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Sample records for additional controlled clinical

  1. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  2. Smog control fuel additives

    SciTech Connect

    Lundby, W.

    1993-06-29

    A method is described of controlling, reducing or eliminating, ozone and related smog resulting from photochemical reactions between ozone and automotive or industrial gases comprising the addition of iodine or compounds of iodine to hydrocarbon-base fuels prior to or during combustion in an amount of about 1 part iodine per 240 to 10,000,000 parts fuel, by weight, to be accomplished by: (a) the addition of these inhibitors during or after the refining or manufacturing process of liquid fuels; (b) the production of these inhibitors for addition into fuel tanks, such as automotive or industrial tanks; or (c) the addition of these inhibitors into combustion chambers of equipment utilizing solid fuels for the purpose of reducing ozone.

  3. Clinical effects of sulphite additives.

    PubMed

    Vally, H; Misso, N L A; Madan, V

    2009-11-01

    Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Topical, oral or parenteral exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however, exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. While contact sensitivity to sulphite additives in topical medications is increasingly being recognized, skin reactions also occur after ingestion of or parenteral exposure to sulphites. Most studies report a 3-10% prevalence of sulphite sensitivity among asthmatic subjects following ingestion of these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. In addition to episodic and acute symptoms, sulphites may also contribute to chronic skin and respiratory symptoms. To date, the mechanisms underlying sulphite sensitivity remain unclear, although a number of potential mechanisms have been proposed. Physicians should be aware of the range of clinical manifestations of sulphite sensitivity, as well as the potential sources of exposure. Minor modifications to diet or behaviour lead to excellent clinical outcomes for sulphite-sensitive individuals.

  4. New ESP additive controls particulates

    SciTech Connect

    Durham, M.D.; Baldrey, K.E.; Bustard, C.J.; Martin, C.E.; Dharmarajan, N.N.

    1997-06-01

    This article reports that a conditioning agent enhanced precipitator performance after plant switched to low-sulfur coal. Firing low-sulfur coal at a power plant designed for medium- or high-sulfur coal will impact the downstream particulate control device. Since the performance of an electro-static precipitator (ESP) is a strong function of the sulfur content in the coal, switching to a low-sulfur coal will severely impact collection efficiency. Particle resistivity is the dominant parameter affecting the performance of an ESP. When the resistivity is too high, the ESP must be increased in size by a factor of two to three, resulting in proportionally increased capital and operating costs. Fly ash from low-sulfur coal is known to have a typical resistivity one or two orders of magnitude above that for ideal collection efficiency in a well-designed ESP. Therefore, when a utility burning a medium- or high-sulfur coal switches to a low-sulfur coal, the increase in particle resistivity resulting from the reduced SO{sub 3} concentration will lead to severe problems in the ESP. There have been many instances where utilities have switched from a high- to a low-sulfur coal, and the problems caused by the increased resistivity have had such a devastating effect on the performance of the ESP that emissions have increased by a factor of 10.

  5. Clinical writing: additional ethical and practical issues.

    PubMed

    Woodhouse, Susan S

    2012-03-01

    The recommendations by Sieck (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice, Psychotherapy, 49, pp. 3-11.) are a helpful starting point for considering the ethical issues involved in the decision to seek or not to seek informed consent from clients before writing about them. Sieck makes a compelling case for the idea that there are circumstances in which the most ethical choice would be to engage in clinical writing about a client without seeking informed consent, but instead disguising the client's identity. The present response raises a number of questions not considered in the article by Sieck. First, how should one disguise a case? Moreover, how should one assess whether the disguise is sufficient to preserve confidentiality while not distorting the clinical material to the point that the material is no longer useful to the field? Second, how can we estimate the likelihood of clients reading clinical writing, particularly in the age of the Internet? Given that psychologist-authored blogs that include reference to clinical material are beginning to emerge, it is crucial that we engage in a much deeper dialogue about the ethics of clinical writing. Third, how does the presentation of clinical material influence public perceptions of psychotherapy and confidentiality? If these public perceptions, in turn, could influence the likelihood of seeking psychotherapy, might these attitudes be important to consider in ethical thinking about clinical writing? Finally, where do we draw the line between clinical writing and single case study research (which requires informed consent)?

  6. Clinical writing: additional ethical and practical issues.

    PubMed

    Woodhouse, Susan S

    2012-03-01

    The recommendations by Sieck (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice, Psychotherapy, 49, pp. 3-11.) are a helpful starting point for considering the ethical issues involved in the decision to seek or not to seek informed consent from clients before writing about them. Sieck makes a compelling case for the idea that there are circumstances in which the most ethical choice would be to engage in clinical writing about a client without seeking informed consent, but instead disguising the client's identity. The present response raises a number of questions not considered in the article by Sieck. First, how should one disguise a case? Moreover, how should one assess whether the disguise is sufficient to preserve confidentiality while not distorting the clinical material to the point that the material is no longer useful to the field? Second, how can we estimate the likelihood of clients reading clinical writing, particularly in the age of the Internet? Given that psychologist-authored blogs that include reference to clinical material are beginning to emerge, it is crucial that we engage in a much deeper dialogue about the ethics of clinical writing. Third, how does the presentation of clinical material influence public perceptions of psychotherapy and confidentiality? If these public perceptions, in turn, could influence the likelihood of seeking psychotherapy, might these attitudes be important to consider in ethical thinking about clinical writing? Finally, where do we draw the line between clinical writing and single case study research (which requires informed consent)? PMID:22369079

  7. Laboratory tests of sludge-control additives

    SciTech Connect

    Tatnall, R.E.

    1996-07-01

    Laboratory {open_quotes}jar{close_quotes} tests compared eleven different fuel oil and diesel fuel sludge-control additives. Factors studied included (1) ability to disperse and prevent buildup of sludge deposits on surfaces, (2) ability to protect steel from corrosion, (3) ability to inhibit growth and proliferation of bacteria, and (4) ability to disperse water. Results varied greatly, and it was found that many commercial products do not do what they claim. It is concluded that fuel retailers should not believe manufacturers` claims for their additive products, but rather should test such products themselves to be sure that the benefits of treatment are real. A simplified form of the procedure used here is proposed as one way for dealers to do such testing.

  8. [Controlling in clinical management].

    PubMed

    Bähr, K; Ellinger, K

    1999-02-01

    Managers of industrial enterprises strive continually to improve the efficiency of production, distribution and service for their customers in order to be able to compete on the market. In socially orientated non-profit-organisations this is not universe practice. Relating to section 17 Abs. 1 KHG and section 13 BPfIV of German social legislation hospital charges are refunded only, if the hospital is working efficiently and economically. Controlling is a tool to achieve these goals. Controlling coordinates the flow of information for planning and evaluation. Strategic and operative controlling are closely interrelated: Strategic controlling is directed towards new and promising activities, operative controlling supports decision--making--including future-oriented aspects-by providing and condensing information. Controlling is definitely not intended to dictate or "command" any action. Its object is to serve as an instrument or tool supporting result-oriented planning, regulating and evaluation.

  9. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  10. Iron-control additives improve acidizing

    SciTech Connect

    Walker, M.; Dill, W. ); Besler, M. )

    1989-07-24

    Iron sulfide and sulfur precipitation in sour wells can be controlled with iron-sequestering agents and sulfide modifiers. Oil production has been routinely increased in sour wells where precipitation of iron sulfide and elemental sulfur has been brought under control. Production increases have been especially noteworthy on wells that had a history of rapid production decline after acid stimulation. Twenty-fold production increases have been recorded. Key to the production increase has been to increase permeability with: Iron chelating agents that control precipitation of iron sulfide. A sulfide modifier that reduces precipitation of solids in the presence of excessive amounts of hydrogen sulfide and prevents precipitation of elemental sulfur.

  11. CONTROL ROD ALLOY CONTAINING NOBLE METAL ADDITIONS

    DOEpatents

    Anderson, W.K.; Ray, W.E.

    1960-05-01

    Silver-base alloys suitable for use in the fabrication of control rods for neutronic reactors are given. The alloy consists of from 0.5 wt.% to about 1.5 wt.% of a noble metal of platinum, ruthenium, rhodium, osmium, or palladium, up to 10 wt.% of cadmium, from 2 to 20 wt.% indium, the balance being silver.

  12. Microstructural Control of Additively Manufactured Metallic Materials

    NASA Astrophysics Data System (ADS)

    Collins, P. C.; Brice, D. A.; Samimi, P.; Ghamarian, I.; Fraser, H. L.

    2016-07-01

    In additively manufactured (AM) metallic materials, the fundamental interrelationships that exist between composition, processing, and microstructure govern these materials’ properties and potential improvements or reductions in performance. For example, by using AM, it is possible to achieve highly desirable microstructural features (e.g., highly refined precipitates) that could not otherwise be achieved by using conventional approaches. Simultaneously, opportunities exist to manage macro-level microstructural characteristics such as residual stress, porosity, and texture, the last of which might be desirable. To predictably realize optimal microstructures, it is necessary to establish a framework that integrates processing variables, alloy composition, and the resulting microstructure. Although such a framework is largely lacking for AM metallic materials, the basic scientific components of the framework exist in literature. This review considers these key components and presents them in a manner that highlights key interdependencies that would form an integrated framework to engineer microstructures using AM.

  13. Birth Control in Clinical Trials

    PubMed Central

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  14. One of two rotodip feeders used to control addition of ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    One of two rotodip feeders used to control addition of alum solution into the water - Division Avenue Pumping Station & Filtration Plant, West 45th Street and Division Avenue, Cleveland, Cuyahoga County, OH

  15. 78. SAC control center aboveground addition partial first floor plan, ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    78. SAC control center aboveground addition partial first floor plan, drawing number AW30-02-09, dated 15 October, 1962 - Offutt Air Force Base, Strategic Air Command Headquarters & Command Center, Headquarters Building, 901 SAC Boulevard, Bellevue, Sarpy County, NE

  16. Control of pyrite addition in coal liquefaction process

    DOEpatents

    Schmid, Bruce K.; Junkin, James E.

    1982-12-21

    Pyrite addition to a coal liquefaction process (22, 26) is controlled (118) in inverse proportion to the calcium content of the feed coal to maximize the C.sub.5 --900.degree. F. (482.degree. C.) liquid yield per unit weight of pyrite added (110). The pyrite addition is controlled in this manner so as to minimize the amount of pyrite used and thus reduce pyrite contribution to the slurry pumping load and disposal problems connected with pyrite produced slag.

  17. An academic, clinical and industrial update on electrospun, additive manufactured and imprinted medical devices.

    PubMed

    Ryan, Christina N M; Fuller, Kieran P; Larrañaga, Aitor; Biggs, Manus; Bayon, Yves; Sarasua, Jose R; Pandit, Abhay; Zeugolis, Dimitrios I

    2015-01-01

    Electrospinning, additive manufacturing and imprint lithography scaffold fabrication technologies have attracted great attention in biomedicine, as they allow production of two- and three- dimensional constructs with tuneable topographical and geometrical features. In vitro data demonstrate that electrospun and imprinted substrates offer control over permanently differentiated and stem cell function. Advancements in functionalisation strategies have further enhanced the bioactivity and reparative capacity of electrospun and additive manufactured devices, as has been evidenced in several preclinical models. Despite this overwhelming success in academic setting, only a few technologies have reached the clinic and only a fraction of them have become commercially available products.

  18. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

  19. Ultrafast amplifier additive timing jitter characterization and control.

    PubMed

    Casanova, Alexis; D'Acremont, Quentin; Santarelli, Giorgio; Dilhaire, Stefan; Courjaud, Antoine

    2016-03-01

    We report on the characterization and long-term compensation of additive timing jitter introduced by a femtosecond ytterbium regenerative amplifier with a 100 kHz repetition rate. A balanced optical cross-correlation technique is used to generate a jitter error signal. This approach is well suited to characterize the additive timing jitter of Yb amplifiers seeded by narrow spectrum Yb oscillators. The balanced optical cross-correlator is in a noncollinear configuration allowing a background free coindence detection. This setup enables the measurement of additive timing jitter from the amplifier, with a noise floor of 300 as integrated from 10 Hz to 10 kHz. The measured additive timing jitter level is about 5 fs, integrated from 0.1 Hz to 10 kHz. The amplifier timing drift characterization and control are performed for more than an hour. PMID:26974074

  20. Emission control devices, fuel additive, and fuel composition changes.

    PubMed Central

    Piver, W T

    1977-01-01

    Emission control devices are installed to meet the exhaust standards of the Clean Air Act for carbon monoxide and hydrocarbons, and it is necessary to know, from a public health point of view, how exhaust emissions may be affected by changes in fuel additives and fuel composition. Since these topics are concerned with developing technologies, the available literature on exhaust emission characteristics and the limited information on health effects, is reviewed. PMID:71235

  1. Prazosin addition to fluvoxamine: A preclinical study and open clinical trial in OCD.

    PubMed

    Feenstra, Matthijs G P; Klompmakers, André; Figee, Martijn; Fluitman, Sjoerd; Vulink, Nienke; Westenberg, Herman G M; Denys, Damiaan

    2016-02-01

    The efficacy of selective serotonin reuptake inhibitors (SRIs) in psychiatric disorders may be "augmented" through the addition of atypical antipsychotic drugs. A synergistic increase in dopamine (DA) release in the prefrontal cortex has been suggested to underlie this augmentation effect, though the mechanism of action is not clear yet. We used in vivo microdialysis in rats to study DA release following the administration of combinations of fluvoxamine (10 mg/kg) and quetiapine (10 mg/kg) with various monoamine-related drugs. The results confirmed that the selective 5-HT1A antagonist WAY-100635 (0.05 mg/kg) partially blocked the fluvoxamine-quetiapine synergistic effect (maximum DA increase dropped from 325% to 214%). A novel finding is that the α1-adrenergic blocker prazosin (1 mg/kg), combined with fluvoxamine, partially mimicked the effect of augmentation (maximum DA increase 205%; area-under-the-curve 163%). As this suggested that prazosin augmentation might be tested in a clinical study, we performed an open clinical trial of prazosin 20 mg addition to SRI in therapy-resistant patients with obsessive-compulsive disorder applying for neurosurgery. A small, non-significant reduction in Yale Brown Obsessive Compulsive Scale (Y-BOCS) scores was observed in 10 patients and one patient was classified as a responder with a reduction in Y-BOCS scores of more than 25%. We suggest that future clinical studies augmenting SRIs with an α1-adrenergic blocker in less treatment resistant cases should be considered. The clinical trial "Prazosin in combination with a serotonin reuptake inhibitor for patients with Obsessive Compulsive disorder: an open label study" was registered at 24/05/2011 under trial number ISRCTN61562706: http://www.controlled-trials.com/ISRCTN61562706. PMID:26712326

  2. A microfluidic abacus channel for controlling the addition of droplets.

    PubMed

    Um, Eujin; Park, Je-Kyun

    2009-01-21

    This paper reports the first use of the abacus-groove structure to handle droplets in a wide microchannel, with no external forces integrated to the system other than the pumps. Microfluidic abacus channels are demonstrated for the sequential addition of droplets at the desired location. A control channel which is analogous to biasing in electronics can also be used to precisely determine the number of added droplets, when all other experimental conditions are fixed including the size of the droplets and the frequency of droplet-generation. The device allows programmable and autonomous operations of complex two-phase microfluidics as well as new applications for the method of analysis and computations in lab-on-a-chip devices.

  3. Control of Microthrix parvicella by aluminium salts addition.

    PubMed

    Durban, N; Juzan, L; Krier, J; Gillot, S

    2016-01-01

    Aluminium and iron chloride were added to a biological nutrient removal pilot plant (1,500 population equivalent) treating urban wastewater to investigate the control of Microthrix parvicella bulking and foaming by metallic salts. Monitoring plant performance over two 6-month periods showed a slight impact on the removal efficiencies. Addition of metallic salts (Me; aluminium or aluminium + iron) at a concentration of 41 mmol Me(kg MLSS·d) (MLSS: mixed liquor suspended solids) over 70 days allowed a stabilization of the diluted sludge volume index (DSVI), whereas higher dosages (94 mmol Me(kg MLSS·d) over 35 days or 137 mmol Me(kg MLSS·d) over 14 days induced a significant improvement of the settling conditions. Microscopic observations showed a compaction of biological aggregates with an embedding of filamentous bacteria into the flocs that is not specific to M. parvicella as bacteria from phylum Chloroflexi are embedded too. The quantitative polymerase chain reaction targeting M. parvicella further indicated a possible growth limitation in addition to the flocculation impact at the high dosages of metallic salts investigated. DSVI appeared to be correlated with the relative abundance of M. parvicella.

  4. Control of Microthrix parvicella by aluminium salts addition.

    PubMed

    Durban, N; Juzan, L; Krier, J; Gillot, S

    2016-01-01

    Aluminium and iron chloride were added to a biological nutrient removal pilot plant (1,500 population equivalent) treating urban wastewater to investigate the control of Microthrix parvicella bulking and foaming by metallic salts. Monitoring plant performance over two 6-month periods showed a slight impact on the removal efficiencies. Addition of metallic salts (Me; aluminium or aluminium + iron) at a concentration of 41 mmol Me(kg MLSS·d) (MLSS: mixed liquor suspended solids) over 70 days allowed a stabilization of the diluted sludge volume index (DSVI), whereas higher dosages (94 mmol Me(kg MLSS·d) over 35 days or 137 mmol Me(kg MLSS·d) over 14 days induced a significant improvement of the settling conditions. Microscopic observations showed a compaction of biological aggregates with an embedding of filamentous bacteria into the flocs that is not specific to M. parvicella as bacteria from phylum Chloroflexi are embedded too. The quantitative polymerase chain reaction targeting M. parvicella further indicated a possible growth limitation in addition to the flocculation impact at the high dosages of metallic salts investigated. DSVI appeared to be correlated with the relative abundance of M. parvicella. PMID:26819398

  5. Method for controlling a laser additive process using intrinsic illumination

    NASA Astrophysics Data System (ADS)

    Tait, Robert; Cai, Guoshuang; Azer, Magdi; Chen, Xiaobin; Liu, Yong; Harding, Kevin

    2015-05-01

    One form of additive manufacturing is to use a laser to generate a melt pool from powdered metal that is sprayed from a nozzle. The laser net-shape machining system builds the part a layer at a time by following a predetermined path. However, because the path may need to take many turns, maintaining a constant melt pool may not be easy. A straight section may require one speed and power while a sharp bend would over melt the metal at the same settings. This paper describes a process monitoring method that uses the intrinsic IR radiation from the melt pool along with a process model configured to establish target values for the parameters associated with the manufacture or repair. This model is based upon known properties of the metal being used as well as the properties of the laser beam. An adaptive control technique is then employed to control process parameters of the machining system based upon the real-time weld pool measurement. Since the system uses the heat radiant from the melt pool, other previously deposited metal does not confuse the system as only the melted material is seen by the camera.

  6. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  7. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  8. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice.

  9. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice. PMID:23421011

  10. Additives and method for controlling clathrate hydrates in fluid systems

    DOEpatents

    Sloan, E.D. Jr.; Christiansen, R.L.; Lederhos, J.P.; Long, J.P.; Panchalingam, V.; Du, Y.; Sum, A.K.W.

    1997-06-17

    Discussed is a process for preventing clathrate hydrate masses from detrimentally impeding the possible flow of a fluid susceptible to clathrate hydrate formation. The process is particularly useful in the natural gas and petroleum production, transportation and processing industry where gas hydrate formation can cause serious problems. Additives preferably contain one or more five member, six member and/or seven member cyclic chemical groupings. Additives include polymers having lactam rings. Additives can also contain polyelectrolytes that are believed to improve conformance of polymer additives through steric hindrance and/or charge repulsion. Also, polymers having an amide on which a C{sub 1}-C{sub 4} group is attached to the nitrogen and/or the carbonyl carbon of the amide may be used alone, or in combination with ring-containing polymers for enhanced effectiveness. Polymers having at least some repeating units representative of polymerizing at least one of an oxazoline, an N-substituted acrylamide and an N-vinyl alkyl amide are preferred.

  11. Additives and method for controlling clathrate hydrates in fluid systems

    DOEpatents

    Sloan, Jr., Earle Dendy; Christiansen, Richard Lee; Lederhos, Joseph P.; Long, Jin Ping; Panchalingam, Vaithilingam; Du, Yahe; Sum, Amadeu Kun Wan

    1997-01-01

    Discussed is a process for preventing clathrate hydrate masses from detrimentally impeding the possible flow of a fluid susceptible to clathrate hydrate formation. The process is particularly useful in the natural gas and petroleum production, transportation and processing industry where gas hydrate formation can cause serious problems. Additives preferably contain one or more five member, six member and/or seven member cyclic chemical groupings. Additives include polymers having lactam rings. Additives can also contain polyelectrolytes that are believed to improve conformance of polymer additives through steric hinderance and/or charge repulsion. Also, polymers having an amide on which a C.sub.1 -C.sub.4 group is attached to the nitrogen and/or the carbonyl carbon of the amide may be used alone, or in combination with ring-containing polymers for enhanced effectiveness. Polymers having at least some repeating units representative of polymerizing at least one of an oxazoline, an N-substituted acrylamide and an N-vinyl alkyl amide are preferred.

  12. Direct laser additive fabrication system with image feedback control

    DOEpatents

    Griffith, Michelle L.; Hofmeister, William H.; Knorovsky, Gerald A.; MacCallum, Danny O.; Schlienger, M. Eric; Smugeresky, John E.

    2002-01-01

    A closed-loop, feedback-controlled direct laser fabrication system is disclosed. The feedback refers to the actual growth conditions obtained by real-time analysis of thermal radiation images. The resulting system can fabricate components with severalfold improvement in dimensional tolerances and surface finish.

  13. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control.... Class I (general controls). Except when used in donor screening, unassayed material is exempt from...

  14. Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control.

    PubMed

    Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

    2014-01-01

    Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part's porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented.

  15. Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control.

    PubMed

    Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

    2014-01-01

    Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part's porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented. PMID:26601041

  16. Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control

    PubMed Central

    Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

    2014-01-01

    Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part’s porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented. PMID:26601041

  17. Part height control of laser metal additive manufacturing process

    NASA Astrophysics Data System (ADS)

    Pan, Yu-Herng

    Laser Metal Deposition (LMD) has been used to not only make but also repair damaged parts in a layer-by-layer fashion. Parts made in this manner may produce less waste than those made through conventional machining processes. However, a common issue of LMD involves controlling the deposition's layer thickness. Accuracy is important, and as it increases, both the time required to produce the part and the material wasted during the material removal process (e.g., milling, lathe) decrease. The deposition rate is affected by multiple parameters, such as the powder feed rate, laser input power, axis feed rate, material type, and part design, the values of each of which may change during the LMD process. Using a mathematical model to build a generic equation that predicts the deposition's layer thickness is difficult due to these complex parameters. In this thesis, we propose a simple method that utilizes a single device. This device uses a pyrometer to monitor the current build height, thereby allowing the layer thickness to be controlled during the LMD process. This method also helps the LMD system to build parts even with complex parameters and to increase material efficiency.

  18. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  19. Regiodivergent Addition of Phenols to Allylic Oxides: Control of 1,2 and 1,4-Additions for Cyclitol Synthesis**

    PubMed Central

    Moschitto, Matthew J.; Vaccarello, David N.; Lewis, Chad A.

    2015-01-01

    Control of 1,2- and 1,4-addition of substituted phenols to allylic oxides is achieved by intercepting palladium π-allyl complexes. The interconversion of palladium complexes results in the total synthesis of MK7607, cyathiformine B type, streptol, and a new cyclitol. PMID:25533617

  20. Clinical and histopathological evaluation of the effect of addition of immunotherapy with Mw vaccine to standard chemotherapy in borderline leprosy.

    PubMed

    Kamal, R; Natrajan, M; Katoch, K; Arora, M

    2012-01-01

    This study reports detailed analysis of clinical parameters and clearance of granuloma in borderline leprosy patients treated with immunotherapy and chemotherapy. It aims to assess the additive effect of immunotherapy (Mwvaccine) with standard MDT on clinical status of untreated borderline leprosy cases and on granuloma fraction of untreated borderline leprosy cases. Patients attending the OPD were serially recruited in two groups. A total of 150 cases in one treatment (trial) group (Mw vaccine plus MDT) and 120 cases in another treatment (control) group (MDT only) of border line leprosy have been included. After the formal written consent, detailed clinical examination, charting, smear examination of all untreated borderline patients of both groups was done, biopsies were taken from the active lesions of all patients of both groups at start of therapy and every six month thereafter till the completion of therapy. The same procedure was repeated every six months during the follow-up period. Standard MDT was given to all the patients of both groups according to type of disease. Mw vaccine 0.1 ml (0.5 x 10(9) bacilli) was injected intra-dermally at the start of therapy and every six months in addition to chemotherapy to the treatment group. The BT cases were followed up after 6 doses of MDT and 2 doses of Mw vaccine, and, the BB, BL cases were followed up after 24 doses of MDT plus 5 doses of Mw vaccine. Clinically, greater and faster improvement was observed in all the clinical parameters, faster attainment of smear negativity and two episodes of lepra reaction occurred in cases treated with combined chemotherapy and immunotherapy, as compared to controls (chemotherapy alone) wherein clinical improvement was slower in all parameters, slower attainment of smear negativity in bacillary index and seven showed the occurrence of reactions, histipathologically in addition to more rapid clearance of granuloma in immunotherapy treated group, a significant finding was an

  1. Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment.

    PubMed

    Tobin, Thomas J; Tobin, Mary L

    2015-01-01

    Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions. PMID:26514264

  2. Clinical applications of biomedical microdevices for controlled drug delivery.

    PubMed

    Gurman, Pablo; Miranda, Oscar R; Clayton, Kevin; Rosen, Yitzhak; Elman, Noel M

    2015-01-01

    Miniaturization of devices to micrometer and nanometer scales, combined with the use of biocompatible and functional materials, has created new opportunities for the implementation of drug delivery systems. Advances in biomedical microdevices for controlled drug delivery platforms promise a new generation of capabilities for the treatment of acute conditions and chronic illnesses, which require high adherence to treatment, in which temporal control over the pharmacokinetic profiles is critical. In addition, clinical conditions that require a combination of drugs with specific pharmacodynamic profiles and local delivery will benefit from drug delivery microdevices. This review provides a summary of various clinical applications for state-of-the-art controlled drug delivery microdevices, including cancer, endocrine and ocular disorders, and acute conditions such as hemorrhagic shock. Regulatory considerations for clinical translation of drug delivery microdevices are also discussed. Drug delivery microdevices promise a remarkable gain in clinical outcomes and a substantial social impact. A review of articles covering the field of microdevices for drug delivery was performed between January 1, 1990, and January 1, 2014, using PubMed as a search engine.

  3. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical toxicology control material. 862.3280... Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and...

