which the experimental animal is subjected to a head-down tilt that mimics both the stress and the cephalad fluid shift experienced in spaceflight. A previous study reported that the peritoneal neutrophils from mice experiencing AOS generated less superoxide than unsuspended controls. We expanded on this study using several different stimuli and measuring the oxidative response of murine neutrophils in a variety of ways. These responses included the rate, lag period, and dose/response characteristics for superoxide generation, FACS analysis with dihydrodichlorofluorescein as a substrate, and a chemiluminescence response with luminol as a substrate. We also examined phagocytosis of three different microorganisms. While some effects of orthostatic suspension (attributable to the stress of the apparatus) were observed, no clear effects of AOS on oxidative function of the peritoneal neutrophils were seen.

  4. Comparison of Ocular Outcomes Across Two 14-Day Bed Rest Platforms

    NASA Astrophysics Data System (ADS)

    Cromwell, Ronita L.; Zanello, Susana B.; Yarbough, Patrice O.; Taibbi, Giovanni; Vizzeri, Gianmarco

    2013-02-01

    One possible mechanism for visual changes reported in astronauts may involve microgravity induced cephalad fluid shifts that lead to elevated retrobulbar cerebrospinal fluid pressure. Because head-down tilt (HDT) bed rest induces cephalad fluid shifts, vision monitoring was implemented for NASA bed rest campaigns. Subjects selected for these campaigns were healthy adults (14 males and 5 females). In one campaign, subjects maintained a horizontal (0°) position while in bed and were exercised six days per week. In the other campaign, subjects were placed at 6° HDT while in bed and did not engage in exercise. Measures common to both studies included intraocular pressure and retinal measures derived from optical coherence tomography. There were no significant differences between subject groups for pre- and post bed rest testing. These preliminary results suggest that exercise combined with horizontal bed rest as compared to 6° HDT bed rest did not produce differences in the ocular response of these subjects. Further investigation is needed to examine both the acute response and long term adaptation of structural and functional ocular parameters in the bed rest platform.

  5. Ventricular Tachycardia in Fabry Disease Detected in a 50-Year-Old Woman during 14-Day Continuous Cardiac Monitoring

    PubMed Central

    Silva-Gburek, Jaime; Rochford, Laura; Hopkin, Robert

    2016-01-01

    Fabry disease is an X-linked lysosomal storage disorder. Female carriers were long thought to be asymptomatic; however, research has revealed the opposite. Cardiac conditions are the chief causes of death in women with Fabry disease. Although ventricular tachycardia has been reported in male patients with Fabry disease, it is not thought to be a frequent finding in females. We describe the case of a 50-year-old woman in whom we used 14-day continuous electrocardiographic monitoring to identify nonsustained ventricular tachycardia, after electrocardiograms and 24-hour Holter monitoring failed to detect the arrhythmia. A permanent implantable cardioverter-defibrillator relieved the patient's symptoms. We discuss why this case supports the need for more extensive electrophysiologic evaluation in women who have Fabry disease. PMID:28100976

  6. Effects of acute and 14-day coenzyme Q10 supplementation on exercise performance in both trained and untrained individuals

    PubMed Central

    Cooke, Matthew; Iosia, Mike; Buford, Thomas; Shelmadine, Brian; Hudson, Geoffrey; Kerksick, Chad; Rasmussen, Christopher; Greenwood, Mike; Leutholtz, Brian; Willoughby, Darryn; Kreider, Richard

    2008-01-01

    Background To determine whether acute (single dose) and/or chronic (14-days) supplementation of CoQ10 will improve anaerobic and/or aerobic exercise performance by increasing plasma and muscle CoQ10 concentrations within trained and untrained individuals. Methods Twenty-two aerobically trained and nineteen untrained male and female subjects (26.1 ± 7.6 yrs, 172 ± 8.7 cm, 73.5 ± 17 kg, and 21.2 ± 7.0%) were randomized to ingest in a double-blind manner either 100 mg of a dextrose placebo (CON) or a fast-melt CoQ10 supplement (CoQ10) twice a day for 14-days. On the first day of supplementation, subjects donated fasting blood samples and a muscle biopsy. Subjects were then given 200 mg of the placebo or the CoQ10 supplement. Sixty minutes following supplement ingestion, subjects completed an isokinetic knee extension endurance test, a 30-second wingate anaerobic capacity test, and a maximal cardiopulmonary graded exercise test interspersed with 30-minutes of recovery. Additional blood samples were taken immediately following each exercise test and a second muscle biopsy sample was taken following the final exercise test. Subjects consumed twice daily (morning and night), 100 mg of either supplement for a period of 14-days, and then returned to the lab to complete the same battery of tests. Data was analyzed using repeated measures ANOVA with an alpha of 0.05. Results Plasma CoQ10 levels were significantly increased following 2 weeks of CoQ10 supplementation (p < 0.001); while a trend for higher muscle CoQ10 levels was observed after acute CoQ10 ingestion (p = 0.098). A trend for lower serum superoxide dismutase (SOD) was observed following acute supplementation with CoQ10 (p = 0.06), whereas serum malondialdehyde (MDA) tended to be significantly higher (p < 0.05). Following acute ingestion of CoQ10, plasma CoQ10 levels were significantly correlated to muscle CoQ10 levels; maximal oxygen consumption; and treadmill time to exhaustion. A trend for increased time to

  7. Transversal Stiffness and Beta-Actin and Alpha-Actinin-4 Content of the M. Soleus Fibers in the Conditions of a 3-Day Reloading after 14-Day Gravitational Unloading

    PubMed Central

    Ogneva, I. V.

    2011-01-01

    The aim of the work was to analyze the structural changes in different parts of the sarcolemma and contractile apparatus of muscle fibers by measuring their transversal stiffness by atomic force microscopy in a three-day reloading after a 14-day gravity disuse, which was carried out by hind-limbs suspension. The object of the study was the soleus muscle of the Wistar rat. It was shown that after 14 days of disuse, there was a reduction of transversal stiffness of all points of the sarcolemma and contractile apparatus. Readaptation for 3 days leads to complete recovery of the values of the transversal stiffness of the sarcolemma and to partial value recovery of the contractile apparatus. The changes in transversal stiffness of sarcolemma correlate with beta-actin and alpha-actinin-4 in membrane protein fractions. PMID:21941432

  8. Alterations in glomerular and tubular dynamics at 1 and 14 days simulated microgravity and after acute return to orthostasis

    NASA Technical Reports Server (NTRS)

    Tucker, Bryan J.; Mendonca, Margarida M.

    1995-01-01

    Head-down tilt (HDT) is utilized to simulate microgravity and produces a cephalad fluid shift, which results in alterations in fluid and electrolyte balance. These changes in volume homeostasis are due, in part, to alterations in multiple volume control mechanisms in which renal function is a major participant. We have previously demonstrated that glomerular filtration rate increases early in HDT and eventually returns to values not different from non-tilt measurements. This early increase in glomerular filtration rate was also demonstrated during days 2 and 8 of the SLS-1 mission. However, urine flow and electrolyte excretion does not parallel the alternations in glomerular filtration rate and the site of this change in nephron fluid reabsorption pattern has not been previously examined. Through determination of the location of alterations in tubular fluid reabsorption within the nephron, a more detailed hypothesis can be forwarded as to which specific neuro-humoral agents participating in control or renal function in microgravity conditions. the importance of this type of examination is that measurements in circulating neuro-humoral agents and urinary excretion patterns alone are not accurate predictors of how renal functional response may alter to head-down tilt or other models of simulated weightlessness. To examine this issue, renal micropuncture techniques were utilized in Munich-Wistar rats submitted 24 hour and 14 day head-down tilt, measuring all the determinants of glomerular ultrafiltration and obtaining data regarding segmental tubular fluid reabsorption. Following these measurements, the rats were returned to an orthostatic position and after 60 minutes, the measurements were repeated.

  9. A Randomised Trial of empiric 14-day Triple, five-day Concomitant, and ten-day Sequential Therapies for Helicobacter pylori in Seven Latin American Sites

    PubMed Central

    Greenberg, E. Robert; Anderson, Garnet L.; Morgan, Douglas R.; Torres, Javier; Chey, William D.; Bravo, Luis Eduardo; Dominguez, Ricardo L.; Ferreccio, Catterina; Herrero, Rolando; Lazcano-Ponce, Eduardo C.; Meza-Montenegro, Mercedes María; Peña, Rodolfo; Peña, Edgar M.; Salazar-Martínez, Eduardo; Correa, Pelayo; Martínez, María Elena; Valdivieso, Manuel; Goodman, Gary E.; Crowley, John J.; Baker, Laurence H.

    2011-01-01

    Summary Background Evidence from Europe, Asia, and North America suggests that standard three-drug regimens of a proton pump inhibitor plus amoxicillin and clarithromycin are significantly less effective for eradicating Helicobacter pylori (H. pylori) infection than five-day concomitant and ten-day sequential four-drug regimens that include a nitroimidazole. These four-drug regimens also entail fewer antibiotic doses and thus may be suitable for eradication programs in low-resource settings. Studies are limited from Latin America, however, where the burden of H. pylori-associated diseases is high. Methods We randomised 1463 men and women ages 21–65 selected from general populations in Chile, Colombia, Costa Rica, Honduras, Nicaragua, and Mexico (two sites) who tested positive for H. pylori by a urea breath test (UBT) to: 14 days of lansoprazole, amoxicillin, and clarithromycin (standard therapy); five days of lansoprazole, amoxicillin, clarithromycin, and metronidazole (concomitant therapy); or five days of lansoprazole and amoxicillin followed by five of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Eradication was assessed by UBT six–eight weeks after randomisation. Findings In intention-to-treat analyses, the probability of eradication with standard therapy was 82·2%, which was 8·6% higher (95% adjusted CI: 2·6%, 14·5%) than with concomitant therapy (73·6%) and 5·6% higher (95% adjusted CI: −0·04%, 11·6%) than with sequential therapy (76·5%). In analyses limited to the 1314 participants who adhered to their assigned therapy, the probabilities of eradication were 87·1%, 78·7%, and 81·1% with standard, concomitant, and sequential therapies, respectively. Neither four-drug regimen was significantly better than standard triple therapy in any of the seven sites. Interpretation Standard 14-day triple-drug therapy is preferable to five-day concomitant or ten-day sequential four-drug regimens as empiric therapy for H. pylori

  10. Quantitative changes of GABA-immunoreactive cells in the hindlimb representation of the rat somatosensory cortex after 14-day hindlimb unloading by tail suspension

    NASA Technical Reports Server (NTRS)

    D'Amelio, F.; Fox, R. A.; Wu, L. C.; Daunton, N. G.

    1996-01-01

    The present study was aimed at evaluating quantitatively gamma-aminobutyric acid (GABA) immunoreactivity in the hindlimb representation of the rat somatosensory cortex after 14 days of hindlimb unloading by tail suspension. A reduction in the number of GABA-immunoreactive cells with respect to the control animals was observed in layer Va and Vb. GABA-containing terminals were also reduced in the same layers, particularly those terminals surrounding the soma and apical dendrites of pyramidal cells in layer Vb. On the basis of previous morphological and behavioral studies of the neuromuscular system of hindlimb-suspended animals, it is suggested that the unloading due to hindlimb suspension alters afferent signaling and feedback information from intramuscular receptors to the cerebral cortex due to modifications in the reflex organization of hindlimb muscle groups. We propose that the reduction in immunoreactivity of local circuit GABAergic neurons and terminals is an expression of changes in their modulatory activity to compensate for the alterations in the afferent information.

  11. Hoffmann reflex is increased after 14 days of daily repeated Achilles tendon vibration for the soleus but not for the gastrocnemii muscles.

    PubMed

    Lapole, Thomas; Pérot, Chantal

    2012-02-01

    In a previous study, Achilles tendon vibrations were enough to improve the triceps surae (TS) activation capacities and also to slightly increase TS Hoffmann reflex (H-reflex) obtained by summing up soleus (Sol) and gastrocnemii (GM and GL) EMGs. The purpose of the present study was to analyze separately Sol and GM or GL reflexes to account for different effects of the vibrations on the reflex excitability of the slow soleus and of the gastrocnemii muscles. A control group (n = 13) and a vibration group (n = 16) were tested in pre-test and post-test conditions. The Achilles tendon vibration program consisted of 1 h of daily vibration (frequency: 50 Hz) applied during 14 days. Maximal Sol, GM and GL H-reflexes, and M-waves were recorded, and their H(max)/M(max) ratios gave the index of reflex excitability. After the vibration protocol, only Sol H(max)/M(max) was enhanced (p < 0.001). The enhanced Sol reflex excitability after vibration is in favor of a decrease in the pre-synaptic inhibition due to the repeated vibrations and the high solicitation of the reflex pathway. Those results of a short period of vibration applied at rest may be limited to the soleus because of its high density in muscle spindles and slow motor units, both structures being very sensitive to vibrations.

  12. Growth and maturational changes in dense fibrous connective tissue following 14 days of rhGH supplementation in the dwarf rat

    NASA Technical Reports Server (NTRS)

    Kyparos, Antonios; Orth, Michael W.; Vailas, Arthur C.; Martinez, Daniel A.

    2002-01-01

    The purpose of this study was to investigate the impact of recombinant human growth hormone (rhGH) on patella tendon (PT), medial collateral ligament (MCL), and lateral collateral ligament (LCL) on collagen growth and maturational changes in dwarf GH-deficient rats. Twenty male Lewis mutant dwarf rats, 37 days of age, were randomly assigned to Dwarf + rhGH (n = 10) and Dwarf + vehicle (n = 10) groups. The GH group received 1.25 mg rhGH/kg body wt twice daily for 14 days. rhGH administration stimulated dense fibrous connective tissue growth, as demonstrated by significant increases in hydroxyproline specific activity and significant decreases in the non-reducible hydroxylysylpyridinoline (HP) collagen cross-link contents. The increase in the accumulation of newly accreted collagen was 114, 67, and 117% for PT, MCL, and LCL, respectively, in 72 h. These findings suggest that a short course rhGH treatment can affect the rate of new collagen production. However, the maturation of the tendon and ligament tissues decreased 18-25% during the rapid accumulation of de novo collagen. We conclude that acute rhGH administration in a dwarf rat can up-regulate new collagen accretion in dense fibrous connective tissues, while causing a reduction in collagen maturation. Copyright 2002 Elsevier Science Ltd.

  13. Does negative affect mediate the relationship between daily PTSD symptoms and daily alcohol involvement in female rape victims? Evidence from 14 days of interactive voice response assessment

    PubMed Central

    Cohn, Amy; Hagman, Brett T.; Moore, Kathleen; Mitchell, Jessica; Ehlke, Sarah

    2014-01-01

    The negative reinforcement model of addiction posits that individuals may use alcohol to reduce with negative affective (NA) distress. The current study investigated the mediating effect of daily NA on the relationship between daily PTSD symptoms and same-day and next-day alcohol involvement (consumption and desire to drink) in a sample of 54 non-treatment-seeking female rape victims who completed 14 days of interactive voice response assessment. The moderating effect of lifetime alcohol use disorder diagnosis (AUD) on daily relationships was also examined. Multilevel models suggested that NA mediated the relationship between PTSD and same-day, but not next-day alcohol involvement. NA was greater on days characterized by more severe PTSD symptoms, and alcohol consumption and desire to drink were greater on days characterized by higher NA. Further, daily PTSD symptoms and NA were more strongly associated with same-day (but not next-day) alcohol consumption and desire to drink for women with an AUD than without. Results suggest that NA plays an important role in female rape victims’ daily alcohol use. Differences between women with and without an AUD indicate the need for treatment matching to sub-types of female rape victims. PMID:24731112

  14. Physiologically adaptive changes of the L5 afferent neurogram and of the rat soleus EMG activity during 14 days of hindlimb unloading and recovery.

    PubMed

    De-Doncker, L; Kasri, M; Picquet, F; Falempin, M

    2005-12-01

    The hindlimb unloading rat model (HU, Morey's model) is usually used to mimic and study neuromuscular changes that develop during spaceflights. This Earth-based model of microgravity induces a muscular atrophy of the slow postural muscle of hindlimbs, such as the soleus, a loss of strength, modifications of contraction kinetics, changes in histochemical and electrophoretical profiles and modifications of the tonic EMG activity. It has been suggested in the literature that some of these neuromuscular effects were due to a reduction of afferent feedback during HU. However, no direct data have confirmed this hypothesis. The aim of this study was to clearly establish if changes of the L5 afferent neurogram are closely related to the soleus EMG activity during and after 14 days of HU. Immediately after HU, the EMG activity of the soleus muscle disappeared and was associated with a decrease in the afferent neurogram. The soleus electromyographic and afferent activities remained lower than the pre-suspension levels until the sixth day of HU and were recovered between the sixth and the ninth day. On the twelfth and fourteenth days, they were increased beyond the pre-suspension levels. During the first recovery day, these activities were significantly higher than those on the fourteenth HU day and returned to the pre-suspension levels between the third and sixth recovery days. To conclude, our study directly demonstrates that the HU conditions cannot be considered as a functional deafferentation, as suggested in the literature, but only as a reduction of afferent information at the beginning of the HU period.

  15. Fertility of Angus cross beef heifers after GnRH treatment on day 23 and timing of insemination in 14-day CIDR protocol.

    PubMed

    Kasimanickam, R K; Hall, J B; Whittier, W D

    2017-02-01

    This study compared artificial insemination pregnancy rate (AI-PR) between 14-day CIDR-GnRH-PGF2α-GnRH and CIDR-PGF2α-GnRH synchronization protocol with two fixed AI times (56 or 72 hr after PGF2α). On day 0, heifers (n = 1311) from nine locations assigned body condition score (BCS: 1, emaciated; 9, obese), reproductive tract score (RTS: 1, immature, acyclic; 5, mature, cyclic) and temperament score (0, calm; and 1, excited) and fitted with a controlled internal drug release (CIDR, 1.38 g of progesterone) insert for 14 days. Within herd, heifers were randomly assigned either to no-GnRH group (n = 635) or to GnRH group (n = 676), and heifers in GnRH group received 100 μg of GnRH (gonadorelin hydrochloride, IM) on day 23. All heifers received 25 mg of PGF2α (dinoprost, IM) on day 30 and oestrous detection aids at the same time. Heifers were observed for oestrus thrice daily until AI. Within GnRH groups, heifers were randomly assigned to either AI-56 or AI-72 groups. Heifers in AI-56 group (n = 667) were inseminated at 56 hr (day 32 PM), and heifers in AI-72 group (n = 644) were inseminated at 72 hr (day 33 AM) after PGF2α administration. All heifers were given 100 μg of GnRH concurrently at the time AI. Controlling for BCS (p < .05), RTS (p < .05), oestrous expression (p < .001), temperament (p < .001) and GnRH treatment by time of insemination (p < .001), the AI-PR differed between GnRH treatment [GnRH (Yes - 60.9% (412/676) vs. No - 55.1% (350/635); p < .05)] and insemination time [AI-56 - 54.6% (364/667) vs. AI-72 - 61.8% (398/644); (p < .01)] groups. The GnRH treatment by AI time interaction influenced AI-PR (GnRH56 - 61.0% (208/341); GnRH72 - 60.9% (204/335); No-GnRH56 - 47.9% (156/326); No-GnRH72 - 62.8% (194/309); p < .001). In conclusion, 14-day CIDR synchronization protocol for FTAI required inclusion of GnRH on day 23 if inseminations were to be performed at 56 hr after PGF2α in order to achieve greater AI-PR.

  16. Outdoor PM2.5, Ambient Air Temperature, and Asthma Symptoms in the Past 14 Days among Adults with Active Asthma

    PubMed Central

    Mirabelli, Maria C.; Vaidyanathan, Ambarish; Flanders, W. Dana; Qin, Xiaoting; Garbe, Paul

    2016-01-01

    Background: Relationships between air quality and health are well-described, but little information is available about the joint associations between particulate air pollution, ambient temperature, and respiratory morbidity. Objectives: We evaluated associations between concentrations of particulate matter ≤ 2.5 μm in diameter (PM2.5) and exacerbation of existing asthma and modification of the associations by ambient air temperature. Methods: Data from 50,356 adult respondents to the Asthma Call-back Survey from 2006–2010 were linked by interview date and county of residence to estimates of daily averages of PM2.5 and maximum air temperature. Associations between 14-day average PM2.5 and the presence of any asthma symptoms during the 14 days leading up to and including the interview date were evaluated using binomial regression. We explored variation by air temperature using similar models, stratified into quintiles of the 14-day average maximum temperature. Results: Among adults with active asthma, 57.1% reported asthma symptoms within the past 14 days, and 14-day average PM2.5 ≥ 7.07 μg/m3 was associated with an estimated 4–5% higher asthma symptom prevalence. In the range of 4.00–7.06 μg/m3 of PM2.5, each 1-μg/m3 increase was associated with a 3.4% [95% confidence interval (CI): 1.1, 5.7] increase in symptom prevalence; across categories of temperature from 1.1 to 80.5°F, each 1-μg/m3 increase was associated with increased symptom prevalence (1.1–44.4°F: 7.9%; 44.5–58.6°F: 6.9%; 58.7–70.1°F: 2.9%; 70.2–80.5°F: 7.3%). Conclusions: These results suggest that each unit increase in PM2.5 may be associated with an increase in the prevalence of asthma symptoms, even at levels as low as 4.00–7.06 μg/m3. Citation: Mirabelli MC, Vaidyanathan A, Flanders WD, Qin X, Garbe P. 2016. Outdoor PM2.5, ambient air temperature, and asthma symptoms in the past 14 days among adults with active asthma. Environ Health Perspect 124:1882–1890;

  17. Effects of 14-day oral low dose selenium nanoparticles and selenite in rat-as determined by metabolite pattern determination.

    PubMed

    Hadrup, Niels; Loeschner, Katrin; Skov, Kasper; Ravn-Haren, Gitte; Larsen, Erik H; Mortensen, Alicja; Lam, Henrik R; Frandsen, Henrik L

    2016-01-01

    Selenium (Se) is an essential element with a small difference between physiological and toxic doses. To provide more effective and safe Se dosing regimens, as compared to dosing with ionic selenium, nanoparticle formulations have been developed. However, due to the nano-formulation, unexpected toxic effects may occur. We used metabolite pattern determination in urine to investigate biological and/or toxic effects in rats administered nanoparticles and for comparison included ionic selenium at an equimolar dose in the form of sodium selenite. Low doses of 10 and 100 fold the recommended human high level were employed to study the effects at borderline toxicity. Evaluations of all significantly changed putative metabolites, showed that Se nanoparticles and sodium selenite induced similar dose dependent changes of the metabolite pattern. Putative identified metabolites included increased decenedioic acid and hydroxydecanedioic acid for both Se formulations whereas dipeptides were only increased for selenite. These effects could reflect altered fatty acid and protein metabolism, respectively.

  18. Effects of 14-day oral low dose selenium nanoparticles and selenite in rat—as determined by metabolite pattern determination

    PubMed Central

    Loeschner, Katrin; Skov, Kasper; Ravn-Haren, Gitte; Larsen, Erik H.; Mortensen, Alicja; Lam, Henrik R.; Frandsen, Henrik L.

    2016-01-01

    Selenium (Se) is an essential element with a small difference between physiological and toxic doses. To provide more effective and safe Se dosing regimens, as compared to dosing with ionic selenium, nanoparticle formulations have been developed. However, due to the nano-formulation, unexpected toxic effects may occur. We used metabolite pattern determination in urine to investigate biological and/or toxic effects in rats administered nanoparticles and for comparison included ionic selenium at an equimolar dose in the form of sodium selenite. Low doses of 10 and 100 fold the recommended human high level were employed to study the effects at borderline toxicity. Evaluations of all significantly changed putative metabolites, showed that Se nanoparticles and sodium selenite induced similar dose dependent changes of the metabolite pattern. Putative identified metabolites included increased decenedioic acid and hydroxydecanedioic acid for both Se formulations whereas dipeptides were only increased for selenite. These effects could reflect altered fatty acid and protein metabolism, respectively. PMID:27781177

  19. Nutritional status changes in humans during a 14-day saturation dive: the NASA Extreme Environment Mission Operations V project.

    PubMed

    Smith, Scott M; Davis-Street, Janis E; Fesperman, J Vernell; Smith, Myra D; Rice, Barbara L; Zwart, Sara R

    2004-07-01

    Ground-based analogs of spaceflight are an important means of studying physiologic and nutritional changes associated with space travel, and the NASA Extreme Environment Mission Operations V (NEEMO) is such an analog. To determine whether saturation diving has nutrition-related effects similar to those of spaceflight, we conducted a clinical nutritional assessment of the NEEMO crew (4 men, 2 women) before, during, and after their 14-d saturation dive. Blood and urine samples were collected before, during, and after the dive. The foods consumed by the crew were typical of the spaceflight food system. A number of physiologic changes were observed, during and after the dive, that are also commonly observed during spaceflight. Hemoglobin and hematocrit were lower (P < 0.05) after the dive. Transferrin receptors were significantly lower immediately after the dive. Serum ferritin increased significantly during the dive. There was also evidence indicating that oxidative damage and stress increased during the dive. Glutathione peroxidase and superoxide dismutase decreased during and after the dive (P < 0.05). Decreased leptin during the dive (P < 0.05) may have been related to the increased stress. Subjects had decreased energy intake and weight loss during the dive, similar to what is observed during spaceflight. Together, these similarities to spaceflight provide a model to use in further defining the physiologic effects of spaceflight and investigating potential countermeasures.

  20. Nutritional status changes in humans during a 14-day saturation dive: the NASA Extreme Environment Mission Operations V project

    NASA Technical Reports Server (NTRS)

    Smith, Scott M.; Davis-Street, Janis E.; Fesperman, J. Vernell; Smith, Myra D.; Rice, Barbara L.; Zwart, Sara R.

    2004-01-01

    Ground-based analogs of spaceflight are an important means of studying physiologic and nutritional changes associated with space travel, and the NASA Extreme Environment Mission Operations V (NEEMO) is such an analog. To determine whether saturation diving has nutrition-related effects similar to those of spaceflight, we conducted a clinical nutritional assessment of the NEEMO crew (4 men, 2 women) before, during, and after their 14-d saturation dive. Blood and urine samples were collected before, during, and after the dive. The foods consumed by the crew were typical of the spaceflight food system. A number of physiologic changes were observed, during and after the dive, that are also commonly observed during spaceflight. Hemoglobin and hematocrit were lower (P < 0.05) after the dive. Transferrin receptors were significantly lower immediately after the dive. Serum ferritin increased significantly during the dive. There was also evidence indicating that oxidative damage and stress increased during the dive. Glutathione peroxidase and superoxide dismutase decreased during and after the dive (P < 0.05). Decreased leptin during the dive (P < 0.05) may have been related to the increased stress. Subjects had decreased energy intake and weight loss during the dive, similar to what is observed during spaceflight. Together, these similarities to spaceflight provide a model to use in further defining the physiologic effects of spaceflight and investigating potential countermeasures.

  1. Sleep, mood, and fatigue during a 14-day He-O2 open-sea saturation dive to 850 fsw with excursions to 950 fsw.

    PubMed

    Townsend, R E; Hall, D A

    1978-06-01

    To obtain information on sleep, mood, and performance of divers and surface support personnel during deep dives in the open sea, 12 divers and 12 surface support personnel were monitored during a 14-day open-sea saturation dive using the U.S. Navy Deep Diving System, Mark 2, Mod O. Divers lived in the deck decompression chambers at 850 fsw equivalent and made 5 days of excursion wet dives to approximately 950 fsw via the Personnel Transfer Capsule. Electroencephalographic and self-report measures of sleep, and measures of mood, anxiety, and 4-choice reaction time performance were obtained during a predive base-line period and throughout the dive and decompression. Results suggested that, unless personnel are rotated, there are limitations to the practical duration of very deep open-sea saturation dives caused by the accumulation of sleep debt, fatigue, and loss of psychological vigor.

  2. Effects of 14 days of spaceflight and nine days of recovery on cell body size and succinate dehydrogenase activity of rat dorsal root ganglion neurons

    NASA Technical Reports Server (NTRS)

    Ishihara, A.; Ohira, Y.; Roy, R. R.; Nagaoka, S.; Sekiguchi, C.; Hinds, W. E.; Edgerton, V. R.

    1997-01-01

    The cross-sectional areas and succinate dehydrogenase activities of L5 dorsal root ganglion neurons in rats were determined after 14 days of spaceflight and after nine days of recovery. The mean and distribution of the cross-sectional areas were similar to age-matched, ground-based controls for both the spaceflight and for the spaceflight plus recovery groups. The mean succinate dehydrogenase activity was significantly lower in spaceflight compared to aged-matched control rats, whereas the mean succinate dehydrogenase activity was similar in age-matched control and spaceflight plus recovery rats. The mean succinate dehydrogenase activity of neurons with cross-sectional areas between 1000 and 2000 microns2 was lower (between 7 and 10%) in both the spaceflight and the spaceflight plus recovery groups compared to the appropriate control groups. The reduction in the oxidative capacity of a subpopulation of sensory neurons having relatively large cross-sectional areas immediately following spaceflight and the sustained depression for nine days after returning to 1 g suggest that the 0 g environment induced significant alterations in proprioceptive function.

  3. Association Between Cardiovascular and Intraocular Pressure Changes in a 14-day 6 deg Head Down Tilt (HDT) Bed Rest Study: Possible Implications in Retinal Anatomy

    NASA Technical Reports Server (NTRS)

    Cromwell, R. L.; Zanello, S. B.; Yarbough, P. O.; Ploutz-Snyder, R.; Taibbi, G.; Brewer, J. L.; Vizzeri, G.

    2013-01-01

    Mean IOP significantly increased while at 6deg HDT and returned towards pre-bed rest values upon leaving bed rest. While mean IOP increased during bed rest, it remained within the normal limits for subject safety. A diuretic shift and cardiovascular deconditioning occurs during in-bed rest, as expected. There was no demonstrable correlation between the largest change in IOP (pre/post) and cardiovascular measure changes (pre/post). Additional mixed effects linear regression modeling may reveal some subclinical physiological changes that might assist in describing the VIIP syndrome pathophysiology.

  4. A Phase I Randomized Placebo Controlled Trial of the Safety of 3% SPL7013 Gel (VivaGel®) in Healthy Young Women Administered Twice Daily for 14 Days

    PubMed Central

    Cohen, Craig R.; Brown, Joelle; Moscicki, Anna-Barbara; Bukusi, Elizabeth A.; Paull, Jeremy R. A.; Price, Clare F.; Shiboski, Stephen

    2011-01-01

    Objective To assess the safety of VivaGel® used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18–24 years in the USA and Kenya. Design Randomized placebo controlled trial. Methods Participants were randomized 2∶1, VivaGel to placebo. Safety was assessed by comparing genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal lactobacilli and laboratory abnormalities by arm. Results Fifty-four women were enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No grade 3 or 4 AEs, or serious AEs occurred. Twenty-five (71%) participants in the VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one grade 1 or 2 GU AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All seven grade 2 GU AEs associated with product use occurred among four women in the VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, urinary frequency and metrorrhagia were more common in the VivaGel arm than the placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product use themselves due to a reported GU AE. Persistence of H2O2-producing and non-producing lactobacilli did not differ by study arm. Conclusions GU AEs and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the VivaGel arm. Trial Registration ClinicalTrials.gov NCT003311032 PMID:21311578

  5. Range Finding with a Plenoptic Camera

    DTIC Science & Technology

    2014-03-27

    obtaining depth information. Two such methods include aerial photogrammetry and lidar. Photogrammetry is the process of extracting real-world position... photogrammetry , in which 3D maps can be generated with comparable accuracy and greater efficiency than afforded by laser scanning techniques [33]. Due...to the greater complexity of lidar systems, photogrammetry also tends to offer a significant cost advantage. 122 Lidar and Photogrammetry are held to

  6. Promising long-term outcome of gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in 14-day schedule as salvage regimen for patients with previously heavily treated Hodgkin's lymphoma and aggressive non-Hodgkin's lymphoma.

    PubMed

    Bai, Bing; Huang, Hui-Qiang; Cai, Qing-Qing; Wang, Xiao-Xiao; Cai, Qi-Chun; Lin, Ze-Xiao; Gao, Yan; Xia, Yi; Bu, Qing; Guo, Ying

    2013-03-01

    The combination of gemcitabine (G), vinorelbine (V), and pegylated liposomal doxorubicin (D) has proved to be effective in relapsed Hodgkin's lymphoma (HL). Its efficacy in non-Hodgkin's lymphoma (NHL) remains to be discussed. We retrospectively evaluated the efficacy and toxicity of the dose-adjusted gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in 14-day schedule in 35 heavily pretreated patients with relapsed and refractory aggressive NHL or HL. Treatment consisted of G: 800 mg/m(2) intravenous (i.v.) on day 1, V: 15 mg/m(2) i.v. on day 1; D: 20 mg/m(2) i.v. on day 1, repeated for 14 days. Patients responded to GVD proceeded to subsequent autologous stem cell transplantation. The objective response rate (ORR) was 48.6 %, with 31.4 % complete remission. A higher ORR was observed in patients with HL than in patients with NHL (80.0 vs. 36.0 %, P = 0.023). With a median follow-up of 26 months, the estimated median progression-free survival and overall survival were 5 (range 1-73 months) and 36 months (range 2-73 months), respectively. The estimated 5-year survival rate was 44.6 % (95 % confidence interval 28.1-61.1 %). Toxicities were mild (grade 3/4 neutropenia 34.3 %, thrombocytopenia 5.7 %). Our results suggest that the dose-adjusted GVD in 14-day schedule is effective and well tolerated in patients with refractory and relapsed HL and aggressive NHL. The potential long-term survival in NHL is promising.

  7. Addition of clidinium-C to the 14-day proton-pump inhibitor-based triple therapy for Helicobacter pylori eradication

    PubMed Central

    Seyyedmajidi, Mohammadreza; Homapoor, Saba; Zanganeh, Elahe; Dadjou, Mohammad; Eskandari Nejad, Shahab; Tajik Galayeri, Mohammad Hadi; Vafaeimanesh, Jamshid

    2016-01-01

    Background: Triple therapy with a proton pump inhibitor and two antibiotics in Helicobacter pylori (HP) eradication is widely accepted, but this combination fails in a considerable number of cases. The aim of this study was to assess the effect of clidinium-C addition on HP eradication and to investigate the efficacy and safety of clidinium-C in prevention of drugs' side effects. Methods: A total of 200 histopathologically confirmed HP positive peptic ulcer enrolled in this study which were randomly assigned to two treatment groups: OAC (20 mg omeprazole bid, 1000 mg amoxicillin bid and 500 mg clarithromycin bid) and OAC + clidinium-C. The effect of treatment and adverse effects were compared 6 weeks after completion of treatment. A13C-urea breath test was performed to confirm HP eradication. Results: A total of 184 patients (90 in group A and 94 in group B) completed the treatment protocols. HP eradication was achieved in 71.1% in OAC versus 72.3% in OCA+clidinium-C, (P=0.73). The frequencies of abdominal pain and stool abnormality, among the side effects recorded during the therapy period, were significantly lower in group B (OCA+clidinium-C) (P=0.01 and P=0.001, respectively). Conclusion: Addition of clidinium-C to OCA triple therapy decreases abdominal pain and frequency of stool abnormalities without affecting HP eradication rate. Based on these findings addition of clidinium-C may increase patient's compliance. PMID:27386057

  8. Absence of Change in Total Daily Energy Expenditure (EE(sub TD)) in Young and Mature Rats During 14 Days of Hypergravity

    NASA Technical Reports Server (NTRS)

    Wade, C. E.; Moran, M. M.; Stein, T. P.; Hoban-Higgins, T. M.; Fuller, P.; Fuller, C. A.; Dalton, Bonnie P. (Technical Monitor)

    1999-01-01

    Effect of age on the response of EE(sub TD) to an increase in gravity was assessed in young (Y; 1.5 month old) and mature (M; 8 month old) Sprague-Dawley rats. Rats were implanted with transmitters to monitor activity, and metabolism was determined by the double labeled water technique. Daily food intake was measured. For each age, rats (n=8 per treatment) were exposed to centrifugation at 2G, or remained at 1G. There was a difference in EE(sub TD) between age groups, 182 plus or minus 11 and 143 plus or minus 5 kcal/kg/day in Y and M, respectively. This difference was attributed in part to a lower activity level in M animals, 48% of Y rats. After day 6 there was no effect on EE(sub TD) of exposure to 2G, or on food intake per 100g BW. Prior studies show a 20% increase in resting EE with hypergravity. In our study the level of activity was reduced to 41% of 1G in both age groups during 2G. For Y at 1G resting EE accounted for 78% of the EE(sub TD) and activity 22%, while at 2G resting EE was 96% of EE(sub TD) and activity 4%. M rats had similar changes. Independent of age, with exposure to hypergravity EE(sub TD) is maintained by behavioral changes.

  9. Psychological Symptoms Before and After a 14-Day Initial Inpatient Treatment in Tuberculosis Patients Compared with Their Primary Caregivers and Healthy Controls

    PubMed Central

    Emami, Habib; Modarressi, Taher; Najmi, Kosar; Radmand, Golnar; Tabarsi, Payam; Richter, Jörg

    2015-01-01

    Background: Tuberculosis (TB) is one of the most challenging public health burdens in the world. Recent research demonstrated high prevalence of mental disorders in TB patients and their caregivers. The purpose of this study was to assess mental health of TB patients and their caregivers in Iran before and after a two-week inpatient treatment and to determine the prevalence of psychological problems in these groups. Materials and Methods: A standardized questionnaire (SCL-90) was used to assess psychological symptoms in 146 hospitalized TB patients and their caregivers (n=89). Furthermore, the scores of both target groups were compared with those of a group of healthy individuals (n=85). Results: The mean scores before the start of the initial treatment of the patients were significantly lower for paranoid ideation (P=0.038) and hostility (P= 0.046), and the scores of depression (P=0.046) and somatization (P=0.001) were significantly higher than those of the healthy individuals. The patients scored significantly higher than the caregivers on depression (0.047) and somatization (P< 0.001), whereas the caregivers scored higher than the healthy individuals on paranoid ideation (P= 0.044) and hostility (P= 0.034). Multiple linear regression showed that age, educational level and marital status were factors affecting the mental health of TB patients and their caregivers. The variance in psychological symptoms of the patients was between 10% (paranoid ideation) and 27% (hostility) of the variance in the symptoms of their caregivers. Conclusion: Tuberculosis control and treatment programs should not only address issues like continued respiratory symptoms, but should also focus on mental health in TB patients and their caregivers. PMID:26858764

  10. Health Risk Assessment of Women in Submarines: Reproductive and Developmental Toxicity Evaluation of Major Submarine Atmosphere Components (CO, CO2, and O2) in Rats (Rattus norvegicus) - Phase 1 (Range Finding Study)

    DTIC Science & Technology

    2011-06-27

    nephropathy , another degenerative disease commonly found in this strain of rat (Turnbull, et al. 1985), was found in 78% of animals examined across...percentage incidence of renal tubular degeneration between the dose groups and the controls. The progressive nephropathy finding from phase 1 will...respiring high CO2 concentrations. Prolonged dehydration is also a potential contributing factor of nephropathy . No definitive statements can be made at

  11. Coagulation Function of Stored Whole Blood is Preserved for 14 Days in Austere Conditions: A ROTEM Feasibility Study During a Norwegian Antipiracy Mission and Comparison to Equal Ratio Reconstituted Blood

    DTIC Science & Technology

    2015-06-24

    in the Gulf of Aden and ending in the Indian Ocean. Crews were on 24-hour emergency alert in preparation for an enemy assault on the frigate. Under...operations from a frigate, beginning in the Gulf of Aden and ending in the Indian Ocean. Crews were on 24-hour emergency alert in preparation for an

  12. Subchronic Toxicity Studies on 1,3,5-Trinitrobenzene, 1,3- Dinitrobenzene, and Tetryl in Rats. 14-Day Toxicity Evaluation of N-Methyl-N, 2, 4,6-Tetranitroaniline in Fischer 344 Rats

    DTIC Science & Technology

    1994-05-01

    odv’ tg t tie I’M * e4o t. w , 6g IC11OA-l. tbeoetN. eC.st^ng datA o•.r’.Sg~the• f ~ are mad laintng the cats neo aed, and cOm0.xemng a d rew.t-rg orn...Weights 28 3 C. Organ Weights 31 D. Hematology Data 38 I E. Clinical Chemistry Data 45 F . Clinical Observations 52 G. Gross and Histopathology Data 54...Design •-- Diet Concentration mGrM No. of Animals Animal Nos. Sex (mg tetryl/ko) 1 5 1-5 F 0 2 5 6-10 F 5000 3 5 11-15 F 2500 4 5 16-20 F 2000 5 5 21

  13. Exercise thermoregulation after 14 days of bed rest

    NASA Technical Reports Server (NTRS)

    Greenleaf, J. E.; Reese, R. D.

    1980-01-01

    The effects of bed rest and exercise training during bed rest on body temperature and thermoregulatory responses at rest and during exercise are investigated. Seven male subjects underwent three two-week periods of bed rest during which isometric, isotonic, or no exercises were performed, separated by two ambulatory control periods and preceded by a two-week control period, during which they exercised regularly. Rectal and mean skin temperatures and sweating responses were determined during 70-min submaximal supine exercise during the bed rest and recovery periods. Measurements reveal a reduction in basal oral temperature during the control-recovery periods, with a relatively constant level during bed rest periods, and a significant increase in the rectal temperature elavation brought on by exercise following all three bed-rest regimes. It is concluded that the excessive increase in rectal temperature could be influenced by changes in skin heat conductance or the inhibition of sweating.

  14. Data acquisition and analysis of range-finding systems for spacing construction

    NASA Technical Reports Server (NTRS)

    Shen, C. N.

    1981-01-01

    For space missions of future, completely autonomous robotic machines will be required to free astronauts from routine chores of equipment maintenance, servicing of faulty systems, etc. and to extend human capabilities in hazardous environments full of cosmic and other harmful radiations. In places of high radiation and uncontrollable ambient illuminations, T.V. camera based vision systems cannot work effectively. However, a vision system utilizing directly measured range information with a time of flight laser rangefinder, can successfully operate under these environments. Such a system will be independent of proper illumination conditions and the interfering effects of intense radiation of all kinds will be eliminated by the tuned input of the laser instrument. Processing the range data according to certain decision, stochastic estimation and heuristic schemes, the laser based vision system will recognize known objects and thus provide sufficient information to the robot's control system which can develop strategies for various objectives.

  15. High sensitivity 1.06 micron optical receiver for precision laser range finding. [YAG laser design

    NASA Technical Reports Server (NTRS)

    Scholl, F. W.; Harris, J. S., Jr.

    1977-01-01

    Aluminum gallium antimonide avalanche photodiodes with average gain of 10, internal quantum efficiency of greater than 60%, capacitance less than 0.2pf, and dark current of less than 1 micron were designed and fabricated for use in a low noise optical receiver suitable for 2 cm accuracy rangefinding. Topics covered include: (1) design of suitable photodetector structures; (2) epitaxial growth of AlGaSb devices; (3) fabrication of photodetectors; and (4) electro-optics characterization.

  16. To Study or to Sleep? The Academic Costs of Extra Studying at the Expense of Sleep

    ERIC Educational Resources Information Center

    Gillen-O'Neel, Cari; Huynh, Virginia W.; Fuligni, Andrew J.

    2013-01-01

    This longitudinal study examined how nightly variations in adolescents' study and sleep time are associated with academic problems on the following day. Participants ("N" = 535, 9th grade M[subscript age] = 14.88) completed daily diaries every day for 14 days in 9th, 10th, and 12th grades. Results suggest that regardless of how much a…

  17. Effects of exercise on fluid exchange and body composition in man during 14-day bed rest

    NASA Technical Reports Server (NTRS)

    Greenleaf, J. E.; Bernauer, E. M.; Juhos, L. T.; Young, H. L.; Morse, J. T.; Staley, R. W.

    1977-01-01

    A description is presented of an investigation in which body composition, fluid intake, and fluid and electrolyte losses were measured in seven normal, healthy men during three 2-wk bed-rest periods, separated by two 3-wk recovery periods. During bed rest the subjects remained in the horizontal position continuously. During the dietary control periods, body mass decreased significantly with all three regimens, including no exercise, isometric exercise, and isotonic excercise. During bed rest, body mass was essentially unchanged with no exercise, but decreased significantly with isotonic and isometric exercise. With one exception, there were no statistically significant changes in body density, lean body mass, or body fat content by the end of each of the three bed-rest periods.

  18. Monitoring of the cardiac and vascular response to LBNP during the 14 day spaceflight "Cassiopee".

    PubMed

    Arbeille, P h; Fomina, G; Sigaudo, D; Alferova, I; Porcher, M; Boulay, J; Gharib, C

    1997-07-01

    The objective of the present experiment was to monitor in real time the cardiac and the peripheral response to inflight LBNP. The second objective was to detect and quantify hemodynamic signs of orthostatic tolerance inflight by measuring the heart rate, blood pressure, cardiac and regional hemodynamics during LBNP.

  19. Voucher-Based Contingent Reinforcement of Smoking Abstinence among Methadone-Maintained Patients: A Pilot Study

    ERIC Educational Resources Information Center

    Dunn, Kelly E.; Sigmon, Stacey C.; Thomas, Colleen S.; Heil, Sarah H.; Higgins, Stephen T.

    2008-01-01

    This study evaluated the efficacy of a contingency management (CM) intervention to promote smoking cessation in methadone-maintained patients. Twenty participants, randomized into contingent (n = 10) or noncontingent (n = 10) experimental conditions, completed the 14-day study. Abstinence was determined using breath carbon monoxide and urine…

  20. Fluid compartment and renal function alterations in the rat during 7 and 14 day head down tilt

    NASA Technical Reports Server (NTRS)

    Tucker, Bryan J.

    1991-01-01

    Exposure to conditions of microgravity for any extended duration can modify the distribution of fluid within the vascular and interstitial spaces, and eventually intracellular volume. Whether the redistribution of fluid and resetting of volume homeostasis mechanisms is appropriate for the long term environmental requirements of the body in microgravity remains to be fully defined. The event that initiates the change in fluid volume homeostasis is the cephalad movement of fluid which potentially triggers volume sensors and stretch receptors (atrial stretch with the resulting release of atrial natriuretic peptide) and suppresses adrenergic activity via the carotid and aortic arch baroreceptors. All these events act in concert to reset blood and interstitial volume to new levels, which in turn modify the renin-angiotensin system. All these factors have an influence on the kidney, the end organ for fluid volume control. How the fluid compartment volume changes interrelate with alterations in renal functions under conditions of simulated microgravity is the focus of the present investigation which utilizes 25-30 deg head-down tilt in the rat.

  1. Distribution and elimination of palladium in male wistar rats following 14-day oral exposure in drinking water.

    PubMed

    Iavicoli, I; Bocca, B; Fontana, L; Caimi, S; Petrucci, F; Bergamaschi, A; Alimonti, A

    2009-01-01

    The Pd tissue distribution and elimination in rats following oral exposure in drinking water of dipotassium hexachloropalladate at doses of 100 or 250 ng/ml for 14 d were determined. The sector field inductively coupled plasma mass spectrometry used for Pd quantification showed the adequate sensitivity (10 ng/l) and accuracy (96-105%), and all the more in consideration of the very low levels of Pd accumulated. Tissues were taken and analyzed after 14 d. The tissue containing the highest Pd concentration was the kidney (4 ng/g dry weight in controls and 75 ng/g dry weight at the maximum dose), with left and right kidneys showing a comparable accumulation. The Pd kidney levels rose, but not significantly, with the administered dose. None of the other organs (liver, lung, spleen, adrenal glands, and bones) appeared to accumulate Pd, even at the highest dose. At the 250-ng/ml dose, small amounts of Pd were found in serum (0.27 ng/ml vs. 0.19 ng/ml in controls), while they were higher in urine (1.2 ng/ml vs. 0.16 ng/ml in controls) and in feces (3,231 ng/g dry weight vs. 69 ng/g dry weight in controls). Feces were the main excretion route for Pd, with a significant linear correlation with exposed dose, which is likely due to low intestinal absorption of Pd.

  2. Cholecystokinin-8 activates myenteric neurons in 21- and 35-day old but not 4- and 14-day old rats.

    PubMed

    Washington, Martha C; Murry, Candace R; Raboin, Shannon J; Roberson, Allison E; Mansour, Mahmoud M; Williams, Carol S; Sayegh, Ayman I

    2011-02-01

    Cholecystokinin (CCK) activates the myenteric neurons of adult rats. The goal of this work is to determine the ontogeny of this activation by CCK-8 in the myenteric plexus of the duodenum (2cm immediately following the pyloric sphincter aborally) and compare it with that of the dorsal vagal complex (DVC) - which occurs in 1-day old pups. Despite the existence of both of the CCK receptors, CCK(1) and CCK(2), in 4, 14, 21 and 35 day old rats, CCK-8 (0, 5, 10, 20 and 40μg/kg, i.p.) increased Fos-like immunoreactivity (Fos-LI, a marker for neuronal activation) in the myenteric neurons of 21- and 35-day old rats but in the DVC of all age groups. As such, this belated activation of myenteric neurons by CCK-8 compared to the DVC may reflect a delayed role for these neurons in CCK-related functions.

  3. Efficacy of Appropriate Antimicrobial Therapy on the Survival of Patients With Carbapenem Nonsusceptible Klebsiella Pneumoniae Infection: A Multicenter Study in Taiwan.

    PubMed

    Lin, Yi-Tsung; Chuang, Chien; Su, Chin-Fang; Chan, Yu-Jiun; Wang, Lih-Shinn; Huang, Ching-Tai; Chuang, Yin-Ching; Siu, L Kristopher; Fung, Chang-Phone

    2015-08-01

    The impact of antimicrobial treatment on the outcome of carbapenem nonsusceptible Klebsiella pneumoniae (CnsKP) infections needs to be elucidated. This nationwide, multicenter study was conducted to evaluate the impact of appropriate antimicrobial therapy on 14-day mortality among patients with CnsKP infection in Taiwan.Patients with CnsKP infections from 11 medical centers and 4 regional hospitals in Taiwan were enrolled in 2013. Carbapenem nonsusceptibility was defined as a minimum inhibitory concentration of ≥2 mg/L for imipenem or meropenem. Predictors of 14-day mortality were determined using the Cox proportional regression model. The influence of infection severity on the impact of appropriate use of antimicrobials on 14-day mortality was determined using the Acute Physiology and Chronic Health Evaluation (APACHE) II score.Overall 14-day mortality was 31.8% (49/154). Unadjusted mortality for appropriate antimicrobial therapy was 23.1% (18/78 patients). Appropriate therapy was independently associated with reduced mortality (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.24-0.80; P = 0.007). A subgroup analysis revealed that the benefit of appropriate therapy was limited to patients with higher APACHE II scores (HR for patients with scores >15 and ≤35, 0.46; 95% CI 0.23-0.92; and for those with scores >35, 0.14; 95% CI, 0.02-0.99).In conclusion, appropriate antimicrobial therapy significantly reduces 14-day mortality for CnsKP infections. Survival benefit is more notable among more severely ill patients.

  4. Suppression of episodic growth hormone secretion in streptozotocin-induced diabetic mice: time-course studies on the hypothalamic pituitary axis.

    PubMed

    Murao, S; Sato, M; Tamaki, M; Niimi, M; Ishida, T; Takahara, J

    1995-10-01

    To elucidate the roles of the hypothalamic peptides, GH-releasing hormone (GRH) and somatostatin (SRIH), potentially responsible for altered GH dynamics in diabetes, we studied the time courses of their changes in level associated with altered GH secretion in streptozotocin (STZ)-induced diabetic mice. Diabetic mice were used at 4, 7, and 14 days after STZ injection for analyses of 1) GH secretion in vivo, 2) hypothalamic GRH and SRIH messenger RNA (mRNA) levels, 3) pituitary GH mRNA and protein contents, and 4) pituitary GH response to GRH in vitro. GH secretion was completely suppressed 7 and 14 days after STZ injection. The hypothalamic GRH mRNA level was reduced to 59.8%, 61.2%, and 48.5% of control values at 4, 7, and 14 days, respectively. In contrast, the hypothalamic SRIH mRNA level was not altered at all of these time points. Pituitary GH mRNA and protein contents were significantly reduced to 70.2% and 61.5% of those in controls, respectively, only at 14 days. Pituitary GH responses to GRH at three doses (10, 50, and 250 nM) in vitro were remarkably increased at 4, 7, and 14 days. These findings indicate that the diabetic state rapidly and primarily inhibits hypothalamic GRH gene expression without affecting SRIH. A persistent decrease in hypothalamic GRH tone has been suggested to result in inhibition of GH synthesis in the pituitary. Enhancement of GH responsiveness to GRH may be due to the up-regulation of GRH receptors in the pituitary.

  5. Subchronic studies of doxylamine in B6C3F1 mice.

    PubMed

    Jackson, C D; Blackwell, B N

    1988-02-01

    Doxylamine succinate, a histamine (H1) antagonist (antihistamine), was administered as an admixture in the feed to male and female B6C3F1 mice for 14 or 90 days. Dose levels of 0, 100, 250, 500, 1000, and 2000 ppm doxylamine were administered to males and females in the 14-day study while dose levels of 0, 80, 162, 325, 750, and 1500 ppm were administered to both sexes in the 90-day study. Little toxicity was seen in the 14-day study. Final body weights in the highest dose group were reduced 4.0 and 7.3% in males and females, respectively. Treatment-related histopathological changes in the 14-day study were limited to a very low incidence of hepatic necrosis in both sexes. There was little toxicity observed in the 90-day study and no clear dose response relative to weight gain was observed. Histologically, the liver was the only organ affected by doxylamine administration. The liver lesions consisted of hepatic cell cytomegaly and/or karyomegaly which varied from mild to severe and a possible dose-related hepatic necrosis.

  6. Studies on Sporulation Optimization and Chracterization of Bacillus subtilis Spore Quality

    DTIC Science & Technology

    2011-12-01

    W-A. ; Pinyupa, P. Film coating of seeds with Bacillus cereus RS87 spores for early plant growth enhancement. Can. J. Microbial. 2008, 54, 861 - 867...Optimization and Characterization of Bacillus subtilis Spore Quality Sb. GRANT NUMBER Sc. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Sd. PROJECT NUMBER Smith...Environmental Protection Agency for the production of Bacillus subtilis spores. The cells require 12- 14 days to sporulate. Our goal was to conduct a study

  7. Single dose cabergoline versus bromocriptine in inhibition of puerperal lactation: randomised, double blind, multicentre study. European Multicentre Study Group for Cabergoline in Lactation Inhibition.

    PubMed Central

    1991-01-01

    OBJECTIVE--To compare the efficacy and safety of a single dose of 1 mg of cabergoline with that of bromocriptine 2.5 mg twice daily for 14 days in the inhibition of puerperal lactation. DESIGN--Prospective, randomised, double blind, parallel group, multicentre study. SETTING--University of hospital departments of obstetrics and gynaecology in different European countries. SUBJECTS--272 puerperal women not wishing to lactate (136 randomised to each drug). INTERVENTIONS--Women randomised to cabergoline received two 0.5 mg tablets of cabergoline and one placebo tablet within 27 hours after delivery and then placebo twice daily for 14 days. Those randomised to bromocriptine received 2.5 mg of bromocriptine and two placebo tablets within 27 hours and then 2.5 mg of bromocriptine twice daily for 14 days. MAIN OUTCOME MEASURES--Success of treatment (complete or partial) according to milk secretion, breast engorgement, and breast pain; rebound symptomatology; serum prolactin concentrations; and number of adverse events. RESULTS--Complete success was achieved in 106 of 136 women randomised to cabergoline and in 94 of 136 randomised to bromocriptine and partial success in 21 and 33 women respectively. Rebound breast symptomatology occurred respectively in five and 23 women with complete success up to day 15 (p less than 0.0001). Serum prolactin concentrations dropped considerably with both drugs from day 2 to day 15; a prolactin secretion rebound effect was observed in women treated with bromocriptine. cabergoline and 36 receiving bromocriptine (p = 0.054), occurring most during the first treatment day. CONCLUSION--A single 1 mg dose of cabergoline is at least as effective as bromocriptine 2.5 mg twice daily for 14 days in preventing puerperal lactation. Because of the considerably lower rate of rebound breast activity and adverse events and the simpler administration schedule cabergoline should be the drug of choice for lactation inhibition. PMID:1676318

  8. Sustained administration of trazodone enhances serotonergic neurotransmission: in vivo electrophysiological study in the rat brain.

    PubMed

    Ghanbari, Ramez; El Mansari, Mostafa; Blier, Pierre

    2010-10-01

    Despite its clinical use for more than two decades, the mechanisms by which trazodone acts as an antidepressant are not clear, because it has affinity for a variety of 5-hydroxytryptamine (5-HT; serotonin) receptors and the 5-HT transporter. This study examined the effects of sustained trazodone administration on 5-HT neurotransmission. Electrophysiological recordings were conducted in anesthetized rats. Subcutaneously implanted minipumps delivered vehicle or trazodone (10 mg/kg/day) for 2 and 14 days. A 2-day trazodone administration suppressed the firing rate of raphe 5-HT neurons, which recovered to baseline after 14 days. This was attributable to 5-HT(1A) autoreceptor desensitization because the suppressant effect of the 5-HT autoreceptor agonist lysergic acid diethylamide was dampened in 14-day trazodone-treated rats. Prolonged trazodone administration did not change the sensitivity of postsynaptic 5-HT(1A) and α(2)-adrenergic receptors in hippocampus, but enhanced synaptic 5-HT levels because the 5-HT(1A) antagonist N-{2-[4 (2-methoxyphenyl)-1-piperazinyl]ethyl}-N-(2-pyridinyl) cyclohexanecarboxamide trihydrochloride (WAY-100635) enhanced hippocampal firing in treated rats, but not in controls. Trazodone administration for 14 days increased the 50% recovery time value, an index of 5-HT transporter blockade in vivo, and decreased the inhibitory function of terminal 5-HT(1B) autoreceptors on the electrically evoked release of 5-HT. The agonistic action of trazodone at 5-HT(1A) receptors was characterized as being full because it did not attenuate the inhibitory action of 5-HT when coapplied locally. The enhanced 5-HT neurotransmission by trazodone is caused in part by reuptake blockade and activation of postsynaptic 5-HT(1A) receptors, which may account for its effectiveness in major depression.

  9. Improved Outcome with Early Rifampicin Combination Treatment in Methicillin-Sensitive Staphylococcus aureus Bacteraemia with a Deep Infection Focus – A Retrospective Cohort Study

    PubMed Central

    Forsblom, Erik; Ruotsalainen, Eeva; Järvinen, Asko

    2015-01-01

    Introduction Rifampicin has been used as adjunctive therapy in Staphylococcus aureus bacteraemia (SAB) with a deep infection focus. However, data for prognostic impact of rifampicin therapy is unestablished including the optimal initiation time point. We studied the impact of rifampicin therapy and the optimal initiation time for rifampicin treatment on prognosis in methicillin-sensitive S. aureus bacteraemia with a deep infection. Methods Retrospective, multicentre study in Finland including 357 SAB patients with a deep infection focus. Patients with alcoholism, liver disease or patients who died within 3 days were excluded. Patients were categorised according to duration of rifampicin therapy and according to whether rifampicin was initiated early (within 7 days) or late (7 days after) after the positive blood cultures. Primary end point was 90 days mortality. Results Twenty-seven percent of patients received no rifampicin therapy, 14% received rifampicin for 1-13 days whereas 59% received rifampicin ≥14 days. The 90 day mortality was; 26% for patients treated without rifampicin, 16% for rifampicin therapy of any length and 10% for early onset rifampicin therapy ≥14 days. Lack of rifampicin therapy increased (OR 1.89, p=0.026), rifampicin of any duration decreased (OR 0.53, p=0.026) and rifampicin therapy ≥14 days with early onset lowered the risk for a fatal outcome (OR 0.33, p<0.01) during 90 days follow-up. Conclusion Rifampicin adjunctive therapy for at least 14 days and initiated within 7 days of positive blood culture associated with improved outcome among SAB patients with a deep infection. PMID:25874546

  10. A Prospective Randomized Experimental Study to Investigate the Eradication Rate of Endometriosis after Surgical Resection versus Aerosol Plasma Coagulation in a Rat Model

    PubMed Central

    Rothmund, Ralf; Scharpf, Marcus; Tsaousidis, Christos; Planck, Constanze; Enderle, Markus Dominik; Neugebauer, Alexander; Kroeker, Kristin; Nuessle, Daniela; Fend, Falko; Brucker, Sara; Kraemer, Bernhard

    2016-01-01

    Purpose To investigate the eradication rate of endometriosis after surgical resection (SR) vs. thermal ablation with aerosol plasma coagulation (AePC) in a rat model. Methods In this prospective, randomized, controlled, single-blinded animal study endometriosis was induced on the abdominal wall of 34 female Wistar rats. After 14 days endometriosis was either removed by SR or ablated by AePC. 14 days later the rats were euthanized to evaluate the eradication rate histopathologically. Intervention times were recorded. Results Eradication rate of endometriosis after 14 days did not significantly differ between AePC and SR (p=0.22). Intervention time per endometrial lesion was 22.1 s for AePC and 51.8 s for SR (p<0.0001). Conclusions This study compares the eradication rate of the new aerosol plasma coagulation device versus standard surgical resection of endometriosis in a rat model. Despite being a thermal method, AePC showed equality towards SR regarding eradication rate but with significantly shorter intervention time. PMID:26941579

  11. Results of a phase I/II British Society of Bone Marrow Transplantation study on PCR-based pre-emptive therapy with valganciclovir or ganciclovir for active CMV infection following alemtuzumab-based reduced intensity allogeneic stem cell transplantation.

    PubMed

    Lim, Z Y; Cook, G; Johnson, P R; Parker, Anne; Zuckerman, M; Marks, D; Wiltshire, H; Mufti, G J; Pagliuca, A

    2009-02-01

    This multi-centre randomized study assessed the bioavailability of ganciclovir in patients undergoing alemtuzumab-based reduced intensity conditioning (RIC) haematopoietic stem cell transplantation (HSCT) after oral administration of valganciclovir. Patients were randomized to 2 groups receiving either oral valganciclovir (900 mg twice daily) or intravenous ganciclovir (5mg/kg twice daily) for 14 days. Twenty-seven patients were recruited and 18 patients (67%) completed allocated treatment resulting in clearance of cytomegolovirus (CMV) DNA load at a median of 14 days. The bioavailability of ganciclovir from valganciclovir was 73% (95% CI: 34-112%). The average exposure in the valganciclovir group (36.9+/-14.9 microg h/ml) was higher than the ganciclovir cohort (27.9+/-7.5 microg h/ml). When compared with intravenous ganciclovir, oral valganciclovir had high bioavailability in patients undergoing alemtuzumab-based RIC HSCT.

  12. Voucher-based contingent reinforcement of smoking abstinence among methadone-maintained patients: a pilot study.

    PubMed

    Dunn, Kelly E; Sigmon, Stacey C; Thomas, Colleen S; Heil, Sarah H; Higgins, Stephen T

    2008-01-01

    This study evaluated the efficacy of a contingency management (CM) intervention to promote smoking cessation in methadone-maintained patients. Twenty participants, randomized into contingent (n=10) or noncontingent (n=10) experimental conditions, completed the 14-day study. Abstinence was determined using breath carbon monoxide and urine cotinine levels. Contingent participants received voucher-based incentives for biochemical evidence of smoking abstinence. Noncontingent participants earned vouchers independent of smoking status. Contingent participants achieved significantly more smoking abstinence and longer durations of continuous smoking abstinence than did noncontingent participants. These results support the potential efficacy of using voucher-based CM to promote smoking cessation among methadone-maintained patients.

  13. Translocation of Campylobacter and Salmonella to the spleen and liver/gallbladder in 7 and 14 day old broiler chicks following oral gavage

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Day-of-hatch broilers were obtained from a commercial hatchery and orally gavaged with 0.10mL of either 103 or 106 cells of a marker strain of Campylobacter coli (CC) or Salmonella Typhimurium (ST). At one and two wk after inoculation 10 broilers from the control and each treatment group were human...

  14. Changes observed in the thymus and lymph nodes 14 days after exposure to BVDV field strains of enhanced or typical virulence in neonatal calves

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Clinical presentation following uncomplicated acute infection with bovine viral diarrhea viruses (BVDV) ranges from clinically unapparent to severe (including hemorrhagic disease and death) depending on the strain virulence. Regardless of clinical presentation, BVDV infection of cattle results in i...

  15. Administration of a GnRH analog on day 9 of a 14-day controlled internal drug release insert with timed artificial insemination in lactating beef cows.

    PubMed

    Giles, R L; Ahola, J K; Whittier, J C; French, J T; Repenning, P E; Kruse, S G; Seidel, G E; Peel, R K

    2013-04-01

    Many estrus synchronization protocols aim to induce a new follicular wave to improve response and enhance pregnancy rate. Our objectives were to determine the effectiveness of GnRH analog administered d 0 and 9 during an extended controlled internal drug release (CIDR) protocol to produce 2 follicular waves, induce cyclicity in anestrus cows, and evaluate the efficacy of a single 50-mg dose of PGF2α to initiate luteal regression on CIDR removal. Lactating beef cows (n = 779) at 3 locations (n = 247, location 1; n = 395, location 2; n = 137, location 3) were randomly assigned to 1 of 3 treatments. Cows in the 14-d 50 PG treatment received a CIDR (1.38 g progesterone) with 100 μg GnRH analog intramuscularly (i.m.) on d 0, 100 μg GnRH analog i.m. on d 9, and CIDR removal concurrent with 50 mg PGF2α i.m. on d 14. Cows in the 14-d 6-h PG treatment were assigned the same protocol as the 14-d 50 PG treatment except that 25 mg PGF2α i.m. was given on d 14 plus 25 mg PGF2α i.m. 6 ± 1 h later. Cows in the control treatment, 5-d CO-Synch + CIDR (5-d CO-Synch), received a CIDR concurrent with 100 μg GnRH analog i.m. on d 9, CIDR removal concurrent with 25 mg PGF2α i.m. on d 14, and 25 mg PGF2α i.m. 6 ± 1 h after first F2α injection. Cows in all treatments received 100 μg GnRH analog i.m. and timed AI (TAI) 72 ± 3 h after CIDR removal. Pregnancy status to TAI was determined by ultrasonography 37 to 40 d after TAI. Averaged over all locations, pregnancy rates to TAI for 14-d 50 PG, 14-d 6-h PG, and 5-d CO-Synch treatments were 58.2%, 46.8%, and 41.9%, respectively. Pregnancy rates to TAI were greater (P < 0.05) in 14-d 50 PG treatment than 14-d 6-h PGF2α and 5-d CO-Synch treatments. Cycling status at 2 locations (n = 243, location 1; n = 391, location 2) was determined from blood collected on d -7 and 0; cows with serum progesterone concentrations >1 ng/mL at either (or both) bleeding date were considered cyclic. Averaged over the 2 locations, there was a tendency (P = 0.06) for a greater number of cyclic animals to become pregnant to TAI in the 14-d 50 PG treatment (64.4%) than 5-d CO-Synch treatment (50.2%). The 14-d CIDR with GnRH analog on d 0 and 9 and a single 50-mg dose of PG i.m. at CIDR removal was a more efficacious protocol to maximize TAI pregnancy rates than the standard 5-d CO-Synch.

  16. 4 CFR 7.6 - Adverse actions: Removal, suspension for more than 14 days, reduced in grade, reduced in pay or...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... by an attorney or other representative; and (4) A written decision and the specific reasons therefor... grade or removal for unacceptable performance under part 4. (6) An action ordered by the GAO Personnel... 4 Accounts 1 2010-01-01 2010-01-01 false Adverse actions: Removal, suspension for more than...

  17. Experiment K-6-02. Biomedical, biochemical and morphological alterations of muscle and dense, fibrous connective tissues during 14 days of spaceflight

    NASA Technical Reports Server (NTRS)

    Vailas, A.; Zernicke, R.; Grindeland, R.; Kaplanski, A.

    1990-01-01

    Findings on the connective tissue response to short-term space flight (12 days) are discussed. Specifically, data regarding the biochemical, biomechanical and morphological characteristics of selected connective tissues (humerus, vertebral body, tendon and skeletal muscle) of growing rats is given. Results are given concerning the humerus cortical bone, the vertebral bone, nutritional effects on bone biomechanical properties, and soft tense fiber connective tissue response.

  18. Toxicity and carcinogenicity studies of boric acid in male and female B6C3F1 mice.

    PubMed

    Dieter, M P

    1994-11-01

    Toxicity and potential carcinogenicity studies of boric acid were investigated in mice to verify in a second rodent species that this was a noncarcinogenic chemical. Earlier chronic studies in rats indicated boric acid was not a carcinogen. The chemical is nominated for testing because over 200 tons are produced annually, there are multiple uses for the product, and there is potential for widespread human exposure, both orally and dermally. Both sexes of B6C3F1 mice were offered diets mixed with boric acid for 14 days, 13 weeks, or 2 years. Dietary doses used in the acute, 14-day study were 0, 0.62, 1.25, 2.5, 5, and 10%; those in the subchronic, 13-week study were 0, 0.12, 0.25, 0.50, 1, and 2%; and doses in the 2-year, chronic study were 0, 0.25, and 0.50% in the diet. Mortality, clinical signs of toxicity, estimates of food consumption, body weight gain, and histopathologic examination of selected tissues constituted the variables measured. In the 14-day study mortality was proportional to dose and time of exposure in both sexes, occurring in dose groups as low as 2.5% and as early as 7 days of exposure. Body weights were depressed more than 10% below controls in the higher dose groups of both sexes. Mortality in the 13-week study was confined to the two highest dose groups in male mice and to the 2%-dose group in females. Body weight depression from 8 to 23% below those of controls occurred in the 0.50% and higher dose groups of both sexes.(ABSTRACT TRUNCATED AT 250 WORDS)

  19. Toxicity and carcinogenicity studies of boric acid in male and female B6C3F1 mice.

    PubMed Central

    Dieter, M P

    1994-01-01

    Toxicity and potential carcinogenicity studies of boric acid were investigated in mice to verify in a second rodent species that this was a noncarcinogenic chemical. Earlier chronic studies in rats indicated boric acid was not a carcinogen. The chemical is nominated for testing because over 200 tons are produced annually, there are multiple uses for the product, and there is potential for widespread human exposure, both orally and dermally. Both sexes of B6C3F1 mice were offered diets mixed with boric acid for 14 days, 13 weeks, or 2 years. Dietary doses used in the acute, 14-day study were 0, 0.62, 1.25, 2.5, 5, and 10%; those in the subchronic, 13-week study were 0, 0.12, 0.25, 0.50, 1, and 2%; and doses in the 2-year, chronic study were 0, 0.25, and 0.50% in the diet. Mortality, clinical signs of toxicity, estimates of food consumption, body weight gain, and histopathologic examination of selected tissues constituted the variables measured. In the 14-day study mortality was proportional to dose and time of exposure in both sexes, occurring in dose groups as low as 2.5% and as early as 7 days of exposure. Body weights were depressed more than 10% below controls in the higher dose groups of both sexes. Mortality in the 13-week study was confined to the two highest dose groups in male mice and to the 2%-dose group in females. Body weight depression from 8 to 23% below those of controls occurred in the 0.50% and higher dose groups of both sexes.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7889889

  20. Lunar Outpost Life Support Trade Studies

    NASA Technical Reports Server (NTRS)

    Lange, Kevin E.; Anderson, Molly S.; Ewert, Michael K.; Barta, Daniel J.