  4. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem. PMID:24165457

  5. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  6. Couples Counseling in Alzheimer's Disease: Additional Clinical Findings from a Novel Intervention Study.

    PubMed

    Auclair, Ursula; Epstein, Cynthia; Mittelman, Mary

    2009-04-01

    This article describes the clinical findings of a study designed to assess the benefit of counseling for couples, one of whom is in the early stage of Alzheimer's disease (AD). We previously reported our findings based on the first 12 couples that enrolled in the study. Based on the treatment of 30 additional couples, we have refined our treatment strategy to include concepts of Gestalt Therapy and Transactional Analysis and identified prevalent issues of concern to this cohort. The study design has remained as described in the earlier article (Epstein et al., 2006), and has proven to be appropriate to meet the goals of this intervention as indicated by our clinical experience and feedback from the participating couples. Case vignettes demonstrate how to conduct the sessions so that the experience of each member of the dyad is validated, while acknowledging the differential impact of the disease on them. PMID:19865591

  7. [Oral candidiasis: clinical features and control].

    PubMed

    Yamamoto, Tetsuya

    2010-10-01

    Candidiasis is the most commonly encountered fungal infection, and oral candidiasis is often observed as a local opportunistic infection. Oral candidiasis is clinically divided into three types: acute forms, chronic forms, and Candida-associated lesions. Candida adhesion and multiplication are largely regulated by the local and systemic factors of the host. The local factors include impairment of the oral mucosal integrity, which is usually impaired by hyposalivation, anticancer drugs/radiation for head and neck cancers, denture wearing, a decrease in the oral bacterial population, and poor oral hygiene. Among Candida species, oral candidiasis is mostly caused by Candida albicans (C. albicans), C. glabrata, or C. tropicalis. Oral Candida induces a variety of symptoms, such as oral mucosal inflammation manifesting as an uncomfortable feeling, pain, erythema, erosion, taste abnormalities, and hyperplasia of the oral mucosa. Candida overgrowth in the oral cavity may disseminate to distant organs. Therefore, in order to avoid the sequelae of systemic candidiasis, oral candidiasis should be rapidly controlled. Oral candidiasis is usually treated by the local application of antifungal drugs. However, oral candidiasis occasionally escapes the control of such local treatment due to the development of multi-drug resistant Candida strains and species or due to the suppression of salivation or cellular immune activity. When drug-resistant strains are suspected as the pathogens and when the host is generally compromised, the oral administration of combinations of antifungal drugs, enhancement of cellular immune activity, and improvement of the nutritional condition are recommended.

  8. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  9. Additional technician tasks and turnaround time in the clinical Stat laboratory

    PubMed Central

    Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Lillo, Rosa; Leiva-Salinas, Carlos

    2016-01-01

    Introduction Many additional tasks in the Stat laboratory (SL) increase the workload. It is necessary to control them because they can affect the service provided by the laboratory. Our aim is to calculate these tasks, study their evolution over a 10 year period, and compare turnaround times (TAT) in summer period to the rest of the year. Materials and methods Additional tasks were classified as “additional test request” and “additional sample”. We collected those incidences from the laboratory information system (LIS), and calculated their evolution over time. We also calculated the monthly TAT for troponin for Emergency department (ED) patients, as the difference between the verification and LIS registration time. A median time of 30 minutes was our indicator target. TAT results and tests workload in summer were compared to the rest of the year. Results Over a 10-year period, the technologists in the SL performed 51,385 additional tasks, a median of 475 per month. The workload was significantly higher during the summer (45,496 tests) than the rest of the year (44,555 tests) (P = 0.019). The troponin TAT did not show this variation between summer and the rest of the year, complying always with our 30 minutes indicator target. Conclusion The technicians accomplished a significant number of additional tasks, and the workload kept increasing over the period of 10 years. That did not affect the TAT results. PMID:27346970

  10. Use of generalised additive models to categorise continuous variables in clinical prediction

    PubMed Central

    2013-01-01

    Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

  11. Analytical optimal controls for the state constrained addition and removal of cryoprotective agents

    PubMed Central

    Chicone, Carmen C.; Critser, John K.

    2014-01-01

    Cryobiology is a field with enormous scientific, financial and even cultural impact. Successful cryopreservation of cells and tissues depends on the equilibration of these materials with high concentrations of permeating chemicals (CPAs) such as glycerol or 1,2 propylene glycol. Because cells and tissues are exposed to highly anisosmotic conditions, the resulting gradients cause large volume fluctuations that have been shown to damage cells and tissues. On the other hand, there is evidence that toxicity to these high levels of chemicals is time dependent, and therefore it is ideal to minimize exposure time as well. Because solute and solvent flux is governed by a system of ordinary differential equations, CPA addition and removal from cells is an ideal context for the application of optimal control theory. Recently, we presented a mathematical synthesis of the optimal controls for the ODE system commonly used in cryobiology in the absence of state constraints and showed that controls defined by this synthesis were optimal. Here we define the appropriate model, analytically extend the previous theory to one encompassing state constraints, and as an example apply this to the critical and clinically important cell type of human oocytes, where current methodologies are either difficult to implement or have very limited success rates. We show that an enormous increase in equilibration efficiency can be achieved under the new protocols when compared to classic protocols, potentially allowing a greatly increased survival rate for human oocytes, and pointing to a direction for the cryopreservation of many other cell types. PMID:22527943

  12. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  13. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  14. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  15. Detection of interleukin-2 in addition to interferon-gamma discriminates active tuberculosis patients, latently infected individuals, and controls.

    PubMed

    Biselli, R; Mariotti, S; Sargentini, V; Sauzullo, I; Lastilla, M; Mengoni, F; Vanini, V; Girardi, E; Goletti, D; D' Amelio, R; Nisini, R

    2010-08-01

    Effective control of tuberculosis (TB) includes discrimination of subjects with active TB from individuals with latent TB infection (LTBI). As distinct interferon (IFN)-gamma and interleukin (IL)-2 profiles of antigen-specific T-cells have been associated with different clinical stages and antigen loads in several viral and bacterial diseases, we analysed these cytokines in TB using a modified QuantiFERON-TB Gold In Tube test. Detection of IL-2 in addition to IFN-gamma distinguishes not only Mycobacterium tuberculosis-infected subjects from healthy controls, but also individuals with LTBI from active TB patients. This may help to improve diagnostic tests for TB.

  16. Influence of an alloy addition on the physical and clinical behaviour of glass ionomer cement

    NASA Astrophysics Data System (ADS)

    Abour, Mohamed Abour Bashir

    These in vitro studies compared the various properties of an experimental high powder liquid content glass ionomer cement (EXPT) with those of a metal addition GIC (Hi-Dense) and disperse phase amalgam (Dispersalloy). Bi-axial, four point flexural and compressive tests were used to evaluate strength. Six groups of ten specimens were constructed for each test for each material and allowed to set in an oven at 37°C for 60 minutes. Specimens were stored in distilled water at 37°C until testing at one day, one week, one, three, six months and year. It was found that the strength of Hi-Dense increased and then maintained over extended time, whereas the strength of EXPT showed a declined at 3 months. The bond strengths of the materials to both enamel and dentine were also evaluated. Ten groups of ten teeth, five for each surface for each glass ionomer materials, were prepared. Teeth were aligned leaving the enamel and dentine surfaces exposed. The mixed material was condensed into a cylinder placed on the appropriate surface. These specimens were also stored in distilled water at 37°C. It was found that Hi-Dense had a higher bond strength to enamel that increased with time. The bond strength to dentine was maintained over the test period. The erosion rate of the materials was evaluated using the lactic acid erosion test. Three groups of six specimens for each material were constructed and tested after one hour, one day and at six months. Each specimen was subjected to an impinging jet of lactic acid solution. The erosion rate was determined by weight loss and dimensional change. It was found that Hi-Dense had a high erosion resistance which was slightly better than the experimental material. The microleakage, around restorations prepared, using the glass ionomer materials, was evaluated after cyclical loading the restoration-tooth complex. It was found that there was less leakage around Hi-Dense than EXPT at both the cervical and occlusal margins. In a clinical

  17. Selecting control interventions for clinical outcome studies.

    PubMed

    Barkauskas, Violet H; Lusk, Sally L; Eakin, Brenda L

    2005-04-01

    In the current research environment the design and management of control groups is becoming more complex. The selection of a control group design is dependent on study goals, presence and quality of existing interventions, urgency of the problem or issue being addressed by the intervention, and factors related to the study site. The purpose of the presentation is to identify various approaches to the design of control groups in experimental studies and to identify their strengths, limitations, and applications. A case study exemplifies the issues associated with control group selection and design.

  18. Analysis of Time to Event Outcomes in Randomized Controlled Trials by Generalized Additive Models

    PubMed Central

    Argyropoulos, Christos; Unruh, Mark L.

    2015-01-01

    Background Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking. Methods By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM) can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated) and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population. Findings PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect) but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data. Conclusions By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial

  19. Additional follow-up telephone counselling and initial smoking relapse: a longitudinal, controlled study

    PubMed Central

    Wu, Lei; He, Yao; Jiang, Bin; Zuo, Fang; Liu, Qinghui; Zhang, Li; Zhou, Changxi

    2016-01-01

    Objectives Smoking cessation services can help smokers to quit; however, many smoking relapse cases occur over time. Initial relapse prevention should play an important role in achieving the goal of long-term smoking cessation. Several studies have focused on the effect of extended telephone support in relapse prevention, but the conclusions remain conflicting. Design and setting From October 2008 to August 2013, a longitudinal, controlled study was performed in a large general hospital of Beijing. Participants The smokers who sought treatment at our smoking cessation clinic were non-randomised and divided into 2 groups: face-to-face individual counselling group (FC group), and face-to-face individual counselling plus telephone follow-up counselling group (FCF group). No pharmacotherapy was offered. Outcomes The timing of initial smoking relapse was compared between FC and FCF groups. Predictors of initial relapse were investigated during the first 180 days, using the Cox proportional hazards model. Results Of 547 eligible male smokers who volunteered to participate, 457 participants (117 in FC group and 340 in FCF group) achieved at least 24 h abstinence. The majority of the lapse episodes occurred during the first 2 weeks after the quit date. Smokers who did not receive the follow-up telephone counselling (FC group) tended to relapse to smoking earlier than those smokers who received the additional follow-up telephone counselling (FCF group), and the log-rank test was statistically significant (p=0.003). A Cox regression model showed that, in the FCF group, being married, and having a lower Fagerström test score, normal body mass index and doctor-diagnosed tobacco-related chronic diseases, were significantly independent protective predictors of smoking relapse. Conclusions Within the limitations of this study, it can be concluded that additional follow-up telephone counselling might be an effective strategy in preventing relapse. Further research is still

  20. Proper use of sludge-control additives in residential heating oil systems

    SciTech Connect

    Tatnall, R.E.

    1995-04-01

    Discussed are various aspects of heating oil `sludge`: How it forms, typical problems it causes, how sludge-control additives work, what should be expected of them, and what happens in a contaminated system when such additives are used. Test results from laboratory and field experiments demonstrate that performance of commercially available additives varies greatly. The concept of `end-of-the-line` treatment is described and compared with bulk fuel treatment. A procedure is described whereby a retailer can test additives himself, and thus determine just what those additives will or will not do for his business. Finally, the economics of an effective treatment program are outlined.

  1. Clinical effect of additional electroacupuncture on thoracolumbar intervertebral disc herniation in 80 paraplegic dogs.

    PubMed

    Han, Hyun-Jung; Yoon, Hun-Young; Kim, Joon-Young; Jang, Ha-Young; Lee, Bora; Choi, Seok Hwa; Jeong, Soon-Wuk

    2010-01-01

    The clinical efficacy of electroacupuncture and acupuncture in combination with medication for the treatment of thoracolumbar intervertebral disc herniation was investigated in paraplegic dogs with intact deep pain perception. To evaluate the additional effect of electroacupuncture, dogs treated with conventional medicines alone were compared to dogs treated with electroacupuncture and acupuncture and conventional medicine. Medical records of 80 dogs were reviewed for this investigation and classified into two groups undergoing different treatment methods: (1) treatment with conventional medicine alone (Group C, n = 37) and (2) treatment with conventional medicine combined with electroacupuncture and acupuncture (Group CE, n = 43). Prednisone was the conventional medicine and electroacupuncture was applied at GV07 and GV02-1 at 0.5-2.5 mV, mixed Hz of 2 and 15 Hz for 25-30 min. Acupuncture was performed locally at urinary bladder meridian points near the lesion, and bilaterally distantly at GB30, GB34, and ST36. Treatment efficacy was evaluated by post-operative neurologic function, ambulation, relapse, complication, and urinary function. Ambulation recovery was more prevalent in Group CE than Group C (p = 0.01) and recovery of ambulation and back pain relief time was shorter in Group CE compared to Group C (p = 0.011 and 0.001, respectively). Relapse rate was significantly lower in Group CE (p = 0.031). The results suggest that a combination of electroacupuncture and acupuncture with conventional medicine is more effective than conventional medicine alone in recovering ambulation, relieving back pain, and decreasing relapse. Electroacupuncture and acupuncture is thus a reasonable option for the treatment of intervertebral disc herniation in paraplegic dogs with intact deep pain perception. PMID:21061457

  2. SMARCE1, a rare cause of Coffin-Siris Syndrome: Clinical description of three additional cases.

    PubMed

    Zarate, Yuri A; Bhoj, Elizabeth; Kaylor, Julie; Li, Dong; Tsurusaki, Yoshinori; Miyake, Noriko; Matsumoto, Naomichi; Phadke, Shubha; Escobar, Luis; Irani, Afifa; Hakonarson, Hakon; Schrier Vergano, Samantha A

    2016-08-01

    Coffin-Siris syndrome (CSS, MIM 135900), is a well-described, multiple congenital anomaly syndrome characterized by coarse facial features, hypertrichosis, sparse scalp hair, and hypo/aplastic digital nails and phalanges, typically of the 5th digits. Mutations in the BAF (SWI/SNF)-complex subunits (SMARCA4, SMARCE1, SMARCB1, SMARCA2, ARID1B, and ARID1A) have been shown to cause not only CSS, but also related disorders including Nicolaides-Baraitser (MIM 601358) syndrome and ARID1B-intellectual disability syndrome (MIM 614562). At least 200 individuals with CSS have been found to have a mutation in the BAF pathway. However, to date, only three individuals with CSS have been reported to have pathogenic variants in SMARCE1. We report here three additional individuals with clinical features consistent with CSS and alterations in SMARCE1, one of which is novel. The probands all exhibited dysmorphic facial features, moderate developmental and cognitive delay, poor growth, and hypoplastic digital nails/phalanges, including digits not typically affected in the other genes associated with CSS. Two of the three probands had a variety of different organ system anomalies, including cardiac disease, genitourinary abnormalities, feeding difficulties, and vision abnormalities. The 3rd proband has not had further investigative studies. Although an increasing number of individuals are being diagnosed with disorders in the BAF pathway, SMARCE1 is the least common of these genes. This report doubles the number of probands with these mutations, and allows for better phenotypic information of this rare syndrome. © 2016 Wiley Periodicals, Inc. PMID:27264197

  3. Highly Diastereoselective Chelation-controlled Additions to α-Silyloxy Ketones

    PubMed Central

    Stanton, Gretchen R.; Koz, Gamze

    2011-01-01

    The polar Felkin-Anh, Cornforth, and Cram-chelation models predict that the addition of organometallic reagents to silyl–protected α–hydroxy ketones proceeds via a non-chelation pathway to give anti-diol addition products. This prediction has held true for the vast majority of additions reported in the literature and few methods for chelation-controlled additions of organometallic reagents to silyl–protected α–hydroxy ketones have been introduced. Herein, we present a general and highly diastereoselective method for the addition of dialkylzincs and (E)-di-, (E)-tri- and (Z)-disubstituted vinylzinc reagents to α-silyloxy ketones using alkyl zinc halide Lewis acids, RZnX, to give chelation-controlled products (dr ≥18:1). The compatibility of organozinc reagents with other functional groups makes this method potentially very useful in complex molecule synthesis. PMID:21534530

  4. Clinical governance and infection control in the United Kingdom.

    PubMed

    Masterson, R G; Teare, E L

    2001-01-01

    The recent organizational changes in the NHS have at their core the concept of clinical governance. Although initially poorly defined and understood this term has now taken on a clear identity, placing quality alongside fiscal probity and corporate governance at the top of NHS priorities. Integral to clinical governance are the basic elements of clear national standards for services and treatments that are to be locally delivered through assured, monitored, high quality healthcare. It is within this framework that workers in infection control must develop their own methods of applying clinical governance. This review explores the implications that the strategy of clinical governance holds for the speciality of infection control, emphasizing the benefits its active adoption can bring and highlighting the key relevance of clinical risk management in this setting. It illustrates clinical governance as a tool to engage colleagues on a multi-disciplinary front, most particularly the crucial link to senior Trust management. PMID:11281117

  5. Clinical governance and infection control in the United Kingdom.

    PubMed

    Masterson, R G; Teare, E L

    2001-01-01

    The recent organizational changes in the NHS have at their core the concept of clinical governance. Although initially poorly defined and understood this term has now taken on a clear identity, placing quality alongside fiscal probity and corporate governance at the top of NHS priorities. Integral to clinical governance are the basic elements of clear national standards for services and treatments that are to be locally delivered through assured, monitored, high quality healthcare. It is within this framework that workers in infection control must develop their own methods of applying clinical governance. This review explores the implications that the strategy of clinical governance holds for the speciality of infection control, emphasizing the benefits its active adoption can bring and highlighting the key relevance of clinical risk management in this setting. It illustrates clinical governance as a tool to engage colleagues on a multi-disciplinary front, most particularly the crucial link to senior Trust management.

  6. Bed Bugs: Clinical Relevance and Control Options

    PubMed Central

    Dwyer, Dominic E.; Peñas, Pablo F.; Russell, Richard C.

    2012-01-01

    Summary: Since the late 1990s, bed bugs of the species Cimex lectularius and Cimex hemipterus have undergone a worldwide resurgence. These bed bugs are blood-sucking insects that readily bite humans. Cutaneous reactions may occur and can start out as small macular lesions that can develop into distinctive wheals of around 5 cm in diameter, which are accompanied by intense itching. Occasionally, bullous eruptions may result. If bed bugs are numerous, the patient can present with widespread urticaria or eythematous rashes. Often, bites occur in lines along the limbs. Over 40 pathogens have been detected in bed bugs, but there is no definitive evidence that they transmit any disease-causing organisms to humans. Anemia may result when bed bugs are numerous, and their allergens can trigger asthmatic reactions. The misuse of chemicals and other technologies for controlling bed bugs has the potential to have a deleterious impact on human health, while the insect itself can be the cause of significant psychological trauma. The control of bed bugs is challenging and should encompass a multidisciplinary approach utilizing nonchemical means of control and the judicious use of insecticides. For accommodation providers, risk management procedures should be implemented to reduce the potential of bed bug infestations. PMID:22232375

  7. Comparison of metabolic control among diabetic subjects at two clinics.

    PubMed Central

    O'Connor, P J; Fragneto, R; Coulehan, J; Crabtree, B F

    1989-01-01

    A cross-sectional study was conducted to investigate whether glucose control in 20 non-insulin-dependent diabetic subjects seen at a remote rural clinic was comparable to control achieved in 66 diabetic subjects seen at the regional hospital clinic. Sampling was done to assure that study subjects were representative of all care-seeking, diagnosed diabetics in a well-defined Navajo community. The two groups of patients were comparable in terms of age, sex, and duration of diabetes from time of diagnosis. Compliance with care, hospitalization rates, and complication rates were similar in each group. Results showed no significant differences in glycemic control between the rural clinic (mean fasting plasma glucose = 177, mean random plasma glucose = 227) and the regional hospital clinic (mean fasting plasma glucose = 187, mean random plasma glucose = 249). The percentages of diabetics under "acceptable" control by American Diabetes Association guidelines was 40 percent at the rural clinic and 29 percent at the hospital clinic (P greater than .05). The authors conclude that adequacy of glycemic control in diabetics is not compromised by providing care at a remote rural clinic. PMID:2508176

  8. Clinical translation of controlled protein delivery systems for tissue engineering

    PubMed Central

    Spiller, Kara L.; Vunjak-Novakovic, Gordana

    2013-01-01

    Strategies that utilize controlled release of drugs and proteins for tissue engineering have enormous potential to regenerate damaged organs and tissues. The multiple advantages of controlled release strategies merit overcoming the significant challenges to translation, including high costs and long, difficult regulatory pathways. This review highlights the potential of controlled release of proteins for tissue engineering and regenerative medicine. We specifically discuss treatment modalities that have reached preclinical and clinical trials, with emphasis on controlled release systems for bone tissue engineering, the most advanced application with several products already in clinic. Possible strategies to address translational and regulatory concerns are also discussed. PMID:25787736

  9. Antagonistic control of a dual-input mammalian gene switch by food additives.

    PubMed

    Xie, Mingqi; Ye, Haifeng; Hamri, Ghislaine Charpin-El; Fussenegger, Martin

    2014-08-01

    Synthetic biology has significantly advanced the design of mammalian trigger-inducible transgene-control devices that are able to programme complex cellular behaviour. Fruit-based benzoate derivatives licensed as food additives, such as flavours (e.g. vanillate) and preservatives (e.g. benzoate), are a particularly attractive class of trigger compounds for orthogonal mammalian transgene control devices because of their innocuousness, physiological compatibility and simple oral administration. Capitalizing on the genetic componentry of the soil bacterium Comamonas testosteroni, which has evolved to catabolize a variety of aromatic compounds, we have designed different mammalian gene expression systems that could be induced and repressed by the food additives benzoate and vanillate. When implanting designer cells engineered for gene switch-driven expression of the human placental secreted alkaline phosphatase (SEAP) into mice, blood SEAP levels of treated animals directly correlated with a benzoate-enriched drinking programme. Additionally, the benzoate-/vanillate-responsive device was compatible with other transgene control systems and could be assembled into higher-order control networks providing expression dynamics reminiscent of a lap-timing stopwatch. Designer gene switches using licensed food additives as trigger compounds to achieve antagonistic dual-input expression profiles and provide novel control topologies and regulation dynamics may advance future gene- and cell-based therapies.

  10. Antagonistic control of a dual-input mammalian gene switch by food additives

    PubMed Central

    Xie, Mingqi; Ye, Haifeng; Hamri, Ghislaine Charpin-El; Fussenegger, Martin

    2014-01-01

    Synthetic biology has significantly advanced the design of mammalian trigger-inducible transgene-control devices that are able to programme complex cellular behaviour. Fruit-based benzoate derivatives licensed as food additives, such as flavours (e.g. vanillate) and preservatives (e.g. benzoate), are a particularly attractive class of trigger compounds for orthogonal mammalian transgene control devices because of their innocuousness, physiological compatibility and simple oral administration. Capitalizing on the genetic componentry of the soil bacterium Comamonas testosteroni, which has evolved to catabolize a variety of aromatic compounds, we have designed different mammalian gene expression systems that could be induced and repressed by the food additives benzoate and vanillate. When implanting designer cells engineered for gene switch-driven expression of the human placental secreted alkaline phosphatase (SEAP) into mice, blood SEAP levels of treated animals directly correlated with a benzoate-enriched drinking programme. Additionally, the benzoate-/vanillate-responsive device was compatible with other transgene control systems and could be assembled into higher-order control networks providing expression dynamics reminiscent of a lap-timing stopwatch. Designer gene switches using licensed food additives as trigger compounds to achieve antagonistic dual-input expression profiles and provide novel control topologies and regulation dynamics may advance future gene- and cell-based therapies. PMID:25030908

  11. Control of terahertz emission in photoconductive antennas through an additional optical continuous wave.

    PubMed

    Bockelt, A; Palací, J; Vidal, B

    2013-08-15

    The manipulation of the operating conditions of photoconductive antennas by means of an additional continuous wave (CW) is reported. It is used to control a fiber-based terahertz (THz) time-domain-spectroscopy system at telecom wavelengths. The injection of an optical CW into the transmitter allows the control of the THz amplitude without causing major degradation to the system performance. This, for instance, can be exploited to perform modulation of the THz signal. PMID:24104665

  12. Torsional Control of Stereoselectivities in Electrophilic Additions and Cycloadditions to Alkenes

    PubMed Central

    Wang, Hao; Houk, K. N.

    2013-01-01

    Torsional effects control the π-facial stereoselectivities of a variety of synthetically important organic reactions. This review surveys theoretical calculations that have led to the understanding of the influence of the torsional effects on several types of stereoselective organic reactions, especially electrophilic additions and cycloadditions to alkenes. PMID:24409340

  13. Control of dynamical localization by an additional quantum degree of freedom

    NASA Astrophysics Data System (ADS)

    Riedel, K.; Törmä, P.; Savichev, V.; Schleich, W. P.

    1999-01-01

    We identify a parameter that controls the localization length in a driven quantum system. This parameter results from an additional quantum degree of freedom. The center-of-mass motion of a two-level ion stored in a Paul trap and interacting with a standing-wave laser field exhibits this phenomenon. We also discuss the influence of spontaneous emission.

  14. 74. SAC control center addition sect 9top three floors, first ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    74. SAC control center addition sect 9-top three floors, first floor plan, drawing number AS-BLT.AW30-02-03, dated May, 1958 - Offutt Air Force Base, Strategic Air Command Headquarters & Command Center, Headquarters Building, 901 SAC Boulevard, Bellevue, Sarpy County, NE

  15. 40 CFR 52.1163 - Additional control measures for East Boston.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 4 2013-07-01 2013-07-01 false Additional control measures for East Boston. 52.1163 Section 52.1163 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... spaces at Logan Airport and increased parking charges at remaining spaces; (5) Construction of...

  16. Chill water additive controls transfer of Salmonella and Campylobacter by improved chlorine efficacy

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In earlier work, we showed that a proprietary additive (T-128) maintains chlorine activity in the presence of organic material such as broiler parts. T-128 improves the efficacy of chlorine to control transfer of Campylobacter and Salmonella from inoculated wings to un-inoculated wings during immer...

  17. Clinical infection control in gene therapy: a multidisciplinary conference.

    PubMed

    Evans, M E; Jordan, C T; Chang, S M; Conrad, C; Gerberding, J L; Kaufman, H L; Mayhall, C G; Nolta, J A; Pilaro, A M; Sullivan, S; Weber, D J; Wivel, N A

    2000-10-01

    Gene therapy is being studied for the treatment of a variety of acquired and inherited disorders. Retroviruses, adenoviruses, poxviruses, adeno-associated viruses, herpesviruses, and others are being engineered to transfer genes into humans. Treatment protocols using recombinant viruses are being introduced into clinical settings. Infection control professionals will be involved in reviewing the safety of these agents in their clinics and hospitals. To date, only a limited number of articles have been written on infection control in gene therapy, and no widely available recommendations exist from federal or private organizations to guide infection control professionals. The goals of the conference were to provide a forum where gene therapy experts could share their perspectives and experience with infection control in gene therapy and to provide an opportunity for newcomers to the field to learn about issues specific to infection control in gene therapy. Recommendations for infection control in gene therapy were proposed.

  18. Cognitive control in alcohol use disorder: deficits and clinical relevance

    PubMed Central

    Wilcox, Claire E.; Dekonenko, Charlene J.; Mayer, Andrew R.; Bogenschutz, Michael P.; Turner, Jessica A.

    2014-01-01

    Cognitive control refers to the internal representation, maintenance, and updating of context information in the service of exerting control over thoughts and behavior. Deficits in cognitive control likely contribute to difficulty in maintaining abstinence in individuals with alcohol use disorders (AUD). In this article, we define three cognitive control processes in detail (response inhibition, distractor interference control, and working memory), review the tasks measuring performance in these areas, and summarize the brain networks involved in carrying out these processes. Next, we review evidence of deficits in these processes in AUD, including both metrics of task performance and functional neuroimaging. Finally, we explore the clinical relevance of these deficits by identifying predictors of clinical outcome and markers that appear to change (improve) with treatment. We observe that individuals with AUD experience deficits in some, but not all, metrics of cognitive control. Deficits in cognitive control may predict clinical outcome in AUD, but more work is necessary to replicate findings. It is likely that performance on tasks requiring cognitive control improves with abstinence, and with some psychosocial and medication treatments. Future work should clarify which aspects of cognitive control are most important to target during treatment of AUD. PMID:24361772

  19. Participants’ perception of pharmaceutical clinical research: a cross-sectional controlled study

    PubMed Central

    González-Saldivar, Gerardo; Rodríguez-Gutiérrez, René; Viramontes-Madrid, José Luis; Salcido-Montenegro, Alejandro; Carlos-Reyna, Kevin Erick Gabriel; Treviño-Alvarez, Andrés Marcelo; Álvarez-Villalobos, Neri Alejandro; González-González, José Gerardo

    2016-01-01

    Background There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. Methods To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. Results Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. Conclusion Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions. PMID:27199549

  20. The aspartame story: a model for the clinical testing of a food additive.

    PubMed

    Stegink, L D

    1987-07-01

    Toxicology is based on the premise that all compounds are toxic at some dose. Thus, it is not surprising that very large doses of aspartame (or its components--aspartate, phenylalanine, and methanol) produce deleterious effects in sensitive animal species. The critical question is whether aspartame ingestion is potentially harmful to humans at normal use and potential abuse levels. This paper reviews clinical studies testing the effects of various doses of aspartame upon blood levels of aspartate, phenylalanine, and methanol. These studies demonstrate that blood levels of these compounds are well below levels associated with adverse effects in sensitive animal species.

  1. A Simple and Inexpensive Device for Slow, Controlled Addition of a Solution to a Reaction Mixture

    NASA Astrophysics Data System (ADS)

    Osvath, Peter

    1995-07-01

    A number of reactions require the slow and controlled addition of a solution containing one reagent to another. Attempting to control the flow rate over a number of hours using a conventional constant pressure addition funnel is a frustrating exercise; commercially available constant volume addition funnels are expensive and must be adjusted by trial and error each time a reaction is carried out. The use of an (expensive) peristaltic pump or syringe pump overcomes these problems but can introduce other complications. We have recently had occasion to carry out the synthesis of thioether macrocycles and cages requiring the slow and controlled addition of DMF solutions of (offensively odoriferous) thiols or (air-sensitive) thiolates to a reactant solution under nitrogen(1), Although the use of a syringe pump was called for, there are obvious difficulties associated with purging the solution and assembling such an apparatus under nitrogen, and we report a simple and inexpensive solution. A Male Luer Lock tip (recovered from a broken syringe) was sweated onto the flattened tip of a pressure-equalizing addition funnel and a syringe needle was attached. Judicious selection of needle length, bore size, and reactant volume can be used to control the addition time simply and reproducibly. With a 250-mL funnel, the flow rate changes by <25% from the beginning to the end of the addition. (In fact, a reduction in the rate of addition may even be advantageous as the reaction proceeds, the reagent in the receiving flask is consumed, its concentration drops, and the rate of reaction will decrease). A piece of fine Teflon tubing of appropriate length attached to the needle can be used to reduce the flow rate even further, but this is only necessary for very slow rates of addition. For example, the time of addition of 200 mL, of an ethanolic solution could be varied from approximately 5 minutes (150mm/17 gauge) to approximately 5 h (200mm/22 gauge), and once the addition time for a

  2. A clinical data repository enhances hospital infection control.

    PubMed Central

    Samore, M.; Lichtenberg, D.; Saubermann, L.; Kawachi, C.; Carmeli, Y.

    1997-01-01

    We describe the benefits of a relational database of hospital clinical data (Clinical Data Repository; CDR) for an infection control program. The CDR consists of > 40 Sybase tables, and is directly accessible for ad hoc queries by members of the infection control unit who have been granted privileges for access by the Information Systems Department. The data elements and functional requirements most useful for surveillance of nosocomial infections, antibiotic use, and resistant organisms are characterized. Specific applications of the CDR are presented, including the use of automated definitions of nosocomial infection, graphical monitoring of resistant organisms with quality control limits, and prospective detection of inappropriate antibiotic use. Hospital surveillance and quality improvement activities are significantly benefited by the availability of a querable set of tables containing diverse clinical data. PMID:9357588

  3. Assessing clinical outcomes of patients with acute calculous cholecystitis in addition to the Tokyo grading: a retrospective study.

    PubMed

    Cheng, Wei-Chun; Chiu, Yen-Cheng; Chuang, Chiao-Hsiung; Chen, Chiung-Yu

    2014-09-01

    The management of acute cholecystitis is still based on clinical expertise. This study aims to investigate whether the outcome of acute cholecystitis can be related to the severity criteria of the Tokyo guidelines and additional clinical comorbidities. A total of 103 patients with acute cholecystitis were retrospectively enrolled and their medical records were reviewed. They were all classified according to therapeutic modality, including early cholecystectomy and antibiotic treatment with or without percutaneous cholecystostomy. The impact of the Tokyo guidelines and the presence of comorbidities on clinical outcome were assessed by univariate and multivariate regression analyses. According to Tokyo severity grading, 48 patients were Grade I, 31 patients were Grade II, and 24 patients were Grade III. The Grade III patients had a longer hospital stay than Grade II and Grade I patients (15.2 days, 9.2 days, and 7.3 days, respectively, p < 0.05). According to multivariate analysis, patients with Grade III Tokyo severity, higher Charlson's Comorbidity Score, and encountering complications had a longer hospital stay. Based on treatment modality, surgeons selected the patients with less severity and fewer comorbidities for cholecystectomy, and these patients had a shorter hospital stay. In addition to the grading of the Tokyo guidelines, comorbidities had an additional impact on clinical outcomes and should be an important consideration when making therapeutic decisions.

  4. Controlling a toxic shock of pentachlorophenol (PCP) to anaerobic digestion using activated carbon addition.

    PubMed

    Xiao, Yeyuan; De Araujo, Cecilia; Sze, Chun Chau; Stuckey, David C

    2015-04-01

    Several powdered and granular activated carbons (PACs and GACs) were tested for adsorption of pentachlorophenol (PCP) in bench-scale anaerobic digestion reactors to control the toxicity of PCP to acetoclastic methanogenesis. Results showed that the adsorption capacities of PAC were reduced by 21-54%, depending on the PAC addition time, in the presence of the methanogenic sludge compared to the controls without sludge. As a preventive measure, PAC at a low dose of 20% (mass ratio to the VSS) added 24 h prior to, or simultaneously with, the addition of PCP could completely eliminate the toxic effects of PCP. At the same dose, PAC also enabled methanogenesis to recover immediately after the sludge had been exposed to PCP for 24h. GAC was not effective in enabling the recovery of methanogenesis due to its slow adsorption kinetics; however, at a dose of 80% it could partially ameliorate the toxic shock of PCP. PMID:25665874

  5. Hierarchical tailoring of strut architecture to control permeability of additive manufactured titanium implants.

    PubMed

    Zhang, Z; Jones, D; Yue, S; Lee, P D; Jones, J R; Sutcliffe, C J; Jones, E

    2013-10-01

    Porous titanium implants are a common choice for bone augmentation. Implants for spinal fusion and repair of non-union fractures must encourage blood flow after implantation so that there is sufficient cell migration, nutrient and growth factor transport to stimulate bone ingrowth. Additive manufacturing techniques allow a large number of pore network designs. This study investigates how the design factors offered by selective laser melting technique can be used to alter the implant architecture on multiple length scales to control and even tailor the flow. Permeability is a convenient parameter that characterises flow, correlating to structure openness (interconnectivity and pore window size), tortuosity and hence flow shear rates. Using experimentally validated computational simulations, we demonstrate how additive manufacturing can be used to tailor implant properties by controlling surface roughness at a microstructual level (microns), and by altering the strut ordering and density at a mesoscopic level (millimetre). PMID:23910314

  6. Low-boiling-point solvent additives can also enable morphological control in polymer solar cells

    SciTech Connect

    Mahadevapuram, Rakesh C.; Carr, John A.; Chen, Yuqing; Bose, Sayantan; Nalwa, Kanwar S.; Petrich, Jacob W.; Chaudhary, Sumit

    2013-11-02

    Processing organic photovoltaic (OPV) blend solutions with high-boiling-point solvent additives has recently been used for morphological control in bulk-heterojunction OPV cells. Here we show that even low-boiling-point solvents can be effective additives. When P3HT:PCBM OPV cells were processed with a low-boiling-point solvent tetrahydrafuran as an additive in parent solvent o-dichlorobenzene, charge extraction increased leading to fill factors as high as 69.5%, without low work-function cathodes, electrode buffer layers or thermal treatment. This was attributed to PCBM demixing from P3HT domains and better vertical phase separation, as indicated by photoluminescence lifetimes, hole mobilities, and shunt leakage currents. Dependence on solvent parameters and applicability beyond P3HT system was also investigated. (C) 2013 Elsevier B.V. All rights reserved.

  7. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  8. Dipeptidyl peptidase-4 inhibitors and the ischemic heart: Additional benefits beyond glycemic control.

    PubMed

    Chattipakorn, Nipon; Apaijai, Nattayaporn; Chattipakorn, Siriporn C

    2016-01-01

    Obese-insulin resistance and type 2 diabetes mellitus (T2DM) have become global health problems, and they are both associated with a higher risk of ischemic heart disease. Although reperfusion therapy is the treatment to increase blood supply to the ischemic myocardium, this intervention potentially causes cardiac tissue damage and instigates arrhythmias, processes known as reperfusion injury. Dipeptidyl peptidase 4 (DPP-4) inhibitors are glycemic control drugs commonly used in T2DM patients. Growing evidence from basic and clinical studies demonstrates that a DPP-4 inhibitor could exert cardioprotection and improve left ventricular function by reducing oxidative stress, apoptosis, and increasing reperfusion injury salvage kinase (RISK) activity. However, recent reports also showed potentially adverse cardiac events due to the use of a DPP-4 inhibitor. To investigate this disparity, future large clinical trials are essential in verifying whether DPP-4 inhibitors are beneficial beyond their glycemic control particularly for the ischemic heart in obese-insulin resistant subjects and T2DM patients.

  9. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial. PMID:16144669

  10. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  11. ADDITIONAL DEMOGRAPHIC AND CLINICAL EVIDENCES ON THE RELEVANCE OF THE SYSTEMIC THERAPY IN ALCOHOL DEPENDENCE.

    PubMed

    Alexinschi, Ovidiu; Chirita, Roxana; Manuela, Padurariu; Ciobica, Alin; Dobrin, Romeo; Petrariu, F D; Timofte, Daniel; Chirita, Vasile

    2015-01-01

    The modern treatment for alcohol dependence is still problematic, in many cases with the costs exceeding benefits. In these conditions a new management approach was developed lately, known as the systemic therapy. In this way, the crystallization and practical transposition of this new treatment approach is represented by the Clubs of Alcoholics in Treatment. These clubs are in fact a form of psycho-social intervention consisting of multi-family communities in order to maintain long-term abstinence from alcohol and to change their lifestyle and behavior. Thus, in the present paper we were interested in understanding the demographics of this systemic theory and how these aspects are influencing the final results of the therapy, as well as studying/confirming how relevant is this systemic approach on the management of alcohol dependence. Our results presented in this report bring additional evidences for the superiority of the systemic, multi-family approach of alcohol-related problems, as complemented to the standard medicinal therapy. Moreover, the data collected from patients in this study might suggest that patients with a higher educational level and therefore better capacity of understanding the information, with family support, and also with a better occupational insertion, have accepted to follow The Clubs of Alcoholics in Treatment program, with a subsequently better evolution. PMID:26793858

  12. Compliance and control characteristics of an additive manufactured-flexure stage

    NASA Astrophysics Data System (ADS)

    Lee, ChaBum; Tarbutton, Joshua A.

    2015-04-01

    This paper presents a compliance and positioning control characteristics of additive manufactured-nanopositioning system consisted of the flexure mechanism and voice coil motor (VCM). The double compound notch type flexure stage was designed to utilize the elastic deformation of two symmetrical four-bar mechanisms to provide a millimeter-level working range. Additive manufacturing (AM) process, stereolithography, was used to fabricate the flexure stage. The AM stage was inspected by using 3D X-ray computerized tomography scanner: air-voids and shape irregularity. The compliance, open-loop resonance peak, and damping ratio of the AM stage were measured 0.317 mm/N, 80 Hz, and 0.19, respectively. The AM stage was proportional-integral-derivative positioning feedback-controlled and the capacitive type sensor was used to measure the displacement. As a result, the AM flexure mechanism was successfully 25 nm positioning controlled within 500 μm range. The resonance peak was found approximately at 280 Hz in closed-loop. This research showed that the AM flexure mechanism and the VCM can provide millimeter range with high precision and can be a good alternative to an expensive metal-based flexure mechanism and piezoelectric transducer.

  13. Compliance and control characteristics of an additive manufactured-flexure stage

    SciTech Connect

    Lee, ChaBum; Tarbutton, Joshua A.

    2015-04-15

    This paper presents a compliance and positioning control characteristics of additive manufactured-nanopositioning system consisted of the flexure mechanism and voice coil motor (VCM). The double compound notch type flexure stage was designed to utilize the elastic deformation of two symmetrical four-bar mechanisms to provide a millimeter-level working range. Additive manufacturing (AM) process, stereolithography, was used to fabricate the flexure stage. The AM stage was inspected by using 3D X-ray computerized tomography scanner: air-voids and shape irregularity. The compliance, open-loop resonance peak, and damping ratio of the AM stage were measured 0.317 mm/N, 80 Hz, and 0.19, respectively. The AM stage was proportional-integral-derivative positioning feedback-controlled and the capacitive type sensor was used to measure the displacement. As a result, the AM flexure mechanism was successfully 25 nm positioning controlled within 500 μm range. The resonance peak was found approximately at 280 Hz in closed-loop. This research showed that the AM flexure mechanism and the VCM can provide millimeter range with high precision and can be a good alternative to an expensive metal-based flexure mechanism and piezoelectric transducer.

  14. Compliance and control characteristics of an additive manufactured-flexure stage.

    PubMed

    Lee, ChaBum; Tarbutton, Joshua A

    2015-04-01

    This paper presents a compliance and positioning control characteristics of additive manufactured-nanopositioning system consisted of the flexure mechanism and voice coil motor (VCM). The double compound notch type flexure stage was designed to utilize the elastic deformation of two symmetrical four-bar mechanisms to provide a millimeter-level working range. Additive manufacturing (AM) process, stereolithography, was used to fabricate the flexure stage. The AM stage was inspected by using 3D X-ray computerized tomography scanner: air-voids and shape irregularity. The compliance, open-loop resonance peak, and damping ratio of the AM stage were measured 0.317 mm/N, 80 Hz, and 0.19, respectively. The AM stage was proportional-integral-derivative positioning feedback-controlled and the capacitive type sensor was used to measure the displacement. As a result, the AM flexure mechanism was successfully 25 nm positioning controlled within 500 μm range. The resonance peak was found approximately at 280 Hz in closed-loop. This research showed that the AM flexure mechanism and the VCM can provide millimeter range with high precision and can be a good alternative to an expensive metal-based flexure mechanism and piezoelectric transducer. PMID:25933897

  15. [Critical role of clinical laboratories in hospital infection control].

    PubMed

    Yagi, Tetsuya

    2010-11-01

    The hospital infection control and prevention is recognized to be more and more important according to the advances in modern medical treatment and care. Clinical microbiology laboratory play critical roles in the hospital infection control as a member of infection control team (ICT). They are the first in a hospital to identify outbreak of MRSA in NICU and molecular epidemiological analysis of the isolates lead proper intervention of ICT to the concerned ward. From a viewpoint of infectious disease specialist, rapid and precise microbiological information is essential for the appropriate diagnosis and treatment of infectious diseases. Each medical technologist need to make efforts to understand the characteristics of the examinations for infectious diseases and send out information useful for clinical practices. In our hospital, with the participation of all members of medical technologists, rapid reporting system was developed for blood culture examinations, which greatly contribute to the appropriate treatment of bloodstream infections. Collaborations of clinical microbiology laboratory with other members of ICT realize high quality hospital infection control. They also need to be aware of themselves as good practitioners of infection control measures to prevent hospital infections.

  16. Multiplicative noise effects on electroconvection in controlling additive noise by a magnetic field

    NASA Astrophysics Data System (ADS)

    Huh, Jong-Hoon

    2015-12-01

    We report multiplicative noise-induced threshold shift of electroconvection (EC) in the presence of a magnetic field H . Controlling the thermal fluctuation (i.e., additive noise) of the rodlike molecules of nematic liquid crystals by H , the EC threshold is examined at various noise levels [characterized by their intensity and cutoff frequency (fc) ]. For a sufficiently strong H (i.e., ignorable additive noise), a modified noise sensitivity characterizing the shift problem is in good agreement with experimental results for colored as well as white noise (fc→∞ ) ; until now, there was a large deviation for (sufficiently) colored noises. The present study shows that H provides us with ideal conditions for studying the corresponding Carr-Helfrich theory considering pure multiplicative noise.

  17. Note: vibration reduction control of an atomic force microscope using an additional cantilever.

    PubMed

    Kim, Chulsoo; Jung, Jongkyu; Park, Kyihwan

    2011-11-01

    Since an atomic force microscope is used to measure sub-nanometer level precision, it is sensitive to external vibration. If the vibration can be measured by using an additional sensor, we can obtain the vibration-free signal by subtracting the vibration signal from the signal containing the vibration. To achieve a highly effective vibration rejection ratio, it is important to decide where to locate the additional sensor. This is because the vibration measured at the sensing position should have the same phase as that of the vibration in the signal. Vibration reduction control using this electrical sensing method is verified through time domain analysis and topology images of a standard grid sample.

  18. Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes

    PubMed Central

    2011-01-01

    Objective To characterize the types of control procedures used in controlled clinical trials of cervical spine manipulation and to evaluate the outcomes obtained by subjects in control groups so as to improve the quality of future clinical trials Methods A search of relevant clinical trials was performed in PubMed 1966-May 2010 with the following key words: "Chiropractic"[Mesh] OR "Manipulation, Spinal"[Mesh]) AND "Clinical Trial "[Publication Type]. Reference lists from these trials were searched for any additional trials. The reference lists of two prior studies, one review and one original study were also searched. Accepted reports were then rated for quality by 2 reviewers using the PEDro scale. Studies achieving a score of >50% were included for data extraction and analysis. Intra-group change scores on pain outcomes were obtained. For determining clinically important outcomes, a threshold of 20% improvement was used where continuous data were available; otherwise, an effect size of 0.30 was employed Results The PubMed search yielded 753 citations of which 13 were selected. Eight (8) other studies were identified by reviewing two systematic reviews and through reference searches. All studies scored >50% on the PEDro scale. There were 9 multi-session studies and 12 single-session studies. The most commonly used control procedure was "manual contact/no thrust". Four (4) studies used a placebo-control (patient blinded). For two of these studies with VAS data, the average change reported was 4.5 mm. For the other control procedures, variable results were obtained. No clinically important changes were reported in 57% of the paired comparisons, while, in 43% of these, changes which would be considered clinically important were obtained in the control groups. Only 15% of trials reported on post-intervention group registration. Conclusions Most control procedures in cervical manipulation trials result in small clinical changes, although larger changes are observed in

  19. Morphological control in polymer solar cells using low-boiling-point solvent additives

    NASA Astrophysics Data System (ADS)

    Mahadevapuram, Rakesh C.

    In the global search for clean, renewable energy sources, organic photovoltaics (OPVs) have recently been given much attention. Popular modern-day OPVs are made from solution-processible, carbon-based polymers (e.g. the model poly(3-hexylthiophene) that are intimately blended with fullerene derivatives (e.g. [6,6]-phenyl-C71-butyric acid methyl ester) to form what is known as the dispersed bulk-heterojunction (BHJ). This BHJ architecture has produced some of the most efficient OPVs to date, with reports closing in on 10% power conversion efficiency. To push efficiencies further into double digits, many groups have identified the BHJ nanomorphology---that is, the phase separations and grain sizes within the polymer: fullerene composite---as a key aspect in need of control and improvement. As a result, many methods, including thermal annealing, slow-drying (solvent) annealing, vapor annealing, and solvent additives, have been developed and studied to promote BHJ self-organization. Processing organic photovoltaic (OPV) blend solutions with high-boiling-point solvent additives has recently been used for morphological control in BHJ OPV cells. Here we show that even low-boiling-point solvents can be effective additives. When P3HT:PCBM OPV cells were processed with a low-boiling-point solvent tetrahydrafuran as an additive in parent solvent o-dichlorobenzene, charge extraction increased leading to fill factors as high as 69.5%, without low work-function cathodes, electrode buffer layers or thermal treatment. This was attributed to PCBM demixing from P3HT domains and better vertical phase separation, as indicated by photoluminescence lifetimes, hole mobilities, and shunt leakage currents. Dependence on solvent parameters and applicability beyond P3HT system was also investigated.

  20. Analysis And Control Of Copper Plating Bath Additives And By-Products

    NASA Astrophysics Data System (ADS)

    Newton, Beverly; Kaiser, Edward

    2003-09-01

    New copper plating bath chemisties are being developed to meet the emerging need of plating copper into submicron features on semiconductor wafers. These chemistries are designed to provide a fast, efficient, fill for even the most challenging wafer terrain. It has been found that maintaining the concentration of the additives in these plating baths at certain levels is critical to the performance of the bath. Plating technology for semiconductor applications requires rigid bath control and disciplined methodology. Establishing correlations between what is found in the plated film and bath chemistry control parameters is fundamental in producing interconnects that are consistent and reliable. To establish these correlations, it is important to have a clear understanding of the chemical composition of the bath. It is theorized that the "suppressor" bath components help moderate the deposition rate of the copper fill and the "leveler" additives improve the topology of the copper overfill. Too much or too little of these components in the bath can be detrimental to the quality of the copper deposition and may result in "fill failure" leading to a higher than necessary scrap rate for the wafers. Indirect bath measurements, such as Cyclic Voltammetric Stripping (CVS), tell an incomplete story as these techniques only measures the combined effect of the additives and by-products on the plating quality. High Performance Liquid (HPLC) and Ion Chromatography are analytical techniques which provide important information on the concentration, chemical balance and trend measurement of major constituents such as additives, brighteners, boosters, stabilizers, carriers, levelers, inhibitors, accelerators, transition metals, metal complexes and contaminants in the plating bath. This information provides for improved device quality, reduced scrap rate and reduced costs of bath maintenance. This, however, is not the end of the story. In addition to additives, copper plating baths

  1. Addition of Dexamethasone and Buprenorphine to Bupivacaine Sciatic Nerve Block: A Randomized, Controlled Trial

    PubMed Central

    YaDeau, Jacques T.; Paroli, Leonardo; Fields, Kara G.; Kahn, Richard L.; LaSala, Vincent R.; Jules-Elysee, Kethy M.; Kim, David H.; Haskins, Stephen C.; Hedden, Jacob; Goon, Amanda; Roberts, Matthew M.; Levine, David S.

    2015-01-01

    Background and Objectives Sciatic nerve block provides analgesia after foot and ankle surgery, but block duration may be insufficient. We hypothesized that perineural dexamethasone and buprenorphine would reduce pain scores at 24 hours. Methods Ninety patients received ultrasound-guided sciatic (25 mL 0.25% bupivacaine) and adductor canal (10 mL 0.25% bupivacaine) blockade, with random assignment into 3 groups (30 patients per group): control blocks + intravenous dexamethasone (4 mg) (control); control blocks + intravenous buprenorphine (150 mcg) + intravenous dexamethasone (intravenous buprenorphine); nerve blocks containing buprenorphine + dexamethasone (perineural). Patients received mepivacaine neuraxial anesthesia and postoperative oxycodone / acetaminophen, meloxicam, pregabalin, and ondansetron. Patients and assessors were blinded to group assignment. The primary outcome was pain with movement at 24 hours. Results There was no difference in pain with movement at 24 hours (median score 0). However, the perineural group had longer block duration vs control (45.6 vs 30.0 hr). Perineural patients had lower scores for “worst pain” vs control (median 0 vs 2). Both intravenous buprenorphine and perineural groups were less likely to use opioids on the day after surgery, vs control (28.6%, 28.6%, 60.7%, respectively). Nausea after intravenous buprenorphine (but not perineural buprenorphine) was severe, frequent, and bothersome. Conclusions Pain scores were very low at 24 hours after surgery in the context of multimodal analgesia and were not improved by additives. However, perineural buprenorphine and dexamethasone prolonged block duration, reduced the worst pain experienced, and reduced opioid use. Intravenous buprenorphine caused troubling nausea and vomiting. Future research is needed to confirm and extend these observations. PMID:25974277

  2. Formulation and bioavailability of controlled release salbutamol sulphate tablets using natural additives.

    PubMed

    Nouh, A T; Abd El-Gawad, A H; Guda, T K

    2010-04-01

    Salbutamol sulphate granules and physical mixtures were prepared using mastic with various natural additives. The prepared granules and physical mixtures were examined using IR and DSC. The obtained results indicate that there is no interaction between salbutamol sulphate and the formulation ingredients used. The physical properties and release behavior of the formulated tablets prepared from granules and physical mixtures were evaluated and showed good physical properties. The rate of drug release from tablets prepared from granules was found to be lower than that prepared from physical mixtures at fixed mastic concentration and the same additive. The rate of drug release decreased with increased mastic concentration in formulated tablets. Pectin and sodium alginate allowed the best controlled release rate of the drug. On the basis of the results obtained from the controlled release studies, selected sulbutamol formulations were subjected to an in vivo comparison with commercial sulbutamol tablets. The pharmacokinetic parameters AUC(0-24), C(max), and T(max) of sulbutamol from the selected formulation were determined after administration of a single oral dose of 8 mg and compared statistically using an ANOVA test. There was no significant difference in the AUC(0-24). On the other hand, there was a significant difference in the C(max) and T(max) between the commercial and the formulated tablets. These results demonstrate that the formulated tablets extended the time of the drug effect.