    2008-01-01

    Engineering trade-off studies of life support system architecture and technology options were conducted for potential lunar surface mission scenarios within NASA's Constellation Program. The scenarios investigated are based largely on results of the NASA Lunar Architecture Team (LAT) Phase II study. In particular, the possibility of Hosted Sortie missions, the high cost of power during eclipse periods, and the potential to reduce life support consumables through scavenging, in-situ resources, and alternative EVA technologies were all examined. These trade studies were performed within the Systems Integration, Modeling and Analysis (SIMA) element of NASA's Exploration Life Support (ELS) technology development project. The tools and methodology used in the study are described briefly, followed by a discussion of mission scenarios, life support technology options and results presented in terms of equivalent system mass for various regenerative life support technologies and architectures. Three classes of repeated or extended lunar surface missions were investigated in this study along with several life support resource scenarios for each mission class. Individual mission durations of 14 days, 90 days and 180 days were considered with 10 missions assumed for each at a rate of 2 missions per year. The 14-day missions represent a class of Hosted Sortie missions where a pre-deployed and potentially mobile habitat provides life support for multiple crews at one or more locations. The 90-day and 180-day missions represent lunar outpost expeditions with a larger fixed habitat. The 180-day missions assume continuous human presence and must provide life support through eclipse periods of up to 122 hours while the 90-day missions are planned for best-case periods of nearly continuous sunlight. This paper investigates system optimization within the assumptions of each scenario and addresses how the scenario selected drives the life support system to different designs

  1. Comparative study of 6-APA production by free and agar immobilized bacteria in nutrient broth culture.

    PubMed

    Dolui, A K; Das, S

    2011-04-01

    In the present study different bacterial samples were isolated from soil of different places of Dibrugarh and screened for biotransformation ability to produce 6-Aminopenicillanic acid. Among ten isolated bacterial samples, three gram positive bacterial samples designated as AKDD-2, AKDD-4 and AKDD-6 showed the production of 6-APA from penicillin G. Assessment of production of 6-APA after incubation in penicillin G (2 mg/ml) by three different samples separately in free and agar immobilization state was done by HPLC analysis. Reusability of immobilized cells was found successful up to 14 days.

  2. Toxicological study of a new maintenance fluid, Veen 3G, in rats.

    PubMed

    Kamei, J; Onodera, K; Kawaguchi, M; Shibata, M; Kagawa, M; Wachi, M; Kojima, J

    2002-10-01

    A study of the different volume and infusion rates of a new maintenance fluid, Veen 3G, on the general conditions of rats was investigated during the 14 days after infusion. In Experiment I, 100 ml/kg and 200 ml/kg of Veen 3G were infused at a rate of 300 ml/kg/h in male and female rats. Results were compared with those for Gurunon Ringer solution (GRS) in male and female rats. We observed only transient polyuria in animals administered by each dose of Veen 3G and GRS for 0-15 min after infusion. Necropsy was not observed in any of the animals tested 14 days after infusion. In Experiment II, 200 ml/kg of Veen 3G was infused at rates of 200, 400, 800 and 1600 ml/kg/h in male rats. At 800 and 1600 ml/kg/h, irregular respiration and decrease in movement were observed concomitantly with polyuria. Three out of 4 rats died immediately after the infusion of Veen 3G at a rate of 1600 ml/kg/h, and one rat was still alive 14 days after the infusion. In this experiment, 200 ml/kg Veen 3G was safe when we infused at a rate of less than 400 ml/kg/h in male rats. Since this rate is about 27-80 times higher than that used clinically in maintenance treatment, Veen 3G is suggested to be safe, with the exception of polyuria, in clinical situations at the standard infusion rate (5-15 ml/kg/h).

  3. Phase I study of intermittent intravenous bromodeoxyuridine (BUdR) with conventional fractionated irradiation

    SciTech Connect

    Kinsella, T.J.; Russo, A.; Mitchell, J.B.; Rowland, J.; Jenkins, J.; Schwade, J.; Myers, C.E.; Collins, J.M.; Speyer, J.; Kornblith, M.D.

    1984-01-01

    A Phase I trial of intravenous bromodeoxyuridine (BUdR) and conventional fractionated radiation therapy was performed in 14 patients with glioblastoma multiforme and 7 patients with other poorly radioresponsive tumors. The BUdR was given as a constant intravenous infusion for 12 hr/day for up to 14 days. Local toxicity (within the radiation field) was minor, with 7 of the 21 patients requiring a brief treatment break for moist skin desquamation. There was no significant CNS toxicity noted clinically nor by autopsy examination. Additionally, no significant enhancement of radiation injury was noted to bowel or liver. Dose-dependent systemic toxicity occurred in bone marrow and skin. Moderate myelosuppression, especially thrombocytopenia, was found following a 14 day cycle of BUdR at and above 650 mg/m/sup 2//12 hr infusion. Approximately one-third of patients developed a maculo-papular erythematous rash to the scalp, neck and upper chest. Pharmacology studies revealed steady-state arterial plasma levels of 2 x 10/sup -6/M/1 during the 12 hr infusion of 650 to 700 mg/m/sup 2/. Radiosensitization was measured by a change in the D/sub 0/ of radiation survival curves of human bone marrow CFUc prior to and following the 14 day infusion in 4 patients. A trend of increasing radiosensitization was noted in most patients as the infusion rate of BUdR was increased from 500 to 870 mg/m/sup 2//12 hr. It is concluded that the maximum tolerable dose of BUdR is 650 to 700 mg/m/sup 2//12 hrs when given as a 2 week intermittent intravenous infusion. Local toxicity is acceptable. The major systemic toxicities are myelosuppression and a maculopapular skin rash.

  4. Biomimetic fiber assembled gradient hydrogel to engineer glycosaminoglycan enriched and mineralized cartilage: An in vitro study.

    PubMed

    Mohan, Neethu; Wilson, Jijo; Joseph, Dexy; Vaikkath, Dhanesh; Nair, Prabha D

    2015-12-01

    The study investigated the potential of electrospun fiber assembled hydrogel, with physical gradients of chondroitin sulfate (CS) and sol-gel-derived bioactive glass (BG), to engineer hyaline and mineralized cartilage in a single 3D system. Electrospun poly(caprolactone) (PCL) fibers incorporated with 0.1% w/w of CS (CSL) and 0.5% w/w of CS (CSH), 2.4% w/w of BG (BGL) and 12.5% w/w of BG (BGH) were fabricated. The CS showed a sustained release up to 3 days from CSL and 14 days from CSH fibers. Chondrocytes secreted hyaline like matrix with higher sulfated glycosaminoglycans (sGAG), collagen type II and aggrecan on CSL and CSH fibers. Mineralization was observed on BGL and BGH fibers when incubated in simulated body fluid for 14 days. Chondrocytes cultured on these fibers secreted a mineralized matrix that consisted of sGAG, hypertrophic proteins, collagen type X, and osteocalcin. The CS and BG incorporated PCL fiber mats were assembled in an agarose-gelatin hydrogel to generate a 3D hybrid scaffold. The signals in the fibers diffused and generated continuous opposing gradients of CS (chondrogenic signal) and BG (mineralization) in the hydrogel. The chondrocytes were encapsulated in hybrid scaffolds; live dead assay at 48 h showed viable cells. Cells maintained their phenotype and secreted specific extracellular matrix (ECM) in response to signals within the hydrogel. Continuous opposing gradients of sGAG enriched and mineralized ECM were observed surrounding each cell clusters on gradient hydrogel after 14 days of culture in response to the physical gradients of raw materials CS and BG. A construct with gradient mineralization might accelerate integration to subchondral bone during in vivo regeneration.

  5. Difluprednate 0.05% Versus Prednisolone Acetate 1% for Endogenous Anterior Uveitis: A Phase III, Multicenter, Randomized Study

    PubMed Central

    Sheppard, John D.; Toyos, Melissa M.; Kempen, John H.; Kaur, Paramjit; Foster, C. Stephen

    2014-01-01

    Purpose. Endogenous anterior uveitis (AU), when untreated, may lead to vision loss. This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition. Methods. This phase III, double-masked, noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05% (n = 56) four times daily, alternating with vehicle four times daily, or prednisolone acetate 1% (n = 54) eight times daily. The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period. The primary efficacy end point was change in anterior chamber cell grade (range, 0 for ≤1 cell to 4 for >50 cells) from baseline to day 14. Results. At day 14, the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate (−2.2 vs. −2.0, P = 0.16). The proportions of difluprednate-treated patients versus prednisolone acetate–treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0% vs. 2.1% (P = 0.046) and at day 21 were 73.9% vs. 63.8% (P = 0.013). A significant between-group difference in the mean IOP increase was seen at day 3 (2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate–treated patients, P = 0.0013) but not at other time points. The mean IOP values in both groups remained less than 21 mm Hg throughout the study. Conclusions. Difluprednate 0.05% four times daily is well tolerated and is noninferior to prednisolone acetate 1% eight times daily for the treatment of endogenous AU. (ClinicalTrials.gov number, NCT01201798.) PMID:24677110

  6. Joint US/USSR study: Comparison of effects of horizontal and head-down bed rest

    NASA Technical Reports Server (NTRS)

    Sandler, Harold; Grigoriev, Anatoli I.

    1990-01-01

    An account is given of the results of the first joint U.S./U.S.S.R. bed rest study. The study was accomplished in two parts: A soviet part (May to June 1979) and an American part (July to August 1979). Both studies were conducted under identical conditions and provided a basis for comparison of physiologic reactions and standardizing procedures and methods. Each experiment consisted of three periods: 14 days of pre-bed rest control, 7 days of bed rest, and a 10 to 14 day recovery period. Ten males participated in each study, with five subjects experiencing horizontal bed rest and five subjects a -6 deg head-down body position. Biochemical and hormonal measurements were made of blood and urine, with particular attention to electrolyte metabolism and kidney function; cardio-pulmonary changes at rest and exercise; influence of Lower Body Negative Pressure (LBNP); and incremental exercise using a bicyle ergometer while supine and sitting. Expected moderate changes were noted to occur for various physiologic parameters. Clinical evidence pointed to the fact that head-down bed rest when compared to horizontal conditions more closely matched the conditions seen after manned spaceflight. For the most part, statistically significant differences between the two body positions were not observed.

  7. Mirtazapine in essential tremor: a double-blind, placebo-controlled pilot study.

    PubMed

    Pahwa, Rajesh; Lyons, Kelly E

    2003-05-01

    We sought to determine whether mirtazapine is safe and well-tolerated as a treatment for essential tremor (ET). We studied mirtazapine in a randomized, double-blind, placebo-controlled, crossover study of 17 ET patients. Patients were started with 15 mg per day of either mirtazapine or placebo for 1 week and the dose was escalated weekly until the targeted dose of 45 mg per day was achieved. This dose was maintained for 2 weeks. Tremor was assessed at baseline and after 14 days of 45 mg of mirtazapine or placebo. There was a minimum washout period of 14 days between the two arms of the study. Tremor assessments included global improvement, Fahn Tolosa Marin Tremor Rating Scale, Beck Depression Inventory and the Parkinson's Disease Questionnaire-39. Patient global improvement ratings indicated that in the placebo condition 12 patients were unchanged and 1 patient was mildly improved. In the mirtazapine condition, 10 patients were unchanged, 2 were moderately improved and 1 was markedly improved. There was no significant improvement with mirtazapine or placebo compared to baseline as measured by the Tremor Rating Scale. Adverse effects were more common in the mirtazapine group and included drowsiness, confusion, dry mouth, weight gain, polyuria, itching, nausea, gait and balance problems, blurred vision, and bad taste. We conclude that the majority of the ET patients do not benefit from mirtazapine. Mirtazapine has significant adverse effects and should be used cautiously in ET patients.

  8. Long life feasibility study for the shuttle infrared telescope facility

    NASA Technical Reports Server (NTRS)

    1985-01-01

    A study was conducted to assess the feasibility of designing an Infrared Telescope of the 1 meter class which would operate effectively as a Shuttleborne, 14-day Spacelab payload and then be adapted with little modification to work as a 6 month Space station or free flyer payload. The optics configuration and requirements from a previous study were used without modification. In addition, an enhancement to 2 year mission lengths was studied. The cryogenic system selected was a hybrid design with an internal solid Hydrogen tank at 8 Kelvin and an internal superfluid tank at 2K. In addition to the cryogenic design, a detailed look at secondary mirror actuators for chopping, focus and decenter was conducted and analysis and cryo test reported.

  9. The Efficacy of Oral Melatonin in Improving Sleep in Cancer Patients with Insomnia: A Randomized Double-Blind Placebo-Controlled Study

    PubMed Central

    Kurdi, Madhuri S; Muthukalai, Sindhu Priya

    2016-01-01

    Background: The natural hormone melatonin has sleep inducing properties. Insomnia in cancer patients is common. So far, melatonin has been seldom tried for the improvement of sleep in patients with malignancies. Keeping this in mind, we planned and conducted a double-blind study to test the efficacy of melatonin in promoting sleep in patients with malignancies suffering from insomnia. Objective: To assess the hypnotic efficacy of oral melatonin in cancer patients with insomnia. Materials and Methods: After Ethical Committee approval, 50 patients (age range 20-65 years) from our pain clinic NIVARANE who met the Diagnostic and Statistical Manual of Mental Disorders 4th edition criteria for primary insomnia were randomized to receive melatonin 3 mg or placebo at 7 pm orally every day for 14 days from our pharmacist. After 1, 7, 14 days, the patients were reviewed with the Athens insomnia scale oral questionnaire to document the subjective sleep quality. The patients and we, the investigators were blinded to the study drug. Results: There were 2 drop outs (one from each group) as they failed to complete visit on day 14. Significant differences in favor of melatonin treatment were found in clinically relevant improvements in insomnia (46.53%; P = 0.00001 vs. 11.30%; P = 0.1026) There was improvement in sleep from 1 to 7 days (19.91%; P = 0.00001 vs. 0.98%; P = 0.2563). More significant improvements were seen between 7 and 14 days (33.24%; P = 0.00001 vs. 10.42%; P = 0.1469). Conclusion: We conclude that daily intake of oral melatonin 2 h before bedtime improves sleep induction and quality in cancer patients with insomnia. PMID:27559258

  10. Engineering Analysis Studies for Preliminary Design of Lightweight Cryogenic Hydrogen Tanks in UAV Applications

    NASA Technical Reports Server (NTRS)

    Sullivan, Roy M.; Palko, Joseph L.; Tornabene, Robert T.; Bednarcyk, Brett A.; Powers, Lynn M.; Mital, Subodh K.; Smith, Lizalyn M.; Wang, Xiao-Yen J.; Hunter, James E.

    2006-01-01

    A series of engineering analysis studies were conducted to investigate the potential application of nanoclay-enhanced graphite/epoxy composites and polymer cross-linked silica aerogels in cryogenic hydrogen storage tank designs. This assessment focused on the application of these materials in spherical tank designs for unmanned aeronautic vehicles with mission durations of 14 days. Two cryogenic hydrogen tank design concepts were considered: a vacuum-jacketed design and a sandwiched construction with an aerogel insulating core. Analyses included thermal and structural analyses of the tank designs as well as an analysis of hydrogen diffusion to specify the material permeability requirements. The analyses also provided material property targets for the continued development of cross-linked aerogels and nanoclay-enhanced graphite/epoxy composites for cryogenic storage tank applications. The results reveal that a sandwiched construction with an aerogel core is not a viable design solution for a 14-day mission. A vacuum-jacketed design approach was shown to be far superior to an aerogel. Aerogel insulation may be feasible for shorter duration missions. The results also reveal that the application of nanoclay-enhanced graphite/epoxy should be limited to the construction of outer tanks in a vacuum-jacketed design, since a graphite/epoxy inner tank does not provide a significant weight savings over aluminum and since the ability of nanoclay-enhanced graphite/epoxy to limit hydrogen permeation is still in question.

  11. Hepatic 3D spheroid models for the detection and study of compounds with cholestatic liability

    PubMed Central

    Hendriks, Delilah F. G.; Fredriksson Puigvert, Lisa; Messner, Simon; Mortiz, Wolfgang; Ingelman-Sundberg, Magnus

    2016-01-01

    Drug-induced cholestasis (DIC) is poorly understood and its preclinical prediction is mainly limited to assessing the compound’s potential to inhibit the bile salt export pump (BSEP). Here, we evaluated two 3D spheroid models, one from primary human hepatocytes (PHH) and one from HepaRG cells, for the detection of compounds with cholestatic liability. By repeatedly co-exposing both models to a set of compounds with different mechanisms of hepatotoxicity and a non-toxic concentrated bile acid (BA) mixture for 8 days we observed a selective synergistic toxicity of compounds known to cause cholestatic or mixed cholestatic/hepatocellular toxicity and the BA mixture compared to exposure to the compounds alone, a phenomenon that was more pronounced after extending the exposure time to 14 days. In contrast, no such synergism was observed after both 8 and 14 days of exposure to the BA mixture for compounds that cause non-cholestatic hepatotoxicity. Mechanisms behind the toxicity of the cholestatic compound chlorpromazine were accurately detected in both spheroid models, including intracellular BA accumulation, inhibition of ABCB11 expression and disruption of the F-actin cytoskeleton. Furthermore, the observed synergistic toxicity of chlorpromazine and BA was associated with increased oxidative stress and modulation of death receptor signalling. Combined, our results demonstrate that the hepatic spheroid models presented here can be used to detect and study compounds with cholestatic liability. PMID:27759057

  12. Caspofungin for the treatment of invasive fungal disease in hematological patients (ProCAS Study).

    PubMed

    Jarque, I; Tormo, M; Bello, J L; Rovira, M; Batlle, M; Julià, A; Tabares, S; Rivas, C; Fernández-Sevilla, A; García-Boyero, R; Debén, G; González-Campos, J; Capote, F J; Sanz, M A

    2013-02-01

    Caspofungin is an echinocandin with proven efficacy in invasive candidiasis (IC) and invasive aspergillosis (IA). This multicenter, prospective, non-comparative, observational ProCAS study was aimed to assess the effectiveness and safety of caspofungin in adult hematological patients with IC or IA under everyday clinical conditions. Favorable outcomes included complete and partial responses on the last day of caspofungin therapy. Safety was assessed up to 14 days post-caspofungin. A total of 115 patients (69 male) with a median age of 52 years (range, 23-78 years) were analyzed. Underlying disease was acute myeloid leukemia in 45 patients (39%), and 21 (18%) were allogeneic stem cell transplant recipients. Thirty-four (29.5%) patients had a diagnosis of IA and 26 (22.6%) had IC (candidemia). The median duration of caspofungin therapy was 14 days (range, 1-100). The overall favorable response rate was 77% (20/26) for patients with IC (69% first-line) and 79% (27/34) for those with IA. Antifungal therapy with caspofungin was generally well tolerated, only two (1.7%) patients having a non-serious drug-related adverse reaction. These results suggest that caspofungin, either alone or in combination, should be considered an effective and safe option for the treatment of invasive mycoses in patients with severe hematological disorders.

  13. Chronic toxicity of chlordane to Daphnia magna and Ceriodaphnia dubia: a comparative study.

    PubMed

    Manar, Rachid; Vasseur, Paule; Bessi, Hlima

    2012-02-01

    Chronic toxicity of chlordane, an organochlorine insecticide, was assessed on Ceriodaphnia dubia under standardized conditions of testing. Results were compared to Daphnia magna to determine the sensitivity of the two freshwater cladoceran species to this persistent organic pollutant (POP) and to explore the possibility of using the 7-day C. dubia test as an alternative to the 21-day D. magna test in chronic toxicity assessment of POPs. The NOEC-7d value of chlordane on reproduction of C. dubia (2.9 μg/L) was much higher than the NOEC-21d value of D. magna (0.18 μg/L), attesting that the 7-day test on C. dubia was less sensitive than the 21-day reproduction test on D. magna to chlordane. However, extending the period of exposure of C. dubia to chlordane from 7 to 14 days led to a NOEC-14d value similar to the NOEC-21d value in D. magna (0.18 μg/L). This study highlights the usefulness of prolonging the exposure time of the reproduction test in C. dubia from 7 to 14 days to increase the performances of the reproduction test on C. dubia for assessing chronic toxicity of POPs.

  14. Subchronic studies of doxylamine in Fischer 344 rats.

    PubMed

    Jackson, C D; Blackwell, B N

    1988-02-01

    Doxylamine succinate was administered as an admixture in the feed to male and female Fischer 344 rats for either 14 or 90 days. The 14-day study included dose levels of 0, 100, 250, 500, 1000, or 2000 ppm doxylamine. Except for a 7% decrease in final body weight in female rats in the 2000 ppm group, there were no significant clinical observations made in the 14-day study. Microscopic lesions judged to be treatment-related were limited to cytoplasmic vacuolization in the livers. The lesions were more numerous in the higher dose groups of males and present only in the 2000 ppm group of females. Dose levels of 0, 162, 405, 1012, 2530, and 6325 ppm doxylamine were administered in the 90-day study. There were no deaths during the study. Final body weights were decreased 13.3% in males of the 6325 ppm group and 5.2, 10.1, and 14.4% in females in the 1012, 2530, and 6325 ppm groups, respectively. Liver/brain weight ratios were increased in all treated male groups and in the two highest dose groups of females. Other organ weight changes were decreases and believed to result from general reduction in weight gain in those groups where the decreases occurred. Treatment-related histological changes were identified in the liver and parotid salivary gland. Cytoplasmic vacuolization or fatty change of the liver was found in all groups of males but was more severe in the higher dose groups. In females, these liver lesions were observed only in the two highest dose groups. A dose-related change in the parotid salivary gland, consisting of cytomegaly with basophilic and coarsely granular or vacuolated cytoplasm, was observed.

  15. Efficacy studies of Aquaprene (emulsifiable concentrate and wettable powder) insect growth regulator formulations against third- and fourth-stage larvae of Ochlerotatus taeniorhynchus in small-plot field studies.

    PubMed

    Floore, T G; Petersen, J L; Shaffer, K R

    2006-03-01

    Efficacy studies were conducted with Aquaprene emulsifiable concentrate (EC) (33.6% active ingredient [AI]) and wettable powder (WP) (40% AI) (S)-methoprene insect growth regulator formulations against larval Ochlerotatus taeniorhynchus in small field test plots. Aquaprene EC was applied at 7.18 and 9.57 g/acre. Approximately one thousand 4th-stage larvae were added to each plot before treatment, and 24 h later pupae were collected to determine emergence inhibition. At both applications rates, Aquaprene EC was extremely effective (99%) at significantly reducing adult emergence in the studies. Two application rates ((S)-methoprene at 2.4 and 4.8 g/acre) of the Aquaprene WP also were evaluated against Oc. taeniorhynchus at 1, 3, 7, and 14 days after treatment. Emergence inhibition and statistical analysis showed that significant differences were found between the (S)-methoprene rates of 2.4 and 4.8 g/acre at each posttreatment assessment. The (S)-methoprene rate of 4.8 g/acre was effective in controlling adult emergence for up to 14 days after treatment.

  16. Developmental Toxicity (Segments II) Study of WR238605 Succinate in Rabbits

    DTIC Science & Technology

    1995-08-08

    8 3. MATERIALS AND METHODS 8 3.1 Test Article 8 3.2 Animals 9 3.3 Experimental Design 10 3.4 Statistical Analyses 12 4. RESULTS ...liquid chromatography by a previously described analytical method (see report UIC/TRL Study No. 098 from August 19, 1993, Part I). Results ... results of a previously conducted dose range-finding study (UIC/TRL 155) where maternal toxicity (abortion, significant reductions in body weight and food

  17. A comparative study of metabolic state of stem cells during osteogenic and adipogenic differentiations via fluorescence lifetime imaging microscopy

    NASA Astrophysics Data System (ADS)

    Chakraborty, Sandeep; Ou, Meng-Hsin; Kuo, Jean-Cheng; Chiou, Arthur

    2016-10-01

    Cellular metabolic state can serve as a biomarker to indicate the differentiation potential of stem cells into other specialized cell lineages. In this study, two-photon fluorescence lifetime imaging microscopy (2P-FLIM) was applied to determine the fluorescence lifetime and the amounts of the auto-fluorescent metabolic co-factor reduced nicotinamide adenine dinucleotide (NADH) to elucidate the cellular metabolism of human mesenchymal stem cells (hMSCs) in osteogenic and adipogenic differentiation processes. 2P-FLIM provides the free to protein-bound NADH ratio which can serve as the indicator of cellular metabolic state. We measured NADH fluorescence lifetime at 0, 7, and 14 days after hMSCs were induced for either osteogenesis or adipogenesis. In both cases, the average fluorescence lifetime increased significantly at day 14 (P < 0.001), while the ratio of free to protein-bound NADH ratio decreased significantly in 7- days (P < 0.001) and 14-days (P < 0.001). Thus, our results indicated a higher metabolic rate in both osteogenic and adipogenic differentiation processes when compared with undifferentiated hMSCs. This approach may be further utilized to study proliferation efficiency and differentiation potential of stem cells into other specialized cell lineages.

  18. Phase I trial of GTI-2040, oxaliplatin, and capecitabine in the treatment of advanced metastatic solid tumors: a California Cancer Consortium Study

    PubMed Central

    Doroshow, James H.; Frankel, Paul; Synold, Timothy W.; Yen, Yun; Gandara, David R.; Lenz, Heinz-Josef; Chow, Warren A.; Leong, Lucille A.; Lim, Dean; Margolin, Kim A.; Morgan, Robert J.; Somlo, George; Newman, Edward M.

    2011-01-01

    Background GTI-2040 is a 20-mer antisense oligonucleotide targeting the mRNA of ribonucleotide reductase M2. It was combined with oxaliplatin and capecitabine in a phase I trial in patients with advance solid tumors based on previous studies demonstrating potentiation of chemotherapy with ribonucleotide reductase inhibitors. Methods Patients at least 18 years of age with advanced incurable solid tumors and normal organ function as well as a Karnofsky performance status of ≥60% were eligible. One prior chemotherapy regimen for advanced disease or relapse within 12 months of adjuvant chemotherapy was required. Patients could have received prior fluoropyrimidines, including capecitabine, but not oxaliplatin. Treatment cycles were 21 days. In each cycle, GTI-2040 was given as a continuous intravenous infusion over 14 days, oxaliplatin as a 2-h intravenous infusion on day 1, and capecitabine orally twice a day for 14 days. In cycle 1 only, oxaliplatin and capecitabine were started on day 2 to allow ribonucleotide reductase mRNA levels to be measured with and without oxaliplatin and capecitabine. Doses were escalated in cohorts of three patients using a standard 3 + 3 design until the maximum tolerated dose was established, defned as no more than one first-cycle dose-limiting toxicity among six patients treated at a given dose level. Results The maximum tolerated dose was estimated to be the combination of GTI-2040 3 mg/kg per day for 14 days, capecitabine 600 mg/m2 twice daily for 14 days, and oxaliplatin 100 mg/m2 every 21 days. Dose-limiting toxicities were hematologic. GTI-2040 pharmacokinetics, obtained at steady-state on days 7 and 14, showed the high inter-patient variability previously reported. Two of six patients had stable disease at the maximum tolerated dose and one patient, with heavily pre-treated non-small cell lung cancer, had a partial response at a higher dose level. In samples from a limited number of patients, there was no clear decrease in

  19. A randomized clinical study of the heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain associated with shoulder impingement syndrome

    PubMed Central

    Radnovich, Richard; Trudeau, Jeremiah; Gammaitoni, Arnold R

    2014-01-01

    Background Treatment for pain due to shoulder impingement syndrome (SIS) typically begins conservatively with nonsteroidal anti-inflammatory drugs and physical therapy and can include subacromial injection of corticosteroids, particularly in patients unresponsive to conservative measures. The heated lidocaine/tetracaine (HLT) patch has been reported to reduce SIS pain in a small case series. Methods This was a prospective, randomized, open-label clinical trial in which adult patients with SIS pain lasting at least 14 days, with an average intensity of ≥4 on a 0–10 scale (0= no pain, 10= worst pain) were randomized to treatment with the HLT patch or a single subacromial injection of triamcinolone acetonide (10 mg). Patients in the HLT patch group applied a single HLT patch to the shoulder for 4 hours twice daily, with a 12-hour interval between treatments during the first 14 days, and could continue to use the patch on an as-needed basis (up to twice daily) during the second 14-day period. No treatment was allowed in the final 14-day period. At baseline and at days 14, 28, and 42, patients rated their pain and pain interference with specific activities (0–10 scale). Results Sixty patients enrolled in the study (average age =51 years, range 18–75, n=21 female). Average pain scores declined from 6.0±1.6 at baseline to 3.5±2.4 at day 42 in the HLT patch group (n=29, P<0.001) and from 5.6±1.2 to 3.2±2.6 in the injection group (n=31, P<0.001). Similar improvements were seen in each group for worst pain; pain interference with general activity, work, or sleep; and range of motion. No significant between-group differences were seen for any pain or pain interference scores at any time point. Conclusion These results suggest that short-term, noninvasive treatment with the HLT patch has similar efficacy to subacromial corticosteroid injections for the treatment of pain associated with SIS. PMID:25525385

  20. Phase II, Randomized, Placebo-controlled, 90-day Study of Emixustat HCL in Geographic Atrophy Associated with Dry Age-Related Macular Degeneration

    PubMed Central

    Dugel, Pravin U.; Novack, Roger L.; Csaky, Karl G.; Richmond, Preston P.; Birch, David G.; Kubota, Ryo

    2015-01-01

    Purpose This study assessed the safety, tolerability, and pharmacodynamics of emixustat hydrochloride (ACU-4429), a novel visual cycle modulator, in subjects with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Methods Subjects were randomly assigned to oral emixustat (2, 5, 7, or 10 mg once daily) or placebo (3:1 ratio) for 90 days. Recovery of rod photoreceptor sensitivity following a photobleach was measured by electroretinography. Safety evaluations included analysis of adverse events (AEs) and ophthalmic examinations. Results Seventy-two subjects (54 emixustat, 18 placebo) were evaluated. Emixustat suppressed rod photoreceptor sensitivity in a dose-dependent manner. Suppression plateaued by Day 14, and was reversible within 7-14 days after drug cessation. No systemic AEs of concern were noted. Dose-related ocular AEs (chromatopsia, 57% emixustat vs. 17% placebo; and delayed dark adaptation, 48% emixustat vs. 6% placebo) were mild to moderate, and the majority resolved on study or within 7-14 days after study drug cessation. Conclusions In this phase II study, emixustat produced a dose-dependent, reversible effect on rod function, and an ocular AE profile that is consistent with the proposed mechanism of action. These results support further testing of emixustat for the treatment of GA associated with dry AMD. PMID:25932553

  1. Part 2: A field study of enhanced remediation of Toluene in the vadose zone using a nutrient solution

    USGS Publications Warehouse

    Tindall, J.A.; Weeks, E.P.; Friedel, M.

    2005-01-01

    The objective of this study was to test the effectiveness of a nitrate-rich nutrient solution and hydrogen peroxide (H2O2) to enhance in-situ microbial remediation of toluene in the unsaturated zone. Three sand-filled plots were tested in three phases (each phase lasting approximately 2 weeks). During the control phase, toluene was applied uniformly via sprinkler irrigation. Passive remediation was allowed to occur during this phase. A modified Hoagland nutrient solution, concentrated in 150 L of water, was tested during the second phase. The final phase involved addition of 230 moles of H2O2 in 150 L of water to increase the available oxygen needed for aerobic biodegradation. During the first phase, measured toluene concentrations in soil gas were reduced from 120 ppm to 25 ppm in 14 days. After the addition of nutrients during the second phase, concentrations were reduced from 90 ppm to about 8 ppm within 14 days, and for the third phase (H 2O2), toluene concentrations were about 1 ppm after only 5 days. Initial results suggest that this method could be an effective means of remediating a contaminated site, directly after a BTEX spill, without the intrusiveness and high cost of other abatement technologies such as bioventing or soil-vapor extraction. However, further tests need to be completed to determine the effect of each of the BTEX components. ?? Springer 2005.

  2. Location of injected polymethylmethacrylate microspheres influences the onset of late adverse effects: an experimental and histopathologic study

    PubMed Central

    de Jesus, Luciano Henrique; de Campos Hildebrand, Laura; Martins, Manoela Domingues; da Rosa, Francinne Miranda; Danilevicz, Chris Krebs; Sant’Ana Filho, Manoel

    2015-01-01

    Polymethylmethacrylate (PMMA) has been widely used in the correction of wrinkles because of its long-lasting cosmetic improvements. However, side effects and complications may occur, and its clinical appearance on the oral mucosa can be similar to that of inflammatory or neoplastic disease. The aim of this research was to compare the clinical and histopathologic responses to PMMA injected by two different methods. Twenty-two rats received an injection of PMMA using the tunneling technique (gold standard), with subcutaneous deposition of the filler in the face, or a variation of the technique with transcutaneous submucosal deposition of the filler in the cheek. The tissue reaction was analyzed clinically every 24 hours during the first week, then once a week for the following 3 months. Histologic evaluation was based on the local inflammatory response to the filler. No clinical changes were observed during the initial evaluation period (0–14 days). After 14 days, only the submucosal group showed extra-oral enlargement (n=4, 18.2%). Histopathologic analysis revealed nodule formation in four animals (18.2%) in the submucosal group, with no nodules observed in the subcutaneous group. The data obtained in this study demonstrate that the technique used to deliver the filler may influence the risk of adverse reactions. PMID:26346665

  3. Enhanced Remediation of Toluene in the Vadose Zone via a Nitrate-Rich Nutrient Solution: Field Study

    NASA Astrophysics Data System (ADS)

    Tindall, J. A.; Friedel, M. J.

    2003-12-01

    The objective of this study was to test the effectiveness of nitrate-rich nutrient solutions and hydrogen peroxide (H202) to enhance in-situ microbial remediation of toluene. Three sand filled plots (2 m2 surface area and 1.5 meters deep) were tested in three phases (each phase lasting approximately 2 weeks). During each phase, toluene (21.6 mol as an emulsion in 50L of water) was applied uniformly via sprinkler irrigation. Passive remediation was allowed to occur during the first (control) phase. A nutrient solution (modified Hoagland), concentrated in 40L of water, was tested during the second phase. The final phase involved addition of 230 moles of H202 in 50L of water to increase the available oxygen needed for aerobic biodegradation. During the first phase, toluene concentrations in soil gas were reduced from 120 ppm to 25 ppm in 14 days. After the addition of nutrients during the second phase, concentrations were reduced from 90 ppm to about 8 ppm within 14 days, and for the third phase (H202), toluene concentrations were about 1 ppm after only five days. Initial results suggest that this method could be an effective means of remediating a contaminated site, directly after a BTEX spill, without the intrusiveness and high cost of other abatement technologies such as bioventing and soil vapor extraction. However, further tests need to be completed to determine the effect of each of the BTEX components.

  4. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia.

    PubMed

    Ballantyne, Christie M; Neutel, Joel; Cropp, Anne; Duggan, William; Wang, Ellen Q; Plowchalk, David; Sweeney, Kevin; Kaila, Nitin; Vincent, John; Bays, Harold

    2015-05-01

    Bococizumab is a humanized monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, which may be a potential therapeutic option for reducing low-density lipoprotein cholesterol (LDL-C) levels in patients with hypercholesterolemia. In this 24-week, multicenter, double-blind, placebo-controlled, dose-ranging study (NCT01592240), subjects with LDL-C levels≥80 mg/dl on stable statin therapy were randomized to Q14 days subcutaneous placebo or bococizumab 50, 100, or 150 mg or Q28 days subcutaneous placebo or bococizumab 200 or 300 mg. Doses of bococizumab were reduced if LDL-C levels persistently decreased to ≤25 mg/dl. The primary end point was the absolute change in LDL-C levels from baseline to week 12 after placebo or bococizumab administration. Continuation of bococizumab administration through to week 24 enabled the collection of safety data over an extended period. Of the 354 subjects randomized, 351 received treatment (placebo [n=100] or bococizumab [n=251]). The most efficacious bococizumab doses were 150 mg Q14 days and 300 mg Q28 days. Compared with placebo, bococizumab 150 mg Q14 days reduced LDL-C at week 12 by 53.4 mg/dl and bococizumab 300 mg Q28 days reduced LDL-C by 44.9 mg/dl; this was despite dose reductions in 32.5% and 34.2% of subjects at week 10 or 8, respectively. Pharmacokinetic/pharmacodynamic model-based simulation assuming no dose reductions predicted that bococizumab would lower LDL-C levels by 72.2 and 55.4 mg/dl, respectively. Adverse events were similar across placebo and bococizumab groups. Few subjects (n=7; 2%) discontinued treatment because of treatment-related adverse events. In conclusion, bococizumab significantly reduced LDL-C across all doses despite dose reductions in many subjects. Model-based simulations predicted greater LDL-C reduction in the absence of bococizumab dose reduction. The Q14 days regimen is being evaluated in phase 3 clinical trials.

  5. MDRS 137 study - Utilization of dry disaster products as space food -

    NASA Astrophysics Data System (ADS)

    Katayama, Naomi; Space Agriculture Task Force

    We became able to stay in the space for a long term. We must be able to save the space foods at normal temperature more than three years. We need the meal which we can store a long term when we have the problem of the disaster on the earth. Therefore development of the meals which I can store a long term is a very important study not only in the space, but also in the earth. We were able to get cooperation of U.S.A. and Japanese Mars association in this time. We ate disaster foods during two weeks by using MDRS.I can eat this disaster foods by pouring hot water or water.We can prepare meals with minimum water. We get cheers when we eat delicious meal in MDRS during 14 days. We want to report various thing of the MDRS study

  6. Bupropion reduces some of the symptoms of marihuana withdrawal in chronic marihuana users: a pilot study.

    PubMed

    Penetar, David M; Looby, Alison R; Ryan, Elizabeth T; Maywalt, Melissa A; Lukas, Scott E

    2012-01-01

    Bupropion's (Zyban(®) SR) effectiveness to treat symptoms experienced in marihuana withdrawal was tested in a double-blind, placebo-controlled study with chronic, heavy marihuana users. Participants maintained their usual marihuana intake until Quit Day after which they were required to cease intake of THC products for 14 days. A Withdrawal Discomfort Score revealed that for 7 days immediately following cessation, placebo-treated subjects reported more symptoms than bupropion-treated subjects. Self-reported craving for marihuana increased for the placebo-treated group but not for those treated with bupropion. Measures of sleep and cognitive performance were not different between the two groups. Participants in the bupropion treatment arm were more likely to complete the study than those randomized to the placebo arm (50% completion for bupropion vs. 33% completion for placebo). These results suggest that bupropion may be useful for alleviating marihuana withdrawal symptoms and be useful in subject retention during long-term cessation programs.

  7. Mootrala Karma of Kusha [Imperata cylindrica Beauv.] and Darbha [Desmostachya bipinnata Stapf.] - A comparative study.

    PubMed

    Shah, Niti T; Pandya, Tarulata N; Sharma, Parameshwar P; Patel, Bhupesh R; Acharya, Rabinarayan

    2012-07-01

    Kusha (Imperata cylindrica Beauv.) and Darbha (Desmostachya bipinnata Stapf.) are enlisted among Trinapanchamoola, which is a well-known diuretic and are individually enumerated in the Mootravirechaneeya Dashemani. The article deals with the evaluation and comparison of the individual Mootrala (diuretic) action of the two drugs in healthy volunteers. In this study, 29 healthy volunteers were divided into three groups administered with Darbha Moola Churna, Kusha Moola Churna, and placebo in each group for 14 days. The volunteers were subjected to evaluation of diuretic activity by maintaining the daily total input-output charts during the course of the study. The volunteers were advised to consume a minimum 2 l of water daily. Results show that Darbha and Kusha leaded to a percentage increase in urine volume as compared to placebo group, but the result was statistically insignificant.

  8. Mootrala Karma of Kusha [Imperata cylindrica Beauv.] and Darbha [Desmostachya bipinnata Stapf.] - A comparative study

    PubMed Central

    Shah, Niti T.; Pandya, Tarulata N.; Sharma, Parameshwar P.; Patel, Bhupesh R.; Acharya, Rabinarayan

    2012-01-01

    Kusha (Imperata cylindrica Beauv.) and Darbha (Desmostachya bipinnata Stapf.) are enlisted among Trinapanchamoola, which is a well-known diuretic and are individually enumerated in the Mootravirechaneeya Dashemani. The article deals with the evaluation and comparison of the individual Mootrala (diuretic) action of the two drugs in healthy volunteers. In this study, 29 healthy volunteers were divided into three groups administered with Darbha Moola Churna, Kusha Moola Churna, and placebo in each group for 14 days. The volunteers were subjected to evaluation of diuretic activity by maintaining the daily total input–output charts during the course of the study. The volunteers were advised to consume a minimum 2 l of water daily. Results show that Darbha and Kusha leaded to a percentage increase in urine volume as compared to placebo group, but the result was statistically insignificant. PMID:23723646

  9. Evaluation of Safety and Pharmacokinetics of Sodium 2,2 Dimethylbutyrate, a Novel Short Chain Fatty Acid Derivative, in a Phase 1, Double-Blind, Placebo-Controlled, Single- and Repeat-Dose Studies in Healthy Volunteers

    PubMed Central

    Perrine, Susan P.; Wargin, William A.; Boosalis, Michael S.; Wallis, Wayne J.; Case, Sally; Keefer, Jeffrey R.; Faller, Douglas V.; Welch, William C.; Berenson, Ronald J.

    2013-01-01

    Pharmacologic induction of fetal globin synthesis is an accepted therapeutic strategy for treatment of the beta hemoglobinopathies and thalassemias, as even small increases in hemoglobin F (HbF) levels reduce clinical severity in sickle cell disease and reduce anemia in beta thalassemia. Prior generation short chain fatty acid therapeutics, arginine butyrate and phenylbutyrate, increased fetal and total hemoglobin levels in patients, but were limited by high doses or intravenous infusion. A fetal globin-inducing therapeutic with convenient oral dosing would be an advance for these classic molecular diseases. Healthy adult human subjects were treated with a novel SCFA derivative, sodium 2,2 dimethylbutyrate (SDMB), or placebo, with one of four single dose levels (2, 5, 10 and 20 mg/kg) or daily doses (5, 10, or 15 mg/kg) over 14 days, and monitored for adverse clinical and laboratory events, drug levels, reticulocytes, and HbF assays. SDMB was well-tolerated with no clinically significant adverse events related to study medication. The terminal half-life ranged from 9–15 hours. Increases in mean absolute reticulocytes were observed at all dose levels in the 14-day study. The favorable PK profiles and safety findings indicate that SDMB warrants further investigation for treatment of anemic subjects with beta hemoglobinopathies. PMID:21422239

  10. Comparative study of the effects of two bleaching agents on oral microbiota.

    PubMed

    Alkmin, Yara Tardelli; Sartorelli, Renata; Flório, Flávia Martão; Basting, Roberta Tarkany

    2005-01-01

    This study evaluated the in vivo effects of bleaching agents containing 10% carbamide peroxide (Platinum/Colgate) or 7.5% hydrogen peroxide (Day White 2Z/Discus Dental) on mutans Streptococcus during dental bleaching. The products were applied on 30 volunteers who needed dental bleaching. In each volunteer, one of the two bleaching agents was used on both dental arches one hour a day for three weeks. Analysis of the bacterial counts was made by collecting saliva before (baseline values), during (7 and 21 days) bleaching treatments and 14 days posttreatment. The Friedman non-parametric analysis (alpha=0.05) found no differences in microorganism counts at different times for each group for both agents (p>0.05). The Mann Whitney nonparametric test (alpha=0.05) showed no differences in micro-organism counts for both agents (p>0.05). Different bleaching agents did not change the oral cavity mutans Streptococcus counts.

  11. Ultrastructural features of masseter muscle exhibiting altered occlusal relationship - a study in a rodent model

    SciTech Connect

    Lisboa, Marcio V.; Aciole, Gilberth T. S.; Oliveira, Susana C. P. S.; Marques, Aparecida M. C.; Pinheiro, Antonio L. B.; Santos, Jean N.; Baptista, Abrahao F.; Aguiar, Marcio C.

    2010-05-31

    The role of occlusion on Tempormandibular Disorders (TMD) is still unclear, mainly regarding muscular function. The aim of this study was to evaluate the occlusion highlights on masseter ultra morphology. Twenty Wistar rats were randomly divided in four groups: 10 for control group, 10 for occlusal alteration group (CCO). Rats underwent unilateral amputation of the left inferior and superior molar cusps to simulate an occlusal wear situation. The rats of control group had no occlusal wear. Half of the animals of each group was sacrificed in 14 days after the occlusal consuming and half 30 days after the occlusal consuming. The masseter muscles ipsilateral to the amputated molars were excised and processed for light microscopy, electron microscopy. The light microscopy did not show differences between the groups. The electron microscopy was able to detect a degree of intracellular damage in muscle fibers of CCO group: swollen mitochondria with disrupted cristae and cleared matrix, signs of hypercontraction of I bands and myofibril disorganization.

  12. Parametric study of a brewery effluent treatment by microalgae Scenedesmus obliquus.

    PubMed

    Mata, Teresa M; Melo, Ana C; Simões, Manuel; Caetano, Nídia S

    2012-03-01

    This work analyses the potential of using microalgae Scenedesmus obliquus (So) for a brewery wastewater treatment and biomass production. The chemical oxygen demand (COD), total nitrogen (TN) and total carbon (TC) was followed in time, and the influence of light exposure, light intensity and culture aeration was studied. Results show that the most adequate conditions for cultivating So in this effluent are the aerated cultures, exposed to a 12h period of daily light, at 12000 Lux intensity. At these conditions it is obtained a maximum of 0.9 g of dry biomass per liter of culture, after 9 days, for a maximum reduction of 57.5% and 20.8% of COD and TN, respectively, after 14 days, and 56.9% of TC, after 13 days, corresponding to the final values of 1692 mg O(2)/L COD, 47 mg N/L TN, and 1mg C/L TC.

  13. Ultrastructural features of masseter muscle exhibiting altered occlusal relationship—a study in a rodent model

    NASA Astrophysics Data System (ADS)

    Lisboa, Marcio V.; Aciole, Gilberth T. S.; Oliveira, Susana C. P. S.; Marques, Aparecida M. C.; Baptista, Abrahão F.; Pinheiro, Antonio L. B.; Aguiar, Marcio C.; Santos, Jean N.

    2010-05-01

    The role of occlusion on Tempormandibular Disorders (TMD) is still unclear, mainly regarding muscular function. The aim of this study was to evaluate the occlusion highlights on masseter ultra morphology. Twenty Wistar rats were randomly divided in four groups: 10 for control group, 10 for occlusal alteration group (CCO). Rats underwent unilateral amputation of the left inferior and superior molar cusps to simulate an occlusal wear situation. The rats of control group had no occlusal wear. Half of the animals of each group was sacrificed in 14 days after the occlusal consuming and half 30 days after the occlusal consuming. The masseter muscles ipsilateral to the amputated molars were excised and processed for light microscopy, electron microscopy. The light microscopy did not show differences between the groups. The electron microscopy was able to detect a degree of intracellular damage in muscle fibers of CCO group: swollen mitochondria with disrupted cristae and cleared matrix, signs of hypercontraction of I bands and myofibril disorganization.

  14. A fourteen-day repeated dose oral toxicity study of APFO in rats.

    PubMed

    Iwai, Hiroyuki; Yamashita, Kotaro

    2006-01-01

    Ammonium perfluoroocanoate (APFO) was repeatedly administered orally to male Crj:CD(SD)IGS rats for 14 days. Doses of APFO were 0, 0.5, 5, and 50 mg/kg. Significant increases and increasing tendencies in absolute/relative weight of the liver and no change in weight of the spleen were observed in all groups. Although inductions of mitochondrion- and peroxisome-specific enzymes were increased, no decrease was seen in any hematological parameter of lipid metabolism. Red blood cell count, hemoglobin concentration, and hematocrit or these tendencies showed a significant decrease or a tendency to decrease, but no influence on lymphocyte subsets was noted. Secondary inhibition of immunocompetent cells, previously reported for mice, was not seen in this study of rats.

  15. In vivo study of two carbamide peroxide gels with different desensitizing agents.

    PubMed

    Matis, Bruce A; Cochran, Michael A; Eckert, George J; Matis, Jeremy I

    2007-01-01

    This study evaluated tooth whitening and sensitivity that occurred during and after 14 days of overnight bleaching with 15% carbamide peroxide gel with potassium nitrate and fluoride (Opalescence 15% PF, OP) and 16% carbamide peroxide with amorphous calcium phosphate (Nite White 16%, NW). Thirty-two subjects bleached their teeth using custom trays. The subjects had a baseline evaluation and returned after 7, 14, 21, 35 and 90 days for subjective and objective color evaluations. The subjects also recorded daily tooth and gingival sensitivity. The treatments were compared for differences in mean L*, a*, b* and shade guide rank order at baseline and each appointment thereafter, using repeated measures analysis of variance (ANOVA). OP and NW showed significant tooth whitening. Subjects using OP were significantly lighter in b* and E* than those using NW, while exhibiting no difference in tooth or gingival sensitivity overall or during any evaluation.

  16. Preclinical animal acute toxicity studies of new developed MRI contrast agent based on gadolinium

    NASA Astrophysics Data System (ADS)

    Nam, I. F.; Zhuk, V. V.

    2015-04-01

    Acute toxicity test of new developed MRI contrast agent based on disodium salt of gadopentetic acid complex were carried out on Mus musculus and Sprague Dawley rats according to guidelines of preclinical studies [1]. Groups of six animals each were selected for experiment. Death and clinical symptoms of animals were recorded during 14 days. As a result the maximum tolerated dose (MTD) for female mice is 2.8 mM/kg of body weight, male mice - 1.4 mM/kg, female rats - 2.8 mM/kg, male rats - 5.6 mM/kg of body weight. No Observed Adverse Effect Dose (NOAEL) for female mice is 1.4 mM/kg, male mice - 0.7 mM/kg, male and female rats - 0.7 mM/kg. According to experimental data new developed MRI contrast agent based on Gd-DTPA complex is low-toxic.

  17. Toxicological Study of Ocimum sanctum Linn Leaves: Hematological, Biochemical, and Histopathological Studies

    PubMed Central

    Gautam, M. K.; Goel, R. K.

    2014-01-01

    The present study was aimed to study the acute and subacute toxicity studies with orally administered 50% ethanolic leaves extract of Ocimum sanctum Linn (OSE). In acute toxicity tests, four groups of mice (n = 6/group/sex) were orally treated with doses of 200, 600, and 2000 mg/kg, and general behavior, adverse effects, and mortality were recorded for up to 14 days. In subacute toxicity study, rats received OSE by gavage at the doses of 200, 400, and 800 mg/kg/day (n = 6/group/sex) for 28 days, and biochemical, hematological, and histopathological changes in tissues (liver, kidney, spleen, heart, and testis/ovary) were determined. OSE did not produce any hazardous symptoms or death and CNS and ANS toxicities in the acute toxicity test. Subacute treatment with OSE did not show any change in body weight, food and water consumption, and hematological and biochemical profiles. In addition, no change was observed both in macroscopic and microscopic aspects of vital organs in rats. Our result showed that Ocimum sanctum extract could be safe for human use. PMID:24616736

  18. Theophylline and warfarin interaction studies with grepafloxacin.

    PubMed

    Efthymiopoulos, C; Bramer, S L; Maroli, A; Blum, B

    1997-01-01

    Two phase I trials, each involving 16 healthy adult volunteers, were performed to investigate possible interactions between grepafloxacin and theophylline or warfarin. In the theophylline study, grepafloxacin 600 mg was administered once daily for 10 days to 12 volunteers who were receiving a maintenance dose of theophylline. This dose of theophylline was designed to produce mean serum theophylline concentrations of 7.5 mg/L; 4 volunteers received theophylline plus placebo. Pharmacokinetic parameters of theophylline were determined before grepafloxacin treatment and on day 10 of grepafloxacin or placebo administration. Peak theophylline concentrations and the area under the concentration-time curve increased significantly during grepafloxacin treatment, and apparent total clearance of theophylline was reduced by approximately 50%. No changes were observed in the placebo group and theophylline appeared to have no effect on the pharmacokinetics of grepafloxacin. In the warfarin study, grepafloxacin 600 mg was given once daily for 14 days to volunteers receiving a maintenance dose of warfarin. Warfarin was discontinued during the last 4 days of grepafloxacin administration. The pharmacodynamics of warfarin did not change after administration of grepafloxacin. Similarly, warfarin had no significant effect on the pharmacokinetics of grepafloxacin. We conclude that during treatment with grepafloxacin maintenance, doses of theophylline should be reduced by 50%, and we recommend that serum concentrations of theophylline be monitored during treatment with grepafloxacin. However, no dose adjustment is necessary for grepafloxacin when it is coadministered with theophylline, and dose adjustment does not seem to be required in concomitant treatment with grepafloxacin and warfarin.

  19. Postmarketing surveillance study of permethrin creme rinse.

    PubMed Central

    Andrews, E B; Joseph, M C; Magenheim, M J; Tilson, H H; Doi, P A; Schultz, M W

    1992-01-01

    BACKGROUND. An observational, epidemiological study was undertaken to evaluate the safety of permethrin 1% creme rinse (Nix) for treatment of head lice infestations. METHODS. Thirty-seven local public health departments enrolled a total of 38,160 patients for 47,578 treatments with permethrin or other pediculicides from September 1, 1986, through January 31, 1988. Follow-up safety information was collected between 7 and 14 days following treatment via return visit or telephone contact. RESULTS. One hundred three adverse events were reported among 41,955 evaluable treatments. The rates of reported adverse events were 2.2 per 1000 treatments among permethrin treatments, 3.4 per 1000 treatments among lindane treatments, and 1.5 per 1000 treatments among other over-the-counter treatments. No serious, unexpected adverse events were detected in the 18,950 patients treated with permethrin. CONCLUSIONS. This study confirmed the safety profile of permethrin in conditions of general use, as seen in clinical trials. Postmarketing safety monitoring in public health departments of drugs used to treat public health conditions was shown to be feasible. PMID:1375002

  20. Establishing a rat model for the study of vitamin K deficiency.

    PubMed

    Mi, Yanni; Xiao, Xue; Liu, Dongzheng; Ping, Nana; Zhu, Yanbing; Li, Bo; Long, Lihui; Cao, Yongxiao

    2016-04-01

    The main vitamin K-deficient model, minidose warfarin, is different from the pathological mechanism of vitamin K deficiency, which is a shortage of vitamin K. The objective of this study was to establish a new method of vitamin K-deficient model combining a vitamin K-deficient diet with the intragastrical administration of gentamicin in rats. The clotting was assayed by an automated coagulation analyser. The plasma PIVKA-II was assayed by ELISA. The vitamin K status was detected by an HPLC-fluorescence system. In the diet- and gentamicin-induced vitamin K-deficient 14-day group, the rats had undetected vitamin K1 and vitamin K2 in the liver and a prolonged APTT. In the 21-day group, there was also a prolonged PT and a decrease of the FIX activities. In the 28-day group, the undetected vitamin K1 and vitamin K2, the prolonged PT and APTT, and the decrease of the FII, FVII, FIX, and FX activities prompted the suggestion that there were serious deficiencies of vitamin K and vitamin K-dependent coagulation in rats. It is suggested that the diet- and gentamicin-induced vitamin K-deficient 14-day or 21-day model can be used for studies related to the status of vitamin K. The vitamin K-deficient 28-day model can be applied to research involving both the status of vitamin K and of vitamin K-dependent coagulation. In conclusion, the combination of a vitamin K-deficient diet with the administration of gentamicin results in a useful model of vitamin K-deficieny.

  1. Linezolid-resistant staphylococcal bacteraemia: A multicentre case-case-control study in Italy.

    PubMed

    Russo, Alessandro; Campanile, Floriana; Falcone, Marco; Tascini, Carlo; Bassetti, Matteo; Goldoni, Paola; Trancassini, Maria; Della Siega, Paola; Menichetti, Francesco; Stefani, Stefania; Venditti, Mario

    2015-03-01

    The aim of this multicentre study was to analyse the characteristics of patients with bloodstream infections due to staphylococcal strains resistant to linezolid. This was a retrospective case-case-control study of patients hospitalised in three large teaching hospitals in Italy. A linezolid-resistant (LIN-R) Staphylococcus spp. group and a linezolid-susceptible (LIN-S) Staphylococcus spp. group were compared with control patients to determine the clinical features and factors associated with isolation of LIN-R strains. All LIN-R Staphylococcus spp. strains underwent molecular typing. Compared with the LIN-S group, central venous catheters were the main source of infection in the LIN-R group. The LIN-R and LIN-S groups showed a similar incidence of severe sepsis or septic shock, and both showed a higher incidence of these compared with the control group. Overall, patients in the LIN-R group had a higher 30-day mortality rate. Multivariate analysis found previous linezolid therapy, linezolid therapy >14 days, antibiotic therapy in the previous 30 days, antibiotic therapy >14 days, previous use of at least two antibiotics and hospitalisation in the previous 90 days as independent risk factors associated with isolation of a LIN-R strain. The G2576T mutation in domain V of 23S rRNA was the principal mechanism of resistance; only one strain of Staphylococcus epidermidis carried the cfr methylase gene (A2503), together with L4 insertion (71GGR72) and L3 substitution (H146Q). LIN-R strains are associated with severe impairment of clinical conditions and unfavourable patient outcomes. Reinforcement of infection control measures may have an important role in preventing these infections.

  2. Platelet Aggregation Unchanged by Lipoprotein-Associated Phospholipase A2 Inhibition: Results from an In Vitro Study and Two Randomized Phase I Trials

    PubMed Central

    Shaddinger, Bonnie C.; Xu, Yanmei; Roger, James H.; Macphee, Colin H.; Handel, Malcolm; Baidoo, Charlotte A.; Magee, Mindy; Lepore, John J.; Sprecher, Dennis L.

    2014-01-01

    Background We explored the theorized upregulation of platelet-activating factor (PAF)– mediated biologic responses following lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibition using human platelet aggregation studies in an in vitro experiment and in 2 clinical trials. Methods and Results Full platelet aggregation concentration response curves were generated in vitro to several platelet agonists in human plasma samples pretreated with rilapladib (selective Lp-PLA2 inhibitor) or vehicle. This was followed by a randomized, double-blind crossover study in healthy adult men (n = 26) employing a single-agonist dose assay of platelet aggregation, after treatment of subjects with 250 mg oral rilapladib or placebo once daily for 14 days. This study was followed by a second randomized, double-blind parallel-group trial in healthy adult men (n = 58) also treated with 250 mg oral rilapladib or placebo once daily for 14 days using a full range of 10 collagen concentrations (0–10 µg/ml) for characterizing EC50 values for platelet aggregation for each subject. Both clinical studies were conducted at the GlaxoSmithKline Medicines Research Unit in the Prince of Wales Hospital, Sydney, Australia. EC50 values derived from multiple agonist concentrations were compared and no pro-aggregant signals were observed during exposure to rilapladib in any of these platelet studies, despite Lp-PLA2 inhibition exceeding 90%. An increase in collagen-mediated aggregation was observed 3 weeks post drug termination in the crossover study (15.4% vs baseline; 95% confidence interval [CI], 3.9–27.0), which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC50 examination. Conclusions Lp-PLA2 inhibition does not enhance platelet aggregation. Trial Registration 1) Study 1: ClinicalTrials.gov NCT01745458 2) Study 2: ClinicalTrials.gov NCT00387257 PMID:24475026

  3. Svarna - vanga - a short duration toxicity study.

    PubMed

    Sharma; Gyaneshwar; Joshi, D; Aryya, N C; Pandey, V B

    1985-10-01

    Swarna - Vanga, an Ayurvedic preparation, is used in the treatment mainly of Pramehas (genitor urinary and metabolic disorders), Sveta Pradara (Leucorrhoea), Kasa - Swasa (Respiratory disorders), etc. The drug contains tin and sulphur as major components along with traces of mercury, iron and aluminum. According to modern point of view certain metals have been claimed toxic to both human and animal. Since Svarna - Vanga contains these metals, it is essential to screen out its toxic effect, if any, although it is claimed in Ayurveda that when a metal is processed as prescribed, it become non - toxic or the least toxic. Considering the above facts, an animal experiment was carried out for short duration (14 days) to screen the toxic effects of Svarna - Vanga (SV) in increasing doses of the drug starting from the maximum therapeutic dose (12.5 mg / 100 gm b.wt / day). The drug was found to have no toxic effects in tissues of the animal at doses of 12.5 mg and 25 mg / 100 gm b.wt. / day. Fine fatty vacuolization in liver and focal superficial mucosal degeneration and necrosis of small intestine confined to one animal each at dose of 50 mg / 100gm b.wt. and 100 mg/ 100 gm. b.wt. / day were observed. Our study indicates that the drug has no toxic effect on tissues at therapeutic dose.

  4. Estimates of Pandemic Influenza Vaccine Effectiveness in Europe, 2009–2010: Results of Influenza Monitoring Vaccine Effectiveness in Europe (I-MOVE) Multicentre Case-Control Study

    PubMed Central

    Valenciano, Marta; Kissling, Esther; Cohen, Jean-Marie; Oroszi, Beatrix; Barret, Anne-Sophie; Rizzo, Caterina; Nunes, Baltazar; Pitigoi, Daniela; Larrauri Cámara, Amparro; Mosnier, Anne; Horvath, Judith K.; O'Donnell, Joan; Bella, Antonino; Guiomar, Raquel; Lupulescu, Emilia; Savulescu, Camelia; Ciancio, Bruno C.; Kramarz, Piotr; Moren, Alain

    2011-01-01

    Background A multicentre case-control study based on sentinel practitioner surveillance networks from seven European countries was undertaken to estimate the effectiveness of 2009–2010 pandemic and seasonal influenza vaccines against medically attended influenza-like illness (ILI) laboratory-confirmed as pandemic influenza A (H1N1) (pH1N1). Methods and Findings Sentinel practitioners swabbed ILI patients using systematic sampling. We included in the study patients meeting the European ILI case definition with onset of symptoms >14 days after the start of national pandemic vaccination campaigns. We compared pH1N1 cases to influenza laboratory-negative controls. A valid vaccination corresponded to >14 days between receiving a dose of vaccine and symptom onset. We estimated pooled vaccine effectiveness (VE) as 1 minus the odds ratio with the study site as a fixed effect. Using logistic regression, we adjusted VE for potential confounding factors (age group, sex, month of onset, chronic diseases and related hospitalizations, smoking history, seasonal influenza vaccinations, practitioner visits in previous year). We conducted a complete case analysis excluding individuals with missing values and a multiple multivariate imputation to estimate missing values. The multivariate imputation (n = 2902) adjusted pandemic VE (PIVE) estimates were 71.9% (95% confidence interval [CI] 45.6–85.5) overall; 78.4% (95% CI 54.4–89.8) in patients <65 years; and 72.9% (95% CI 39.8–87.8) in individuals without chronic disease. The complete case (n = 1,502) adjusted PIVE were 66.0% (95% CI 23.9–84.8), 71.3% (95% CI 29.1–88.4), and 70.2% (95% CI 19.4–89.0), respectively. The adjusted PIVE was 66.0% (95% CI −69.9 to 93.2) if vaccinated 8–14 days before ILI onset. The adjusted 2009–2010 seasonal influenza VE was 9.9% (95% CI −65.2 to 50.9). Conclusions Our results suggest good protection of the pandemic monovalent vaccine against medically attended pH1N1 and no

  5. Pharmacokinetics and adverse reactions of a new liposomal cisplatin (Lipoplatin): phase I study.

    PubMed

    Stathopoulos, George P; Boulikas, Teni; Vougiouka, Maria; Deliconstantinos, George; Rigatos, Sotirios; Darli, Eleftheria; Viliotou, Vasiliki; Stathopoulos, John G

    2005-04-01

    Lipoplatin, a new liposomal cisplatin formulation, is formed from cisplatin and liposomes composed of dipalmitoyl phosphatidyl glycerol (DPPG), soy phosphatidyl choline (SPC-3), cholesterol and methoxy-polyethylene glycol-distearoyl phosphatidylethanolamine (mPEG2000-DSPE). Following intravenous infusion, the nanoparticles (110 nm) are distributed into tissues and concentrate preferentially at tumor sites supposedly via extravasation through the leaky tumor vasculature. This study was designed to investigate the pharmacokinetics and the toxicity of this new liposomal cisplatin in patients with pretreated advanced malignant tumors. The drug was infused for 8 h every 14 days at escalating doses. Twenty-seven patients were included and 3-5 patients were selected for each dosage level; levels started at 25 mg/m2 and were increased by 25 to 125 mg/m2. Three patients were also treated at higher dose levels, one each at 200, 250 and 300 mg/m2. Blood was taken at certain time intervals in order to estimate total platinum plasma levels. At level 5 (125 mg/m2), grades 1 and 2 GI tract and hematological toxicities were detected. No nephrotoxicity was observed. Seven additional patients were added at the 4th level (100 mg/m2) for further pharmacokinetic evaluation. Measurement of platinum levels in the plasma of patients as a function of time showed that a maximum platinum level is attained at 6-8 h. The half-life of Lipoplatin was 60-117 h depending on the dose. Urine excretion reached about 40% of the infused dose in 3 days. The data demonstrate that Lipoplatin up to a dose of 125 mg/m2 every 14 days has no nephrotoxicity and it lacks the serious side effects of cisplatin.

  6. Central venous catheterization: a prospective, randomized, double-blind study.

    PubMed

    Mer, Mervyn; Duse, Adriano Gianmaria; Galpin, Jacqueline Suzanne; Richards, Guy Antony

    2009-02-01

    Central venous catheters (CVCs) are extensively used worldwide. Mechanical, infectious and thrombotic complications are well described with their use and may be associated with prolonged hospitalization, increased medical costs and mortality. CVCs account for an estimated 90% of all catheter-related bloodstream infections (CRBSI) and a host of risk factors for CVC-related infections have been documented. The duration of use of CVCs remains controversial and the length of time such devices can safely be left in place has not been fully and objectively addressed in the critically ill patient. Antimicrobial-impregnated catheters have been introduced in an attempt to limit catheter-related infection (CRI) and increase the time that CVCs can safely be left in situ. Recent meta-analyses concluded that antimicrobial-impregnated CVCs appear to be effective in reducing CRI. The authors conducted a prospective, randomized, double-blind study at Johannesburg Hospital over a 4-year period. The study entailed a comparison of standard triple-lumen versus antimicrobial impregnated CVCs on the rate of CRI. Our aim was to determine whether we could safely increase the duration of catheter insertion time from our standard practice of seven days to 14 days, to assess the influence of the antimicrobial impregnated catheter on the incidence of CRI, and to elucidate the epidemiology and risks of CRI. One hundred and eighteen critically ill patients were included in the study which spanned 34 951.5 catheter hours (3.99 catheter years). It was found that antimicrobial catheters did not provide any significant benefit over standard catheters, which the authors feel can safely be left in place for up to 14 days with appropriate infection control measures. The most common source of CRI was the skin. The administration of parenteral nutrition and the site of catheter insertion (internal jugular vein vs subclavian vein) were not noted to be risk factors for CRI. There was no clinical evidence

  7. Folate bioavailability from foods rich in folates assessed in a short term human study using stable isotope dilution assays.

    PubMed

    Mönch, Sabine; Netzel, Michael; Netzel, Gabriele; Ott, Undine; Frank, Thomas; Rychlik, Michael

    2015-01-01

    Different sources of folate may have different bioavailability and hence may impact the standard definition of folate equivalents. In order to examine this, a short term human study was undertaken to evaluate the relative native folate bioavailabilities from spinach, Camembert cheese and wheat germs compared to pteroylmonoglutamic acid as the reference dose. The study had a single-centre, randomised, four-treatment, four-period, four-sequence, cross-over design, i.e. the four (food) items to be tested (referred to as treatments) were administered in sequences according to the Latin square, so that each experimental treatment occurred only once within each sequence and once within each study period. Each of the 24 subjects received the four experimental items separated by a 14-day equilibrium phase and received a pteroylmonoglutamic acid supplement for 14 days before the first testing and between the testings for saturation of body pools. Folates in test foods, plasma and urine samples were determined by stable isotope dilution assays, and in urine and plasma, the concentrations of 5-methyltetrahydrofolate were evaluated. Standard non-compartmental methods were applied to determine the biokinetic parameters C(max), t(max) and AUC from baseline corrected 5-methyltetrahydrofolate concentrations within the interval from 0 to 12 hours. The variability of AUC and C(max) was moderate for spinach and oral solution of pteroylmonoglutamic acid but high for Camembert cheese and very high for wheat germs. The median t(max) was lowest for spinach, though t(max) showed a high variability among all treatments. When comparing the ratio estimates of AUC and C(max) for the different test foods, highest bioavailability was found for spinach followed by that for wheat germs and Camembert cheese. The results underline the dependence of folate bioavailability on the type of food ingested. Therefore, the general assumption of 50% bioavailability as the rationale behind the definition of

  8. Uptake of silica covered Quantum Dots into living cells: Long term vitality and morphology study on hyaluronic acid biomaterials.

    PubMed

    D'Amico, Michele; Fiorica, Calogero; Palumbo, Fabio Salvatore; Militello, Valeria; Leone, Maurizio; Dubertret, Benoit; Pitarresi, Giovanna; Giammona, Gaetano

    2016-10-01

    Quantum Dots (QDs) are promising very bright and stable fluorescent probes for optical studies in the biological field but water solubility and possible metal bio-contamination need to be addressed. In this work, a simple silica-QD hybrid system is prepared and the uptake in bovine chondrocytes living cells without any functionalization of the external protective silica shield is demonstrated. Moreover, long term treated cells vitality (up to 14days) and the transfer of silica-QDs to the next cell generations are here reported. Confocal fluorescence microscopy was also used to determine the morphology of the so labelled cells and the relative silica-QDs distribution. Finally, we employ silica-QD stained chondrocytes to characterize, as proof of concept, hydrogels obtained from an amphiphilic derivative of hyaluronic acid (HA-EDA-C18) functionalized with different amounts of the RGD peptide.

  9. Circadian Behavioral Study: LED vs Cool White Fluorescent - 0.1, 1, 10, 40, 80 lux. Part 2

    NASA Technical Reports Server (NTRS)

    Holley, Daniel C.; Syrkin, N.; Mele, G.

    2000-01-01

    Currently, the light source most commonly used in animal habitat lighting is cool white fluorescent (CWF) light. It was the objective of this study to evaluate a novel LED light source for use in animal habitat lighting by comparing its effectiveness to CWF light in producing and maintaining a normal circadian entrainment. The LED and CWF lights had similar spectral power distributions. Sprague-Dawley rats (175-350 g) were kept individually in metabolic cages, under a strict lighting control: 4 days of acclimation at 12:12 LD, 14 days of 12:12 LD, 14 days of 24:0 LD (free-run), and finally 12:12 LD. Food and water were provided ad libitum. Three behavioral parameters were monitored continuously: gross locomotor activity, drinking, and feeding. Combined mean free run periods (tau) were (mean +/- SEM): 24.6 +/- 0.1 and 24.7 +/- 0.2 at 0.1 lux, 25.5 +/- 0.1 and 25.7 +/- 0.1 at 1.0 lux, 25.3 +/- 0.2 and 25.4 +/- 0.2 at 10 lux, 25.8 +/- 0.1 and 25.9 +/- 0.1 at 40 lux, and 25.9 +/- 0.1 and 25.9 +/- 0.1 at 80 lux, CWF and LED respectively. ANOVA found a significant effect (p < 0.05) due to light level, but no difference in tau between rats exposed to constant CWF light and rats exposed to constant LED light. This study has shown that LED light can produce the same entrainment pattern as a conventional CWT light at similar intensities (0.1, 1, 10, 40, and 80 lux). LED light sources may be a suitable replacement for conventional light sources used in animal habitat lighting while providing many mechanical and economical advantages.

  10. Assessment of Anxiety and Depression in Oral Mucositis Patients Undergoing Cancer Chemoradiotherapy: A Randomized Cross-sectional Study

    PubMed Central

    Chaitanya, Nallan CSK; Garlapati, Komali; Priyanka, Danam Reshma; Soma, Sravani; Suskandla, Ujwala; Boinepally, Niharika Harsha

    2016-01-01

    Introduction: Oral mucositis is an unavoidable complication occurring during the treatment of cancer by radiotherapy, concurrent chemoradiotherapy (CCRT), or chemotherapy. This is a painful sequelae, significantly affecting the nutritional intake and quality of life. Materials and Methods: A multicentric cross-sectional study was done at four cancer centers in Hyderabad. About 455 subjects of both genders between 20 and 80 years undergoing cancer treatment such as chemotherapy (Group I), CCRT (Group II), radiotherapy within 14 days of initiation (Group III), and radiotherapy after 14 days of initiation of therapy (Group IV) who had oral mucositis were included in the study. A self-addressed Hospital Anxiety and Depression Scale questionnaire was used to assess the anxiety/depression in cancer therapy-induced oral mucositis patients. Results: Group III had established anxiety (58.82%) followed by Group IV (47.5%) of patients showing severe oral mucositis. In Group I, 47.17% and in Group II, 40% patients with borderline anxiety had mild mucositis, which was statistically significant (P = 0.01). Group III had established depression in 56.36%, followed by Group IV with 39.62% patients showed severe oral mucositis. Group I and II had mild to moderate mucositis, which was associated with established depression at statistically significant result (P = 0.02). Conclusion: Group IV had maximum participants with anxiety and depression, closely followed by Group II, Group III, and least in Group I. Thus appropriate intervention in the form of nonpharmacological and pharmacological treatment is warranted. PMID:27803567

  11. A study of the temporal variability of atrazine in private well water. Part I: Study design, implementation, and database development

    USGS Publications Warehouse

    Lorber, M.; Johnson, K.; Kross, B.; Pinsky, P.; Burmeister, L.; Thurman, M.; Wilkins, A.; Hallberg, G.

    1997-01-01

    In 1988, the Iowa Department of Natural Resources, along with the University of Iowa conducted the Statewide Rural Well Water Survey, commonly known as SWRL. A total of 686 private rural drinking water wells was selected by use of a probability sample and tested for pesticides and nitrates. Sixty-eight of these wells, the '10% repeat' wells, were additionally sampled in October, 1990 and June, 1991. Starting in November, 1991, the University of Iowa, with sponsorship from the United States Environmental Protection Agency, revisited these wells to begin a study of the temporal variability of atrazine and nitrates in wells. Other wells, which had originally tested positive for atrazine in SWRL but were not in the 10% repeat population, were added to the study population. Temporal sampling for a year-long period began in February of 1992 and concluded in January of 1993. All wells were sampled monthly, one subset was sampled weekly, and a second subset was sampled for 14-day consecutive periods. Two unique aspects of this study were the use of an immunoassay technique to screen for triazines before gas chromatography/mass spectrometry (GC/MS) analysis and quantification of atrazine, and the use of well owners to sample the wells. A total of 1771 samples from 83 wells are in the final data base for this study. This paper reviews the study design, the analytical methodologies, and development of the data base. A companion paper discusses the analysis of the data from this survey.

  12. Acute flesinoxan treatment produces a different effect on rat brain serotonin synthesis than chronic treatment: an alpha-methyl-l-tryptophan autoradiographic study.

    PubMed

    Tohyama, Yoshihiro; Mück-Seler, Dorotea; Diksic, Mirko

    2007-12-01

    5-HT(1A) receptor agonists display anxiolytic and anti-depressant properties in clinical studies. In this study, we used the alpha-[(14)C]methyl-l-tryptophan (alpha-MTrp) autoradiographic method to evaluate the effects of the 5-HT(1A) agonist, flesinoxan, on regional 5-HT synthesis in the rat brain, following acute or a 14-day continuous treatment. In the first series of experiments, flesinoxan (5mg/kg; i.p.) was administered 40min before the alpha-MTrp. It resulted in a significant increase of the arterial blood oxygen partial pressure (pO(2)) and a reduction of the regional rate of 5-HT synthesis throughout the brain, with the exception of a few regions (medial geniculate body and thalamus). In the second series of experiments, flesinoxan (5mg/kgday) was administered for 14 days, using an osmotic minipump implanted subcutaneously. When compared to rats treated with saline, there was an overall significant (p<0.05) reduction in the synthesis (one-sample two-tailed t-test). However, there was no significant influence on the 5-HT synthesis rate in the dorsal and median raphe nuclei and the majority of their projection areas. A significant (p<0.05) reduction was observed in the nucleus raphe magnus, medial caudate, ventral thalamus, amygdala, ventral tegmental area, medial forebrain bundle, nucleus accumbens, medial anterior olfactory nucleus and superior olive. The unaltered 5-HT synthesis rates in a large majority of regions following the 14-day treatment of flesinoxan may reflect the normalization (implies to not be different from salne treated control) of synthesis due to a desensitization of 5-HT(1A) autoreceptors on the cell body of 5-HT neurons as well as at postsynaptic sites, which is known to occur following long-term treatment with 5-HT(1A) agonists. It is of some importance to note that the normalization of the synthesis occurred in the majority of the brain limbic structures, the brain areas implicated in affective disorders and the corresponding

  13. Cattle and environmental sample-level factors associated with the presence of Salmonella in a multi-state study of conventional and organic dairy farms.

    PubMed

    Fossler, C P; Wells, S J; Kaneene, J B; Ruegg, P L; Warnick, L D; Eberly, L E; Godden, S M; Halbert, L W; Campbell, A M; Bolin, C A; Zwald, A M Geiger

    2005-01-01

    The objective of this study was to evaluate associations between cattle-level factors and environmental samples with the isolation of Salmonella from dairy farms in Minnesota, Wisconsin, Michigan, and New York. The study farms included 129 conventional and organic farms enrolled without regard to previous history of Salmonella infection. Herds were sampled at two-month intervals over a one-year period. Cattle groups more likely to be associated with Salmonella shedding (compared to preweaned calves) were cows designated as sick by farm personnel (OR=2.5, 95% CI: 1.7, 3.7), cows within 14 days of calving (OR=1.8, 95% CI: 1.1, 2.8), and cows due for culling within 14 days (OR=1.9, 95% CI: 1.0, 3.4). State of origin was also associated with the presence of Salmonella in samples from cattle and the farm environment; Midwestern states were more likely to have Salmonella-positive samples compared to New York. Cattle treated with antimicrobials within 14 days of sampling were more likely to be Salmonella-negative compared with nontreated cattle (OR=2.0, 95% CI: 1.1, 3.4). Farms with at least 100 cows were more likely to have Salmonella-positive cattle compared with smaller farms (OR=2.6, 95% CI: 1.4, 4.6). Season was associated with Salmonella shedding in cattle, and compared to the winter period, summer had the highest odds for shedding (OR=2.4, 95% CI: 1.5, 3.7), followed by fall (OR=1.9, 95% CI: 1.2, 3.1) and spring (OR=1.8, 95% CI: 1.2, 2.6). Environmental samples significantly more likely to be Salmonella-positive (compared to bulk tank milk) included, in descending order, samples from sick pens (OR=7.4, 95% CI: 3.4, 15.8), manure storage areas (OR=6.4, 95% CI: 3.5, 11.7), maternity pens (OR=4.2, 95% CI: 2.2, 8.1), haircoats of cows due to be culled (OR=3.9, 95% CI: 2.2, 7.7), milk filters (OR=3.3, 95% CI: 1.8, 6.0), cow waterers (OR=2.8, 95% CI: 1.4, 5.7), calf pens (OR=2.7, 95% CI: 1.3, 5.3), and bird droppings from cow housing (OR=2.4, 95% CI: 1.3, 4.4). Parity

  14. DISTRESS AND PTSD IN PATIENTS WITH CANCER: COHORT STUDY CASE

    PubMed Central

    Pranjic, Nurka; Bajraktarevic, Amila; Ramic, Enisa

    2016-01-01

    Introduction: embarrassed emotional experience may affect the ability to oncology patient effectively cope with cancer, symptoms and treatment. Distress extends a long period, from common, normal feelings of vulnerability, sadness and fears to problems of PTSD, depression, anxiety, panic, social isolation and the perception of spiritual crisis. The aim of the research is to determine the level of distress and PTSD in cancer patients. Patients and Methods: In a prospective, cohort study cases from 2011- 2014 were included patients with cancer who are treated under the supervision of his chosen family medicine doctor. Including a factor for the participation of patients in the study is that from the moment of diagnosis of malignant disease passed <12 months. The total sample was 174 of the planned 200 (response rate=87%). The subjects were divided into three groups. A key factor in the creation of the group was the time elapsed from the moment of acknowledgment and confirmation of the diagnosis: T1 <14 days, n=56 patients; T2>14 days-<6 months, n=79 patients; T3>6 months n=39 patients. To achieve the set goals of the research was used instruments of 3 questionnaires: Questionnaire on the clinical characteristics of patients with malignant disease, demographic and individual characteristics; questionnaire distress oncology patient–hospital scales of depression and anxiety, HADS scale (Hospital Anxiety and Depression Scale - HADS) and a rapid test for self-assessment of the symptoms of PTSD. Results: Age of patients was 54.63 ± 11:46 years, and the age of the respondents when they were diagnosed with cancer 54.34 ± 11.26 years. The prevalence of distress was a high 76% 82x higher than expected), and PTSD 55%. Predictors of burnout syndrome in cancer patients are all important determinants of malignant disease: the time elapsed since the diagnosis of the disease which determines the clinical status of malignant disease (β=0.280; P=0.001; 95% CI, 0742

  15. Toxicology Studies on Lewisite and Sulfur Mustard Agents: Modified Dominant Lethal Study of Sulfur Mustard in Rats Final Report

    SciTech Connect

    Sasser, L. B.; Cushing, J. A.; Kalkwarf, D. R.; Buschbom, R. L.

    1989-05-01

    Occupational health standards have not been established for sulfur mustard (HD) [bis{2-chloroethyl)-sulfide) ' a strong alkylating agent with known mutagenic properties. Little, however, is known about the mutagenic activity of HD in mammalian species and data regarding the dominant lethal effects of HD are ambiguous. The purpose of this study was to determine the dominant lethal effect in male and female rats orally exposed to HD. The study was conducted in two phases; a female dominant lethal phase and a male dominant lethal phase. Sprague-Dawley rats of each sex were administered 0.08, 0.20, or 0.50 mg/kg HD in sesame oil 5 days/week for 10 weeks. For the female phase, treated or untreated males were mated with treated females and their fetuses were evaluated at approximately 14 days after copulation. For the male dominant lethal phase, treated males cohabited with untreated femal (during 5 days of each week for 10 weeks) and females were sacrificed for fetal evaluation 14 days after the midweek of cohabitation during each of the 10 weeks. The appearance and behavior of the rats were unremarkable throughout the experiment and there were no treatment-related deaths. Growth rates were reduced in both female and male rats treated with 0.50 mg/kg HD. Indicators of reproductive performance did not demonstrate significant female dominant lethal effects, although significant male dominant lethal effects were observed at 2 and 3 week post-exposure. These effects included increases of early fetal resorptions and preimplantation losses and decreases of total live embryo implants. These effects were most consistently observed at a dose of 0.50 mg/kg, but frequently occurred at the lower doses. Although no treatment-related effects on male reproductive organ weights or sperm motility were found, a significant increase in the percentage of abnormal sperm was detected in males exposed to 0. 50 mg/kg HD. The timing of these effects is consistent with an effect during the

  16. Usefulness of full outline of unresponsiveness score to predict extubation failure in intubated critically-ill patients: A pilot study

    PubMed Central

    Said, Tarek; Chaari, Anis; Hakim, Karim Abdel; Hamama, Dalia; Casey, William Francis

    2016-01-01

    Objective: To assess the usefulness of the full outline of unresponsiveness (FOUR) score in predicting extubation failure in critically ill intubated patients admitted with disturbed level of conscious in comparison with the Glasgow coma scale (GCS). Patients and Methods: All intubated critically ill patients with a disturbed level of consciousness were assessed using both the FOUR score and the GCS. The FOUR score and the GCS were compared regarding their predictive value for successful extubation at 14 days after intubation as a primary outcome measure. The 28-day mortality and the neurological outcome at 3 months were used as secondary outcome measures. Results: Eighty-six patients were included in the study. Median age was 63 (50–77) years. Sex–ratio (M/F) was 1.46. On admission, median GCS was 7 (3–10) while median FOUR score was 8.5 (2.3–11). A GCS ≤ 7 predicted the extubation failure at 14 days after intubation with a sensitivity of 88.5% and specificity of 68.3%, whereas a FOUR score <10 predicted the same outcome with a sensitivity of 80.8% and a specificity of 81.7%. The areas under the curves was significantly higher with the FOUR score than with GCS (respectively 0.867 confidence interval [CI]: 95% [0790–0.944] and 0.832 CI: 95% [0.741–0.923]; P = 0.014). When calculated before extubation, FOUR score <12 predicted extubation failure with a sensitivity of 92.3% and a specificity of 85%, whereas a GCS <12 predicted the same outcome with a sensitivity of 73% and a specificity of 61.7%. Both scores had similar accuracy for predicting 28-day mortality and neurological outcome at 3 months. Conclusion: The FOUR score is superior to the GCS for the prediction of successful extubation of intubated critically ill patients. PMID:28149821

  17. STUDIES ON THE NATURE OF THE AGENT TRANSMITTING LEUCOSIS OF FOWLS

    PubMed Central

    Furth, J.

    1932-01-01

    The filterable agent transmitting leucosis resists drying, retaining its activity for at least 54 days. The conditions of successful desiccation have not been precisely ascertained. By the addition of glycerin the agent can be preserved for at least 104 days. It is not inactivated by freezing in liquid air. At 37.5°C. it loses its activity within 14 days, but retains some of its activity for at least 14 days when kept at 4°C. PMID:19870007

  18. Myorelaxant Effect of Bee Venom Topical Skin Application in Patients with RDC/TMD Ia and RDC/TMD Ib: A Randomized, Double Blinded Study

    PubMed Central

    Baron, Stefan

    2014-01-01

    The aim of the study was the evaluation of myorelaxant action of bee venom (BV) ointment compared to placebo. Parallel group, randomized double blinded trial was performed. Experimental group patients were applying BV for 14 days, locally over masseter muscles, during 3-minute massage. Placebo group patients used vaseline for massage. Muscle tension was measured twice (TON1 and TON2) in rest muscle tonus (RMT) and maximal muscle contraction (MMC) on both sides, right and left, with Easy Train Myo EMG (Schwa-medico, Version 3.1). Reduction of muscle tonus was statistically relevant in BV group and irrelevant in placebo group. VAS scale reduction was statistically relevant in both groups: BV and placebo. Physiotherapy is an effective method for myofascial pain treatment, but 0,0005% BV ointment gets better relief in muscle tension reduction and analgesic effect. This trial is registered with Clinicaltrials.gov NCT02101632. PMID:25050337

  19. Endogenous oncornaviral gene expression in adult and fetal mice: quantitative, histologic, and physiologic studies of the major viral glycorprotein, gp70

    PubMed Central

    1976-01-01

    Endogenous expression of the murine leukemia virus (MuLV) genome has been studied in a number of strains of mice. Expression of the major envelope glycoprotein, gp70, is restricted to certain anatomical sites and cell types, prominent among which are lymphoid and epithelial cells. On a quantitative basis, the major site of gp70 expression is the male genital tract. During development, gp70 first appears in the hematopoietic liver of 14-day-old embryos and by day 18, it is already expressed at anatomical sites similar to those of the adult. In toto, these results show that control of expression of the MuLV genome in adult and developing mice is linked to differentiation. PMID:172586

  20. Myorelaxant effect of bee venom topical skin application in patients with RDC/TMD Ia and RDC/TMD Ib: a randomized, double blinded study.

    PubMed

    Nitecka-Buchta, Aleksandra; Buchta, Piotr; Tabeńska-Bosakowska, Elżbieta; Walczyńska-Dragoń, Karolina; Baron, Stefan

    2014-01-01

    The aim of the study was the evaluation of myorelaxant action of bee venom (BV) ointment compared to placebo. Parallel group, randomized double blinded trial was performed. Experimental group patients were applying BV for 14 days, locally over masseter muscles, during 3-minute massage. Placebo group patients used vaseline for massage. Muscle tension was measured twice (TON1 and TON2) in rest muscle tonus (RMT) and maximal muscle contraction (MMC) on both sides, right and left, with Easy Train Myo EMG (Schwa-medico, Version 3.1). Reduction of muscle tonus was statistically relevant in BV group and irrelevant in placebo group. VAS scale reduction was statistically relevant in both groups: BV and placebo. Physiotherapy is an effective method for myofascial pain treatment, but 0,0005% BV ointment gets better relief in muscle tension reduction and analgesic effect. This trial is registered with Clinicaltrials.gov NCT02101632.

  1. Development of a Feeder for Uninterrupted Centrifugation Studies

    NASA Technical Reports Server (NTRS)

    Mulenburg, Gerald M.; Vasques, Marilyn F.; Gundo, Daniel P.; Griffith, Jon B.; Wade, Charles E. (Technical Monitor)

    1994-01-01

    A specialized paste diet feeder was developed in support of a hypergravity (2G) centrifuge study. The centrifuge study was to be compared to a previously flown Russian Cosmos spaceflight so experimental parameters of the 14 day spaceflight had to be duplicated. In order to duplicate at hyper G an experiment that took place in weightlessness, all other conditions must be as identical as possible. Stopping the centrifuge to provide maintenance for the animals causes unacceptable changes in experimental research results. Thus the experimental protocol required the delivery of a designated amount of paste diet at regular intervals for a two week period without stopping the centrifuge. A centrifuge and a stationary control cage, each containing 10 laboratory rats, were fitted with feeders that were calibrated to provide 140 plus or minus 2g of paste diet every 6 hours. This paper describes development of the feeder design and results of its operation over the two week experiment. The design philosophy and details of the feeder system are provided with recommendations for future such devices.

  2. Studies on a suitable antibiotic therapy for treating swine brucellosis.

    PubMed

    Dieste-Pérez, L; Fraile, L; de Miguel, M J; Barberán, M; Blasco, J M; Muñoz, P M

    2015-08-01

    The aim of this work was developing effective treatments against Brucella suis biovar 2, responsible for swine brucellosis in Europe. MICs for antibiotics used classically in brucellosis and two new macrolides (tulathromycin and tildipirosin) were determined for 33 B. suis biovar 2 field and B. suis reference strains. MIC90 values ranged from 0.01 to 0.25 μg/mL. The best candidates, given alone or combined, were then evaluated in mice. Ten groups (n = 7) of BALB/c mice were inoculated (1 × 10(5) CFU/mouse) with a virulent B. suis biovar 2 field strain. All groups, excepting untreated control, were treated for 14 days with, respectively, doxycycline, dihydrostreptomycin, tulathromycin (one or two doses), or tildipirosin (one or two doses) given alone, and doxycycline combined with dihydrostreptomycin, tulathromycin, or tildipirosin. Combined tildipirosin treatment was the most effective, then selected for pig studies. Sixteen B. suis biovar 2 naturally infected sows were treated with oxytetracycline (20 mg/kg BW/daily) for 21 days. The half of these received also tildipirosin (4 mg/kg BW) in two doses with a 10-day interval. An extensive bacteriological study conducted ten days after ceasing treatments proved the efficacy of this combined oxytetracycline/tildipirosin treatment.

  3. Animal studies on growth and development.

    PubMed

    Lerchl, Alexander

    2011-12-01

    Despite the fact that no plausible biological mechanism has yet been identified how electromagnetic fields below recommended exposure limits could negatively affect health of animals or humans, many experiments have been performed in various animal species, mainly mice and rats, to investigate the possible effects on growth and development. While older studies often suffered from sub-optimal exposure conditions, recent investigations, using sophisticated exposure devices and thus preventing thermal effects, have been performed without these limitations. In principle, two types of studies can be addressed: those which have investigated the carcinogenic or co-carcinogenic effects of exposure in developing animals, and those which have been done in developing animals without the focus on carcinogenic or co-carcinogenic effects. In both areas, the vast majority of publications did not show adverse effects. The largest study so far has been done in normal mice which have been chronically exposed to UMTS signals up to 1.3 W/kg SAR, thus 16 times higher than the whole-body exposure limit for humans. Even after four generations, no systematic or dose-dependent alterations in development or fertility could be found, supporting the view that negative effects on humans are very unlikely. Ongoing experiments in our laboratory investigate the effects of head-only exposure in rats (up to 10 W/kg local SAR) which are exposed from 14 days of age daily for 2 h. A battery of behavioral tests is performed in young, adult, and pre-senile animals. The results will help to clarify possible effects of exposure on brain development.

  4. Neuroprotection by α2-Adrenergic Receptor Stimulation after Excitotoxic Retinal Injury: A Study of the Total Population of Retinal Ganglion Cells and Their Distribution in the Chicken Retina

    PubMed Central

    Galindo-Romero, Caridad; Harun-Or-Rashid, Mohammad; Jiménez-López, Manuel; Vidal-Sanz, Manuel; Agudo-Barriuso, Marta

    2016-01-01

    We have studied the effect of α2-adrenergic receptor stimulation on the total excitotoxically injured chicken retinal ganglion cell population. N-methyl-D-aspartate (NMDA) was intraocularly injected at embryonic day 18 and Brn3a positive retinal ganglion cells (Brn3a+ RGCs) were counted in flat-mounted retinas using automated routines. The number and distribution of the Brn3a+ RGCs were analyzed in series of normal retinas from embryonic day 8 to post-hatch day 11 retinas and in retinas 7 or 14 days post NMDA lesion. The total number of Brn3a+ RGCs in the post-hatch retina was approximately 1.9x106 with a density of approximately 9.2x103 cells/mm2. The isodensity maps of normal retina showed that the density decreased with age as the retinal size increased. In contrast to previous studies, we did not find any specific region with increased RGC density, rather the Brn3a+ RGCs were homogeneously distributed over the central retina with decreasing density in the periphery and in the region of the pecten oculli. Injection of 5–10 μg NMDA caused 30–50% loss of Brn3a+ cells and the loss was more severe in the dorsal than in the ventral retina. Pretreatment with brimonidine reduced the loss of Brn3a+ cells both 7 and 14 days post lesion and the protective effect was higher in the dorsal than in the ventral retina. We conclude that α2-adrenergic receptor stimulation reduced the impact of the excitotoxic injury in chicken similarly to what has been shown in mammals. Furthermore, the data show that the RGCs are evenly distributed over in the retina, which challenges previous results that indicate the presence of specific high RGC-density regions of the chicken retina. PMID:27611432

  5. Effects of Combination Treatment of Alpha 1-Adrenergic Receptor Antagonists on Voiding Dysfunction: Study on Target Organs in Overactive Bladder Rats

    PubMed Central

    2016-01-01

    Purpose Overactive bladder (OAB) causes urinary urgency, usually accompanied by frequency and nocturia. Alpha 1-adrenergic receptor (α1-AR) antagonists are known to improve lower urinary tract symptoms associated with OAB. The α1-AR antagonists constitute a variety of drugs according to the receptor subtype affinity. This study investigated the efficacy of tamsulosin, naftopidil, and a combination of the two on OAB rats. Methods The OAB rat model was induced by an intraperitoneal injection of cyclophosphamide for 14 days. The experimental groups were divided into 5 groups: control group, OAB-induction group, OAB-induction and tamsulosin monotherapy group, OAB-induction and naftopidil monotherapy group, and OAB-induction and tamsulosin-naftopidil combination therapy group. For the drug-treated groups, each drug was administrated for 14 days after the OAB induction. Cystometry for urodynamic evaluation and immunohistochemical stain for c-Fos and nerve growth factor (NGF) expressions in the central micturition centers were performed. Results Increased contraction pressure and time with enhanced c-Fos and NGF expressions in the central micturition centers were found in the OAB rats. Tamsulosin suppressed contraction pressure and time while inhibiting c-Fos and NGF expressions. Naftopidil showed no significant effect and combination therapy showed less of an effect on contraction pressure and time. Naftopidil and combination therapy exerted no significant effect on the c-Fos and NGF expressions. Conclusions Tamsulosin showed the most prominent efficacy for the treatment of OAB compared to the naftopidil and combination. The combination of tamsulosin with naftopidil showed no synergistic effects on OAB; however, further studies of addon therapy might provide opportunities to find a new modality. PMID:27915481

  6. Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat soft mist inhaler: findings from two dose-ranging studies in healthy men.

    PubMed

    Feifel, Ulrich; Wallenstein, Gudrun; Rominger, Karl-Ludwig; Trommeshauser, Dirk; Platz, Juliane

    2008-01-01

    Data are presented from two randomized, double-blind, placebo-controlled studies in which the tolerability of tiotropium Respimat Soft MistTM Inhaler (SMI), a new-generation, propellant-free device for use in COPD, and the ocular safety oftiotropium were examined. In Study 1, 36 healthy males received tiotropium 8, 16, or 32 microg (n = 9/dose) or placebo (n = 3/dose level), administered once daily via Respimat SMI for 14 days. Safety and pharmacokinetics were evaluated. In Study 2, 48 healthy males received tiotropium 0.02, 0.04, 0.08, 0.16, 0.28, or 0.40 microg (n = 6/dose) or placebo (n = 2/dose level), applied as two drops to one eye (the highest dose was a significant multiple of a percentage of the proposed Respimat SMI clinical dose that could be inadvertently deposited in the eye). Ocular parameters were measured over 24 hours. Tiotropium Respimat SMI at doses up to 32 microg was well tolerated in Study 1; typical dose-dependent anticholinergic adverse events of mild-to-moderate intensity were observed. In Study 2, ocular tiotropium administration did not affect pupil diameter, pupillary reflex, intraocular pressure, or accommodation. Tiotropium Respimat SMI was well tolerated. Inadvertent ocular exposure to tiotropium up to 0.40 g is unlikely to result in ocular adverse effects.

  7. Natural history of human calicivirus infection: a prospective cohort study.

    PubMed

    Rockx, Barry; De Wit, Matty; Vennema, Harry; Vinjé, Jan; De Bruin, Erwin; Van Duynhoven, Yvonne; Koopmans, Marion

    2002-08-01

    We investigated the natural history of human Calicivirus infection in the community. Clinical information was obtained from 99 subjects infected with Norwalk-like viruses (NLV) and 40 subjects infected with Sapporo-like viruses (SLV) in a prospective, community-based cohort study. NLV infection was common in all age groups, whereas SLV infection was mainly restricted to children aged <5 years. Symptoms lasted for a median of 5 and 6 days for NLV and SLV infections, respectively. Disease was characterized by diarrhea during the first 5 days (87% of patients with NLV infection and 95% of patients with SLV infection) and vomiting on the first day (74% for NLV and 60% for SLV). Vomiting was less common in children aged <1 year (59% for NLV and 44% for SLV) than it was among children aged >/=1 year (>75% for NLV and >67% for SLV). Overall, NLV was detected in 26% of patients up to 3 weeks after the onset of illness. This proportion was highest (38%) for children aged <1 year. SLV shedding subsided after 14 days. These data show that the durations of disease and viral shedding of caliciviruses are longer than has been described elsewhere. Therefore, the impact of these infections may have been underestimated.

  8. Double-blind, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics and pharmacodynamics of TAK-683, an investigational metastin analogue in healthy men

    PubMed Central

    Scott, Graham; Ahmad, Irfan; Howard, Katy; MacLean, David; Oliva, Cristina; Warrington, Steve; Wilbraham, Darren; Worthington, Paul

    2013-01-01

    Aims Two randomized, double-blind, placebo-controlled studies were performed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the investigational metastin analogue, TAK-683, in healthy men. Methods We first investigated a single subcutaneous (s.c.) dose of TAK-683 (0.01–2.0 mg) in 60 subjects (TAK-683, n = 42; placebo, n = 18). We then assessed a single s.c. bolus of 0.03–1.0 mg TAK-683 on day 1, followed by a 0.01–2.0 mg day−1 continuous infusion on days 2–13, to simulate a depot formulation, in 30 subjects (TAK-683, n = 25; placebo, n = 5) for 14 days. Results TAK-683 was well tolerated up to a dose of 2.0 mg day−1 by continuous s.c. infusion for 14 days. Adverse events were similar between TAK-683 and placebo subjects at all dose levels. TAK-683 plasma concentrations generally increased in proportion to dose with single and continuous dosing, with steady-state concentrations achieved by day 2 of continuous dosing. TAK-683 at 2.0 mg day−1 suppressed testosterone below castration level (<50 ng dl−1) in four of five subjects by day 7 of continuous dosing. Luteinizing hormone and follicle stimulating hormone concentrations were suppressed with TAK-683 continuous dosing compared with placebo by up to 70 and 43%, respectively, but this was not consistently dose-dependent. Conclusions In healthy men, s.c. administration of TAK-683 was well tolerated at all dose levels. The PK profile of TAK-683 was favourable, and TAK-683 suppressed testosterone profoundly during continuous dosing. Further investigation of metastin analogues is warranted for the treatment of castration-resistant prostate cancer. PMID:22803642

  9. Effects of aripiprazole on prolactin levels in subjects with schizophrenia during cross-titration with risperidone or olanzapine: analysis of a randomized, open-label study.

    PubMed

    Byerly, Matthew J; Marcus, Ronald N; Tran, Quynh-Van; Eudicone, James M; Whitehead, Richard; Baker, Ross A

    2009-02-01

    Hyperprolactinemia, an adverse effect associated with the use of typical antipsychotics and the atypical antipsychotic risperidone, has both acute and chronic clinical consequences. One option for clinical management is switching to an agent with a lower liability for inducing hyperprolactinemia. This post-hoc sub-analysis of an 8-week, open-label study in outpatients with schizophrenia (CN138-215) examined short-term effects on prolactin levels during a switch from risperidone or olanzapine to aripiprazole 30 mg/day. Three switch strategies were used: (I) immediate aripiprazole initiation with simultaneous immediate discontinuation of olanzapine/risperidone; (II) immediate aripiprazole initiation while tapering off olanzapine/risperidone over 14 days; (III) titrating aripiprazole upwards while tapering off olanzapine/risperidone over 14 days. Changes in prolactin levels from baseline to each last observation carried forward time point were compared with t-tests using Bonferroni correction for multiple comparisons. This sub-analysis included 269 subjects: 105 previously treated with risperidone; 164 previously treated with olanzapine. Mean baseline prolactin levels (ng/mL) were within normal range for the three olanzapine groups (Group-I, 11.7; Group-II, 13.2; Group-III, 11.2), but above normal for the risperidone groups (Group-I, 39.7; Group-II, 48.5; Group-III, 33.5). Following aripiprazole initiation, mean prolactin levels decreased significantly (p<0.001) at week-1 and were maintained to week-8 in all groups irrespective of prior treatment. Previously elevated prolactin levels in the risperidone groups were reduced to within normal range within 1 week, irrespective of switching strategy. Tolerability was good regardless of prior medication or switching strategy. Overall, rapid decreases of prolactin levels were achieved safely with all three aripiprazole switching strategies. Reversal of hyperprolactinemia during the crossover period indicates the safety and

  10. A Phase 1 Study of 131I-CLR1404 in Patients with Relapsed or Refractory Advanced Solid Tumors: Dosimetry, Biodistribution, Pharmacokinetics, and Safety

    PubMed Central

    Grudzinski, Joseph J.; Titz, Benjamin; Kozak, Kevin; Clarke, William; Allen, Ernest; Trembath, LisaAnn; Stabin, Michael; Marshall, John; Cho, Steve Y.; Wong, Terence Z.; Mortimer, Joanne; Weichert, Jamey P.

    2014-01-01

    Introduction 131I-CLR1404 is a small molecule that combines a tumor-targeting moiety with a therapeutic radioisotope. The primary aim of this phase 1 study was to determine the administered radioactivity expected to deliver 400 mSv to the bone marrow. The secondary aims were to determine the pharmacokinetic (PK) and safety profiles of 131I-CLR1404. Methods Eight subjects with refractory or relapsed advanced solid tumors were treated with a single injection of 370 MBq of 131I-CLR1404. Whole body planar nuclear medicine scans were performed at 15–35 minutes, 4–6, 18–24, 48, 72, 144 hours, and 14 days post injection. Optional single photon emission computed tomography imaging was performed on two patients 6 days post injection. Clinical laboratory parameters were evaluated in blood and urine. Plasma PK was evaluated on 127I-CLR1404 mass measurements. To evaluate renal clearance of 131I-CLR1404, urine was collected for 14 days post injection. Absorbed dose estimates for target organs were determined using the RADAR method with OLINDA/EXM software. Results Single administrations of 370 MBq of 131I-CLR1404 were well tolerated by all subjects. No severe adverse events were reported and no adverse event was dose-limiting. Plasma 127I-CLR1404 concentrations declined in a bi-exponential manner with a mean t½ value of 822 hours. Mean Cmax and AUC(0-t) values were 72.2 ng/mL and 15753 ng•hr/mL, respectively. An administered activity of approximately 740 MBq is predicted to deliver 400 mSv to marrow. Conclusions Preliminary data suggest that 131I-CLR1404 is well tolerated and may have unique potential as an anti-cancer agent. Trial Registration ClinicalTrials.gov NCT00925275 PMID:25402488

  11. Tracer studies on the incorporation of [2-14C]-DL-mevalonate into chlorophylls a and b, alpha-chaconine, and alpha-solanine of potato sprouts.

    PubMed

    Kozukue, N; Tsuchida, H; Friedman, M

    2001-01-01

    Chlorophyll and glycoalkaloids are synthesized in different parts of the potato plant including leaves, tubers, and sprouts. Although light stimulates the biosynthesis of both constituents, the question of whether the two biosynthetic pathways are under the same genetic control has not been resolved. This study investigated the dynamics of incorporation of labeled [2-(14)C]-DL-mavalonate into chlorophyll a, chlorophyll b, and the glycoalkaloids alpha-chaconine and alpha-solanine in potato sprouts after 7 and 14 days of storage in the light and in the dark. No chlorophyll synthesis occurred in the dark. Fractionation of the "glycoalkaloid" extract followed by high-performance liquid chromatography produced four peaks. The fractions were collected and analyzed for radioactivity. About 80% of the radioactivity resided in fraction 1, the composition of which is unknown. Two of the fractions, with 1-14% of the original label, were alpha-chaconine and alpha-solanine. The radioactivity derived from mevalonate largely resides in unidentified compound(s) eluting as a single peak on the HPLC column before the peaks associated with the glycoalkaloids. The specific radioactivity of alpha-chaconine and alpha-solanine increased approximately 2-fold in going from 7 to 14 days of exposure in the light and in the dark. These and additional observations point to the near identity of the dynamics of biosynthesis of the two glycoalkaloids. These data also implicate a non-mevalonate pathway for the synthesis of both chlorophylls and the glycoalkaloids and are consistent with independent genetic control of the concurrent formation of the two classes of compounds during greening of potatoes.

  12. Influence of exposure time to saliva and antioxidant treatment on bond strength to enamel after tooth bleaching: an in situ study

    PubMed Central

    MIRANDA, Thais Aglaet Matos; MOURA, Sandra Kiss; AMORIM, Vitor Hugo de Oliveira; TERADA, Raquel Sano Suga; PASCOTTO, Renata Corrêa

    2013-01-01

    Objectives This study evaluated the influence of different exposure times to saliva in situ in comparison with an antioxidant treatment on composite resin bond strength to human enamel restored after tooth bleaching. Material and Methods Forty human teeth specimens measuring 5x5 mm were prepared and randomly allocated into 5 groups with 8 specimens each: Gct (control group, restored on unbleached enamel); Gbl (restored immediately after bleaching); Gsa (bleached, treated with 10% sodium ascorbate gel for 60 min and restored); G7d (bleached, exposed to saliva in situ for 7 days and restored); and G14d (bleached, exposed to saliva in situ for 14 days and restored). Restored samples were cut into 0.8 mm2 sticks that were tested in microtensile. Specimens were microscopically analyzed and failure modes were classified as adhesive, cohesive, or mixed. Pretest and cohesive failures were not considered in the statistical analysis, which was performed with one-way ANOVA and Tukey's post-hoc test (α=0.05), with the dental specimen considered as the experimental unit. Results Mean bond strength results found for Gbl in comparison with Gct indicated that bleaching significantly reduced enamel adhesiveness (P<0.01). However, no statistically significant differences were found between Gct, Gsa and G7d (P>0.05). Bond strength found for G14d was significantly higher than for Gsa (P<0.01). Fractures modes were predominantly of a mixed type. Conclusions Bonding strength to bleached enamel was immediately restored with the application of sodium ascorbate and exposure to human saliva in situ for at least 7 days. Best results were obtained with exposure to human saliva in situ for 14 days. Treatment with sodium ascorbate gel for 60 min may be recommended in cases patients cannot wait for at least 7 days for adhesive techniques to be performed. PMID:24473724

  13. Clarithromycin suspension: bioequivalence studies on two different strengths.

    PubMed

    Koytchev, Rossen; Ozalp, Yildiz; Erenmemisoglu, Aydin; van der Meer, Mike John; Alpan, Recep Serdar

    2004-09-01

    Two studies were performed in different groups of volunteers, with the aim to prove the bioequivalence of test (Klaromin) and reference clarithromycin (CAS 81103-11-9) suspensions containing in 5 mL either 125 mg (study 1) or 250 mg (study 2) of the drug, administered as an oral dose of 10 mL. Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in healthy volunteers with a wash-out period from 7 to 14 days. Blood samples were taken up to 24 h in both studies, and concentrations of clarithromycin and its principal active 14-hydroxy metabolite were determined by HPLC. In the first study, the 90% confidence interval for intra-individual ratios of AUC0-t and Cmax of clarithromycin were between 0.84 and 1.03 (AUC0-t) and between 0.89 and 1.03 (Cmax). In the second study, i.e. after administration of clarithromycin suspension 250mg/5mL, the 90% confidence interval for intra-individual ratios of AUC0-inf and Cmax of clarithromycin were between 1.01 and 1.17 (AUC0-inf) and between 1.01 and 1.16 (Cmax). All these values were within the acceptance ranges for bioequivalence studies. In both studies, the 90% confidence interval for intra-individual ratios of AUC0-inf and Cmax of 14-hydroxy-clarithromycin were also within the acceptance ranges. In the light of the results of the studies reported here it can be concluded that the clarithromycin test formulations are bioequivalent to the respective reference formulations, i.e. suspensions containing 125 mg/5 mL and 250 mg/5 mL of the drug.

  14. Pinimenthol ointment in patients suffering from upper respiratory tract infections - a post-marketing observational study.

    PubMed

    Kamin, Wolfgang; Kieser, Meinhard

    2007-12-01

    In order to gain further experience regarding the tolerability of Pinimenthol ointment(1) in adolescents (> or = 12 years) and adults suffering from upper respiratory tract infections, a post-marketing observational study was performed. In this study, data of 3060 patients were collected (64.9% prospectively over an individual observation period of 5-14 days, 35.1% retrospectively). The prospective documentation also comprised data concerning treatment effects. Sample size of the post-marketing observational study was calculated in the way that adverse drug reactions with an event probability of at least 1:1000 would occur within the study at least once with a probability of 95%. Most patients suffered from cold, acute or chronic bronchitis, bronchial catarrh or hoarseness. Pinimenthol ointment was prescribed to inunction (29.6%), inhalation (17.3%) or inunction and inhalation (53.1%), respectively. The mean duration of study participation was 8.0 +/- 3.4 days. The tolerability was rated as excellent or good by 96.7% of physicians and 95.7% of patients. A total of 22 patients (0.7%) reported adverse drug reactions which mostly affected the skin or mucus membrane and therefore correspond to the expected adverse effects profile of Pinimenthol ointment. The treatment effect was mostly judged as excellent or good (physicians: 88.3%; patients: 88.1%). In conclusion, the study confirms Pinimenthol ointment as a well tolerated therapy option for upper respiratory tract infections in both adolescents and adults.

  15. Review of in vivo studies of dimethyl sulfoxide cryopreserved platelets.

    PubMed

    Slichter, Sherrill J; Jones, Melinh; Ransom, Janet; Gettinger, Irena; Jones, Mary Kay; Christoffel, Todd; Pellham, Esther; Bailey, S Lawrence; Corson, Jill; Bolgiano, Doug

    2014-10-01

    A literature review was conducted to assess the efficacy and safety of dimethyl sulfoxide (DMSO) cryopreserved platelets for potential military use. In vivo DMSO cryopreserved platelet studies published between 1972 and June of 2013 were reviewed. Assessed were the methods of cryopreservation, posttransfusion platelet responses, prevention or control of bleeding, and adverse events. Using the Department of Defense's preferred 6% DMSO cryopreservation method with centrifugation to remove the DMSO plasma before freezing at -65°C and no postthaw wash, mean radiolabeled platelet recoveries in 32 normal subjects were 33% ± 10% (52% ± 12% of the same subject's fresh platelet recoveries), and survivals were 7.5 ± 1.2 days (89% ± 15% of fresh platelet survivals). Using a variety of methods to freeze autologous platelets from 178 normal subjects, mean radiolabeled platelet recoveries were consistently 39% ± 9%, and survivals, 7.4 ± 1.4 days. More than 3000 cryopreserved platelet transfusions were given to 1334 patients. There were 19 hematology/oncology patient studies, and, in 9, mean 1-hour corrected count increments were 11 100 ± 3600 (range, 5700-15 800) after cryopreserved autologous platelet transfusions. In 5 studies, bleeding times improved after transfusion; in 3, there was either no improvement or a variable response. In 4 studies, there was immediate cessation of bleeding after transfusion; in 3 studies, patients being supported only with cryopreserved platelets had no bleeding. In 1 cardiopulmonary bypass study, cryopreserved platelets resulted in significantly less bleeding vs standard platelets. In 3 trauma studies, cryopreserved platelets were hemostatically effective. No significant adverse events were reported in any study. In summary, cryopreserved platelets have platelet recoveries that are about half of fresh platelets, but survivals are only minimally reduced. The platelets appear hemostatically effective and have no significant adverse events.

  16. Toxicological evaluation of peroxy sulfonated oleic acid (PSOA) in subacute and developmental toxicity studies.

    PubMed

    Pechacek, Nathan; Laidlaw, Karen; Clubb, Stephanie; Aulmann, Walter; Osorio, Magdalena; Caudill, Jeff

    2013-12-01

    Peroxy sulfonated oleic acid (PSOA) is a new coupler used in sanitizing solutions primarily for the food and beverage industry. The toxicity of PSOA was evaluated in a 28-day repeat dose study according to OECD 407 guidelines with a 14-day recovery period and a developmental toxicity study according to OECD 414 guidelines. In both studies, PSOA was administered once daily via gavage at 0, 5, 15 and 50 mg/kg/day to Sprague-Dawley rats. Due to its corrosive properties, the highest test concentration was restricted to 0.5%. No findings related to PSOA administration were observed for the 28-day repeat-dose study and the NOEL is 50 mg/kg/day. Additionally, no impairment of the mucous membranes of the gastrointestinal tract was observed up to 0.5%, which is considered the NOEC in terms of local toxicity. For the developmental study, an embryo-fetal NOEL of 50 mg/kg/day was identified and the maternal NOEL is considered to be 15 mg/kg/day, based on slight reductions in maternal body weight and food consumption, as well as a modest increase in the incidence of clinical observations at the high dose. These findings demonstrate that PSOA appears to have minimal potential to induce toxicity associated with repeat-dose or developmental exposures.

  17. Flooding and Emergency Room Visits for Gastrointestinal Illness in Massachusetts: A Case-Crossover Study

    PubMed Central

    Wade, Timothy J.; Lin, Cynthia J.; Jagai, Jyotsna S.; Hilborn, Elizabeth D.

    2014-01-01

    Introduction Floods and other severe weather events are anticipated to increase as a result of global climate change. Floods can lead to outbreaks of gastroenteritis and other infectious diseases due to disruption of sewage and water infrastructure and impacts on sanitation and hygiene. Floods have also been indirectly associated with outbreaks through population displacement and crowding. Methods We conducted a case-crossover study to investigate the association between flooding and emergency room visits for gastrointestinal illness (ER-GI) in Massachusetts for the years 2003 through 2007. We obtained ER-GI visits from the State of Massachusetts and records of floods from the National Oceanic and Atmospheric Association’s Storm Events Database. ER-GI visits were considered exposed if a flood occurred in the town of residence within three hazard periods of the visit: 0–4 days; 5–9 days; and 10–14 days. A time-stratified bi-directional design was used for control selection, matching on day of the week with two weeks lead or lag time from the ER-GI visit. Fixed effect logistic regression models were used to estimate the risk of ER-GI visits following the flood. Results and Conclusions A total of 270,457 ER-GI visits and 129 floods occurred in Massachusetts over the study period. Across all counties, flooding was associated with an increased risk for ER-GI in the 0–4 day period after flooding (Odds Ratio: 1.08; 95% Confidence Interval: 1.03–1.12); but not the 5–9 days (Odds Ratio: 0.995; 95% Confidence Interval: 0.955–1.04) or the 10–14 days after (Odds Ratio: 0.966, 95% Confidence Interval: 0.927–1.01). Similar results were observed for different definitions of ER-GI. The effect differed across counties, suggesting local differences in the risk and impact of flooding. Statewide, across the study period, an estimated 7% of ER-GI visits in the 0–4 days after a flood event were attributable to flooding. PMID:25329916

  18. Safety assessment of the fermented Phylloporia ribis (Lonicera japonica Thunb.) mycelia by oral acute toxicity study in mice and 90-day feeding study in rats.

    PubMed

    Lu, Lianhua; Fan, Yiou; Yao, Wenhuan; Xie, Wei; Guo, Jie; Yan, Yan; Yang, Fei; Xu, Lingchuan

    2014-07-01

    Phylloporia ribis is an edible fungus in China. Its fermented mycelia have been approved by the National Health and Family Planning Commission (NHFPC) of PR China for use as a novel food material, but little information on its safety is available. The present research was the first to evaluate acute and subchronic toxicity in experimental animals of fermented Phylloporia ribis mycelia (FPM) following standard procedures. In acute toxicity study, FPM was orally administered to male and female mice twice a day at single dose of 10 g/kg bw. The Maximum Tolerated Dose (MTD) of FPM for mice of both sexes was over 10 g/kg bw. No death and abnormal behaviors occurred during 14 days study except for an increased locomotor activity in three animals. In 90-day feeding study, male and female Sprague-Dawley rats were fed diets containing 10.0%, 5.0%, 2.5%, 1.25% and 0% (control) FPM for 90 days. The treatment caused no effects on mortality, gross pathology, histology, hematology, and blood chemistry, no dose-dependent changes in food consumption, but caused effect on body weight gain compared with control group. The No Observed Adverse-Effect Level (NOAEL) of FPM was greater than 8.7 g/kg bw/day in both sexes of rats.

  19. Everolimus as an mTOR Inhibitor Suppresses Endometriotic Implants: an Experimental Rat Study

    PubMed Central

    Kacan, T.; Yildiz, C.; Baloglu Kacan, S.; Seker, M.; Ozer, H.; Cetin, A.

    2017-01-01

    Introduction Mammalian target of rapamycin is a pathway to block apoptosis. Recent studies showed that the activity of mammalian target of rapamycin pathway increases in endometriotic lesions. Aim of the present study was to study the effect of everolimus agent, a rapamycin analog, in an experimental endometriosis model. Materials and Methods Endometriosis established by the autotransplantation of uterine tissue in the peritoneal cavity was confirmed in 24 rats. The animals were then randomly divided into three groups to receive either everolimus (1.5 mg/kg/day, p. o.), anastrozole (0.004 mg/day, p. o.), or normal saline (0.1 mL, i. p.) for 14 days. Endometriotic foci were excised, stained with hematoxylin and eosin, and endometriosis was scored semiquantitatively. In addition, immunohistochemical examination were performed using primary antibodies of vascular endothelial growth factor, CD117, and Bax. Results Both anastrozole and everolimus lowered endometriosis scores. Significant decreases in ovarian follicles were observed following anastrozole treatment but not everolimus treatment. Conclusion Through its apoptosis-promoting effect, everolimus suppressed endometriotic foci without negatively affecting ovarian reserve. These findings support the hypothesis that everolimus merits further study on the way to developing a new endometriosis drug. PMID:28190891

  20. Bioequivalence study of 400 and 100 mg imatinib film-coated tablets in healthy volunteers.

    PubMed

    Ostrowicz, Andrzej; Mikołajczak, Przemysław L; Wierzbicka, Marzena; Boguradzki, Piotr

    2014-01-01

    The aim of the study was to investigate the bioavailability of a generic product of 100 mg and 400 mg imatinib film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence. The secondary objective of the study was to evaluate tolerability of both products. An open-label, randomized, crossover, two-period, single-dose, comparative study was conducted in 43 (Imatynib-Biofarm 100 mg film-coated tablet) and in 42 (Imatynib-Biofarm 400 mg film-coated tablet), brand name Imatenil, Caucasian healthy volunteers in fed conditions. A single oral dose administration of the test or reference product was separated by 14-day washout period. The imatinib and its metabolite N-desmethyl imatinib concentrations were determined using a validated LC MS/MS method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Imatynib-Biofarm 100 mg and 400 mg film-coated tablets manufactured by Biofarm Sp. z o.o. (test products) are bioequivalent to those of Glivec 100 mg and 400 mg film-coated tablets manufactured by Novartis Pharma GmbH (reference products). Both products in the two doses of imatinib were well tolerated.

  1. Acute and repeated dose toxicity studies of different β-cyclodextrin-based nanosponge formulations.

    PubMed

    Shende, Pravin; Kulkarni, Yogesh A; Gaud, R S; Deshmukh, Kiran; Cavalli, Roberta; Trotta, Francesco; Caldera, Fabrizio

    2015-05-01

    Nanosponges (NS) show promising results in different fields such as medicine, agriculture, water purification, fire engineering and so on. The present study was designed to evaluate toxicity of different NS formulations (namely, S1-S6) synthesized with different cross-linking agents such as carbonyl diimidazole, pyromellitic dianhydride and hexamethylene diisocynate; and preparation methods in experimental animals. Acute and repeated dose toxicity studies of formulations were carried out as per OECD guidelines 423 and 407, respectively. For acute toxicity study, formulations were administered to female rats at doses of 300 and 2000 mg/kg orally. The general behaviour of the rats was continuously monitored for 1 h after dosing, periodically during the first 24 h and daily thereafter for a total of 14 days. On day 14, animals were fasted overnight, weighed, and sacrificed. After sacrification, animals were subjected to necropsy. For repeated dose toxicity study, rats of either sex were orally administered with formulations at the dose of 300 mg/kg per day for a period of 28 days. The maximally tolerated dose of all formulations was found to be 2000 mg/kg. Repeated administration of formulations for 28 days did not show any significant changes in haematological and biochemical parameters in experimental animals. These results indicate that the formulations are safe, when tested in experimental animals.

  2. Impact of Repeated Tail Clip and Saphenous Vein Phlebotomy on Rats Used in Toxicology Studies.

    PubMed

    Wickremsinhe, Enaksha R; Renninger, Matthew; Paulman, April; Pritt, Michael; Schultze, Albert E

    2016-10-01

    Sampling blood for toxicokinetic (TK) evaluation in rodents is typically performed using a satellite group of animals to avoid depleting the blood volume and inducing an additional stressor in the main study animals. This practice does not allow for direct comparison of individual animal toxicity to exposure. These studies evaluated serial collection of twelve, 40-µl blood samples from each rat from either a tail clip or a saphenous vein bleed and its impact on toxicologic parameters over 4- and 14-day periods. The results show the feasibility of successfully collecting TK samples from main study animals, using either of the two techniques. Both procedures were amenable to execution by a single technician using dried blood spot sampling. Any changes observed in the primary markers of erythroid mass between the nonbled control rats and repeat sampled rats were minimal and the range of values often overlapped. This technique would improve the quality of data generated from toxicology studies by allowing a direct comparison of systemic exposure to toxicity while at the same time reducing the number of rats by obviating the need for satellite groups.

  3. Antioxidant and Toxicity Studies of 50% Methanolic Extract of Orthosiphon stamineus Benth

    PubMed Central

    Lim, Chung Pin; Fung Ang, Lee; Por, Lip Yee; Wong, Siew Tung; Asmawi, Mohd. Zaini

    2013-01-01

    The present study evaluated the antioxidant activity and potential toxicity of 50% methanolic extract of Orthosiphon stamineus (Lamiaceae) leaves (MEOS) after acute and subchronic administration in rats. Superoxide radical scavenging, hydroxyl radical scavenging, and ferrous ion chelating methods were used to evaluate the antioxidant properties of the extract. In acute toxicity study, single dose of MEOS, 5000 mg/kg, was administered to rats by oral gavage, and the treated rats were monitored for 14 days. While in the subchronic toxicity study, MEOS was administered orally, at doses of 1250, 2500, and 5000 mg/kg/day for 28 days. From the results, MEOS showed good superoxide radical scavenging, hydroxyl radical scavenging, ferrous ion chelating, and antilipid peroxidation activities. There was no mortality detected or any signs of toxicity in acute and subchronic toxicity studies. Furthermore, there was no significant difference in bodyweight, relative organ weight, and haematological and biochemical parameters between both male and female treated rats in any doses tested. No abnormality of internal organs was observed between treatment and control groups. The oral lethal dose determined was more than 5000 mg/kg and the no-observed-adverse-effect level (NOAEL) of MEOS for both male and female rats is considered to be 5000 mg/kg per day. PMID:24490155

  4. Stress, Workload and Physiology Demand During Extravehicular Activity: A Pilot Study

    PubMed Central

    Rai, Balwant; Kaur, Jasdeep; Foing, Bernard H

    2012-01-01

    Background: Extravehicular activity (EVA), such as exercise performed under unique environmental conditions, is essential for supporting daily living in weightlessness and for further space exploration like long Mars mission. Aim: The study was planned stress, workload, and physiological demands of simulated Mars exploration. Materials and Methods: In this study, the six-person crew lived (24 hours) for 14 days during a short-term stay at the Mars Desert Research Station. The heart rates, salivary cortisol, workload, peak oxygen uptake or maximal aerobic capacity of the crew are measured before, during and after an EVA. Results: Data for heart rate showed the same trend as peak oxygen uptake or maximal aerobic capacity, with a maximal increase to 85% of peak. The rating of subscale showed a significant increase in EVA as compared to run. Salivary cortisol levels and heart rates were increased in both groups, although significant increased of cortisol levels and heart rates more in EVA as compared to hill running crew members. Conclusion: Further study is required on large scale taken into account of limitations of this study and including other physiological and psychological parameters in Mars analog environment. PMID:22754877

  5. Safety assessment of methanol extract of red dragon fruit (Hylocereus polyrhizus): acute and subchronic toxicity studies.

    PubMed

    Hor, Sook Yee; Ahmad, Mariam; Farsi, Elham; Yam, Mun Fei; Hashim, Mohd Akmal; Lim, Chung Pin; Sadikun, Amirin; Asmawi, Mohd Zaini

    2012-06-01

    Recently, the fruits of Hylocereus polyrhizus, known as red dragon fruit, have received much attention from growers worldwide. However, there is little toxicological information regarding the safety of repeated exposure to these fruits. The present study evaluated the potential toxicity of a methanol extract of H. polyrhizus fruit after acute and subchronic administration in rats. In the acute toxicity study, single doses of fruit extract (1250, 2500 and 5000 mg/kg) were administered to rats by oral gavage, and the rats were then monitored for 14 days. In the subchronic toxicity study, the fruit extract was administered orally to rats at doses of 1250, 2500 and 5000 mg/kg/day for 28 days. There was no mortality or signs of acute or subchronic toxicity. There was no significant difference in body weight, relative organ weight or hematological parameters in the subchronic toxicity study. Biochemical analysis showed some significant changes, including creatinine, globulin, total protein and urea levels. No abnormality of internal organs was observed between treatment and control groups. The lethal oral dose of the fruit extract is more than 5000 mg/kg and the no-observed-adverse-effect level (NOAEL) of the extract for both male and female rats is considered to be 5000 mg/kg per day for 28 days.

  6. Distributed situation awareness in complex collaborative systems: A field study of bridge operations on platform supply vessels

    PubMed Central

    Sandhåland, Hilde; Oltedal, Helle A; Hystad, Sigurd W; Eid, Jarle

    2015-01-01

    This study provides empirical data about shipboard practices in bridge operations on board a selection of platform supply vessels (PSVs). Using the theoretical concept of distributed situation awareness, the study examines how situation awareness (SA)-related information is distributed and coordinated at the bridge. This study thus favours a systems approach to studying SA, viewing it not as a phenomenon that solely happens in each individual's mind but rather as something that happens between individuals and the tools that they use in a collaborative system. Thus, this study adds to our understanding of SA as a distributed phenomenon. Data were collected in four field studies that lasted between 8 and 14 days on PSVs that operate on the Norwegian continental shelf and UK continental shelf. The study revealed pronounced variations in shipboard practices regarding how the bridge team attended to operational planning, communication procedures, and distracting/interrupting factors during operations. These findings shed new light on how SA might decrease in bridge teams during platform supply operations. The findings from this study emphasize the need to assess and establish shipboard practices that support the bridge teams' SA needs in day-to-day operations. Practitioner points Provides insights into how shipboard practices that are relevant to planning, communication and the occurrence of distracting/interrupting factors are realized in bridge operations. Notes possible areas for improvement to enhance distributed SA in bridge operations. PMID:26028823

  7. Distributed situation awareness in complex collaborative systems: A field study of bridge operations on platform supply vessels.

    PubMed

    Sandhåland, Hilde; Oltedal, Helle A; Hystad, Sigurd W; Eid, Jarle

    2015-06-01

    This study provides empirical data about shipboard practices in bridge operations on board a selection of platform supply vessels (PSVs). Using the theoretical concept of distributed situation awareness, the study examines how situation awareness (SA)-related information is distributed and coordinated at the bridge. This study thus favours a systems approach to studying SA, viewing it not as a phenomenon that solely happens in each individual's mind but rather as something that happens between individuals and the tools that they use in a collaborative system. Thus, this study adds to our understanding of SA as a distributed phenomenon. Data were collected in four field studies that lasted between 8 and 14 days on PSVs that operate on the Norwegian continental shelf and UK continental shelf. The study revealed pronounced variations in shipboard practices regarding how the bridge team attended to operational planning, communication procedures, and distracting/interrupting factors during operations. These findings shed new light on how SA might decrease in bridge teams during platform supply operations. The findings from this study emphasize the need to assess and establish shipboard practices that support the bridge teams' SA needs in day-to-day operations.

  8. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study

    PubMed Central

    Ley, Benedikt; Alam, Mohammad Shafiul; Thriemer, Kamala; Hossain, Mohammad Sharif; Kibria, Mohammad Golam; Auburn, Sarah; Poirot, Eugenie; Price, Ric N.; Khan, Wasif Ali

    2016-01-01

    Background The Bangladeshi national treatment guidelines for uncomplicated malaria follow WHO recommendations but without G6PD testing prior to primaquine administration. A prospective observational study was conducted to assess the efficacy of the current antimalarial policy. Methods Patients with uncomplicated malaria, confirmed by microscopy, attending a health care facility in the Chittagong Hill Tracts, Bangladesh, were treated with artemether-lumefantrine (days 0–2) plus single dose primaquine (0.75mg/kg on day2) for P. falciparum infections, or with chloroquine (days 0–2) plus 14 days primaquine (3.5mg/kg total over 14 days) for P. vivax infections. Hb was measured on days 0, 2 and 9 in all patients and also on days 16 and 30 in patients with P. vivax infection. Participants were followed for 30 days. The study was registered with the clinical trials website (NCT02389374). Results Between September 2014 and February 2015 a total of 181 patients were enrolled (64% P. falciparum, 30% P. vivax and 6% mixed infections). Median parasite clearance times were 22.0 (Interquartile Range, IQR: 15.2–27.3) hours for P. falciparum, 20.0 (IQR: 9.5–22.7) hours for P. vivax and 16.6 (IQR: 10.0–46.0) hours for mixed infections. All participants were afebrile within 48 hours, two patients with P. falciparum infection remained parasitemic at 48 hours. No patient had recurrent parasitaemia within 30 days. Adjusted male median G6PD activity was 7.82U/gHb. One male participant (1/174) had severe G6PD deficiency (<10% activity), five participants (5/174) had mild G6PD deficiency (10–60% activity). The Hb nadir occurred on day 2 prior to primaquine treatment in P. falciparum and P. vivax infected patients; mean fractional fall in Hb was -8.8% (95%CI -6.7% to -11.0%) and -7.4% (95%CI: -4.5 to -10.4%) respectively. Conclusion The current antimalarial policy remains effective. The prevalence of G6PD deficiency was low. Main contribution to haemolysis in G6PD normal

  9. A Prospective, Descriptive, Quality Improvement Study to Decrease Incontinence-Associated Dermatitis and Hospital-Acquired Pressure Ulcers.

    PubMed

    Hall, Kimberly D; Clark, Rebecca C

    2015-07-01

    Incontinence is a common problem among hospitalized patients and has been associated with multiple health complications, including incontinence-associated dermatitis (IAD) and hospital-acquired pressure ulcers (HAPUs). A prospective, descriptive study was conducted in 2 acute care neurology units to 1) assess the prevalence of incontinence and incidence of IAD and HAPUs among incontinent patients, and 2) evaluate the effect of caregiver education and use of a 1-step cleanser, moisturizer, barrier product on the development of IAD and HAPUs among patients with incontinence. During a period of 1 month, the incontinence status of admitted patients was recorded and skin was assessed for the presence/absence of IAD and HAPUs twice per day. After the 1-month data collection, all clinicians on the study units completed a facility-based online education program about IAD, HAPUs, and skin care followed by the implementation of a 1-step cleanser/barrier product for skin care of all patients with incontinence. Data collection procedures remained the same. Data were collected using a paper/pencil instrument and entered into a spreadsheet for analysis. Descriptive statistics were calculated and prevalence and incidence rates were compared between the pre-intervention and post-intervention phase using Fisher's exact analysis. During the first phase of the study, 17 of 40 admitted patients (42.5%) were incontinent. Of those, 5 (29.4%) developed IAD and all of these patients developed HAPUs (5 of 40 admitted, 29.4%) during an average length of stay of 7.3 (range: 2-14) days. In the intervention phase of the study, 25 of 46 (54.3%) patients were incontinent and none developed IAD or a HAPU during an average length of stay of 7.4 (range: 2-14) days. The average Braden scale score was 14.14 in the pre-intervention group of patients with incontinence and 12.74 in the intervention group. The prevalence of incontinence among patients admitted to acute care neurology units and the rate

  10. Efficacy of budesonide inhalation suspension in infants and young children with persistent asthma. Budesonide Inhalation Suspension Study Group.

    PubMed

    Mellon, M

    1999-10-01

    This paper reviews the results from 3 randomized, double-blind, placebo-controlled, multicenter studies that assessed the efficacy and safety of once- and twice-daily dosing of budesonide inhalation suspension (BIS) in infants and young children with persistent asthma. In children with mild persistent asthma that was previously treated with bronchodilators or noncorticosteroid anti-inflammatory agents (study A), nighttime and daytime asthma symptoms were significantly improved in 0.25-mg once daily, 0.5-mg once daily, and 1.0-mg once daily BIS treatment groups compared with placebo (P 14 days) compared with placebo (P <.05). The proportion of patients who discontinued this therapy because of worsening asthma was greater in the placebo group than in the BIS groups, with the difference between placebo (23%) and the 1. 0-mg BIS group (13%) being statistically significant (P =.020). All BIS doses except 0.5 mg once daily showed nonsignificant numeric improvement in morning and evening peak expiratory flow (PEF) compared with placebo. In children with asthma that was previously treated with inhaled corticosteroids (study B), BIS doses of 0.25 mg, 0.5 mg, and 1.0 mg twice daily resulted in significant improvements in nighttime symptoms scores versus placebo (P 14 days) compared with placebo (P

  11. In vivo comparative study of tissue reaction to bare and antimicrobial polymer coated transcutaneous implants.

    PubMed

    Calliess, Tilman; Bartsch, Ivonne; Haupt, Maike; Reebmann, Mattias; Schwarze, Michael; Stiesch, Meike; Pfaffenroth, Cornelia; Sluszniak, Magda; Dempwolf, Wibke; Menzel, Henning; Witte, Frank; Willbold, Elmar

    2016-04-01

    We coated transcutaneous implants made of titanium alloy Ti6Al4V with copolymer dimethyl (2-methacryloyloxy-ethyl) phosphonate and 4-vinylpyridine and investigated the tissue reaction with respect to its biocompatible and antimicrobial properties in vivo. We distinguished between clinically observable superficial inflammations and histologically detectable deep infections. The vinylpyridine moieties were transferred into cationic pyridinium groups by reaction with hexyl bromide. Thus polymers with both antimicrobial capacity and good biocompatibility were obtained. In a short-term study, we implanted specially designed bare or coated implants in hairless but immunocompetent mice and analyzed the tissue reaction histologically. No difference was found between bare and coated implants in the initial healing phase of up to 14 days; however, after 21 days the scar tissue formation was higher in the bare implant group. The degree of epithelial downgrowth was comparable in both groups at any time point. In a long-term study of up to 168 days, we analyzed resistance to infection. In the bare implant group, 7 of the 12 implantation sites became infected deep whereas in the coated implant group only two deep infections were observed. The other implantation sites showed only superficial signs of inflammation. These results generally accord with previous in-vitro studies.