  3. Low fluid leakoff cementing compositions and filtration control additive for cement

    SciTech Connect

    Forrest, G.T.

    1993-07-20

    A cementing composition is described, for cementing oil or gas wells penetrating subterranean formations, capable of forming a fluid slurry when mixed with water comprising: dry hydraulic cement; and a filtration control additive of from about 0.2 to 5.0 percent by weight, based upon dry hydraulic cement, of finely ground peanut hulls, wherein 10 percent or more of the finely ground peanut hulls is in the particle size range of less than 20 standard sieve mesh and greater than 500 standard sieve mesh. In a process for cementing a casing in an oil or gas well penetrating a subterranean formation wherein a cement slurry, formed by mixing water and hydraulic cement, is pumped down the well to flow upwardly between the casing and the subterranean formation, the improvement is described comprising: utilizing as a filtration control additive of from about 0.2 to 5.0 percent by weight, based upon dry hydraulic cement, of finely ground peanut hulls, and utilizing finely ground peanut hulls wherein 10 percent or more of the finely ground peanut hulls is in the particle size range of less than 20 standard sieve mesh and greater than 500 standard sieve mesh.

  4. Proteasome and thiol involvement in quality control of glycosylphosphatidylinositol anchor addition.

    PubMed Central

    Wilbourn, B; Nesbeth, D N; Wainwright, L J; Field, M C

    1998-01-01

    Improperly processed secretory proteins are degraded by a hydrolytic system that is associated with the endoplasmic reticulum (ER) and appears to involve re-export of lumenal proteins into the cytoplasm for ultimate degradation by the proteasome. The chimaeric protein hGHDAF28, which contains a crippled glycosylphosphatidylinositol (GPI) C-terminal signal peptide, is degraded by a pathway highly similar to that for other ER-retained proteins and is characterized by formation of disulphide-linked aggregates, failure to reach the Golgi complex and intracellular degradation with a half life of approximately 2 h. Here we show that N-acetyl-leucinal-leucinal-norleucinal, MG-132 and lactacystin, all inhibitors of the proteasome, protect hGHDAF28; hGHDAF28 is still proteolytically cleaved in the presence of lactacystin or MG-132, by the removal of approximately 2 kDa, but the truncated fragment is not processed further. We demonstrate that the ubiquitination system accelerates ER-degradation of hGHDAF28, but is not essential to the process. Overall, these findings indicate that GPI quality control is mediated by the cytoplasmic proteasome. We also show that the presence of a cysteine residue in the GPI signal of hGHDAF28 is required for retention and degradation, as mutation of this residue to serine results in secretion of the fusion protein, implicating thiol-mediated retention as a mechanism for quality control of some GPI signals. Removal of the cysteine also prevents inclusion of hGHDAF28 in disulphide-linked aggregates, indicating that aggregate formation is an additional retention mechanism for this class of protein. Therefore our data suggest that an unpaired terminal cysteine is the retention motif of the hGHDAF28 GPI-processing signal and that additional information may be required for efficient engagement of ER quality control systems by the majority of GPI signals which lack cysteine residues. PMID:9576858

  5. Ethical considerations in placebo-controlled randomised clinical trials

    PubMed Central

    2015-01-01

    Summary Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raised by Chen et al’s article ‘Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials’ and serves as an invitation for further submissions to BJPsych Open on ethics, research design and informed consent. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  6. A tuneable switch for controlling environmental degradation of bioplastics: addition of isothiazolinone to polyhydroxyalkanoates.

    PubMed

    Woolnough, Catherine Anne; Yee, Lachlan Hartley; Charlton, Timothy Stuart; Foster, Leslie John Ray

    2013-01-01

    Controlling the environmental degradation of polyhydroxybutyrate (PHB) and polyhydroxyvalerate (P(HB-co-HV)) bioplastics would expand the range of their potential applications. Combining PHB and P(HB-co-HV) films with the anti-fouling agent 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one (DCOI, <10% w/w) restricted microbial colonisation in soil, but did not significantly affect melting temperature or the tensile strength of films. DCOI films showed reduced biofouling and postponed the onset of weight loss by up to 100 days, a 10-fold increase compared to unmodified films where the microbial coverage was significant. In addition, the rate of PHA-DCOI weight loss, post-onset, reduced by about 150%; in contrast a recorded weight loss of only 0.05% per day for P(HB-co-HV) with a 10% DCOI loading was observed. This is in stark contrast to the unmodified PHB film, where a recorded weight loss of only 0.75% per day was made. The 'switch' that initiates film weight loss, and its subsequent reduced rate, depended on the DCOI loading to control biofouling. The control of biofouling and environmental degradation for these DCOI modified bioplastics increases their potential use in biodegradable applications.

  7. A tuneable switch for controlling environmental degradation of bioplastics: addition of isothiazolinone to polyhydroxyalkanoates.

    PubMed

    Woolnough, Catherine Anne; Yee, Lachlan Hartley; Charlton, Timothy Stuart; Foster, Leslie John Ray

    2013-01-01

    Controlling the environmental degradation of polyhydroxybutyrate (PHB) and polyhydroxyvalerate (P(HB-co-HV)) bioplastics would expand the range of their potential applications. Combining PHB and P(HB-co-HV) films with the anti-fouling agent 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one (DCOI, <10% w/w) restricted microbial colonisation in soil, but did not significantly affect melting temperature or the tensile strength of films. DCOI films showed reduced biofouling and postponed the onset of weight loss by up to 100 days, a 10-fold increase compared to unmodified films where the microbial coverage was significant. In addition, the rate of PHA-DCOI weight loss, post-onset, reduced by about 150%; in contrast a recorded weight loss of only 0.05% per day for P(HB-co-HV) with a 10% DCOI loading was observed. This is in stark contrast to the unmodified PHB film, where a recorded weight loss of only 0.75% per day was made. The 'switch' that initiates film weight loss, and its subsequent reduced rate, depended on the DCOI loading to control biofouling. The control of biofouling and environmental degradation for these DCOI modified bioplastics increases their potential use in biodegradable applications. PMID:24146779

  8. A Tuneable Switch for Controlling Environmental Degradation of Bioplastics: Addition of Isothiazolinone to Polyhydroxyalkanoates

    PubMed Central

    Woolnough, Catherine Anne; Yee, Lachlan Hartley; Charlton, Timothy Stuart; Foster, Leslie John Ray

    2013-01-01

    Controlling the environmental degradation of polyhydroxybutyrate (PHB) and polyhydroxyvalerate (P(HB-co-HV)) bioplastics would expand the range of their potential applications. Combining PHB and P(HB-co-HV) films with the anti-fouling agent 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one (DCOI, <10% w/w) restricted microbial colonisation in soil, but did not significantly affect melting temperature or the tensile strength of films. DCOI films showed reduced biofouling and postponed the onset of weight loss by up to 100 days, a 10-fold increase compared to unmodified films where the microbial coverage was significant. In addition, the rate of PHA-DCOI weight loss, post-onset, reduced by about 150%; in contrast a recorded weight loss of only 0.05% per day for P(HB-co-HV) with a 10% DCOI loading was observed. This is in stark contrast to the unmodified PHB film, where a recorded weight loss of only 0.75% per day was made. The ‘switch’ that initiates film weight loss, and its subsequent reduced rate, depended on the DCOI loading to control biofouling. The control of biofouling and environmental degradation for these DCOI modified bioplastics increases their potential use in biodegradable applications. PMID:24146779

  9. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. PMID:26523771

  10. Unhealthy Weight Control Practices: Culprits and Clinical Recommendations

    PubMed Central

    Ferraro, Zachary Michael; Patterson, Sean; Chaput, Jean-Philippe

    2015-01-01

    Preoccupation with weight status and a desire to lose weight appears common. Many individuals seek “magic bullet” approaches to weight loss and waive the risks of using these products. In this paper, we review the challenges of weight maintenance, highlight some unhealthy weight control practices, and discuss the futility and potential danger of unregulated weight control agents. Novel clinical strategies are discussed that health care providers may use to triage patients with obesity in an attempt to make ethical and personalized treatment decisions. PMID:25733947

  11. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety.

  12. Stereo- and Temporally Controlled Coordination Polymerization Triggered by Alternating Addition of a Lewis Acid and Base.

    PubMed

    Liu, Bo; Cui, Dongmei; Tang, Tao

    2016-09-19

    Significant progress has been made with regard to temporally controlled radical and ring-opening polymerizations, for example, by means of chemical reagents, light, and voltage, whereas quantitative switch coordination polymerization is still challenging. Herein, we report the temporally and stereocontrolled 3,4-polymerization of isoprene through allosterically regulating the active metal center by alternating addition of Lewis basic pyridine to "poison" the Lewis acidic active metal species through acid-base interactions and Lewis acidic Al(i) Bu3 to release the original active species through pyridine abstraction. This process is quick, quantitative, and can be repeated multiple times while maintaining high 3,4-selectivity. Moreover, this strategy is also effective for the switch copolymerization of isoprene and styrene with dual 3,4- and syndiotactic selectivity. Tuning the switch cycles and intervals enables the isolation of various copolymers with different distributions of 3,4-polyisoprene and syndiotactic polystyrene sequences. PMID:27539866

  13. Bingel-Hirsch addition on endohedral metallofullerenes: kinetic versus thermodynamic control.

    PubMed

    Alegret, Núria; Rodríguez-Fortea, Antonio; Poblet, Josep M

    2013-04-15

    An extensive theoretical study of the Bingel-Hirsch addition of bromomalonate on scandium nitride endohedral fullerenes has been carried out. The prototypical and highly symmetrical Sc3N@I(h)-C80, with a structure that satisfies the isolated pentagon rule (IPR), and the non-IPR Sc3N@D3(6140)-C68 fullerene show analogous reaction paths despite the distinct topology of the carbon networks and different rotation freedom of the internal nitride cluster. For the two metallofullerenes, our results predict that the reaction takes place under kinetic control yielding open-cage fulleroids on [6,6] bonds, which is in good agreement with experimental data. The theoretical studies also show that predicting the reactivity of endohedral metallofullerenes is not straightforward and often an accurate analysis of the potential energy surface is required.

  14. Catalytic enantioselective addition of organoboron reagents to fluoroketones controlled by electrostatic interactions

    NASA Astrophysics Data System (ADS)

    Lee, Kyunga; Silverio, Daniel L.; Torker, Sebastian; Robbins, Daniel W.; Haeffner, Fredrik; van der Mei, Farid W.; Hoveyda, Amir H.

    2016-08-01

    Organofluorine compounds are central to modern chemistry, and broadly applicable transformations that generate them efficiently and enantioselectively are in much demand. Here we introduce efficient catalytic methods for the addition of allyl and allenyl organoboron reagents to fluorine-substituted ketones. These reactions are facilitated by readily and inexpensively available catalysts and deliver versatile and otherwise difficult-to-access tertiary homoallylic alcohols in up to 98% yield and >99:1 enantiomeric ratio. Utility is highlighted by a concise enantioselective approach to the synthesis of the antiparasitic drug fluralaner (Bravecto, presently sold as the racemate). Different forms of ammonium–organofluorine interactions play a key role in the control of enantioselectivity. The greater understanding of various non-bonding interactions afforded by these studies should facilitate the future development of transformations that involve fluoroorganic entities.

  15. Catalytic enantioselective addition of organoboron reagents to fluoroketones controlled by electrostatic interactions.

    PubMed

    Lee, KyungA; Silverio, Daniel L; Torker, Sebastian; Robbins, Daniel W; Haeffner, Fredrik; van der Mei, Farid W; Hoveyda, Amir H

    2016-08-01

    Organofluorine compounds are central to modern chemistry, and broadly applicable transformations that generate them efficiently and enantioselectively are in much demand. Here we introduce efficient catalytic methods for the addition of allyl and allenyl organoboron reagents to fluorine-substituted ketones. These reactions are facilitated by readily and inexpensively available catalysts and deliver versatile and otherwise difficult-to-access tertiary homoallylic alcohols in up to 98% yield and >99:1 enantiomeric ratio. Utility is highlighted by a concise enantioselective approach to the synthesis of the antiparasitic drug fluralaner (Bravecto, presently sold as the racemate). Different forms of ammonium-organofluorine interactions play a key role in the control of enantioselectivity. The greater understanding of various non-bonding interactions afforded by these studies should facilitate the future development of transformations that involve fluoroorganic entities.

  16. Controlling the corrosion and cathodic activation of magnesium via microalloying additions of Ge

    NASA Astrophysics Data System (ADS)

    Liu, R. L.; Hurley, M. F.; Kvryan, A.; Williams, G.; Scully, J. R.; Birbilis, N.

    2016-06-01

    The evolution of corrosion morphology and kinetics for magnesium (Mg) have been demonstrated to be influenced by cathodic activation, which implies that the rate of the cathodic partial reaction is enhanced as a result of anodic dissolution. This phenomenon was recently demonstrated to be moderated by the use of arsenic (As) alloying as a poison for the cathodic reaction, leading to significantly improved corrosion resistance. The pursuit of alternatives to toxic As is important as a means to imparting a technologically safe and effective corrosion control method for Mg (and its alloys). In this work, Mg was microalloyed with germanium (Ge), with the aim of improving corrosion resistance by retarding cathodic activation. Based on a combined analysis herein, we report that Ge is potent in supressing the cathodic hydrogen evolution reaction (reduction of water) upon Mg, improving corrosion resistance. With the addition of Ge, cathodic activation of Mg subject to cyclic polarisation was also hindered, with beneficial implications for future Mg electrodes.

  17. Catalytic enantioselective addition of organoboron reagents to fluoroketones controlled by electrostatic interactions.

    PubMed

    Lee, KyungA; Silverio, Daniel L; Torker, Sebastian; Robbins, Daniel W; Haeffner, Fredrik; van der Mei, Farid W; Hoveyda, Amir H

    2016-08-01

    Organofluorine compounds are central to modern chemistry, and broadly applicable transformations that generate them efficiently and enantioselectively are in much demand. Here we introduce efficient catalytic methods for the addition of allyl and allenyl organoboron reagents to fluorine-substituted ketones. These reactions are facilitated by readily and inexpensively available catalysts and deliver versatile and otherwise difficult-to-access tertiary homoallylic alcohols in up to 98% yield and >99:1 enantiomeric ratio. Utility is highlighted by a concise enantioselective approach to the synthesis of the antiparasitic drug fluralaner (Bravecto, presently sold as the racemate). Different forms of ammonium-organofluorine interactions play a key role in the control of enantioselectivity. The greater understanding of various non-bonding interactions afforded by these studies should facilitate the future development of transformations that involve fluoroorganic entities. PMID:27442282

  18. Catalytic enantioselective addition of organoboron reagents to fluoroketones controlled by electrostatic interactions

    NASA Astrophysics Data System (ADS)

    Lee, Kyunga; Silverio, Daniel L.; Torker, Sebastian; Robbins, Daniel W.; Haeffner, Fredrik; van der Mei, Farid W.; Hoveyda, Amir H.

    2016-08-01

    Organofluorine compounds are central to modern chemistry, and broadly applicable transformations that generate them efficiently and enantioselectively are in much demand. Here we introduce efficient catalytic methods for the addition of allyl and allenyl organoboron reagents to fluorine-substituted ketones. These reactions are facilitated by readily and inexpensively available catalysts and deliver versatile and otherwise difficult-to-access tertiary homoallylic alcohols in up to 98% yield and >99:1 enantiomeric ratio. Utility is highlighted by a concise enantioselective approach to the synthesis of the antiparasitic drug fluralaner (Bravecto, presently sold as the racemate). Different forms of ammonium-organofluorine interactions play a key role in the control of enantioselectivity. The greater understanding of various non-bonding interactions afforded by these studies should facilitate the future development of transformations that involve fluoroorganic entities.

  19. Quality control of laser- and powder bed-based Additive Manufacturing (AM) technologies

    NASA Astrophysics Data System (ADS)

    Berumen, Sebastian; Bechmann, Florian; Lindner, Stefan; Kruth, Jean-Pierre; Craeghs, Tom

    The quality of metal components manufactured by laser- and powder bed-based additive manufacturing technologies has continuously been improved over the last years. However, to establish this production technology in industries with very high quality standards the accessibility of prevalent quality management methods to all steps of the process chain needs still to be enhanced. This publication describes which tools are and will be available to fulfil those requirements from the perspective of a laser machine manufacturer. Generally five aspects of the part building process are covered by separate Quality Management (QM) modules: the powder quality, the temperature management, the process gas atmosphere, the melt pool behaviour and the documentation module. This paper sets the focus on melt pool analysis and control.

  20. No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

    PubMed

    Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

    2016-08-01

    Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups. PMID:27299418

  1. Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

    NASA Astrophysics Data System (ADS)

    Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

    2004-04-01

    Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

  2. Development of a clinical data warehouse for hospital infection control.

    PubMed

    Wisniewski, Mary F; Kieszkowski, Piotr; Zagorski, Brandon M; Trick, William E; Sommers, Michael; Weinstein, Robert A

    2003-01-01

    Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse.

  3. Development of a Clinical Data Warehouse for Hospital Infection Control

    PubMed Central

    Wisniewski, Mary F.; Kieszkowski, Piotr; Zagorski, Brandon M.; Trick, William E.; Sommers, Michael; Weinstein, Robert A.

    2003-01-01

    Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse. PMID:12807807

  4. Probiotics in addition to antibiotics for the treatment of acute tonsillitis: a randomized, placebo-controlled study.

    PubMed

    Gilbey, P; Livshits, L; Sharabi-Nov, A; Avraham, Y; Miron, D

    2015-05-01

    Probiotics are live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. The probiotic Streptococcus salivarius has been shown to be effective in reducing the frequency of recurrent pharyngeal infections in children and adult populations. However, probiotics have not yet been evaluated in the treatment of acute pharyngotonsillitis in adults. We aimed to examine whether the addition of S. salivarius probiotics to the routine therapy of acute pharyngotonsillitis in adult patients may shorten disease duration and reduce symptom severity. This study was a prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in addition to antibiotics in patients who were hospitalized with severe pharyngotonsillitis. Laboratory results, pain levels, body temperature, and daily volume of fluids consumed were recorded for both groups. Sixty participants were recruited, 30 for each group. No statistically significant differences between the two groups were observed regarding any of the major clinical and laboratory parameters examined. Supplement probiotic treatment with S. salivarius in patients with acute pharyngotonsillitis treated with penicillin is ineffective in relation to the parameters examined in this study and we cannot, therefore, recommend the use of S. salivarius during active pharyngotonsillar infection treated with penicillin.

  5. Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomized controlled trial

    PubMed Central

    2013-01-01

    control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08). Conclusions Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 Please see related commentary: http://www.biomedcentral.com/10.1186/1741-7015-11-199. PMID:24228854

  6. The CERN antiproton source: Controls aspects of the additional collector ring and fast sampling devices

    NASA Astrophysics Data System (ADS)

    Chohan, V.

    1990-08-01

    The upgrade of the CERN antiproton source, meant to gain an order of magnitude in antiproton flux, required the construction of an additional ring to complement the existing antiproton accumulator (AA) and an entire rebuild of the target zone. The AA also needed major modifications to handle the increased flux and perform purely as an accumulator, preceded by collection in the collector ring (AC). The upgrade, known as the ACOL (antiproton collector) project, was approved under strict time and budgetary constraints and the existing AA control system, based on the Proton Synchrotron (PS) Divisional norms of CAMAC and Norsk-Data computers, had to be extended in the light of this. The limited (9 months) installation period for the whole upgrade meant that substantial preparatory and planning activities had to be carried out during the normal running of the AA. Advantage was taken of the upgrade to improve and consolidate the AA. Some aspects of the control system related to this upgrade are discussed together with the integration of new applications and instrumentation. The overall machine installation and running-in was carried out within the defined milestones and the project has now achieved the physics design goals.

  7. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    PubMed

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3). PMID:18498589

  8. A sequential procedure for monitoring clinical trials against historical controls.

    PubMed

    Xiong, Xiaoping; Tan, Ming; Boyett, James

    2007-03-30

    In this paper, we develop a sequential procedure to monitor clinical trials against historical controls. When there is a strong ethical concern about randomizing patients to existing treatment because biological and medical evidence suggests that the new treatment is potentially superior to the existing one, or when the enrollment is too limited for randomization of subjects into experimental and control groups, one can monitor the trial sequentially against historical controls if the historical data with required quality and sample size are available to form a valid reference for the trial. This design of trial is sometimes the only alternative to a randomized phase III trial design that is intended but not feasible in situations such as above. Monitoring this type of clinical trial leads to a statistical problem of comparing two population means in a situation in which data from one population are sequentially collected and compared with all data from the other population at each interim look. The proposed sequential procedures is based on the sequential conditional probability ratio test (SCPRT) by which the conclusion of the sequential test would be virtually the same as that arrived at by a non-sequential test based on all data at the planned end of the trial. We develop the sequential procedure by proposing a Brownian motion that emulates the test statistic, and then proposing an SCPRT that is adapted to the special properties of the trial. PMID:16900551

  9. Whole-lake nitrate addition for control of methylmercury in mercury-contaminated Onondaga Lake, NY.

    PubMed

    Matthews, David A; Babcock, David B; Nolan, John G; Prestigiacomo, Anthony R; Effler, Steven W; Driscoll, Charles T; Todorova, Svetoslava G; Kuhr, Kenneth M

    2013-08-01

    Methylmercury (MeHg) strongly bioaccumulates in aquatic food webs resulting in exposure to humans and wildlife through consumption of fish. Production of MeHg is promoted by anaerobic conditions and the supply of inorganic Hg (Hg(2+)), sulfate (SO4(2-)), and labile organic carbon. The anaerobic sediments of stratified lakes are particularly active zones for methylation of Hg(2+) and can be an important source of MeHg to the water column during summer anoxia and fall turnover. Nitrate (NO3(-)) addition has recently been proposed as a novel approach for the control of MeHg accumulation in the hypolimnia of Hg-contaminated lakes. In 2011, a whole-lake NO3(-) addition pilot test was conducted in Hg-contaminated Onondaga Lake, NY with the objective of limiting release of MeHg from the pelagic sediments to the hypolimnion through maintenance of NO3(-)-N concentrations >1mgN/L. A liquid calcium-nitrate solution was added to the hypolimnion as a neutrally buoyant plume approximately three times per week during the summer stratification interval. Maximum hypolimnetic concentrations of MeHg and soluble reactive phosphorus (SRP) decreased 94% and 95% from 2009 levels, suggesting increased sorption to Fe and Mn oxyhydroxides in surficial sediments as the regulating mechanism. Increased MeHg concentrations in the upper waters during fall turnover, which had been a generally recurring pattern, did not occur in 2011, resulting in decreased exposure of aquatic organisms to MeHg. Over the 1992-2011 interval, the hypolimnetic NO3(-) supply explained 85% and 95% of the interannual variations in hypolimnetic accumulations of SRP and MeHg, respectively.

  10. Addition of lidocaine injection immediately before physiotherapy for frozen shoulder: a randomized controlled trial.

    PubMed

    Hsu, Wei-Chun; Wang, Tao-Liang; Lin, Yi-Jia; Hsieh, Lin-Fen; Tsai, Chun-Mei; Huang, Kuang-Hui

    2015-01-01

    The intraarticular injection of lidocaine immediately before a physiotherapy session may relieve pain during the stretching and mobilization of the affected joint in patients with a frozen shoulder, thus enhancing the treatment effect. To compare the effects of intraarticular injection of lidocaine plus physiotherapy to that of physiotherapy alone in the treatment of a frozen shoulder, a prospective randomized controlled trial was conducted in the rehabilitation department of a private teaching hospital. Patients with a frozen shoulder were randomized into the physiotherapy group or the lidocaine injection plus physiotherapy (INJPT) group. The subjects in the INJPT group underwent injection of 3 ml of 1% lidocaine into the affected shoulder 10 to 20 minutes before each physiotherapy session. In each group, the treatment lasted 3 months. The primary outcome measures were the active and passive range of motion of the affected shoulder. The secondary outcome measures were the results of the Shoulder Disability Questionnaire, the Shoulder Pain and Disability Index, and the 36-item Short-Form Health Survey (SF-36). The outcome measures were evaluated before treatment and 1, 2, 3, 4, and 6 months after the start of treatment. The group comparisons showed significantly greater improvement in the INJPT group, mainly in active and passive shoulder range of motion in flexion and external rotation and improvements in pain and disability (P < 0.05); however, no significant group difference was seen in the SF-36 results. The intraarticular injection of lidocaine immediately before a physiotherapy session might be superior to physiotherapy alone in the treatment of a frozen shoulder. Trial registration: ClinicalTrials.gov NCT01817348.

  11. Drug Signature-based Finding of Additional Clinical Use of LC28-0126 for Neutrophilic Bronchial Asthma

    PubMed Central

    Shin, Eunji; Lee, Yong Chul; Kim, So Ri; Kim, Soon Ha; Park, Joonghoon

    2015-01-01

    In recent decades, global pharmaceutical companies have suffered from an R&D innovation gap between the increased cost of a new drug’s development and the decreased number of approvals. Drug repositioning offers another opportunity to fill the gap because the approved drugs have a known safety profile for human use, allowing for a reduction of the overall cost of drug development by eliminating rigorous safety assessment. In this study, we compared the transcriptional profile of LC28-0126, an investigational drug for acute myocardial infarction (MI) at clinical trial, obtained from healthy male subjects with molecular activity profiles in the Connectivity Map. We identified dyphilline, an FDA-approved drug for bronchial asthma, as a top ranked connection with LC28-0126. Subsequently, we demonstrated that LC28-0126 effectively ameliorates the pathophysiology of neutrophilic bronchial asthma in OVALPS-OVA mice accompanied with a reduction of inflammatory cell counts in the bronchoalveolar lavage fluid (BALF), inhibition of the release of proinflammatory cytokines, relief of airway hyperactivity, and improvement of histopathological changes in the lung. Taken together, we suggest that LC28-0126 could be a potential therapeutic for bronchial asthma. In addition, this study demonstrated the potential general utility of computational drug repositioning using clinical profiles of the investigational drug. PMID:26626943

  12. Controlling the corrosion and cathodic activation of magnesium via microalloying additions of Ge

    PubMed Central

    Liu, R. L.; Hurley, M. F.; Kvryan, A.; Williams, G.; Scully, J. R.; Birbilis, N.