  12. Acute and Subchronic Toxicity Study of Euphorbia hirta L. Methanol Extract in Rats

    PubMed Central

    Yuet Ping, Kwan; Darah, Ibrahim; Chen, Yeng; Sreeramanan, Subramaniam

    2013-01-01

    Despite Euphorbia hirta L. ethnomedicinal benefits, very few studies have described the potential toxicity. The aim of the present study was to evaluate the in vivo toxicity of methanolic extracts of E. hirta. The acute and subchronic oral toxicity of E. hirta was evaluated in Sprague Dawley rats. The extract at a single dose of 5000 mg/kg did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. Therefore, the LD 50 of this plant was estimated to be more than 5000 mg/kg. In the repeated dose 90-day oral toxicity study, the administration of 50 mg/kg, 250 mg/kg, and 1000 mg/kg/day of E. hirta extract per body weight revealed no significant difference (P > 0.05) in food and water consumptions, body weight change, haematological and biochemical parameters, relative organ weights, and gross findings compared to the control group. Macropathology and histopathology examinations of all organs including the liver did not reveal morphological alteration. Analyses of these results with the information of signs, behaviour, and health monitoring could lead to the conclusion that the long-term oral administration of E. hirta extract for 90 days does not cause sub-chronic toxicity. PMID:24386634

  13. Safety Evaluation of Zingiber cassumunar Roxb. Rhizome Extract: Acute and Chronic Toxicity Studies in Rats

    PubMed Central

    Koontongkaew, Sittichai; Poachanukoon, Orapan; Sireeratawong, Seewaboon; Dechatiwongse Na Ayudhya, Thaweephol; Khonsung, Parirat; Jaijoy, Kanjana; Soawakontha, Ruedee; Chanchai, Monraudee

    2014-01-01

    Zingiber cassumunar Roxb. has been used for traditional medicine, but few studies have described its potential toxicity. In this study, the acute and chronic oral toxicity of Z. cassumunar extract granules were evaluated in Sprague-Dawley rats. The extract at a single dose of 5000 mg/kg body weight did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. However, a decrease in body weights was observed in treated males (P < 0.05). The weights of lung and kidney of treated females were increased (P < 0.05). Treated males were increased in spleen and epididymis weights (P < 0.05). In repeated dose 270-day oral toxicity study, the administration of the extracts at concentrations of 0.3, 3, 30, 11.25, 112.5, and 1,125 mg/kg body weight/day revealed no-treatment toxicity. Although certain endpoints among those monitored (i.e., organ weight, hematological parameters, and clinical chemistry) exhibited statistically significant effects, none was adverse. Gross and histological observations revealed no toxicity. Our findings suggest that the Z. cassumunar extract granules are well tolerated for both single and chronic administration. The oral no-observed-adverse-effect level (NOAEL) for the extract was 1,125 mg/kg body weight/day for males and females. PMID:27379341

  14. Safety Evaluation of Zingiber cassumunar Roxb. Rhizome Extract: Acute and Chronic Toxicity Studies in Rats.

    PubMed

    Koontongkaew, Sittichai; Poachanukoon, Orapan; Sireeratawong, Seewaboon; Dechatiwongse Na Ayudhya, Thaweephol; Khonsung, Parirat; Jaijoy, Kanjana; Soawakontha, Ruedee; Chanchai, Monraudee

    2014-01-01

    Zingiber cassumunar Roxb. has been used for traditional medicine, but few studies have described its potential toxicity. In this study, the acute and chronic oral toxicity of Z. cassumunar extract granules were evaluated in Sprague-Dawley rats. The extract at a single dose of 5000 mg/kg body weight did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. However, a decrease in body weights was observed in treated males (P < 0.05). The weights of lung and kidney of treated females were increased (P < 0.05). Treated males were increased in spleen and epididymis weights (P < 0.05). In repeated dose 270-day oral toxicity study, the administration of the extracts at concentrations of 0.3, 3, 30, 11.25, 112.5, and 1,125 mg/kg body weight/day revealed no-treatment toxicity. Although certain endpoints among those monitored (i.e., organ weight, hematological parameters, and clinical chemistry) exhibited statistically significant effects, none was adverse. Gross and histological observations revealed no toxicity. Our findings suggest that the Z. cassumunar extract granules are well tolerated for both single and chronic administration. The oral no-observed-adverse-effect level (NOAEL) for the extract was 1,125 mg/kg body weight/day for males and females.

  15. Opioid Analgesia in Mechanically Ventilated Children: Results from the multicenter MOTIF study

    PubMed Central

    Anand, Kanwaljeet J. S.; Clark, Amy E.; Willson, Douglas F.; Berger, John; Meert, Kathleen L.; Zimmerman, Jerry J.; Harrison, Rick; Carcillo, Joseph A.; Newth, Christopher J. L.; Bisping, Stephanie; Holubkov, Richard; Dean, J. Michael; Nicholson, Carol E.

    2013-01-01

    Objective To examine the clinical factors associated with increased opioid dose among mechanically ventilated children in the Pediatric Intensive Care Unit (PICU). Design Prospective, observational study with 100% accrual of eligible patients. Setting Seven PICUs from tertiary-care children’s hospitals in the Collaborative Pediatric Critical Care Research Network. Patients 419 children treated with morphine or fentanyl infusions. Interventions None Measurements and Main Results Data on opioid use, concomitant therapy, demographic and explanatory variables were collected. Significant variability occurred in clinical practices, with up to 100-fold differences in baseline opioid doses, average daily or total doses, or peak infusion rates. Opioid exposure for 7 or 14 days required doubling of the daily opioid dose in 16% patients (95%CI: 12–19%) and 20% patients (95%CI: 16–24%) respectively. Among patients receiving opioids for longer than 3 days (n=225), this occurred in 28% (95%CI 22–33%) and 35% (95%CI 29–41%) by 7 or 14 days respectively. Doubling of the opioid dose was more likely to occur following opioid infusions for 7 days or longer (OR 7.9, 95%CI 4.3–14.3; p<0.001) or co-therapy with midazolam (OR 5.6, 95%CI 2.4–12.9; p<0.001), and it was less likely to occur if morphine was used as the primary opioid (vs. fentanyl) (OR 0.48, 95%CI 0.25–0.92; p=0.03), for patients receiving higher initial doses (OR 0.96, 95%CI 0.95–0.98; p<0.001), or if patients had prior PICU admissions (OR 0.37, 95%CI 0.15–0.89, p=0.03). Conclusions Mechanically ventilated children require increasing opioid doses, often associated with prolonged opioid exposure or the need for additional sedation. Efforts to reduce prolonged opioid exposure and clinical practice variation may prevent the complications of opioid therapy. PMID:23132396

  16. A Micropuncture Study of Potassium Excretion by the Remnant Kidney

    PubMed Central

    Bank, Norman; Aynedjian, Hagop S.

    1973-01-01

    In order to study the mechanism of enhanced potassium excretion by the remaining nephrons of the remnant kidney, micropuncture and clearance experiments were carried out in rats after surgical ablation of 3/4 of the total renal mass. The potassium intake in all animals was approximately 5 meq/day. Animals were studied 24 h and 10-14 days after 3/4 nephrectomy. Balance measurements in the chronic animals before micropuncture study indicated that 24 h K+ excretion by the remnant kidney was equal to that of the two kidneys before ablation of renal mass. Measurements of distal tubular inulin and potassium concentrations revealed progressive reabsorption of potassium in this segment of the nephron in both the 24-h and chronic 3/4-nephrectomized rats, as well as in normal control rats. A large increase in tubular fluid potassium content occurred between the end of the distal tubule and the final urine in the 3/4-nephrectomized rats, but not in the normal controls. These observations suggest that the segment of the nephron responsible for enhanced potassium excretion by remaining nephrons was the collecting duct. In additional experiments, potassium was completely eliminated from the diet of chronic 3/4-nephrectomized rats before micropuncture study. In these animals, no addition of K+ occurred beyond the distal tubules. Normal rats infused with 0.15 M KCl to acutely elevate serum K+ concentration, demonstrated reabsorption of K+ in the distal tubule and a large addition of K+ to the urine beyond the distal tubule. We conclude that the collecting duct is the major site of regulation of urinary potassium excretion in normal rats and is responsible for the adaptation to nephron loss by the remnant kidney. PMID:4703232

  17. Toxicological studies of aqueous extract of Acacia nilotica root

    PubMed Central

    Adesokan, Abdulfatai Ayoade; Salawu, Oluwakanyinsola Adeola; Akanji, Musbau Adewunmi

    2015-01-01

    Acacia nilotica is a widely used plant in traditional medical practice in Northern Nigeria and many African countries. The aim of this study was to determine the toxicological effects of a single dose (acute) and of repeated doses (sub-acute) administration of aqueous extract of A. nilotica root in rodents, following our earlier study on antiplasmodial activity. In the acute toxicity test, three groups of Swiss albino mice were orally administered aqueous extract of A. nilotica (50, 300 and 2000 mg/kg body weight) and signs of toxicity were observed daily for 14 days. In the sub-acute toxicity study, four groups of 12 rats (6 male and 6 female) were used. Group 1 received 10 ml/kg b.w distilled water (control), while groups 2, 3 and 4 received 125, 250 and 500 mg/kg b.w of the extract, respectively, for 28 consecutive days by oral gavage. Signs of toxicity/mortality, food and water intake and body weight changes were observed. Biochemical parameters were analysed in both plasma and liver homogenate. In the acute and sub-acute toxicity studies, the extract did not cause mortality. A significant reduction in the activity of lactate dehydrogenase was observed at 250 and 500 mg/kg b.w, while alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase activities were significantly higher than control values at 500 mg/kg b.w. The aqueous extract of A. nilotica was found to be safe in single dose administration in mice but repeated administration of doses higher than 250 mg/kg b.w of the extract for 28 days in rats may cause hepatotoxicity. PMID:27486360

  18. Phase I study of intravenous iododeoxyuridine as a clinical radiosensitizer

    SciTech Connect

    Kinsella, T.J.; Russo, A.; Mitchell, J.B.; Collins, J.M.; Rowland, J.; Wright, D.; Glatstein, E.

    1985-11-01

    Twenty-four patients with locally advanced (19 patients) or metastatic (5 patients) tumors were treated in a Phase I study combining constant intravenous infusions of iododeoxyuridine (IUdR) and hyperfractionated radiation therapy. IUdR was given as a constant infusion for 12 hours/day for two separate 14-day infusion periods in most patients. The dose of IUdR was escalated from 250 to 1200 mg/m2/12-hour infusion in this study. The initial tumor volume was treated to 45 Gy/1.5 Gy BID/3 weeks followed by a cone-down boost to 20-25 Gy/1.25 Gy BID/2 weeks after a planned 2-week break. THe IUdR infusion preceded the initial and cone-down irradiation by 1 week. Local acute toxicity (within the radiation volume) was uncommon and few patients required an alteration of the planned treatment schedule. Two patients developed late local toxicity with one patient showing clinical signs of radiation hepatitis and another patient developing a large bowel obstruction that required surgical bypass. Dose-limiting systemic toxicity was confined to the bone marrow with moderate to severe thrombocytopenia developing on Day 10-14 of infusions at 1200 mg/m2/12 hours. Mild stomatitis and partial alopecia occurred in some patients at this dose level. No systemic skin toxicity was seen. Pharmacology studies revealed steady-state arterial plasma levels of IUdR of 1 to 8 X 10(-6) M over the dose range used. In vivo IUdR incorporation into tumors was studied in three patients with high-grade sarcomas using an anti-IUdR monoclonal antibody and immunohistochemistry and demonstrated incorporation in up to 50-70% of tumor cells. The preliminary treatment results, particularly in patients with unresectable sarcomas, are encouraging.

  19. Hemodynamic monitoring of large animal chronic studies after median sternotomy: experiences with different telemetric physiological devices.

    PubMed

    Fujii, Yasuhiro; Pitsillides, Koullis; Ferro, Giuseppe; Kagawa, Hiroshi; Centola, Luca; Kinouchi, Katsushi; Zhu, Liqun; Ferrier, William T; Talken, Linda; Nasirov, Teimour; Riemer, R Kirk; Reinhartz, Olaf

    2015-01-01

    Telemetric physiological monitoring systems (TPMS) have enabled accurate continuous measurement of animal blood pressures and flows. However, few studies describe approaches for use of TPMS in the great vessels or inside the heart. We describe our initial experiences using two types of TPMSs. Twelve lambs (20-37 kg) underwent sternotomy. Two lambs were not instrumented and were killed at 14 days to confirm normal sternal wound healing (sham group, n = 2). Ten lambs underwent placement of either standard indwelling pressure-monitoring catheter and perivascular-flow-probe (CFP group, n = 3) or TPMS implantation (TPMS group, n = 7). The TPMS used were EG1-V3S2T-M2 (EG1, n = 5; Transonic Endogear Inc.) and Physio Tel Digital L21 (PTD, n = 2; Data Sciences Inc.). Two deaths because of respiratory problems occurred in TPMS group, attributed to lung compression by the implanted device. In TPMS group, more consistent trends of blood pressures and flows were recorded, and management of animals was easier and less labor-intensive. Comparing the two TPMSs, the initiation and renewal costs for each case was $28 K vs. $20 K and $1,700 vs. $0, (PTD versus EG1, respectively). In conclusion, TPMS implantation was feasible via median sternotomy in lambs. Telemetric physiological monitoring systems significantly improve reliability of hemodynamic monitoring in chronic survival animal study. EG1 was less costly than PTD.

  20. Bupropion Reduces Some of the Symptoms of Marihuana Withdrawal in Chronic Marihuana Users: A Pilot Study

    PubMed Central

    Penetar, David M.; Looby, Alison R.; Ryan, Elizabeth T.; Maywalt, Melissa A.; Lukas, Scott E.

    2012-01-01

    Bupropion’s (Zyban® SR) effectiveness to treat symptoms experienced in marihuana withdrawal was tested in a double-blind, placebo-controlled study with chronic, heavy marihuana users. Participants maintained their usual marihuana intake until Quit Day after which they were required to cease intake of THC products for 14 days. A Withdrawal Discomfort Score revealed that for 7 days immediately following cessation, placebo-treated subjects reported more symptoms than bupropion-treated subjects. Self-reported craving for marihuana increased for the placebo-treated group but not for those treated with bupropion. Measures of sleep and cognitive performance were not different between the two groups. Participants in the bupropion treatment arm were more likely to complete the study than those randomized to the placebo arm (50% completion for bupropion vs. 33% completion for placebo). These results suggest that bupropion may be useful for alleviating marihuana withdrawal symptoms and be useful in subject retention during long-term cessation programs. PMID:22879754

  1. Comparative study on the effect of Eurycoma longifolia and Smilax myosotiflora on male rats fertility

    NASA Astrophysics Data System (ADS)

    Mahmoud, Amal Salem Farag; Noor, Mahanem Mat

    2013-11-01

    The effects of Eurycoma longifolia Jack and Smilax myosotiflora were studied on sperm quality include sperm count, motility, viability and histology of the testis and pregnancy rate after mating with fertile proved females, as well as litter size on Sprague-Dawley (S-D) adult male rats. After dosing them with distilled water group A, group B 150 mg/kg body weight of aqueous extract of E. longifolia roots, group C 150 mg/kg body weight aqueous extract of S. myosotiflora leaf and group D 150 mg/kg body weight of E. longifolia combined with 150 mg/kg S. myosotiflora body weight daily for 14 days of stage (a) and 28 days for stage (b) of treatments. Results exhibited no significant variation (P>0.05) of stage (a),while results showed that E. longifolia Jack increase (P<0.05) the sperm count, motility, viability and histology of the testis and gender (male) of the litter size respectively of stage (b). This study provides evidence that E. longifolia Jack is a potent stimulator of fertility in male rat.

  2. Phytochemical Screening and Acute Oral Toxicity Study of Java Tea Leaf Extracts

    PubMed Central

    Safinar Ismail, Intan; Azam, Amalina Ahmad; Abas, Faridah; Shaari, Khozirah; Sulaiman, Mohd Roslan

    2015-01-01

    The term Java tea refers to the decoction of Orthosiphon stamineus (OS) Benth (Lamiaceae) leaves, which are widely consumed by the people in Europe and South East Asian countries. The OS leaves are known for their use in traditional medicinal systems as a prophylactic and curative agent for urinary stone, diabetes, and hypertension and also as a diuretic agent. The present study was aimed at evaluating its possible toxicity. Herein, the major phytochemical constituents of microwave dried OS leaf, which is the common drying process for tea sachets in the market, were also identified. The acute oral toxicity test of aqueous, 50% aqueous ethanolic, and ethanolic extracts of OS was performed at a dose of 5000 mg/Kg body weight of Sprague-Dawley rats. During the 14-day study, the animals were observed for any mortality, behavioral, motor-neuronal abnormalities, body weight, and feed-water consumption pattern. The hematological and serum biochemical parameters to assess the kidney and liver functions were carried out, along with the histological analysis of these organs. It was found that all microwave dried OS leaf extracts did not cause any toxic effects or mortality at the administered dose. No abnormality was noticed in all selected parameters in rats of both sexes as compared with their respective control groups. Thus, the possible oral lethal dose for microwave dried Java tea leaves is more than 5000 mg/Kg body weight. PMID:26819955

  3. Study of influence on harvesting point in Brazilian Tommy Atkins mangoes submitted to gamma radiation

    NASA Astrophysics Data System (ADS)

    Sabato, S. F.; Cruz, J. N.; Rela, P. R.; Broisler, P. O.

    2009-07-01

    Brazil is a great producer of tropical fruits including mangoes. Among several purposes gamma radiation can be applied as phytosanitary treatment. This is well studied in scientific papers and more recently demonstrated through commercial advances like bilateral protocols established between India and USA. The whole experiment evolved two parts where each of them used fruits from different maturity stages (stages 2 and 3). This experiment was carried out with around 300 fruits in each part of the study. The main objective was to get the experience close to commercial conditions. The irradiation was realized in Multipurpose Cobalt-60 source belonging to IPEN-CNEN/SP (developed in house by own technology). The absorbed doses were 0.2, 0.5 and 0.75 kGy. After irradiation all fruits were kept at 12 °C in acclimatized chamber during 14 days. After this period the fruits were brought to environmental conditions (25 °C) for around 14 more days of duration. These conditions were established to simulate the exportation conditions from Brazil to distant countries. Physical-chemical analysis (pH, titrable acidity, total soluble solids (°Brix) and texture) as well as visual observation (mass loss, rotting, internal and skin color) were evaluated. The results from this experiment could demonstrate that the characteristics of the mangoes are more dependent on time and temperature storage rather than irradiation.

  4. Contrasting Regulatory Focus and Reinforcement Sensitivity: A Daily Diary Study of Goal Pursuit and Emotion.

    PubMed

    Eddington, Kari M; Majestic, Catherine; Silvia, Paul J

    2012-08-01

    This study examined the moderating effects of motivational orientation on daily affect and goal pursuit. Based on recent revisions to Reinforcement Sensitivity Theory, measures of BIS (BIS-r and Fight-Flight-Freeze System or FFFS), BAS, and regulatory focus (Promotion and Prevention) were administered to 84 college students who participated in a 14-day diary study. Diary items assessed goal-directed activities and positive and negative affect (PA and NA). Results showed that higher FFFS and Promotion were consistently associated with higher NA and PA, respectively, and FFFS was also associated with avoidance of responsibilities. Higher Promotion predicted greater daily goal progress and tendencies to rate goals as more promotion- and prevention-focused. Relationships between daily goal-directed activities and both sadness and satisfaction were moderated by BIS-r. Inconsistent with our hypothesis, low BAS Reward Responsiveness predicted increased enthusiasm with greater goal progress. A trend in the data showed evidence of regulatory fit in daily activities predicted by both Promotion and Prevention. Implications for the theoretical and practical distinctions between measures of motivational orientation are discussed.

  5. Toxicity studies of the water extract from the calyces of Hibiscus sabdariffa L. in rats.

    PubMed

    Sireeratawong, Seewaboon; Itharat, Arunporn; Khonsung, Parirat; Lertprasertsuke, Nirush; Jaijoy, Kanjana

    2013-01-01

    Acute and chronic toxicities of the water extract from calyces of Hibiscus sabdariffa were studied in male and female rats. After 14 days of a single oral administration of test substance 5,000 mg/kg body weight, measurement of the body and organ weights, necropsy and health monitoring were performed. No signs and differences of the weights or behaviour compared to the control rats were observed. The results indicated that the single oral administration of H. sabdariffa extract in the amount of 5,000 mg/kg body weight does not produce acute toxicity. The chronic toxicity was determined by oral feeding both male and female rats daily with the extract at the doses of 50, 100, and 200 mg/kg body weight for 270 days. The examinations of signs, animal behaviour and health monitoring showed no defects in the test groups compared to the control groups. Both test and control groups (day 270th) and satellite group (day 298th) were analysed by measuring their final body and organ weights, taking necropsy, and examining haematology, blood clinical chemistry, and microanatomy. Results showed no differences from the control groups. Overall, our study demonstrated that an oral administration of H. sabdariffa extract at the doses of 50, 100 and 200 mg/kg body weight for 270 days does not cause chronic toxicity in rat.

  6. Effect of opium dependency on secondary intention wound healing in a rat model: an experimental study.

    PubMed

    Vahedian, Jalal; Mirshekari, Tooraj-Reza; Nabavizadeh, Fatemeh

    2013-06-01

    Opium dependency is a social and health problem in some middle eastern countries like Iran. Many of these people may require surgery. This study investigates the effects of opium dependency on histological parameters of secondary intention wound healing in rat. A full-thickness wound (2 × 2 cm in diameters) was created on the dorsum of two groups of rats, a normal control group and a second group of rat depended to opium (Badawy's method). Several times during 14 days postwounding, the wound was excised with peripheral margins of normal skin and was evaluated for cellular population, reepithelialisation and revascularisation. Results are presented as the mean ± standard error. Data were compared by an unpaired t-test or analysis of variance. Histological examination of the wound tissue showed evidence of increased population of fibroblasts, decreased recruitment of neutrophile and plateau of macrophage cells in opium depended animals comparing with control group. In the depended animals, reepithelialisation was seen to be enhanced significantly, while prohibiting progression of revascularisation. This study shows that opium dependency enhances reepitheliazation as well as tissue recruitment of fibroblasts; thereby probable enhancement of secondary intention wound healing.

  7. A daily diary study of perceived social isolation, dietary restraint, and negative affect in binge eating.

    PubMed

    Mason, Tyler B; Heron, Kristin E; Braitman, Abby L; Lewis, Robin J

    2016-02-01

    Negative affect and dietary restraint are key predictors of binge eating, yet less is known about the impact of social factors on binge eating. The study sought to replicate and extend research on the relationships between negative affect, dietary restraint, perceived social isolation and binge eating using a daily diary methodology. College women (N = 54) completed measures of dietary restraint, negative affect, perceived social isolation, and binge eating daily for 14 days. Participants completed the measures nightly each day. A series of generalized estimating equations showed that dietary restraint was associated with less binge eating while controlling for negative affect and for perceived social isolation separately. Negative affect and perceived social isolation were associated with greater binge eating while controlling for restraint in separate analyses, but only perceived social isolation was significant when modeled simultaneously. All two-way interactions between negative affect, dietary restraint, and perceived social isolation predicting binge eating were nonsignificant. This study furthers our understanding of predictors of binge eating in a nonclinical sample. Specifically, these data suggest perceived social isolation, negative affect, and dietary restraint are important variables associated with binge eating in daily life and warrant further research.

  8. Acute Toxicity Study of Zerumbone-Loaded Nanostructured Lipid Carrier on BALB/c Mice Model

    PubMed Central

    Rahman, Heshu Sulaiman; Rasedee, Abdullah; Othman, Hemn Hassan; Chartrand, Max Stanley; Namvar, Farideh; Abdul Samad, Nozlena; Andas, Reena Joys; Ng, Kuan Beng; How, Chee Wun

    2014-01-01

    Zerumbone- (ZER-) loaded nanostructure lipid carrier (NLC) (ZER-NLC) prepared for its antileukemia effect in vitro was evaluated for its toxicological effects by observing changes in the liver, kidney, spleen, lung, heart, and brain tissues, serum biochemical parameters, total haemogram, and bone marrow stem cells. The acute toxicity study for ZER-NLC was conducted by orally treating BALB/c mice with a single dose with either water, olive oil, ZER, NLC, or ZER-NLC for 14 days. The animals were observed for clinical and behavioral abnormalities, toxicological symptoms, feed consumption, and gross appearance. The liver, kidney, heart, lung, spleen, and brain tissues were assessed histologically. Total haemogram was counted by hemocytometry and microhematocrit reader. Bone marrow examination in terms of cellular morphology was done by Wright staining with bone marrow smear. Furthermore, serum biochemical parameters were determined spectrophotometrically. Grossly all treated mice, their investigated tissues, serum biochemical parameters, total haemogram, and bone marrow were normal. At oral doses of 100 and 200 mg/kg ZER-NLC there was no sign of toxicity or mortality in BALB/c mice. This study suggests that the 50% lethal dose (LD50) of ZER-NLC is higher than 200 mg/kg, thus, safe by oral administration. PMID:25276798

  9. Effects of Medical Resonance Therapy Music on patients with psoriasis and neurodermatitis--a pilot study.

    PubMed

    Lazaroff, I; Shimshoni, R

    2000-01-01

    Stress medicine has shown that emotional disharmony can be a substantial factor for skin diseases. The harmonisation of the emotional status and a corresponding reduction of stress hormones by the Medical Resonance Therapy Music (MRT-Music) as shown in other studies (1,2,3,4) inspired us to investigate its benefits for patients with psoriasis vulgaris and neurodermatitis (neurodermatitis constitutionalis atopica). Over a period of 14 days we measured the parameters of blood pressure, heart rate, stimulus to scratch and the degree of sickness in two, respectively four groups of 68 patients in total: two experimental groups (psoriasis/neurodermatitis) and two control groups. All patients received the normal treatment of our hospital, the experimental groups were additionally treated with 3 x 30 minutes of MRT-Music per day, while the controls were asked to somehow relax during this time. In the experimental groups the measurements showed a reduction of blood pressure and heart rate and revealed an enhanced reduction of the stimulus to scratch and an enhanced reduction in the degree of sickness. Interestingly the effects of MRT-Music were stronger with the psoriasis patients than with the neurodermatitis patients. The results of this pilot study convinced us to offer the treatment with the Medical Resonance Therapy Music to all our patients.

  10. Therapeutic efficacy of artemether-lumefantrine for Plasmodium vivax infections in a prospective study in Guyana

    PubMed Central

    2012-01-01

    Background In Guyana, chloroquine + primaquine is used for the treatment of vivax malaria. A worldwide increase of chloroquine resistance in Plasmodium vivax led to questioning of the current malaria treatment guidelines. A therapeutic efficacy study was conducted using artemether-lumefantrine + primaquine against P. vivax to evaluate a treatment alternative for chloroquine. Methods From 2009 to 2010, a non-controlled study in two hospitals in Guyana was conducted. A total 61 patients with P. vivax infection were treated with artemether-lumefantrine as a six-dose regimen twice a day for three days with additional 0.25 mg/kg/d primaquine at day 0 for 14 days. Clinical and parasitological parameters were followed on days 0,1,2,3,7,14 and 28 in agreement with WHO guidelines. Plasmodium vivax DNA from eight patients was analysed for pvmdr1, molecular marker of resistance. Results Artemether-lumefantrine cleared 100% of parasites on day 1, but two patients (3%) had recurrence of parasites on day 28, suggesting relapse. No pvmdr1 Y976F polymorphism was detected. The treatment regimen was well tolerated. Conclusions In Guyana, artemether-lumefantrine represents an adequate treatment option against P. vivax when combined with primaquine. Availability of this alternative will be of great importance in case of emerging chloroquine resistance against P. vivax. PMID:23083017

  11. (1)H nuclear magnetic resonance-based metabolomics study of earthworm Perionyx excavatus in vermifiltration process.

    PubMed

    Wang, Lei; Huang, Xulei; Laserna, Anna Karen Carrasco; Li, Sam Fong Yau

    2016-10-01

    In this study, (1)H nuclear magnetic resonance (NMR)-based metabolomics approach was used to characterize the metabolic response of the earthworm Perionyx excavatus in continuous vermifiltration for two months under hydraulic loading rates of 1m(3)m(-2)d(-1) (VF1) and 1.5m(3)m(-2)d(-1) (VF1.5). Both VF1 and VF1.5 showed higher removal of chemical oxygen demand and total nitrogen than the biofilter without earthworms. Principal component analysis of the NMR spectra of earthworm metabolites showed significant separations between those not subjected to wastewater filtration (control) and VF1 or VF1.5. Temporal variations of earthworm biomass, and the identified metabolites that are significantly different between control, VF1 and VF1.5 revealed that worms underwent increasing metabolic activity within 20days in VF1 and 14days in VF1.5, then decreasing metabolic activity. The use of NMR-based metabolomics in monitoring earthworm metabolism was demonstrated to be a novel approach in studying engineered vermifiltration systems.

  12. Carbamazepine pharmacokinetics are not affected by zonisamide: in vitro mechanistic study and in vivo clinical study in epileptic patients.

    PubMed

    Ragueneau-Majlessi, Isabelle; Levy, Rene H; Bergen, Donna; Garnett, William; Rosenfeld, William; Mather, Gary; Shah, Jaymin; Grundy, John S

    2004-11-01

    Carbamazepine is metabolized by CYP3A4 and several other cytochrome P450 enzymes. The potential effects of zonisamide on carbamazepine pharmacokinetics (PK) have not been well characterized, with contradictory literature reports. Hence, an in vitro study was designed to evaluate the cytochrome P450 inhibition spectrum of zonisamide using human liver microsomes. Further, an in vivo steady-state study was performed to measure the effect of zonisamide on carbamazepine PK in epileptic patients, and monitor zonisamide PK. In vitro human liver microsomes were incubated with zonisamide (200, 600 or 1000 microM) in the presence of appropriate probe substrates to assess selected cytochrome P450 activities. In vivo, the effect of zonisamide, up to 400 mg/day, on the steady-state PK of carbamazepine and carbamazepine-epoxide (CBZ-E) was studied in 18 epileptic patients. In vitro, zonisamide did not inhibit CYP1A2 and 2D6, and only weakly inhibited CYP2A6, 2C9, 2C19, and 2E1. The estimated Ki for zonisamide inhibition of CYP3A4 was 1076 microM, 12 times higher than typical unbound therapeutic serum zonisamide concentrations. In vivo, no statistically significant differences were observed for mean Cmax, Tmax, and AUC0-12 of total and free carbamazepine and CBZ-E measured before and after zonisamide administration (300-400 mg/day for 14 days). However, CBZ-E renal clearance was significantly (p < 0.05) reduced by zonisamide. The observed mean zonisamide t1/2 (36.3h), relative to approximately 65 h reported in subjects on zonisamide monotherapy, reflects known CYP3A4 induction by carbamazepine. Based on the lack of clinically relevant in vitro and in vivo effects, adjustment of carbamazepine dosing should not be required with concomitant zonisamide administration.

  13. Neuroendocrine studies with fluvoxamine

    PubMed Central

    Cella, S.; Pen̄alva, A.; Locatelli, V.; Novelli, A.; Cocchi, D.; Müller, E. E.

    1983-01-01

    1 Administration of the potent 5-hydroxytryptamine (5-HT) re-uptake inhibitor fluvoxamine (25 mg/kg i.p. for 14 days) to adult cycling female rats did not alter either the number of oestrous episodes or the plasma concentrations of luteinizing hormone determined on days 2, 9 and 14 of treatment. 2 Fluvoxamine (25 mg/kg i.p.) induced in male rats a clear-cut lowering of β-endorphin-like immunoreactivity from the anterior pituitary, but not the neurointermediate lobe, and increased concomitantly plasma levels of β-endorphin and β-lipotropin. 3 Fluvoxamine (12.5 and 25 mg/kg i.p.) stimulated, although not strikingly, prolactin (PRL) secretion in adult male rats, and at 25 mg/kg i.p. potentiated the PRL-releasing effect of 5-hydroxytryptophan (30 mg/kg i.p.). 4 In male rats treated daily with fluvoxamine (25 mg/kg i.p.) the PRL-releasing effect of an additional acute fluvoxamine administration (same dose) was abolished after 4 days maintenance treatment. One week after withdrawal of maintenance, which had been given for 14 days, the challenge dose of fluvoxamine was still unable to raise plasma PRL levels. 5 The endocrine effects of acute fluvoxamine administration are compatible with activation of 5-HT neurotransmission in the central nervous system. The mechanism(s) underlying tolerance to the PRL-releasing action of the drug is presently obscure. Its elucidation should provide insight into the mechanism of action of antidepressant drugs affecting 5-HT function. PMID:6134546

  14. Analysis of different device-based intrathoracic impedance vectors for detection of heart failure events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring study).

    PubMed

    Heist, E Kevin; Herre, John M; Binkley, Philip F; Van Bakel, Adrian B; Porterfield, James G; Porterfield, Linda M; Qu, Fujian; Turkel, Melanie; Pavri, Behzad B

    2014-10-15

    Detect Fluid Early from Intrathoracic Impedance Monitoring (DEFEAT-PE) is a prospective, multicenter study of multiple intrathoracic impedance vectors to detect pulmonary congestion (PC) events. Changes in intrathoracic impedance between the right ventricular (RV) coil and device can (RVcoil→Can) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds) are used clinically for the detection of PC events, but other impedance vectors and algorithms have not been studied prospectively. An initial 75-patient study was used to derive optimal impedance vectors to detect PC events, with 2 vector combinations selected for prospective analysis in DEFEAT-PE (ICD vectors: RVring→Can + RVcoil→Can, detection threshold 13 days; CRT-D vectors: left ventricular ring→Can + RVcoil→Can, detection threshold 14 days). Impedance changes were considered true positive if detected <30 days before an adjudicated PC event. One hundred sixty-two patients were enrolled (80 with ICDs and 82 with CRT-Ds), all with ≥1 previous PC event. One hundred forty-four patients provided study data, with 214 patient-years of follow-up and 139 PC events. Sensitivity for PC events of the prespecified algorithms was as follows: ICD: sensitivity 32.3%, false-positive rate 1.28 per patient-year; CRT-D: sensitivity 32.4%, false-positive rate 1.66 per patient-year. An alternative algorithm, ultimately approved by the US Food and Drug Administration (RVring→Can + RVcoil→Can, detection threshold 14 days), resulted in (for all patients) sensitivity of 21.6% and a false-positive rate of 0.9 per patient-year. The CRT-D thoracic impedance vector algorithm selected in the derivation study was not superior to the ICD algorithm RVring→Can + RVcoil→Can when studied prospectively. In conclusion, to achieve an acceptably low false-positive rate, the intrathoracic impedance algorithms studied in DEFEAT-PE resulted in low sensitivity for the prediction of heart

  15. Gut hormone release and appetite regulation in healthy non-obese participants following oligofructose intake. A dose-escalation study.

    PubMed

    Pedersen, Camilla; Lefevre, Solenne; Peters, Véronique; Patterson, Michael; Ghatei, Mohammad A; Morgan, Linda M; Frost, Gary S

    2013-07-01

    Prevention of weight gain in adults is a major public health target. Animal experiments have consistently demonstrated a relationship between fermentable carbohydrate intake, such as oligofructose, anorectic gut hormones, and appetite suppression and body weight control. This study was designed to determine the dose of oligofructose which would augment the release of anorectic gut hormones and reduce appetite consistently in non-obese humans. Twelve non-obese participants were recruited for a 5-week dose-escalation study. Following a 9-14-day run-in, participants increased their daily oligofructose intake every week from 15, 25, 35, 45, to 55 g daily. Subjective appetite and side effects were monitored daily. Three-day food diaries were completed every week. Appetite study sessions explored the acute effects of 0, 15, 35, and 55 g oligofructose on appetite-related hormones, glycaemia, subjective appetite, and energy intake. In the home environment, oligofructose suppressed hunger, but did not affect energy intake. Oligofructose dose-dependently increased peptide YY, decreased pancreatic polypeptide and tended to decrease ghrelin, but did not significantly affect appetite profile, energy intake, glucose, insulin, or glucagon-like peptide 1 concentrations during appetite study sessions. In conclusion, oligofructose supplementation at ≥ 35 g/day increased peptide YY and suppressed pancreatic polypeptide and hunger; however, energy intake did not change significantly.

  16. Genotoxicity, acute and subchronic toxicity studies in rats of a rooster comb extract rich in sodium hyaluronate.

    PubMed

    Canut, Lourdes; Zapatero, Jorge; López, Sílvia; Torrent, Anna; Ruhí, Ramon; Vicente, Laura

    2012-04-01

    The toxicity of a rooster comb extract (IB0004) that contains mainly sodium hyaluronate was assessed in acute and subchronic studies and in a bacterial reverse mutation assay. In a single dose acute study, male and female rats were administered 2000 mg/kg body weight (bw) of the product and observed for 14 days. No mortality was recorded, thus it was considered that the minimum lethal dose for rats by oral route was greater than 2000 mg/kg bw. A 90-day subchronic study (5, 55 and 600 mg/kg bw/day, oral gavage) with 50 male and 50 female Wistar-Hannover rats produced no significant adverse effects on food consumption, body weight, mortality, clinical biochemistry, hematology, gross pathology, and histopathology. Although some differences were observed between the treated and control animals in body weight gain (%) and some hematological parameters, these changes were generally minor in nature and, are considered to be of no toxicological significance. The no-observable-adverse-effects level was established at 600 mg/kg bw/day. There was no evidence of mutagenic activity in Salmonella typhimurium TA98, TA100, TA1535 and TA1537 or in Escherichia coli WP2 uvra pkM101. In conclusion, the results from these safety studies support the safety of rooster comb extract IB0004 in food.

  17. Biomarker detection of rhGH doping: an excretion study.

    PubMed

    Jing, Jing; Zhou, Xinmiao; He, Chunji; Zhang, Lisi; Yang, Sheng; Xu, Youxuan; Xie, Minhao; Yan, Yi; Su, Hao; Wu, Moutian

    2012-10-01

    The purpose of this research is to validate the biomarker-based approach for the detection of doping with recombinant human growth hormone (rhGH) in sport. The GH-2000 project proposed an indirect method for the detection of exogenously administered growth hormone (GH) based on the measurement of the GH-dependent markers: insulin-like growth factor-I (IGF-I) and Type III pro-collagen (P-III-P). These markers rise in a dose-dependent manner after GH application. In this study, the concentrations of IGF-I, IGF-BP3, and P-III-P in serum were determined to provide further incentives for the implementation of this detection assay in modern anti-doping programmes. This paper reports on an administration study of rhGH involving 25 Chinese male volunteers at a dose of 0.1 IU /kg/day for a continuous 14-day period. We observed that the serum IGF-I concentration increased rapidly in the rhGH treatment group and showed significantly higher levels compared to baseline between days 4 and day 16 after administration. Although the response of P-III-P to rhGH administration was delayed compared to the IGF-I axis, the P-III-P concentration remained increased for a longer period (from day 4 to day 28). Statistical analysis was carried out to establish a discriminant formula with Statistical Product and Service Solutions (SPSS) concluding that the biomarker methodology is valid and universally applicable.

  18. Sleep Restriction Impairs Vocabulary Learning when Adolescents Cram for Exams: The Need for Sleep Study

    PubMed Central

    Huang, Sha; Deshpande, Aadya; Yeo, Sing-Chen; Lo, June C.; Chee, Michael W.L.; Gooley, Joshua J.

    2016-01-01

    Study Objectives: The ability to recall facts is improved when learning takes place at spaced intervals, or when sleep follows shortly after learning. However, many students cram for exams and trade sleep for other activities. The aim of this study was to examine the interaction of study spacing and time in bed (TIB) for sleep on vocabulary learning in adolescents. Methods: In the Need for Sleep Study, which used a parallel-group design, 56 adolescents aged 15–19 years were randomly assigned to a week of either 5 h or 9 h of TIB for sleep each night as part of a 14-day protocol conducted at a boarding school. During the sleep manipulation period, participants studied 40 Graduate Record Examination (GRE)-type English words using digital flashcards. Word pairs were presented over 4 consecutive days (spaced items), or all at once during single study sessions (massed items), with total study time kept constant across conditions. Recall performance was examined 0 h, 24 h, and 120 h after all items were studied. Results: For all retention intervals examined, recall of massed items was impaired by a greater amount in adolescents exposed to sleep restriction. In contrast, cued recall performance on spaced items was similar between sleep groups. Conclusions: Spaced learning conferred strong protection against the effects of sleep restriction on recall performance, whereas students who had insufficient sleep were more likely to forget items studied over short time intervals. These findings in adolescents demonstrate the importance of combining good study habits and good sleep habits to optimize learning outcomes. Citation: Huang S, Deshpande A, Yeo SC, Lo JC, Chee MW, Gooley JJ. Sleep restriction impairs vocabulary learning when adolescents cram for exams: the Need for Sleep Study. SLEEP 2016;39(9):1681–1690. PMID:27253768

  19. Toxicity studies on Agents GB and GD (Phase 2): 90-day subchronic study of GB (Sarin, Type I) in CD rats. Final report, Jul 85-Aug 91

    SciTech Connect

    Bucci, T.J.; Parker, R.M.; Crowell, J.A.; Thurman, J.D.; Gosnell, P.A.

    1991-08-01

    A two-phase Dose Range finding study and a 90-Day Subchronic study were conducted in CD rats using the organophosphate ester Sarin (Agent GB, Type I, CAS Number 107-44-8). The highest dose level without lethality in the second phase of the range finding study was designated the maximum tolerated dose (MTD). The doses selected for the subchronic study were the MTD (300 micron GBI/Kg/day), MTD/2 (150, micron GBI/Kg/day), MTD/4 (75 micron GBI/Kg/day), and a vehicle control (O micron /Kg/day). Forty-eight male and forty-eight female CD rats were randomly allocated at 11-12 weeks of age into four treatment groups (12 per sex per group). The animals were gavaged Monday through Friday for 13 weeks and euthanized with carbon dioxide at the beginning of the fourteenth week. Animals were observed daily for clinical signs of toxicity and were weighed weekly. The rats were bled (6 rats/sex/dose) during weeks -1, 1, 3, 7, and at necropsy. Necropsy examination was performed on all animals. Microscopic evaluation was performed on all high-dose and control animals, and on those tissues of lower dose animals that were abnormal at necropsy. All gross lesions and all animals dying or removed early received histological examination. A cause of death or morbidity for animals removed before the end of the study, determined from histopathological examination, was established in four of the eight cases. There were several statistically significant effects in the clinical chemistry and hematology data. These effects were scattered among the treatment groups and were not numerous enough to develop a pattern of organ toxicity.

  20. In vivo studies of low level laser (light) therapy for traumatic brain injury

    NASA Astrophysics Data System (ADS)

    Xuan, Weijun; Wu, Qiuhe; Huang, Ying-Ying; Ando, Takahiro; Huang, Liyi; Hamblin, Michael R.

    2012-03-01

    Low-level laser (or light) therapy (LLLT) is attracting growing interest to treat both stroke and traumatic brain injury (TBI). The fact that near-infrared light can penetrate into the brain allows non-invasive treatment to be carried out with a low likelihood of treatment-related adverse events. It is proposed that red and NIR light is absorbed by chromophores in the mitochondria of cells leading to changes in gene transcription and upregulation of proteins involved in cell survival, antioxidant production, collagen synthesis, reduction of chronic inflammation and cell migration and proliferation. We developed a mouse model of controlled cortical impact (CCI) TBI and examined the effect of 0, 1, 3, and 14 daily 810-nm CW laser treatments in the CCI model as measured by neurological severity score and wire grip and motion test. 1 laser Tx gave a significant improvement while 3 laser Tx was even better. Surprisingly 14 laser Tx was no better than no treatment. Histological studies at necropsy suggested that the neurodegeneration was reduced at 14 days and that the cortical lesion was repaired by BrdU+ve neural progenitor (stem) cells at 28 days. Transcranial laser therapy is a promising treatment for acute (and chronic TBI) and the lack of side-effects and paucity of alternative treatments encourages early clinical trials.

  1. Decreased human circadian pacemaker influence after 100 days in space: a case study

    NASA Technical Reports Server (NTRS)

    Monk, T. H.; Kennedy, K. S.; Rose, L. R.; Linenger, J. M.

    2001-01-01

    OBJECTIVE: The objectives of this study were (1) to assess the circadian rhythms and sleep of a healthy, 42-year-old male astronaut experiencing microgravity (weightlessness) for nearly 5 months while living aboard Space Station Mir as it orbited Earth and (2) to determine the effects of prolonged space flight on the endogenous circadian pacemaker, as indicated by oral temperature and subjective alertness rhythms, and their ramifications for sleep, alertness, and performance. METHODS: For three 12- to 14-day blocks of time (spread throughout the mission), oral temperatures were taken and subjective alertness was self-rated five times per day. Sleep diaries and performance tests were also completed daily during each block. RESULTS: Examination of the subject's circadian alertness and oral temperature rhythms suggested that the endogenous circadian pacemaker seemed to function quite well up to 90 days in space. Thereafter (on days 110-122), the influence of the endogenous circadian pacemaker on oral temperature and subjective alertness circadian rhythms was considerably weakened, with consequent disruptions in sleep. CONCLUSIONS: Space missions lasting more than 3 months might result in diminished circadian pacemaker influence in astronauts, leading to eventual sleep problems.

  2. [Comparative study of cefaclor versus amoxicillin in urinary tract infections (author's transl)].

    PubMed

    Naber, K; Kaldewey, W

    1979-01-01

    In a comparative, prospective, open randomised clinical study, the efficacy and tolerance of cefaclor (3 x 500 mg) and amoxicillin (3 x 750 mg) in the treatment of urinary tract infection (UTI) were investigated and compared. A total of 110 patients (51 males and 59 females) age 10 to 83 years were treated for a period of five to 14 days (average 10 days). Fifty-nine of the patients had complicated, and 51 uncomplicated UTI. In all patients , organisms were cultured from the urine which were sensitive to both antibiotics in vitro. In each group there were three cases of mixed infection and 35 cases of Escherichia coli monoinfection. The distribution of pathogens in the other patients was likewise very similar. Better results, i.e. a reduction in the cell count to < 10(4)/ml immediately after completion of therapy, were obtained in patients treated with cefaclor. This is largely due to a statistically significantly higher rate of elimination in E. coli infections. The long-term results at follow-up examinations 14 to 60 days after completion of therapy in both groups with uncomplicated infections were, however, equally as good in about half the cases. In complicated infections therapy was successful overall in only about a quarter of the cases, better results being obtained in the amoxicillin group. It must be taken into account that among the patients treated, the groups with complicated UTI are difficult to compare, relapses primarily being determined by underlying disease. Both antibiotics were tolerated well.

  3. Antenatal anxiety disorder as a predictor of postnatal depression: a longitudinal study.

    PubMed

    Coelho, Helen F; Murray, Lynne; Royal-Lawson, Melanie; Cooper, Peter J

    2011-03-01

    Previous research has implicated high levels of antenatal anxiety as a predictor of postnatal depression, but there is a paucity of evidence on the relationship between the various forms of anxiety and postnatal depression. A longitudinal study of 246 mothers (56 with antenatal generalised anxiety disorder (GAD), 68 with antenatal generalised social phobia, 28 with both disorders in the antenatal period, and 94 with no antenatal GAD or social phobia) allowed us to explore whether antenatal social phobia and GAD predict high Edinburgh Postnatal Depression Scale (EPDS) scores (probable depression >12) at 10-14 days, 10-12 weeks, 10 months, 14 months, and 24 months postnatally. We found that, after accounting for the presence of other antenatal anxiety disorders, antenatal depression, maternal age at child's birth, socio-economic status and ethnicity in the models, antenatal GAD independently predicted depression at all time points after delivery. A less robust relationship was found for antenatal social phobia, which predicted postnatal depression at only 10 months after birth. One possibility consistent with our findings is that there may be differences in the timing of postnatal depression with different forms of antenatal anxiety disorders.

  4. Fabrication and feasibility study of an absorbable diacetyl chitin surgical suture for wound healing.

    PubMed

    Shao, Kai; Han, Baoqin; Gao, Jinning; Jiang, Zhiwen; Liu, Weizhi; Liu, Wanshun; Liang, Ye

    2016-01-01

    Diacetyl chitin (DAC) is an acidylated chitin obtained using acetic anhydride mixed perchloric acid system. By wet spinning and weaving technique, DAC has been successfully developed into a novel absorbable surgical suture. Thanks to the unique properties of chitins, the potential application of this novel monocomponent multifilament DAC suture may break the monopoly of synthetic polymer sutures in wound closure area. In this study, DAC was synthesized and characterized by multiple approaches including elemental analysis, Fourier transform infrared spectrometry (FTIR), and X-ray diffraction (XRD). In addition, we performed the feasibility assessment of DAC suture (USP 2-0) as absorbable suture for wound healing. Several lines of evidences suggested that DAC suture had comparable mechanical properties as synthetic polymer sutures. Moreover, DAC suture retained approximately 63% of the original strength at 14 days and completely absorbed in 42 days with no remarkable tissue reaction in vivo. Most important of all, DAC suture significantly promoted skin regeneration with faster tissue reconstruction and higher wound breaking strength on a linear incisional wound model. All these results demonstrated the potential use of DAC suture in short- or middle-term wound healing, such as epithelial and connective tissue.

  5. Use of gold mill tailings in making bricks: a feasibility study.

    PubMed

    Roy, Surendra; Adhikari, Govind R; Gupta, Rama N

    2007-10-01

    Mill tailings dumps at Kolar Gold Fields, Karnataka, are creating environmental problems. One of the solutions to these problems is to use the mill tailings for some useful purpose. This study examined the possibility of making bricks from the mill tailings with some additives in laboratory experiments. Samples of the mill tailings and the additives were analysed for particle size distribution, Atterberg limits and specific gravity. The plasticity index of the mill tailings being zero, they could not be used directly for making bricks. Therefore some additives that had plasticity or binding properties were mixed with the mill tailings. Ordinary Portland cement, black cotton soils and red soils were selected as additives. Each of the additives was mixed separately with the mill tailings in different proportions by weight and a large number of bricks were prepared using metallic moulds. The bricks were termed as cement-tailings bricks or soil-tailings bricks, depending on the additives used. The cement-tailings bricks were cured for different periods and their corresponding compressive strengths were determined. The bricks with 20% of cement and 14 days of curing were found to be suitable. The soil-tailings bricks were sun-dried and then fired in a furnace at different temperatures. The quality of bricks was assessed in terms of linear shrinkage, water absorption and compressive strength. The cost analysis revealed that cement-tailings bricks would be uneconomical whereas the soil-tailings bricks would be very economical.

  6. [Home parenteral nutrition in elderly patients with cancer: an observational prospective study].

    PubMed

    Seys, Patrick; Tadmouri, Abir; Senesse, Pierre; Radji, Abderraouf; Rotarski, Maciej; Balian, Axel; Culine, Stéphane; Dufour, Patrick; Chambrier, Cécile

    2014-03-01

    Malnutrition is a bad prognostic factor that reduces the quality of life (QoL) in patients with cancer. The objective was to assess the impact of home parenteral nutrition (HPN) on the QoL of elderly malnourished patients with cancer. This French prospective observational study included patients, aged 70 years or older, with cancer, for whom HPN was prescribed for at least 14 days. The patient, the physician and a family member or home caregiver had to fill in a questionnaire at inclusion and 28 days later. Included patients (n = 221) were mainly suffering from a digestive cancer. After HPN intake, improved weight was noticed in 68% and 14% of patients had reached the target weight. Improved global QoL was reported in 59% of patients. Physicians noticed a significant improvement for the same compounds. These results suggest a benefit of the HPN on the nutritional status and QoL in elderly patients with cancer. Further controlled randomised trials are needed to prove the benefit of HPN in the routine management of these patients.

  7. [The study of precedent subgingival flora colonization on four kinds of crown and bridge restorative materials].

    PubMed

    Gao, N; Zhao, Y; Xiao, X

    1998-02-01

    The purpose of this in vitro study was to investigate the effects of microbial colonization on different crown or fixed bridge-used restorative materials and discuss the standards for evaluating those materials microscopically. Four kinds of restorative materials such as SDA-II type medium alloy, ceramic-fused-to-metal material, heat cure composite resin for crown restoration, Plat castable ceramics and four species of precedent subgingival flora (A. viscosus, F. nucleterm, C. ochracea, S. sanguis) were used. The material specimen had been continuously anaerobic cultured with the experimental bacterial fluid for 3, 7 and 14 days respectively, then the OD values of the specimenwashing fluid which could stand for the biomass of colonized bacteria on the surfaces of materials were measured. The results indicated that the quantity of precedent subgingival flora colonization on the surfaces of different restorative materials varied among different species of bacteria, which might concern with the surface structure, composition, property of anticorrosion and antisoluability of those materials.

  8. Effects of ethylene dibromide on hydra oligactis: parent and offspring toxicity study

    SciTech Connect

    Wilson, B.A.; Adams, J.A.

    1988-04-01

    Ethylene Dibromide (EDB) has become increasingly prevalent in the environment due to its uses as soil, fruit, and grain fumigants, lead scavengers in petrol, and industrial solvent. Because of its increasing environmental prevalence and its proposed toxic effects of EDB on Hydras, parents (P1) which have been pre-exposed to an established sublethal concentration for 14 days. The effect of nonexposed offspring (F1/P2) taken from pre-exposed parents (P1) versus their untreated offspring (F2) will also be evaluated. This mortality study revealed that the LC50 of both parents and F1's shifted from 50 mg/L, to 106.25 mg/L and 118.75 mg/L respectively, which suggest that exposed Hydras possibly become more tolerant to EDB. In the F2 generation, after 48 and 72 hrs 10% mortality was observed in the 200 mg/L group, 30% at 250 mg/L and 20% at 300 mg/L which indicated that the resistance to EDB toxicity is inheritable. There is also a strong dose-response correlation between EDB concentration and mortality.

  9. A Pilot Chemical and Physical Stability Study of Extemporaneously Compounded Levetiracetam Intravenous Solution.

    PubMed

    Raphael, Chenzira D; Zhao, Fang; Hughes, Susan E; Juba, Katherine M

    2015-01-01

    Levetiracetam is a commonly used antiepileptic medication for tumor-related epilepsy. However, the 100 mL intravenous (IV) infusion volume can be burdensome to imminently dying hospice patients. A reduced infusion volume would improve patient tolerability. The purpose of this study was to evaluate the stability of 1000 mg/25 mL (40 mg/mL) levetiracetam IV solution in sodium chloride 0.9%. We prepared levetiracetam 40 mg/mL IV solution and added it to polyvinyl chloride (PVC) bags, polyolefin bags, and polypropylene syringes. Triplicate samples of each product were stored at refrigeration (2-8°C) and analyzed on days 0, 1, 4, 7, and 14. Samples were subjected to visual inspection, pH measurement, and stability-indicating high-performance liquid chromatography (HPLC) analysis. Over the 2-week storage period, there was no significant change in visual appearance or pH for any of the stability samples. The HPLC results confirmed that all stability samples retained 94.2-101.3% of initial drug concentration and no degradation products or leachable material from the packaging materials were observed. We conclude that levetiracetam 1000 mg/25 mL IV solution in sodium chloride 0.9% is physically and chemically stable for up to 14 days under refrigeration in polypropylene syringes, PVC bags, and polyolefin bags.

  10. Transient lingual papillitis: A retrospective study of 11 cases and review of the literature

    PubMed Central

    Tosios, Konstantinos I.; Nikitakis, Nikolaos G.; Kamperos, Georgios; Sklavounou, Alexandra

    2017-01-01

    Background Transient lingual papillitis (TLP) is a common, under-diagnosed, inflammatory hyperplasia of one or multiple fungiform lingual that has an acute onset, and is painful and transient in nature. Material and Methods Eleven cases of TLP were diagnosed based on their clinical features. Information on demographics, clinical characteristics, symptoms, individual or family history of similar lesions, medical history, management and follow-up were extracted from the patients’ records. The English literature was reviewed on TLP differential diagnosis, pathogenesis and management. Results The study group included 8 females and 3 males (age: 10-53 years, mean age 31.7±12.88 years). Seven cases were classified as generalized form of TLP and 4 as localized form. Nine cases were symptomatic. Time to onset ranged from 1 to 14 days. A specific causative factor was not identified in any case and management was symptomatic. Conclusions Although TLP is not considered as a rare entity, available information is limited. Diagnosis is rendered clinically, while biopsy is required in cases with a differential diagnostic dilemma. TLP should be included in the differential diagnosis of acute, painful tongue nodules. Key words:Transient lingual papillitis, fungiform papillary glossitis, tongue, nodules. PMID:28149482

  11. Development of lycopene-loaded lipid-core nanocapsules: physicochemical characterization and stability study

    NASA Astrophysics Data System (ADS)

    dos Santos, Priscilla Pereira; Paese, Karina; Guterres, Silvia Stanisçuaski; Pohlmann, Adriana Raffin; Costa, Tania Hass; Jablonski, André; Flôres, Simone Hickmann; Rios, Alessandro de Oliveira

    2015-02-01

    The objective of this study was to develop lycopene-loaded lipid-core nanocapsules (Lyc-LNCs) by the interfacial deposition of preformed poly(ɛ-caprolactone) (PCL). Lyc extract (93.9 %) was obtained from tomatoes, and the organic phase was prepared with polymer (PCL), caprylic/capric triglycerides, sorbitan monostearate, and Lyc in a mixture of acetone and ethanol under magnetic stirring at 40 °C. The organic phase was injected into an aqueous phase containing polysorbate 80, and the suspension was concentrated under reduced pressure. The formulation with a Lyc concentration of 85 µg/mL was characterized in terms of size distribution, zeta potential, encapsulation efficiency, pH, viscosity, and color. The Lyc-LNC formulation presented stable values for the z-average (193 ± 4.7 nm) and zeta potential (-11.5 ± 0.40 mV). Despite the lower pH, Lyc content, and color change of the suspension, the nanocapsules showed satisfactory stability, presenting around 50 % Lyc content after 14 days of storage at room temperature (25 °C).

  12. [Study on standard of safe application of thiamethoxam on GAP of Lonicera japonica].

    PubMed

    Liu, Ya-nan; Li, Yong; Dong, Jie; Zhang, Jin-liang; Wang, Pin-shu; Ding, Wan-long

    2015-09-01

    The paper is aimed to establish a method of residue analysis for thiamethoxam and to study its degradation dynamic and final residue and its standard of safe application of thiamethoxam on Lonicera japonica. Samples extracted with methanol by ultrasonication were purified with dichloromethane by liquid-liquid extraction and SPE column and analysed by HPLC-UV. The results showed that average rate was 84.91%-94.44% and RSD 1.74%-4.96% with addition of thiamethoxam in respectively diverse concentration, which meets inspection requirement of pesticide residue. Two kinds of dosages of thiamethoxam were treated- varying from recommended dosage (90 g x hm(-2)) to high dosage (135 g x hm(-2)), Results of two years test showed that thiamethoxam was degraded more than 90% seven days after application and the half - life period of thiamethoxam was 1.54-1.66 d. The digestion rate of thiamethoxam was fast in the L. japonica. The recommended MRL of thiamethoxam in the L. japonica is 0.1 mg x kg(-1), the dosage of 25% thiamethoxam WDG from 90-135 g x hm(-2) is sprayed less than three times a year on L. japonica and 14 days is proposed for the safety interval of the last pesticide application's and harvest's date.

  13. Wound healing studies of skin incisions in animal models: laser soldering versus other bonding methods

    NASA Astrophysics Data System (ADS)

    Simhon, David; Vasilyev, Tamar; Brosh, Tamar; Nevo, Zvi; Tennenbaum, Tamar; Kariv, Naam; Katzir, Abraham

    2003-06-01

    In the past, we have successfully used laser soldering for bonding cuts in the skin of medium and large size animal models. In this work, we have used the same method for bonding cuts on the backs of rabbits and mature pigs model. Cuts were created in dorsally depilated skins of rabbits and mature pigs. 47% bovine serum albumin (BSA) solder was applied onto the approximated edges of each cut, using a special approximation device. An infrared fiberoptic CO2 laser system was used to heat a spot on the cut, under good temperature control, to 65°C for 10 seconds. Other glued or sutured cuts, served as controls. Immediate tensile strength measurements were done on bonded incisions in rabbit skins. We found that laser soldered incisions exhibited similar strength to one bonded by cayanoacrylate glue. No dehiscence of wound edges was found in both treatments. The laser soldering procedure was 25% faster then suturing. A 14-day follow up of the bonded pig skin incisions was carried out, using punch biopsies. We found better aesthetic appearance of the soldered incisions. We observed better and faster wound repair in the laser-soldered scars, using histological and molecular staining. The temperature controlled laser soldering offers immediate strength similar to that of cyanoacrylate glues and better aesthetic and wound healing properties, in comparison to suturing techniques. We have clearly demonstrated the potential of this novel technique, which will pave thw way for clinical studies.

  14. Experiment K-7-29: Connective Tissue Studies. Part 3; Rodent Tissue Repair: Skeletal Muscle

    NASA Technical Reports Server (NTRS)

    Stauber, W.; Fritz, V. K.; Burkovskaya, T. E.; Ilyina-Kakueva, E. I.

    1994-01-01

    Myofiber injury-repair was studied in the rat gastrocnemius following a crush injury to the lower leg prior to flight in order to understand if the regenerative responses of muscles are altered by the lack of gravitational forces during Cosmos 2044 flight. After 14 days of flight, the gastrocnemius muscle was removed from the 5 injured flight rodents and various Earth-based treatment groups for comparison. The Earth-based animals consisted of three groups of five rats with injured muscles from a simulated, tail-suspended, and vivarium as well as an uninjured basal group. The gastrocnemius muscle from each was evaluated by histochemical and immunohistochemical techniques to document myofiber, vascular, and connective tissue alterations following injury. In general the repair process was somewhat similar in all injured muscle samples with regard to extracellular matrix organization and myofiber regeneration. Small and large myofibers were present with a newly organized extracellular matrix indicative of myogenesis and muscle regeneration. In the tail-suspended animals, a more complete repair was observed with no enlarged area of non-muscle cells or matrix material visible. In contrast, the muscle samples from the flight animals were less well differentiated with more macrophages and blood vessels in the repair region but small myofibers and proteoglycans, nevertheless, were in their usual configuration. Thus, myofiber repair did vary in muscles from the different groups, but for the most part, resulted in functional muscle tissue.

  15. FT-Raman spectroscopy study of organic matrix degradation in nanofilled resin composite.

    PubMed

    Soares, Luís Eduardo Silva; Nahórny, Sídnei; Martin, Airton Abrahão

    2013-04-01

    This in vitro study evaluated the effect of light curing unit (LCU) type, mouthwashes, and soft drink on chemical degradation of a nanofilled resin composite. Samples (80) were divided into eight groups: halogen LCU, HS--saliva (control); HPT--Pepsi Twist®; HLC--Listerine®; HCP--Colgate Plax®; LED LCU, LS--saliva (control); LPT--Pepsi Twist®; LLC--Listerine®; LCP--Colgate Plax®. The degree of conversion analysis and the measure of the peak area at 2,930 cm-1 (organic matrix) of resin composite were done by Fourier-transform Raman spectroscopy (baseline, after 7 and 14 days). The data were subjected to multifactor analysis of variance (ANOVA) at a 95% confidence followed by Tukey's HSD post-hoc test. The DC ranged from 58.0% (Halogen) to 59.3% (LED) without significance. Differences in the peak area between LCUs were found after 7 days of storage in S and PT. A marked increase in the peak intensity of HLC and LLC groups was found. The soft-start light-activation may influence the chemical degradation of organic matrix in resin composite. Ethanol contained in Listerine® Cool Mint mouthwash had the most significant degradation effect. Raman spectroscopy is shown to be a useful tool to investigate resin composite degradation.

  16. Salivary antioxidants of male athletes after aerobic exercise and garlic supplementation on: A randomized, double blind, placebo-controlled study

    PubMed Central

    Damirchi, Arsalan; Saati Zareei, Alireza; Sariri, Reyhaneh

    2015-01-01

    Purpose Production of reactive oxygen species and reactive nitrogen species is a natural biological event in metabolism. However, the presence of antioxidants can highly reduce the negative effect of free radicals. Thus, the efficiency of antioxidant system in the physiology of exercise is very important. Design Considering the known antioxidant capacity of garlic, the purpose of this study was to evaluate the effect on combining 14 days aerobic exercise till exhaustion with garlic extract supplementation on the antioxidant capacity of saliva. Methods Sixteen young men volunteered to participate in this randomized, double blind, placebo-controlled study and were randomly placed into two groups, placebo (Group I) and garlic extract (Group II). The participants performed exhaustive aerobic exercise on a treadmill before and after supplementation. Their unstimulated salivary samples were collected before, immediately after, and 1 h after the activity. The antioxidant activity in terms of peroxidase (POD), superoxide dismutase (SOD), and catalase (CAT) was then measured in the collected samples using their specific substrates. Results A significant increase in salivary antioxidant activity of SOD, POD, and CAT was observed in saliva of the supplement group compared to the placebo group (P ≤ 0.05). Conclusion The findings from this study suggest that increased activity of antioxidant enzymes could possibly decrease exercise-induced oxidative damage in male athletes. PMID:26605139

  17. Comparative analysis between Chamomilla recutita and corticosteroids on wound healing. An in vitro and in vivo study.

    PubMed

    Martins, Manoela Domingues; Marques, Márcia Martins; Bussadori, Sandra Kalil; Martins, Marco Antonio Trevizani; Pavesi, Vanessa Christina Santos; Mesquita-Ferrari, Raquel Agnelli; Fernandes, Kristianne Porta Santos

    2009-02-01

    The comparison of chamomile and corticosteroids for treating ulcers was done in vitro and in vivo. The experimental groups were: control; chamomile recutita; triamcinolone acetonide and clobetasol propionate. For the in vitro study the cell viability of fibroblasts cultured for 24 h in media conditioned by the substances was obtained by the MTT reduction analysis. For the in vivo study, 125 male rats were submitted to experimental ulcers treated or not (control) by the substances tested. At 1, 3, 5, 7 and 14 days later 5 animals of each group were sacrificed. The lesions were analyzed by means of clinical observation and histological wound-healing grading. Data were compared by ANOVA (p study, we concluded that chamomile in comparison to corticosteroids promotes faster wound healing process.

  18. Micro-PIXE study of Ag in digestive glands of a nano-Ag fed arthropod ( Porcellio scaber, Isopoda, Crustacea)

    NASA Astrophysics Data System (ADS)

    Tkalec, Živa Pipan; Drobne, Damjana; Vogel-Mikuš, Katarina; Pongrac, Paula; Regvar, Marjana; Štrus, Jasna; Pelicon, Primož; Vavpetič, Primož; Grlj, Nataša; Remškar, Maja

    2011-10-01

    Micro-proton induced X-ray emission (micro-PIXE) method was applied to study the micro-localization of silver (Ag) in digestive glands of a terrestrial arthropod (Porcellio scaber) after feeding on silver nanoparticles (nano-Ag) dosed food. The aim of our work was to assess whether feeding on nano-Ag results in the assimilation of silver (Ag) in digestive gland cells. To study micro-localization and elemental distribution of Ag, the animals were fed on food dosed with nanoparticles for 14 days under controlled laboratory conditions. At the end of the feeding exposure, the animals were dissected and digestive glands prepared for micro-PIXE analyses and TEM investigation. The results obtained by micro-PIXE documented high amounts of Ag inside S-cells of the digestive gland epithelium; however, TEM investigation did not show particle aggregates inside digestive gland cells. Also no adverse effect on feeding behavior was recorded what is a measure of toxic effects. We explain the presence of Ag inside the cells as a result of the assimilation of dissoluted Ag ions from ingested nano-Ag particles. Assimilation of excessive amounts of ingested metal ions in S-cells is a well known metal detoxification mechanism in isopods. We discuss the advantages of using micro-PIXE for the micro-localization of elements in biological tissue in studies of interactions between nanoparticles and biological systems.

  19. Comparative study between two animal models of extrapyramidal movement disorders: prevention and reversion by pecan nut shell aqueous extract.

    PubMed

    Trevizol, Fabiola; Benvegnú, Dalila M; Barcelos, Raquel C S; Pase, Camila S; Segat, Hecson J; Dias, Verônica Tironi; Dolci, Geisa S; Boufleur, Nardeli; Reckziegel, Patrícia; Bürger, Marilise E

    2011-08-01

    Acute reserpine and subchronic haloperidol are animal models of extrapyramidal disorders often used to study parkinsonism, akinesia and tardive dyskinesia. In humans, these usually irreversible and disabling extrapyramidal disorders are developed by typical antipsychotic treatment, whose pathophysiology has been related to oxidative damages development. So far, there is no treatment to prevent these problems of the psychiatric clinic, and therefore further studies are needed. Here we used the animal models of extrapyramidal disorders cited above, which were performed in two distinct experiments: orofacial dyskinesia (OD)/catalepsy induced by acute reserpine and subchronic haloperidol after (experiment 1) and before (experiment 2) oral treatment with pecan shell aqueous extract (AE), a natural and promissory antioxidant. When administered previously (exp.1), the AE prevented OD and catalepsy induced by both reserpine and haloperidol. When reserpine and haloperidol were administered before the extract (exp.2), the animals developed OD and catalepsy all the same. However, the orofacial parameter (but not catalepsy) in both animal models was reversed after 7 and 14 days of AE treatment. These results indicate that, acute reserpine and subchronic haloperidol administrations induced similar motor disorders, although through different mechanisms, and therefore are important animal models to study the physiopathology of extrapyramidal disorders. Comparatively, the pecan shell AE was able to both prevent and reverse OD but only to prevent catalepsy. These results reinforce the role of oxidative stress and validate the two animal models used here. Our findings also favor the idea of prevention of extrapyramidal disorders, rather than their reversal.

  20. Decreased nocturnal awakenings in young adults performing bikram yoga: a low-constraint home sleep monitoring study.

    PubMed

    Kudesia, Ravi S; Bianchi, Matt T

    2012-01-01

    This pilot study evaluated the impact of Bikram Yoga on subjective and objective sleep parameters. We compared subjective (diary) and objective (headband sleep monitor) sleep measures on yoga versus nonyoga days during a 14-day period. Subjects (n = 13) were not constrained regarding yoga-practice days, other exercise, caffeine, alcohol, or naps. These activities did not segregate by choice of yoga days. Standard sleep metrics were unaffected by yoga, including sleep latency, total sleep time, and percentage of time spent in rapid eye movement (REM), light non-REM, deep non-REM, or wake after sleep onset (WASO). Consistent with prior work, transition probability analysis was a more sensitive index of sleep architecture changes than standard metrics. Specifically, Bikram Yoga was associated with significantly faster return to sleep after nocturnal awakenings. We conclude that objective home sleep monitoring is feasible in a low-constraint, real-world study design. Further studies on patients with insomnia will determine whether the results generalize or not.

  1. 14C-NaVP and 14C-PEV repeated dose study in rat. Pharmacokinetic study in rats after repeated oral administrations of 14C-valproic acid sodium salt and 14C-valproic acid pivaloyl oxymethyl ester.

    PubMed

    Bertolino, M; Acerbi, D; Canali, S; Giachetti, C; Poli, G; Ventura, P; Zanolo, G

    1998-01-01

    The absorption, excretion and tissue distribution of radioactivity after repeated oral equimolar doses of 14C-valproic acid sodium salt (NaVP) or 14C-valproic acid pivaloyl oxymethyl ester (PEV) was investigated in male rats treated once a day for 14 consecutive days. The 14th day plasma time-course of radioactivity after PEV administrations was characterised by a slow absorption rate with a delayed peak (tmax 2 h, Cmax 7.52 +/- 1.35 microg eq./ml), followed by a plateau lasting up to 8 h. After NaVP treatment, the main peak of radioactivity was observed 0.5 h after administration (Cmax 8.30 +/- 1.26 microg eq./ml) followed by a secondary peak due to biliary enterohepatic recycling. Starting from 4 h onwards, radioactivity levels after PEV treatment were higher than those after NaVP (AUCtau = 113.3 h.microg eq./ml after PEV vs 71.9 h.microg eq./ml after NaVP), but concentrations declined with similar terminal half-lives (52.8 h for PEV and 49.7 h for NaVP). Radioactivity recovered (0-432 h interval) in urine accounted for 79.3% (PEV) and 56.1% (NaVP) while, in faeces accounted for 9.1% (PEV) and 26.1% (NaVP) of total administered dose (14 days). The difference is attributable to a higher excretion of radioactivity in the bile for NaVP. The missing fraction in the total radioactivity balance is probably excreted in expired air, as observed in single dose studies. Radioactivity excreted in bile (0-8 h interval of the last 14th day) accounted for 5.1% (NaVP) and 0.23% (PEV) of the total administered dose (14 days). A possible explanation of this difference may be a different metabolism pattern for the two compounds. The negligible biliary excretion observed after PEV administration is probably due to an inhibition of the glucuronation of valproic acid (or other metabolites) caused by the pivalic acid. Due to the presence of the enterohepatic recycle, the radioactivity levels in intestine, 0.5 and 2 h after administration, were higher after NaVP administration

  2. Evaluation of the repeated-dose liver micronucleus assay using N-nitrosomorpholine in young adult rats: report on collaborative study by the Collaborative Study Group for the Micronucleus Test (CSGMT)/Japanese Environmental Mutagen Society (JEMS)-Mammalian Mutagenicity Study (MMS) Group.

    PubMed

    Hayashi, Aya; Kosaka, Mizuki; Kimura, Aoi; Wako, Yumi; Kawasako, Kazufumi; Hamada, Shuichi

    2015-03-01

    The present study was conducted to evaluate the suitability of a repeated-dose liver micronucleus (LMN) assay in young adult rats as a collaborative study by the Mammalian mutagenicity study (MMS) group. All procedures were performed in accordance with the standard protocols of the MMS Group. Six-week-old male Crl:CD(SD) rats (5 animals/group) received oral doses of the hepatocarcinogen N-nitrosomorpholine (NMOR) at 0 (control), 5, 10, and 30mg/kg/day (10mL/kg) for 14 days. Control animals received vehicle (water). Hepatocytes were collected from the liver 24h after the last dose, and the number of micronucleated hepatocytes (MNHEPs) was determined by microscopy. The number of micronucleated immature erythrocytes (MNIMEs) in the femoral bone marrow was also determined. The liver was examined using histopathologic methods after formalin fixation. The results showed statistically significant and dose-dependent increases in the number of MNHEPs in the liver at doses of 10mg/kg and greater when compared with the vehicle control. However, no significant increase was noted in the number of MNIMEs in the bone marrow at doses of up to 30mg/kg. Histopathology of the liver revealed hypertrophy and single cell necrosis of hepatocytes at doses of 5mg/kg and above. These results showed that the induction of micronuclei by NMOR was detected by the repeated-dose LMN assay, but not by the repeated-dose bone marrow micronucleus assay.

  3. Adverse childhood experiences and frequent insufficient sleep in 5 U.S. States, 2009: a retrospective cohort study

    PubMed Central

    2013-01-01

    Background Although adverse childhood experiences (ACEs) have previously been demonstrated to be adversely associated with a variety of health outcomes in adulthood, their specific association with sleep among adults has not been examined. To better address this issue, this study examines the relationship between eight self-reported ACEs and frequent insufficient sleep among community-dwelling adults residing in 5 U.S. states in 2009. Methods To assess whether ACEs were associated with frequent insufficient sleep (respondent did not get sufficient rest or sleep ≥14 days in past 30 days) in adulthood, we analyzed ACE data collected in the 2009 Behavioral Risk Factor Surveillance System, a random-digit-dialed telephone survey in Arkansas, Louisiana, New Mexico, Tennessee, and Washington. ACEs included physical abuse, sexual abuse, verbal abuse, household mental illness, incarcerated household members, household substance abuse, parental separation/divorce, and witnessing domestic violence before age 18. Smoking status and frequent mental distress (FMD) (≥14 days in past 30 days when self-perceived mental health was not good) were assessed as potential mediators in multivariate logistic regression analyses of frequent insufficient sleep by ACEs adjusted for race/ethnicity, gender, education, and body mass index. Results Overall, 28.8% of 25,810 respondents reported frequent insufficient sleep, 18.8% were current smokers, 10.8% reported frequent mental distress, 59.5% percent reported ≥1 ACE, and 8.7% reported ≥ 5 ACEs. Each ACE was associated with frequent insufficient sleep in multivariate analyses. Odds of frequent insufficient sleep were 2.5 (95% CI, 2.1-3.1) times higher in persons with ≥5 ACEs compared to those with no ACEs. Most relationships were modestly attenuated by smoking and FMD, but remained significant. Conclusions Childhood exposures to eight indicators of child maltreatment and household dysfunction were significantly associated with

  4. Effects of Different Surface Treatment Methods and MDP Monomer on Resin Cementation of Zirconia Ceramics an In Vitro Study

    PubMed Central

    Tanış, Merve Çakırbay; Akçaboy, Cihan

    2015-01-01

    Introduction: Resin cements are generally preferred for cementation of zirconia ceramics. Resin bonding of zirconia ceramics cannot be done with the same methods of traditional ceramics because zirconia is a silica-free material. In recent years, many methods have been reported in the literature to provide the resin bonding of zirconia ceramics. The purpose of this in vitro study is to evaluate effects of different surface treatments and 10-metacryloxydecyl dihydrogen phosphate (MDP) monomer on shear bond strength between zirconia and resin cement. Methods: 120 zirconia specimens were treated as follows: Group I: sandblasting, group II: sandblasting + tribochemical silica coating + silane, group III: sandblasting + Nd:YAG (neodymium: yttrium-aluminum-garnet) laser. One specimen from each group was evaluated under scanning electron microscope (SEM). Specimens in each group were bonded either with conventional resin cement Variolink II or with a MDP containing resin cement Panavia F2.0. Subgroups of bonded specimens were stored in distilled water (37°C) for 24 hours or 14 days. Following water storage shear bond strength test was performed at a crosshead speed of 1 mm/min in a universal test machine. Then statistical analyses were performed. Results: Highest shear bond strength values were observed in group II. No significant difference between group I and III was found when Panavia F2.0 resin cement was used. When Variolink II resin cement was used group III showed significantly higher bond strength than group I. In group I, Panavia F2.0 resin cement showed statistically higher shear bond strength than Variolink II resin cement. In group II no significant difference was found between resin cements. No significant difference was found between specimens stored in 37°C distilled water for 24 hours and 14 days. In group I surface irregularities with sharp edges and grooves were observed. In group II less roughened surface was observed with silica particles. In group

  5. Quality control of a national bone marrow donor registry: results of a pilot study and proposal for a standardized approach.

    PubMed

    Tiercy, J-M; Stadelmann, S; Chapuis, B; Gratwohl, A; Schanz, U; Seger, R A; Faveri, G Nicoloso de; Kern, M; Morell, A; Schwabe, R; Schneider, P

    2003-09-01

    Unrelated hematopoietic stem cell transplantation (HSCT) is a recognized therapy for hematological diseases and over 8 million HLA-typed donors are ready to donate. Increased international exchanges and rapid requests through the Bone Marrow Donor Worldwide (BMDW) ask for standardized quality assurance. Since no such standards have been established to date, we tested a pilot program in order to evaluate donor availability and quality of HLA typing of the Swiss Registry. The 18500 donors of the registry have been analyzed by serology for HLA-AB and by molecular typing for HLA-DR. Through three successive annual quality control (QC) exercises, a total of 114 donor requests were sent to 13 blood transfusion centers responsible for donor recruitment asking for a blood sample. Donors were randomly selected according to recruitment periods (1988-1993; 1994-1997; 1998-2000), and to homozygosity for HLA-A and/or -B antigens. An additional 80 frozen blood samples from the repository corresponding to the three periods (n=26) and to the 2001 period (n=54) were also included in the HLA study. HLA-AB typings were done by polymerase chain reaction-sequence specific primers (PCR-SSP) and all discrepancies were retyped. The results showed that 79 samples provided by 69.3% of the requested donors were received within 14 days, and 19 samples (16.7%) were received in >14 days. Altogether, an 86% rate of donor availability was observed, independent of the recruitment period. Among the requested donors, 16 (14%) were not available: for medical reasons (two), for personal reasons (eight), for loss (one), and for an unknown reason (five). The HLA-A/B DNA typing results of 166 homozygous and 12 heterozygous blood samples showed that 437/439 (99.5%) of the assigned A/B antigens were correct. However in 36/178 donors (20.2%) an HLA-A or -B antigen had been missed (34 donors) or misassigned (two donors) by serology, with a decreasing discrepancy rate of 30% (1988-1993) to 18.5% in 2001

  6. Human habitation field study of the Habitat Demonstration Unit (HDU)

    NASA Astrophysics Data System (ADS)

    Litaker, Harry L.; Archer, Ronald D.; Szabo, Richard; Twyford, Evan S.; Conlee, Carl S.; Howard, Robert L.

    2013-10-01

    Landing and supporting a permanent outpost on a planetary surface represents humankind's capability to expand its own horizons and challenge current technology. With this in mind, habitability of these structures becomes more essential given the longer durations of the missions. The purpose of this evaluation was to obtain preliminary human-in-the-loop performance data on the Habitat Demonstration Unit (HDU) in a Pressurized Excursion Module (PEM) configuration during a 14-day simulated lunar exploration field trial and to apply this knowledge to further enhance the habitat's capabilities for forward designs. Human factors engineers at the NASA/Johnson Space Center's Habitability and Human Factors Branch recorded approximately 96 h of crew task performance with four work stations. Human factors measures used during this study included the NASA Task Load Index (TLX) and customized post questionnaires. Overall the volume for the PEM was considered acceptable by the crew; however; the habitat's individual work station volume was constrained when setting up the vehicle for operation, medical operations, and suit maintenance while general maintenance, logistical resupply, and geo science was considered acceptable. Crew workload for each station indicated resupply as being the lowest rated, with medical operations, general maintenance, and geo science tasks as being light, while suit maintenance was considered moderate and general vehicle setup being rated the highest. Stowage was an issue around the habitat with the Space Exploration Vehicle (SEV) resupply stowage located in the center of the habitat as interfering with some work station volumes and activities. Ergonomics of the geo science station was considered a major issue, especially with the overhead touch screens.

  7. [Reproductive and developmental toxicity studies of lactitol (NS-4) (1)--Fertility study in rats by oral administration].

    PubMed

    Ninomiya, H; Kondo, J; Ide, Y; Yamashita, Y; Nishikawa, K; Kishida, K; Watanabe, M; Sumi, N

    1994-11-01

    A study of fertility and fetal development was conducted in Sprague-Dawley rats. Male rats were given lactitol, a hepatic encephalopathy drug, orally from 63 days before mating to the end of mating period. Female rats were given from 14 days before mating to day 7 of pregnancy. The dose levels for both males and females were 0 (control), 0.7, 2.65 and 10 g/kg. The females were sacrificed on day 20 of pregnancy for examination of their fetuses. The decrease in food consumption in either male or female was observed in the intermediate and high dose groups. The high dose caused soft stool, diarrhea and increase in water consumption in either male or female. Moreover, the high dose caused salivation and suppression of body weight gain in male. In the pathological examination, the enlargement of cecum were observed in male of the intermediate and high dose groups. The increase in cecum weight were observed in male in all lactitol groups, and in female of the high dose group. Lactitol did not affect on copulation and fertility indexes in either male or female rats. Lactitol failed to affect on estrous cycle in female rats, and number of corpora lutea, implantations and preimplantation egg losses. In the fetal examination, lactitol did not affect on the development of live fetuses. The results show that no-effect dose levels of lactitol are less than 0.7 g/kg in male rats and 0.7 g/kg in female rats for general toxicity, and 10 g/kg for reproductive function in parent animals and fetuses.

  8. Studies on the effect of inoculation of activated sludge with bacteria actively degrading hydrocarbons on the biodegradation of petroleum products.

    PubMed

    Bieszkiewicz, Ewa; Boszczyk-Maleszak, Hanka; Włodarczyk, Anna; Horoch, Maciej

    2002-01-01

    Eighteen strains of bacteria were isolated from activated sludge purifying petroleum-refining wastewaters. These strains were plated on solidified mineral medium supplemented with oil fraction in concentration 1000 mg/l. Four of the strains that grew best in the presence of oil were selected for further studies. The strains were identified based on Bonde's scheme and microscopic observations. Three of them belonged to the genus Arthrobacter and one to the genus Micrococcus. Stationary cultures of single strains and their mixtures were set up in mineral medium containing oil (sterile and non-sterile) as sole carbon source in concentration 1000 mg/l. The oils were found to be removed the most efficiently by a mixture of the strains. After 14 days of culture the amount of oil was utilized by from 63 to 95%. In the next stage of the studies the bacteria were used to inoculate activated sludge. Stationary cultures of the activated sludge were set up in mineral medium with oil. The utilisation of petroleum products by non-inoculated activated sludge (control), activated sludge inoculated with a single strain or a mixture of all four strains was examined. In both inoculated activated sludge cultures approximately 80% of the oils were removed, compared to 60% in the control activated sludge. Therefore, inoculated activated sludge showed 20% higher effectiveness of removal of petroleum derivatives.

  9. Does work stress make you shorter? An ambulatory field study of daily work stressors, job control, and spinal shrinkage.

    PubMed

    Igic, Ivana; Ryser, Samuel; Elfering, Achim

    2013-10-01

    Body height decreases throughout the day due to fluid loss from the intervertebral disk. This study investigated whether spinal shrinkage was greater during workdays compared with nonwork days, whether daily work stressors were positively related to spinal shrinkage, and whether job control was negatively related to spinal shrinkage. In a consecutive 2-week ambulatory field study, including 39 office employees and 512 days of observation, spinal shrinkage was measured by a stadiometer, and calculated as body height in the morning minus body height in the evening. Physical activity was monitored throughout the 14 days by accelerometry. Daily work stressors, daily job control, biomechanical workload, and recreational activities after work were measured with daily surveys. Multilevel regression analyses showed that spinal disks shrank more during workdays than during nonwork days. After adjustment for sex, age, body weight, smoking status, biomechanical work strain, and time spent on physical and low-effort activities during the day, lower levels of daily job control significantly predicted increased spinal shrinkage. Findings add to knowledge on how work redesign that increases job control may possibly contribute to preserving intervertebral disk function and preventing occupational back pain.

  10. Effect of Vortioxetine on Cardiac Repolarization in Healthy Adult Male Subjects: Results of a Thorough QT/QTc Study.

    PubMed

    Wang, Ying; Nomikos, George G; Karim, Aziz; Munsaka, Melvin; Serenko, Michael; Liosatos, Maggie; Harris, Stuart

    2013-10-01

    This double-blind, randomized, placebo- and positive-controlled, parallel-group study evaluated the effect of vortioxetine (Lu AA21004), an investigational multimodal antidepressant, on QT interval in accordance with current guidelines of the International Conference on Harmonisation (ICH-E14). A total of 340 healthy men were randomized to receive 1 of 4 treatments for 14 days: (1) vortioxetine 10 mg once daily (QD), (2) vortioxetine 40 mg QD, (3) placebo QD, or (4) placebo QD on Days 1 through 13 followed by a single dose of moxifloxacin 400 mg (positive control). The primary endpoint was the largest time-matched, baseline-adjusted least-squares (LS) mean difference for the individual-corrected QT interval (QTcNi [linear]) between vortioxetine and placebo. Alternative QT correction formulas (i.e., Fredericia [QTcF], Bazett [QTcB], Framingham [QTcFm], and QTcNi [nonlinear]) were used as secondary endpoints. The upper bound of the 2-sided 90% confidence interval around the LS mean difference from placebo for baseline-adjusted QTcNi (linear), QTcF, QTcB, QTcFm, and QTcNi (nonlinear) did not exceed 10 ms at any time point after multiple doses of vortioxetine 10 mg (therapeutic) or 40 mg (supratherapeutic). Overall, the study results indicate that vortioxetine is unlikely to affect cardiac repolarization in healthy subjects.

  11. Histopathological and expression profiling studies of early tumor responses to near-infrared PDT treatment in SCID mice

    NASA Astrophysics Data System (ADS)

    Starkey, Jean R.; Rebane, Aleksander; Drobizhev, Mikhail A.; Meng, Fanqin; Gong, Aijun; Elliott, Aleisha; McInnerney, Kate; Pascucci, Elizabeth; Spangler, Charles W.

    2008-02-01

    A novel class of porphyrin-based near-infrared photodynamic therapy (PDT) sensitizers is studied. We achieve regressions of human small cell lung cancer (NCI-H69), non-small cell lung cancer (A 459) and breast cancer (MDAMB- 231) xenografts in SCID mice at significant tissue depth by irradiation with an amplified femtosecond pulsed laser at 800 nm wavelength. Significant tumor regressions were observed during the first 10-14 days post treatment. Tumor histopathology was consistent with known PDT effects, while no significant changes were noted in irradiated normal tissues. In vivo imaging studies using intravenous injections of fluorescent dextran demonstrated an early loss of tumor blood flow. RNA was isolated from NCI-H69 PDT treated SCID mouse xenografts and paired untreated xenografts at 4 hours post laser irradiation. Similarly RNA was isolated from PDT treated and untreated Lewis lung carcinomas growing in C57/Bl6 mice. Expression profiling was carried out using Affymetrix TM human and mouse GeneChips®. Cluster analysis of microarray expression profiling results demonstrated reproducible increases in transcripts associated with apoptosis, stress, oxygen transport and gene regulation in the PDT treated NCI-H69 samples. In addition, PDT treated Lewis lung carcinomas showed reproducible increases in transcripts associated with immune response and lipid biosynthesis. PDT treated C57/Bl6 mice developed cytotoxic T cell activity towards this tumor, while untreated tumor bearing mice failed to do so.

  12. Effectiveness of probiotic, chlorhexidine and fluoride mouthwash against Streptococcus mutans – Randomized, single-blind, in vivo study

    PubMed Central

    Jothika, Mohan; Vanajassun, P. Pranav; Someshwar, Battu

    2015-01-01

    Aim: To determine the short-term efficiency of probiotic, chlorhexidine, and fluoride mouthwashes on plaque Streptococcus mutans level at four periodic intervals. Materials and Methods: This was a single-blind, randomized control study in which each subject was tested with only one mouthwash regimen. Fifty-two healthy qualified adult patients were selected randomly for the study and were divided into the following groups: group 1- 10 ml of distilled water, group 2- 10 ml of 0.2% chlorhexidine mouthwash, group 3- 10 ml of 500 ppm F/400 ml sodium fluoride mouthwash, and group 4- 10 ml of probiotic mouthwash. Plaque samples were collected from the buccal surface of premolars and molars in the maxillary quadrant. Sampling procedure was carried out by a single examiner after 7 days, 14 days, and 30 days, respectively, after the use of the mouthwash. All the samples were subjected to microbiological analysis and statistically analyzed with one-way analysis of variance (ANOVA) and post-hoc test. Results: One-way ANOVA comparison among groups 2, 3, and 4 showed no statistical significance, whereas group 1 showed statistically significant difference when compared with groups 2, 3, and 4 at 7th, 14th, and 30th day. Conclusion: Chlorhexidine, sodium fluoride, and probiotic mouthwashes reduce plaque S. mutans levels. Probiotic mouthwash is effective and equivalent to chlorhexidine and sodium fluoride mouthwashes. Thus, probiotic mouthwash can also be considered as an effective oral hygiene regimen. PMID:25984467

  13. A Randomized, Double-blind, Placebo-Controlled Study of Efficacy of Oral Acyclovir in the Treatment of Pityriasis Rosea

    PubMed Central

    2014-01-01

    Background: Pityriasis rosea is an acute self-limiting skin disorder of unknown aetiology. Recently human herpes virus 6 and 7 has been hypothesized to be the cause of pityriasis rosea. Objective: To determine the efficacy of acyclovir, an anti-viral drug, in the treatment of pityriasis rosea. Materials and Methods: A randomized, double-blind, placebo-controlled study of efficacy of oral acyclovir in the treatment of pityriasis rosea was conducted on 73 patients. Thirty eight randomly selected patients were started on oral acyclovir. Thirty-five patients were prescribed placebo. The patients as well as the chief investigator were unaware of the therapeutic group to which patients belonged (acyclovir or placebo). Patients in both the groups were evaluated clinically after 7 and 14 days following the first visit and the data were analysed. Results: Follow up data of 60 patients was available and these were included in the statistical analysis. 53.33% and 86.66% of the patients belonging to the acyclovir group showed complete resolution on the 7th day and 14th day respectively following the first visit compared to 10% and 33.33% of patients from the placebo group. The findings were statistically significant. Conclusion: The study showed that high dose acyclovir is effective in the treatment of pityriasis rosea. PMID:24995231

  14. Assessment of carcinogenic risk from personal exposure to benzo(a)pyrene in the Total Human Environmental Exposure Study (THEES)

    SciTech Connect

    Butler, J.P.; Post, G.B.; Lioy, P.J.; Waldman, J.M.; Greenberg, A. )

    1993-07-01

    The Total Human Environmental Exposure Study (THEES) was an investigation of multimedia exposure to the ubiquitous environmental carcinogen, benzo(a)pyrene (BaP). The three-phase study was conducted in Phillipsburg, New Jersey and involved the participation of 14-15 individuals (8-10 homes) during each 14-day monitoring period. Microenvironmental sampling of air, food, water and soil indicated that environmental exposure to BaP was primarily through air and food. Exposure and risk estimates were, therefore, based on the results of personal monitoring of breathing zone air and prepared food samples. Based on a comparison of the range and magnitude of inhalation and dietary BaP exposures, food ingestion was clearly the predominant exposure to pathway. The relative contributions of other potential sources of community exposure to BaP (e.g., soil and drinking water ingestion) were also assessed. The excess cancer risk estimates for food ingestion were consistently greater than those for personal air, reflecting both the predominantly higher BaP exposures through the diet and the higher carcinogenic potency value for oral exposure. Overall, the total lifetime risk from personal exposure to BaP for nonsmokers in the community was estimated at 10(-5). In identifying risk reduction options, it is important to account for the observation that personal activities, lifestyle, and diet strongly influenced individual exposures to BaP.

  15. Mechanistic Investigation of Toxaphene Induced Mouse Liver Tumors.

    PubMed

    Wang, Zemin; Neal, Barbara H; Lamb, James C; Klaunig, James E

    2015-10-01

    Chronic exposure to toxaphene resulted in an increase in liver tumors in B6C3F1 mice. This study was performed to investigate the mode of action of toxaphene induced mouse liver tumors. Following an initial 14 day dietary dose range-finding study in male mice, a mechanistic study (0, 3, 32, and 320 ppm toxaphene in diet for 7, 14, and 28 days of treatment) was performed to examine the potential mechanisms of toxaphene induced mouse liver tumors. Toxaphene induced a significant increase in expression of constitutive androstane receptor (CAR) target genes (Cyp2b10, Cyp3a11) at 32 and 320 ppm toxaphene. aryl hydrocarbon receptor (AhR) target genes (Cyp1a1 and Cyp1a2) were slightly increased in expression at the highest toxaphene dose (320 ppm). No increase in peroxisome proliferator-activated receptor alpha activity or related genes was seen following toxaphene treatment. Lipid peroxidation was seen following treatment with 320 ppm toxaphene. These changes correlated with increases in hepatic DNA synthesis. To confirm the role of CAR in this mode of action, CAR knockout mice (CAR(-/-)) treated with toxaphene confirmed that the induction of CAR responsive genes seen in wild-type mice was abolished following treatment with toxaphene for 14 days. These findings, taken together with previously reported studies, support the mode of action of toxaphene induced mouse liver tumors is through a nongenotoxic mechanism involving primarily a CAR-mediated processes that results in an increase in cell proliferation in the liver, promotes the clonal expansion of preneoplastic lesions leading to adenoma formation.

  16. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment

    PubMed Central

    2013-01-01

    Background Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. Methods/Design In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During

  17. Acute and Subchronic Toxicity Study of the Median Septum of Juglans regia in Wistar Rats

    PubMed Central

    Ravanbakhsh, Asma; Mahdavi, Majid; Jalilzade-Amin, Ghader; Javadi, Shahram; Maham, Masoud; Mohammadnejad, Daryosh; Rashidi, Mohammad Reza

    2016-01-01

    Purpose: Median septum of Juglans regia L. (Juglandaceae) with anti-diabetic effects has been used in Iranian traditional medicine. The present study estimates both oral acute and subchronic toxicities. Methods: In the oral acute toxicity study, female Wistar rats were treated with doses of 10, 100, 1000, 1600, 2900 and 5000 mg/ kg of the Juglans regia septum of methanol extract (JRSME), and were monitored for 14 days. In subchronic study, JRSME was administered by gavage at dose of 1000 mg/kg daily in Wistar rats for 28 days. Antioxidant status and biochemical examinations were fulfilled, and the vital organs were subjected to pathological analyses. Results: The extract did not produce any toxic signs or deaths; the medium lethal dose must be higher than 5000 mg/kg. In subchronic study, No significant morphological and histopathological changes were observed in the studied tissues. There was a significant increase in serum malondialdehyde (MDA) level in treated group compared to control after 4 weeks of JRSME intake. The treatment of rats resulted in a significant reduction of serum urea level (p<0.05), kidney’s xanthine dehydrogenase (XDH) activity (p<0.001) and elevation of aldehyde oxidase (AO) activity (p<0.05) in kidney. In the treated group, the mean diameter of glomerulus and proximal urine tube epithelium stature was slightly greater than control group. A significant increase in serum MDA level is subject for further studies. Conclusion: This study showed that the extract has no acute or subacute adverse effects with dose of 1000 mg/kg. The administration of JRSME may improve kidney structure and function and help in treatment of some chronic diseases. PMID:28101461

  18. Toxicology and carcinogenesis studies of amosite asbestos (CAS No. 12172-73-5) in F344/N rats (feed studies). Technical report series

    SciTech Connect

    McConnell, E.E.

    1990-11-01

    Carcinogenesis studies of amosite asbestos alone or in combination with the intestinal carcinogen 1,2-dimethylhydrazine dihydrochloride (DMH) were conducted in male and female F344/N rats. Amosite asbestos was administered at a concentration of 1% in pelleted diet for the entire lifetime of the rats, starting with the dams of the study animals. The DMH was administered by gavage at a dose of 7.5 mg/kg for males and 15 mg/kg for females every 14 days, starting at 8 weeks of age, for a total of five doses. The administration of DMH did not affect body weight gain either in amosite-exposed or nonexposed animals. Significant increases in the incidences of C-cell carcinomas of the thyroid gland (untreated control, 11/117; amosite, 50/246, P<0.05; amosite preweaning gavage, 14/100) and of leukemia (38/117; 106/249, P<0.05; 49/100, P<0.01) in male rats were observed in amosite-exposed groups. However, the biologic significance of the C-cell carcinomas in relation to amosite asbestos exposure is discounted because of a lack of significance when C-cell adenomas and carcinomas were combined and because the positive effect was not observed in the amosite preweaning gavage group. DMH caused a high incidence (62%-74%) of intestinal neoplasia in amosite-exposed and nonexposed groups. Neither an enchanced carcinogenic nor a protective effect was demonstrated by exposure to amosite asbestos. Under the conditions of these feed studies, amosite asbestos was not overtly toxic, did not affect survival, and was not carcinogenic when ingested at a concentration of 1% in the diet by male or female F344/N rats. The cocarcinogenic studies using DMH were considered inadequate because of the high incidence of DMH-induced intestinal neoplasia in both the amosite asbestos-exposed and nonexposed groups.

  19. Pilot Study on Folate Bioavailability from a Camembert Cheese Reveals Contradictory Findings to Recent Results from a Human Short-term Study

    PubMed Central

    Mönch, Sabine; Netzel, Michael; Netzel, Gabriele; Ott, Undine; Frank, Thomas; Rychlik, Michael

    2016-01-01

    Different dietary sources of folate have differing bioavailabilities, which may affect their nutritional “value.” In order to examine if these differences also occur within the same food products, a short-term human pilot study was undertaken as a follow-up study to a previously published human trial to evaluate the relative native folate bioavailabilities from low-fat Camembert cheese compared to pteroylmonoglutamic acid as the reference dose. Two healthy human subjects received the test foods in a randomized cross-over design separated by a 14-day equilibrium phase. Folate body pools were saturated with a pteroylmonoglutamic acid supplement before the first testing and between the testings. Folates in test foods and blood plasma were analyzed by stable isotope dilution assays. The biokinetic parameters Cmax, tmax, and area under the curve (AUC) were determined in plasma within the interval of 0–12 h. When comparing the ratio estimates of AUC and Cmax for the different Camembert cheeses, a higher bioavailability was found for the low-fat Camembert assessed in the present study (≥64%) compared to a different brand in our previous investigation (8.8%). It is suggested that these differences may arise from the different folate distribution in the soft dough and firm rind as well as differing individual folate vitamer proportions. The results clearly underline the importance of the food matrix, even within the same type of food product, in terms of folate bioavailability. Moreover, our findings add to the increasing number of studies questioning the general assumption of 50% bioavailability as the rationale behind the definition of folate equivalents. However, more research is needed to better understand the interactions between individual folate vitamers and other food components and the potential impact on folate bioavailability and metabolism. PMID:27092303

  20. A randomized, double-blind, placebo-controlled trial of a Chinese herbal Sophora flower formula in patients with symptomatic haemorrhoids: a preliminary study.

    PubMed

    Man, Kee-Ming; Chen, Wen-Chi; Wang, Hwei-Ming; Chen, Huey-Yi; Shen, Jui-Lung; Chen, Lieh-Der; Tsai, Fuu-Jen; Chen, Yung-Hsiang; Yu, De-Xin; Chiang, Feng-Fan

    2013-01-01

    Dried flowers and buds of Sophora japonica (Huaihua) are used in China, Japan and Korea for treating haematemesis and bleeding haemorrhoids. This study compared the clinical safety and efficacy of a Sophora flower formula with a placebo for the conservative treatment of symptomatic haemorrhoids. The study was a prospective, double-blind, randomized placebo-controlled trial. The clinical effective rate, symptom score and the incidence of important clinical events were used as observation indices to evaluate the effect of the Sophora flower formula. The results showed that after 7 days of treatment, improvement was observed in 87.0% of the patients' major symptoms in the Sophora flower formula group compared with 81.8% of those in the placebo group. After 14 days, 78.2% patients in the Sophora flower formula group were asymptomatic, whereas 40.9% of those in the placebo group exhibited residual symptoms. However, the difference between both groups was not statistically significant. As the bowel habits of the patients improved and as the patients took sitz baths, their symptoms improved drastically, regardless of the use of the Sophora flower formula. These findings indicate that the traditional Chinese Sophora flower formula is clinically safe; however, its effects on haemorrhoids need to be studied in a larger sample size and with different dosages. The present study results may be a potential clinical reference for physicians prescribing medications for patients with symptomatic haemorrhoids.

  1. Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults.

    PubMed

    Kalman, Douglas; Harvey, Philip D; Perez Ojalvo, Sara; Komorowski, James

    2016-11-18

    Inositol-stabilized arginine silicate (ASI; Nitrosigine(®)) has been validated to increase levels of arginine, silicon and nitric oxide production. To evaluate potential enhancement of mental focus and clarity, ASI (1500 mg/day) was tested in two double-blind placebo-controlled crossover (DBPC-X) studies using the Trail Making Test (TMT, Parts A and B). In the two studies, healthy males took ASI for 14 and 3 days, respectively. In the first study, after 14 days of dosing, TMT B time decreased significantly from baseline (28% improvement, p = 0.045). In the second study evaluating shorter-term effects, TMT B time decreased significantly compared to placebo (33% improvement, p = 0.024) in a 10-min period. After 3 days of dosing, TMT B time significantly decreased from baseline scores (35% improvement, p < 0.001). These findings show that ASI significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning.

  2. Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults

    PubMed Central

    Kalman, Douglas; Harvey, Philip D.; Perez Ojalvo, Sara; Komorowski, James

    2016-01-01

    Inositol-stabilized arginine silicate (ASI; Nitrosigine®) has been validated to increase levels of arginine, silicon and nitric oxide production. To evaluate potential enhancement of mental focus and clarity, ASI (1500 mg/day) was tested in two double-blind placebo-controlled crossover (DBPC-X) studies using the Trail Making Test (TMT, Parts A and B). In the two studies, healthy males took ASI for 14 and 3 days, respectively. In the first study, after 14 days of dosing, TMT B time decreased significantly from baseline (28% improvement, p = 0.045). In the second study evaluating shorter-term effects, TMT B time decreased significantly compared to placebo (33% improvement, p = 0.024) in a 10-min period. After 3 days of dosing, TMT B time significantly decreased from baseline scores (35% improvement, p < 0.001). These findings show that ASI significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning. PMID:27869715

  3. R-CHOP-14 in patients with diffuse large B-cell lymphoma younger than 70 years: a multicentre, prospective study.

    PubMed

    Rueda, Antonio; Sabin, Pilar; Rifá, Juli; Llanos, Marta; Gómez-Codina, José; Lobo, Francisco; García, Ramón; Herrero, Joaquin; Provencio, Mariano; Jara, Carlos

    2008-03-01

    Several studies have shown that adding rituximab to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) or reducing the interval between chemotherapy cycles from 3 weeks to 2 weeks improves survival in patients with diffuse large B-cell lymphoma (DLBCL). These studies prompted our group (GOTEL) to evaluate prospectively in a pilot study the feasibility and efficacy of R-CHOP-14 in patients with DLBCL. Patients (<70 years) with stage II bulky or stage III or IV DLBCL and no significant comorbidities were included in the study. Rituximab was administered on day 1 before chemotherapy. R-CHOP was given every 14 days. All patients received filgrastim (5 microg/kg) from days 4 to 10. From May 2002 to August 2004, 80 patients were recruited. Median age was 53 years and 58 patients were <60 years. According to the age-adjusted international prognostic index (aaIPI), 13 patients (16%) had low-risk disease, 31 (39%) low-to-intermediate risk, 27 (34%) high-to-intermediate risk and 9 (11%) high-risk disease. Grade 3-4 neutropenia was observed in 15 patients (17.5%) and grade 3-4 infections in 13 patients (16%). After therapy, 58 patients (73%) achieved CR-CRu (95% CI: 55-90%). With a median follow-up of 26 months, progression-free survival (PFS) and overall survival (OS) at 30 months were 72% and 86%, respectively. Administration of R-CHOP-14 is feasible and effective in patients <70 years.

  4. Muscle atrophy and bone loss after 90 days' bed rest and the effects of flywheel resistive exercise and pamidronate: results from the LTBR study.

    PubMed

    Rittweger, Jörn; Frost, Harold M; Schiessl, Hans; Ohshima, Hiroshi; Alkner, Björn; Tesch, Per; Felsenberg, Dieter

    2005-06-01

    Muscle atrophy and bone loss pose substantial problems for long-term space flight and in clinical immobilization. We therefore tested the efficacy of flywheel resistive exercise and pamidronate to counteract such losses. Twenty five young healthy males underwent strict bed rest with -6 degrees head-down tilt for 90 days. Subjects were randomized into an exercise group that practiced resistive exercise with a 'flywheel' (FW) device every 2-3 days, a pamidronate group (Pam) that received 60 mg pamidronate i.v. 14 days prior to bed rest and a control group (Ctrl) that received none of these countermeasures. During the study, Ca(++) and protein intake were controlled. Peripheral quantitative computed tomography (pQCT) was used to assess bone mineral content (BMC) and muscle cross sectional area (mCSA) of calf and forearm. Measurements were taken twice during baseline data collection, after 28 and after 89 days bed rest, and after 14 days recovery. On the same days, urinary Pyridinoline excretion and serum levels of alkaline phosphatase, Ca(++) and PTH were measured. Pre-study exercise habits were assessed through the Freiburg questionnaire. Losses in calf mCSA were significantly reduced in FW (Ctrl: -25.6% +/- 2.5% Pam: -25.6% +/- 3.7%, FW: -17.3% +/- 2.7%), but not in the forearm mCSA (Ctrl: -6.4% +/- 4.33%, Pam: -7.7% +/- 4.1%, FW: -7.6% +/- 3.3%). Both diaphyseal and epiphyseal BMC losses of the tibia were mitigated in Pam and FW as compared to Ctrl, although this was significant only at the diaphysis. Inter-individual variability was significantly greater for changes in BMC than in mCSA, and correlation of BMC losses was poor among different locations of the tibia. A significant positive correlation was found between change in tibia epiphyseal BMC and serum cortisol levels. These findings suggest that both countermeasures are only partly effective to preserve BMC (FW and Pam) and mCSA (FW) of the lower leg during bed rest. The partial efficacy of flywheel exercise

  5. Extracellular matrix-enriched polymeric scaffolds as a substrate for hepatocyte cultures: in vitro and in vivo studies.

    PubMed

    Zavan, B; Brun, P; Vindigni, V; Amadori, A; Habeler, W; Pontisso, P; Montemurro, D; Abatangelo, G; Cortivo, R

    2005-12-01

    Tissue engineering is a promising approach to developing hepatic tissue suitable for the functional replacement of a failing liver. The aim of the present study was to investigate whether an extracellular cell matrix obtained from fibroblasts-cultured within scaffolds of hyaluronic acid (HYAFF) could influence the proliferation rate and survival of rat hepatocytes both during long-term culture and after in vivo transplantation. Cultures were evaluated by histological and morphological analysis, a proliferation assay and metabolic activity (albumin secretion). Hepatocytes cultured in extracellular matrix-enriched scaffolds exhibited a round cellular morphology and re-established cell-cell contacts, growing into aggregates of several cells along and/or among fibers in the fabric. Hepatocytes were able to secrete albumin up to 14 days in culture. In vivo results demonstrated the biocompatibility of HYAFF-11 implanted in nude mice, in which hepatocytes maintained small well-organised aggregates until the 35th day. In conclusion, the presence of a fibroblast-secreted extracellular matrix improved the biological properties of the hyaluronan scaffold, favoring the survival and morphological integrity of hepatocytes in vitro and in vivo.

  6. Prevention and Treatment of Lower Limb Deep Vein Thrombosis after Radiofrequency Catheter Ablation: Results of a Prospective active controlled Study

    PubMed Central

    Li, Lan; Zhang, Bao-jian; Zhang, Bao-ku; Ma, Jun; Liu, Xu-zheng; Jiang, Shu-bin

    2016-01-01

    We conducted a prospective, single-center, active controlled study from July 2013 to January 2015, in Chinese patients with rapid ventricular arrhythmia who had received radiofrequency catheter ablation (RFCA) treatment to determine formation of lower extremity deep vein thrombosis (LDVT) post RFCA procedure, and evaluated the effect of rivaroxaban on LDVT. Patients with asymptomatic pulmonary thromboembolism who had not received any other anticoagulant and had received no more than 36 hours of treatment with unfractionated heparin were included. Post RFCA procedure, patients received either rivaroxaban (10 mg/d for 14 days beginning 2–3 hours post-operation; n = 86) or aspirin (100 mg/d for 3 months beginning 2–3 hours post-operation; n = 90). The primary outcome was a composite of LDVT occurrence, change in diameter of femoral veins, and safety outcomes that were analyzed based on major or minor bleeding events. In addition, blood flow velocity was determined. No complete occlusive thrombus or bleeding events were reported with either of the group. The lower incidence rate of non-occluded thrombus in rivaroxaban (5.8%) compared to the aspirin group (16.7%) indicates rivaroxaban may be administered post-RFCA to prevent and treat femoral venous thrombosis in a secure and effective way with a faster inset of action than standard aspirin therapy. PMID:27329582

  7. Enamel demineralization with two forms of archwire ligation investigated using an in situ caries model--a pilot study.

    PubMed

    Gameiro, Gustavo Hauber; Nouer, Darcy Flávio; Cenci, Maximiliano Sérgio; Cury, Jaime Aparecido

    2009-10-01

    A modified in situ model to assess enamel demineralization around orthodontic devices was developed and a pilot study was conducted to evaluate two types of archwire ligation. Enamel blocks were placed in palatal removable appliances where orthodontic brackets were bonded. The brackets on one side of the appliance were ligated with elastomeric rings and those on the other side with stainless steel wires. Four volunteers (two males, two females), mean age 27 years, wore the appliances for 14 days during which time a 20 per cent sucrose solution was dripped eight times a day onto the enamel blocks. The biofilm formed around the brackets was collected for microbiological analyses and the mineral loss around the brackets was determined by cross-sectional microhardness measurement. The ligatures evaluated did not differ significantly from each other regarding biofilm weight, total bacteria, total streptococci, mutans streptococci, or lactobacilli counts (P > 0.05, Wilcoxon paired test). Enamel demineralization was also not different around the brackets for the different ligation methods (P > 0.05, split-split-plot analysis of variance). However, a statistical power analysis based on the data showed a trend to higher demineralization around brackets ligated with elastomeric rings. The developed modified in situ model may be suitable to assess the caries potential of clinical procedures used in orthodontic treatment.

  8. In vitro study of the neuropathic potential of the organophosphorus compounds fenamiphos and profenofos: Comparison with mipafox and paraoxon.

    PubMed

    Emerick, Guilherme L; Fernandes, Laís S; de Paula, Eloísa Silva; Barbosa, Fernando; dos Santos, Neife Aparecida Guinaim; dos Santos, Antonio Cardozo

    2015-08-01

    Organophosphorus-induced delayed neuropathy (OPIDN) is a central-peripheral distal axonopathy that develops 8-14 days after poisoning by a neuropathic organophosphorus compound (OP). Several OPs that caused OPIDN were withdrawn from the agricultural market due to induction of serious delayed effects. Therefore, the development of in vitro screenings able to differentiate neuropathic from non-neuropathic OPs is of crucial importance. Thus, the aim of this study was to evaluate the differences in the neurotoxic effects of mipafox (neuropathic OP) and paraoxon (non-neuropathic OP) in SH-SY5Y human neuroblastoma cells, using the inhibition and aging of neuropathy target esterase (NTE), inhibition of acetylcholinesterase (AChE), activation of calpain, neurite outgrowth, cytotoxicity and intracellular calcium as indicators. Additionally, the potential of fenamiphos and profenofos to cause acute and/or delayed effects was also evaluated. Mipafox had the lowest IC50 and induced the highest percentage of aging of NTE among the OPs evaluated. Only mipafox was able to cause calpain activation after 24 h of incubation. Concentrations of mipafox and fenamiphos which inhibited at least 70% of NTE were also able to reduce neurite outgrowth. Cytotoxicity was higher in non-neuropathic than in neuropathic OPs while the intracellular calcium levels were higher in neuropathic than in non-neuropathic OPs. In conclusion, the SH-SY5Y cellular model was selective to differentiate neuropathic from non-neuropathic OPs; fenamiphos, but not profenofos presented results compatible with the induction of OPIDN.

  9. Studies on the regulatory effect of Peony-Glycyrrhiza Decoction on prolactin hyperactivity and underlying mechanism in hyperprolactinemia rat model.

    PubMed

    Wang, Di; Wang, Wei; Zhou, Yulin; Wang, Juan; Jia, Dongxu; Wong, Hei Kiu; Zhang, Zhang-Jin

    2015-10-08

    Clinical trials have demonstrated the beneficial effects of Peony-Glycyrrhiza Decoction (PGD) in alleviating antipsychotic-induced hyperprolactinemia (hyperPRL) in schizophrenic patients. In previous experiment, PGD suppressed prolactin (PRL) level in MMQ cells, involving modulating the expression of D2 receptor (DRD2) and dopamine transporter (DAT). In the present study, hyperPRL female rat model induced by dopamine blocker metoclopramide (MCP) was applied to further confirm the anti-hyperpPRL activity of PGD and underlying mechanism. In MCP-induced hyperPRL rats, the elevated serum PRL level was significantly suppressed by either PGD (2.5-10 g/kg) or bromocriptine (BMT) (0.6 mg/kg) administration for 14 days. However, in MCP-induced rats, only PGD restored the under-expressed serum progesterone (P) to control level. Both PGD and BMT administration restore the under-expression of DRD2, DAT and TH resulted from MCP in pituitary gland and hypothalamus. Compared to untreated group, hyperPRL animals had a marked reduction on DRD2 and DAT expression in the arcuate nucleus. PGD (10 g/kg) and BMT (0.6 mg/kg) treatment significant reversed the expression of DRD2 and DAT. Collectively, the anti-hyperPRL activity of PGD associates with the modulation of dopaminergic neuronal system and the restoration of serum progesterone level. Our finding supports PGD as an effective agent against hyperPRL.

  10. Comparative study of the effects of gentamicin, neomycin, streptomycin and ofloxacin antibiotics on sperm parameters and testis apoptosis in rats.

    PubMed

    Khaki, Arash; Novin, Marefat Ghaffari; Khaki, Amir Afshin; Nouri, Mohammad; Sanati, Ehsan; Nikmanesh, Mahdad

    2008-07-01

    The aim of this study was to investigate the comparative effects of aminoglycosides and fluoroquinolones on testis apoptosis and sperm parameters in rats. Fifty male Wistar rats were randomly divided into control (n = 10) and experimental (n = 40) groups. The experimental groups subdivided into four groups often. Each received 5 mg kg(-1) (IP) gentamicin, 50 mg kg(-1) (IP) neomycin, 40 mg kg(-1) (IP) streptomycin and 72 mg kg(-1) (IP) ofloxacin daily for 14 days, respectively; however, the control group just received vehicle (IP). In the fourteenth day, rats were killed and sperm analyzed for sperm parameters. Testis tissues were also prepared for TUNEL assay for detection of apoptosis. There was a significant decrease in sperm count, viability and motility in all of experimental groups when compared with control group. Although in streptomycin group these parameters were less decreased than in the other experimental groups. The apoptotic cells were significantly increased in all experimental groups when compared with those seen in the controlled group. Gentamicin, neomycin and streptomycin and ofloxacin have negative effects on sperm parameters and testis apoptosis in rats. However, these side effects are less seen in the streptomycin group. Therefore, it is recommended that usage of this drug have fewer side effects on male fertility.

  11. High dietary caffeine consumption is associated with a modest increase in headache prevalence: results from the Head-HUNT Study.

    PubMed

    Hagen, Knut; Thoresen, Kari; Stovner, Lars Jacob; Zwart, John-Anker

    2009-06-01

    The aim of this study was to investigate the association between caffeine consumption and headache type and frequency in the general adult population. The results were based on cross-sectional data from 50,483 (55%) out of 92,566 invited inhabitants aged >or=20 years who participated in the Nord-Trøndelag Health Survey. In the multivariate analyses, adjusting for age, gender, smoking, and level of education as confounding factors, a weak but significant association (OR = 1.16, 95% CI 1.09-1.23) was found between high caffeine consumption and prevalence of infrequent headache. In contrast, headache >14 days/month was less likely among individuals with high caffeine consumption compared to those with low caffeine consumption. The results may indicate that high caffeine consumption changes chronic headache into infrequent headache due to the analgesic properties of caffeine. Alternatively, chronic headache sufferers tend to avoid intake of caffeine to not aggravate their headaches, whereas individuals with infrequent headache are less aware that high caffeine use can be a cause.

  12. Prospective Study of Plasmodium vivax Malaria Recurrence after Radical Treatment with a Chloroquine-Primaquine Standard Regimen in Turbo, Colombia

    PubMed Central

    Blair, Silvia; Akinyi Okoth, Sheila; Udhayakumar, Venkatachalam; Marcet, Paula L.; Escalante, Ananias A.; Alexander, Neal; Rojas, Carlos

    2016-01-01

    Plasmodium vivax recurrences help maintain malaria transmission. They are caused by recrudescence, reinfection, or relapse, which are not easily differentiated. A longitudinal observational study took place in Turbo municipality, Colombia. Participants with uncomplicated P. vivax infection received supervised treatment concomitantly with 25 mg/kg chloroquine and 0.25 mg/kg/day primaquine for 14 days. Incidence of recurrence was assessed over 180 days. Samples were genotyped, and origins of recurrences were established. A total of 134 participants were enrolled between February 2012 and July 2013, and 87 were followed for 180 days, during which 29 recurrences were detected. The cumulative incidence of first recurrence was 24.1% (21/87) (95% confidence interval [CI], 14.6 to 33.7%), and 86% (18/21) of these events occurred between days 51 and 110. High genetic diversity of P. vivax strains was found, and 12.5% (16/128) of the infections were polyclonal. Among detected recurrences, 93.1% (27/29) of strains were genotyped as genetically identical to the strain from the previous infection episode, and 65.5% (19/29) of infections were classified as relapses. Our results indicate that there is a high incidence of P. vivax malaria recurrence after treatment in Turbo municipality, Colombia, and that a large majority of these episodes are likely relapses from the previous infection. We attribute this to the primaquine regimen currently used in Colombia, which may be insufficient to eliminate hypnozoites. PMID:27185794

  13. Comparative Study on Vegetative and Reproductive Development between Weedy Rice Morphotypes and Commercial Rice Varieties in Perak, Malaysia

    PubMed Central

    Ahmed, Quazi Nasim; Hussain, PMD Zainudin; Othman, Ahmad Sofiman

    2012-01-01

    This study was conducted to examine the variabilities in the chronology of vegetative and reproductive development of weedy rice (Oryza spp.) in comparison with commercial varieties. Data at different growth stages of 14 weedy rice morphotypes and 4 commercial rice varieties were recorded and analysed. Plant height of all weedy rice morphotypes were observed to be significantly higher compared to the commercial varieties at every growth stages; increase in height was between 10–37 cm for weedy rice morphotype, for every 2 weeks. Initial tillering ability at 14 days after planting (DAP) was higher in weedy morphotypes, however all the commercial rice varieties produced significantly higher number of tillers throughout the rest of the vegetative phases. Correlation between plant height and tiller number detected that taller plants produce fewer tillers than shorter plants. Higher leaf area index (LAI) of all weedy morphotypes except PWR01 at early growth stages indicated the vigorous growth of the morphotypes. Weedy rice morphotypes showed a wide range of anthesis and maturity duration. Accessions from the same weedy rice morphotypes were more heterogeneous in the flowering, anthesis and maturity period than the commercial varieties. These traits enables identification of weedy rice morphotypes at their different growth stages in the field. PMID:24575230

  14. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

    PubMed Central

    Dal-Ré, R; Espada, J; Ortega, R

    1999-01-01

    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. PMID:10390685

  15. Gyro pump wear and deformation analysis in vivo study: creep deformation.

    PubMed

    Nakata, K; Yoshikawa, M; Takano, T; Maeda, T; Nonaka, K; Linneweber, J; Kawahito, S; Glueck, J; Fujisawa, A; Makinouchi, K; Yokokawa, M; Nosé, Y

    2000-08-01

    The Gyro pump has a double pivot bearing system to support its impeller. In this study, the integrity of the bearing system was examined after ex vivo studies. The pumps were implanted into calves and evaluated for different periods as a paracorporeal left ventricular assist device (LVAD). One pump was subjected to a test of 30 days, 1 for 15 days, 4 for 14 days, 1 for 10 days, 1 for 7 days, 2 for 4 days, and 4 for 2 days. One additional pump was subjected to percutaneous cardiopulmonary support (PCPS) condition for 6 days (total pressure head 500 mm Hg with a pump flow rate of 3 L/min). The anticoagulation treatment consisted of a continuous administration of heparin to maintain an achieved clotting time (ACT) of 200-250 s during the LVAD study and 250-300 s during the PCPS study. After the experiment, the pumps were disassembled, and the wear and deformation of male and female bearings were analyzed. There were no dimensional changes on male bearings but there were on female bearings. Wear and deformation of the female bearings were calculated as follows: wear and deformation = (depth of female before pumping) - (depth after pumping). Thirteen assembled Gyro pumps were disassembled to measure the depth of the female bearings before pumping. There was no statistical relationship between the wear and deformation and the motor speed x driving period. From these results, the deformation was not due to wear but to the creep or elastic deformation. This study suggested that the double pivot bearing system of the Gyro pump is highly durable.

  16. The tardigrade Hypsibius dujardini, a new model for studying the evolution of development.

    PubMed

    Gabriel, Willow N; McNuff, Robert; Patel, Sapna K; Gregory, T Ryan; Jeck, William R; Jones, Corbin D; Goldstein, Bob

    2007-12-15

    Studying development in diverse taxa can address a central issue in evolutionary biology: how morphological diversity arises through the evolution of developmental mechanisms. Two of the best-studied developmental model organisms, the arthropod Drosophila and the nematode Caenorhabditis elegans, have been found to belong to a single protostome superclade, the Ecdysozoa. This finding suggests that a closely related ecdysozoan phylum could serve as a valuable model for studying how developmental mechanisms evolve in ways that can produce diverse body plans. Tardigrades, also called water bears, make up a phylum of microscopic ecdysozoan animals. Tardigrades share many characteristics with C. elegans and Drosophila that could make them useful laboratory models, but long-term culturing of tardigrades historically has been a challenge, and there have been few studies of tardigrade development. Here, we show that the tardigrade Hypsibius dujardini can be cultured continuously for decades and can be cryopreserved. We report that H. dujardini has a compact genome, a little smaller than that of C. elegans or Drosophila, and that sequence evolution has occurred at a typical rate. H. dujardini has a short generation time, 13-14 days at room temperature. We have found that the embryos of H. dujardini have a stereotyped cleavage pattern with asymmetric cell divisions, nuclear migrations, and cell migrations occurring in reproducible patterns. We present a cell lineage of the early embryo and an embryonic staging series. We expect that these data can serve as a platform for using H. dujardini as a model for studying the evolution of developmental mechanisms.

  17. Oral Toxicity Study and Skin Sensitization Test of a Cricket

    PubMed Central

    Ryu, Hyeon Yeol; Lee, Somin; Ahn, Kyu Sup; Kim, Hye Jin; Lee, Sang Sik; Ko, Hyuk Ju; Lee, Jin Kyu; Cho, Myung-Haing; Ahn, Mi Young; Kim, Eun Mi; Lim, Jeong Ho; Song, Kyung Seuk

    2016-01-01

    Crickets have been attracting considerable interest in the field of nutrition and toxicology due to the global exhaustion of food resulting from a growing population. The cricket is normally eaten in several countries after roasting, similar to the grasshopper; however, safety evaluation data on cricket powder is limited. Here, we performed general toxicity studies of cricket powder including a single, 2-week repeated dose range evaluation test, a 13-week repeated oral dose toxicity test in Sprague-Dawley rats, a single oral dose toxicity test in Beagle dogs, and a skin sensitization test in guinea pigs following the Organization for Economic Cooperation and Development test guidelines 406 and 408 in addition to Good Laboratory Practice. To investigate the NOAEL and target organs of cricket powder, Sprague-Dawley rats were allocated to 4 groups: vehicle control, 1,250 mg/kg, 2,500 mg/kg, 5,000 mg/kg dose test groups and cricket powder was administered over 13 weeks after single dose and dose range finding studies in rats based on the results of the single oral administration toxicity study in rats and Beagle dogs. The results of the study showed that the NOAEL of cricket powder was over 5,000 mg/kg for both sexes of rats without adverse effects in a 13-week repeated oral toxicity study and there was no skin hypersensitivity reaction. Therefore, our results reveal that crickets can be widely used as a new substitute food or nutrient resource. PMID:27123167

  18. A comparative study of the effects of topical application of Aloe vera, thyroid hormone and silver sulfadiazine on skin wounds in Wistar rats.

    PubMed

    Tarameshloo, Mahsa; Norouzian, Mohsen; Zarein-Dolab, Saeed; Dadpay, Masoomeh; Gazor, Roohollah

    2012-03-01

    Many research studies report the healing effects of Aloe Vera, thyroid hormone cream and silver sulfadiazine. However, the effects of these therapeutic agents are not well understood and have not been compared in one study. This study aimed at investigating the effects of topical application of an Aloe vera gel, a thyroid hormone cream and a silver sulfadiazine cream on the healing of skin wounds surgically induced in Wistar rats for determining the treatment of choice. In a randomized controlled trial, twelve male rats, aged 120 days and with a mean weight of 250 to 300 g, were divided randomly into 5 groups based on drug treatments: Aloe vera gel (AV), thyroid hormone cream (TC), silver sulfadiazine 1% (S), vehicle (V) and control. To evaluate the efficacy of each treatment technique, a biomechanical approach was used to assess tensile stress after 14 days of treatment. Tensile stress was significantly improved in the Aloe vera gel group as compared with the other four groups (P≤0.05). While the other treatment options resulted in better healing than the control group, this difference was not significant. We conclude that Aloe vera topical application accelerated the healing process more than thyroid hormone, silver sulfadiazine and vehicle in surgically induced incisions in rats.

  19. Biofilm forming capacity of Enterococcus faecalis on Gutta-percha points treated with four disinfectants using confocal scanning laser microscope: An in vitro study

    PubMed Central

    Ravi Chandra, Polavarapu Venkata; Kumar, Vemisetty Hari; Reddy, Surakanti Jayaprada; Kiran, Dandolu Ram; Krishna, Muppala Nagendra; Kumar, Golla Vinay

    2015-01-01

    Background: The aim of this study was to evaluate and compare the in vitro biofilm forming capacity of Enterococcus faecalis on Gutta-percha points disinfected with four disinfectants. Materials and Methods: A total of 50 Gutta-percha points used in this study were divided into four test groups based on disinfectant (5.25% sodium hypochlorite, 2% chlorhexidine gluconate, 20% neem, 13% benzalkonium chloride [BAK]), and one control group. The Gutta-percha points were initially treated with corresponding disinfectants followed by anaerobic incubation in Brain Heart Infusion broth suspended with human serum and E. faecalis strain for 14 days. After incubation, these Gutta-percha points were stained with Acridine Orange (Sigma – Aldrich Co., St. Louis, MO, USA) and 0.5 mm thick cross section samples were prepared. The biofilm thickness of E. faecalis was analyzed quantitatively using a confocal scanning laser microscope. Results statistically analyzed using analysis of variance. P < 0.05 was considered to be significant. Results: Confocal scanning laser microscope showed reduced amount of E. faecalis biofilm on Gutta-percha points treated with BAK and sodium hypochlorite. Post-hoc (least square differences) test revealed that there is no statistically significant difference between BAK and sodium hypochlorite groups (P > 0.05). Conclusion: This study illustrates that the Gutta-percha points disinfected with sodium hypochlorite and BAK showed minimal biofilm growth on its surface. PMID:26288622

  20. A fast, sensitive and simple method for mirtazapine quantification in human plasma by HPLC-ESI-MS/MS. Application to a comparative bioavailability study.

    PubMed

    Borges, Ney Carter; Barrientos-Astigarraga, Rafael Eliseo; Sverdloff, Carlos Eduardo; Donato, José Luiz; Moreno, Patricia; Felix, Leila; Galvinas, Paulo Alexandre Rebelo; Moreno, Ronilson Agnaldo

    2012-11-01

    In the present study a simple, fast, sensitive and robust method to quantify mirtazapine in human plasma using quetiapine as the internal standard (IS) is described. The analyte and the IS were extracted from human plasma by a simple protein precipitation with methanol and were analyzed by high-performance liquid chromatography coupled to an electrospray tandem triple quadrupole mass spectrometer (HPLC-ESI-MS/MS). Chromatography was performed isocratically on a C(18), 5 µm analytical column and the run time was 1.8 min. The lower limit of quantitation was 0.5 ng/mL and a linear calibration curve over the range 0.5-150 ng/mL was obtained, showing acceptable accuracy and precision. This analytical method was applied in a relative bioavailability study in order to compare a test mirtazapine 30 mg single-dose formulation vs a reference formulation in 31 volunteers of both sexes. The study was conducted in an open randomized two-period crossover design and with a 14 day washout period. Since the 90% confidence interval for C(max) , AUC(last) and AUC(0-inf) were within the 80-125% interval proposed by the Food and Drug Administration and ANVISA (Brazilian Health Surveillance Agency), it was concluded that mirtazapine 30 mg/dose is bioequivalent to the reference formulation, according to both the rate and extent of absorption.

  1. A comparative study of the effects of topical application of Aloe vera, thyroid hormone and silver sulfadiazine on skin wounds in Wistar rats

    PubMed Central

    Norouzian, Mohsen; Zarein-Dolab, Saeed; Dadpay, Masoomeh; Gazor, Roohollah

    2012-01-01

    Many research studies report the healing effects of Aloe Vera, thyroid hormone cream and silver sulfadiazine. However, the effects of these therapeutic agents are not well understood and have not been compared in one study. This study aimed at investigating the effects of topical application of an Aloe vera gel, a thyroid hormone cream and a silver sulfadiazine cream on the healing of skin wounds surgically induced in Wistar rats for determining the treatment of choice. In a randomized controlled trial, twelve male rats, aged 120 days and with a mean weight of 250 to 300 g, were divided randomly into 5 groups based on drug treatments: Aloe vera gel (AV), thyroid hormone cream (TC), silver sulfadiazine 1% (S), vehicle (V) and control. To evaluate the efficacy of each treatment technique, a biomechanical approach was used to assess tensile stress after 14 days of treatment. Tensile stress was significantly improved in the Aloe vera gel group as compared with the other four groups (P≤0.05). While the other treatment options resulted in better healing than the control group, this difference was not significant. We conclude that Aloe vera topical application accelerated the healing process more than thyroid hormone, silver sulfadiazine and vehicle in surgically induced incisions in rats. PMID:22474470

  2. Evaluation of Mallotus oppositifolius Methanol Leaf Extract on the Glycaemia and Lipid Peroxidation in Alloxan-Induced Diabetic Rats: A Preliminary Study

    PubMed Central

    Nwaehujor, C. O.; Ezeigbo, I. I.; Nwinyi, F. C.

    2013-01-01

    Objective. Mallotus oppositifolius (Geiseler) Müll. Arg. (Euphorbiaceae) is folklorically used to “treat” diabetic conditions in some parts of Nigeria therefore the study, to investigate the extract of the leaves for activities on hyperglycaemia, lipid peroxidation, and increased cholesterol levels in vivo in alloxan diabetic rats as well as its potential antioxidant activity in vitro. Methods. Albino rats (240–280 g) were given an injection of 120 mg/kg body weight, i.p. of alloxan monohydrate. After 8 days, diabetic animals with elevated fasting blood glucose levels (>9 mmol/L) were considered and selected for the study. Results. Oral treatment with the extract administered every 12 h by gavage at doses of 100, 200, and 400 mg/kg of the extract to the test rats, for 14 days, resulted in a significant dose-dependent decrease in blood glucose levels from 12.82 ± 1.02 mmol/dL to 4.92 ± 2.01 mmol/dL at the highest dose of 400 mg/kg compared to the control drug and glibenclamide as well as attendant significant decline in diabetic rats employed in the study. Conclusion. The extract also showed in vitro concentration-dependent antioxidant activity following the 1,1-diphenyl-2-picryl-hydrazyl (DPPH) and ferric reducing assays. Findings further suggest the presence of active antidiabetic and antioxidant principles in M. oppositifolius leaves. PMID:24224091

  3. Erosive potential of commonly used beverages, medicated syrup, and their effects on dental enamel with and without restoration: An in vitro study

    PubMed Central

    Trivedi, Krishna; Bhaskar, Vijay; Ganesh, Mahadevan; Venkataraghavan, Karthik; Choudhary, Prashant; Shah, Shalin; Krishnan, Ramesh

    2015-01-01

    Aim: This study evaluates erosive potential of commonly used beverages, medicated syrup, and their effects on dental enamel with and without restoration in vitro. Materials and Methods: Test medias used in this study included carbonated beverage, noncarbonated beverage, high-energy sports drink medicated cough syrup, distilled water as the control. A total of 110 previously extracted human premolar teeth were selected for the study. Teeth were randomly divided into two groups. Test specimens were randomly distributed to five beverages groups and comprised 12 specimens per group. Surface roughness (profilometer) readings were performed at baseline and again, following immersion for 14 days (24 h/day). Microleakage was evaluated. The results obtained were analyzed for statistical significance using SPSS-PC package using the multiple factor ANOVA at a significance level of P < 0.05. Paired t-test, Friedman test ranks, and Wilcoxon signed ranks test. Results: For surface roughness high-energy sports drink and noncarbonated beverage showed the highly significant difference with P values of 0.000 and 0.000, respectively compared to other test media. For microleakage high-energy sports drink had significant difference in comparison to noncarbonated beverage (P = 0.002), medicated syrup (P = 0.000), and distilled water (P = 0.000). Conclusion: High-energy sports drink showed highest surface roughness value and microleakage score among all test media and thus greater erosive potential to enamel while medicated syrup showed least surface roughness value and microleakage among all test media. PMID:26538901

  4. FOURTEEN-DAY TOXICITY STUDY OF 1,3,5-TRINITROBENZENE IN FISCHER 344 RATS

    EPA Science Inventory

    Toxic effects of 1,3,5-trinitrobenzene (TNB) in male and female rats were evaluated by feeding powdered certified laboratory chow diet supplemented with varied concentrations of TNB (0,50,200,400,800 and 1200 mg kg-1 diet) for 14 days. Food intake by female rats in 400,800 and 12...

  5. TGA and DTA studies of solvent-exchanged gels

    SciTech Connect

    Leeb, K.; Durakpasa, H.; Breiter, M.W.

    1994-12-31

    Sols were prepared in the system TMOS:H{sub 2}O:SOLV:HCl with molar ratios of 1:4:3:0.0005 for SOLV = MEOH, ETOH and DMF. The gelation and aging of these sols took place in cuvettes covered by parafilm. The gels were removed from the cuvettes 14 days after gelation. Solvent exchange was carried out in each of the three solvents for a period of 14 days. Starting with fresh solvent, the exchange was repeated three times. TGA and DTA curves were taken with pieces of the original gels and of gels after the 2nd and 3rd solvent exchange. The TGA curves display a considerable weight loss in the temperature range of solvent evaporation. A small step is observed at higher temperatures if MEOH or ETOH represent the exchange solvent. The DTA curves allow a distinction what mixtures of solvents are present. The effectiveness of the solvent exchange can be evaluated.

  6. Double-blind, randomised, placebo-controlled study of two concentrations of azelastine eye drops in seasonal allergic conjunctivitis or rhinoconjunctivitis.

    PubMed

    Lenhard, G; Mivsek-Music, E; Perrin-Fayolle, M; Obtulowicz, K; Secchi, A

    1997-01-01

    This double-blind, randomised, placebo-controlled study was carried out to assess the efficacy and safety of 0.025% and 0.05% azelastine eye drops twice daily administered for 14 days to patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. A total of 278 patients were recruited and 226 patients were evaluable for per protocol analysis. The target parameter was the response rate. Four eye symptoms, including the main symptom (itching) were recorded by patients in diaries and eight symptoms were assessed by physicians before and after seven and 14 days of treatment. Severity of symptoms was measured on a four-point scale. The response rates for itching (improvement of at least one score point within the first three days) according to patient assessment were 43% for placebo, 52% for 0.025% and 56% for 0.05% azelastine (NS). However, a more objective assessment of the three main eye symptoms by physicians showed a concentration-dependent improvement in response rate compared with placebo (a decrease of > or = 3 points from a baseline total score of > or = 6), which reached statistical significance for 0.05% azelastine on Day 7 (p < 0.002). In the evaluable patient population, the scores of the three main eye symptoms as well as of all eight recorded eye symptoms, as assessed by the physician, were significantly (p < 0.05) lower in the 0.05% azelastine eye drops group in comparison with the placebo group at Day 7. Inefficacy was the cause of withdrawal in five and three patients on 0.025% and 0.05% azelastine, respectively, and in six patients on placebo. Adverse drug effects, mainly a mild, transient irritation and a bitter or unpleasant taste, were reported by 14% (0.025%), 20% (0.05%) and 15% (placebo) of the patients. No serious side-effects occurred. Azelastine eye drops are effective and well tolerated at a concentration of 0.05% for the treatment of seasonal allergic conjunctivitis.

  7. Ultrasound-Guided Pulsed Radiofrequency for Carpal Tunnel Syndrome: A Single-Blinded Randomized Controlled Study

    PubMed Central

    2015-01-01

    Objective We assessed the therapeutic efficiency of ultrasound-guided pulsed radiofrequency (PRF) treatment of the median nerve in patients with carpal tunnel syndrome (CTS). Methods We conducted a prospective, randomized, controlled, single-blinded study. Forty-four patients with CTS were randomized into intervention or control groups. Patients in the intervention group were treated with PRF and night splint, and the control group was prescribed night splint alone. Primary outcome was the onset time of significant pain relief assessed using the visual analog scale (VAS), and secondary outcomes included evaluation of the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) results, cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity (SNCV) of the median nerve, and finger pinch strength. All outcome measurements were performed at 1, 4, 8, and 12 weeks after treatment. Results Thirty-six patients completed the study. The onset time of pain relief in the intervention group was significantly shorter (median onset time of 2 days vs. 14 days; hazard ratio = 7.37; 95% CI, 3.04–17.87) compared to the control group (p < 0.001). Significant improvement in VAS and BCTQ scores (p < 0.05) was detected in the intervention group at all follow-up periods compared to the controls (except for the severity subscale of BCTQ at week 1). Ultrasound-guided PRF treatment resulted in a lower VAS score and stronger finger pinch compared to the control group over the entire study. Conclusions Our study shows that ultrasound-guided PRF serves as a better approach for pain relief in patients with CTS. Trial Registration ClinicalTrials.gov NCT02217293 PMID:26067628

  8. Acute oral toxicity and biodistribution study of zinc-aluminium-levodopa nanocomposite

    NASA Astrophysics Data System (ADS)

    Kura, Aminu Umar; Saifullah, Bullo; Cheah, Pike-See; Hussein, Mohd Zobir; Azmi, Norazrina; Fakurazi, Sharida

    2015-03-01

    Layered double hydroxide (LDH) is an inorganic-organic nano-layered material that harbours drug between its two-layered sheets, forming a sandwich-like structure. It is attracting a great deal of attention as an alternative drug delivery (nanodelivery) system in the field of pharmacology due to their relative low toxic potential. The production of these nanodelivery systems, aimed at improving human health through decrease toxicity, targeted delivery of the active compound to areas of interest with sustained release ability. In this study, we administered zinc-aluminium-LDH-levodopa nanocomposite (ZAL) and zinc-aluminium nanocomposite (ZA) to Sprague Dawley rats to evaluate for acute oral toxicity following OECD guidelines. The oral administration of ZAL and ZA at a limit dose of 2,000 mg/kg produced neither mortality nor acute toxic signs throughout 14 days of the observation. The percentage of body weight gain of the animals showed no significant difference between control and treatment groups. Animal from the two treated groups gained weight continuously over the study period, which was shown to be significantly higher than the weight at the beginning of the study ( P < 0.05). Biochemical analysis of animal serum showed no significant difference between rats treated with ZAL, ZA and controls. There was no gross lesion or histopathological changes observed in vital organs of the rats. The results suggested that ZAL and ZA at 2,000 mg/kg body weight in rats do not induce acute toxicity in the animals. Elemental analysis of tissues of treated animals demonstrated the wider distribution of the nanocomposite including the brain. In summary, findings of acute toxicity tests in this study suggest that zinc-aluminium nanocomposite intercalated with and the un-intercalated were safe when administered orally in animal models for short periods of time. It also highlighted the potential distribution ability of Tween-80 coated nanocomposite after oral administration.