    2016-01-01

    The evolution of corrosion morphology and kinetics for magnesium (Mg) have been demonstrated to be influenced by cathodic activation, which implies that the rate of the cathodic partial reaction is enhanced as a result of anodic dissolution. This phenomenon was recently demonstrated to be moderated by the use of arsenic (As) alloying as a poison for the cathodic reaction, leading to significantly improved corrosion resistance. The pursuit of alternatives to toxic As is important as a means to imparting a technologically safe and effective corrosion control method for Mg (and its alloys). In this work, Mg was microalloyed with germanium (Ge), with the aim of improving corrosion resistance by retarding cathodic activation. Based on a combined analysis herein, we report that Ge is potent in supressing the cathodic hydrogen evolution reaction (reduction of water) upon Mg, improving corrosion resistance. With the addition of Ge, cathodic activation of Mg subject to cyclic polarisation was also hindered, with beneficial implications for future Mg electrodes. PMID:27350286

  13. Postural control in response to a perturbation: role of vision and additional support.

    PubMed

    Krishnan, Vennila; Vennila, Krishnan; Aruin, Alexander S

    2011-07-01

    The purpose of the study was to investigate the availability of vision and additional support on anticipatory (APA) and compensatory (CPA) postural adjustments and their interaction. Eight healthy adults were exposed to external perturbations induced at the shoulder level while standing with and without holding onto a walker in full vision and while blindfolded. Electrical activity of the trunk and leg muscles and center of pressure (COPAP) displacement were recorded and quantified within the time intervals typical of APA and CPA. The results showed that with full vision, there was no difference in both APA and CPA in standing with and without holding onto a walker. With subjects holding onto a walker, CPA in standing blindfolded were comparable to CPA in full vision; this was seen in changes in the electrical activity of most of the muscles at the individual muscle, joint, and the muscle group levels as well as in COPAP displacement. The findings suggest that (1) in conditions where vision is available, vision overrules simultaneously available proprioceptive information from the support, (2) while in conditions where vision is not available, proprioceptive information from the support or support itself could be substituted for vision. It is possible to suggest that using a non-stabilizing support could be a valuable strategy to improve postural control when visual information is not available or compromised.

  14. Animated sulfonated or sulformethylated lignins as cement fluid loss control additives

    SciTech Connect

    Schilling, P.

    1991-05-07

    This patent describes a method of cementing a zone in a well penetrating a subterranean formation comprising injecting down the well and positioning in the zone to be cemented a hydraulic aqueous cement slurry composition. It comprises: a hydraulic cement, and the following expressed as parts by weight per 100 parts of the hydraulic cement, water from about 25 to 105 parts, and a fluid loss control additive comprising from about 0.5 to 2.5 parts of a compound selected from the group consisting of a sulfonated lignin and a sulfomethylated lignin, wherein the lignin has been aminated by reacting it with between about 2-5 moles of a polyamine and 2-5 moles of an aldehyde per 1,000g of the lignin, and 0.1 to 1.5 parts of a compound selected from the group consisting of sodium carbonate, sodium metasilicate, sodium phosphate, sodium sulfite and sodium naphthalene sulfonate and a combination thereof.

  15. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    PubMed

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect. PMID:26149004

  16. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    PubMed

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  17. The Use of Additives to Control the Morphology of Thin Films Synthesized Using Aerosol Assisted Chemical Vapour Deposition

    NASA Astrophysics Data System (ADS)

    Kaye, Karl; Turner, David; McKenna, David; Cackett, Adam; Hyett, Geoffrey

    This paper identifies and discusses the use of additives to control the morphology of nanoscale crystalline zinc oxide films, grown using AACVD, principally from a solution of zinc acetate in methanol. We will discuss the use of both positively charged additives such as tetramethylammonium bromide and cetyltrimethylammonium bromide as well as negatively charged additives like sodium dodecylsulphate. Additives such as these, combined with other experimental parameters such as deposition time, have allowed us to control the size of the particles (from 100 to 400 nm in diameter), their orientation, and the regularity of their shape, from rough edged plates to well defined hexagons. We will show that the additives can be used to control morphology consistently over a temperature range of 250-400 °C, and that this technique can be applied generally to a number of additives and solvents.

  18. Compliance with infection control practices in an university hospital dental clinic

    PubMed Central

    Mutters, Nico T.; Hägele, Ulrike; Hagenfeld, Daniel; Hellwig, Elmar; Frank, Uwe

    2014-01-01

    Aim: Compliance with infection control practices is the key to quality care and excellence in dentistry. Infection control remains one of the most cost-beneficial interventions available. However, implementing control procedures requires full compliance of the whole dental team. The aim of our study was to measure the compliance in daily clinical practice. Methods: The compliance with infection control practices in dentistry by dental health care personnel (DHCP) in a German university dental clinic was observed during clinical work. In addition, a survey was conducted to assess the individual knowledge about infection control procedures. Contamination of the workplace during invasive dental procedures was tested, as well. Results: A total of 58 invasive dental treatments implying close contacts between HCWs and patients were scrutinized. All HCWs (100%) wore gloves during dental work, but in some cases (female dentists: 14.3%; dental assistants: 28.6%) gloves were neither changed nor hands were disinfected between different activities or patient contacts (female dentists: 68.6%; male dentists: 60.9%; dental assistants: 93%). Only 31.4% of female and 39.1% of male dentists carried out adequate hygienic hand disinfection after removing gloves. Male dentists wore significantly more often (100%) protective eyewear compared to 77.1% of female dentists (p<0.05). In addition, most of female dentists (62.9%) and dental assistants (80.7%) wore jewelry during dental procedures. Conclusion: Despite the knowledge of distinct hygiene procedures only a small percentage of dental staff performs hygiene practices according to recommended guidelines. Strict audit is clearly needed in the dental setting to ensure compliance with infection control guidelines to prevent transmission of pathogens. Our results provide insights for the development of a targeted education and training strategy to enhance compliance of dental staff especially of dental assistants with infection control

  19. Time optimal control of an additional food provided predator-prey system with applications to pest management and biological conservation.

    PubMed

    Srinivasu, P D N; Prasad, B S R V

    2010-04-01

    Use of additional food has been widely recognized by experimental scientists as one of the important tools for biological control such as species conservation and pest management. The quality and quantity of additional food supplied to the predators is known to play a vital role in the controllability of the system. The present study is continuation of a previous work that highlights the importance of quality and quantity of the additional food in the dynamics of a predator-prey system in the context of biological control. In this article the controllability of the predator-prey system is analyzed by considering inverse of quality of the additional food as the control variable. Control strategies are offered to steer the system from a given initial state to a required terminal state in a minimum time by formulating Mayer problem of optimal control. It is observed that an optimal strategy is a combination of bang-bang controls and could involve multiple switches. Properties of optimal paths are derived using necessary conditions for Mayer problem. In the light of the results evolved in this work it is possible to eradicate the prey from the eco-system in the minimum time by providing the predator with high quality additional food, which is relevant in the pest management. In the perspective of biological conservation this study highlights the possibilities to drive the state to an admissible interior equilibrium (irrespective of its stability nature) of the system in a minimum time.

  20. Steric Effects Compete with Aryne Distortion to Control Regioselectivities of Nucleophilic Additions to 3-Silylarynes

    PubMed Central

    Bronner, Sarah M.; Mackey, Joel L.

    2012-01-01

    We report an experimental and computational study of 3-silylarynes. The addition of nucleophiles yield ortho-substituted products as a result of aryne distortion, but meta-substituted products form predominately when the nucleophile is large. Computations correctly predict the preferred site of attack observed in both nucleophilic addition and cycloaddition experiments. Nucleophilic additions to 3-t-butylbenzyne, which is not significantly distorted, give meta-substituted products. PMID:22876797

  1. A feasibility study regarding the addition of a fifth control to a rotorcraft in-flight simulator

    NASA Technical Reports Server (NTRS)

    Turner, Simon; Andrisani, Dominick, II

    1992-01-01

    The addition of a large movable horizontal tail surface to the control system of a rotorcraft in-flight simulator being developed from a Sikorsky UH-60A Black Hawk Helicopter is evaluated. The capabilities of the control surface as a trim control and as an active control are explored. The helicopter dynamics are modeled using the Generic Helicopter simulation program developed by Sikorsky Aircraft. The effect of the horizontal tail on the helicopter trim envelope is examined by plotting trim maps of the aircraft attitude and controls as a function of the flight speed and horizontal tail incidence. The control power of the tail surface relative to that of the other controls is examined by comparing control derivatives extracted from the simulation program over the flight speed envelope. The horizontal tail's contribution as an active control is evaluated using an explicit model following control synthesis involving a linear model of the helicopter in steady, level flight at a flight speed of eighty knots. The horizontal tail is found to provide additional control flexibility in the longitudinal axis. As a trim control, it provides effective control of the trim pitch attitude at mid to high forward speeds. As an active control, the horizontal tail provides useful pitching moment generating capabilities at mid to high forward speeds.

  2. Clinical situations associated with difficult-to-control hypertension.

    PubMed

    Oliveras, Anna; Schmieder, Roland E

    2013-03-01

    There is no doubt that patients with high blood pressure (BP) are at higher cardiovascular and death risk than those subjects whose BP levels are below the admitted normal threshold. However, most of the epidemiological surveys show that BP is uncontrolled in more than fifty percent of hypertensive subjects. There are several reasons that can justify this lack of hypertension control, some of them depending on the patient, such as therapeutic adherence, or some related to the doctor, due to therapeutic inertia or reluctance to increment the number and doses of antihypertensive drugs. Sometimes the efficacy or adverse effects related to the antihypertensive drugs underlie the uncontrolled hypertension. And, finally, there are some clinical conditions that are associated with difficult-to-control hypertension. Among them, comorbidities such as diabetes, obesity, obstructive sleep apnoea syndrome or chronic kidney disease, but also drug-related hypertension or resistant hypertension. In this article we review the epidemiology and the conditions which are related to poorly controlled hypertension and that can explain why hypertension may become difficult-to-treat. PMID:23389084

  3. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes

    PubMed Central

    Cook, Andrea J.; Wellman, Robert D.; Cherkin, Daniel C.; Kahn, Janet R.; Sherman, Karen J.

    2015-01-01

    Background Context This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of non-pharmacological treatments. Purpose To determine the optimal dose of massage for neck pain. Study Design/Setting Two-phase randomized trial for persons with chronic non-specific neck pain. Primary randomization to one of 5 groups receiving 4 weeks of massage (30 minutes 2×/ or 3×/week or 60 minutes 1×, 2×, or 3×/week). Booster randomization of participants to receive an additional 6 massages, 60 minute 1×/week, or no additional massage. Patient Sample 179 participants from Group Health and the general population of Seattle, WA USA recruited between June 2010 and August 2011. Outcome Measures Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as >5 point decrease in dysfunction and > 30% decrease in pain from baseline. Methods Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations. Secondary analyses for the continuous outcomes used linear generalized estimating equations. This study was funded the National Center for Complementary and Alternative Medicine, NIH, USA (R01 AT004411). The funders had no role in the interpretation or reporting of results. Results There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: RR=1.56(1.08–2.25), P=0.018; pain: RR=1.25(0.98–1.61); P=0.077), but those were non-significant at 26 weeks (dysfunction: RR=1.22(0.85–1.74); pain: RR=1.09(0.82–1.43)). Subgroup analysis by primary and booster treatments found the booster dose only

  4. Review and evaluation of literature on testing of chemical additives for scale control in geothermal fluids. Final report

    SciTech Connect

    Crane, C.H.; Kenkeremath, D.C.

    1981-01-01

    A selected group of reported tests of chemical additives in actual geothermal fluids are reviewed and evaluated to summarize the status of chemical scale-control testing and identify information and testing needs. The task distinguishes between scale control in the cooling system of a flash plant and elsewhere in the utilization system due to the essentially different operating environments involved. Additives for non-cooling geothermal fluids are discussed by scale type: silica, carbonate, and sulfide.

  5. Field Testing of a Wet FGD Additive for Enhanced Mercury Control - Pilot-Scale Test Results

    SciTech Connect

    Gary M. Blythe

    2006-03-01

    This Topical Report summarizes progress on Cooperative Agreement DE-FC26-04NT42309, ''Field Testing of a Wet FGD Additive.'' The objective of the project is to demonstrate the use of a flue gas desulfurization (FGD) additive, Degussa Corporation's TMT-15, to prevent the reemissions of elemental mercury (Hg{sup 0}) in flue gas exiting wet FGD systems on coal-fired boilers. Furthermore, the project intends to demonstrate that the additive can be used to precipitate most of the mercury (Hg) removed in the wet FGD system as a fine TMT salt that can be separated from the FGD liquor and bulk solid byproducts for separate disposal. The project will conduct pilot and full-scale tests of the TMT-15 additive in wet FGD absorbers. The tests are intended to determine required additive dosage requirements to prevent Hg{sup 0} reemissions and to separate mercury from the normal FGD byproducts for three coal types: Texas lignite/Power River Basin (PRB) coal blend, high-sulfur Eastern bituminous coal, and low-sulfur Eastern bituminous coal. The project team consists of URS Group, Inc., EPRI, TXU Generation Company LP, Southern Company, and Degussa Corporation. TXU Generation has provided the Texas lignite/PRB co-fired test site for pilot FGD tests, Monticello Steam Electric Station Unit 3. Southern Company is providing the low-sulfur Eastern bituminous coal host site for wet scrubbing tests, as well as the pilot and full-scale jet bubbling reactor (JBR) FGD systems to be tested. A third utility, to be named later, will provide the high-sulfur Eastern bituminous coal full-scale FGD test site. Degussa Corporation is providing the TMT-15 additive and technical support to the test program. The project is being conducted in six tasks. Of the six project tasks, Task 1 involves project planning and Task 6 involves management and reporting. The other four tasks involve field testing on FGD systems, either at pilot or full scale. The four tasks include: Task 2 - Pilot Additive Testing in

  6. Ligand- and base-free Pd(II)-catalyzed controlled switching between oxidative Heck and conjugate addition reactions.

    PubMed

    Walker, Sarah E; Boehnke, Julian; Glen, Pauline E; Levey, Steven; Patrick, Lisa; Jordan-Hore, James A; Lee, Ai-Lan

    2013-04-19

    A simple change of solvent allows controlled and efficient switching between oxidative Heck and conjugate addition reactions on cyclic Michael acceptor substrates, catalyzed by a cationic Pd(II) catalyst system. Both reactions are ligand- and base-free and tolerant of air and moisture, and the controlled switching sheds light on some of the factors which favor one reaction over the other.

  7. 78 FR 74218 - Imposition of Additional Sanctions on Syria Under the Chemical and Biological Weapons Control and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... Imposition of Additional Sanctions on Syria Under the Chemical and Biological Weapons Control and Warfare... chemical weapons in violation of international law or lethal chemical weapons against its own nationals... the Chemical and Biological Weapons Control and Warfare Elimination Act of 1991, 22 U.S.C. 5604(a)...

  8. Clinical Use of Cannabinoids for Symptom Control in Multiple Sclerosis.

    PubMed

    Notcutt, William G

    2015-10-01

    The endocannabinoid system was discovered in 1988 but has received little attention for its potential therapeutic possibilities. That has started to change, and since 2000, a significant number of clinical trials of cannabinoids, principally for the control of spasticity in multiple sclerosis, have been undertaken. These studies have been difficult because of the nature of the disease and have involved patients for whom other therapies have failed or proved inadequate. This paper outlines the background to the use of cannabinoids available and discusses the principles of practice associated with their safe use. The focus has been on nabiximols, being the most studied and the only cannabinoid that has been both adequately researched for use in multiple sclerosis and granted a license by the regulators. However, what has emerged is that the effect for many patients can be much wider than just control of spasticity. Within and outside of neurology there seems to be an expanding range of possibilities for the therapeutic use of cannabinoids.

  9. Control of Escherichia coli O157:H7 in contaminated alfalfa silage: Effects of silage additives.

    PubMed

    Ogunade, I M; Kim, D H; Jiang, Y; Weinberg, Z G; Jeong, K C; Adesogan, A T

    2016-06-01

    This study was conducted to examine if adding microbial inoculants or propionic acid to alfalfa silages contaminated with Escherichia coli O157:H7 would inhibit the growth of the pathogen during or after ensiling. Alfalfa forage was harvested at the early bloom stage, wilted to a dry matter concentration of 54%, chopped to 19-mm lengths, and ensiled after treatment with one of the following: (1) distilled water (control); (2) 1×10(5) cfu/g of E. coli O157:H7 (EC); (3) EC and 1×10(6) cfu/g of Lactobacillus plantarum (EC+LP); (4) EC and 1×10(6) cfu/g of Lactobacillus buchneri (EC+LB); and (5) EC and 2.2g/kg of propionic acid (EC+PA). Each treatment was ensiled in quadruplicate in laboratory silos for 0, 3, 7, 16, and 100d and analyzed for EC counts, pH, and organic acids. In addition, samples from d 100 were analyzed for chemical composition, ammonia-N, counts of yeasts and molds, and aerobic stability. Escherichia coli O157:H7 was detected in all silages until d 7, but by d 16 it was not detected in those treated with EC+LB and EC+LP, though it was still detected in EC and EC+PA silages. However, by d 100, the pathogen was not detected in any silage. The rate of pH decrease to 5.0 was fastest for the EC+LP silage (7d), followed by the EC+LB silage (16d). Nevertheless, all silages had attained a pH of or less than 5.0 by d 100. The rapid decrease in pH in EC+LP and EC+LB silages was observed due to higher lactate and acetate concentrations, respectively, relative to the other silages during the early fermentation phase (d 3-16). Propionic acid was only detected in the EC+PA silage. Yeast counts were lowest in EC+LB and EC+PA silages. Subsamples of all d-100 silages were reinoculated with 1×10(5) cfu/g of EC immediately after silo opening. When the pathogen was subsequently enumerated after 168h of aerobic exposure, it was not detected in silages treated with EC+PA, EC+LB, or EC+LP, which all had pH values less than 5.0. Whereas the EC silage had a pH value of 5

  10. Control of Escherichia coli O157:H7 in contaminated alfalfa silage: Effects of silage additives.

    PubMed

    Ogunade, I M; Kim, D H; Jiang, Y; Weinberg, Z G; Jeong, K C; Adesogan, A T

    2016-06-01

    This study was conducted to examine if adding microbial inoculants or propionic acid to alfalfa silages contaminated with Escherichia coli O157:H7 would inhibit the growth of the pathogen during or after ensiling. Alfalfa forage was harvested at the early bloom stage, wilted to a dry matter concentration of 54%, chopped to 19-mm lengths, and ensiled after treatment with one of the following: (1) distilled water (control); (2) 1×10(5) cfu/g of E. coli O157:H7 (EC); (3) EC and 1×10(6) cfu/g of Lactobacillus plantarum (EC+LP); (4) EC and 1×10(6) cfu/g of Lactobacillus buchneri (EC+LB); and (5) EC and 2.2g/kg of propionic acid (EC+PA). Each treatment was ensiled in quadruplicate in laboratory silos for 0, 3, 7, 16, and 100d and analyzed for EC counts, pH, and organic acids. In addition, samples from d 100 were analyzed for chemical composition, ammonia-N, counts of yeasts and molds, and aerobic stability. Escherichia coli O157:H7 was detected in all silages until d 7, but by d 16 it was not detected in those treated with EC+LB and EC+LP, though it was still detected in EC and EC+PA silages. However, by d 100, the pathogen was not detected in any silage. The rate of pH decrease to 5.0 was fastest for the EC+LP silage (7d), followed by the EC+LB silage (16d). Nevertheless, all silages had attained a pH of or less than 5.0 by d 100. The rapid decrease in pH in EC+LP and EC+LB silages was observed due to higher lactate and acetate concentrations, respectively, relative to the other silages during the early fermentation phase (d 3-16). Propionic acid was only detected in the EC+PA silage. Yeast counts were lowest in EC+LB and EC+PA silages. Subsamples of all d-100 silages were reinoculated with 1×10(5) cfu/g of EC immediately after silo opening. When the pathogen was subsequently enumerated after 168h of aerobic exposure, it was not detected in silages treated with EC+PA, EC+LB, or EC+LP, which all had pH values less than 5.0. Whereas the EC silage had a pH value of 5

  11. Field Testing of a Wet FGD Additive for Enhanced Mercury Control

    SciTech Connect

    Gary Blythe; MariJon Owens

    2007-12-31

    This document is the final report for DOE-NETL Cooperative Agreement DE-FC26-04NT42309, 'Field Testing of a Wet FGD Additive'. The objective of the project has been to demonstrate the use of two flue gas desulfurization (FGD) additives, Evonik Degussa Corporation's TMT-15 and Nalco Company's Nalco 8034, to prevent the re-emission of elemental mercury (Hg{sup 0}) in flue gas exiting wet FGD systems on coal-fired boilers. Furthermore, the project was intended to demonstrate whether such additives can be used to precipitate most of the mercury (Hg) removed in the wet FGD system as a fine salt that can be separated from the FGD liquor and bulk solid byproducts for separate disposal. The project involved pilot- and full-scale tests of the additives in wet FGD absorbers. The tests were intended to determine required additive dosages to prevent Hg{sup 0} re-emissions and to separate mercury from the normal FGD byproducts for three coal types: Texas lignite/Powder River Basin (PRB) coal blend, high-sulfur Eastern bituminous coal, and low-sulfur Eastern bituminous coal. The project team consists of URS Group, Inc., EPRI, Luminant Power (was TXU Generation Company LP), Southern Company, IPL (an AES company), Evonik Degussa Corporation and the Nalco Company. Luminant Power provided the Texas lignite/PRB co-fired test site for pilot FGD tests and project cost sharing. Southern Company provided the low-sulfur Eastern bituminous coal host site for wet scrubbing tests, the pilot- and full-scale jet bubbling reactor (JBR) FGD systems tested, and project cost sharing. IPL provided the high-sulfur Eastern bituminous coal full-scale FGD test site and cost sharing. Evonik Degussa Corporation provided the TMT-15 additive, and the Nalco Company provided the Nalco 8034 additive. Both companies also supplied technical support to the test program as in-kind cost sharing. The project was conducted in six tasks. Of the six tasks, Task 1 involved project planning and Task 6 involved

  12. Efficacy and nontarget effects of Larvadex as a feed additive for controlling house flies in caged-layer poultry manure.

    PubMed

    Axtell, R C; Edwards, T D

    1983-12-01

    The insect growth regulator N-cyclopropyl-1,3,5-triazine-2,4,6 triamine (Larvadex, CGA 72662, cyromazine) was provided as a feed additive (.3% Premix per ton of feed) to caged laying hens under field conditions in high rise, wide span and narrow poultry houses. The chemical effectively controlled house flies (Musca domestica) and soldier flies (Hermetia illucens). The feed additive had no adverse effect on the populations of manure-inhabiting mites (Macrochelidae and Uropodidae) and histerid beetles (Carcínops pumulio), which prey on fly eggs and larvae. Satisfactory fly control was demonstrated by use of the additive 50% of the time when the interval without the additive in the feed was 4 days but not when the interval was 7 days. Use of a fly monitoring program to time the use of the feed additive is advocated.

  13. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  14. Effectiveness of iron-based fuel additives for diesel soot control

    SciTech Connect

    Zeller, H.W.; Westphal, T.E.

    1992-01-01

    The U.S. Bureau of Mines evaluated the effects of two iron-based fuel additives on diesel particulate matter (DPM) emissions. The 5.6-L, six-cylinder test engine is typical of engines used in underground mines. One additive, ferrous picrate, did not measurably affect exhaust emissions. This report is mainly about a ferrocene-based additive that reduced DPM between 4 and 45 pct, depending on engine operating conditions. The report concludes that the DPM reductions were caused by the catalytic oxidation properties of a ferric oxide coating that developed inside the engine's combustion chamber. The ferric oxide coating also decreased gas-phase hydrocarbons and O[sub 2], but it increased CO[sub 2] and NO[sub x]. The increase in NO[sub x], of about 12 pct, is considered the only adverse effect of the ferrocene-based fuel additive. The results suggest that the effectiveness of ferrocene was partially offset by increased sulfates because of the high-sulfur fuel used. Recommendations for continuing fuel additive research are presented.

  15. High-dose inhaled corticosteroids or addition of theophylline in patients with poorly controlled asthma?

    PubMed

    Celis, Pilar; Rada, Gabriel

    2015-08-19

    There are several management strategies for patients with poorly controlled asthma despite usual treatment. Increasing doses of inhaled corticosteroids or adding theophylline are among the therapeutic alternatives. However, the latter is associated with important adverse effects. Searching in Epistemonikos database, which is maintained by screening 30 databases, we identified only one systematic review including four pertinent randomized controlled trials. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded it is not clear whether theophylline or high-dose inhaled corticosteroids constitute a better alternative for symptomatic control or reduction in exacerbations in poorly controlled asthmatic patients because the certainty of the evidence is very low.

  16. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly.

    PubMed

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  17. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

    PubMed Central

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  18. Control of Asymmetry in the Radical Addition Approach to Chiral Amine Synthesis

    PubMed Central

    Friestad, Gregory K.

    2014-01-01

    The state-of-the-science in asymmetric free radical additions to imino compounds is presented, beginning with an overview of methods involving stereocontrol by various chiral auxiliary approaches. Chiral N-acylhydrazones are discussed with respect to their use as radical acceptors for Mn-mediated intermolecular additions, from design to scope surveys to applications to biologically active targets. A variety of aldehydes and ketones serve as viable precursors for the chiral hydrazones, and a variety of alkyl iodides may be employed as radical precursors, as discussed in a critical review of the functional group compatibility of the reaction. Applications to amino acid and alkaloid synthesis are presented to illustrate the synthetic potential of these versatile stereocontrolled carbon–carbon bond construction reactions. Asymmetric catalysis is discussed, from seminal work on the stereocontrol of radical addition to imino compounds by non-covalent interactions with stoichiometric amounts of catalysts, to more recent examples demonstrating catalyst turnover. PMID:24085561

  19. LONG-TERM DEMONSTRATION OF SORBENT ENHANCEMENT ADDITIVE TECHNOLOGY FOR MERCURY CONTROL

    SciTech Connect

    Jason D. Laumb; Dennis L. Laudal; Grant E. Dunham; John P. Kay; Christopher L. Martin; Jeffrey S. Thompson; Nicholas B. Lentz; Alexander Azenkeng; Kevin C. Galbreath; Lucinda L. Hamre

    2011-05-27

    Long-term demonstration tests of advanced sorbent enhancement additive (SEA) technologies have been completed at five coal-fired power plants. The targeted removal rate was 90% from baseline conditions at all five stations. The plants included Hawthorn Unit 5, Mill Creek Unit 4, San Miguel Unit 1, Centralia Unit 2, and Hoot Lake Unit 2. The materials tested included powdered activated carbon, treated carbon, scrubber additives, and SEAs. In only one case (San Miguel) was >90% removal not attainable. The reemission of mercury from the scrubber at this facility prevented >90% capture.

  20. Tantalum trabecular metal - addition of human skeletal cells to enhance bone implant interface strength and clinical application.

    PubMed

    Smith, J O; Sengers, B G; Aarvold, A; Tayton, E R; Dunlop, D G; Oreffo, R O C

    2014-04-01

    The osteo-regenerative properties of allograft have recently been enhanced by addition of autogenous human bone marrow stromal cells (HBMSCs). Limitations in the use of allograft have prompted the investigation of tantalum trabecular metal (TTM) as a potential alternative. TTM is already in widespread orthopaedic use, although in applications where there is poor initial stability, or when TTM is used in conjunction with bone grafting, initial implant loading may need to be limited. The aim of this study was to evaluate the osteo-regenerative potential of TTM with HBMSCs, in direct comparison to human allograft and autograft. HBMSCs were cultured on blocks of TTM, allograft or autograft in basal and osteogenic media. Molecular profiling, confocal and scanning electron microscopy (SEM) and biochemical assays were used to characterize cell adherence, proliferation and phenotype. Mechanical testing was used to define the tensile characteristics of the constructs. HBMSCs displayed adherence and proliferation throughout TTM, evidenced by immunocytochemistry and SEM, with significant cellular ingrowth and matrix production through TTM. In contrast to cells cultured with allograft, cell proliferation assays showed significantly higher activity with TTM (p < 0.001), although molecular profiling confirmed no significant difference in expression of osteogenic genes. In contrast to acellular constructs, mechanical testing of cell-TTM constructs showed enhanced tensile characteristics, which compared favourably to cell-allograft constructs. These studies demonstrated the ability of TTM to support HBMSC growth and osteogenic differentiation comparable to allograft. Thus, TTM represents an alternative to allograft for osteo-regenerative strategies, extending its clinical applications as a substitute for allograft.

  1. Developmentally controlled telomere addition in wild-type and mutant paramecia.

    PubMed Central

    Forney, J D; Blackburn, E H

    1988-01-01

    We analyzed sites of macronuclear telomere addition at a single genetic locus in Paramecium tetraurelia. We showed that in homozygous wild-type cells, differential genomic processing during macronuclear development resulted in the A surface antigen gene being located 8, 13, or 26 kilobases upstream from a macronuclear telomere. We describe variable rearrangements that occurred at the telomere 8 kilobases from the A gene. A mutant (d48) that forms a telomere near the 5' end of the A gene was also analyzed. This mutant was shown to create simple terminal deletions; telomeric repeats were added directly to the truncated wild-type A gene sequence. In both the mutant and wild-type cells, the telomeric sequences (a mixture of C4A2 and C3A3 repeats) were added to various sequences within a specific 200- to 500-base-pair region rather than to a single site. No similarities were found in the primary sequences surrounding the telomere addition sites. The mutation in d48 changed the region of telomere addition at the A gene locus; this is the first example in ciliates of a mutation that affects the site of telomere addition. Images PMID:3336360

  2. [Hospital infection control in 21st century, the importance of networking with each division and clinical laboratory in the hospital. 1. From the aspect of clinical laboratory division].

    PubMed

    Mitsuda, T

    2001-08-01

    Clinical laboratory division plays an important roll for the management of nosocomial infection. Staff from clinical laboratory division including technologist and/or medical doctor can work as a part of infection control team. Since the bacterial surveillance data from clinically isolated strains accumulates in the clinical laboratory division, these staff have a chance to notice outbreak in hospital at first time. While handling information from each strain, we need to feedback these data with additional information for physicians. From June, 2000, a national project started. That was a surveillance program for drag-resistant bacteria. We can compare information from local isolates and nation-wide isolates by this project. Genotypic methods especially pulsed-field gel electrophoresis(PFGE) is suitable for the identification of infection route in the hospital environment. And PFGE analysis for pathogenic strains works effective in our hospital.

  3. Controlled laboratory challenge demonstrates substantial additive genetic variation in resistance to Streptococcus iniae in Nile tilapia

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Streptococcus iniae is an etiologic agent of streptococcal disease in tilapia and is one of several Streptococcus spp. that negatively impact worldwide tilapia production. Methods for the prevention and control of S. iniae include vaccines, management strategies, and antibiotics. An alternative and ...

  4. PCB bioavailability control in Lumbriculus variegatus through different modes of activated carbon addition to sediments

    SciTech Connect

    Xueli Sun; Upal Ghosh

    2007-07-01

    PCB bioavailability to a freshwater oligochaete (Lumbriculus variegatus) was studied using sediments from a PCB-impacted river that was treated with different modes of granular activated carbon (GAC) addition. The GAC used was bituminous coal-based type TOP. For sediment treated with 2.6% GAC and mixed for 2 min prior to L. variegatus addition, the reduction in total PCB biouptake was 70% for 75-300 {mu}m size carbon, and 92% for the 45-180 {mu}m size carbon. For the case where the GAC was placed as a thin layer on top of the sediments without mixing, the reduction in total PCB uptake was 70%. PCB biouptake kinetics study using treated and untreated sediment showed that the maximum PCB uptake in tissue was achieved at 28 days and decreased after that time. Although the absolute uptake of PCB changed over time, the percent reduction in total PCB uptake upon GAC amendment remained constant after the first few days. Our results indicated that PCB bioavailability was reduced upon the addition and little or no mixing of GAC into sediments. PCB aqueous equilibrium concentration and desorption rates were greatly reduced after GAC amendment, indicating reductions in the two primary mechanisms of PCB bioavailability in sediments: chemical activity and chemical accessibility. 29 refs., 5 figs., 1 tab.

  5. Additive manufacturing of scaffolds with dexamethasone controlled release for enhanced bone regeneration.

    PubMed

    Costa, Pedro F; Puga, Ana M; Díaz-Gomez, Luis; Concheiro, Angel; Busch, Dirk H; Alvarez-Lorenzo, Carmen

    2015-12-30

    The adoption of additive manufacturing in tissue engineering and regenerative medicine (TERM) strategies greatly relies on the development of novel 3D printable materials with advanced properties. In this work we have developed a material for bone TERM applications with tunable bioerosion rate and dexamethasone release profile which can be further employed in fused deposition modelling (the most common and accessible 3D printing technology in the market). The developed material consisted of a blend of poly-ϵ-caprolactone (PCL) and poloxamine (Tetronic®) and was processed into a ready-to-use filament form by means of a simplified melt-based methodology, therefore eliminating the utilization of solvents. 3D scaffolds composed of various blend formulations were additively manufactured and analyzed revealing blend ratio-specific degradation rates and dexamethasone release profiles. Furthermore, in vitro culture studies revealed a similar blend ratio-specific trend concerning the osteoinductive activity of the fabricated scaffolds when these were seeded and cultured with human mesenchymal stem cells. The developed material enables to specifically address different regenerative requirements found in various tissue defects. The versatility of such strategy is further increased by the ability of additive manufacturing to accurately fabricate implants matching any given defect geometry.

  6. Biological rationales and clinical applications of temperature controlled hyperthermia--implications for multimodal cancer treatments.

    PubMed

    Schildkopf, P; Ott, O J; Frey, B; Wadepohl, M; Sauer, R; Fietkau, R; Gaipl, U S

    2010-01-01

    Hyperthermia (HT)--heating the tumor in the range of 40.0- 44.0 °C--combined with radiation (RT) and/or chemotherapy (CT) is a well proven treatment for malignant tumors. The improvement of the techniques for monitoring and adapting of the desired temperatures even in deep seated tumors has led to a renaissance of, now quality-controlled, HT in multimodal tumor therapy approaches. Randomized clinical trials have shown improved disease-free survival and local tumor control without an increase in toxicity for the combined treatment. In this review, we will focus on biological rationales of HT comprising direct cytotoxicity, systemic effects, chemosensitization, radiosensitization, and immune modulation. The latter is a prerequisite for the control of recurrent tumors and micrometastases. Immunogenic tumor cell death forms induced by HT will be introduced. Modulations of the cytotoxic properties of chemotherapeutic agents by HT as well as synergistic effects of HT with RT will be presented in the context of the main aims of anti-tumor therapy. Furthermore, modern techniques for thermal mapping like magnet resonance imaging will be outlined. The effectiveness of HT will be demonstrated by reviewing recent clinical trials applying HT in addition to CT and/or RT. We conclude that hyperthermia is a very potent radio- as well as chemosensitizer, which fosters the induction of immunogenic dead tumor cells leading to local and in special cases also to systemic tumor control.

  7. Tribotronic control of friction in oil-based lubricants with ionic liquid additives.

    PubMed

    Cooper, P K; Li, H; Rutland, M W; Webber, G B; Atkin, R

    2016-08-24

    Atomic force microscopy (AFM) reveals that tribotronic control of friction using an external potential applied to a gold surface is possible for ionic liquid (IL) concentrations as low as 5 mol% in hexadecane. The IL used is trihexyl(tetradecyl)phosphonium bis(2,4,4-trimethylpentyl)phosphinate, in which both the cation and anion have surfactant-like structures, and is miscible with hexadecane in all proportions. For IL concentrations less than 5 mol% friction does not vary with applied potential, but for 5 mol% and above changing the potential changes the composition of the IL boundary layer from cation-enriched (negative potentials) to anion-enriched (positive potentials). As the lubricities of the cation-rich and anion-rich boundary layers differ, this enables active control of friction in oil-based lubricants. PMID:27511143

  8. Mosquitocidal vaccines: a neglected addition to malaria and dengue control strategies.

    PubMed

    Billingsley, Peter F; Foy, Brian; Rasgon, Jason L

    2008-09-01

    The transmission of vector-borne diseases is dependent upon the ability of the vector to survive for longer than the period of development of the pathogen within the vector. One means of reducing mosquito lifespan, and thereby reducing their capacity to transmit diseases, is to target mosquitoes with vaccines. Here, the principle behind mosquitocidal vaccines is described, their potential impact in malaria and dengue control is modeled and the current research that could make these vaccines a reality is reviewed. Mosquito genome data, combined with modern molecular techniques, can be exploited to overcome the limited advances in this field. Given the large potential benefit to vector-borne disease control, research into the development of mosquitocidal vaccines deserves a high profile. PMID:18678529

  9. Evidence for additive polygenic control of pupation height in Drosophila ananassae.

    PubMed

    Singh, B N; Pandey, M B

    1993-01-01

    In order to study the mode of inheritance of pupation height in Drosophila ananassae, two mass culture stocks derived from ecogeographically different localities in India, were used to make a complete set of 16 crosses, which include parentals, F1, backcrosses, and F2. Pupation height defined as the distance a larva pupates over the surface of culture medium was scored in all 16 crosses. The two parental lines showed significant difference in pupation height. The F1 larvae in both reciprocal crosses had intermediate pupation height and there was no difference between two reciprocal crosses as well as between F1 and mid parent value. However, there was greater variance in the F2 generation. These findings provide evidence that the inheritance of pupation height fits a classical additive polygenic model and suggested that there is substantial amount of additive genetic variation in natural populations of D. ananassae. Furthermore, the analysis of reciprocal backcrosses shows significant maternal effect. Progeny with low pupating mothers showed lower pupation height than those with low pupating fathers and progeny with high pupating mothers had higher pupation height than those with high pupating fathers. Since the maternal effect was found only in backcrosses but not in the F1, it is suggested that this maternal effect on pupation height follows the pattern of inheritance of a transient maternal effect.

  10. Peripherally acting opioids and clinical implications for pain control.

    PubMed

    Sehgal, Nalini; Smith, Howard S; Manchikanti, Laxmaiah

    2011-01-01

    Opioid receptors are widely expressed in the central and peripheral nervous system and in the non-neuronal tissues. Data from animal and human clinical studies support the involvement of peripheral opioid receptors in analgesia, especially in the presence of inflammation. Inflammation has been shown to increase the synthesis of opioid receptors in the dorsal root ganglion neurons and enhance transport and accumulation of opioid receptors in the peripheral terminals of sensory neurons. Under the influence of chemokines and adhesion molecules, opioid peptide-containing immune cells extravasate and accumulate in the injured tissues. Stress, chemokines, cytokines, and other releasing factors in inflamed tissues stimulate these granulocytes to release opioid peptides. Once secreted, opioid peptides bind to and activate peripheral opioid receptors on sensory nerve fibers and produce analgesia by decreasing the excitability of sensory nerves and/or inhibiting release of pro-inflammatory neuropeptides. Research has revealed that local application of exogenous opioid agonists produces a potent analgesic effect by activating peripheral opioid receptors in inflamed tissues. The analgesic activity occurs without activation of opioid receptors in the central nervous system (CNS), and therefore centrally mediated side effects, such as respiratory depression, mental clouding, altered consciousness, or addiction, are not associated with peripheral opioid activity. This discovery has stimulated research on developing peripherally restricted opioid agonists that lack CNS effects. In addition, it has been recognized that opioid receptors modulate inflammation, and that opioids have anti-inflammatory effects. The anti-inflammatory actions of opioids are not well known or understood. Conflicting reports on mu-opioids suggest both anti-inflammatory and pro-inflammatory effects. This article will present the basis for peripheral opioid analgesia and describe current research directed at

  11. From lab to industrial: PZT nanoparticles synthesis and process control for application in additive manufacturing

    NASA Astrophysics Data System (ADS)

    Huang, Hsien-Lin

    Lead Zirconate Titanate (PZT) nanoparticles hold many promising current and future applications, such as PZT ink for 3-D printing or seeds for PZT thick films. One common method is hydrothermal growth, in which temperature, duration time, or mineralizer concentrations are optimized to produce PZT nanoparticles with desired morphology, controlled size and size distribution. A modified hydrothermal process is used to fabricate PZT nanoparticles. The novelty is to employ a high ramping rate (e.g., 20 deg C/min) to generate abrupt supersaturation so as to promote burst nucleation of PZT nanoparticles as well as a fast cooling rate (e.g., 5 deg C/min) with a controlled termination of crystal growth. As a result, PZT nanoparticles with a size distribution ranging from 200 nm to 800 nm are obtained with cubic morphology and good crystallinity. The identification of nanoparticles is confirmed through use of X-ray diffractometer (XRD). XRD patterns are used to compare sample variations in their microstructures such as lattice parameter. A cubic morphology and particle size are also examined via SEM images. The hydrothermal process is further modified with excess lead (from 20% wt. to 80% wt.) to significantly reduce amorphous phase and agglomeration of the PZT nanoparticles. With a modified process, the particle size still remains within the 200 nm to 800 nm. Also, the crystal structures (microstructure) of the samples show little variations. Finally, a semi-continuous hydrothermal manufacturing process was developed to substantially reduce the fabrication time and maintained the same high quality as the nanoparticles prepared in an earlier stage. In this semi-continuous process, a furnace is maintained at the process temperature (200 deg C), whereas autoclaves containing PZT sol are placed in and out of the furnace to control the ramp-up and cooling rates. This setup eliminates an extremely time-consuming step of cooling down the furnace, thus saving tremendous amount of

  12. Formalin treatments pass new tests. Additional notes on the control of ecto-parasitic protozoa

    USGS Publications Warehouse

    1940-01-01

    After the completion of the eхреriments reported recently, in which the efficacy of formalin in controlling infections of Gostia mecatrix was demonstrated, the author was afforded an opportunity to test the value of formalin solutions in combatting established mixed infections of (Gyrodactylus, Tricbodina, Cyclochaeta) and a stalked protozoan on rainbow trout fingerlings. This opportunity was provided through the courtesy and cooperation of Clarence F. Pautzke, Chief Biologist for the Washington State Game Department, and Lee Walters, Superintendent of the Washington State Hatchery at Seward Park, Seattle.

  13. Sodium Bicarbonate Prevents Contrast-Induced Nephropathy in Addition to Theophylline: A Randomized Controlled Trial.

    PubMed

    Huber, Wolfgang; Huber, Toni; Baum, Stephan; Franzen, Michael; Schmidt, Christian; Stadlbauer, Thomas; Beitz, Analena; Schmid, Roland M; Schmid, Sebastian

    2016-05-01

    In this study, we investigated whether hydration with sodium bicarbonate is superior to hydration with saline in addition to theophylline (both groups) in the prophylaxis of contrast-induced nephropathy (CIN). It was a prospective, randomized, double-blinded study in a university hospital on 2 general intensive care units (63% of investigations) and normal wards.After approval of the local ethics committee and informed consent 152 patients with screening serum creatinine ≥1.1 mg/dL and/or at least 1 additional risk factor for CIN undergoing intravascular contrast media (CM) exposure were randomized to receive a total of 9 mL/kg bicarbonate 154 mmol/L (group B; n = 74) or saline 0.9% (group S; n = 78) hydration within 7 h in addition to intravenous application of 200 mg theophylline. Serum creatinine was determined immediately before, 24 and 48 h after CM exposure. As primary endpoint we investigated the incidence of CIN (increase of serum creatinine ≥0.5 mg/dL and/or ≥25% within 48 h of CM).Both groups were comparable regarding baseline characteristics. Incidence of CIN was significantly less frequent with bicarbonate compared to sodium hydration (1/74 [1.4%] vs 7/78 [9.0%]; P = 0.035). Time course of serum creatinine was more favorable in group B with decreases in serum creatinine after 24 h (-0.084 mg/dL [95% confidence interval: -0.035 to -0.133 mg/dL]; P = 0.008) and 48 h (-0.093 mg/dL (-0.025 to -0.161 mg/dL); P = 0.007) compared to baseline which were not observed in group S.In patients at increased risk of CIN receiving prophylactic theophylline, hydration with sodium bicarbonate reduces contrast-induced renal impairment compared to hydration with saline. PMID:27227933

  14. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial.

    PubMed

    Riva, Giuseppe; Bacchetta, Monica; Cesa, Gianluca; Conti, Sara; Castelnuovo, Gianluca; Mantovani, Fabrizia; Molinari, Enrico

    2006-08-01

    For many, obesity is just a problem of energy input and expenditure: more energy input than expenditure. However, the clinical practice and epidemiological data clearly show that weight control is more complex than expected by this simple equation. This is particularly true in morbid obesity, a form of severe obesity in which a person's Body Mass Index (BMI, kg/m(2)) is over 40. If we compare the definitions and diagnostic criteria for "dependence" and "addiction" with the situation of many severe obese subjects, it is apparent that they match very well. Further, different neurological studies confirm this similarity: both addiction and obesity patients have a deficiency of dopamine receptors. Nevertheless, when we compare many of the actual obesity treatments with the ones used in the area of addictions it is possible to find relevant differences: obesity treatments neither consider different levels of type and intensity of care, nor a multidimensional approach. To overcome these limitations, in this paper we propose a bio-psychosocial approach in which the genetic influence (lack of dopamine receptors) is matched by psychosocial issues (pressure for thinness and diet as main body image dissatisfaction treatment). Further, the paper outlines how this approach may influence the treatment options, by focusing both on the lessons coming from actual addiction treatment and the opportunities offered by virtual reality. Finally, the paper presents and discusses the outcome of a controlled trial, based on the proposed approach, including a 6-month follow-up (211 morbid obese females with a BMI of >40 and a documented history of failures.

  15. 77 FR 29307 - Control of Alcohol and Drug Use: Addition of Post-Accident Toxicological Testing for Non...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-17

    ... substances under the Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention... substances by safety- sensitive employees, may be too narrow to cover the use of prescription and OTC drugs... additional costs to employers would be minimal and indirect, such as the cost of responding to an......

  16. Summary of Previous Chamber or Controlled Anthrax Studies and Recommendations for Possible Additional Studies

    SciTech Connect

    Piepel, Gregory F.; Amidan, Brett G.; Morrow, Jayne B.

    2010-12-29

    This report and an associated Excel file(a) summarizes the investigations and results of previous chamber and controlled studies(b) to characterize the performance of methods for collecting, storing and/or transporting, extracting, and analyzing samples from surfaces contaminated by Bacillus anthracis (BA) or related simulants. This report and the Excel are the joint work of the Pacific Northwest National Laboratory (PNNL) and the National Institute of Standards and Technology (NIST) for the Department of Homeland Security, Science and Technology Directorate. The report was originally released as PNNL-SA-69338, Rev. 0 in November 2009 with limited distribution, but was subsequently cleared for release with unlimited distribution in this Rev. 1. Only minor changes were made to Rev. 0 to yield Rev. 1. A more substantial update (including summarizing data from other studies and more condensed summary tables of data) is underway

  17. Powder Layer Preparation Using Vibration-controlled Capillary Steel Nozzles for Additive Manufacturing

    NASA Astrophysics Data System (ADS)

    Stichel, Thomas; Laumer, Tobias; Baumüller, Tobias; Amend, Philipp; Roth, Stephan

    In this report, the dry delivery of polyamide 12 powders by vibrating capillary steel nozzles is investigated and discussed regarding its potential for powder layer preparation in Laser Beam Melting. Therefore, a setup including a steel nozzle assembled on a piezoelectric actuator is presented, which enables the precise control over very small powder quantities by vibration excitation. An analysis reveals that the mass flow through the nozzle can be adjusted by the vibration modes in a certain range depending on the nozzle's specifications, whereas the vibration modes themselves show a complicated behaviour. Using a positioning system in combination with the vibrating nozzle, single-layer patterns consisting of polyamide 12 are produced and characterized regarding surface homogeneity and selectivity using a laser stripe sensor.

  18. Foreword: Additive Manufacturing: Interrelationships of Fabrication, Constitutive Relationships Targeting Performance, and Feedback to Process Control

    DOE PAGES

    Carpenter, John S.; Beese, Allison M.; Bourell, David L.; Hamilton, Reginald F.; Mishra, Rajiv; Sears, James

    2015-06-26

    Additive manufacturing (AM) offers distinct advantages over conventional manufacturing processes including the capability to both build and repair complex part shapes; to integrate and consolidate parts and thus overcome joining concerns; and to locally tailor material compositions as well as properties. Moreover, a variety of fields such as aerospace, military, automotive, and biomedical are employing this manufacturing technique as a way to decrease costs, increase manufacturing agility, and explore novel geometry/functionalities. In order to increase acceptance of AM as a viable processing method, pathways for qualifying both the material and the process need to be developed and, perhaps, standardized. Thismore » symposium was designed to serve as a venue for the international AM community—including government, academia, and industry—to define the fundamental interrelationships between feedstock, processing, microstructure, shape, mechanical behavior/materials properties, and function/performance. Eventually, insight into the connections between processing, microstructure, property, and performance will be achieved through experimental observations, theoretical advances, and computational modeling of physical processes. Finally, once this insight matures, AM will be able to move from the realm of making parts to making qualified materials that are certified for use with minimal need for post-fabrication characterization.« less

  19. Foreword: Additive Manufacturing: Interrelationships of Fabrication, Constitutive Relationships Targeting Performance, and Feedback to Process Control

    SciTech Connect

    Carpenter, John S.; Beese, Allison M.; Bourell, David L.; Hamilton, Reginald F.; Mishra, Rajiv; Sears, James

    2015-06-26

    Additive manufacturing (AM) offers distinct advantages over conventional manufacturing processes including the capability to both build and repair complex part shapes; to integrate and consolidate parts and thus overcome joining concerns; and to locally tailor material compositions as well as properties. Moreover, a variety of fields such as aerospace, military, automotive, and biomedical are employing this manufacturing technique as a way to decrease costs, increase manufacturing agility, and explore novel geometry/functionalities. In order to increase acceptance of AM as a viable processing method, pathways for qualifying both the material and the process need to be developed and, perhaps, standardized. This symposium was designed to serve as a venue for the international AM community—including government, academia, and industry—to define the fundamental interrelationships between feedstock, processing, microstructure, shape, mechanical behavior/materials properties, and function/performance. Eventually, insight into the connections between processing, microstructure, property, and performance will be achieved through experimental observations, theoretical advances, and computational modeling of physical processes. Finally, once this insight matures, AM will be able to move from the realm of making parts to making qualified materials that are certified for use with minimal need for post-fabrication characterization.

  20. Seagrass metabolism across a productivity gradient using the eddy covariance, Eulerian control volume, and biomass addition techniques

    NASA Astrophysics Data System (ADS)

    Long, Matthew H.; Berg, Peter; Falter, James L.

    2015-05-01

    The net ecosystem metabolism of the seagrass Thalassia testudinum was studied across a nutrient and productivity gradient in Florida Bay, Florida, using the Eulerian control volume, eddy covariance, and biomass addition techniques. In situ oxygen fluxes were determined by a triangular Eulerian control volume with sides 250 m long and by eddy covariance instrumentation at its center. The biomass addition technique evaluated the aboveground seagrass productivity through the net biomass added. The spatial and temporal resolutions, accuracies, and applicability of each method were compared. The eddy covariance technique better resolved the short-term flux rates and the productivity gradient across the bay, which was consistent with the long-term measurements from the biomass addition technique. The net primary production rates from the biomass addition technique, which were expected to show greater autotrophy due to the exclusion of sediment metabolism and belowground production, were 71, 53, and 30 mmol carbon m-2 d-1 at 3 sites across the bay. The net ecosystem metabolism was 35, 25, and 11 mmol oxygen m-2 d-1 from the eddy covariance technique and 10, -103, and 14 mmol oxygen m-2 d-1 from the Eulerian control volume across the same sites, respectively. The low-flow conditions in the shallow bays allowed for periodic stratification and long residence times within the Eulerian control volume that likely reduced its precision. Overall, the eddy covariance technique had the highest temporal resolution while producing accurate long-term flux rates that surpassed the capabilities of the biomass addition and Eulerian control volume techniques in these shallow coastal bays.

  1. Controlling Phase Separation of Interpenetrating Polymer Networks by Addition of Block Copolymers

    NASA Astrophysics Data System (ADS)

    Rohde, Brian; Krishnamoorti, Ramanan; Robertson, Megan

    2015-03-01

    Interpenetrating polymer networks (IPNs) offer a unique way to produce mechanically superior thermoset blends relative to the neat components. In this study, IPNs were prepared consisting of polydicyclopentadiene (polyDCPD), contributing high fracture toughness, and an epoxy resin (the diglycidyl ether of bisphenol A cured with nadic methyl anhydride), contributing high tensile strength and modulus. In the absence of compatibilization, the simultaneous curing of the networks leads to a macroscopically phase separated blend that exhibits poor mechanical behavior. To control phase separation and drive the system towards more mechanically robust nanostructured IPNs, block copolymers were designed to compatibilize this system, where one block possesses affinity to polyDCPD (polynorbornene in this study) and the other block possesses affinity to DGEBA (poly(ɛ-caprolactone) in this study). The influence of the block copolymer composition on the degree of phase separation and interfacial adhesion in the IPN was studied using a combination of small-angle scattering and imaging techniques. The resultant mechanical properties were explored and structure-property relationships were developed in this blend system.