  9. Immunohistochemical Approach to Study Cylindrospermopsin Distribution in Tilapia (Oreochromis niloticus) under Different Exposure Conditions

    PubMed Central

    Guzmán-Guillén, Remedios; Gutiérrez-Praena, Daniel; Risalde, María de los Ángeles; Moyano, Rosario; Prieto, Ana Isabel; Pichardo, Silvia; Jos, Ángeles; Vasconcelos, Vitor; Cameán, Ana María

    2014-01-01

    Cylindrospermopsin (CYN) is a cytotoxic cyanotoxin produced by several species of freshwater cyanobacteria (i.e., Aphanizomenon ovalisporum). CYN is a tricyclic alkaloid combined with a guanidine moiety. It is well known that CYN inhibits both protein and glutathione synthesis, and also induces genotoxicity and the alteration of different oxidative stress biomarkers. Although the liver and kidney appear to be the main target organs for this toxin based on previous studies, CYN also affects other organs. In the present study, we studied the distribution of CYN in fish (Oreochromis niloticus) under two different exposure scenarios using immunohistochemical (IHC) techniques. In the first method, fish were exposed acutely by intraperitoneal injection or by gavage to 200 µg pure CYN/Kg body weight (bw), and euthanized after 24 h or five days of exposure. In the second method, fish were exposed by immersion to lyophilized A. ovalisporum CYN-producing cells using two concentration levels (10 or 100 µg/L) for two different exposure times (7 or 14 days). The IHC was carried out in liver, kidney, intestine, and gills of fish. Results demonstrated a similar pattern of CYN distribution in both experimental methods. The organ that presented the most immunopositive results was the liver, followed by the kidney, intestine, and gills. Moreover, the immunolabeling signal intensified with increasing time in both assays, confirming the delayed toxicity of CYN, and also with the increment of the dose, as it is shown in the sub-chronic assay. Thus, IHC is shown to be a valuable technique to study CYN distribution in these organisms. PMID:24406981

  10. Predictors of opioid efficacy in patients with chronic pain: A prospective multicenter observational cohort study

    PubMed Central

    Olesen, Anne E.; Gram, Mikkel; Jonsson, Torsten; Kamp-Jensen, Michael; Andresen, Trine; Nielsen, Christian; Pozlep, Gorazd; Pfeiffer-Jensen, Mogens; Morlion, Bart; Drewes, Asbjørn M.

    2017-01-01

    Opioids are increasingly used for treatment of chronic pain. However, they are only effective in a subset of patients and have multiple side effects. Thus, studies using biomarkers for response are highly warranted. The current study prospectively examined 63 opioid-naïve patients initiating opioid use for diverse types of chronic pain at five European centers. Quantitative sensory testing, electroencephalography (EEG) recordings, and assessment of pain catastrophizing were performed prior to treatment. The co-primary outcomes were change from baseline in ratings of chronic pain and quality of life after 14 days of opioid treatment. Secondary outcomes included patient’s global impression of clinical change and side effects. Logistic regression models adjusted for age and sex were used to identify biomarkers predictive for successful treatment, defined as at least a 30% reduction in average pain intensity or an improvement in quality of life of at least 10 scale points. Fifty-nine patients (94%) completed the study. The mean age was 55 ± 16 years and 69% were females. Pain reduction was predicted by cold pain intensity (OR: 0.69; P = 0.01), pain catastrophizing (OR: 0.82; P = 0.03), relative delta (OR: 0.76; P = 0.03) and beta EEG activity (OR: 1.18; P = 0.04) induced by experimental cold pain. None of the study variables were related to improvement in quality of life. For the first time, individual pain processing characteristics have been linked to opioid response in a mixed chronic pain population. This has the potential to personalize treatment of chronic pain and restrict opioid use to patients with high likelihood for response. PMID:28158269

  11. Transport and evolution of a pollution plume from northern China: A satellite-based case study

    NASA Astrophysics Data System (ADS)

    Li, Can; Krotkov, Nickolay A.; Dickerson, Russell R.; Li, Zhanqing; Yang, Kai; Chin, Mian

    2010-04-01

    On 5 April 2005, during the East Asian Study of Tropospheric Aerosols: An International Regional Experiment (EAST-AIRE) aircraft campaign, heavy loadings of SO2 (20 ppb near ground, 1-3 ppb at ˜2 km altitude) and dust with aerosol optical depth of ˜1 were measured over Shenyang, an industrialized city ˜600 km NE of Beijing. In this study, Ozone Monitoring Instrument (OMI) and MODIS satellite sensors are employed to look into this air pollution episode at a regional scale and to track the transport and evolution of the plume from China to the NW Pacific on the following days. A method is proposed to combine in situ measurements and trajectory tracer modeling with satellite observations to quantify the change in the SO2 mass during plume transport. We demonstrate that an air mass factor correction is needed for quantitative use of the OMI SO2 data, to account for the effects of the viewing geometry, the SO2 profile shape, and the aerosol/cloud interference on retrievals. The total SO2 loading of the plume decreased from ˜1.1 × 1011 g on 5 April to ˜5.0 × 1010 g on 7 April. The overall, e-folding lifetime of SO2 in this plume, empirically derived from the rate of SO2 decay, was ˜2 days (range of 1-4 days). SO2 to sulfate conversion increased the aerosol optical depth by ˜0.1-0.4 near the center of the plume on 6 and 7 April, while the loss of primary dust particles reduced the aerosol loading of the plume by a similar amount. Simulations with a chemical transport model suggest similar loss of dust and formation of sulfate within the plume during transport. The method established in this study can be further developed and applied to study other episodes of pollution transport and their impact on weather and climate.

  12. The effect of fluoride toothpaste on root dentine demineralization progression: a pilot study.

    PubMed

    Botelho, Juliana Nunes; Del Bel Cury, Altair Antoninha; Silva, Wander Jose da; Tenuta, Livia Maria Andalo; Cury, Jaime Aparecido

    2014-01-01

    The anticaries effect of fluoride (F) toothpaste containing 1100 µg F/g in reducing enamel demineralization is well established, but its effect on dentine has not been extensively studied. Furthermore, it has been shown that toothpaste containing a high F concentration is necessary to remineralize root dentine lesions, suggesting that a 1100 µg F/g concentration might not be high enough to reduce root dentine demineralization, particularly when dentine is subjected to a high cariogenic challenge. Thus, the aim of this pilot study was to evaluate in situ the effect of F toothpaste, at a concentration of 1100 µg F/g, on dentine demineralization. In a crossover and double-blind study, conducted in two phases of 14 days, six volunteers wore a palatal appliance containing four slabs of bovine root dentine whose surface hardness (SH) was previously determined and to which a 10% sucrose solution was applied extra-orally 8×/day. Volunteers used a non-F toothpaste (negative control) or F toothpaste (1100 µg F/g, NaF/SiO2) three times a day. On the 10th and 14th days of each phase, two slabs were collected and SH was determined again. Dentine demineralization was assessed as percentage of SH loss (%SHL). The effect of toothpaste was significant, showing lower %SHL for the F toothpaste group (42.0 ± 9.7) compared to the non-F group (62.0 ± 6.4; p < 0.0001), but the effect of time was not significant (p > 0.05). This pilot study suggests that F toothpaste at 1100 µg F/g is able to decrease dentine caries even under a high cariogenic challenge of biofilm accumulation and sugar exposure.

  13. Vegetative Erosion Control Studies Tennessee-Tombigbee Waterway.

    DTIC Science & Technology

    1981-01-01

    coated seed , bahiagrass seed is often mechanically scarified to improve germination . Average germination time for bahiagrass is 12-14 days. Bahiagrass...establishment and temporary cover. It germinates in 4-5 days and has a rapid rate of establishment following germination . Annual ryegrass seed is widely...temperature tolerance for seed germination . The major uses of a.,nual rye- grass for soil stabilization on distributed soil is for rapid soil

  14. [Reproductive and developmental toxicity study of prednisolone farnesylate (PNF)--study by subcutaneous administration of PNF prior to and in the early stages of pregnancy in rats].

    PubMed

    Taniguchi, H; Yoshitomi, H; Miyazaki, K; Koga, N; Himeno, Y; Hara, Y; Nakamura, M; Tsuji, M; Tanaka, H; Shinomiya, M

    1992-11-01

    A fertility study of Prednisolone farnesylate (PNF), a newly synthesized corticosteroid, was conducted in Sprague-Dawley rats. This compound was administered subcutaneously at dose levels of 0(control), 0.04, 0.2 and 1 mg/kg/day to males for 63 days before mating and during the mating period, and to females for 14 days before mating, through the mating period and until day 7 of pregnancy. Each 24 male and female rats were mated, and females were killed on day 20 of pregnancy to examine their fetuses. 1. In the parental animals, loss of fur or thin fur and incrustation of treated site occurred in male rats treated at doses of 0.2 mg/kg or more and female rats treated at dose of 1 mg/kg, and at the same dose groups, the thinning of skin, atrophy of the thymus and intention of the substance at the injected site were noted. Moreover, body weight gains and food consumption were suppressed in both sexes treated at the dose of 1 mg/kg. 2. Fertility and reproductive ability in both sexes, and estrus cycles in female rats were not affected by administration of PNF. 3. In the fetuses, no embryonic or fetal lethal effect and teratogenic effect were noted. From these results, the no-effect dose levels of PNF on the parental general states, the parental reproductive ability and those of the fetuses are thought to be 0.04 mg/kg/day, 1 mg/kg/day or more and 1 mg/kg/day or more, respectively, under the experimental conditions of this study.

  15. A phase 2 study of fluorouracil/leucovorin in combination with paclitaxel and oxaliplatin as a salvage treatment in patients with refractory or relapsed advanced gastric cancer.

    PubMed

    Lin, Rongbo; Fan, Nanfeng; Wu, Guangfeng; Chen, Ying; Guo, Zengqing; Wang, Xiaojie; Jin, Feng; Chen, Ling; Liu, Jie

    2015-02-01

    The aim of this study was to evaluate the efficacy and safety of paclitaxel plus oxaliplatin plus fluorouracil/leucovorin (POF) as salvage chemotherapy in pretreated advanced gastric cancer. Fifty-two pretreated patients with the advanced gastric cancer were eligible for this study. The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m(2)) followed by oxaliplatin (85 mg/m(2)) and leucovorin (400 mg/m(2)), administered simultaneously over a 2-hour infusion period, followed by an infusion of fluorouracil (2400 mg/m(2)) over a 46-hour period, every 14 days. From an intention-to-treat analysis, overall response rate and stable disease rate were 28.8 and 38.5%, respectively. The median time to progression and overall survival were 4.1 and 7.9 months, respectively. Grade 3 or 4 neutropaenia, thrombocytopaenia, fatigue, and neuropathy were 38.5, 15.4, 17.3, and 15.4%, respectively. The POF regimen is active in pretreated advanced gastric cancer as salvage chemotherapy, with a favourable toxicity profile.

  16. A PET study with [11-C]raclopride in Parkinson's disease: preliminary results on the effect of amantadine on the dopaminergic system.

    PubMed

    Volonté, M A; Moresco, R M; Gobbo, C; Messa, C; Carpinelli, A; Rizzo, G; Comi, G; Fazio, F

    2001-02-01

    Amantadine has been proved to be beneficial in Parkinson's disease. Although it is still uncertain which neurochemical events are modified at therapeutic doses, an increase in dopaminergic tone secondary to NMDA receptor blockade and a direct inhibition of the glutamatergic overactivity have been suggested to be involved in its clinical effects. The aim of this study was to evaluate the effects of amantadine on the dopaminergic system by measuring the in vivo binding of [11-C]raclopride to D2 dopamine receptors in the basal ganglia of 6 patients with idiopathic Parkinson's disease. Each patient underwent a PET study, before and after 14 days of treatment with amantadine (200 mg/day). Repeated treatment with therapeutic doses of amantadine induced a moderate increase in the in vivo binding of [11C]raclopride in the putamen of PD patients. This observation indicates that in PD patients, 200 mg/day amantadine does not produce an increase in extracellular levels of dopamine sufficiently to inhibit raclopride binding or that, if present, is it masked by a concurrent increase in receptor availability, as recently reported in rat striatum.

  17. On the central mechanism underlying ghrelin's chronic pro-obesity effects in rats: new insights from studies exploiting a potent ghrelin receptor antagonist.

    PubMed

    Salomé, N; Hansson, C; Taube, M; Gustafsson-Ericson, L; Egecioglu, E; Karlsson-Lindahl, L; Fehrentz, J A; Martinez, J; Perrissoud, D; Dickson, S L

    2009-09-01

    In the present study, we explore the central nervous system mechanism underlying the chronic central effects of ghrelin with respect to increasing body weight and body fat. Specifically, using a recently developed ghrelin receptor antagonist, GHS-R1A (JMV2959), we investigate the role of GHS-R1A in mediating the effects of ghrelin on energy balance and on hypothalamic gene expression. As expected, in adult male rats, chronic central treatment with ghrelin for 14 days, when compared to vehicle-treated control rats, resulted in an increased body weight, lean mass and fat mass (assessed by dual X-ray absorptiometry), dissected white fat pad weight, cumulative food intake, food efficiency, respiratory exchange ratio and a decrease of energy expenditure. Co-administration of the ghrelin receptor antagonist JMV2959 suppressed/blocked the majority of these effects, with the notable exception of ghrelin-induced food intake and food efficiency. The hypothesis emerging from these data, namely that GHS-R1A mediates the chronic effects of ghrelin on fat accumulation, at least partly independent of food intake, is discussed in light of the accompanying data regarding the hypothalamic genes coding for peptides and receptors involved in energy balance regulation, which were found to have altered expression in these studies.

  18. Hymecromone in the treatment of motor disorders of the bile ducts: a multicenter, double-blind, placebo-controlled clinical study.

    PubMed

    Abate, A; Dimartino, V; Spina, P; Costa, P L; Lombardo, C; Santini, A; Del Piano, M; Alimonti, P

    2001-01-01

    Biliary dyskinesia is frequently encountered in clinical practice and is characterized by pain during or after meals. The present study was designed to assess the action of hymecromone in patients with motor disorders of the bile ducts. One hundred twenty-three patients (36 men and 87 women) were enrolled in the multicenter double-blind placebo-controlled study. The mean age was 60.3 years +/- 14.2 SD. Diagnosis was dyspepsia in 58 patients, dyskinesia in 59, cholelithiasis in five and hepatopathy in one. The patients were divided into two groups. One group (61 patients) was treated with hymecromone (300 mg tablets at a dosage of 1,200 mg/day, 2 tablets midday and evening) and another group (62 patients) was treated with placebo. Treatment lasted for 14 days. Control of dyspepsia and pain symptoms of biliary origin was more marked and constant with hymecromone than with placebo. By the end of the treatment, patients in the hymecromone group showed a 70.3% reduction in intensity of spontaneous abdominal pain, while the placebo group showed a 43.8% reduction. Hymecromone was well accepted by the patients and judged to be effective by the investigator in 88.5% of patients treated. The possibility of using hymecromone in 300-mg tablets in the treatment of motor disorders of the bile ducts is thus confirmed.

  19. Randomized 5-treatment crossover study to assess the effects of external heat on serum fentanyl concentrations during treatment with transdermal fentanyl systems.

    PubMed

    Moore, Kenneth T; Sathyan, Gayatri; Richarz, Ute; Natarajan, Jaya; Vandenbossche, Joris

    2012-08-01

    This randomized, open-label, 5-treatment, 5-sequence crossover study was designed to evaluate the effects of a heating pad on serum fentanyl concentrations with reservoir and matrix transdermal fentanyl systems. Subjects were randomized to 1 of 5 treatment sequences, receiving 5 fentanyl treatments (1 per period) for 36 hours: 25 µg/h reservoir without heat, 25 µg/h reservoir with heat, 25 µg/h matrix without heat, 25 µg/h matrix with heat, and a 50 µg/h reservoir without heat. The 25 µg/h systems with heat had a heating pad applied from 0 to 10 and 26 to 36 hours post application. Washout periods between treatments were 5 to 14 days. Naltrexone was given to block the opioid effects of fentanyl. Study results indicate that external heat had a similar effect on both matrix and reservoir systems, with heat applied during the first 10 hours of treatment increasing fentanyl exposure by approximately 61% to 81% at 10 hours (observed serum concentration at 10 hours) and overall exposure (area under the curve from 0 to 10 hours) by approximately 120% to 184%, but had minimal effect from 26 to 36 hours. The increased exposure observed with heat in both 25 µg/h systems, between 0 and 10 hours, was higher than that obtained with the 50 µg/h reservoir system applied without heat.

  20. Single- and repeated-dose oral toxicity studies of citicoline free-base (choline cytidine 5'-pyrophosphate) in Sprague-Dawley rats.

    PubMed

    Schauss, A G; Somfai-Relle, S; Financsek, I; Glavits, R; Parent, S C; Endres, J R; Varga, T; Szücs, Z; Clewell, A

    2009-01-01

    The dietary supplement Citicoline free-base (choline cytidine 5'-pyrophosphate) was toxicologically evaluated in Sprague-Dawley rats using oral gavage. In an acute 14-day study, 2000 mg/kg was well tolerated. In a 90-day study, 100, 350, and 1000 mg/kg/day doses resulted in no mortality. In males, slight significant increases in serum creatinine (350 and 1000 mg/kg/day), and decreases in urine volume (all treated groups) were observed. In females, slight significant increases in total white blood cell and absolute lymphocyte counts (1000 mg/kg/day), and blood urea nitrogen (BUN) (100 and 350, but not 1000 mg/kg/day) were noted. A dose-related increase in renal tubular mineralization, without degenerative or inflammatory reaction, was found in females (all treated groups) and two males (1000 mg/kg/day). Renal mineralization in rats (especially females) is influenced by calcium:phosphorus ratios in the diet. A high level of citicoline consumption resulted in increased phosphorus intake in the rats, and likely explains this result.

  1. Phase I randomised double-blind pilot study of micronized resveratrol (SRT501) in patients with hepatic metastases - safety, pharmacokinetics and pharmacodynamics

    PubMed Central

    Howells, L. M.; Berry, D. P.; Elliott, P.J.; Jacobson, E. W.; Hoffmann, E.; Hegarty, B.; Brown, K.; Steward, W. P.; Gescher, A. J.

    2011-01-01

    The phytochemical resveratrol has undergone extensive preclinical investigation for its putative cancer chemopreventive properties. Low systemic availability of the parent compound due to rapid and extensive metabolism, may confound its usefulness as a potential agent to prevent malignancies in organs remote from the site of absorption. Micronization allows increased drug absorption, thus increasing availability. Here we describe a pilot study of SRT501, micronized resveratrol, given at 5.0 g daily for 14 days, to patients with colorectal cancer and hepatic metastases scheduled to undergo hepatectomy. The purpose of the study was to assess the safety, pharmacokinetics and pharmacodynamics of the formulation. SRT501 was found to be well tolerated. Mean plasma resveratrol levels following a single dose of SRT501 administration were 1942±1422 ng/mL, exceeding those published for equivalent doses of non-micronized resveratrol by 3.6-fold. Resveratrol was detectable in hepatic tissue following SRT501 administration (up to 2287 ng/g). Cleaved caspase-3, a marker of apoptosis, was significantly increased by 39% in malignant hepatic tissue following SRT501 treatment, compared to tissue from the placebo-treated patients. SRT501 warrants further clinical exploration to assess its potential clinical utility. PMID:21680702

  2. How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study

    PubMed Central

    Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Burucoa, Christophe

    2015-01-01

    Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI. PMID:26637380

  3. How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study.

    PubMed

    Bémer, Pascale; Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Corvec, Stéphane; Burucoa, Christophe

    2016-02-01

    Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI.

  4. [A kinetic study of gamma interferon production in herpes simplex virus-1 DNA prime-protein boost regimen comparing to DNA or subunit vaccination].

    PubMed

    Arefian, Ehsan; Bamdad, Taravat; Soleimanjahi, Hoorieh; Akhood, Mohamad Reza; Parsania, Masaoud; Ghaemi, Amir

    2009-01-01

    The vast majority of the world's population is infected with Herpes simplex virus (HSV). Although antiviral therapy can reduce the incidence of reactivation and asymptomatic viral shedding, and limit morbidity and mortality from active disease, it cannot cure infection. Therefore, the development of an effective vaccine is an important global health priority. In this study, the induction of IFN-gamma production was compared by different herpes simplex virus 1 (HSV1) vaccines. Glycoprotein D (gD1) as a major immunogenic HSV1 glycoprotein was chosen to our study. Balb/c mice were administered with DNA vaccine encoding gD1, subunit glycoprotein vaccine including insect cells infected by a gD1 recombinant Baculovirus, prime DNA vaccine boosted by subunit glycoprotein vaccine, inactivated KOS strain as a positive control, PcDNA3 plasmid and Sf9 cells as a negative control. Evaluation tests showed kinetics of IFN-gamma mRNA at 8, 16 and 32 hours after restimulation sharply decreased whereas, IFN-gamma protein is significantly increased. Our results revealed that at 14 days after immunization IFN-gamma secretion of stimulated cells in all of the vaccinate groups dramatically raised rather than secreted IFN-gamma levels in mice that were analyzed at 7 days after vaccination. In comparison to other groups; Prime-Boost immunization dramatically caused vigorous and prompt IFN-gamma production at 7 days after immunization and 8 hours after restimulation.

  5. Comparative study of the topical application of Aloe vera gel, therapeutic ultrasound and phonophoresis on the tissue repair in collagenase-induced rat tendinitis.

    PubMed

    Maia Filho, Antonio Luiz Martins; Villaverde, Antonio Balbin; Munin, Egberto; Aimbire, Flávio; Albertini, Regiane

    2010-10-01

    The aim of our study was to compare topical use of Aloe vera gel, pulsed mode ultrasound (US) and Aloe vera phonophoresis on rat paw with collagenase-induced tendinitis. Edema size, tensile tendon strength, tendon elasticity, number of inflammatory cells and tissue histology were studied at 7 and 14 days after tendinitis induction. Pulse mode US parameters were: 1 MHz frequency, 100 Hz repetition rate, 10% duty cycle, and 0.5 W/cm(2) intensity, applied for 2 min each session. A 0.5 mL of Aloe vera gel at 2% concentration was applied for 2 min per session, topically and by phonophoresis. Topical application of Aloe vera gel did not show any statistically significant improvement in the inflammatory process, whereas phonophoresis enhanced the gel action reducing edema and number of inflammatory cells, promoting the rearrangement of collagen fibers and promoting also the recovery of the tensile strength and elasticity of the inflamed tendon to recover their normal pre-injury status. Results seem to indicate that Aloe vera phonophoresis is a promising technique for tendinitis treatment, without the adverse effect provoked by systemic anti-inflammatory drugs.

  6. Safety and Biosimilarity of ior(®)LeukoCIM Compared to Neupogen(®) Based on Toxicity, Pharmacodynamic, and Pharmacokinetic Studies in the Sprague-Dawley Rat.

    PubMed

    Licollari, Albert; Riddle, Katherine; Taylor, Simon R; Ledon, Nuris; Bolger, Gordon T

    2017-02-24

    This study examined the safety, pharmacodynamic and pharmacokinetic similarity of the human recombinant filgrastim products ior(®)LeukoCIM and Neupogen(®) following a 28-day repeated subcutaneous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology, and pathology findings for control rats dosed with vehicle and rats dosed either with 15, 75, and 150 μg/kg of ior(®)LeukoCIM or with 150 μg/kg of Neupogen(®). The major adverse treatment-related clinical finding was mild to severe swelling of the hock-joint (tarsal joint) and hind limb, alone or accompanied with lameness which was more prominent in males and which had a similar frequency of occurrence for both ior(®)LeukoCIM and Neupogen(®). All adverse findings were fully reversible. As expected, ior(®)LeukoCIM and Neupogen(®) both increased white blood cell and neutrophil levels in rats and to a similar extent for high-dose ior(®)LeukoCIM and Neupogen(®). The pharmacokinetics of filgrastim following dosing with ior(®)LeukoCIM were well behaved and comparable for high-dose ior(®)LeukoCIM and Neupogen(®). The results of this study imply that ior(®)LeukoCIM and Neupogen(®) had similar safety profiles, pharmacodynamic responses, and pharmacokinetic profiles that suggest they are biosimilar.

  7. Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)

    PubMed Central

    Gudiol, C; Royo-Cebrecos, C; Tebe, C; Abdala, E; Akova, M; Álvarez, R; Maestro-de la Calle, G; Cano, A; Cervera, C; Clemente, W T; Martín-Dávila, P; Freifeld, A; Gómez, L; Gottlieb, T; Gurguí, M; Herrera, F; Manzur, A; Maschmeyer, G; Meije, Y; Montejo, M; Peghin, M; Rodríguez-Baño, J; Ruiz-Camps, I; Sukiennik, T C; Carratalà, J

    2017-01-01

    Introduction Bloodstream infection (BSI) due to extended-spectrum β-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although β-lactam/β-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. Methods and analysis A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. Sample size The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. Ethics and dissemination The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group

  8. Hypoglycemic and anti-hyperglycemic study of Gynura procumbens leaf extracts

    PubMed Central

    Algariri, Khalid; Meng, Kuong Y; Atangwho, Item J; Asmawi, Mohd Z; Sadikun, Amirin; Murugaiyah, Vikneswaran; Ismail, Norhyati

    2013-01-01

    Objective To study the antidiabetic activity of Gynura procumbens (G. procumbens) used in the traditional management of diabetes in Southern Asia. Methods G. procumbens leaves were extracted sequentially with graded percentage of ethanol in water (95%, 75%, 50%, 25% and 0%), and the extracts were tested for antidiabetic activity using acute (7 h), subcutaneous glucose tolerance test and sub-chronic (14 d) test in non-diabetic and streptozotocin-induced diabetic rats. The extracts were further subjected to phytochemical studies. Results In acute dose (1 g/kg), the extracts significantly lowered fasting blood glucose (FBG) in streptozotocin-induced diabetic rats (P<0.05). However, the FBG-lowering effect of the 25% extract compared to the other extracts, was rapid (47% after 2 h) and the highest: 53%, 53% and 60% in the 3rd, 5th, and 7th h, respectively (P<0.05), comparable only to the effect of metformin. Furthermore, the extracts suppressed peak FBG in subcutaneous glucose tolerance test, but only the 0% and 25% extracts, and metformin sustained the decrease until the 90th min (P<0.05). Moreover, in the 14 days study, the 25% extract exerted the highest FBG-lowering effect, namely 49.38% and 65.43% on days 7 and 14, respectively (P<0.05), similar to the effect of metformin (46.26% and 65.42%). Total flavanoid and phenolic contents in the extracts were found to decrease with increase in polarity of extraction solvents. The composition of reference compounds (chlorogenic acid, rutin, astragalin and kaempferol-3-O-rutinoside) followed a similar trend. Conclusions G. procumbens contains antidiabetic principles, most extracted in 25% ethanol. Interaction among active components appears to determine the antidiabetic efficacy, achieved likely by a metformin-like mechanism. PMID:23646298

  9. Impact of oseltamivir use on the reduction of complications in patients with influenza: a prospective study.

    PubMed

    Vardakas, Konstantinos Z; Theocharis, George; Tansarli, Giannoula S; Rafailidis, Petros; Falagas, Matthew E

    2016-09-01

    To evaluate the factors associated with oseltamivir prescription and to study the effectiveness of oseltamivir in reducing influenza-related complications. A prospective cohort study using the SOS Doctors (a network of physicians who perform house-call visits in Attica, Greece). Patients with confirmed or clinically suspected influenza were followed up to 14 days during the 2011-2012 influenza period. 410 patients with confirmed or suspected influenza were included. Healthy adults were mainly enrolled, with a median age of 44 years. Influenza diagnosis was mainly based on clinical criteria (65.8 % of patients). Oseltamivir was prescribed for 45.4 % of them. In a multivariate analysis, prescription of oseltamivir was associated with the attending physician (p < 0.001), positive influenza test (p < 0.001) and diabetes (p = 0.027). Data on complications were available for 351 patients, and 50 (15.8 %) of them reported at least one. Seven patients required hospitalization. Types of complications (pneumonia, bronchitis, etc.) were not significantly different between patients receiving and those not receiving oseltamivir. In the multivariate analysis, higher oseltamivir prescription rate was associated with fewer complications (p < 0.001). Bearing in mind the limitations of a non-randomized study, in a real-life setting, oseltamivir prescription and the rate of complications in patients with influenza were associated with the attending physician, underlying diseases and diagnostic tests. Overall, when the frequency of oseltamivir prescription increased, the influenza-related complications decreased.

  10. Favipiravir Pharmacokinetics in Nonhuman Primates and Insights for Future Efficacy Studies of Hemorrhagic Fever Viruses.

    PubMed

    Madelain, Vincent; Guedj, Jérémie; Mentré, France; Nguyen, Thi Huyen Tram; Jacquot, Frédéric; Oestereich, Lisa; Kadota, Takumi; Yamada, Koichi; Taburet, Anne-Marie; de Lamballerie, Xavier; Raoul, Hervé

    2017-01-01

    Favipiravir is an RNA polymerase inhibitor that showed strong antiviral efficacy in vitro and in small-animal models of several viruses responsible for hemorrhagic fever (HF), including Ebola virus. The aim of this work was to characterize the complex pharmacokinetics of favipiravir in nonhuman primates (NHPs) in order to guide future efficacy studies of favipiravir in large-animal models. Four different studies were conducted in 30 uninfected cynomolgus macaques of Chinese (n = 17) or Mauritian (n = 13) origin treated with intravenous favipiravir for 7 to 14 days with maintenance doses of 60 to 180 mg/kg of body weight twice a day (BID). A pharmacokinetic model was developed to predict the plasma concentrations obtained with different dosing regimens, and the model predictions were compared to the 50% effective concentration (EC50) of favipiravir against several viruses. Favipiravir pharmacokinetics were described by a model accounting for concentration-dependent aldehyde oxidase inhibition. The enzyme-dependent elimination rate increased over time and was higher in NHPs of Mauritian origin than in those of Chinese origin. Maintenance doses of 100 and 120 mg/kg BID in Chinese and Mauritian NHPs, respectively, are predicted to achieve median trough plasma free concentrations above the EC50 for Lassa and Marburg viruses until day 7. For Ebola virus, higher doses are required. After day 7, a 20% dose increase is needed to compensate for the increase in drug clearance over time. These results will help rationalize the choice of dosing regimens in future studies evaluating the antiviral effect of favipiravir in NHPs and support its development against a variety of HF viruses.

  11. The kinetics of the oxidation of pyrite by ferric ions and dissolved oxygen: An electrochemical study

    SciTech Connect

    Holmes, P.R.; Crundwell, F.K.

    2000-01-01

    The dissolution of pyrite is important in the geochemical cycling of iron and sulphur, in the formation of acid mine drainage, and in the extraction of metals by bacterial leaching. Many researchers have studied the kinetics of dissolution, and the rate of dissolution has often been found to be half-order in ferric ions or oxygen. Previous work has not adequately explained the kinetics of dissolution of pyrite. The dissolution of pyrite is an oxidation-reduction reaction. The kinetics of the oxidation and reduction half-reactions was studied independently using electrochemical techniques of voltammetry. The kinetics of the overall reaction was studied by the electrochemical technique of potentiometry, which consisted of measuring the mixed potential of a sample of corroding pyrite in solutions of different compositions. The kinetics of the half reactions are related to the kinetics of the overall dissolution reaction by the condition that there is no accumulation of charge. This principle is used to derive expressions for the mixed potential and the rate of dissolution, which successfully describe the mixed potential measurements and the kinetics of dissolution reported in the literature. It is shown that the observations of half-order kinetics and that the oxygen in the sulphate product arises from water are both a direct consequence of the electrochemical mechanism. Thus it is concluded that the electrochemical reaction steps occurring at the mineral-solution interface control the rate of dissolution. Raman spectroscopy was used to analyze reaction products formed on the pyrite surface. The results indicated that small amounts of polysulphides form on the surface of the pyrite. However, it was also found that the mixed (corrosion) potential does not change over a 14-day leaching period. This indicates that even though polysulphide material is present on the surface, it does not influence the rate of the reactions occurring at the surface. Measurement of the

  12. Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus

    PubMed Central

    Dehennis, Andrew; Mortellaro, Mark A.; Ioacara, Sorin

    2015-01-01

    Background: Continuous glucose monitoring (CGM), which enables real-time glucose display and trend information as well as real-time alarms, can improve glycemic control and quality of life in patients with diabetes mellitus. Previous reports have described strategies to extend the useable lifetime of a single sensor from 1-2 weeks to 28 days. The present multisite study describes the characterization of a sensing platform achieving 90 days of continuous use for a single, fully implanted sensor. Method: The Senseonics CGM system is composed of a long-term implantable glucose sensor and a wearable smart transmitter. Study subjects underwent subcutaneous implantation of sensors in the upper arm. Eight-hour clinic sessions were performed every 14 days, during which sensor glucose values were compared against venous blood lab reference measurements collected every 15 minutes using mean absolute relative differences (MARDs). Results: All subjects (mean ± standard deviation age: 43.5 ± 11.0 years; with 10 sensors inserted in men and 14 in women) had type 1 diabetes mellitus. Most (22 of 24) sensors reported glucose values for the entire 90 days. The MARD value was 11.4 ± 2.7% (range, 8.1-19.5%) for reference glucose values between 40-400 mg/dl. There was no significant difference in MARD throughout the 90-day study (P = .31). No serious adverse events were noted. Conclusions: The Senseonics CGM, composed of an implantable sensor, external smart transmitter, and smartphone app, is the first system that uses a single sensor for continuous display of accurate glucose values for 3 months. PMID:26224762

  13. Assessment of nephrotoxicity in patients receiving amphotericin B lipid complex: a pharmacosurveillance study in Spain.

    PubMed

    Aguado, J-M; Lumbreras, C; González-Vidal, D

    2004-09-01

    This study assessed the risk of haematological, renal and hepatic toxicity associated with amphotericin B lipid complex (ABLC; Abelcet) in a multicentre, open-label, non-comparative study of 93 patients from 17 different hospitals who received ABLC because of proven or suspected systemic fungal infection or leishmaniasis. Most (66%) patients had onco-haematological diseases. Optimum treatment with ABLC comprised a slow (2-h) infusion dose of 5 mg/kg/day for a minimum period of 14 days. Biochemical and haematological parameters were measured pre-, during and post-treatment. In the overall patient group, the mean serum creatinine concentration was similar pre- and post-study (1.00 +/- 1.14 mg/dL vs. 1.20 +/- 1.19 mg/dL; p > 0.05). There were no significant changes pre- and post-treatment in concentrations of haemoglobin, potassium, transaminases and bilirubin. There was no significant correlation between the dose administered and the concentrations of serum creatinine (Spearmann 0.22). There was no greater nephrotoxicity in the patients with previous renal failure, or in those who had received amphotericin B previously. There were serious adverse events in five patients, but other alternative causes that could explain these events were present in three of these patients. Fevers or chills were experienced by 23% of the patients during the ABLC infusion, but only in one case did this necessitate the suspension of treatment. It was concluded that ABLC is a drug with low nephrotoxicity, even when administered to patients with pre-existing renal insufficiency. Adverse events were generally slight or moderate, and were managed easily with appropriate pre-medication.

  14. Towards the Establishment of a Porcine Model to Study Human Amebiasis

    PubMed Central

    Girard-Misguich, Fabienne; Cognie, Juliette; Delgado-Ortega, Mario; Berthon, Patricia; Rossignol, Christelle; Larcher, Thibaut; Melo, Sandrine; Bruel, Timothée; Guibon, Roseline; Chérel, Yan; Sarradin, Pierre; Salmon, Henri; Guillén, Nancy; Meurens, François

    2011-01-01

    Background Entamoeba histolytica is an important parasite of the human intestine. Its life cycle is monoxenous with two stages: (i) the trophozoite, growing in the intestine and (ii) the cyst corresponding to the dissemination stage. The trophozoite in the intestine can live as a commensal leading to asymptomatic infection or as a tissue invasive form producing mucosal ulcers and liver abscesses. There is no animal model mimicking the whole disease cycle. Most of the biological information on E. histolytica has been obtained from trophozoite adapted to axenic culture. The reproduction of intestinal amebiasis in an animal model is difficult while for liver amebiasis there are well-described rodent models. During this study, we worked on the assessment of pigs as a new potential model to study amebiasis. Methodology/Principal Findings We first co-cultured trophozoites of E. histolytica with porcine colonic fragments and observed a disruption of the mucosal architecture. Then, we showed that outbred pigs can be used to reproduce some lesions associated with human amebiasis. A detailed analysis was performed using a washed closed-jejunal loops model. In loops inoculated with virulent amebas a severe acute ulcerative jejunitis was observed with large hemorrhagic lesions 14 days post-inoculation associated with the presence of the trophozoites in the depth of the mucosa in two out four animals. Furthermore, typical large sized hepatic abscesses were observed in the liver of one animal 7 days post-injection in the portal vein and the liver parenchyma. Conclusions The pig model could help with simultaneously studying intestinal and extraintestinal lesion development. PMID:22205970

  15. Toxicologic evaluation of tungsten: 28-day inhalation study of tungsten blue oxide in rats.

    PubMed

    Rajendran, Narayanan; Hu, Shu-Chieh; Sullivan, Dennis; Muzzio, Miguel; Detrisac, Carol J; Venezia, Carmen

    2012-12-01

    The toxicity and toxicokinetics of tungsten blue oxide (TBO) were examined. TBO is an intermediate in the production of tungsten powder, and has shown the potential to cause cellular damage in in vitro studies. However, in vivo evidence seems to indicate a lack of adverse effects. The present study was undertaken to address the dearth of longer-term inhalation toxicity studies of tungsten oxides by investigating the biological responses induced by TBO when administered via nose-only inhalation to rats at levels of 0.08, 0.325, and 0.65 mg TBO/L of air for 6 h/day for 28 consecutive days, followed by a 14-day recovery period. Inhaled TBO was absorbed systemically and blood levels of tungsten increased as inhaled concentration increased. Among the tissues analyzed for tungsten levels, lung, femur and kidney showed increased levels, with lung at least an order of magnitude greater than kidney or femur. By exposure day 14, tungsten concentration in tissues had reached steady-state. Increased lung weight was noted for both terminal and recovery animals and was attributed to deposition of TBO in the lungs, inducing a macrophage influx. Microscopic evaluation of tissues revealed a dose-related increase in alveolar pigmented macrophages, alveolar foreign material and individual alveolar foamy macrophages in lung. After a recovery period there was a slight reduction in the incidence and severity of histopathological findings. Based on the absence of other adverse effects, the increased lung weights and the microscopic findings were interpreted as nonadverse response to exposure and were not considered a specific reaction to TBO.

  16. "Omics" of High Altitude Biology: A Urinary Metabolomics Biomarker Study of Rats Under Hypobaric Hypoxia.

    PubMed

    Koundal, Sunil; Gandhi, Sonia; Kaur, Tanzeer; Mazumder, Avik; Khushu, Subash

    2015-12-01

    High altitude medicine is an emerging subspecialty that has crosscutting relevance for 21(st) century science and society: from sports medicine and aerospace industry to urban and rural communities living in high altitude. Recreational travel to high altitude has also become increasingly popular. Rarely has the biology of high altitude biology been studied using systems sciences and omics high-throughput technologies. In the present study, 1H-NMR-based metabolomics, along with multivariate analyses, were employed in a preclinical rat model to characterize the urinary metabolome under hypobaric hypoxia stress. Rats were exposed to simulated altitude of 6700 m above the sea level. The urine samples were collected from pre- and post-exposure (1, 3, 7, and 14 days) of hypobaric hypoxia. Metabolomics urinalysis showed alterations in TCA cycle metabolites (citrate, α-ketoglutarate), cell membrane metabolism (choline), gut micro-flora metabolism (hippurate, phenylacetylglycine), and others (N-acetyl glutamate, creatine, taurine) in response to hypobaric hypoxia. Taurine, a potential biomarker of hepatic function, was elevated after 3 days of hypobaric hypoxia, which indicates altered liver functioning. Liver histopathology confirmed the damage to tissue architecture due to hypobaric hypoxia. The metabolic pathway analysis identified taurine metabolism and TCA as important pathways that might have contributed to hypobaric hypoxia-induced pathophysiology. This study demonstrates the use of metabolomics as a promising tool for discovery and understanding of novel biochemical responses to hypobaric hypoxia exposure, providing new insight in the field of high altitude medicine and the attendant health problems that occur in response to high altitude. The findings reported here also have potential relevance for sports medicine and aviation sciences.

  17. Studies on potential effects of fumaric acid on rumen microbial fermentation, methane production and microbial community.

    PubMed

    Riede, Susanne; Boguhn, Jeannette; Breves, Gerhard

    2013-01-01

    The greenhouse gas methane (CH4) contributes substantially to global climate change. As a potential approach to decrease ruminal methanogenesis, the effects of different dosages of fumaric acid (FA) on ruminal microbial metabolism and on the microbial community (archaea, bacteria) were studied using a rumen simulation technique (RUSITEC). FA acts as alternative hydrogen acceptor diverting 2H from methanogenesis of archaea towards propionate formation of bacteria. Three identical trials were conducted with 12 fermentation vessels over a period of 14 days. In each trial, four fermentation vessels were assigned to one of the three treatment groups differing in FA dosage: low fumaric acid (LFA), high fumaric acid (HFA) and without FA (control). FA was continuously infused with the buffer. Grass silage and concentrate served as substrate. FA led to decreases in pH and to higher production rates of total short chain fatty acids (SCFA) mediated by increases in propionate for LFA of 1.69 mmol d(-1) and in propionate and acetate production for HFA of 4.49 and 1.10 mmol d(-1), respectively. Concentrations of NH3-N, microbial crude protein synthesis, their efficiency, degradation of crude nutrients and detergent fibre fraction were unchanged. Total gas and CH4 production were not affected by FA. Effects of FA on structure of microbial community by means of single strand conformation polymorphism (SSCP) analyses could not be detected. Given the observed increase in propionate production and the unaffected CH4 production it can be supposed that the availability of reduction equivalents like 2H was not limited by the addition of FA in this study. It has to be concluded from the present study that the application of FA is not an appropriate approach to decrease the ruminal CH4 production.

  18. Over-the-Counter and Prescription Sleep Medication and Incident Stroke: The REGARDS Study

    PubMed Central

    Petrov, Megan E. Ruiter; Howard, Virginia J.; Kleindorfer, Dawn; Grandner, Michael A.; Molano, Jennifer R.; Howard, George

    2014-01-01

    Purpose Preliminary evidence suggests sleep medications are associated with risk of vascular events; however, the long-term vascular consequences are understudied. This study investigated the relation between sleep medication use and incident stroke. Methods Within the REasons for Geographic And Racial Differences in Stroke study, 21,678 black and white participants (≥45yrs) with no history of stroke were studied. Participants were recruited from 2003−2007. From 2008−2010, participants self-reported their prescription and over-the-counter sleep medication use over the past month. Suspected stroke events were identified by telephone contact at 6-month intervals, and associated medical records were retrieved and physician-adjudicated. Proportional hazards analysis was used to the estimate hazard ratios for incident stroke associated with sleeping medication use (0, 1−14, and 15+ days per month) controlling for sociodemographics, stroke risk factors, mental health symptoms, and sleep apnea risk. Results At the sleep assessment, 9.6% of the sample used prescription sleep medication and 11.1% used over-the-counter sleep aids. Over an average follow-up of 3.3±1.0 years, 297 stroke events occurred. Over-the-counter sleep medication use was associated with increased risk for incident stroke in a frequency-response relationship (p-trend = 0.014), with a 46% increased risk for 1–14 days of use per month (HR=1.46; 95%CI: 0.99–2.15) and a 65% increased risk for 15+ days (HR=1.65; 95%CI: 0.96–2.85). There was no significant association with prescription sleep medications (p = 0.80). Conclusions Over-the-counter sleep medication use may independently increase the risk of stroke beyond other risk factors in middle-aged to older individuals with no history of stroke. PMID:25113086

  19. Decreased organ failure in patients with severe SIRS and septic shock treated with the platelet-activating factor antagonist TCV-309: a prospective, multicenter, double-blind, randomized phase II trial. TCV-309 Septic Shock Study Group.

    PubMed

    Poeze, M; Froon, A H; Ramsay, G; Buurman, W A; Greve, J W

    2000-10-01

    Sepsis and organ failure remain the main cause of death on the ICU. Sepsis is characterized by a severe inflammatory response, in which platelet-activating factor (PAF) is considered to play an important role. This study investigated whether treatment with the PAF-antagonist TCV-309 reduces morbidity and mortality in patients with septic shock. The study was conducted as a double-blind, randomized, placebo controlled multicenter study. The included patients had to fulfill the SIRS criteria with a clinical suspicion of infection, an admission APACHE II score greater than 15, and shock, defined as a mean arterial pressure <70 mmHg and/or a decrease > or =40 mmHg despite adequate fluid resuscitation. Patients received 1.0 mg/kg TCV-309 or placebo, twice daily, intravenously during 14 days. The prospectively set goals were MOF score, recovery from shock, mortality, and assessment of the safety of the medication. A total of 98 patients were included of which 97 were analyzed on an intention-to-treat basis. The overall survival at day 56 of TCV-309 treated patients was similar compared to placebo treated patients (51.0% vs. 41.7%, P = 0.47). In contrast, the mean percentage of failed organs per patient present after 14 days in the TCV-309 treated patients was significantly lower compared to the placebo treated patients (11.9% vs. 25.1%, P = 0.04), leading to a reduced need for vasopressors, dialysis, and ventilatory support. Furthermore, the mean APACHE-II score during treatment with TCV-309 was significantly lower and the number of patients recovered from shock after day 14 was significantly higher in the TCV-309 treated patient group (2/32 vs. 9/29, P = 0.01). The number of adverse events was not significantly different between the TCV-309 and placebo treated patients. TCV-309 did not change overall mortality of septic shock, however a substantial reduction in organ dysfunction and morbidity, frequently associated with septic shock was achieved, without significant

  20. Who Studies Women's Studies?

    ERIC Educational Resources Information Center

    Price, Marion; Owen, Mairead

    1998-01-01

    Studied a cohort (originally 44) of students who entered a British university to study women's studies in 1994. The strong emphases on the salience of the students' choice and the experiential importance of identity as a concept were striking. Theoretical difficulties in theorizing identity are explored. (SLD)

  1. Stem injection of Populus nigra with EDU to study ozone effects under field conditions.

    PubMed

    Bortier, K; Dekelver, G; De Temmerman, L; Ceulemans, R

    2001-01-01

    EDU or ethylenediurea (N-[2-(2-oxo-1-imidazolidinyl)ethyl]-N'-phenylurea) has been used in experiments to assess ozone effects on vegetation under field conditions because it provides protection against oxidative damage. Tests have mainly been conducted on crop plants, but for woody species only few reports have provided evidence that it can be used in long-term experiments. In this study we tested the technique of stem injection of EDU to study the effects of ozone exposure on Populus nigra cv. Wolterson over one growing season. Cuttings of Populus nigra were grown in pots in the field and between mid-July and early September plants were repeatedly injected with EDU solution (5 mg/plant) or with water at 14-day intervals. Significant differences were found between EDU- and water-injected plants: water-treated plants had more foliar injury, more chlorotic leaves, and shedding of leaves started earlier, suggesting EDU was effective in preventing visible ozone injury and acceleration of senescence. Photosynthetic rates, measured for one leaf age, showed no differences but were mostly higher for the EDU-treated plants. At the end of the growing season diameter increment was 16% higher and there was a non-significant trend for above-ground biomass to be increased by 9% for the EDU-treated plants. This experiment has provided evidence that for this clone serious ozone damage occurs at relatively low concentrations and that EDU can provide protection against visible injury, as well as against longer term growth reductions.

  2. Amantadine versus biperiden: a double-blind study of treatment efficacy in neuroleptic extrapyramidal movement disorders.

    PubMed

    König, P; Chwatal, K; Havelec, L; Riedl, F; Schubert, H; Schultes, H

    1996-01-01

    Anticholinergic treatment of neuroleptic extrapyramidal movement disorders (EPS) has been associated with induction of tardive dyskinesia. Also an increasing abuse of anticholinergics by schizophrenic patients is noted. Since as early as 1976, positive effects of amantadine (AMA) on neuroleptic EPS have been described, therefore a controlled study of these reports seemed worthwhile. Forty-two schizophrenic patients (of which 7 were dropouts) of three centers entered the study and were treated for EPS in a double-blind design: 18 (11 m, 7 f) with AMA and 17 (8 m, 9 f) with biperiden (BIP). Identical preparations of AMA 100 mg, tid) and BIP (2 mg, tid) were used in treatment of haloperidol-induced EPS (AMA, mean 22.4 mg haloperidol; BIP, mean 19.6 mg haloperidol). Effects of treatment and possible side effects were rated: EPS for the intensity of EPS, BPRS for quantification of psychotic symptoms, FSUCL for rating the side effects and KUSTA to document patients' mood. Ratings were recorded on days 0, 3, 7, 14, 28 and at discontinuation, respectively. All patients were treated with haloperidol and levomepromazine (for tranquilization/sleep induction) and the respective antiparkinsonian agent for 14 days. Patient characteristics did not differ significantly in either groups. In the AMA treatment group, 2 patients dropped out for noncompliance, in the BIP group, 5 (3 no effect, 1 noncompliance, 1 agitation). All results as recorded with the different rating instruments showed a significant (p < 0.01) overall improvement, whereas no significant differences between treatment groups could be determined, notably the treatment effect of both drugs on EPS was similar. Thus, the application of AMA in cases of neuroleptic EPS seems justified and is a useful alternative of anticholinergic drugs. Certain advantageous aspects of AMA treatment of EPS with regard to the glutamate hypothesis of schizophrenia and tardive dyskinesia are discussed.

  3. Feasibility and Outcome of Proximal Catheter Ileostomy – A Pilot Study

    PubMed Central

    Ansari, Maulana M.; Ahmad, Shakeel; Hasan, Syed H.; Haleem, Shahla

    2011-01-01

    Background/Aim: Loop ileostomy has high complication rates and causes much patient inconvenience. This study was carried out to evaluate the feasibility and outcome of a proximal catheter ileostomy in place of loop ileostomy in patients treated by intestinal repair and/or resection-anastomosis.Design: Prospective study.Setting: J. N. Medical College Hospital, Aligarh Muslim University, Aligarh, India. Patients and Methods: From November 2006 to November 2009, in all patients treated surgically by primary repair and/or resection-anastomosis of small and/or large bowel, we constructed a catheter ileostomy when a defunctioning proximal protective loop ileostomy was considered advisable. Catheter ileostomy was constructed in the fashion of catheter jejunostomy, with postoperative saline irrigation. Results: Catheter ileostomy was performed in 20 patients in the 3-year period. The mean age of the subjects was 28.6 years and the male: female ratio was 1.86:1. Four patients died of septicemia and multiple organ failure unrelated to catheter ileostomy in the immediate postoperative period. Catheter ileostomy started functioning within 48 hours of the operation, and twice-daily irrigation was found sufficient in 81.25% of the surviving patients. Only one patient developed peritubal leak with mild skin excoriation that cleared within 5 days. Another patient with Koch's abdomen underwent conversion to loop colostomy on re-exploration for postoperative adhesive obstruction. There was no instance of intestinal leak. Ileostomy wounds closed spontaneously within 7–14 days of catheter removal, and none required formal closure. Hospital stay ranged from 12–35 days (mean: 23 days). Conclusions: Catheter ileostomy is effective in protecting intestinal anastomosis/repair; there is minimal morbidity and no catheter-related leak/mortality, and we recommend the procedure. PMID:21727735

  4. The study on the mechanical characteristics of articular cartilage in simulated microgravity

    NASA Astrophysics Data System (ADS)

    Niu, Hai-Jun; Wang, Qing; Wang, Yue-Xiang; Li, Ang; Sun, Lian-Wen; Yan, Yan; Fan, Fan; Li, De-Yu; Fan, Yu-Bo

    2012-10-01

    The microgravity environment of a long-term space flight may induce acute changes in an astronaut's musculo-skeletal systems. This study explores the effects of simulated microgravity on the mechanical characteristics of articular cartilage. Six rats underwent tail suspension for 14 days and six additional rats were kept under normal earth gravity as controls. Swelling strains were measured using high-frequency ultrasound in all cartilage samples subject to osmotic loading. Site-specific swelling strain data were used in a triphasic theoretical model of cartilage swelling to determine the uniaxial modulus of the cartilage solid matrix. No severe surface irregularities were found in the cartilage samples obtained from the control or tail-suspended groups. For the tail-suspended group, the thickness of the cartilage at a specified site, as determined by ultrasound echo, showed a minor decrease. The uniaxial modulus of articular cartilage at the specified site decreased significantly, from (6.31 ± 3.37)MPa to (5.05 ± 2.98)MPa ( p < 0.05). The histology-stained image of a cartilage sample also showed a reduced number of chondrocytes and decreased degree of matrix staining. These results demonstrated that the 14 d simulated microgravity induced significant effects on the mechanical characteristics of articular cartilage. This study is the first attempt to explore the effects of simulated microgravity on the mechanical characteristics of articular cartilage using an osmotic loading method and a triphasic model. The conclusions may provide reference information for manned space flights and a better understanding of the effects of microgravity on the skeletal system.

  5. A ten year, multicentre study of coagulase negative staphylococcal infections in Australasian neonatal units

    PubMed Central

    Isaacs, D

    2003-01-01

    Objective: To study late onset systemic infections with coagulase negative staphylococci. Methods: Prospective longitudinal study of coagulase negative staphylococcal infection in 18 Australasian neonatal nurseries. Results: From 1991 to 2000 inclusive, there were 1281 cases of coagulase negative staphylococcal (CoNS) sepsis, comprising 57.1% of all late onset infections. The male/female ratio was 1.27:1 (p < 0.05). The incidence of CoNS sepsis was 3.46 episodes per 1000 live births. Most infected babies (71%) were 24–29 weeks gestation at birth (mode 26 weeks). The first positive culture was day 7–14 in 49% of babies (mode 10 days). Five cases of meningitis were reported, an incidence of 0.4% of all CoNS infections. Twenty nine babies (2.3%) had concurrent necrotising enterocolitis and CoNS septicaemia. Four babies (0.3%) died from CoNS infection, but CoNS infection possibly contributed to the death of an additional 20 babies (1.6%). The mortality directly attributable to CoNS infection was significantly lower than that from late onset infections with Staphylococcus aureus (13.1%; relative risk (RR) = 36.1 (95% confidence interval (CI) 13.0 to 100.2) or with Gram negative bacilli (14.2%; RR = 45.5 (95% CI 16.8 to 123.3)). Conclusions: CoNS are currently responsible for most late onset neonatal infections. Most infected babies are < 30 weeks gestation at birth, and usually present between 7 and 14 days of age. CoNS infections may be associated with necrotising enterocolitis, although causality is unproven. Neonatal CoNS infections are relatively benign: meningitis is rare and mortality low compared with infection from other organisms. Over-vigorous attempts to reduce the incidence of CoNS infections using prophylactic antibiotics are not advisable. PMID:12598493

  6. Clinical, ultrasonographic, and endocrinological studies on donkey pregnancy.

    PubMed

    Crisci, Angelica; Rota, Alessandra; Panzani, Duccio; Sgorbini, Micaela; Ousey, Jennifer C; Camillo, Francesco

    2014-01-15

    Although donkey breeding has gained new interest in the past two decades, knowledge about donkey reproduction is still scarce, particularly on jenny pregnancy. The aim of this study was to describe the ultrasonographic and endocrine profiles of the physiological pregnancy in the jenny. The study was performed on 12 pregnancies of 7 Amiata donkeys from Day 10 after ovulation to delivery. Because three pregnancies, respectively at weeks 42, 44, and 45, were considered pathologic and treated pharmacologically, data collected from 2 weeks before diagnosis to the end of pregnancy were removed from the analysis. Average length of the normal pregnancies was 353.4 ± 13.0 days (range, 339-370 days). Timing, dimensions, and development during the first phases of embryonic growth, evaluated using transrectal ultrasound, were similar to that previously described in jennies and mares: first detection of embryonic vesicle was at 11.8 ± 1.3 days of gestation and diameter was 6.5 ± 1.9 mm, loss of spherical shape occurred at 18.5 ± 1.4 days, and embryo and heart beat were first seen at 22.0 ± 1.1 and 25 ± 1.1 days, respectively. The intrauterine growth in the second half of pregnancy, evaluated using the transrectal and transabdominal approach, also showed strong positive correlations, similar to that reported for the mare. The trends of the combined thickness of the utero-placental unit and the echogenicity of the amniotic and allantoic fluids are examples. The diameters (mm) of fetal chest, eye orbit, and aorta increased throughout pregnancy and were 40.6 ± 2.9, 8.7 ± 1.5, and 3.5 ± 0.7, respectively, at week 13, and 190.9 ± 12.0, 21.4 ± 1.5, and 30.6 ± 1.8 at the last evaluation before parturition. In contrast, heart rate decreased as pregnancy progressed. Regression analyses between these parameters and day of gestation were statistically significant (P < 0.001). All fetuses consistently showed some intrauterine activity. Maternal plasma progestagens and estrone

  7. The Benefit of a Mechanical Needle Stimulation Pad in Patients with Chronic Neck and Lower Back Pain: Two Randomized Controlled Pilot Studies

    PubMed Central

    Hohmann, Claudia; Ullrich, Isabella; Lauche, Romy; Choi, Kyung-Eun; Lüdtke, Rainer; Rolke, Roman; Cramer, Holger; Saha, Felix Joyonto; Rampp, Thomas; Michalsen, Andreas; Langhorst, Jost; Dobos, Gustav; Musial, Frauke

    2012-01-01

    Objectives. The objective was to investigate whether a treatment with a needle stimulation pad (NSP) changes perceived pain and/or sensory thresholds in patients with chronic neck (NP) and lower back pain (BP). Methods. 40 patients with chronic NP and 42 patients with chronic BP were equally randomized to either treatment or waiting list control group. The treatment group self-administered a NSP over a period of 14 days. Pain ratings were recorded on numerical rating scales (NRSs). Mechanical detection thresholds (MDTs) and pressure pain thresholds (PPTs) were determined at the site of maximal pain and in the adjacent region, vibration detection thresholds (VDT) were measured at close spinal processes. The Northwick Park Neck Pain Questionnaire (NPQ) and the Oswestry Disability Index (ODI) were utilized for the NP and BP study, respectively. Results. NRS ratings were significantly reduced for the treatment groups compared to the control groups (NP: P = .021 and BP: P < .001), accompanied by a significant increase of PPT at pain maximum (NP: P = .032 and BP: P = .013). There was no effect on VDT and MDT. The NPQ showed also a significant improvement, but not the ODI. Conclusions. The mechanical NSP seems to be an effective treatment method for chronic NP and BP. PMID:22997531

  8. A pilot study of the DBT coach: an interactive mobile phone application for individuals with borderline personality disorder and substance use disorder.

    PubMed

    Rizvi, Shireen L; Dimeff, Linda A; Skutch, Julie; Carroll, David; Linehan, Marsha M

    2011-12-01

    Dialectical behavior therapy (DBT) has received strong empirical support and is practiced widely as a treatment for borderline personality disorder (BPD) and BPD with comorbid substance use disorders (BPD-SUD). Therapeutic success in DBT requires that individuals generalize newly acquired skills to their natural environment. However, there have been only a limited number of options available to achieve this end. The primary goal of this research was to develop and test the feasibility of the DBT Coach, a software application for a smartphone, designed specifically to enhance generalization of a specific DBT skill (opposite action) among individuals with BPD-SUD. We conducted a quasiexperimental study in which 22 individuals who were enrolled in DBT treatment programs received a smartphone with the DBT Coach for 10 to 14 days and were instructed to use it as needed. Participants used the DBT Coach an average of nearly 15 times and gave high ratings of helpfulness and usability. Results indicate that both emotion intensity and urges to use substances significantly decreased within each coaching session. Furthermore, over the trial period, participants reported a decrease in depression and general distress. Mobile technology offering in vivo skills coaching may be a useful tool for reducing urges to use substances and engage in other maladaptive behavior by directly teaching and coaching in alternative, adaptive coping behavior.

  9. [Effect of copper ions on spatial density of NO-synthase-positive cells in the intestine of the mussel Crenomytilus grayanus (Mollusca: Bivalvia: Mytilidae) a histochemical study].

    PubMed

    Pimenova, E A

    2010-01-01

    By the histochemical method of detection of NADPH-diaphorase (NADPH-d) (EC 1.6.99.1) the state of nitroxidergic enteric nervous system of the mussel Crenomytilus grayanus was studied under conditions of an increased copper concentration in water. Under the action of copper ions the density of distribution of NADPH-d-positive cells has been established to be changed as compared with control throughout 28 days. A sharp rise of proportion of the labeled cells and their enzyme activity was noted after one day of the experiment. The labeled bipolar cells were of dark blue color and were located within the epithelium. There were revealed numerous nerve fibers penetrating the intestinal epithelium throughout its entire length as well as bipolar nerve cells in epithelium of the minor typhlosole and of crystalline style sac; in control molluscs the NADPH-d-positive cells in these parts were absent. After 7 days the difference between control and experimental decreased and remained at this level after 14 days, while after 21 days of exposition the proportion of labeled cells in the experimental mussels was lower than in control, but increased again after 28 days. It is suggested that nitric oxide is an important protective factor of the intestinal epithelium of the mussel C. grayanus and participates in adaptation of this mollusc to action of the elevated concentration of copper ions in water.

  10. Influence of carbamide peroxide on the flexural strength of tooth-colored restorative materials: an in vitro study at different environmental temperatures.

    PubMed

    Yu, Hao; Li, Qing; Lin, Yao; Buchalla, Wolfgang; Wang, Yining

    2010-01-01

    The current study investigated the influence of carbamide peroxide on the flexural strength of tooth-colored restorative materials at two environmental temperatures. Seven restorative materials were used, including four resin composites (Filtek Z350, Filtek Z250, Synergy Flow and Filtek P60), a polyacid-modified composite (Dyract AP), a conventional glass-ionomer cement (Ketac Molar Easymix) and a ceramic (Vitablocs Mark II). For each type of material, 80 bar-shaped specimens were fabricated and divided into four groups (n = 20): bleaching group at 25 degrees C, control group at 25 degrees C, bleaching group at 37 degrees C and control group at 37 degrees C. The specimens in the bleaching groups were treated with 10% carbamide peroxide gel for eight hours/day, while the control specimens in their respective groups were stored in deionized water. After 14-day treatment, the flexural strength of the specimens was determined using a universal testing machine. All the results were analyzed with ANOVA and the Tukey's post-hoc test. The data were also submitted to Weibull distribution. The flexural strength and its Weibull distribution of polyacid-modified composite and glass-ionomer cement were more seriously affected by bleaching agents than the resin composite and ceramic, especially at the higher environmental temperature.

  11. An indoor mesocosm system to study the effect of climate change on the late winter and spring succession of Baltic Sea phyto- and zooplankton.

    PubMed

    Sommer, Ulrich; Aberle, Nicole; Engel, Anja; Hansen, Thomas; Lengfellner, Kathrin; Sandow, Marcel; Wohlers, Julia; Zöllner, Eckart; Riebesell, Ulf

    2007-01-01

    An indoor mesocosm system was set up to study the response of phytoplankton and zooplankton spring succession to winter and spring warming of sea surface temperatures. The experimental temperature regimes consisted of the decadal average of the Kiel Bight, Baltic Sea, and three elevated regimes with 2 degrees C, 4 degrees C, and 6 degrees C temperature difference from that at baseline. While the peak of the phytoplankton spring bloom was accelerated only weakly by increasing temperatures (1.4 days per degree Celsius), the subsequent biomass minimum of phytoplankton was accelerated more strongly (4.25 days per degree Celsius). Phytoplankton size structure showed a pronounced response to warming, with large phytoplankton being more dominant in the cooler mesocosms. The first seasonal ciliate peak was accelerated by 2.1 days per degree Celsius and the second one by 2.0 days per degree Celsius. The over-wintering copepod populations declined faster in the warmer mesocosm, and the appearance of nauplii was strongly accelerated by temperature (9.2 days per degree Celsius). The strong difference between the acceleration of the phytoplankton peak and the acceleration of the nauplii could be one of the "Achilles heels" of pelagic systems subject to climate change, because nauplii are the most starvation-sensitive life cycle stage of copepods and the most important food item of first-feeding fish larvae.

  12. The Effect of an Eextremely Low Frequency Magnetic Field on Larvae Production in the Parasite-Host System: Fasciola hepatica-Galba truncatula: a Preliminary Study.

    PubMed

    Kołodziejczyk, Lidia; Podraza, Wojciech; Gonet, Bolesław; Dzika, Ewa; Kosik-Bogacka, Danuta I

    2016-01-01

    The aim of this study was to determine the effect of an extremely low-frequency magnetic field (ELFMF) on the production of liver fluke larvae in a parasite-host system: Fasciola hepatica--Galba truncatula. Both F. hepatica eggs and F. hepatica-infected snails were exposed to an ELFMF (50 Hz, 2.0 mT) for 14 days and 36 days, respectively. F. hepatica-infected snails were divided into 4 groups, 10 specimens each. The snails of groups I and II were infected with F. hepatica larvae--miracidia obtained from control cultures, while the snails of groups III and IV were infected with miracidia reared from eggs that had been incubated in an ELFMF. After infection, the snails of groups II and IV were placed in an ELFMF, while those of groups I (control) and III were housed outside the ELFMF. At 36 days post-infection (dpi) there were no statistically significant differences between the number of F. hepatica larvae--cercariae and metacercariae, obtained from G. truncatula snails in the control group (group I) and the snail groups exposed to ELFMF (groups II, III and IV). However, a statistically significant difference between the average number of F. hepatica larvae in snail groups III and IV may indicate that the duration of exposure to ELFMF, i.e. embryogenesis period vs. the entire larval development, played a role in the production of F. hepatica larvae, and resulted in a reduction of their number.

  13. Pre-registration efficacy study of a novel marker vaccine against classical swine fever on maternally derived antibody positive (MDA+) target animals.

    PubMed

    Farsang, A; Lévai, R; Barna, T; Fábián, K; Blome, S; Belák, K; Bálint, Á; Koenen, F; Kulcsár, G

    2017-01-01

    Maternally Derived Antibodies (MDA) can have a negative effect on the efficacy of live attenuated vaccines against classical swine fever (CSF). For this reason, a marker vaccine candidate CP7_E2alf was tested for its efficacy in the presence of MDA. Pregnant sows were vaccinated four weeks before farrowing with CSF virus (CSFV) strain "Thiverval". A total of 40 piglets with MDAs were included in this study. At six weeks of age the piglets were allocated into three treatment groups using generalized randomized block design (GRBD) blocking on serological status and pen location. Of the 40 piglets with MDAs, 30 piglets were vaccinated either orally (n = 15) or intramuscularly (n = 15) with a single dose of vaccine candidate produced under Good Laboratory Practice (GLP) conditions. The ten remaining piglets were allocated into the untreated control group. All 40 piglets were oronasally challenged with 2 ml of the highly virulent CSFV strain "Koslov" 14 days after vaccination. It was revealed that presence of MDAs negatively influences the efficacy of the live marker vaccine candidate, however, the extent of this negative impact depends on the route of vaccine administration. Based on our observations, intramuscular vaccination is recommended during CSF control programs in order to develop superior immune protection.

  14. A randomised phase II study of OSI-7904L versus 5-fluorouracil (FU)/leucovorin (LV) as first-line treatment in patients with advanced biliary cancers.

    PubMed

    Ciuleanu, T; Diculescu, M; Hoepffner, N M; Trojan, J; Sailer, V; Zalupski, M; Herrmann, T; Roth, A; Chick, J; Brock, K; Albert, D; Philip, P A

    2007-08-01

    The prognosis of advanced biliary tract carcinoma is poor with chemotherapy limited to a palliative role. This randomised study was designed to evaluate the effectiveness of a new liposomal thymidylate synthase inhibitor (TSI), OSI-7904L, in parallel with a modified de Gramont regimen of 5-FU/LV in patients with advanced biliary cancer. Patients with previously untreated advanced or metastatic carcinoma of the biliary tract were randomised to receive either OSI-7904L 12 mg/m2 intravenously every 21 days or a modified de Gramont schedule of 5-FU/LV (intravenous l-LV 200 mg/m2, bolus 5-FU 400 mg/m2 and a 46-h infusion of 5-FU 2,400 mg/m2) every 14 days. Twenty-two patients were randomised, 11 to each group. No patients responded in the OSI-7904L arm, while one patient achieved a partial response in the 5-FU/LV arm. The rates of disease stabilisation were 4/11 (OSI-7904L) and 10/11 (5-FU/LV). Both treatment arms were generally well tolerated. These results show that the activity of OSI-7904L is below a level of clinical relevance in advanced biliary tract cancer, providing only a small degree of disease stabilisation. A simplified de Gramont schedule appears to have marginally more activity. Both treatments were well tolerated.

  15. Comparison between IV immune globulin (IVIG) and anti-D globulin for treatment of immune thrombocytopenia: a randomized open-label study.