  2. Controlling Phase Separation of Tough Interpenetrating Polymer Networks via Addition of Amphiphilic Block Copolymers

    NASA Astrophysics Data System (ADS)

    Rohde, Brian; Krishnamoorti, Ramanan; Robertson, Megan

    Interpenetrating polymer networks (IPNs) offer a unique way to combine the mechanical properties of two thermoset systems. Often used to create a material that possesses both high toughness and tensile properties, here we use polydicyclopentadiene, cured via ring opening metathesis polymerization, to contribute high toughness and diglycidyl ether of bisphenol A cured via anhydride chemistry to contribute high tensile strength and modulus. As the uncompatibilized system reacts in the presence of one another, mesoscopic phase separation occurs and dictates the overall efficacy of combining mechanical properties. To control phase separation and drive the system towards more mechanically robust nanostructed IPNs, amphiphilic block copolymers of polybutadiene- b-polyethylene oxide, where one block possesses strong affinity to polyDCPD and the other the DGEBA, were added to the system. Here we present a systematic study of the influence of block copolymer composition in the overall blend on degree of phase separation and morphology using a combination of small-angle x-ray scattering (SAXS) and scanning electron microscopy (SEM) techniques. The resultant mechanical properties are then explored in an effort to link mechanical properties to blend morphology.

  3. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.

    PubMed

    Prohászka, Zoltán; Nilsson, Bo; Frazer-Abel, Ashley; Kirschfink, Michael

    2016-11-01

    In recent years, complement analysis of body fluids and biopsies, going far beyond C3 and C4, has significantly enhanced our understanding of the disease process. Such expanded complement analysis allows for a more precise differential diagnosis and for critical monitoring of complement-targeted therapy. These changes are a result of the growing understanding of the involvement of complement in a diverse set of disorders. To appreciate the importance of proper complement analysis, it is important to understand the role it plays in disease. Historically, it was the absence of complement as manifested in severe infection that was noted. Since then complement has been connected to a variety of inflammatory disorders, such as autoimmune diseases and hereditary angioedema. While the role of complement in the rejection of renal grafts has been known longer, the significant impact of complement. In certain nephropathies has now led to the reclassification of some rare kidney diseases and an increased role for complement analysis in diagnosis. Even more unexpected is that complement has also been implicated in neural, ophtalmological and dermatological disorders. With this level of involvement in some varied and impactful health issues proper complement testing is clearly important; however, analysis of the complement system varies widely among laboratories. Except for a few proteins, such as C3 and C4, there are neither well-characterized standard preparations nor calibrated assays available. This is especially true for the inter-laboratory variation of tests which assess classical, alternative, or lectin pathway function. In addition, there is a need for the standardization of the measurement of complement activation products that are so critical in determining whether clinically relevant complement activation has occurred in vivo. Finally, autoantibodies to complement proteins (e.g. anti-C1q), C3 and C4 convertases (C3 and C4 nephritic factor) or to regulatory proteins

  4. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.

    PubMed

    Prohászka, Zoltán; Nilsson, Bo; Frazer-Abel, Ashley; Kirschfink, Michael

    2016-11-01

    In recent years, complement analysis of body fluids and biopsies, going far beyond C3 and C4, has significantly enhanced our understanding of the disease process. Such expanded complement analysis allows for a more precise differential diagnosis and for critical monitoring of complement-targeted therapy. These changes are a result of the growing understanding of the involvement of complement in a diverse set of disorders. To appreciate the importance of proper complement analysis, it is important to understand the role it plays in disease. Historically, it was the absence of complement as manifested in severe infection that was noted. Since then complement has been connected to a variety of inflammatory disorders, such as autoimmune diseases and hereditary angioedema. While the role of complement in the rejection of renal grafts has been known longer, the significant impact of complement. In certain nephropathies has now led to the reclassification of some rare kidney diseases and an increased role for complement analysis in diagnosis. Even more unexpected is that complement has also been implicated in neural, ophtalmological and dermatological disorders. With this level of involvement in some varied and impactful health issues proper complement testing is clearly important; however, analysis of the complement system varies widely among laboratories. Except for a few proteins, such as C3 and C4, there are neither well-characterized standard preparations nor calibrated assays available. This is especially true for the inter-laboratory variation of tests which assess classical, alternative, or lectin pathway function. In addition, there is a need for the standardization of the measurement of complement activation products that are so critical in determining whether clinically relevant complement activation has occurred in vivo. Finally, autoantibodies to complement proteins (e.g. anti-C1q), C3 and C4 convertases (C3 and C4 nephritic factor) or to regulatory proteins

  5. Precise control of polymer coated nanopores by nanoparticle additives: Insights from computational modeling

    NASA Astrophysics Data System (ADS)

    Eskandari Nasrabad, Afshin; Jasnow, David; Zilman, Anton; Coalson, Rob D.

    2016-08-01

    Polymer-nanoparticle composites are a promising new class of materials for creation of controllable nano-patterned surfaces and nanopores. We use coarse-grained molecular dynamics simulations augmented with analytical theory to study the structural transitions of surface grafted polymer layers (brushes) induced by infiltration of nanoparticles that are attracted to the polymers in the layer. We systematically compare two different polymer brush geometries: one where the polymer chains are grafted to a planar surface and the other where the chains are grafted to the inside of a cylindrical nanochannel. We perform a comprehensive study of the effects of the material parameters such as the polymer chain length, chain grafting density, nanoparticle size, strength of attraction between nanoparticles and polymer monomers, and, in the case of the cylindrically grafted brush, the radius of the cylinder. We find a very general behavioral motif for all geometries and parameter values: the height of the polymer brush is non-monotonic in the nanoparticle concentration in solution. As the nanoparticle concentration increases, the brush height first decreases and after passing through a minimum value begins to increase, resulting in the swelling of the nanoparticle infused brush. These morphological features may be useful for devising tunable "smart" nano-devices whose effective dimensions can be reversibly and precisely adjusted by changing the nanoparticle concentration in solution. The results of approximate Self-Consistent Field Theory (SCFT) calculations, applicable in the regime of strong brush stretching, are compared to the simulation results. The SCFT calculations are found to be qualitatively, even semi-quantitatively, accurate when applied within their intended regime of validity, and provide a useful and efficient tool for modeling such materials.

  6. Control over hygroscopic growth of saline aqueous aerosol using Pluronic polymer additives.

    PubMed

    Haddrell, Allen E; Hargreaves, Graham; Davies, James F; Reid, Jonathan P

    2013-02-25

    difference in diameter is RH dependent, and may be much greater at higher humidities. These findings suggest that the addition of μM concentrations of larger Pluronic polymers to nebulizer formulations may greatly reduce the size of aerosols produced. PMID:23333755

  7. Ring Walking/Oxidative Addition Reactions for the Controlled Synthesis of Conjugated Polymers

    SciTech Connect

    Bazan, Guillermo C

    2012-04-03

    Power conversion efficiencies of plastic solar cells depend strongly on the molecular weight characteristics of the semiconducting polymers used for their fabrication. The synthesis of these materials typically relies on transition metal mediated catalytic reactions. In many instances, the ideal structures cannot be attained because of deficiencies in these reactions, particularly when it comes to being able to achieve high number average molecular weights and narrow molecular weight distributions. Another important conjugated polymer structure of interest is one in which a single functional group is attached at the end group of the chain. Such systems would be ideal for modifying surface properties at interfaces and for labeling biomolecular probes used in fluorescent biosensors. To respond to the challenges above, our efforts have centered on the design of homogenous transition metal complexes that are easy to prepare and effective in carrying out living, or quasi-living, condensative chain polymerization reactions. The key mechanistic challenge for the success of this reaction is to force the insertion of one monomer unit at a time via a process that involves migration of the transition metal-containing fragment to one terminus of the polymer chain. Chain growth characteristics are therefore favored when the metal does not dissociate from the newly formed reductive elimination product. We have proposed that dissociation is disfavored by the formation of a -complex, in which the metal can sample various locations of the electronically delocalized framework, a process that we term ring-walking , and find the functionality where oxidative addition takes place. Success has been achieved in the nickel-mediated cross coupling reaction of Grignard reagents with aromatic halides by using bromo[1,2-bis(diphenylphosphino)ethane]phenylnickel. This reagent can yield poly(thiophene)s (one of the most widely used type of polymer in plastic solar cells) with excellent

  8. Functional MRI in human motor control studies and clinical applications.

    PubMed

    Toma, Keiichiro; Nakai, Toshiharu

    2002-07-01

    Functional magnetic resonance imaging (fMRI) has been a useful tool for the noninvasive mapping of brain function associated with various motor and cognitive tasks. Because fMRI is based on the blood oxygenation level dependent (BOLD) effect, it does not directly record neural activity. With the fMRI technique, distinguishing BOLD signals created by cortical projection neurons from those created by intracortical neurons appears to be difficult. Two major experimental designs are used in fMRI studies: block designs and event-related designs. Block-designed fMRI presupposes the steady state of regional cerebral blood flow and has been applied to examinations of brain activation caused by tasks requiring sustained or repetitive movements. By contrast, the more recently developed event-related fMRI with time resolution of a few seconds allows the mapping of brain activation associated with a single movement according to the transient aspects of the hemodynamic response. Increasing evidence suggests that multiple motor areas are engaged in a networked manner to execute various motor acts. In order to understand functional brain maps, it is important that one understands sequential and parallel organizations of anatomical connections between multiple motor areas. In fMRI studies of complex motor tasks, elementary parameters such as movement length, force, velocity, acceleration and frequency should be controlled, because inconsistency in those parameters may alter the extent and intensity of motor cortical activation, confounding interpretation of the findings obtained. In addition to initiation of movements, termination of movements plays an important role in the successful achievement of complex movements. Brain areas exclusively related to the termination of movements have been, for the first time, uncovered with an event-related fMRI technique. We propose the application of fMRI to the elucidation of the pathophysiology of movement disorders, particularly dystonia

  9. 77 FR 38084 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... FR 24984, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Clinical Supplies... U.S.C. 823(a) and 952(a) and determined that the registration of Clinical Supplies Management,...

  10. Cement cake properties in static filtration--On the role of fluid loss control additives on the cake porosity

    SciTech Connect

    Desbrieres, J. )

    1993-11-01

    The mechanism of the action of fluid loss control additives in cementing oilwell operations is principally the reduction of permeability of the cement filter cake. From filtration equations physical characteristics as porosity of the cement filter cake were investigated and compared with experimental data. A good correlation is observed when no adsorption is involved. The smallest pore diameter for obtaining an efficient control of fluid loss is shown to be of the same order of magnitude as the gyration radius of used macromolecular chains.

  11. Empathy in Boys with Gender Identity Disorder: A Comparison to Externalizing Clinical Control Boys and Community Control Boys and Girls

    ERIC Educational Resources Information Center

    Owen-Anderson, Allison F. H.; Jenkins, Jennifer M.; Bradley, Susan J.; Zucker, Kenneth J.

    2008-01-01

    Objective: The construct of empathy was examined in 20 boys with gender identity disorder (GID), 20 clinical control boys with externalizing disorders (ECC), 20 community control boys (NCB), and 20 community control girls (NCG). The mean age of the children was 6.86 years (range = 4-8 years). It was hypothesized that boys with GID would show…

  12. Metabolic Correction in the Management of Diabetic Peripheral Neuropathy: Improving Clinical Results Beyond Symptom Control

    PubMed Central

    Miranda-Massari, Jorge R.; Gonzalez, Michael J.; Jimenez, Francisco J.; Allende-Vigo, Myriam Z.; Duconge, Jorge

    2013-01-01

    Current Clinical Management Guidelines of Diabetic Peripheral Neuropathy (DPN) are based on adequate glucose control and symptomatic pain relief. However, meticulous glycemic control could delay the onset or slow the progression of diabetic neuropathy in patients with DM type 2, but it does not completely prevent the progression of the disease. Complications of DPN as it continues its natural course, produce increasing pain and discomfort, loss of sensation, ulcers, infections, amputations and even death. In addition to the increased suffering, disability and loss of productivity, there is a very significant economic impact related to the treatment of DPN and its complications. In USA alone, it has been estimated that there are more than 5,000,000 patients suffering from DPN and the total annual cost of treating the disease and its complications is over $10,000 million dollars. In order to be able to reduce complications of DPN, it is crucial to improve or correct the metabolic conditions that lead to the pathology present in this condition. Pathophysiologic mechanisms implicated in diabetic neuropathy include: increased polyol pathway with accumulation of sorbitol and reduced Na+/K+-ATPase activity, microvascular damage and hypoxia due to nitric oxide deficit and increased oxygen free radical activity. Moreover, there is a decrease in glutathione and increase in homocysteine. Clinical trials in the last two decades have demonstrated that the use of specific nutrients can correct some of these metabolic derangements, improving symptom control and providing further benefits such as improved sensorium, blood flow and nerve regeneration. We will discuss the evidence on lipoic acid, acetyi-L-carnitine, benfotiamine and the combination of active B vitamins L-methylfolate, methylcobalamin and piridoxal-6-phosphate. In addition, we discuss the role of metforrnin, an important drug in the management of diabetes, and the presence of specific polymorphic genes, in the risk

  13. Additional value of F-18 FDG PET/CT for initial staging in breast cancer with clinically negative axillary nodes.

    PubMed

    Jeong, Young Jin; Kang, Do-Young; Yoon, Hyun Jin; Son, Hye Joo

    2014-05-01

    The aim of this study was to evaluate the clinical impact of the preoperative ¹⁸F-FDG PET/CT in the initial workup of breast cancer with clinically negative axillary nodes. Whether the status of the clinical axillary nodal involvement can be considered a parameter for making a decision to omit the preoperative ¹⁸F-FDG PET/CT in the situation reported herein was also determined. A total of 178 patients who had newly diagnosed breast cancer and for whom the conventional diagnostic modalities showed no sign of axillary node metastasis were retrospectively enrolled in this study. All the patients underwent preoperative ¹⁸F-FDG PET/CT. The images and histologic results that were obtained were analyzed. ¹⁸F-FDG PET/CT detected primary lesions in 156 of the 178 patients, with an overall sensitivity of 87.6 %, and false negative results were obtained for 22 patients (12.4 %). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ¹⁸F-FDG PET/CT in the detection of axillary nodes were 20.8, 86.9, 37.0, 74.8, and 69.1 %, respectively. Extra-axillary node metastasis was identified in two patients (1.1 %) who had internal mammary nodes. There was no distant metastasis, but coexisting primary tumor was detected in five patients (2.8 %). In total, the therapeutic plan was changed based on ¹⁸F-FDG PET/CT in seven (3.9 %) of the 178 patients, but considering only the cases confined to breast cancer, the change occurred in only two patients (1.1 %). ¹⁸F-FDG PET/CT almost did not affect the initial staging and treatment plan in breast cancer with clinically negative axillary node. If the axillary node is clinically negative in the preoperative workup of breast cancer, then ¹⁸F-FDG PET/CT can be omitted.

  14. Relations of Anxiety Sensitivity, Control Beliefs, and Maternal Over-Control to Fears in Clinic-Referred Children with Specific Phobia

    PubMed Central

    Kane, Elisabeth J; Braunstein, Kara; Ollendick, Thomas H.; Muris, Peter

    2014-01-01

    The relations of fear to anxiety sensitivity, control beliefs, and maternal overprotection were examined in 126 7- to 13-year-old clinically referred children with specific phobias. Results indicated that anxiety sensitivity and control beliefs were significant predictors of children’s fear levels, accounting for approximately 48% of the total variance. Unexpectedly, age, gender, and maternal overprotection did not emerge as significant predictors of fear in the overall sample. In subsequent analyses, anxiety sensitivity was found to be a consistent, significant predictor for both girls and boys, for both younger and older children, and for children with and without an additional anxiety disorder diagnosis. Control beliefs were only a significant predictor for girls, younger children, and children with an additional anxiety diagnosis. Maternal overprotection was not a significant predictor for any group. Children with an additional anxiety disorder diagnosis had higher levels of fear, anxiety sensitivity, and maternal overprotection, as well as lower levels of control beliefs than the non-additional anxiety disorder subgroup. Future directions and clinical implications are explored. PMID:26273182

  15. Effect of kaolin addition on the performance of controlled low-strength material using industrial waste incineration bottom ash.

    PubMed

    Naganathan, Sivakumar; Razak, Hashim Abdul; Hamid, Siti Nadzriah Abdul

    2010-09-01

    Incineration of industrial waste produces large quantities of bottom ash which are normally sent to secured landfill, but is not a sustainable solution. Use of bottom ash in engineering applications will contribute to sustainability and generate revenue. One way of using the industrial waste incineration bottom ash is in controlled low-strength material (CLSM). Use of bottom ash in CLSM has problems related to bleeding and excessive strength development and so an additive has to be used to control bleeding and strength development. The main objective of this research is to study the effect of kaolin addition on the performance of CLSM made using industrial waste incineration bottom ash. CLSM mixes were made with bottom ash, cement, and refined kaolin. Various tests were performed on the CLSM in fresh and hardened states including compressive strength, water absorption, California bearing ratio (CBR) and the tests for concentration of leachable substances on the bleed and leachate. The compressive strength of CLSM tested ranged from 0.11 to 9.86 MPa. CBR values ranged from 6 to 46, and water absorption values from 12 to 36%. It was shown that the addition of kaolin delayed the initial setting time of CLSM mixtures, reduced bleeding, lowered the compressive strength, and increased the values of water absorption, sorption, and initial surface absorption. The CLSM tested did not have corrosivity. It was shown that the hardened CLSM was non hazardous, and the addition of kaolin increased the concentration of heavy metals and salts in the bleed and leachate.

  16. Clinical Characteristics of Impaired Trunk Control in Children with Spastic Cerebral Palsy

    ERIC Educational Resources Information Center

    Heyrman, Lieve; Desloovere, Kaat; Molenaers, Guy; Verheyden, Geert; Klingels, Katrijn; Monbaliu, Elegast; Feys, Hilde

    2013-01-01

    This study aimed to identify clinical characteristics of impaired trunk control in hundred children with spastic CP (mean age 11.4 [plus or minus] 2.1 years, range 8-15 years). Assessment of trunk control was performed with the Trunk Control Measurement Scale (TCMS). Trunk control was clearly impaired, indicated by a median total TCMS score of…

  17. Ant colony method to control variance reduction techniques in the Monte Carlo simulation of clinical electron linear accelerators

    NASA Astrophysics Data System (ADS)

    García-Pareja, S.; Vilches, M.; Lallena, A. M.

    2007-09-01

    The ant colony method is used to control the application of variance reduction techniques to the simulation of clinical electron linear accelerators of use in cancer therapy. In particular, splitting and Russian roulette, two standard variance reduction methods, are considered. The approach can be applied to any accelerator in a straightforward way and permits, in addition, to investigate the "hot" regions of the accelerator, an information which is basic to develop a source model for this therapy tool.

  18. When the FRAX® test is applied to controlled clinical trials

    PubMed Central

    Fiore, Carmelo Erio; Gaudio, Agostino

    2012-01-01

    Summary FRAX® is a computer-based algorithm developed by the World Health Organization Collaborating Centre for Metabolic Bone Diseases in Sheffield (UK). This algorithm calculates fracture probability from easily obtained clinical risk factors in men and women: age, sex, body mass index and dichotomized variables comprising prior fragility fracture, parental history of hip fracture, current tobacco smoking, use of long-term oral glucocorticoid, rheumatoid arthritis, other causes of secondary osteoporosis and high alcohol consumption (femoral neck bone mineral density can be optionally input to enhance fracture risk prediction). The output of FRAX® is the 10-year probability of a major osteoporotic fracture (hip, clinical spine, humerus or wrist fracture) and the 10-year probability of hip fracture. Recently various Authors have re-evaluated the effectiveness of drugs approved for postmenopausal osteoporosis to test whether they are more effective in women with higher FRAX® probabilities. PMID:23289024

  19. [Controlling methods of clinical research on acu-moxibustion commonly used of abroad].

    PubMed

    Wang, Xin-juan; Zhao, Bai-xiao

    2006-06-01

    With the application of scientific studying methods, the level of clinical study has been improved greatly, and people has been paid more attention to scientific evaluation of the clinical effect of Chinese medicine and acu-moxibustion. Formerly, because of lack in acceptance and application of modern scientific studying methods in Chinese clinical acu-moxibustion researchers, their achievements weren't approved by the international academy for the faulty model of study. Randomized Control Trial (RCT) is the golden standard method widely accepted at present, so it is of great importance for clinical acu-moxibustion researchers to exert control methods correctly and effectively. The commonly used controlling methods of overseas clinical acu-moxibustion studies were discussed in this article in order to give some suggestion and benifits to the internal acu-moxibustion clinical researchers. PMID:16841681

  20. [Controlling methods of clinical research on acu-moxibustion commonly used of abroad].

    PubMed

    Wang, Xin-juan; Zhao, Bai-xiao

    2006-06-01

    With the application of scientific studying methods, the level of clinical study has been improved greatly, and people has been paid more attention to scientific evaluation of the clinical effect of Chinese medicine and acu-moxibustion. Formerly, because of lack in acceptance and application of modern scientific studying methods in Chinese clinical acu-moxibustion researchers, their achievements weren't approved by the international academy for the faulty model of study. Randomized Control Trial (RCT) is the golden standard method widely accepted at present, so it is of great importance for clinical acu-moxibustion researchers to exert control methods correctly and effectively. The commonly used controlling methods of overseas clinical acu-moxibustion studies were discussed in this article in order to give some suggestion and benifits to the internal acu-moxibustion clinical researchers.

  1. Computer AIDS for Clinical Research Management and Control: General Analysis and Design

    PubMed Central

    Willard, Christopher G.; Gatewood, Laël C.; Ellis, Lynda B. M.

    1979-01-01

    Clinical research projects involve concurrent management of subjects, protocol, analysis and study. This complicated management problem could be aided by the use of computerized data systems. For most effective aid, such a system should consider all aspects of clinical research. We have analyzed clinical research tasks involving data collection, communication, and management and have used this task analysis to develop a system model for clinical research data management and control. The model deals with data control, study monitoring, user interfaces, report and analysis libraries, and study subject and support data bases. It may be used as a basis for computerized data system study and development. The model also indicates that the role of computerized systems in clinical research could be expanded into such areas as automatic report generation and control, process control aids, quality assurance monitoring, and study documentation.

  2. Clinical Evaluation of Functional Vision of +1.5 Diopters near Addition, Aspheric, Rotational Asymmetric Multifocal Intraocular Lens

    PubMed Central

    Khoramnia, Rahmin; Attia, Mary Safwat; Koss, Michael Janusz; Linz, Katharina; Auffarth, Gerd Uwe

    2016-01-01

    Purpose To evaluate postoperative outcomes and visual performance in intermediate distance after implantation of a +1.5 diopters (D) addition, aspheric, rotational asymmetric multifocal intraocular lens (MIOL). Methods Patients underwent bilateral cataract surgery with implantation of an aspheric, asymmetric MIOL with +1.5 D near addition. A complete ophthalmological examination was performed preoperatively and 3 months postoperatively. The main outcome measures were monocular and binocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UNVA) and distance corrected keratometry, and manifest refraction. The Salzburg Reading Desk was used to analyze unilateral and bilateral functional vision with uncorrected and corrected reading acuity, reading distance, reading speed, and the smallest log-scaled print size that could be read effectively at near and intermediate distances. Results The study comprised 60 eyes of 30 patients (mean age, 68.30 ± 9.26 years; range, 34 to 80 years). There was significant improvement in UDVA and CDVA. Mean UIVA was 0.01 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and mean DCIVA was -0.02 ± 0.11 logMAR. In Salzburg Reading Desk analysis for UIVA, the mean subjective intermediate distance was 67.58 ± 8.59 cm with mean UIVA of -0.02 ± 0.09 logMAR and mean word count of 96.38 ± 28.32 words/min. Conclusions The new aspheric, asymmetric, +1.5 D near addition MIOL offers good results for distance visual function in combination with good performance for intermediate distances and functional results for near distance. PMID:27729759

  3. The influence of deposit control additives on nitrogen oxides emissions from spark ignition engines (case study: Tehran).

    PubMed

    Bidhendi, Gholamreza Nabi; Zand, Ali Daryabeigi; Tabrizi, Alireza Mikaeili; Pezeshk, Hamid; Baghvand, Akbar

    2007-04-15

    In the present research, the influence of a deposit control additive on NOx emissions from two types of gasoline engine vehicles i.e., Peykan (base on Hillman) and Pride (South Korea Kia motors) was studied. Exhaust NOx emissions were measured in to stages, before decarbonization process and after that. Statistical analysis was conducted on the measurement results. Results showed that NOx emissions from Peykans increased 0.28% and NOx emissions from Pride automobiles decreased 6.18% on average, due to the elimination of engine deposits. The observed variations were not statistically and practically significant. The results indicated that making use of detergent additives is not an effective way to reduce the exhaust NOx emissions from gasoline engine vehicles. PMID:19069943

  4. Stability of ZnO quantum dots tuned by controlled addition of ethylene glycol during their growth

    NASA Astrophysics Data System (ADS)

    Zimmermann, Lizandra M.; Baldissera, Paulo V.; Bechtold, Ivan H.

    2016-07-01

    ZnO quantum dots were prepared via a sol–gel route from zinc acetate and sodium hydroxide. The influence of ethylene glycol addition during the first stages of reaction (1–5 min) as a stabilizer, as well as the influence of its concentration in 2-propanol were investigated. The optimization led to particles with enough stability and homogeneity around 3.7 nm of diameter to allow for quantum confinement effect. Spectroscopic UV–vis absorption measurements allowed to explore the underlying mechanism of nucleation and growth and to have the control of it. The emission of the ZnO nanoparticles was explored under experimental perturbations with addition of small amounts of water to investigate the interplay between surface defects and the excitonic effect. The results suggest that the water interferes directly on the defects first and later on the excitonic recombination. Their morphology was determined with transmission electron microscopy.

  5. Stability of ZnO quantum dots tuned by controlled addition of ethylene glycol during their growth

    NASA Astrophysics Data System (ADS)

    Zimmermann, Lizandra M.; Baldissera, Paulo V.; Bechtold, Ivan H.

    2016-07-01

    ZnO quantum dots were prepared via a sol-gel route from zinc acetate and sodium hydroxide. The influence of ethylene glycol addition during the first stages of reaction (1-5 min) as a stabilizer, as well as the influence of its concentration in 2-propanol were investigated. The optimization led to particles with enough stability and homogeneity around 3.7 nm of diameter to allow for quantum confinement effect. Spectroscopic UV-vis absorption measurements allowed to explore the underlying mechanism of nucleation and growth and to have the control of it. The emission of the ZnO nanoparticles was explored under experimental perturbations with addition of small amounts of water to investigate the interplay between surface defects and the excitonic effect. The results suggest that the water interferes directly on the defects first and later on the excitonic recombination. Their morphology was determined with transmission electron microscopy.

  6. Development of a New Hypersonic Shock Tunnel Facility to Investigate Electromagnetic Energy Addition for Flow Control and Basic Supersonic Combustion

    NASA Astrophysics Data System (ADS)

    Toro, P. G. P.; Minucci, M. A. S.; Chanes, J. B.; Pereira, A. L.; Nagamatsu, H. T.