    PubMed

    Eghbali, Aziz; Azadmanesh, Peyman; Bagheri, Bahador; Taherahmadi, Hasan; Sadeghi Sedeh, Bahman

    2016-08-01

    To compare the effect of IV immune globulin (IVIG) and anti-D globulin (anti-D) for treatment of immune thrombocytopenia (ITP) in children. A randomized, open-label, single-center clinical trial was carried out in Amir-Kabir Hospital (Arak, Iran). The study was performed on 60 children with acute and chronic ITP, aged from 1 to 15 years. Patients were randomly assigned (1:1) to 50 μg/kg anti-D or 1 g/kg IVIG. Platelet counting was performed at baseline and at 3, 7, and 14 days after treatment termination. Safety assessment was performed in all patients. Anti-D caused a quicker response on the 3rd day of treatment (P < 0.001). Both drugs caused a significant rise in number of platelets on the 7th and the 14th day of treatment. Compared to IVIG, except a significant drop in hemoglobin concentration (P < 0.001), anti-D had lower rate of side effects including fever (P < 0.05), allergy (P < 0.01), and headache (P < 0.001). Our results showed that anti-D was associated with rapid rise of platelets compared to IVIG. In addition, anti-D treatment had acceptable safety profile.

  16. A pilot double-blind, randomized, and placebo-controlled study of orally administered IFN-alpha-n1 (Ins) in pediatric patients with measles.

    PubMed

    Lecciones, J A; Abejar, N H; Dimaano, E E; Bartolome, R; Cinco, S; Mariano, N; Yerro, M E; Cobar, S; Fuggan, B

    1998-09-01

    To determine the safety and effectiveness of low-dose oral interferon-alpha (IFN-alpha) against measles, 30 confined pediatric patients were prospectively and randomly assigned to either a placebo or an oral IFN-alpha group and observed daily for 14 days in a double-blind manner. The IFN patients received a daily sublingual dose of 200 IU of human lymphoblastoid IFN-alpha. The IFN-treated group showed shorter average duration of malaise (3.2 vs. 10.7 days, p < 0.0001), anorexia (3.1 vs. 6.7 days, p < 0.0001), and irritability (1.1 vs. 2.2 days, p < 0.01) and shorter duration of macular/maculopapular/papular lesions (4.3 vs. 8.2 days,p < 0.0001) and branny desquamation (4.6 vs. 5.8 days, p > 0.05) and shorter time for rash to become generalized (5.5 vs. 10.3 days, p < 0.0001). No hematologic, renal, or liver toxicities were noted. It, therefore, appears that low-dose oral human lymphoblastoid IFN-alpha used in this pilot study is both safe and effective in children with measles infection.

  17. A dose-finding study with a novel water-soluble formulation of paclitaxel for the treatment of malignant high-grade solid tumours in dogs.

    PubMed

    von Euler, H; Rivera, P; Nyman, H; Häggström, J; Borgå, O

    2013-12-01

    A new formulation of water-soluble paclitaxel (Paccal® Vet) has been developed for canine cancer patients, without the need for pre-medication (traditionally required in non-water-soluble paclitaxel formulations). The objective of the study was to determine a clinically safe and efficacious dose of Paccal Vet and to estimate progression-free and overall survival and to evaluate single-dose pharmacokinetics in tumour-bearing dogs. A positive risk:benefit ratio was established for Paccal Vet administered at 150 mg m(-2) intravenous (IV) for three or more treatment cycles. Preliminary efficacy was demonstrated by best objective response rate (86%), median time to response (14 days) and median progression-free survival (131 days). Paccal Vet was associated with expected adverse events (AE) (e.g. myelosuppression), however the majority were transient, clinically silent and manageable. This is the first clinical report of a water-soluble formulation of paclitaxel suggesting successful administration and being safely used without pre-medication in dogs.

  18. A Randomized Controlled Pilot Study of the Triple Stimulation Technique in the Assessment of Electroacupuncture for Motor Function Recovery in Patients with Acute Ischemic Stroke

    PubMed Central

    Tan, Feng; Wang, Xuewen; Li, Hui-qin; Lu, Lin; Li, Ming; Li, Ji-huang; Fang, Meifeng; Meng, Di

    2013-01-01

    The objective of this pilot study was to objectively assess electroacupuncture for motor function recovery in patients with acute ischemic stroke using the triple-stimulation technique (TST). The patients received either electroacupuncture plus western conventional medication (WCM) (n = 32) or single WCM (n = 31) for 14 days. The total clinical effective rate was statistically significantly superior in electroacupuncture group to that in WCM group (P < 0.01). Fugl-Meyer Assessment Scale (FMA) score, National Institutes of Health Stroke Scale (NIHSS) score, and TSTratio were statistically more significant in electroacupuncture group than those in WCM group (P < 0.01). There was positive correlation between TSTratio and NIHS score both before and after treatment (P < 0.01) and negative correlation between TSTratio and FAM score both before treatment and after treatment (P < 0.01). Comparing between the two groups or between pretreatment and posttreatment, adverse events, electrocardiogram, liver function, and kidney function showed no statistically significant difference (P > 0.05). In conclusion, electroacupuncture was beneficial for the motor function recovery of patients with acute ischemic stroke and was generally safe. TST can be used for quantitative evaluation of electroacupuncture for motor function recovery in patients with acute ischemic stroke because it can objectively analyze the injury and recovery of corticospinal tract impairments. PMID:23840255

  19. COMPARATIVE STUDY OF THE EFFECTS OF LOW-LEVEL LASER AND LOW-INTENSITY ULTRASOUND ASSOCIATED WITH BIOSILICATE® ON THE PROCESS OF BONE REPAIR IN THE RAT TIBIA

    PubMed Central

    Oliveira, Poliani de; Fernandes, Kelly Rosseti; Sperandio, Evandro Fornias; Pastor, Fabio Alexandre Casarin; Nonaka, Keico Okino; Parizotto, Nivaldo Antonio; Renno, Ana Claudia Muniz

    2015-01-01

    Objective: Verify the effects of the association between Biosilicate® and ultrasound and, Biosilicate® and laser in bone consolidation process of rats, through the biomechanical and histological analysis. Methods: Forthy male rats were used. The animals were randomized into four groups (n=10): control group fracture no treated (CGF); group treated with Biosilicate® (BG); group treated with Biosilicate® and laser (BLG); group treated with Biosilicate® and ultrasound (BUG). Results: The biomechanical analysis showed no significant difference among any groups after 14 days post-surgery. In the morphometric analysis, the control group showed moderate presence of new formed bone tissue inside the defects areas and the Biosilicate® group showed similar results. Despite those facts, the biomaterial osteogenic potential was demonstrated by the great amount of cells and bone tissue around the particles. Curiously, the Biosilicate® plus laser or ultrasound groups showed lower amounts of bone tissue deposition when compared with control fracture and Biosilicate® groups. Conclusion: The data from this study can conclude that Biosilicate® was able to accelerate and optimized the bone consolidation, through the modulation of the inflammatory process and the stimulation of new bone formation. However, when resources were associated, there are no positive results. PMID:27027088

  20. Associations between school difficulties and health-related problems and risky behaviours in early adolescence: A cross-sectional study in middle-school adolescents in France.

    PubMed

    Chau, Kénora; Kabuth, Bernard; Causin-Brice, Odile; Delacour, Yves; Richoux-Picard, Catherine; Verdin, Monique; Armand, Isabelle; Chau, Nearkasen

    2016-10-30

    Health-related problems and risky behaviours (substance use) are frequent in adolescents, may alter their physical and mental capabilities, and may thus generate school absenteeism, low academic performance, and school dropout ideation. This study assessed their associations and the contribution of socioeconomic factors among 1559 middle-school adolescents (mean age 13.5+1.3) from north-eastern France. They completed a questionnaire including socioeconomic characteristics, health-related problems (poor physical health, psychological health, social relationships, and living environment) assessed with the World Health Organization's quality of life measure (score<25th percentile), risky behaviours, school absences during the present school year, last-trimester academic performance, and school dropout ideation. Data were analysed using logistic regression models. School absenteeism was frequent (12.6% of subjects for 8-14 days, and 6.0% for ≥15 days); 8.2% of subjects had low academic performance (average school-mark <10/20) and 3.9% school dropout ideation. All school difficulties were strongly associated with all health-related problems (gender-age-school-level-adjusted odds ratios gasOR between 1.5 and 4.2), and with risky behaviours (gasOR between 1.4 and 14). Socioeconomic factors differently contributed to these associations (contribution reaching 77%). Policy makers, schools, physicians and parents should be more aware of the problems and help adolescents to reduce health-related problems and risky behaviours and to increase resilience.

  1. Can a bleaching toothpaste containing Blue Covarine demonstrate the same bleaching as conventional techniques? An in vitro, randomized and blinded study

    PubMed Central

    DANTAS, Andréa Abi Rached; BORTOLATTO, Janaina Freitas; RONCOLATO, Ávery; MERCHAN, Hugo; FLOROS, Michael Christopher; KUGA, Milton Carlos; de OLIVEIRA, Osmir Batista

    2015-01-01

    ABSTRACT Objective The purpose of this in vitro study was to compare the efficacy of a bleaching toothpaste containing Blue Covarine vs. conventional tooth bleaching techniques using peroxides (both in-office and at-home). Material and Methods Samples were randomly distributed into five experimental groups (n=15): C - Control; BC – Bleaching toothpaste containing Blue Covarine; WBC – Bleaching toothpaste without Blue Covarine; HP35 - In-office bleaching using 35% hydrogen peroxide; and CP10 – At-home bleaching with 10% carbamide peroxide. The dental bleaching efficacy was determined by the color difference (ΔE), luminosity (ΔL), green-red axis (Δa), and blue-yellow axis (Δb). The CIELab coordinates were recorded with reflectance spectroscopy at different times: T0 - baseline, T1 – immediately after bleaching, T2 - 7 days, T3 - 14 days, and T4 - 21 days after the end of treatments. Data were analyzed by a repeated measures mixed ANOVA and post hoc Bonferroni test, with a significance level of 5%. Results No significant differences were found between the treatment groups C, BC, and WBC. The groups HP35 and CP10 showed significantly higher whitening efficacy than groups C, BC, and WBC. Conclusions There were no significant differences in the whitening efficacy between a Blue Covarine containing toothpaste, a standard whitening toothpaste, and a control. Neither of the whitening toothpastes tested were as effective as in-office or at-home bleaching treatments. PMID:26814462

  2. Intranasal immunization in mice with non-ionic surfactants vesicles containing HSV immunogens: a preliminary study as possible vaccine against genital herpes.

    PubMed

    Cortesi, Rita; Ravani, Laura; Rinaldi, Francesca; Marconi, Peggy; Drechsler, Markus; Manservigi, Marco; Argnani, Rafaela; Menegatti, Enea; Esposito, Elisabetta; Manservigi, Roberto

    2013-01-20

    The purpose of this study was to investigate the potential of intranasal immunization with non-ionic surfactant vesicles (NISV) containing either the secretory recombinant form of glycoprotein B (gBs) of herpes simplex virus type 1 or a related polylysine reach peptides (DTK) for induction of protective immunity against genital herpes infection in mice. NISV were prepared by lipid film hydration method. The mean diameter of vesicles was around 390 nm for DTK-containing NISV (DTK-NISV) and 320 nm for gB1s-containing NISV (gB1s-NISV). The encapsulation efficiency of the molecules was comprised between 57% and 70%. After 7-14 day NISV maintained stable dimensions and a drug encapsulation higher than 48%. We showed that intranasal immunization with gB1s-NISV induces gB-specific IgG antibody and lymphoproliferative responses, whereas vaccination with DTK-NISV was not able to generate a gB-specific immune response. Our results indicate that vaccination of BALB/c mice with gB1s-NISV induced Th1 responses, as characterized by increased titre of IG2a in plasma and IFN-production in CD4+ splenic cells. Intranasal immunization with gB1s-NISV could elicit 90% (almost complete) protection against a heterologous lethal vaginal challenge with herpes simplex virus type 2. These data may have implications for the development of a mucosal vaccine against genital herpes.

  3. Study of the viral interference between infectious pancreatic necrosis virus (IPNV) and infectious haematopoietic necrosis virus (IHNV) in rainbow trout (Oncorhynchus mykiss).

    PubMed

    Byrne, N; Castric, J; Lamour, F; Cabon, J; Quentel, C

    2008-05-01

    The resistance of rainbow trout (Oncorhynchus mykiss) to an infectious haematopoietic necrosis virus (IHNV) challenge following a preceding non-lethal infection with infectious pancreatic necrosis virus (IPNV) was investigated through experimental dual infections. Trout initially infected with IPNV were inoculated 14 days later with IHNV. Single infections of trout with 1 of the 2 viruses or with cell culture supernatant were also carried out and constituted control groups. No mortality was noted in fish after a single infection with IPNV. This virus had no influence on the head kidney leucocyte phagocytic activity and plasma haemolytic complement activity. IHNV induced a high mortality (72%) and reduced the macrophage phagocytic activity and complement haemolytic activity. It also induced a late production of anti-IHNV antibodies which occurred after clearance of the virus in the fish. In trout co-infected with both viruses, a mortality rate of 2% occurred and the immune parameters were similar to those observed in the fish infected with IPNV only, demonstrating that in co-infected trout IPNV inhibits the effects of IHNV. The studied parameters did not allow us to define the mechanism of interference occurring between these 2 viruses, but some hypothesis are put forward to explain the interference between the 2 viruses.

  4. Intermittent pneumatic compression devices combined with anticoagulants for prevention of symptomatic deep vein thrombosis after total knee arthroplasty: a pilot study

    PubMed Central

    Liu, Pengcheng; Liu, Junfeng; Chen, Liyang; Xia, Kuo; Wu, Xing

    2017-01-01

    Objectives To investigate the effectiveness of intermittent pneumatic compression (IPC) devices combined with anticoagulants for the prevention of deep vein thrombosis (DVT) after total knee arthroplasty (TKA). Patients and methods In total 120 patients were involved in this pilot study. Patients in the control group received 10 mg of rivaroxaban per day after surgery. In addition to the prescription of rivaroxaban, IPC devices were used in the experimental group. The diagnosis of DVT was made by compression duplex ultrasound on postoperative day 9. Results The incidence rates of overall, proximal, distal, and intermuscular DVT were 8.3%, 0%, 1.67%, and 6.67% in the experimental group; and 18.3%, 0%, 5%, and 13.33% in the control group, respectively. The incidence rates of total, distal, and intermuscular DVT in TKA patients was significantly lower in the experimental group than in the control group. For patients with DVT, enoxaparin was used instead of rivaroxaban, and DVT was found to have disappeared 10–14 days postoperatively. Conclusion Compared with the use of rivaroxaban alone, IPC devices combined with anticoagulants can significantly reduce the incidence rate of distal DVT and intermuscular DVT in the early postoperative period after TKA. PMID:28243107

  5. Sheep Milk Yogurt from a Short Food Supply Chain: Study of the Microbiological, Chemico-Physical and Organoleptic Parameters in Relation to Shelf-Life.

    PubMed

    Marri, Nicla; Carfora, Virginia; Patriarca, Daniela; Veschetti, Maria Cristina; Giacinti, Giuseppina; Giangolini, Gilberto; Amatiste, Simonetta

    2014-08-28

    Aim of this work was to analyse some microbiological, chemico-physical and organoleptic parameters of sheep milk yogurt during and after its declared shelf-life. Five samples of a sheep's milk yogurt of the same lot, collected from a short supply chain ovine dairy farm of the Roman province, were analysed. Declared shelf-life of the product was 30 days. The products were examined at 2, 14, 30, 35 and 40 days from the production date, performing the following microbiological analyses: enumeration of i) colony-forming units characteristic of the yogurt, ii) Enterobacteriaceae, iii) yeasts and/or moulds at 25°C. Microbiological identification was performed by miniature biochemical tests and for the lactic acid bacteria also by PCR. At every test interval, evaluation of organoleptic parameters and pH was also performed. The analysed product maintained an almost constant amount of lactic acid bacteria until the end of the declared shelf-life. Concerning lactic acid bacteria, a 100% concordance of the results observed by using biochemical identification methods and PCR assays was obtained. After 14 days from the production, the presence of yeasts (Candida famata) was revealed, while the presence of moulds was detected after 30 days. Ralstonia picketii, an environmental microorganism, was also isolated. The results obtained in this study indicate that yogurt spoilage is mainly due to the growth of specific microorganisms of spoilage, such as yeasts and moulds.

  6. Phase II and Biomarker Study of the Dual MET/VEGFR2 Inhibitor Foretinib in Patients With Papillary Renal Cell Carcinoma

    PubMed Central

    Choueiri, Toni K.; Vaishampayan, Ulka; Rosenberg, Jonathan E.; Logan, Theodore F.; Harzstark, Andrea L.; Bukowski, Ronald M.; Rini, Brian I.; Srinivas, Sandy; Stein, Mark N.; Adams, Laurel M.; Ottesen, Lone H.; Laubscher, Kevin H.; Sherman, Laurie; McDermott, David F.; Haas, Naomi B.; Flaherty, Keith T.; Ross, Robert; Eisenberg, Peter; Meltzer, Paul S.; Merino, Maria J.; Bottaro, Donald P.; Linehan, W. Marston; Srinivasan, Ramaprasad

    2013-01-01

    Purpose Foretinib is an oral multikinase inhibitor targeting MET, VEGF, RON, AXL, and TIE-2 receptors. Activating mutations or amplifications in MET have been described in patients with papillary renal cell carcinoma (PRCC). We aimed to evaluate the efficacy and safety of foretinib in patients with PRCC. Patients and Methods Patients were enrolled onto the study in two cohorts with different dosing schedules of foretinib: cohort A, 240 mg once per day on days 1 through 5 every 14 days (intermittent arm); cohort B, 80 mg daily (daily dosing arm). Patients were stratified on the basis of MET pathway activation (germline or somatic MET mutation, MET [7q31] amplification, or gain of chromosome 7). The primary end point was overall response rate (ORR). Results Overall, 74 patients were enrolled, with 37 in each dosing cohort. ORR by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was 13.5%, median progression-free survival was 9.3 months, and median overall survival was not reached. The presence of a germline MET mutation was highly predictive of a response (five of 10 v five of 57 patients with and without germline MET mutations, respectively). The most frequent adverse events of any grade associated with foretinib were fatigue, hypertension, gastrointestinal toxicities, and nonfatal pulmonary emboli. Conclusion Foretinib demonstrated activity in patients with advanced PRCC with a manageable toxicity profile and a high response rate in patients with germline MET mutations. PMID:23213094

  7. Systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial

    PubMed Central

    2011-01-01

    Background Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. Methods/Design The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis. Discussion This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants. Trial registration number Netherlands Trial Register (NTR): NTR2768 PMID:22070744

  8. School-based peer-related social competence interventions for children with autism spectrum disorder: a meta-analysis and descriptive review of single case research design studies.

    PubMed

    Whalon, Kelly J; Conroy, Maureen A; Martinez, Jose R; Werch, Brittany L

    2015-06-01

    The purpose of this review was to critically examine and summarize the impact of school-based interventions designed to facilitate the peer-related social competence of children with autism spectrum disorder (ASD). Reviewed studies employed a single-case experimental design, targeted peer-related social competence, included children 3-12 years old with an ASD, and took place in school settings. Articles were analyzed descriptively and using the evaluative method to determine study quality. Additionally, effect size estimates were calculated using nonoverlap of all pairs method and Tau-U. A total of 37 studies including 105 children were reviewed. Overall, ES estimates ranged from weak to strong, but on average, the reviewed interventions produced a moderate to strong effect, and quality ratings were generally in the acceptable to high range. Findings suggest that children with ASD can benefit from social skill interventions implemented with peers in school settings.

  9. Low back disability among self-employed dentists, veterinarians, physicians and physical therapists in The Netherlands. A retrospective study over a 13-year period (N = 1,119) and an early intervention program with 1-year follow-up (N = 134).

    PubMed

    van Doorn, J W

    1995-06-01

    This study was carried out among self-employed dentists, veterinarians, physicians and physical therapists insured against the financial consequences of disability by the insurance company Movir in Nieuwegein, the Netherlands. Disability for an individual was defined as a condition in which someone, due to illness or accident, regardless of the cause, is unable to pursue his/her profession, according to medical assessment. It concerned both short-term and long-term periods of sickness absence. The study consists of two parts: a) A retrospective investigation into the magnitude of the problem of low back disability from 1977 through 1989. b) A test of an early intervention program, introduced in 1990, involving a control group of low back disability claimants of 1987 and 1988 combined. Low back pain was the main cause of disability in 1,119 claims, submitted by 839 claimants. In 795 cases, this involved the first low back disability claim during the whole insurance period. The incidence of low back disability increased by 211 percent, from 3.48 per 1,000 persons at risk in 1977 to 7.35 in 1989. The costs of compensation for low back disability increased from 5.7 percent of the total compensation paid in 1977 to 13 percent in 1989. Nearly a quarter of the claims, all of which lasted longer than six months, accounted for 90 percent of the compensation costs of low back disability. The present study showed that in the case of veterinarians over 34 years of age and dentists over 44 years of age, specific low back pain, nonspecific low back pain in combination with a deferred period of 14 days or more, low back problems before acceptance, and the presence of psychosocial problems at the start of the disability were significantly associated with the duration of low back disability. This means that these "factors" predicted a longer duration. Based on the retrospective data, a predictive model of long-term low back disability was developed, which could be used for

  10. Actigraphy-defined Measures of Sleep and Movement Across the Menstrual Cycle In Midlife Menstruating Women: SWAN Sleep Study

    PubMed Central

    Zheng, Huiyong; Harlow, Siobán D; Kravitz, Howard M; Bromberger, Joyce; Buysse, Daniel J; Matthews, Karen A; Gold, Ellen B; Owens, Jane F; Hall, Martica

    2014-01-01

    Objective To evaluate patterns in actigraphy-defined sleep measures across the menstrual cycle, testing the hypothesis that sleep would be more disrupted in the premenstrual period, i.e. in the 14 days prior to menses. Methods A community-based, longitudinal study of wrist actigraphy-derived sleep measures was conducted with 163 women (58 African-American, 78 White, and 27 Chinese) of late reproductive age (mean=51.5, SD=2.0 years) from the Study of Women's Health Across the Nation (SWAN) Sleep Study. Daily measures of sleep [sleep efficiency (%) and total sleep time (minutes)] and movement during sleep [mean activity score (counts)] were characterized using wrist actigraphy across a menstrual cycle or 35 days, whichever was shorter. Data were standardized to 28 days to account for the variation of unequal cycle lengths and divided into four weekly segments for analyses. Results Sleep efficiency percentage declined gradually across the menstrual cycle, but the decline became pronounced in fourth week, the premenstrual period. Compared with third week, sleep efficiency declined by 5% (p<0.0001) and mean total sleep time was 25 minutes less (p=0.0002) in fourth week. No significant mean differences were found when comparing the means of second week versus third week. The association of weekly segments with sleep efficiency or minutes of total sleep time was modified by sociodemographic and lifestyle factors, including body mass index (BMI), race, study site, financial strain, marital status, and smoking. Conclusions Sleep varied systematically across the menstrual cycle in women of late reproductive age, including a gradual decline in sleep efficiency across all weeks, with a more marked change premenstrually during the last week of the menstrual cycle. These sleep changes may be modifiable by altering lifestyle factors. PMID:24845393

  11. Growth of Infants Fed Formula with Evolving Nutrition Composition: A Single-Arm Non-Inferiority Study

    PubMed Central

    Spalinger, Johannes; Nydegger, Andreas; Belli, Dominique; Furlano, Raoul I.; Yan, Jian; Tanguy, Jerome; Pecquet, Sophie; Destaillats, Frédéric; Egli, Delphine; Steenhout, Philippe

    2017-01-01

    The nutritional composition of human milk evolves over the course of lactation, to match the changing needs of infants. This single-arm, non-inferiority study evaluated growth against the WHO standards in the first year of life, in infants consecutively fed four age-based formulas with compositions tailored to infants’ nutritional needs during the 1st, 2nd, 3rd–6th, and 7th–12th months of age. Healthy full-term formula-fed infants (n = 32) were enrolled at ≤14 days of age and exclusively fed study formulas from enrollment, to the age of four months. Powdered study formulas were provided in single-serving capsules that were reconstituted using a dedicated automated preparation system, to ensure precise, hygienic preparation. The primary outcome was the weight-for-age z-score (WAZ) at the age of four months (vs. non-inferiority margin of −0.5 SD). Mean (95% CI) z-scores for the WAZ (0.12 (−0.15, 0.39)), as well as for the length-for-age (0.05 (−0.19, 0.30)), weight-for-length (0.16 (−0.16, 0.48)), BMI-for-age (0.11 (−0.20, 0.43)), and head circumference-for-age (0.41 (0.16, 0.65)) at the age of four months, were non-inferior. Throughout the study, anthropometric z-scores tracked closely against the WHO standards (within ±1 SD). In sum, a four-stage, age-based infant formula system with nutritional compositions tailored to infants’ evolving needs, supports healthy growth consistent with WHO standards, for the first year of life. PMID:28257044

  12. Effect of chlorhexidine varnish on gingival growth in orthodontic patients: a randomized prospective split-mouth study

    PubMed Central

    Pretti, Henrique; Barbosa, Gabriella Lopes de Rezende; Lages, Elizabeth Maria Bastos; Gala-García, Alfonso; de Magalhães, Claudia Silami; Moreira, Allyson Nogueira

    2015-01-01

    Introduction: Fixed orthodontic appliances patients suffer limitations on the effective control of biofilm by mechanical methods, bringing the need of a coadjutant in the control of inflammation and oral health improvement. Objective: The aim of this prospective split-mouth blind study was to analyze the effect of a 40% chlorhexidine (CHX) varnish on gingival growth of patients with orthodontic fixed appliances. Methods: Healthy teenage patients with fixed orthodontic appliances and increased gingival volume were recruited (n = 30). Each individual was his own control, having in the maxilla one control side and one treatment side. An application of varnishes occurred on the vestibular area of the upper premolars and first molar crowns, on the control side (placebo varnish) and on the experimental side (EC40(r) Biodentic CHX varnish). The varnishes and sides were randomly chosen and its identification and group was kept by a third party observer and it was not revealed to the researchers and participants until the end of study. In order to establish a baseline registration, digital photographs were taken by a trained photographer before varnish application at baseline (T0), as well as 14 days (T14) and 56 days (T56) after the application. The gingival volume was calculated indirectly using the vestibular areas (mm2) of the upper second premolars' clinical crowns by RapidSketch(r) software, at all study times. The data were analyzed using ANOVA and the Turkey-Krammer test. Results: It was observed, in the final sample of 30 individuals, that at T0, the control and treatment groups were similar. At T14 and T56, a progressive reduction of the clinical crown area was seen in the control group, and an increase in the average area was detected in the experimental group (p < 0,05). Conclusions: The use of 40% CHX varnish decreases the gingival overgrowth in patients undergoing orthodontic treatment. Further studies are necessary to set the action time and frequency of

  13. TST36 stapling for rectocele and hemorrhoidal prolapse – early results of the prospective German multicenter study

    PubMed Central

    Petersen, Sven; Sterzing, Daniel; Ommer, Andreas; Mladenov, Assen; Nakic, Zrino; Pakravan, Faramaz; Wolff, Katja; Lorenz, Eric P. M.; Prosst, Ruediger L.; Sailer, Marco; Scherer, Roland

    2016-01-01

    Introduction: The aim of the study was to evaluate the safety and feasibility of stapled transanal procedures performed by a 36 mm stapling device, the so-called TST36 stapler. Methods: From September 2013 to June 2014 a prospective observational study was carried out by 8 proctology centers in Germany. The Cleveland Clinic Incontinence Score (CCIS) for incontinence and the Altomare ODS score were determined preoperatively. Follow-up examinations were performed after 14 days, one month and 6 months, at this time both scores were reevaluated. Results: 110 consecutive patients (71 women, 39 men) with a mean age of 59.7 years (±13.8 years) were included in the study. The eight participating institutes entered 3 to 31 patients each into the study. The indication for surgery was an advanced hemorrhoidal disease in 55 patients and ODS with rectal intussusception or rectocele in 55 patients. Mechanical problems with stapler introduction occurred in 22 cases (20%) and a partial stapleline dehiscence in 4 cases (3.6%). Additional stitches for bleeding from stapleline were necessary in 86 patients (78.2%). Reintervention was necessary for bleeding 7 times (6.3%). Severe complications during follow-up were stapleline dehiscence in one case and recurrent hemorrhoidal prolapse in 5 cases (4.5%). Altomare ODS score and CCIS improved significantly after surgery. Conclusions: Despite a notable complication rate during surgery and the postoperative period, the TST36 can be considered as an effective tool for low rectal stapling for anorectal prolapse causing hemorrhoids or obstructed defecation. PMID:28066159

  14. Medical Research and Evaluation Facility (MREF) and studies supporting the Medical Chemical Defense Program on Task 89-01: Screening of candidate pretreatment and therapeutic compounds in in vivo models. Final report Jul 89-Sep 91

    SciTech Connect

    Olson, C.T.; Kiser, R.C.; Dill, G.S.

    1992-02-01

    This task was a continuation of Task 86-29 initiated for Contract D. It provided in vivo screens for evaluating the efficacy of candidate pretreatment and treatment compounds submitted by the Drug Assessment Division of U.S. Army Medical Research of Chemical Defense against soman, tabun, and/or cyanide. A total of 578 compounds were received for testing and their maximum solubility in-vehicles comparable with in vivo testing in mice was determined. Range-finding and median lethal dose determinations following IM and/or oral administrations were conducted for 436 compounds submitted for nerve agent screening and range finding and median lethal dose determinations following IP administration were conducted for up to 142 compounds submitted for cyanide screening. Of 332 compounds evaluated, 154 passed the GD treatment efficacy evaluation, and 90 of 156 compounds submitted passed the GA treatment efficacy evaluation. For pretreatment studies against a GD challenge, 224 of 379 compounds submitted passed the IM efficacy evaluation and 96 of 143 compounds submitted passed the oral efficacy evaluation. Only 12 of 133 compounds evaluated as cyanide pretreatment compounds passed the efficacy evaluations. The mission of Task 89-01 was combined under Task 91-20 for the duration of Contract DAMD17-89-C-9050.

  15. CYTOLOGICAL STUDIES OF ORGANOTYPIC CULTURES OF RAT DORSAL ROOT GANGLIA FOLLOWING X-IRRADIATION IN VITRO

    PubMed Central

    Masurovsky, Edmund B.; Bunge, Mary Bartlett; Bunge, Richard P.

    1967-01-01

    Long-term organotypic cultures of rat dorsal root ganglia were exposed to a single 40 kR dose of 184 kvp X-rays and studied in the living and fixed states by light or electron microscopy at 1–14 day intervals thereafter. Within the first 4 days following irradiation, over 30% of the neurons display chromatolytic reactions (eccentric nuclei, peripheral dispersal of Nissl substance, central granular zone) as well as abnormal nucleolar changes and dissociation of ribosomes from endoplasmic reticulum cisternae. Some satellite cells undergo retraction or acute degeneration, leaving only basement membrane to cover the neuron in these areas. 8 days after irradiation, neurons also exhibit (a) areas in which ribosomes are substantially reduced, (b) regions of cytoplasmic sequestration, (c) extensive vacuolization of granular endoplasmic reticulum and Golgi complex, and (d) diversely altered mitochondria (including the presence of ribosome-like particles or association with abnormal glycogen and lipid deposits). Nucleolar components become altered or reoriented and may form abnormal projections and ringlike configurations. Sizeable areas of the neuronal soma are now denuded of satellite cells; underlying these areas, nerve processes are found abnormally invaginated into the neuronal cytoplasm. By the 14th day following irradiation, most neurons display marked degenerative changes including extensive regions of ribosome depletion, sequestration, vacuolization, autolysis, and, in some areas, swirls of filaments, myelin figures, and heterogeneous dense bodies. These observations demonstrate that X-irradiation produces profound cytopathological changes in nervous tissue isolated from the host and that many of these changes resemble the effects of radiation on nervous tissue in vivo. PMID:10976234

  16. Potentially high-risk medication categories and unplanned hospitalizations: a case–time–control study

    PubMed Central

    Lin, Chih-Wan; Wen, Yu-Wen; Chen, Liang-Kung; Hsiao, Fei-Yuan

    2017-01-01

    Empirical data of medication-related hospitalization are very limited. We aimed to investigate the associations between 12 high risk medication categories (diabetic agents, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, antiplatelets, antihypertensives, antiarrhythmics, anticonvulsants, antipsychotics, antidepressants, benzodiazepine (BZD)/Z-hypnotics, and narcotics) and unplanned hospitalizations. A population-based case–time–control study was performed using Taiwan’s National Health Insurance Research Database. Patients who experienced an unplanned hospitalization (index visit) were identified as index subjects and matched to a randomly selected reference visit within users of a specific category of high-risk medication. An unplanned hospitalization was defined as a hospital admission immediately after an emergency department visit. Discordant exposures to the high-risk medication during the case period (1–14 days before the visit) and the control period (366–379 days before the visit) were examined in both index and reference visits. Antipsychotics was associated with the highest risk of unplanned hospitalizations (adjusted OR: 1.54, 95% CI [1.37–1.73]), followed by NSAIDs (1.50, [1.44–1.56]), anticonvulsants (1.34, [1.10–1.64]), diuretics (1.24, [1.15–1.33]), BZD/Z-hypnotics (1.23, [1.16–1.31]), antidepressants (1.17, [1.05–1.31]) and antiplatelets (1.16, [1.07–1.26]). NSAIDs and narcotics were associated with the highest risks of unplanned hospitalizations with a length of stay ≥10 days. These medication categories should be targeted for clinical and policy interventions. PMID:28112193

  17. Intrathecal or intraventricular therapy for post-neurosurgical Gram-negative meningitis: matched cohort study.

    PubMed

    Shofty, B; Neuberger, A; Naffaa, M E; Binawi, T; Babitch, T; Rappaport, Z H; Zaaroor, M; Sviri, G; Paul, M

    2016-01-01

    Gram-negative post-operative meningitis due to carbapenem-resistant bacteria (CR-GNPOM) is a dire complication of neurosurgical procedures. We performed a nested propensity-matched historical cohort study aimed at examining the possible benefit of intrathecal or intraventricular (IT/IV) antibiotic treatment for CR-GNPOM. We included consecutive adults with GNPOM in two centres between 2005 and 2014. Patients receiving combined systemic and IT/IV treatment were matched to patients receiving systemic treatment only. Matching was done based on the propensity of the patients to receive IT/IV treatment. We compared patient groups with 30-day mortality defined as the primary outcome. The cohort included 95 patients with GNPOM. Of them, 37 received IT/IV therapy in addition to systemic treatment (22 with colistin and 15 with amikacin), mostly as initial therapy, through indwelling cerebrospinal fluid drains. Variables associated with IT/IV therapy in the propensity score included no previous neurosurgery, time from admission to meningitis, presence of a urinary catheter and GNPOM caused by carbapenem-resistant Gram-negative bacteria. Following propensity matching, 23 patients given IT/IV therapy and 27 controls were analysed. Mortality was significantly lower with IT/IV therapy: 2/23 (8.7%) versus 9/27 (33.3%), propensity-adjusted OR 0.19, 95% CI 0.04-0.99. Death or neurological deterioration at 30 days, 14-day and in-hospital mortality were lower with IT/IV therapy (OR <0.4 for all) without statistically significant differences. Among patients discharged alive, those receiving IT/IV therapy did not experience more neurological deterioration. Serious adverse events with IT/IV therapy were not documented. Our results support the early use of IT antibiotic treatment for CR-GNPOM when a delivery method is available.

  18. The German version of the Generalized Pathological Internet Use Scale 2: a validation study.

    PubMed

    Barke, Antonia; Nyenhuis, Nele; Kröner-Herwig, Birgit

    2014-07-01

    The Generalized Pathological Internet Use Scale (GPIUS2) assesses cognitive behavioral aspects of problematic Internet use. To date, the 15-item scale has only been available in English, and the aim of this study was to translate and validate a German version. An online sample (ON, n=1,041, age 24.2±7.2 years, 46.7% men) completed an Internet version of the translated GPIUS2, and a student sample (OF, n=841, age 23.5±3.0 years, 46.8% men) filled in a pencil and paper version. A third sample of 108 students (21.5±2.0 years, 25.7% men) completed the questionnaire twice to determine the 14-day retest reliability. Participants also answered questions regarding their Internet use habits (OF, ON) and depression, loneliness, and social anxiety (ON). The internal consistencies were α=0.91 (ON) and α=0.86 (OF). Item-whole correlations ranged from r=0.53 to r=0.69 (ON) and from r=0.39 to r=0.63 (OF). The 2 week retest reliability was rtt=0.85. Confirmatory factor analyses found a satisfactory fit for the factorial model proposed by Caplan for the original version. The GPIUS2 score correlated moderately with time spent on the Internet for private purposes in a typical week (ON: r=0.40; OF: r=0.36). Loneliness, depression, and social anxiety explained 46% of the variance in GPIUS2 scores. The German version of the GPIUS2 has good psychometric properties in a pencil and paper version as well as in a web-based format, and the observations regarding loneliness, depression, and social anxiety support the underlying model.

  19. Modulation of oxidative stress by enalapril and valsartan in adrenaline treated rats: a comparative study.

    PubMed

    Huda, S; Akhter, N

    2014-04-01

    Angiotensin (Ang II) II is known to promote oxidative stress in acute myocardial infarction (AMI). Inhibition of renin angiotensin system (RAS) or blockade of Ang II receptors may therefore be effective in reducing oxidative stress during AMI. The study evaluates and compares the protective effect of Angiotensin Converting Enzyme (ACE) inhibitor and AT1 receptor blocker in adrenaline induced oxidative stress in rats. Rats were treated with two successive injections of adrenaline subcutaneously at a dose of 2 mg/kg administered 24 hours apart. In other two groups of rats enalapril (30 mg/kg) or valsartan (30 mg/kg) were given orally once daily through intragastric tube for 2 weeks and then two injections of adrenaline were administered 24 hours apart. Serum Aspertate Transaminase (AST), plasma Malonde Aldehyde (MDA), erythrocyte GSH and serum vitamin E levels were measured 24 hours after the 2nd injection of adrenaline in all the groups. Administration of adrenaline caused significant increase (p < 0.001) in serum AST and plasma MDA levels and decrease (p < 0.001) in erythrocyte GSH and serum vitamin E levels. Pre-treatment of enalapril or valsartan for 14 days reduced (p < 0.001) serum AST and plasma MDA levels and increased the concentration of erythrocyte GSH in enalapril pre-treated group (p < 0.01) and in valsartan pre-treated group (p < 0.05). Pre-treatment of enalapril or valsartan also increased (p < 0.01) serum vitamin E levels in adrenaline treated rats. However, no significant difference was noted between the effect of enalapril and valsartan on serum AST, plasma MDA, erythrocyte GSH and serum vitamin E levels. It may be concluded that both enalapril and valsartan offered cardioprotection in adrenaline induced oxidative stress, but the protection afforded by valsartan was not superior to enalapril.

  20. Vibrational study on the bioactivity of Portland cement-based materials for endodontic use

    NASA Astrophysics Data System (ADS)

    Taddei, P.; Tinti, A.; Gandolfi, M. G.; Rossi, P. L.; Prati, C.

    2009-04-01

    The bioactivity of a modified Portland cement (wTC) and a phosphate-doped wTC cement (wTC-P) was studied at 37 °C in Dulbecco's Phosphate Buffered Saline (DPBS). The cements, prepared as disks, were analysed at different ageing times (from 1 day to 2 months) by micro-Raman and ATR/FT-IR spectroscopies. The presence of deposits on the surface of the cements and the composition changes as a function of the storage time were investigated. The presence of an apatite deposit on the surface of both cements was already revealed after one day of ageing in DPBS. The trend of the I 965/I 991 Raman intensity ratio indicated the formation of a meanly thicker apatite deposit on the wTC-P cement at all the investigated times. This result was confirmed by the trend of the I 1030/I 945 IR intensity ratio calculated until 14 days of ageing. At 2 months, the thickness of the apatite deposit on wTC and wTC-P was about 200 and 500 μm, respectively, as estimated by micro-Raman spectroscopy, confirming the higher bioactivity of the phosphate-doped cement. Vibrational techniques allowed to gain more insights into the cement transformation and the different hydration rates of the various cement component. The setting of the cement and the formation of the hydrated silicate gel (C-S-H phase) was spectroscopically monitored through the I 830/I 945 IR intensity ratio.

  1. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD

    PubMed Central

    Nguyen, Huong Q; Gill, Dawn P; Wolpin, Seth; Steele, Bonnie G; Benditt, Joshua O

    2009-01-01

    Objective To determine the feasibility and efficacy of a six-month, cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation. Methods Participants who completed a two-week run-in were randomly assigned to either MOBILE-Coached (n = 9) or MOBILE-Self-Monitored (n = 8). All participants met with a nurse to develop an individualized exercise plan, were issued a pedometer and exercise booklet, and instructed to continue to log their daily exercise and symptoms. MOBILE-Coached also received weekly reinforcement text messages on their cell phones; reports of worsening symptoms were automatically flagged for follow-up. Usability and satisfaction were assessed. Participants completed incremental cycle and six minute walk (6MW) tests, wore an activity monitor for 14 days, and reported their health-related quality of life (HRQL) at baseline, three, and six months. Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18% predicted. Participants reported that logging their exercise and symptoms (FEV1) of 40 ± was easy and that keeping track of their exercise helped them remain active. There were no differences between groups over time in maximal workload, 6MW distance, or HRQL (p > 0.05); however, MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months (p =0.04). Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring. The latter finding needs to be interpreted with caution since this was a purely exploratory study. Trial registration ClinicalTrials.gov (NCT00373932). PMID:19750190

  2. Effects of Acid Treatment on Dental Zirconia: An In Vitro Study

    PubMed Central

    Xie, Haifeng; Shen, Shuping; Qian, Mengke; Zhang, Feimin; Chen, Chen; Tay, Franklin R.

    2015-01-01

    The aim of this study was to evaluate the effects of hydrofluoric (HF) acid, acetic acid, and citric acid treatments on the physical properties and structure of yttria-stabilized tetragonal zirconia polycrystal (Y-TZP) at ambient temperature. In total, 110 bar-shaped zirconia specimens were randomly assigned to 11 groups. The specimens in the control group (C) received no surface treatment, while those in the Cage group were hydrothermally aged at 134°C and 0.2 MPa for 20 h. Ten specimens each were immersed at ambient temperature in 5% and 40% HF acid for 2 h (40HF0), 1 day (5HF1, 40HF1), and 5 days (5HF5, 40HF5), while 10 each were immersed at ambient temperature in 10% acetic acid and 20% citric acid for 7 (AC7, CI7) and 14 days (AC14, CI14). X-ray diffraction (XRD) was used to quantitatively estimate the monoclinic phase. Furthermore, flexural strength, surface roughness, and surface Vickers hardness were measured after treatment. Scanning electron microscopy (SEM) was used to characterize the surface morphology. The Cage group specimens exhibited an increased monoclinic phase and flexural strength. Furthermore, 40% HF acid immersion decreased the flexural strength and surface hardness and deteriorated the surface finish, while 5% HF acid immersion only decreased the surface hardness. All the HF acid-immersed specimens showed an etched surface texture on SEM observations, while the other groups did not. These findings suggest that the treatment of Y-TZP with 40% HF acid at ambient temperature causes potential damage, while treatment with 5% HF acid, acetic acid, and citric acid is safe. PMID:26301413

  3. Toxicological studies for some agricultural waste extracts on mosquito larvae and experimental animals

    PubMed Central

    El-Maghraby, Somia; Nawwar, Galal A; Bakr, Reda FA; Helmy, Nadia; Kamel, Omnia MHM

    2012-01-01

    Objective To evaluate some agricultural waste extracts as insecticide and their effects on enzyme activities in liver and kidney of male mice. Methods The insecticidal activity of five tested compounds (one crude extract and 4 waste compounds) was bioassay against the 3rd instars of the Culex pipiens (Cx. pipiens) larvae in the laboratory. The LC50 values of eucalyptol, apricot kernel, Rice bran, corn, black liquor and white liquor are 91.45, 1 166.1, 1 203.3, 21 449.65, 4 025.78 and 6 343.18 ppm, respectively. Selection of the compounds for the subsequent studies was not only dependent on LC50 values but also on the persistence of these wastes products on large scale. Results White and black liquor did not produce any gross effect at 200 mg/Kg body weight. No apparent toxic symptoms were observed in tested animals during the whole period of the experiment which run out for 14 days. No statistically significance was observed in the enzyme cholinesterase activity, the activities of liver enzymes and kidney function in treated mice with black and white liquors. While, no and slight inhibition was observed after the 2 weeks of treatment period with deltamethrin and fenitrothion reached to about 24% in plasma cholinesterase enzyme activity. Significantly increase in the activities of liver enzymes and kidney function in treated mice with deltamethrin and fenitrothion. Conclusions Black liquor can be used efficiently to control Cx. pipiens larvae under laboratory condition. Environmental problem caused by rice straw can be solved by converting the waste material to beneficial natural selective insecticide. PMID:23569971

  4. Investigation of Poultry Waste for Anaerobic Digestion: A Case Study

    NASA Astrophysics Data System (ADS)

    Salam, Christopher R.

    Anaerobic Digestion (AD) is a biological conversion technology which is being used to produce bioenergy all over the world. This energy is created from biological feedstocks, and can often use waste products from various food and agricultural processors. Biogas from AD can be used as a fuel for heating or for co-generation of electricity and heat and is a renewable substitute to using fossil fuels. Nutrient recycling and waste reduction are additional benefits, creating a final product that can be used as a fertilizer in addition to energy benefits. This project was conducted to investigate the viability of three turkey production wastes as AD feedstock: two turkey litters and a material separated from the turkey processing wastewater using dissolved air flotation (DAF) process. The DAF waste contained greases, oils and other non-commodity portions of the turkey. Using a variety of different process methods, types of bacteria, loading rates and food-to-microorganism ratios, optimal loading rates for the digestion of these three materials were obtained. In addition, the co-digestion of these materials revealed additional energy benefits. In this study, batch digestion tests were carried out to treat these three feedstocks, using mesophilic and thermophilic bacteria, using loading rates of 3 and 6 gVS/L They were tested separately and also as a mixture for co-digestion. The batch reactor used in this study had total and working volumes of 1130 mL and 500 mL, respectively. The initial organic loading was set to be 3 gVS/L, and the food to microorganism ratio was either 0.6 or 1.0 for different treatments based on the characteristics of each material. Only thermophilic (50 +/- 2ºC) temperatures were tested for the litter and DAF wastes in continuous digestion, but mesophilic and thermophilic batch digestion experiments were conducted. The optimum digestion time for all experiments was 14 days. The biogas yields of top litter, mixed litter, and DAF waste under

  5. A randomized, double-masked, parallel-group, comparative study to evaluate the clinical efficacy and safety of 1% azithromycin–0.1% dexamethasone combination compared to 1% azithromycin alone, 0.1% dexamethasone alone, and vehicle in the treatment of subjects with blepharitis

    PubMed Central

    Hosseini, Kamran; Lindstrom, Richard L; Foulks, Gary; Nichols, Kelly K

    2016-01-01

    Purpose To evaluate the clinical efficacy and safety of a 1% azithromycin–0.1% dexamethasone combination in DuraSite (“combination”) compared to 0.1% dexamethasone in DuraSite, 1% azithromycin in DuraSite, and vehicle in the treatment of subjects with blepharitis. Materials and methods This was a Phase III, double-masked, vehicle-controlled, four-arm study in which 907 subjects with blepharitis were randomized to combination (n=305), 0.1% dexamethasone (n=298), 1% azithromycin (n=155), or vehicle (n=149). Ten study visits were scheduled: screening visit, days 1 and 4 (dosing phase) and 15, and months 1–6 (follow-up phase). On day 1, subjects applied one drop of the study drug to the eyelid of the inflamed eye(s) twice daily, and continued with twice-daily dosing for 14 days. After completing 14 days of dosing, subjects were followed for 6 months for efficacy and safety. Results A total of 57 subjects (6.3%) had complete clinical resolution at day 15: 25 (8.2%), 17 (5.7%), 8 (5.2%), and 7 (4.7%) subjects in the combination-, 0.1% dexamethasone-, 1% azithromycin-, and vehicle-treatment groups, respectively. The combination was superior to 1% azithromycin and vehicle alone, but not to 0.1% dexamethasone alone. Mean composite (total) clinical sign and symptom scores improved in all four treatment groups during the post-treatment evaluation phase for the intent-to-treat population, but outcomes were superior when a drop containing 0.1% dexamethasone was utilized. Clinical response was noted as early as day 4, and persisted as long as 6 months. Most adverse events were considered mild in severity and not related to the study drug. Conclusion A higher percentage of subjects in the combination group achieved complete clinical resolution of the signs and symptoms of blepharitis at day 15 than with 1% azithromycin and vehicle, but outcomes were similar to treatment with 0.1% dexamethasone alone. The combination was well tolerated. PMID:27570444

  6. Early Anti-Pseudomonal Acquisition in Young Patients with Cystic Fibrosis: Rationale and Design of the EPIC Clinical Trial and Observational Study

    PubMed Central

    Treggiari, Miriam M; Rosenfeld, Margaret; Mayer-Hamblett, Nicole; Retsch-Bogart, George; Gibson, Ronald L.; Williams, Judy; Emerson, Julia; Kronmal, Richard A; Ramsey, Bonnie W

    2009-01-01

    Background The primary cause of morbidity and mortality in patients with cystic fibrosis (CF) is progressive obstructive pulmonary disease due to chronic endobronchial infection, particularly with Pseudomonas aeruginosa (Pa). Risk factors for and clinical impact of early Pa infection in young CF patients are less well understood. Purpose The present studies are designed to evaluate risk factors and outcomes associated with early Pa acquisition, and the benefits and harms of four anti-pseudomonal treatment regimens in young CF patients initiated after the first Pa positive respiratory culture. Methods The Early Pseudomonas Infection Control (EPIC) program consists of two studies, a randomized multicenter trial in CF patients ages 1–12 years at first isolation of Pa from a respiratory culture, and a longitudinal cohort study enrolling Pa-negative patients. Using a factorial design, trial participants are assigned for 18 months to either anti-pseudomonal treatment on a scheduled quarterly basis (cycled therapy) or based on recovery of Pa from quarterly respiratory cultures (culture-based therapy). The study drugs include inhaled tobramycin (300 mg BID) for 28 days, combined with either oral ciprofloxacin (15–20 mg/kg BID) or oral placebo for 14 days. The primary endpoints of the trial are the time to pulmonary exacerbation requiring IV antibiotics or hospitalization for respiratory symptoms, and the proportion of patients with new Pa-positive respiratory cultures during the study. The broad goals of the observational study are to describe the risk factors and outcomes associated with early acquisition of Pa. 306 patients were randomized in the clinical trial and 1,787 were enrolled in the cohort study. Conclusions These companion studies will provide valuable epidemiological and microbiological information on early CF lung disease and Pa acquisition, and safety and clinical efficacy data on anti-pseudomonal treatment strategies for early Pa infections in the

  7. Neurological and cytological response as potential early predictors of time-to-progression and overall survival in patients with leptomeningeal carcinomatosis treated with intrathecal liposomal cytarabine: a retrospective cohort study.

    PubMed

    Fusco, Juan P; Castañón, Eduardo; Carranza, Omar E; Zubiri, Leire; Martín, Patricia; Espinós, Jaime; Rodríguez, Javier; Santisteban, Marta; Aramendía, José M; Gil-Bazo, Ignacio

    2013-12-01

    Interesting neurological and cytological response rates after intrathecal (i.t) liposomal cytarabine have been observed in patients with leptomeningeal carcinomatosis (LMC) from solid tumors. However, the potential use of those responses as early predictors of time-to-progression (TTP) and overall survival (OS) is unexplored. 27 consecutive patients with LMC treated with 50 mg i.t liposomal cytarabine under compassionate drug use were retrospectively studied. All patients received i.t treatment every 2 weeks during induction and every 4 weeks during maintenance periods. Neurological and cytological responses were assessed before every liposomal cytarabine cycle. Most of the patients were female (17/27) diagnosed with breast cancer (15/27). A complete neurological response was seen among 11 % of the patients; partial response in 22 % of the patients; stable disease in 30 % of the patients and progressive disease in 37 % of them. Cytological assessment was available in 11/27 patients showing a 26 % complete response rate. The median time to neurological and cytological response was 15 days and 14 days, respectively. Patients showing a combined neurological and cytological response showed a significantly longer median TTP (122 vs. 3 days; p = 0.001) and OS (141 vs. 3 days; p = 0.002) compared to those showing both neurological and cytological progression. No grade 4 toxicities were recorded. According to these preliminary results, early neurological and cytological responses may be further studied as early predictors of TTP and OS in patients receiving i.t liposomal cytarabine for LMC.

  8. Early evaluation of tumour metabolic response using [18F]fluorodeoxyglucose and positron emission tomography:a pilot study following the phase II chemotherapy schedule for temozolomide in recurrent high-grade gliomas

    PubMed Central

    Brock, C S; Young, H; O'Reilly, S M; Matthews, J; Osman, S; Evans, H; Newlands, E S; Price, P M

    2000-01-01

    Quantitation of metabolic changes in tumours may provide an objective measure of clinical and subclinical response to anticancer therapy. This pilot study assesses the value of quantitation of metabolic rate of glucose (MRGlu) measured in mmol min−1ml−1to assess early subclinical response to therapy in a relatively non-responsive tumour. Nine patients receiving the CRC Phase II study schedule of temozolomide were assessed with [18F]fluorodeoxyglucose ([18F]FDG) dynamic positron emission tomography (PET) scans prior to and 14 days after treatment with temozolomide given as 750–1000 mg m−2over 5 days every 28 days. Tumour MRGlu was calculated and compared with objective response at 8 weeks. Pretreatment MRGlu was higher in responders than non-responders. The responding patient group had a greater than 25% reduction in MRGlu in regions of high focal tumour uptake (HFU). Whole tumour changes in MRGlu did not correlate with response. Percentage change in HFU standardized uptake value (SUV) did discriminate the responding from the non-responding patients, but not as well as with MRGlu. Large differences also occurred in the normal brain SUV following treatment. Thus, MRGlu appeared to be a more sensitive discriminator of response than the simplified static SUV analysis. Changes in MRGlu may reflect the degree of cell kill following chemotherapy and so may provide an objective, quantitative subclinical measure of response to therapy. © 2000 Cancer Research Campaign PMID:10682673

  9. Evaluation of antidepressant like activity of curcumin and its combination with fluoxetine and imipramine: an acute and chronic study.

    PubMed

    Sanmukhani, Jayesh; Anovadiya, Ashish; Tripathi, Chandrabhanu B

    2011-01-01

    Curcumin is the active ingredient of commonly used spice Curuma longa Linn. In the present study, the antidepressant like activity of curcumin and its combination with fluoxetine and imipramine was studied in acute model (three doses 24, 5 and 1 h before test) of forced swimming test (FST) in glass jar and tail suspension test (TST) in mice and in chronic model (14 day study) of FST with water wheel in rats. All the tests were carried out in the following seven groups (n = 6 in each group), drugs being given orally (doses for mice): Group 1 (vehicle), group 2 (curcumin 50 mg/kg), group 3 (curcumin 100 mg/kg), group 4 (fluoxetine 20 mg/kg), group 5 (imipramine 15 mg/kg), group 6 (curcumin 100 mg/kg plus fluoxetine 20 mg/kg) and group 7 (curcumin 100 mg/kg plus imipramine 15 mg/kg). Equivalent doses for rats were used. Both the acute model of FST and TST, and the chronic model of FST with water wheel showed significant antidepressant like activity of curcumin in 100 mg/kg dose as compared to vehicle control (p < 0.05). The effect of curcumin (100 mg/kg) was similar to that of fluoxetine and imipramine (p > 0.05) but its addition to fluoxetine and imipramine did not improve their antidepressant activity (p > 0.05). Curcumin increased both the swimming and climbing behavior in FST, thus its antidepressant like activity could be due to an increase in serotonin, norepinephrine and dopamine levels in the brain. Curcumin can be a useful antidepressant especially in cases which respond to drugs having mixed effects on serotonin and catecholamines levels in the brain.

  10. Effect of Peripheral Electrical Stimulation (PES) on Nocturnal Blood Glucose in Type 2 Diabetes: A Randomized Crossover Pilot Study

    PubMed Central

    Catalogna, Merav; Doenyas-Barak, Keren; Sagi, Roi; Abu-Hamad, Ramzia; Nevo, Uri; Efrati, Shai

    2016-01-01

    Background Regulation of hepatic glucose production has been a target for antidiabetic drug development, due to its major contribution to glucose homeostasis. Previous pre-clinical study demonstrated that peripheral electrical stimulation (PES) may stimulate glucose utilization and improve hepatic insulin sensitivity. The aim of the present study was to evaluate safety, tolerability, and the glucose-lowering effect of this approach in patients with type 2 diabetes (T2DM). Methods Twelve patients with T2DM were recruited for an open label, interventional, randomized trial. Eleven patients underwent, in a crossover design, an active, and a no-intervention control periods, separated with a two-week washout phase. During the active period, the patients received a daily lower extremity PES treatment (1.33Hz/16Hz burst mode), for 14 days. Study endpoints included changes in glucose levels, number of hypoglycemic episodes, and other potential side effects. Endpoints were analyzed based on continuous glucose meter readings, and laboratory evaluation. Results We found that during the active period, the most significant effect was on nocturnal glucose control (P < 0.0004), as well as on pre-meal mean glucose levels (P < 0.02). The mean daily glucose levels were also decreased although it did not reach clinical significance (P = 0.07). A reduction in serum cortisol (P < 0.01) but not in insulin was also detected after 2 weeks of treatment. No adverse events were recorded. Conclusions These results indicate that repeated PES treatment, even for a very short duration, can improve blood glucose control, possibly by suppressing hepatic glucose production. This effect may be mediated via hypothalamic-pituitary-adrenal axis modulation. Trial registration ClinicalTrials.gov NCT02727790 PMID:27997608

  11. Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study

    PubMed Central

    2011-01-01

    Introduction As the immunosuppressive potency of 15-deoxyspergualin (DSG) has been shown in the therapy of renal transplant rejection and Wegener's granulomatosis, the intention of this study was to evaluate the safety of DSG in the therapy of lupus nephritis (LN). Methods Patients with histologically proven active LN after prior treatment with at least one immunosuppressant were treated with 0.5 mg/kg normal body weight/day DSG, injected subcutaneously for 14 days, followed by a break of one week. These cycles were repeated to a maximum of nine times. Doses of oral corticosteroids were gradually reduced to 7.5 mg/day or lower by cycle 4. Response was measured according to a predefined decision pattern. The dose of DSG was adjusted depending on the efficacy and side effects. Results A total of 21 patients were included in this phase-I/II study. After the first DSG injection, one patient was excluded from the study due to renal failure. Five patients dropped out due to adverse events or serious adverse events including fever, leukopenia, oral candidiasis, herpes zoster or pneumonia. Eleven out of 20 patients achieved partial (4) or complete responses (7), 8 were judged as treatment failures and 1 patient was not assessable. Twelve patients completed all nine cycles; in those patients, proteinuria decreased from 5.88 g/day to 3.37 g/day (P = 0.028), Selena-SLEDAI (Safety of Estrogens in Lupus Erythematosus - National Assessment - systemic lupus erythematosus disease activity index) decreased from 17.6 to 11.7. In 13 out of 20 patients, proteinuria decreased by at least 50%; in 7 patients to less than 1 g/day. Conclusions Although the number of patients was small, we could demonstrate that DSG provides a tolerably safe treatment for LN. The improvement in proteinuria encourages larger controlled trials. Trial registration ClinicalTrials.gov: NCT00709722 PMID:21356124

  12. Reappraisal of the outcome of healthcare-associated and community-acquired bacteramia: a prospective cohort study

    PubMed Central

    2013-01-01

    Background Healthcare-associated (HCA) bloodstream infections (BSI) have been associated with worse outcomes, in terms of higher frequencies of antibiotic-resistant microorganisms and inappropriate therapy than strict community-acquired (CA) BSI. Recent changes in the epidemiology of community (CO)-BSI and treatment protocols may have modified this association. The objective of this study was to analyse the etiology, therapy and outcomes for CA and HCA BSI in our area. Methods A prospective multicentre cohort including all CO-BSI episodes in adult patients was performed over a 3-month period in 2006–2007. Outcome variables were mortality and inappropriate empirical therapy. Adjusted analyses were performed by logistic regression. Results 341 episodes of CO-BSI were included in the study. Acquisition was HCA in 56% (192 episodes) of them. Inappropriate empirical therapy was administered in 16.7% (57 episodes). All-cause mortality was 16.4% (56 patients) at day 14 and 20% (71 patients) at day 30. After controlling for age, Charlson index, source, etiology, presentation with severe sepsis or shock and inappropriate empirical treatment, acquisition type was not associated with an increase in 14-day or 30-day mortality. Only an stratified analysis of 14th-day mortality for Gram negatives BSI showed a statically significant difference (7% in CA vs 17% in HCA, p = 0,05). Factors independently related to inadequate empirical treatment in the community were: catheter source, cancer, and previous antimicrobial use; no association with HCA acquisition was found. Conclusion HCA acquisition in our cohort was not a predictor for either inappropriate empirical treatment or increased mortality. These results might reflect recent changes in therapeutic protocols and epidemiological changes in community pathogens. Further studies should focus on recognising CA BSI due to resistant organisms facilitating an early and adequate treatment in patients with CA resistant BSI. PMID

  13. Granulocyte-colony stimulating factor improves Parkinson's disease associated with co-morbid depression: An experimental exploratory study

    PubMed Central

    Prakash, Ajay; Chopra, Kanwaljit; Medhi, Bikash

    2013-01-01

    Introduction: The present study was designed to evaluate the effect of granulocyte-colony stimulating factor (G-CSF) in the treatment of Parkinson's disease (PD), the second most common neurodegenerative disease characterized by muscle and movement disorder, often associated with depression. PD is very difficult to treat. Hence, the present study was aimed to evaluate the effect of G-CSF in PD associated with depression. Materials and Methods: Adult Wistar male rats weighing about 180-250 g were selected and divided into five groups in parallel designed method namely; control group (n = 5); sham operated group (n = 5); Vehicle group (n = 5); G-CSF group (70 μg/kg, s.c.) (n = 5) and L-DOPA group (n = 5). The rats were treated with 6-hydroxydopamine (6-OHDA) on day 0 and then treatment was continued for 14 day of L-DOPA/carbidopa, whereas G-CSF (70 μg/kg, s.c.) was given from day 1 to 6. Thereafter, adhesive removal and forced swim tests were conducted to evaluate the behavioral outcome of G-CSF treatment. The finding was correlated and analyzed with Nissl staining findings for the final conclusion. Results: The behavioral parameters were assessed and found to be ameliorate the symptoms of Parkinson's and reduced the depression like behavior in PD. The histological findings were supported the behavioral findings and showed pathological improvement. Conclusion: As a preliminary work, the present study first time suggested that G-CSF have a potential role in PD and associated depression. PMID:24347771

  14. Experiment K-7-28: Lung Morphology Study

    NASA Technical Reports Server (NTRS)

    West, J. B.; Elliott, A. R.; Mathieu-Costello, O.; Kaplansky, A. S.

    1994-01-01

    There are no previous studies investigating the effect of microgravity exposure during spaceflight on lung tissue. We examined the ultrastructure of the left lungs of 5 Czechoslovakian Wistar rats flown on the 13 day, 19+ hr. Cosmos 2044 mission, and compared them to 5 vivarium and 5 synchronous controls at 1-g conditions, and 5 rats exposed to 14 days of tail-suspension. Within 10 minutes of sacrifice by decapitation, the lungs were removed and immersed in 3% glutaraldehyde in 0.1M phosphate buffer (total osmolarity of the fixative: 560 mOsm; pH = 7.4). The tissue stored at 5 C was transported to our laboratory where it was processed for light and electron microscopy. No significant perivascular cuffing caused by interstitial edema was present in the tissue samples. Some of the flight, tail-suspended, and synchronous control rats showed alveolar edema, while vivarium controls did not. The pulmonary capillaries appeared to be more congested in the flight animals than in the other groups. This could be related to the increased hematocrit due to the microgravity exposure. In all 5 flight, 4 tail-suspended, and 3 synchronous rats, red blood cells (RBC) were present in the alveolar spaces. The RBC were either suspended free in the alveoli or observed lining the alveolar wall. The frequency of RBC lining the alveolar walls appeared greater in the dorsal (gravity non-dependent) than in ventral (gravity dependent) regions of the lung in these three animal groups. In 3 of the vivarium controls, a few RBC were found in the alveolar spaces. Intra-capillary fluid-filled vesicles were observed in the flight, tail-suspended and synchronous animals, but not in the vivarium controls. The formation of intra-capillary fluid-filled vesicles has been previously associated with pulmonary hypertension induced by high altitude exposure and mitral stenosis. In conclusion, pulmonary hemorrhage and alveolar edema of unknown origin occurred to a greater extent in the flight, tail

  15. An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101.

    PubMed

    Wittert, G A; Harrison, R W; Buckley, M J; Wlodarczyk, J

    2016-01-01

    We compared a novel 5% testosterone (T) cream (AndroForte 5, Lawley Pharmaceuticals, Australia) with a 1% T gel (Testogel, Besins Healthcare, Australia). Using an open-label crossover design, subjects were randomized to one of two treatment sequences using either the T gel or T cream first in a 1 : 1 ratio. Each treatment period was 30 days with a 7-14 days washout period between them. On Days 1 and 30 of each treatment period blood was sampled at -15, -5 min, 0, 2, 4, 5, 6, 7, 8, 9, 10, 12 and 16 h post study drug administration. Sixteen men with established androgen deficiency aged between 29 and 73 years, who had undertaken a washout from prior testosterone therapy participated in the study. One subject failed to complete both arms and another was excluded post-completion because of a major protocol violation. Bioequivalence was established based on key pharmacokinetic (PK) variables: AUC, C(avg), C(max), T(max), % fluctuation (with and without baseline correction) for the two formulations of testosterone on Day 1 and Day 30. The ratio and 90% CI of AUC 0.99 (0.86-1.14), C(max) 1.02 (0.84-1.24) and C(avg) 0.99 (0.86-1.14) for T cream/T gel were within the predetermined bio-equivalence criteria of 80% to 125% at Day 30. There were no statistically significant differences between secondary biochemical markers: serum dihydrotestosterone (DHT), oestradiol (E2), sex hormone-binding globulin (SHBG), luteinizing hormone (LH) and (FSH). The two testosterone formulations were shown to be bioequivalent.

  16. Concentration, chlorination, and chemical analysis of drinking water for disinfection byproduct mixtures health effects research: U.S. EPA's Four Lab Study.

    PubMed

    Pressman, Jonathan G; Richardson, Susan D; Speth, Thomas F; Miltner, Richard J; Narotsky, Michael G; Hunter, E Sidney; Rice, Glenn E; Teuschler, Linda K; McDonald, Anthony; Parvez, Shahid; Krasner, Stuart W; Weinberg, Howard S; McKague, A Bruce; Parrett, Christopher J; Bodin, Nathalie; Chinn, Russell; Lee, Chih-Fen T; Simmons, Jane Ellen

    2010-10-01

    The U.S. Environmental Protection Agency's "Four Lab Study" involved participation of researchers from four national Laboratories and Centers of the Office of Research and Development along with collaborators from the water industry and academia. The study evaluated toxicological effects of complex disinfection byproduct (DBP) mixtures, with an emphasis on reproductive and developmental effects that have been associated with DBP exposures in some human epidemiologic studies. This paper describes a new procedure for producing chlorinated drinking water concentrate for animal toxicology experiments, comprehensive identification of >100 DBPs, and quantification of 75 priority and regulated DBPs. In the research reported herein, complex mixtures of DBPs were produced by concentrating a natural source water with reverse osmosis membranes, followed by addition of bromide and treatment with chlorine. By concentrating natural organic matter in the source water first and disinfecting with chlorine afterward, DBPs (including volatiles and semivolatiles) were formed and maintained in a water matrix suitable for animal studies. DBP levels in the chlorinated concentrate compared well to those from EPA's Information Collection Rule (ICR) and a nationwide study of priority unregulated DBPs when normalized by total organic carbon (TOC). DBPs were relatively stable over the course of the animal studies (125 days) with multiple chlorination events (every 5-14 days), and a significant portion of total organic halogen was accounted for through a comprehensive identification approach. DBPs quantified included regulated DBPs, priority unregulated DBPs, and additional DBPs targeted by the ICR. Many DBPs are reported for the first time, including previously undetected and unreported haloacids and haloamides. The new concentration procedure not only produced a concentrated drinking water suitable for animal experiments, but also provided a greater TOC concentration factor (136

  17. Assessment of the effects of laser or LED photobiomodulation on hypothyroid rats of cutaneous wound healing: A morphometric study.

    NASA Astrophysics Data System (ADS)

    De Castro, Isabele Cardoso Vieira; Paraguassú, Gardênia Matos; dod Reis Júnior, João Alves; Xavier, Flávia Caló Aquino; Rodriguez, Tânia Tavares; Ramalho, Maria José Pedreira; Pinheiro, Antônio L. B.; Ramalho, Luciana Maria Pedreira

    2012-09-01

    Hypothyroid has been associated to a disruption of the body's metabolism, including the healing process. Laser and LED have been shown to be effective on improving healing in many situations, but their benefit in the improvement of healing on hypothyroidism remains unknown. The aim of this study was to assess, morphometrically, the influence of Laser (λ660nm, 24 J/cm2, 40mW, CW, spot output= 4mm2;) and LED (λ630nm ± 20, 24 J/cm2, 150mW, CW, spot output= 0.5 cm2) on the wound healing of rats with Hypothyroid. Under general anesthesia, a standard surgical wound (1cm2) was created on the dorsum of 72 male Wistar rats divided into 6 groups of 12 animals each: G1: Euthyroid; G2: Euthyroid + Laser; G3: Euthyroid + LED; G4: Hypothyroid; G5: Hypothyroid + Laser and G6: Hypothyroid + LED. Hypothyroidism was induced in rats with propylthiouracil (0.05g/100mL) administered orally for 4 weeks and maintained until the end of the experiment. Rats were irradiated after surgery each 48h then killed after 7 and 14 days. Statistical analysis was performed using ANOVA and Tukey's test. Hypothyroid rats with phototherapy laser or LED showed significant less wound contraction than euthyroid's rats at the 7th day (p<0.05). At the 14th day, the longitudinal measurement was significantly higher in euthyroids (control and irradiated with laser) when compared to the hypothyroid group (p <0.05). This study has shown that hypothyroidism delays wound healing and Laser and LED photobiomodulation using 24 J/cm2 per session improved cutaneous wound healing in hypothyroid rats.

  18. Azelastine eye-drops in seasonal allergic conjunctivitis or rhinoconjunctivitis. A double-blind, randomized, placebo-controlled study.

    PubMed

    Giede-Tuch, C; Westhoff, M; Zarth, A

    1998-09-01

    This study was carried out to assess the efficacy of 0.025% and 0.05% azelastine eye-drops in patients with seasonal allergic conjunctivitis of > or = 1 year's duration. A total of 151 patients received 0.025% or 0.05% azelastine eye-drops or placebo b.i.d. for 14 days according to a double-blind, randomized, placebo-controlled, parallel-dosing design; 129 patients completed the study as planned. The three target symptoms, scored on 4-point scales, were itching, lacrimation, and redness of the eyes; responders were patients whose symptom sum score decreased by > or = 3 from a baseline score of > or = 6 by day 3. Mean scores of these and five other symptoms were recorded also on days 7 and 14, and patients kept daily diaries of the three main symptoms and swollen eyelids. Responder rates were 73% for 0.025% (P=0.115 vs placebo) and 82% for 0.05% azelastine eye-drops (P=0.011 vs placebo) and 56% for placebo. The time courses of the mean (investigators' and patients') scores for the three main symptoms reflected the dose-dependent effect of azelastine eye-drops. One patient each from the two azelastine groups and three from the placebo group withdrew because of inefficacy. Adverse drug reactions were reported by 14 and 24 patients receiving 0.025% and 0.05% azelastine eye-drops, respectively, and by eight placebo patients. These reactions were mainly slight application site reactions and taste perversion (bitter or unpleasant taste). Azelastine eye-drops are effective and well tolerated at a dose of 0.05% for the treatment of seasonal allergic conjunctivitis.

  19. A Phase II Trial of Vorinostat (Suberoylanilide Hydroxamic Acid, -SAHA) in Metastatic Breast Cancer: A California Cancer Consortium Study

    PubMed Central

    Luu, Thehang H; Morgan, Robert J; Leong, Lucille; Lim, Dean; McNamara, Mark; Portnow, Jana; Frankel, Paul; Smith, David D.; Doroshow, James H.; Gandara, David R; Aparicio, Ana; Somlo, George

    2011-01-01

    Purpose The primary goal of this trial was to determine the response rate of single-agent vorinostat in patients with metastatic breast cancer. The secondary goals included assessment of time to progression, evaluation of toxicities, and overall survival. Experimental Design From June 2005 to March 2006, fourteen patients received vorinostat, 200 mg orally, twice daily for 14 days of each 21 day cycle. Response and progression were evaluated using RECIST criteria. Results The median age for all patients was 60.5 years (range: 37–88). Eight patients were ER and/or PR positive, four were Her-2 positive. Sites of metastatic disease included brain, liver, lungs, bones, pelvis, pleura, chest wall, and distant lymph nodes. Patients received a median of 1.5 prior (range: 0–2) chemotherapeutic regimens for metastatic disease. Fatigue, nausea, diarrhea, and lymphopenia were the most frequent clinically significant adverse effects. The median number of cycles delivered was two (range: 1–20). There were no complete or partial responses and the study was terminated after the first stage, however 4 patients were observed with stable disease with time to progression of 4,8,9 and 14 months. The median number of months that patients received treatment on this study was 1.7 (range: 0.5–14). Conclusion While not meeting the RECIST response criteria for adequate single-agent activity, the observed tolerable toxicities and the potential for clinical benefit in terms of stable disease suggest that further assessment of vorinostat as a part of combination therapy with either chemotherapeutic or targeted agents in metastatic breast might be undertaken. PMID:18981013

  20. A retrospective observational study of length of stay in hospital after colorectal cancer surgery in England (1998–2010)

    PubMed Central

    Aravani, Ariadni; Samy, Elizabeth F.; Thomas, James D.; Quirke, Phil; Morris, Eva J.A.; Finan, Paul J.

    2016-01-01

    Abstract The National Health Service (NHS) is facing financial constraints and thus there is considerable interest in ensuring the shortest but optimal hospital stays possible. The aim of this study was to investigate patterns of postoperative length of stay (LOS) stay across the English NHS and to identify factors that significantly influence both optimal and prolonged LOS. Data were obtained from the National Cancer Data Repository (NCDR). National patterns of LOS were examined and multilevel mixed effects logistic regression was used to study factors associated with an “ideal” (≤5 days) or a prolonged (≥21 days) LOS in hospital after major resection. Funnel plots were used to examine variation across hospitals in both risk-adjusted and unadjusted LOS. All 240,873 individuals who underwent major resection for colorectal cancer were diagnosed between 1998 and 2010 in the English NHS. The overall median LOS was 10 (interquartile range [IQR] 7–14 days) days, but it fell over time from 11 (IQR 9–15) days in 1998 to 7 (IQR 5–12) days in 2010. The proportion of people experiencing “ideal” LOS increased dramatically from 4.9% in 1998 to 34.2% in 2010, but the decrease in the proportion of patients who experienced a prolonged LOS was less marked falling from 11.2% to 8.4%, respectively. Control charts showed that there was significant variation in short and prolonged LOS across NHS trusts even after adjustment for case-mix. Significant variation in LOS existed between NHS hospitals in England throughout period 1998 to 2010. Understanding the underlying causes of this variation between surgical providers will make it possible to identify and spread best practice, improve services, and ultimately reduce LOS following colorectal cancer surgery. PMID:27893655

  1. Case-Control Study of Telavancin as an Alternative Treatment for Gram-Positive Bloodstream Infections in Patients with Cancer

    PubMed Central

    Hachem, Ray; Jordan, Mary; Garoge, Kumait; Al Hamal, Zainab; El Zakhem, Aline; Viola, George M.; Granwehr, Bruno; Mulanovich, Victor; Gagel, Andrew; Reitzel, Ruth; Yousif, Ammar; Jiang, Ying; Raad, Issam

    2015-01-01

    Gram-positive bacterial infections are an important cause of morbidity and death among cancer patients, despite current therapy. In this case-control study, we evaluated the clinical outcomes and safety of telavancin in cancer patients with uncomplicated Gram-positive bloodstream infections (BSIs). Between March 2011 and May 2013, we enrolled cancer patients with uncomplicated Gram-positive BSIs to receive intravenous telavancin therapy for at least 14 days for Staphylococcus aureus and 7 days for other Gram-positive cocci. Patients with baseline creatinine clearance (CLCR) values of >50 ml/min received 10 mg/kg/day of telavancin, and those with CLCR values between 30 and 49 ml/min received 7.5 mg/kg/day. Patients were compared with a retrospective cohort of 39 historical patients with Gram-positive BSIs, matched for underlying malignancy, infecting organism, and neutropenia status, who had been treated with vancomycin. A total of 78 patients were analyzed, with 39 in each group. The most common pathogen causing BSIs was S. aureus (51%), followed by alpha-hemolytic streptococci (23%), Enterococcus spp. (15%), coagulase-negative staphylococci (8%), and beta-hemolytic streptococci (3%). Sixty-two percent of patients had hematological malignancies, and 38% had solid tumors; 51% of the patients were neutropenic. The overall response rate determined by clinical outcome and microbiological eradication at 72 h following the initiation of therapy, in the absence of relapse, deep-seated infections, and/or infection-related death, was better with telavancin than with vancomycin (86% versus 61%; P = 0.013). Rates of drug-related adverse events were similar in the two groups (telavancin, 31%; vancomycin, 23%; P = 0.79), with similar rates of renal adverse events. Telavancin may provide a useful alternative to standard vancomycin therapy for Gram-positive BSIs in cancer patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT01321879.) PMID

  2. Lower stratospheric temperature differences between meteorological analyses in two cold Arctic winters and their impact on polar processing studies

    NASA Astrophysics Data System (ADS)

    Manney, Gloria L.; Sabutis, Joseph L.; Pawson, Steven; Santee, Michelle L.; Naujokat, Barbara; Swinbank, Richard; Gelman, Melvyn E.; Ebisuzaki, Wesley

    2003-03-01

    A quantitative comparison of six meteorological analyses is presented for the cold 1999/2000 and 1995/1996 Arctic winters. Using different analyzed data sets to obtain temperatures and temperature histories can have significant consequences. The area with temperatures below a polar stratospheric cloud (PSC) formation threshold commonly varies by ˜25% between the analyses, with some differences over 50%. Biases between analyses vary from year to year; in January 2000, Met Office analyses were coldest and National Centers for Environmental Prediction (NCEP) analyses were warmest, while NCEP analyses were usually coldest in 1995/1996 and NCEP/National Center for Atmospheric Research Reanalysis (REAN) were usually warmest. Freie Universität Berlin analyses are often colder than others at T ≲ 205 K. European Centre for Medium-Range Weather Forecasts (ECMWF) temperatures agreed better with other analyses in 1999/2000, after improvements in the assimilation system, than in 1995/1996. Temperature history case studies show substantial differences using Met Office, NCEP, REAN, ECMWF, and NASA Data Assimilation Office (DAO) analyses. In January 2000 (when a large cold region was centered in the polar vortex), all analyses gave qualitatively similar results. However, in February 2000 (a much warmer period) and in January and February 1996 (comparably cold to January 2000 but with the cold region near the polar vortex edge), distributions of "potential PSC lifetimes" and total time spent below a PSC formation threshold varied significantly between the analyses. Largest peaks in "PSC lifetime" distributions in January 2000 were at 4-6 and 11-14 days, while in 1996 they were at 1-3 days. Different meteorological conditions in comparably cold winters have a large impact on expectations for PSC formation and on the effects of discrepancies between different meteorological analyses. Met Office, NCEP, REAN, ECMWF, and DAO analyses are commonly used in modeling polar processes

  3. Topical Effect of a Medically Prescribed Pediatric Antibiotic on Dental Biofilm: A Cross-Over, In Situ Study

    PubMed Central

    Pierro, Viviane Santos da Silva; Ferreira, Dennis de Carvalho; de Jesus, Hugo Emiliano; Rosado, Alexandre Soares; Luiz, Ronir Raggio; dos Santos, Kátia Regina Netto; Maia, Lucianne Cople

    2013-01-01

    Objective This study aimed to investigate the possible topical effect of a broad-spectrum antibiotic on dental biofilm formed in situ in the absence or presence of sucrose. Methods A crossover study was conducted in three phases of 14 days each, during which 11 volunteers wore palatal devices containing 6 enamel blocks covered with meshes to allow biofilm formation. Dental blocks were extraorally submitted to a 20% sucrose solution at three different frequencies of exposure (0, 3 and 8 times/day), and to a suspension of amoxicillin/clavulanate potassium (A/CP) or a placebo (P) suspension at an 8-hour time interval application regimen. On the 14th day of each phase, biofilms were collected for microbiological (conventional culture) and molecular (Denaturing Gradient Gel Electrophoresis – DGGE) analyses. Results In the absence of sucrose exposure (SE) and at the 3-time daily frequency, dental biofilms treated with A/CP showed lower total biofilm weight and lower counts of total microbiota than the ones treated with P (p>0.05). A/CP presented higher counts of Candida spp. when compared with P in the presence of SE, especially at the 8-time daily frequency (p<0.05). Considering the DGGE analysis, the mean number of bands was higher for P (p>0.05), regardless of SE. However, DGGE profiles demonstrated large interindividual variability. Conclusion Both conventional culture and DGGE have demonstrated some differences on total microbiota of dental biofilms when exposed to the A/CP or P suspensions, mainly in the absence of sucrose, which suggests a possible topical effect of the sugar-free A/CP suspension on dental biofilm. PMID:23383224

  4. Morphometric studies on the structural development of the lung in Macaca fascicularis during fetal and postnatal life.

    PubMed Central

    Hislop, A; Howard, S; Fairweather, D V

    1984-01-01

    The structural development of the normal monkey lung (Macaca fascicularis) from 61 days of gestation to 14 days postnatal age has been described using quantitative morphometric techniques. The lung of the adult monkey has also been studied. The airway and arterial branching pattern has been traced using serial sections. The alveolar number and size have been estimated and the structure of the arteries after postmortem arterial injection has been assessed. Comparison of lung morphology in monkey and man shows that there are similarities in segmental arrangement, structure and branching pattern of airways, in arterial structure and in changes in the arteries after birth. Although there are differences in the number of lobes, the number of generations of different types of airways and the number and size of alveoli, the overall structure in the monkey is more similar to that in man than is the structure of the lung in species such as sheep, pig or rat. During fetal life the monkey lung passes through the same stages of development as the human fetus but at birth the monkey has a full complement of airways and mature alveoli. Postnatal growth of airways and alveoli is due to increase in size rather than to multiplication. In man there is an increase in the number of alveoli and alveolar ducts after birth as well as an increase in size. Despite the differences between the species it seems appropriate to use the monkey in experimental studies on the lung. Images Fig. 1 (cont.) Fig. 1 Fig. 4 (cont.) Fig. 4 PMID:6706842

  5. Kiwifruit-derived supplements increase stool frequency in healthy adults: a randomized, double-blind, placebo-controlled study.

    PubMed

    Ansell, Juliet; Butts, Christine A; Paturi, Gunaranjan; Eady, Sarah L; Wallace, Alison J; Hedderley, Duncan; Gearry, Richard B

    2015-05-01

    The worldwide growth in the incidence of gastrointestinal disorders has created an immediate need to identify safe and effective interventions. In this randomized, double-blind, placebo-controlled study, we examined the effects of Actazin and Gold, kiwifruit-derived nutritional ingredients, on stool frequency, stool form, and gastrointestinal comfort in healthy and functionally constipated (Rome III criteria for C3 functional constipation) individuals. Using a crossover design, all participants consumed all 4 dietary interventions (Placebo, Actazin low dose [Actazin-L] [600 mg/day], Actazin high dose [Actazin-H] [2400 mg/day], and Gold [2400 mg/day]). Each intervention was taken for 28 days followed by a 14-day washout period between interventions. Participants recorded their daily bowel movements and well-being parameters in daily questionnaires. In the healthy cohort (n = 19), the Actazin-H (P = .014) and Gold (P = .009) interventions significantly increased the mean daily bowel movements compared with the washout. No significant differences were observed in stool form as determined by use of the Bristol stool scale. In a subgroup analysis of responders in the healthy cohort, Actazin-L (P = .005), Actazin-H (P < .001), and Gold (P = .001) consumption significantly increased the number of daily bowel movements by greater than 1 bowel movement per week. In the functionally constipated cohort (n = 9), there were no significant differences between interventions for bowel movements and the Bristol stool scale values or in the subsequent subgroup analysis of responders. This study demonstrated that Actazin and Gold produced clinically meaningful increases in bowel movements in healthy individuals.

  6. Incidence of Venous Thromboembolism in Patients Undergoing Major Hip Surgeries at a Single Institution: A Prospective Study

    PubMed Central

    Yamanaka, Yasuhiro; Ito, Hiroshi

    2016-01-01

    Background: Venous thoromboembolism (VTE) is one of the most significant complications after hip surgeries. Many studies have been reported about the incidence of VTE after THA, but a small number of reports were found concerning Periacetabular osteotomy, Revision THA and Surgery for hip fracture postoperatively. Furthermore, there exists no comparative study of the incidence of VTE among major hip surgeries at a single institution. We reported the incidence of VTE among hip surgeries performed at a single institution. Methods: A total of 820 Hip surgeries were performed at same institution. The procedures included 420 hips that underwent primary total hip arthroplasties (THA), 91 revision or removal of total hip arthroplasties (Revision THA), 144 periacetabular osteotomy (PAO) and 165 surgery for hip fracture (SHF) between 2006 and 2012. VTE was detected by Multidetector computed tomography (MDCT) that scanned 768 cases and by ultrasound that scanned 52cases postoperative 10-14 days. Results: The overall incidence of VTE was 12.2% (100 of 820). The incidence of VTE after THA was 13.1% (55 of 420), Revision THA was 13.2% (12 of 91), PAO was 2.1% (3 of 144) and SHF was 18.1% (30 of 165). The incidence of VTE was significantly higher in SHF than in PAO. Conclusion: This data indicates that the incidence of VTE after PAO is significantly lower than SHF and relatively lower than THA and Revision THA. A younger age and non-invasion of the bone marrow of the femur may have affected the result. Prophylaxis therapy was effective especially on SHF. PMID:27499823

  7. Sudden Unexpected Deaths and Vaccinations during the First Two Years of Life in Italy: A Case Series Study

    PubMed Central

    Traversa, Giuseppe; Spila-Alegiani, Stefania; Bianchi, Clara; Ciofi degli Atti, Marta; Frova, Luisa; Massari, Marco; Raschetti, Roberto; Salmaso, Stefania; Scalia Tomba, Gianpaolo

    2011-01-01

    Background The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy. Methodology/Principal Findings The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. Conclusions The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age. PMID:21298113

  8. Premorbid functioning and treatment response in recent-onset schizophrenia: prospective study with risperidone long-acting injectable.

    PubMed

    Rabinowitz, Jonathan; Napryeyenko, Oleksandr; Burba, Benjaminas; Martinez, Guadalupe; Neznanov, Nikolay G; Fischel, Tsvi; Baylé, Franck J; Cavallaro, Roberto; Smeraldi, Enrico; Schreiner, Andreas

    2011-02-01

    Premorbid functioning may be associated with treatment response, but this is confounded by a lack of prospective longitudinal data and controls for medication compliance. This study tested the hypothesis that good premorbid functioning will be associated with better antipsychotic treatment response after controlling for drug adherence by using a long-acting injectable antipsychotic. This was a 6-month, open label, multicenter, phase IV trial in recent-onset schizophrenia treated with flexible doses of risperidone long-acting injectable (25-50 mg every 14 days). Premorbid functioning was assessed with the Premorbid Adjustment Scale (PAS)-Structured Interview; efficacy was evaluated with clinician-rated Positive and Negative Syndrome Scale, Clinical Global Impression scale of Severity of Illness, Clinical Global Impression scale of Change, Global Assessment of Functioning Scale, and trial participant completed SF-36. Analyses controlled for baseline scores and demographics. With the use of a priori PAS scoring criteria, the participants' premorbid functioning was categorized as stable-good (n = 142), stable-poor (n = 116), and deteriorating (n = 36). At baseline, the stable-good group had the best functioning on most efficacy measures. All groups showed significant improvement on efficacy measures with treatment. Improvement was significantly higher for the stable-good group. The PAS global assessment of highest level of functioning scale (excellent, n = 75; good, n = 117; fair, n = 78; and poor, n = 31) showed a strong association with baseline functioning and improvement and had a significant linear association with meeting Remission in Schizophrenia Working Group symptom criteria at baseline (P = 0.003) and attained and sustained remission for 3 months during study (47.7%, 49.3%, 29.6%, and 22.2%; P = 0.006). Good premorbid functioning corresponds with better treatment response in recent-onset psychosis as captured on both clinician and patient-reported measures.

  9. A comparative study of red and blue light-emitting diodes and low-level laser in regeneration of the transected sciatic nerve after an end to end neurorrhaphy in rabbits.

    PubMed

    Takhtfooladi, Mohammad Ashrafzadeh; Sharifi, Davood

    2015-12-01

    This study aimed at evaluating the effects of red and blue light-emitting diodes (LED) and low-level laser (LLL) on the regeneration of the transected sciatic nerve after an end-to-end neurorrhaphy in rabbits. Forty healthy mature male New Zealand rabbits were randomly assigned into four experimental groups: control, LLL (680 nm), red LED (650 nm), and blue LED (450 nm). All animals underwent the right sciatic nerve neurotmesis injury under general anesthesia and end-to-end anastomosis. The phototherapy was initiated on the first postoperative day and lasted for 14 consecutive days at the same time of the day. On the 30th day post-surgery, the animals whose sciatic nerves were harvested for histopathological analysis were euthanized. The nerves were analyzed and quantified the following findings: Schwann cells, large myelinic axons, and neurons. In the LLL group, as compared to other groups, an increase in the number of all analyzed aspects was observed with significance level (P < 0.05). This finding suggests that postoperative LLL irradiation was able to accelerate and potentialize the peripheral nerve regeneration process in rabbits within 14 days of irradiation.

  10. [Clinical study on a new acetylsalicylic acid/paracetamol preparation with gastric acid resistant coating (Safapryn), and on two various phenylbutazone dosages in patients with primary chronic polyarthritis as based on a new evaluation method].

    PubMed

    Brooks, P M; Walker, J J; Lee, P; Bell, A M; Buchanan, W W; Fowler, P D; Anderson, J A

    1975-01-01

    The authors describe a simple non-crossover-blind test for the evaluation of subjective indices. A table for recording pains during the 14 days' study is described. The patient's satisfaction with the treatment and the number of days until withdrawal from the trial are recorded. The statistical procedure takes into consideration differences between the treatment groups and makes possible a valuable comparison with drugs tested in other clinical trials. The three dose schedules of antirheumatic treatment were tested on 122 patients and the results compared with those of 342 patients treated with the 6 other antirheumatic drugs (enteric-coated aspirin, paracetamol, indomethacin, flurbiprofen, mefenamic acid, and prednisolone) and those of 41 patients who received placebos. The results show that Safapryn (3,6 g aspirin + 3.0 g paracetamol daily) compared with 3.9 g enteric coated aspirin does not offer any advantage in its analgesic effect, although it gives rise to fewer side effects. Phenylbutazone (3000 mg) was almost as effective as 15 mg prednisolone daily. Between the effects of this dosage of phenylbutazone and other non-steroidal antirheumatic drugs, however, no significant difference could be detected. 50 mg phenylbutazone daily and placebo treatment could not be distinguished. The authors thank the Arthritis and Rheumatism Council for Research in Great Britain for its financial support. One of the authors (PL) was a Merck, Sharp, and Dohme Research Fellow and another one (PMB) received a Robins research scholarship.

  11. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies).

    PubMed

    Abbate, Antonio; Kontos, Michael Christopher; Abouzaki, Nayef Antar; Melchior, Ryan David; Thomas, Christopher; Van Tassell, Benjamin Wallace; Oddi, Claudia; Carbone, Salvatore; Trankle, Cory Ross; Roberts, Charlotte Susan; Mueller, George Herman; Gambill, Michael Lucas; Christopher, Sanah; Markley, Roshanak; Vetrovec, George Wayne; Dinarello, Charles Anthony; Biondi-Zoccai, Giuseppe

    2015-02-01

    Two pilot studies of interleukin-1 (IL-1) blockade in ST-segment elevation myocardial infarction (STEMI) showed blunted acute inflammatory response and overall favorable outcomes at 3 months follow-up. We hereby present a patient-level pooled analysis with extended follow-up of 40 patients with clinically stable STEMI randomized to anakinra, a recombinant IL-1 receptor antagonist, 100 mg/day for 14 days or placebo in a double-blinded fashion. End points included death, cardiac death, recurrent acute myocardial infarction (AMI), stroke, unstable angina, and symptomatic heart failure. Median follow-up was 28 (interquartile range 3 to 38) months. Sixteen patients (40%) had a total of 22 adverse cardiovascular events: 1 cardiac death, 4 recurrent AMI, 5 episodes of unstable angina pectoris requiring hospitalization and/or urgent revascularization, and 11 new diagnoses of heart failure. Treatment with anakinra was associated with a hazard ratio of 1.08 (95% confidence interval 0.31 to 3.74, p = 0.90) for the combined end point of death, recurrent AMI, unstable angina pectoris, or stroke and a hazard ratio of 0.16 (95% confidence interval 0.03 to 0.76, p = 0.008) for death or heart failure. In conclusion, IL-1 blockade with anakinra for 2 weeks appears, therefore, to have a neutral effect on recurrent ischemic events, whereas it may prevent new-onset heart failure long term after STEMI.

  12. Acute and 28-Day Subacute Toxicity Studies of Hexane Extracts of the Roots of Lithospermum erythrorhizon in Sprague-Dawley Rats

    PubMed Central

    Han, Chung-Tack; Kim, Myoung-Jun; Moon, Seol-Hee; Jeon, Yu-Rim; Hwang, Jae-Sik; Nam, Chunja; Park, Chong-Woo; Lee, Sun-Ho; Na, Jae-Bum; Park, Chan-Sung; Park, Hee-Won; Lee, Jung-Min; Jang, Ho-Song; Park, Sun-Hee; Han, Kyoung-Goo; Choi, Young Whan

    2015-01-01

    Lithospermum erythrorhizon has long been used as a traditional oriental medicine. In this study, the acute and 28-day subacute oral dose toxicity studies of hexane extracts of the roots of L. erythrorhizon (LEH) were performed in Sprague-Dawley rats. In the acute toxicity study, LEH was administered once orally to 5 male and 5 female rats at dose levels of 500, 1,000, and 2,000 mg/kg. Mortality, clinical signs, and body weight changes were monitored for 14 days. Salivation, soft stool, soiled perineal region, compound-colored stool, chromaturia and a decrease in body weight were observed in the extract-treated groups, and no deaths occurred during the study. Therefore, the approximate lethal dose (ALD) of LEH in male and female rats was higher than 2,000 mg/kg. In the subacute toxicity study, LEH was administered orally to male and female rats for 28 days at dose levels of 25, 100, and 400 mg/kg/day. There was no LEH-related toxic effect in the body weight, food consumption, ophthalmology, hematology, clinical chemistry and organ weights. Compound-colored (black) stool, chromaturia and increased protein, ketone bodies, bilirubin and occult blood in urine were observed in the male and female rats treated with the test substance. In addition, the necropsy revealed dark red discoloration of the kidneys, and the histopathological examination showed presence of red brown pigment or increased hyaline droplets in the renal tubules of the renal cortex. However, there were no test substance-related toxic effects in the hematology and clinical chemistry, and no morphological changes were observed in the histopathological examination of the kidneys. Therefore, it was determined that there was no significant toxicity because the changes observed were caused by the intrinsic color of the test substance. These results suggest that the no-observed-adverse-effect Level (NOAEL) of LEH is greater than 400 mg/kg/day in both sexes. PMID:26877842

  13. Comparative SAXS and DSC study on stratum corneum structural organization in an epidermal cell culture model (ROC): impact of cultivation time.

    PubMed

    Kuntsche, Judith; Herre, Angela; Fahr, Alfred; Funari, Sérgio S; Garidel, Patrick

    2013-12-18

    Cell cultured skin equivalents present an alternative for dermatological in vitro evaluations of drugs and excipients as they provide the advantage of availability, lower variability and higher assay robustness compared to native skin. For penetration/permeation studies, an adequate stratum corneum barrier similar to that of human stratum corneum is, however, a prerequisite. In this study, the stratum corneum lipid organization in an epidermal cell culture model based on rat epidermal keratinocytes (REK organotypic culture, ROC) was investigated by small-angle X-ray scattering (SAXS) in dependence on ROC cultivation time and in comparison to native human and rat stratum cornea. In addition, the thermal phase behavior was studied by differential scanning calorimetry (DSC) and barrier properties were checked by measurements of the permeability of tritiated water. The development of the barrier of ROC SC obtained at different cultivation times (7, 14 and 21 days at the air-liquid interface) was connected with an increase in structural order of the SC lipids in SAXS measurements: Already cultivation for 14 days at the air-liquid interface resulted overall in a competent SC permeability barrier and SC lipid organization. Cultivation for 21 days resulted in further minor changes in the structural organization of ROC SC. The SAXS patterns of ROC SC had overall large similarities with that of human SC and point to the presence of a long periodicity phase with a repeat distance of about 122Å, e.g. slightly smaller than that determined for human SC in the present study (127Å). Moreover, SAXS results also indicate the presence of covalently bound ceramides, which are crucial for a proper SC barrier, although the corresponding thermal transitions were not clearly detectable by DSC. Due to the competent SC barrier properties and high structural and organizational similarity to that of native human SC, ROC presents a promising alternative for in vitro studies, particularly as

  14. Safety, Acceptability, and Feasibility of Early Infant Male Circumcision Conducted by Nurse-Midwives Using the AccuCirc Device: Results of a Field Study in Zimbabwe

    PubMed Central

    Mavhu, Webster; Larke, Natasha; Hatzold, Karin; Ncube, Getrude; Weiss, Helen A; Mangenah, Collin; Chonzi, Prosper; Mugurungi, Owen; Mufuka, Juliet; Samkange, Christopher A; Gwinji, Gerald; Cowan, Frances M; Ticklay, Ismail

    2016-01-01

    ABSTRACT Background: For prevention of HIV, early infant male circumcision (EIMC) needs to be scaled up in countries with high HIV prevalence. Routine EIMC will maintain the HIV prevention gains anticipated from current adult male circumcision initiatives. We present here the results of a field study of EIMC conducted in Zimbabwe. Methods: The study was observational and based on the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices. We recruited parents of newborn male infants between August 2013 and July 2014 from 2 clinics. Nurse-midwives used the AccuCirc device to circumcise eligible infants. We followed participants for 14 days after EIMC. Outcome measures were EIMC safety, acceptability, and feasibility. Results: We enrolled 500 male infants in the field study (uptake 11%). The infants were circumcised between 6 and 60 days postpartum. The procedure took a median of 17 minutes (interquartile range of 5 to 18 minutes). Mothers’ knowledge of male circumcision was extensive. Of the 498 mothers who completed the study questionnaire, 91% knew that male circumcision decreases the risk of HIV acquisition, and 83% correctly stated that this prevention is partial. Asked about their community’s perception of EIMC, 40% felt that EIMC will likely be viewed positively in their community; 13% said negatively; and 47% said the perception could be both ways. We observed 7 moderate or severe adverse events (1.4%; 95% confidence interval, 0.4% to 2.4%). All resolved without lasting effects. Nearly all mothers (99%) reported great satisfaction with the outcome, would recommend EIMC to other parents, and would circumcise their next sons. Conclusion: This first field study in sub-Saharan Africa of the AccuCirc device for EIMC demonstrated that EIMC conducted by nurse-midwives with this device is safe, feasible, and acceptable to parents. PMID:27413083

  15. Hindlimb Suspension as a Model to Study Ophthalmic Complications in Microgravity Status Report: Optimization of Rat Retina Flat Mounts Staining to Study Vascular Remodeling

    NASA Technical Reports Server (NTRS)

    Theriot, Corey A.; Zanello, Susana B.

    2014-01-01

    Preliminary data from a prior tissue-sharing experiment has suggested that early growth response protein-1 (Egr1), a transcription factor involved in various stress responses in the vasculature, is induced in the rat retina after 14 days of hindlimb suspension (HS) and may be evidence that mechanical stress is occurring secondary to the cephalad fluid shift. This mechanical stress could cause changes in oxygenation of the retina, and the subsequent ischemia- or inflammation-driven hypoxia may lead to microvascular remodeling. This microvascular remodeling process can be studied using image analysis of retinal vessels and can be then be quantified by the VESsel GENeration Analysis (VESGEN) software, a computational tool that quantifies remodeling patterns of branching vascular trees and capillary or vasculogenic networks. Our project investigates whether rodent HS is a valid model to study the effects of simulated-weightlessness on ocular structures and their relationship with intracranial pressure (ICP). One of the hypotheses to be tested is that HS-induced cephalad fluid shift is accompanied by vascular engorgement that produces changes in retinal oxygenation, leading to oxidative stress, hypoxia, microvascular remodeling, and cellular degeneration. We have optimized the procedure to obtain flat mounts of rat retina, staining of the endothelial lining in vasculature and acquisition of high quality images suitable for VESGEN analysis. Briefly, eyes were fixed in 4% paraformaldehyde for 24 hours and retinas were detached and then mounted flat on microscope slides. The microvascular staining was done with endothelial cell-specific isolectin binding, coupled to Alexa-488 fluorophore. Image acquisition at low magnification and high resolution was performed using a new Leica SP8 confocal microscope in a tile pattern across the X,Y plane and multiple sections along the Z-axis. This new confocal microscope has the added capability of dye separation using the Linear

  16. A phase I study of danusertib (PHA-739358) in adult patients with accelerated or blastic phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant or intolerant to imatinib and/or other second generation c-ABL therapy

    PubMed Central

    Borthakur, Gautam; Dombret, Herve; Schafhausen, Philippe; Brummendorf, Tim Henrik; Boissel, Nicolas; Jabbour, Elias; Mariani, Mariangela; Capolongo, Laura; Carpinelli, Patrizia; Davite, Cristina; Kantarjian, Hagop; Cortes, Jorge E.

    2015-01-01

    Danusertib is a pan-aurora kinase inhibitor with potent activity against Abl kinase including the gatekeeper T315I mutant. A phase 1 dose escalation study of danusertib was conducted in patients with accelerated or blastic phase chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. Two dosing schedules were studied: schedule A, in which danusertib was given by 3-hour intravenous infusion daily for 7 consecutive days (days 1–7) in a 14-day cycle, and schedule B, in which the danusertib was given by 3-hour intravenous infusion daily for 14 consecutive days (days 1–14) in a 21-day cycle. A total of 37 patients were treated, 29 with schedule A and eight with schedule B. The recommended phase 2 dose for schedule A was 180 mg/m2. Enrollment to schedule B was stopped early because of logistical problems with the frequency of infusions. Febrile neutropenia and mucositis were dose-limiting toxicities in schedule A. Four patients with T315I ABL kinase mutation, all treated with schedule A, responded. Danusertib has an acceptable toxicity profile and is active in patients with Bcr-Abl-associated advanced hematologic malignancies. This study was registered with the European Clinical Trails Data Base (EudraCT number 2007-004070-18). PMID:25887498

  17. U.S. Army Corps of Engineers Recreation Study. A Plan Prepared for the Assistant Secretary of the Army (Civil Works). Volume 1. Main Report

    DTIC Science & Technology

    1990-09-01

    overall increase in opcrational efficiency. With the exception of elimi nation of frcc canping. and possibly the 14-day stay limit, little opposition to...supplemental funding sources to help finance the Corps recreation O&M program is credible in the abstract. However, concrete means of obtaining such funds

  18. Feasibility of Ecological Momentary Assessment of Daily Sexting and Substance Use Among Young Adult African American Gay and Bisexual Men: A Pilot Study

    PubMed Central

    Elmasry, Hoda; Webb Hooper, Monica; Niaura, Raymond S; Hamilton, Alison B; Milburn, Norweeta G

    2017-01-01

    Background Recent evidence suggests that sexualized text communication (“sexting”) is associated with substance use and sexual risk behaviors among young adults, yet little is known about this relationship among young adult African American gay and bisexual men, a population disproportionately impacted by HIV in the United States. Rapid advances in mobile phone technology indicate a clear need for research using mobile health (mHealth) methods such as ecological momentary assessment (EMA) to serve as a viable counterpart to retrospective evaluation methods by using real-time data collection to assess sexting and substance use among this population. Objective The objective of this pilot study was to (1) describe the EMA study design and protocol, (2) characterize the study population, and (3) assess the feasibility of a random prompt text message-based thrice-daily EMA over 14 days, as a means of prospectively studying sexting, marijuana, and alcohol use among a sample of young adult African American gay and bisexual men ages 21 to 25. Methods Participants were recruited through flyers and snowball sampling during spring and summer 2015 at a community-based HIV/AIDS prevention, care, and support organization in Washington, DC. Eligible participants were enrolled in a one-time in-person study visit that consisted of informed written consent to participate in the study, a self-administered survey, a semi-structured interview, and enrollment and training in EMA data collection. Commencing the day after the study visit, a random prompt survey was texted to participants on their personal mobile phones 3 times a day over a 14-day data collection period assessing mood, texts sent, texts received, sexts sent, sexts received, marijuana want, marijuana use, and alcohol use. Results EMA feasibility was tested with 25 self-identified African American gay (n=16) and bisexual (n=9) men (mean age of 23.48 years, SD 1.5). Each random prompt survey had 8 questions with responses

  19. A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for treatment of community-acquired pneumonia

    PubMed Central

    Zhao, Tiemei; Chen, Liang-An; Wang, Ping; Tian, Guizhen; Ye, Feng; Zhu, Huili; He, Bei; Zhang, Baiying; Shao, Changzhou; Jie, Zhijun; Gao, Xiwen; Wang, Dongxia; Song, Weidong; Pan, Zhijie; Chen, Jin; Zhang, Xingyi; Gao, Zhancheng; Chen, Ping

    2016-01-01

    Background To compare 5-day regimen of levofloxacin 750 mg IV daily with 7–14-day conventional regimen of levofloxacin 500 mg intravenous to oral (IV/PO) daily for treatment of community-acquired pneumonia (CAP) in Chinese population. Methods This was a non-inferiority study to assess the difference of clinical efficacy at the end of treatment (EOT) between two regimens. Adult CAP patients with CURB-65 score 0–2 were enrolled from 17 hospitals in China from November 2012 to July 2014. The subjects were randomized into levofloxacin 750 or 500 mg group and the clinical data were collected. Sputum and blood specimens were sent for bacterial culture. The urinary antigen of Streptococcus pneumoniae (S. pneumoniae) was detected as well. At EOT, the clinical efficacy (primary endpoint), microbiological efficacy and safety were evaluated. Results A total of 457 patients were enrolled. Intent-to-treat (ITT) for primary endpoint analysis and per-protocol set (PPS) populations were 448 and 427 patients respectively. The therapeutic durations were 4.86 and 10.35 days and the mean drug exposure was 3,641.4 and 5,169.6 mg in 750 and 500 mg groups respectively. The clinical efficacy rate was 91.40% (202/221) in 750 mg group and 94.27% (214/227) in 500 mg group (ITT, P=0.2449). The difference in clinical efficacy rate was −2.87 (95% CI: −7.64, 1.90) between the two groups. The non-inferiority hypothesis of two groups was tenable (Δ=10%). The bacterial eradication rate was 100.00% in both groups. The most common drug-related clinical adverse events were injection site and gastrointestinal reactions. The most common drug-related laboratory abnormalities were WBC decrease and ALT/AST elevation. No statistical difference was found between two groups (P>0.05). Conclusions The 5-day regimen of levofloxacin 750 mg daily is non-inferior to 7–14-day conventional regimen of 500 mg daily in clinical efficacy for treatment of mild to moderate Chinese CAP population. The short

  20. A comparative study of the effects of bromelain and fresh pineapple juice on the early phase of healing in acute crush achilles tendon injury.

    PubMed

    Aiyegbusi, Ayoola I; Olabiyi, Olaleye O; Duru, Francis I O; Noronha, Cressie C; Okanlawon, Abayomi O

    2011-04-01

    Bromelain, an enzyme extracted from the stem of the pineapple plant, has been reported to reduce pain and swelling in acute soft tissue injuries, but no study has been done to compare its effect with that of fresh pineapple juice on the healing of acute tendon injuries. This study compared the effects of commercial bromelain and fresh pineapple juice on tenocyte proliferation and the malondialdehyde (MDA) level in the early stage of healing in a crush injury to the Achilles tendon of Sprague-Dawley rats. Twenty-four male rats were divided randomly into three groups of eight rats each; all the rats had induced crush injury to the Achilles tendon: Group 1 (control), no treatment; Group 2, oral bromelain treatment at a dosage of 7 mg/kg of body weight daily; and Group 3, fresh diluted pineapple juice at a dosage of 30 mg/kg of body weight. Treatment was given over the first 14 days post-injury. On day 15 post-injury, the animals were sacrificed, and the tendons were excised and processed for histological study and MDA assay. Results show a significant difference in the tenocyte population between the bromelain group and the control (P < .05), whereas pineapple juice also increased the tenocyte population, although not significantly (P = .36). Pineapple juice, however, significantly lowered the MDA level compared with both the control and bromelain-treated groups. Based on this study, 600 GDU bromelain given at a dosage of 7 mg/kg had a better effect on tenocyte proliferation than fresh pineapple juice given once daily in acute tendon injury.

  1. A phase 1, single-dose study of fresolimumab, an anti-TGF-β antibody, in treatment-resistant primary focal segmental glomerulosclerosis.

    PubMed

    Trachtman, Howard; Fervenza, Fernando C; Gipson, Debbie S; Heering, Peter; Jayne, David R W; Peters, Harm; Rota, Stefano; Remuzzi, Giuseppe; Rump, L Christian; Sellin, Lorenz K; Heaton, Jeremy P W; Streisand, James B; Hard, Marjie L; Ledbetter, Steven R; Vincenti, Flavio

    2011-06-01

    Primary focal segmental glomerulosclerosis (FSGS) is a disease with poor prognosis and high unmet therapeutic need. Here, we evaluated the safety and pharmacokinetics of single-dose infusions of fresolimumab, a human monoclonal antibody that inactivates all forms of transforming growth factor-β (TGF-β), in a phase I open-label, dose-ranging study. Patients with biopsy-confirmed, treatment-resistant, primary FSGS with a minimum estimated glomerular filtration rate (eGFR) of 25  ml/min per 1.73  m(2), and a urine protein to creatinine ratio over 1.8  mg/mg were eligible. All 16 patients completed the study in which each received one of four single-dose levels of fresolimumab (up to 4  mg/kg) and was followed for 112 days. Fresolimumab was well tolerated with pustular rash the only adverse event in two patients. One patient was diagnosed with a histologically confirmed primitive neuroectodermal tumor 2 years after fresolimumab treatment. Consistent with treatment-resistant FSGS, there was a slight decline in eGFR (median decline baseline to final of 5.85 ml/min per 1.73  m(2)). Proteinuria fluctuated during the study with the median decline from baseline to final in urine protein to creatinine ratio of 1.2  mg/mg with all three Black patients having a mean decline of 3.6  mg/mg. The half-life of fresolimumab was ∼14 days, and the mean dose-normalized Cmax and area under the curve were independent of dose. Thus, single-dose fresolimumab was well tolerated in patients with primary resistant FSGS. Additional evaluation in a larger dose-ranging study is necessary.

  2. Phase 1B study of the pharmacokinetics and safety of posaconazole intravenous solution in patients at risk for invasive fungal disease.

    PubMed

    Maertens, Johan; Cornely, Oliver A; Ullmann, Andrew J; Heinz, Werner J; Krishna, Gopal; Patino, Hernando; Caceres, Maria; Kartsonis, Nicholas; Waskin, Hetty; Robertson, Michael N

    2014-07-01

    This was a phase 1B, dose-ranging, multicenter, pharmacokinetics, and safety study of cyclodextrin-based posaconazole intravenous (i.v.) solution administered through a central line to subjects at high risk for invasive fungal disease (part 1 of a 2-part study [phase 1B/3]). Initially, the safety and tolerability of single-dose posaconazole i.v. 200 mg (n = 10) were compared with those of a placebo (n = 11). Subsequently, 2 doses were evaluated, posaconazole i.v. 200 mg once daily (q.d.) (n = 21) and 300 mg q.d. (n = 24). The subjects received twice-daily (b.i.d.) posaconazole i.v. on day 1, followed by 13 days of posaconazole i.v. q.d., then 14 days of posaconazole oral suspension 400 mg b.i.d. The steady-state (day 14) exposure target (average concentration [areas under concentration-time curve {AUCs}/24 h, average concentrations at steady state {Cavgs}], of ≥ 500 to ≤ 2,500 ng/ml in ≥ 90% of the subjects) was achieved by 94% of the subjects for 200 mg posaconazole q.d. and by 95% of subjects for 300 mg posaconazole q.d. The desired exposure target (mean steady-state Cavg, ∼ 1,200 ng/ml) was 1,180 ng/ml in the 200-mg dosing cohort and was exceeded in the 300-mg dosing cohort (1,430 ng/ml). Posaconazole i.v. was well tolerated. Posaconazole i.v. 300 mg q.d. was selected for the phase 3 study segment. (This study has been registered at ClinicalTrials.gov under registration no. NCT01075984.).

  3. An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study.

    PubMed

    Sardo, Christine L; Kitzmiller, Joseph P; Apseloff, Glen; Harris, Robin B; Roe, Denise J; Stoner, Gary D; Jacobs, Elizabeth T

    2016-01-01

    This study was a 14-day, outpatient, open-label randomized crossover trial of lyophilized black raspberries (BRBs) in older overweight or obese males to determine whether BRB consumption affects postprandial inflammation associated with consumption of a high-fat high-calorie (HFHC) meal. Ten study participants consumed 45 g/d of lyophilized BRBs for 4 days, followed by a HFHC breakfast plus BRBs on day 6 or consumed the HFHC breakfast on day 6 without previous consumption of BRBs and then crossed over to the other treatment after a 2-day washout period. Blood samples were obtained before and 1, 2, 4, 8, and 12 hours after consumption of the HFHC breakfast. The primary study outcomes were changes in area under the concentration-time curve (AUC) for interleukin-6 (IL-6), C-reactive protein (CRP), and tumor necrosis factor-alpha (TNF-α). The secondary outcomes were safety and tolerability of lyophilized BRB powder. The chronology and values of measured serum concentrations for IL-6, TNF-α, and CRP were consistent with those described previously by other investigators. The AUC of serum IL-6 was lowered significantly (P = 0.03, n = 10) with BRB consumption (34.3 ± 7.6 pg·mL⁻¹·h⁻¹ compared with 42.4 ± 17.9 pg·mL⁻¹·h⁻¹ for consumption of the HFHC meal alone). However, no significant differences (change in AUC) were calculated for serum CRP and TNF-α. The findings of this pilot study suggest that consumption of lyophilized BRBs may attenuate postprandial inflammation in overweight or obese males consuming a HFHC meal. Further investigation of BRBs is warranted to better elucidate their inflammomodulatory potential.

  4. Oral risperidone with lorazepam versus oral zuclopenthixol with lorazepam in the treatment of acute psychosis in emergency psychiatry: a prospective, comparative, open-label study.

    PubMed

    Hovens, J E; Dries, P J T; Melman, C T M; Wapenaar, R J C; Loonen, A J M

    2005-01-01

    Acutely psychotic patients presenting as psychiatric emergencies with aggression or agitation are often administered conventional antipsychotics intramuscularly. However, patients view intramuscular administration as coercive, and conventional antipsychotics are often associated with adverse events. In this open study, consecutive adult patients presenting with an acute exacerbation of schizophrenia or other psychotic disorder were assigned to oral risperidone 2-6 mg/day (n = 48) or oral zuclopenthixol 20-50 mg/day (n = 27) for 7-14 days. Lorazepam (either oral or intramuscular) was administered to both groups as needed. Patients were assessed regularly until day 14 or discharge. Mean Positive And Negative Syndrome Scale (PANSS) aggression scores (sum of item scores on excitement, poor impulse control, hostility and uncooperativeness) decreased steadily and similarly in both groups; the mean changes from baseline were statistically significant at days 10 and 14 and at study end-point. The mean decrease at study end-point in the PANSS component score for hostility was statistically significant in the risperidone group, but not in the zuclopenthixol group. Social Dysfunction and Aggression Scale aggression scores and Clinical Global Impression scores decreased significantly and similarly in both groups. Overall, 18.7% of patients showed minor extrapyramidal symptoms during the study, but only 16.7% of risperidone-treated patients, compared to 59.3% of zuclopenthixol-treated patients, received anti-parkinsonian medication (p < 0.001). Lorazepam was administered to all of the patients assigned to risperidone and to 89% of those assigned to zuclopenthixol. Oral risperidone plus lorazepam is a convenient, effective and well-tolerated alternative to conventional antipsychotics for the treatment of acute psychosis in emergency psychiatry.

  5. Signals from Fat After Injury: Plasma Adipokines and Ghrelin Concentrations in the Severely Burned

    DTIC Science & Technology

    2012-09-26

    single burn ICU , 17 burn patients with an expected stay >14 days were studied. Study period began within 14 days of admission. Over 7 days, plasma...critical illness in response to inflammation and inadequacy of nutritional support [4]. Adiponec- tin is reduced in ICU patients and associated with...admitted to a single burn ICU and a comparison control group of non-fasted healthy volunteers were enrolled in the study. All subjects enrolled in this

  6. Does a toothpaste containing blue covarine have any effect on bleached teeth? An in vitro, randomized and blinded study.

    PubMed

    Bortolatto, Janaina Freitas; Dantas, Andrea Abi Rached; Roncolato, Ávery; Merchan, Hugo; Floros, Michael Christopher; Kuga, Milton Carlos; Oliveira Junior, Osmir Batista de

    2016-01-01

    The objective of this study was to analyze the effect of bleaching toothpastes, both conventional and those containing the new whitening agent Blue Covarine, on teeth previously bleached by conventional techniques (in-office and at-home). Squared bovine enamel/dentin blocks (6.0 x 6.0 x 2.0 mm) were randomly distributed in 6 groups (n = 15), according to the technique used to bleach them (in-office: HP35%; at-home: PC10%) and the type of bleaching toothpaste (none: control; Blue Covarine containing: BC; and without Blue Covarine: NBC). Experimental groups denominated HP35%, HP35%BC and HP35%NBC received in-office tooth bleaching before toothbrushing, and groups PC10%, PC10%BC and PC10%NBC were subjected to at-home tooth bleaching prior to toothbrushing. After bleaching treatment, groups HP35%BC, PC10%BC, HP35%NBC and PC10%NBC underwent daily tooth brushing in a brushing machine for 3 minutes (150 strokes/min, with a load of 375 g). Tooth color alteration was measured by reflectance spectroscopy (Vita EasyShade, Vident, Brea, CA, USA) at: T0 (baseline) - after in-office or at-home bleaching treatment; T1 - immediately after tooth brushing; T2 - 7 days and T3 - 14 days after tooth brushing. Data was analyzed by repeated measures mixed ANOVA and the Bonferroni post hoc test, with a significance level of 5%. Statistically significant differences were found between different experimental groups, evaluation times and for the interaction between them (p < 0.001). Tooth brushing using either bleaching toothpaste (conventional or with Blue Covarine) showed no color alteration on teeth previously bleached by in-office and at-home tooth bleaching. The use of bleaching toothpastes on previously bleached teeth did not produce a color alteration.

  7. Efficacy of thiabendazole, mebendazole, levamisole and ivermectin against gullet worm, Gongylonema pulchrum: in vitro and in vivo studies.

    PubMed

    Kudo, Noboru; Kubota, Hiroki; Gotoh, Hideyuki; Ishida, Hidekazu; Ikadai, Hiromi; Oyamada, Takashi

    2008-01-25

    In vitro and in vivo studies were conducted to evaluate the effects of thiabendazole, mebendazole, levamisole and ivermectin against Gongylonema pulchrum. For in vitro assays, third-stage larvae (L3) incubated with the drugs were administered orally to mice and the ability of larvae to invade the gastric mucosa of the animals was examined. After incubation, only those larvae treated with high concentrations of levamisole (1 and 10 microg/ml) were tightly coiled with intestines exhibiting morphological abnormalities. Good dose-response data for the drugs tested was observed at the time of worm recovery from mice, with no worms recovered at the two highest concentrations of levamisole. In vivo efficacy of the drugs against adult worms was evaluated in six groups of three rabbits, each of which was infected with 30 L3 of G. pulchrum and treated with thiabendazole at 100 mg/kg for 3 days, mebendazole at 70 mg/kg for 3 days, levamisole as a single dose of 8 mg/kg, and subcutaneously injected ivermectin as a single dose of 0.2 mg/kg or vehicles of the drugs (control) at 4 months post-infection. Necropsy 14 days after treatment revealed that levamisole, mebendazole and ivermectin reduced worm burdens by 63.2%, 22.8% and 25.8%, respectively, with no reductions in worms observed with thiabendazole. The surviving worms were principally found in the esophagus with the remainder distributed among the buccal mucosa, the tongue, and/or pharyngeal mucosa in all groups. A number of morphologically abnormal eggs were observed within the uterus and ovijector in female worms recovered from the thiabendazole-treated group. These findings suggest that levamisole exhibits in vivo efficacy against G. pulchrum infection and that the larval invasion tests using mice could be used to screen for anthelmintic susceptibility of nematodes.

  8. Effects of environmental noise on cognitive (dys)functions in schizophrenia: A pilot within-subjects experimental study.

    PubMed

    Wright, Bernice; Peters, Emmanuelle; Ettinger, Ulrich; Kuipers, Elizabeth; Kumari, Veena

    2016-05-01

    Cognitive impairment, particularly in attention, memory and executive function domains, is commonly present and associated with poor functional outcomes in schizophrenia. In healthy adults, environmental noise adversely affects many cognitive domains, including those known to be compromised in schizophrenia. This pilot study examined whether environmental noise causes further cognitive deterioration in a small sample of people with schizophrenia. Eighteen outpatients with schizophrenia on stable doses of antipsychotics and 18 age and sex-matched healthy participants were assessed on a comprehensive cognitive battery including measures of psychomotor speed, attention, executive functioning, working memory, and verbal learning and memory under three different conditions [quiet: ~30dB(A); urban noise: building site noise, 68-78dB(A); and social noise: background babble and footsteps from a crowded hall without any discernible words, 68-78dB(A)], 7-14days apart, with counter-balanced presentation of noise conditions across participants of both groups. The results showed widespread cognitive impairment in patients under all conditions, and noise-induced impairments of equal magnitude on specific cognitive functions in both groups. Both patient and healthy participant groups showed significant disruption of delayed verbal recall and recognition by urban and social noise, and of working memory by social noise, relative to the quiet condition. Performance under urban and social noise did not differ significantly from each other for any cognitive measure in either group. We conclude that noise has adverse effects on the verbal and working memory domains in schizophrenia patients and healthy participants. This may be particularly problematic for patients as it worsens their pre-existing cognitive deficits.

  9. Effect of Garlic, Gingko and St. John's Wort Extracts on the Pharmacokinetics of Fexofenadine: A Mechanistic Study.

    PubMed

    Turkanovic, Jasmina; Gerber, Jacobus P; Ward, Michael B; Milne, Robert W

    2017-02-10

    The aim of this study was to determine the effects of garlic and ginkgo herbal extracts on the pharmacokinetics of the P-glycoprotein (P-gp)/Organic anion transporting polypeptides (Oatps) substrate fexofenadine. Male rats were dosed orally with garlic (120 mg/kg), ginkgo (17 mg/kg), St. John's wort (SJW; 1000 mg/kg; positive control) or milli Q water for 14 days. On day 15, rats were either administered fexofenadine (orally or intravenously), had their livers isolated and perfused with fexofenadine, or the small intestine divided into four segments (SI-SIV) and analysed for P-gp and Oatp1a5. In vivo, SJW increased the CL of fexofenadine by 28%. Garlic increased the AUC0-∞ and Cmax of fexofenadine by 47% and 85%, respectively. Ginkgo and SJW had no effect on the oral absorption of fexofenadine. In the perfused liver, garlic, ginkgo and SJW increased the biliary clearance of fexofenadine with respect to perfusate by 71%, 121% and 234%, respectively. SJW increased the biliary clearance relative to the liver concentration by 64%. The ratio of liver to perfusate concentrations significantly increased in all treated groups. The expression of Oatp1a5 in SI was increased by garlic (88%) and SJW (63%). There were no significant changes in the expression of P-gp. Induction of intestinal Oatp1a5 by garlic may explain the increased absorption of orally administered fexofenadine. Ginkgo had no effect on the expression of intestinal P-gp or Oatp1a5. A dual inductive effect by SJW on opposing intestinal epithelial transport by Oatp1a5 and P-gp remains a possibility.

  10. Evaluation of Flexural Strength of Thermocycled Interim Resin Materials Used in Prosthetic Rehabilitation- An In-vitro Study

    PubMed Central

    Kadiyala, Krishna Kishore; Anne, Gopinadh; Anche, Sampath Chowdary; Chiramana, Sandeep; Muvva, Suresh Babu; Zakkula, Srujana; Jyothula, Ravi Rakesh Dev

    2016-01-01

    Introduction Provisional restoration is an analytical component of fixed prosthodontics serving as a ground plan for the design of fixed dental prosthesis. Flexural strength is critical in case of long standing fixed dental prosthesis, to appreciate success of full mouth rehabilitation cases and temporomandibular joint dysfunction therapies. Aim The present study was to evaluate the flexural strength of different provisional restorative resins used for prosthetic rehabilitation. Materials and Methods Forty identical samples (n=10 for each material) measuring 25mm×2mm×2mm according to ADA/ANSI specification no. 27 were fabricated using autopolymerizing Poly Methyl Methacrylate (PMMA) (Group A); heat activated PMMA (Group B); autopolymerizing Bis-GMA composite resin (Group C) and light activated Urethane Dimethacrylate Resin (UDMA) (Group D). For 14 days all these samples were stored in artificial saliva. Ten samples from each material were subjected to thermal cycling for 2500 cycles (5°C to 55°C). Later, a standard three point bending test was conducted on all the specimens with a universal testing machine at a crosshead speed of 0.75mm/min. Statistical analysis used included Kruskal-Wallis and Mann-Whitney U test. Results The mean flexural strength of specimens confirmed higher flexural strength for Group C (102.98 Mpa) followed by Group B (91.86 Mpa), Group A (79.13 Mpa) and Group D (60.01 Mpa). There were significant differences between any two materials tested (p <0.05). Comparison between mean flexural strength values between four groups revealed significant difference between the interim materials (p <0.05). Conclusion The greatest flexural strength was observed for Bis-GMA composite resins followed by heat cure methacrylate resins, autopolymerizing methacrylate resins and was least for light cure resins. While fabricating provisional restorations, these greater values should be considered for better outcome of the treatment. PMID:27790588

  11. Mucosal adaptation to aspirin induced gastric damage in humans. Studies on blood flow, gastric mucosal growth, and neutrophil activation.

    PubMed Central

    Konturek, J W; Dembinski, A; Stoll, R; Domschke, W; Konturek, S J

    1994-01-01

    The gastropathy associated with the ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin is a common side effect of this class of drugs, but the precise mechanisms by which they cause mucosal damage have not been fully explained. During continued use of an injurious substance, such as aspirin, the extent of gastric mucosal damage decreases and this phenomenon is named gastric adaptation. To assess the extent of mucosal damage by aspirin and subsequent adaptation the effects of 14 days of continuous, oral administration of aspirin (2 g per day) to eight healthy male volunteers was studied. To estimate the rate of mucosal damage, gastroscopy was performed before (day 0) and at days 3, 7, 14 of aspirin treatment. Gastric microbleeding and gastric mucosal blood flow were measured using laser Doppler flowmeter and mucosal biopsy specimens were taken for the estimation of tissue DNA synthesis and RNA and DNA concentration. In addition, the activation of neutrophils in peripheral blood was assessed by measuring their ability to associate with platelets. Aspirin induced acute damage mainly in gastric corpus, reaching at day 3 about 3.5 on the endoscopic Lanza score but lessened to about 1.5 at day 14 pointing to the occurrence of gastric adaptation. Mucosal blood flow increased at day 3 by about 50% in the gastric corpus and by 88% in the antrum. The in vitro DNA synthesis and RNA concentration, an index of mucosal growth, were reduced at day 3 but then increased to reach about 150% of initial value at the end of aspirin treatment. It is concluded that the treatment with aspirin in humans induces gastric adaptation to this agent, which entails the increase in mucosal blood flow, the rise in neutrophil activation, and the enhancement in mucosal growth. PMID:7959223

  12. The measurement and estimation of total energy expenditure in Japanese patients with ALS: a doubly labelled water method study.

    PubMed

    Shimizu, Toshio; Ishikawa-Takata, Kazuko; Sakata, Akiko; Nagaoka, Utako; Ichihara, Noriko; Ishida, Chiho; Nakayama, Yuki; Komori, Tetsuo; Nishizawa, Masatoyo

    2017-02-01

    Appropriate nutritional therapy has not been established for patients with amyotrophic lateral sclerosis (ALS). Our objective was to measure the total energy expenditure (TEE) and determine an equation to estimate the energy requirements for Japanese patients with ALS. Twenty-six Japanese patients with ALS participated in the study. The TEE was measured using the doubly labelled water (DLW) method for a 14-day period. Using a range of clinical parameters and multiple regression analyses, we determined an adequate equation to calculate TEE. Results showed that the median value of total energy intake (TEI) was 1581 (interquartile 1278-1782) kcal/d. TEE and TEE/body weight were 1628 kcal/d (1352-1865) and 31.3 kcal/kg (29.2-34.4), respectively. The ratio of TEE/estimated TEE by the Harris-Benedict equation was 1.14 (1.09-1.26). The difference between TEI and TEE was -63 kcal (-221 - 122), and 15 patients (57.7%) showed a negative balance. From regression analyses, we determined an equation to estimate TEE using the resting metabolic rate estimated by the Harris-Benedict equation (RMR-HB) and scores of the revised ALS Functional Rating Scale (ALSFRS-R): TEE = (1.67 × RMR-HB) + (11.8 × ALSFRS-R) - 680 (p < 0.0001). In conclusion, energy expenditure of Japanese patients with ALS was higher than expected, and we proposed a preliminary equation to estimate TEE for future nutritional intervention.

  13. [High-grade pressure sores in frail older high-risk persons. A retrospective postmortem case-control-study].

    PubMed

    Von Renteln-Kruse, W; Krause, T; Anders, J; Kühl, M; Heinemann, A; Püschel, K

    2004-04-01

    Some old persons at risk do develop, but others, at comparable risk, do not develop high-grade pressure sores. To evaluate potentially different risk factors, we performed a post mortem case-control study in old persons who developed high-grade pressure sores within six months until 14 days before death. Consecutive cases with pressure sores grade >/=3 and potential controls at comparably high risk for pressure sores were examined before cremation. After written informed consent had been obtained by the next relatives, all available nursing and medical records of the deceased were thoroughly evaluated. Cases and controls were matched according to age, gender, immobility, and cachexia.A total of 100 cases with 71 pressure sores grade 3 and 29 pressure sores grade 4 were compared to 100 controls with 27 pressure sores grade

  14. A Phase I Study of EKB-569 in Combination with Capecitabine in Patients with Advanced Colorectal Cancer

    PubMed Central

    Laheru, Dan; Croghan, Gary; Bukowski, Ronald; Rudek, Michelle; Messersmith, Wells; Erlichman, Charles; Pelley, Robert; Jimeno, Antonio; Donehower, Ross; Boni, Joseph; Abbas, Richat; Martins, Patricia; Zacharchuk, Charles; Hidalgo, Manuel

    2011-01-01

    Purpose To determine the maximum tolerated dose (MTD), characterize the principal toxicities, and assess the pharmacokinetics of EKB-569, an oral selective irreversible inhibitor of the epidermal growth factor receptor tyrosine kinase, in combination with capecitabine in patients with advanced colorectal cancer. Experimental Design Patients were treated with EKB-569 daily for 21days and capecitabine twice daily for14 days of a 21-day cycle. The dose levels of EKB-569 (mg/day) and capecitabine (mg/m2 twice daily) assessed were 25/750, 50/750, 50/1,000 and 75/1,000. An expanded cohort was enrolled at the MTD to better study toxicity and efficacy. Samples of plasma were collected to characterize the pharmacokinetics of the agents. Treatment efficacy was assessed every other cycle. Results A total of 37 patients, the majority of whom had prior chemotherapy, received a total of 163 cycles of treatment. Twenty patients were treated at the MTD, 50 mg EKB-569, daily and 1,000 mg/m2 capecitabine twice daily. Dose-limiting toxicities were diarrhea and rash. No patients had complete or partial responses but 48% had stable disease. The conversion of capecitabine to 5-fluorouracil was higher for the combination of EKB-569 and capecitabine (321 ± 151 ng*h/mL) than for capecitabine alone (176 ± 62 ng*hours/mL; P = 0.0037). Conclusion In advanced colorectal cancer, 50 mg EKB-569 daily can be safely combined with 1,000 mg/m2 capecitabine twice a day. A statistically significant increase in plasma levels of 5-fluorouracil for the combination of EKB-569 and capecitabine may be due to the single-dose versus multiple-dose exposure difference, variability in exposure or a potential drug interaction. PMID:18765554

  15. Acute and long-term dysphagia in critically ill patients with severe sepsis: results of a prospective controlled observational study.

    PubMed

    Zielske, Joerg; Bohne, Silvia; Brunkhorst, Frank M; Axer, Hubertus; Guntinas-Lichius, Orlando

    2014-11-01

    Dysphagia is a major risk factor for morbidity and mortality in critically ill patients treated in intensive care units (ICUs). Structured otorhinolaryngological data on dysphagia in ICU survivors with severe sepsis are missing. In a prospective study, 30 ICU patients with severe sepsis and thirty without sepsis as control group were examined using bedside fiberoptic endoscopic evaluation of swallowing after 14 days in the ICU (T1) and 4 months after onset of critical illness (T2). Swallowing dysfunction was assessed using the Penetration-Aspiration Scale (PAS). The Functional Oral Intake Scale was applied to evaluate the diet needed. Primary endpoint was the burden of dysphagia defined as PAS score >5. At T1, 19 of 30 severe sepsis patients showed aspiration with a PAS score >5, compared to 7 of 30 in critically ill patients without severe sepsis (p = 0.002). Severe sepsis and tracheostomy were independent risk factors for severe dysphagia with aspiration (PAS > 5) at T1 (p = 0.042 and 0.006, respectively). 4-month mortality (T2) was 57 % in severe sepsis patients compared to 20 % in patients without severe sepsis (p = 0.006). At T2, more severe sepsis survivors were tracheostomy-dependent and needed more often tube or parenteral feeding (p = 0.014 and p = 0.040, respectively). Multivariate analysis revealed tracheostomy at T1 as independent risk factor for severe dysphagia at T2 (p = 0.030). Severe sepsis appears to be a relevant risk factor for long-term dysphagia. An otorhinolaryngological evaluation of dysphagia at ICU discharge is mandatory for survivors of severe critical illness to plan specific swallowing rehabilitation programs.

  16. High-dose esomeprazole and amoxicillin dual therapy for first-line Helicobacter pylori eradication: a proof of concept study

    PubMed Central

    Zullo, Angelo; Ridola, Lorenzo; Francesco, Vincenzo De; Gatta, Luigi; Hassan, Cesare; Alvaro, Domenico; Bellesia, Annamaria; de Nucci, Germana; Manes, Gianpiero

    2015-01-01

    Background The prevalence of resistance to clarithromycin and metronidazole has considerably increased, with a corresponding decrease in the eradication rate for Helicobacter pylori (H. pylori) infection. Primary resistance to amoxicillin is extremely low, and esomeprazole was found to exert a noteworthy antimicrobial activity in vitro against H. pylori. A dual therapy with high-dose of esomeprazole coupled with high-dose amoxicillin might be therefore an ideal first-line treatment for H. pylori eradication. We aimed to assess the efficacy of a first-line 10-day, high-dose dual therapy consisting of amoxicillin and esomeprazole to eradicate H. pylori infection. Methods Consecutive naïve H. pylori-infected patients, who underwent an upper endoscopy in 4 Italian hospitals due to dyspeptic symptoms and found to be infected at routine histological assessment, were invited to participate. Patients enrolled received a 10-day, high-dose dual therapy comprising esomeprazole (40 mg t.i.d) and amoxicillin (1 g t.i.d.). At least 4 weeks after the end of the treatment a 13C-urea breath test was performed to evaluate the eradication. Results A total of 56 patients agreed to participate in the study and were all followed-up. The overall eradication was 87.5% (95% CI=78.8•96.2), without a statistically significant difference among centres. Overall, 5 (8.9%; 1.5•16.4%) patients complained of side-effects. Conclusions The 10-day, high-dose dual therapy with esomeprazole and amoxicillin might be an effective and safe first-line regimen. The efficacy of a longer 14-day regimen should be tested. PMID:26423014

  17. Sickness absence as a prognostic marker for common chronic conditions: analysis of mortality in the GAZEL study

    PubMed Central

    Kivimaki, Mika; Head, Jenny; Ferrie, Jane E.; Singh-Manoux, Archana; Westerlund, Hugo; Vahtera, Jussi; Leclerc, Annette; Melchior, Maria; Chevalier, Anne; Alexanderson, Kristina; Zins, Marie; Goldberg, Marcel

    2008-01-01

    Objectives To determine whether sickness absence is a prognostic marker in terms of mortality among people with common chronic conditions. Methods Prospective occupational cohort study of 13 077 men and 4871 women aged 37 to 51 from the National Gas and Electricity Company, France. Records of physician-certified sickness absences over a 3-year period were obtained from employers’ registers. Chronic conditions were assessed in annual surveys over the same period. The main outcome measure was all-cause mortality (803 deaths, mean follow-up after assessment of sickness absence, 13.9 years) Results In Cox proportional-hazard models adjusted for age, sex, socioeconomic position and co-morbidity, >28 annual sickness absence days vs no absence days was associated with an excess mortality risk among those with cancer (hazard ratio 5.4, 95% CI 2.2 to 13.1), depression (1.7, 1.1 to 2.8), chronic bronchitis/asthma (2.7, 1.6 to 4.6), and hypertension (1.6, 1.0 to 2.6). The corresponding hazard ratios for more than 5 long (>14 days) sickness absence episodes per 10 person-years vs no such episodes were 5.4 (2.2 to 13.1), 1.8 (1.3 to 2.7), 2.0 (1.3 to 3.2) and 1.8 (1.2 to 2.7), respectively. Areas under receiver-operating-characteristics curves for these absence measures varied between 0.56 and 0.73 indicating the potential of these measures to distinguish groups at high risk of mortality. The findings were consistent across sex, age and socioeconomic groups and in those with and without co-morbid conditions. Conclusion Data on sickness absence may provide useful prognostic information for common chronic conditions at the population level. PMID:18611969

  18. Restaurant outbreak of Legionnaires' disease associated with a decorative fountain: an environmental and case-control study

    PubMed Central

    O'Loughlin, Rosalyn E; Kightlinger, Lon; Werpy, Matthew C; Brown, Ellen; Stevens, Valerie; Hepper, Clark; Keane, Tim; Benson, Robert F; Fields, Barry S; Moore, Matthew R

    2007-01-01

    Background From June to November 2005, 18 cases of community-acquired Legionnaires' disease (LD) were reported in Rapid City South Dakota. We conducted epidemiologic and environmental investigations to identify the source of the outbreak. Methods We conducted a case-control study that included the first 13 cases and 52 controls randomly selected from emergency department records and matched on underlying illness. We collected information about activities of case-patients and controls during the 14 days before symptom onset. Environmental samples (n = 291) were cultured for Legionella. Clinical and environmental isolates were compared using monoclonal antibody subtyping and sequence b