    2006-05-01

    A new 0.6-m. diameter Hypersonic Shock Tunnel is been designed, fabricated and will be installed at the Laboratory of Aerothermodynamics and Hypersonics IEAv-CTA, Brazil. The brand new hypersonic facility, designated as T3, is primarily intended to be used as an important tool in the investigation of supersonic combustion management and of electromagnetic energy addition for flow control. The design of the runnel enables relatively long test times, 2-10 milliseconds, suitable for basic supersonic combustion and energy addition by laser experiments. Free stream Mach numbers ranging from 6 to 25 can be produced and stagnation pressures and temperatures of 200 atm. and 5,500 K, respectively, can be generated. Shadowgraph and schlieren optical techniques will be used for flow visualization and the new facility is expected to be commissioned by the end of 2006.

  7. Clinical Effects of Subgingivally Delivered Spirulina Gel in Chronic Periodontitis Cases: A Placebo Controlled Clinical Trial

    PubMed Central

    Mahendra, Jaideep; Mahendra, Little; Muthu, Jananni; John, Libby; Romanos, Georgios E.

    2013-01-01

    Aims and Objectives: The aim of this study was to assess the clinical effects of Spirulina in-situ gel as an adjunct to Scaling And Root Planning (SRP) in the treatment of chronic periodontitis subjects. Material and Methods: 64 sites were selected with probing pocket depth of ≥5mm and they were divided into 2 groups; 33 sites were treated with SRP along with spirulina gel (Group A) and 31 sites were treated with SRP alone (Group B). Clinical parameters were recorded at baseline before SRP and at 120th day after the treatment therapy. The parameters included Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). Results: Both the groups showed significant improvement in the parameters. However, Group A (SRP along with spirulina) showed statistically significant decrease in mean probing pocket depth and gain in the clinical attachment level after 120 days as compared to Group B SRP alone. Conclusion: Locally delivered spirulina gel, along with scaling and root planning, has been shown to cause a beneficial impact. The efficacy of the product as a local drug delivery system in the non-surgical treatment of periodontitis without any side effects has been proved. Spirulina appears to be promising. It exerts strong anti-inflammatory effects which are closely connected with its antioxidative activity. This study can have a significant impact on the treatment procedures of periodontitis, with the use of blue green algae in the future. PMID:24298522

  8. Effect of kaolin addition on the performance of controlled low-strength material using industrial waste incineration bottom ash.

    PubMed

    Naganathan, Sivakumar; Razak, Hashim Abdul; Hamid, Siti Nadzriah Abdul

    2010-09-01

    Incineration of industrial waste produces large quantities of bottom ash which are normally sent to secured landfill, but is not a sustainable solution. Use of bottom ash in engineering applications will contribute to sustainability and generate revenue. One way of using the industrial waste incineration bottom ash is in controlled low-strength material (CLSM). Use of bottom ash in CLSM has problems related to bleeding and excessive strength development and so an additive has to be used to control bleeding and strength development. The main objective of this research is to study the effect of kaolin addition on the performance of CLSM made using industrial waste incineration bottom ash. CLSM mixes were made with bottom ash, cement, and refined kaolin. Various tests were performed on the CLSM in fresh and hardened states including compressive strength, water absorption, California bearing ratio (CBR) and the tests for concentration of leachable substances on the bleed and leachate. The compressive strength of CLSM tested ranged from 0.11 to 9.86 MPa. CBR values ranged from 6 to 46, and water absorption values from 12 to 36%. It was shown that the addition of kaolin delayed the initial setting time of CLSM mixtures, reduced bleeding, lowered the compressive strength, and increased the values of water absorption, sorption, and initial surface absorption. The CLSM tested did not have corrosivity. It was shown that the hardened CLSM was non hazardous, and the addition of kaolin increased the concentration of heavy metals and salts in the bleed and leachate. PMID:20852000

  9. Use of Antimicrobial Food Additives as Potential Dipping Solutions to Control Pseudomonas spp. Contamination in the Frankfurters and Ham

    PubMed Central

    Oh, Mi-Hwa; Park, Beom-Young; Choi, Kyoung-Hee

    2014-01-01

    This study evaluated the effect of sodium diacetate and sodium lactate solutions for reducing the cell count of Pseudomonas spp. in frankfurters and hams. A mixture of Pseudomonas aeruginosa (NCCP10338, NCCP10250, and NCCP11229), and Pseudomonas fluorescens (KACC10323 and KACC10326) was inoculated on cooked frankfurters and ham. The inoculated samples were immersed into control (sterile distilled water), sodium diacetate (5 and 10%), sodium lactate (5 and 10%), 5% sodium diacetate + 5% sodium lactate, and 10% sodium diacetate + 10% sodium lactate for 0-10 min. Inoculated frankfurters and ham were also immersed into acidified (pH 3.0) solutions such as acidified sodium diacetate (5 and 10%), and acidified sodium lactate (5 and 10%) in addition to control (acidified distilled water) for 0-10 min. Total aerobic plate counts for Pseudomonas spp. were enumerated on Cetrimide agar. Significant reductions (ca. 2 Log CFU/g) in Pseudomonas spp. cells on frankfurters and ham were observed only for a combination treatment of 10% sodium lactate + 10% sodium diacetate. When the solutions were acidified to pH 3.0, the total reductions of Pseudomonas spp. were 1.5-4.0 Log CFU/g. The order of reduction amounts of Pseudomonas spp. cell counts was 10% sodium lactate > 5% sodium lactate ≥ 10% sodium diacetate > 5% sodium diacetate > control for frankfurters, and 10% sodium lactate > 5% sodium lactate > 10% sodium diacetate > 5% sodium diacetate > control for ham. The results suggest that using acidified food additive antimicrobials, as dipping solutions, should be useful in reducing Pseudomonas spp. on frankfurters and ham. PMID:26761492

  10. [Ancient literature on the heat control of umbilicus fumigation method and the modern clinical research].

    PubMed

    Zhang, Xiaoning; Guo, Xin; Yu, Baoluo; Zhang, Na; Ma, Yuxia

    2016-01-01

    In order to improve the clinical efficacy of the umbilicus fumigation method, the ancient literature with the heat control of umbilicus fumigation method involved is collected extensively and analyzed systematically, and the heat control, precautions and contraindications of this method are discussed. In association with the cases and the present clinical experience, the main factors to the heat control are introduced, such as preparation of doughnuts, filling quantity, size of moxa cone and numbers of moxa cones so that the clinical application of the umbilicus fumigation method can be promoted and enhanced.

  11. Chloride ion addition for controlling shapes and properties of silver nanorods capped by polyvinyl alcohol synthesized using polyol method

    NASA Astrophysics Data System (ADS)

    Junaidi, Yunus, Muhammad; Triyana, Kuwat; Harsojo, Suharyadi, Edi

    2016-04-01

    We report our investigation on the effect of chloride ions on controlling the shapes and properties of silver nanorods (AgNRs) synthesized using a polyol method. In this study, we used polyvinyl alcohol (PVA) as a capping agent and sodium chloride (NaCl) as a salt precursor and performed at the oil bath temperature of 140°C. The chloride ions originating from the NaCl serve to control the growth of the silver nanorods. Furthermore, the synthesized silver nanorods were characterized using SEM and XRD. The results showed that besides being able to control the growth of AgCl atoms, the chloride ions were also able to control the growth of multi-twinned-particles into the single crystalline of silver nanorods by micrometer-length. At an appropriate concentration of NaCl, the diameter of silver nanorods decreased significantly compared to that of without chloride ion addition. This technique may be useful since a particular diameter of silver nanorods affects a particular application in the future.

  12. Maternal Control and Adolescent Depression: Ethnic Differences among Clinically Referred Girls.

    ERIC Educational Resources Information Center

    Finkelstein, Jo-Ann S.; Donenberg, Geri R.; Martinovich, Zoran

    2001-01-01

    Examined the relationship between perceived maternal control and depression for 11 urban adolescent girls seeking psychological services at an outpatient clinic. No relation between control and depression was found for Caucasian and Latina girls, but high control was linked to less depression among African American girls. Findings highlight the…

  13. 77 FR 14805 - Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention: Notice of Charter Renewal This gives notice under the... Improvement Advisory Committee, Centers for Disease Control and Prevention (CDC), Department of Health...

  14. Creation and implementation of a historical controls database from randomized clinical trials

    PubMed Central

    Desai, Jigar R; Bowen, Edward A; Danielson, Mark M; Allam, Rajasekhar R; Cantor, Michael N

    2013-01-01

    Background Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation. Objective To create a historical controls database by leveraging internal clinical trial data at Pfizer, focusing on patients who received only placebo in randomized controlled trials. Methods We transformed disparate clinical data sources by indexing, developing, and integrating clinical data within internal databases and archives. We focused primarily on trials mapped into a consistent standard and trials in the pain therapeutic area as a pilot. Results Of the more than 20 000 internal Pfizer clinical trials, 2404 completed placebo controlled studies with a parallel design were identified. Due to challenges with informed consent and data standards used in older clinical trials, studies completed before 2000 were excluded, yielding 1134 studies from which placebo subjects and associated clinical data were extracted. Conclusions It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process. PMID:23449762

  15. Optimal Control of Shock Tube Flow via Water Addition with Application to Ignition Overpressure Mitigation in Launch Vehicles

    NASA Astrophysics Data System (ADS)

    Moshman, Nathan

    2009-11-01

    Ignition Overpressure (IOP) in launch vehicles occurs at the start of ignition when a steep rise in pressure propagates outward from the rocket nozzle. It is crucial to minimize the overpressure so as to decrease risk of damage to the rocket body. Currently, CFD studies exist on this situation but there are no optimization studies of the water addition as a means to suppress the IOP. The proposed dissertation will use a numerical method to compute an approximate solution for an optimal control problem constrained by the one-dimensional Euler PDEs of fluid dynamics as well as volume fraction conservation. A model for inter-phase transport of mass momentum and energy and fluid interface quantities will be given. The control will be water addition from external nozzles. The adjoint system of equations will be derived and discretized. Necessary optimal conditions will be derived. An SQP method will solve an optimal situation. Predictions will be validated against shock tube experiments at the NPS rocket lab.

  16. 78 FR 54913 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... notice published in the Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for... Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies..., 2013, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103,...

  17. 77 FR 47109 - Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for registration to import a basic... Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies..., 2012, Clinical Supplies ] Management Inc., 342 42nd Street South, Fargo, North Dakota 58103,...

  18. 77 FR 24984 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... the Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for registration to import... Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies.... Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on November 13, 2011, Clinical...

  19. Controlling Rater Stringency Error in Clinical Performance Rating: Further Validation of a Performance Rating Theory.

    ERIC Educational Resources Information Center

    Cason, Gerald J.; And Others

    Prior research in a single clinical training setting has shown Cason and Cason's (1981) simplified model of their performance rating theory can improve rating reliability and validity through statistical control of rater stringency error. Here, the model was applied to clinical performance ratings of 14 cohorts (about 250 students and 200 raters)…

  20. Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial

    PubMed Central

    2014-01-01

    Background Communication and information in order to reduce anxiety in the intensive care unit (ICU) has been described as area needing improvement. Therefore, the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients. Methods Multicenter, two-armed, non-blinded, parallel-group randomized controlled trial in hospitals in the cities of Marburg, Halle, and Stuttgart (Germany). The trial was performed in cardiac surgery, general surgery, and internal medicine ICUs. Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study (intervention group, n = 104; control group, n = 107). The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts: (1) A more standardized part about predefined ICU specific aspects – mainly procedural, sensory and coping information, and (2) an individualized part about fears and questions of the patient. The control group received a non-specific episodic conversation of similar length additional to standard care. Both conversations took place at the beginning of the ICU stay and lasted 10–15 minutes. Study nurses administered both interventions. The primary outcome ICU-related anxiety (CINT-Score, 0–100 pts., higher scores indicate higher anxiety) was assessed after admission to a regular ward. Results The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 (SD 14.4) compared to 20.8 (SD 14.7) and a mean difference of −0.2 (CI 95% -4.5 to 4.1). Conclusions A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration. Reduction of anxiety in ICU patients will probably require more continuous

  1. 78 FR 39339 - Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ..., 77 FR 50162, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103... importer of the basic classes of controlled substances: Drug Schedule Methylphenidate (1724) II...

  2. Chemical additive to enhance antimicrobial efficacy of chlorine and control cross-contamination during immersion chill of broiler carcasses.

    PubMed

    Schambach, B T; Berrang, M E; Harrison, M A; Meinersmann, R J

    2014-09-01

    Immersion chilling of broiler carcasses can be a site for cross-contamination between the occasional highly contaminated carcass and those that are co-chilled. Chlorine is often used as an antimicrobial but can be overcome by organic material. A proprietary chlorine stabilizer (T-128) based on phosphoric acid-propylene glycol was tested as a chill tank additive in experiments simulating commercial broiler chilling. In bench-scale experiments, 0.5% T-128 was compared with plain water (control), 50 ppm of chlorine, and the combination of 0.5% T-128 with 50 ppm of chlorine to control transfer of Salmonella and Campylobacter from inoculated wing drummettes to co-chilled uninoculated drummettes. Both chlorine and T-128 lessened cross-contamination with Salmonella (P < 0.05); T-128 and T-128 with chlorine were significantly more effective (P < 0.05) than the control or plain chlorine for control of Campylobacter. T-128 treatments were noted to have a pH of less than 4.0; an additional experiment demonstrated that the antimicrobial effect of T-128 was not due merely to a lower pH. In commercial broiler chilling, a pH close to 6.0 is preferred to maximize chlorine effectiveness, while maintaining water-holding capacity of the meat. In a set of pilot-scale experiments with T-128, a near-ideal pH of 6.3 was achieved by using tap water instead of the distilled water used in bench-scale experiments. Pilot-scale chill tanks were used to compare the combination of 0.5% T-128 and 50 ppm of chlorine with 50 ppm of plain chlorine for control of cross-contamination between whole carcasses inoculated with Salmonella and Campylobacter and co-chilled uninoculated carcasses. The T-128 treatment resulted in significantly less crosscontamination by either direct contact or water transfer with both organisms compared with plain chlorine treatment. T-128 may have use in commercial broiler processing to enhance the effectiveness of chlorine in processing water. PMID:25198851

  3. Chemical additive to enhance antimicrobial efficacy of chlorine and control cross-contamination during immersion chill of broiler carcasses.

    PubMed

    Schambach, B T; Berrang, M E; Harrison, M A; Meinersmann, R J

    2014-09-01

    Immersion chilling of broiler carcasses can be a site for cross-contamination between the occasional highly contaminated carcass and those that are co-chilled. Chlorine is often used as an antimicrobial but can be overcome by organic material. A proprietary chlorine stabilizer (T-128) based on phosphoric acid-propylene glycol was tested as a chill tank additive in experiments simulating commercial broiler chilling. In bench-scale experiments, 0.5% T-128 was compared with plain water (control), 50 ppm of chlorine, and the combination of 0.5% T-128 with 50 ppm of chlorine to control transfer of Salmonella and Campylobacter from inoculated wing drummettes to co-chilled uninoculated drummettes. Both chlorine and T-128 lessened cross-contamination with Salmonella (P < 0.05); T-128 and T-128 with chlorine were significantly more effective (P < 0.05) than the control or plain chlorine for control of Campylobacter. T-128 treatments were noted to have a pH of less than 4.0; an additional experiment demonstrated that the antimicrobial effect of T-128 was not due merely to a lower pH. In commercial broiler chilling, a pH close to 6.0 is preferred to maximize chlorine effectiveness, while maintaining water-holding capacity of the meat. In a set of pilot-scale experiments with T-128, a near-ideal pH of 6.3 was achieved by using tap water instead of the distilled water used in bench-scale experiments. Pilot-scale chill tanks were used to compare the combination of 0.5% T-128 and 50 ppm of chlorine with 50 ppm of plain chlorine for control of cross-contamination between whole carcasses inoculated with Salmonella and Campylobacter and co-chilled uninoculated carcasses. The T-128 treatment resulted in significantly less crosscontamination by either direct contact or water transfer with both organisms compared with plain chlorine treatment. T-128 may have use in commercial broiler processing to enhance the effectiveness of chlorine in processing water.

  4. An audit of blood pressure control in clinical practice in Thailand.

    PubMed

    Buranakitjaroen, Peera

    2006-11-01

    To gain "real life" data on the BP control of hypertensive patients in clinical practice in Thailand, a multi-centre cross-sectional study was carried out. Demographic data, cardiovascular risk factors, and antihypertensive regimens were collected. A total of 1,259 patients were enrolled between October 2003 and December 2003, 924 cases from 6 regions of different levels of health care and 335 cases from 4 medical training centres and a tertiary care hospital in Bangkok. Eighty one percent of the patients, age ranged from 45 to 75 years (61.2 +/- 11.6). Forty four percent of patients in audit had a BP < 140/90 mm Hg and only 12.3% of DM patients had attained a JNC 7 recommended BP target of 130/80 mm Hg. Hypercholesterolaemia (65.3%) was the most prevalent risk followed by DM (27. 7%). Antihypertensive drug used at the initial visit compared with the last visit were ARB (0.9% vs 6.1%), ACE Inhibitors (30.1% vs 40.0%), beta-blockers (27.3% vs 46. 7%), CCBs (23.2% vs 37.7%), and diuretics (46.0% vs 53.5%). In addition, the numbers of antihypertensive drugs used at the initial visit compared with the last clinic visit were one drug (62.0% vs 33.0%), two drugs (29.7% vs 45.8%), three drugs or more (3.7% vs 20.4%), with an average of 1.3 +/- 0.6 vs 1.9 +/- 0.8 drugs per patient. Two thirds of patients (66.2%) were on 2 or more antihypertensive drugs. Among the type 2 DM, 5% had records of microalbuminuria, and 50.6% and 9.8% were receiving ACE Inhibitors and ARBs, respectively at the last clinic visit. PMID:17718243

  5. Pilot study on the additive effects of berberine and oral type 2 diabetes agents for patients with suboptimal glycemic control

    PubMed Central

    Di Pierro, Francesco; Villanova, Nicola; Agostini, Federica; Marzocchi, Rebecca; Soverini, Valentina; Marchesini, Giulio

    2012-01-01

    Background Suboptimal glycemic control is a common situation in diabetes, regardless of the wide range of drugs available to reach glycemic targets. Basic research in diabetes is endeavoring to identify new actives working as insulin savers, use of which could delay the introduction of injectable insulin or reduce the insulin dose needed. Commonly available as a nutraceutical, berberine is a potential candidate. Methods and results Because its low oral bioavailability can be overcome by P-glycoprotein inhibitors like herbal polyphenols, we have tested the nutraceutical combination of Berberis aristata extract and Silybum marianum extract (Berberol®) in type 2 diabetes in terms of its additive effect when combined with a conventional oral regimen for patients with suboptimal glycemic control. After 90 days of treatment, the nutraceutical association had a positive effect on glycemic and lipid parameters, significantly reducing glycosylated hemoglobin, basal insulin, homeostatic model assessment of insulin resistance, total and low-density lipoprotein cholesterol, and triglycerides. A relevant effect was also observed in terms of liver function by measuring aspartate transaminase and alanine transaminase. The product had a good safety profile, with distinctive gastrointestinal side effects likely due to its acarbose-like action. Conclusion Although further studies should be carried out to confirm our data, Berberol could be considered a good candidate as an adjunctive treatment option in diabetes, especially in patients with suboptimal glycemic control. PMID:22924000

  6. Chloride ion addition for controlling shapes and properties of silver nanorods capped by polyvinyl alcohol synthesized by polyol method

    NASA Astrophysics Data System (ADS)

    Junaidi, Triyana, Kuwat; Harsojo, Suharyadi, Edi

    2016-04-01

    We report our investigation on the effect of chloride ions oncontrolling the shapes and properties of silver nanorods(AgNRs) synthesized using a polyol method. In this study, we used polyvinyl alcohol (PVA) as a capping agent and sodium chloride (NaCl) as asalt precursor and performed at the oilbath temperature of 140 °C. The chloride ions originating from the NaCl serve to control the growth of the silver nanorods. Furthermore, the synthesized silver nanorodswere characterized using UV-VIS, XRD, SEM and TEM. The results showed that besides being able to control the growth of AgCl atoms, the chloride ions were also able to control the growth of multi-twinned-particles into the single crystalline silver nanorods by micrometer-length. At an appropriate concentration of NaCl, the diameter of silver nanorodsdecreased significantly compared to that of without chloride ion addition. This technique may be useful since a particular diameter of silver nanorods affects a particular application in the future.

  7. A dynamic in vitro lipolysis model. I. Controlling the rate of lipolysis by continuous addition of calcium.

    PubMed

    Zangenberg, N H; Müllertz, A; Kristensen, H G; Hovgaard, L

    2001-09-01

    Lipolysis by pancreatic lipase was investigated with the aim to establish an in vitro lipolysis model, which can be used to investigate the dissolution of poorly soluble lipophilic drug substances at controlled hydrolysis rates. The effects of three experimental parameters -- the concentrations of bile salts and Ca(2+) and the lipase activity -- were investigated. The effect on the rate of hydrolysis of emulsified soybean oil was investigated in experiments in a pH-stat at pH 6.5 and 37 degrees C. The free fatty acids produced by the hydrolysis were titrated at pH 6.5. It was shown that all three investigated parameters influence the initial rate of hydrolysis, whereas only the lipase activity and the concentration of Ca(2+) affect the subsequent stages. It was also shown that the rate of lipolysis can be controlled by the rate of adding Ca(2+). Thus, it is possible to design an in vitro model using readily available and inexpensive materials in which the hydrolysis rate can be controlled by the continuous addition of Ca(2+).

  8. 'Simple schizophrenia': a controlled MRI and clinical/neuropsychological study.

    PubMed

    Galderisi, S; Bucci, P; Mucci, A; D'Amato, A C; Conforti, R; Maj, M

    1999-10-11

    The present study explored the frequency of neuromorphological, neurological and neuropsychological abnormalities in 13 patients with an ICD-8/9 diagnosis of simple schizophrenia, also fulfilling DSM-IV criteria for 'simple deteriorative disorder', and in 13 matched patients with an ICD-8/9 diagnosis of a subtype of schizophrenia other than simple schizophrenia, fulfilling DSM-IV criteria for schizophrenia. The frequency of neuromorphological abnormalities in the two patient groups was also compared with that observed in 13 neurological control subjects. Both patients with simple schizophrenia and those with other schizophrenia subtypes showed a higher frequency of brain developmental abnormalities and greater ventricular and subarachnoid space volumes than controls. There was no significant difference between the two groups of patients with respect to neuromorphological variables. Two patients with simple schizophrenia (vs. none of those with other schizophrenia subtypes) had gross brain abnormalities; they were the most deteriorated subjects in the whole sample. Patients with simple schizophrenia, as compared to those with other schizophrenia subtypes, presented a higher frequency of soft neurological signs and a greater impairment of social relationships.

  9. Preoperative whole body disinfection--a controlled clinical study.

    PubMed

    Hayek, L J; Emerson, J M

    1988-04-01

    Preoperative whole body washing with chlorhexidine scrub was compared with soap for its effect on prevention of wound infection in clean surgery. Two thousand and fifteen patients were studied using chlorhexidine scrub, placebo or plain soap. The overall infection rate in the control and placebo groups was 12.8% (p less than 0.05) and 11.7% as opposed to 9% (p less than 0.05) in the treated group. Three per cent fewer infections were found in treated 'clean surgery' patients, and the incidence of Staphylococcus aureus infections was reduced from 6% (bar soap) to 3% (chlorhexidine). The saving in bed occupancy from prevention of infection is a significant cost-saving.

  10. A Pragmatic Guide on How Physicians Can Take Over Financial Control of Their Clinical Practice

    PubMed Central

    Fischer, Thorsten

    2012-01-01

    Control of clinical cost is becoming increasingly important in health care worldwide. Physicians should accept the limitation of resources and take responsibility to improve their clinical cost-reimbursement ratio. To achieve this, they will need basic education in clinic management to control and adjust costs and reimbursement, without impacting professional quality of care. Rational use of diagnostics and therapy should be implemented and frequently verified. Physicians are the only professionals that are able to integrate economics with health care. This is in the best interest of patients and will improve a physician's position, influence, and professional freedom levels within our hospitals. PMID:23484576

  11. Controlling the drying and film formation processes of polymer solution droplets with addition of small amount of surfactants.

    PubMed

    Kajiya, Tadashi; Kobayashi, Wataru; Okuzono, Tohru; Doi, Masao

    2009-11-26

    We studied how the addition of surfactants alters the drying and film formation processes of polymer solution droplets with contact lines strongly fixed by bank structures. We found that even if the amount of surfactant is quite small, it drastically changes the final profile of the polymer film from a ringlike profile to a flat profile. This property is observed commonly, irrespective of the polymer concentration, droplet volume, and type of solvent. We conjecture that the inhomogeneous distribution of the surfactant caused by the outward capillary flow induces the Marangoni flow directed toward the center of the droplet, which suppresses the outward flow. The present phenomenon implies an effective method for controlling the profile of the polymer film in inkjet printing technologies.

  12. Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

    PubMed Central

    Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

    2016-01-01

    ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

  13. Family Physician Clinical Inertia in Glycemic Control among Patients with Type 2 Diabetes

    PubMed Central

    Lang, Valerija Bralić; Marković, Biserka Bergman; Kranjčević, Ksenija

    2015-01-01

    Background Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. Material/Methods This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15–25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. Results A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Conclusions Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control. PMID:25652941

  14. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  15. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  16. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  17. Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison

    PubMed Central

    Coombes, Brooke K; Bisset, Leanne; Connelly, Luke B; Brooks, Peter; Vicenzino, Bill

    2009-01-01

    Background Corticosteroid injection and physiotherapy are two commonly prescribed interventions for management of lateral epicondylalgia. Corticosteroid injections are the most clinically efficacious in the short term but are associated with high recurrence rates and delayed recovery, while physiotherapy is similar to injections at 6 weeks but with significantly lower recurrence rates. Whilst practitioners frequently recommend combining physiotherapy and injection to overcome harmful effects and improve outcomes, study of the benefits of this combination of treatments is lacking. Clinicians are also faced with the paradox that the powerful anti-inflammatory corticosteroid injections work well, albeit in the short term, for a non-inflammatory condition like lateral epicondylalgia. Surprisingly, these injections have not been rigorously tested against placebo injections. This study primarily addresses both of these issues. Methods A randomised placebo-controlled clinical trial with a 2 × 2 factorial design will evaluate the clinical efficacy, cost-effectiveness and recurrence rates of adding physiotherapy to an injection. In addition, the clinical efficacy and adverse effects of corticosteroid injection beyond that of a placebo saline injection will be studied. 132 participants with a diagnosis of lateral epicondylalgia will be randomly assigned by concealed allocation to one of four treatment groups – corticosteroid injection, saline injection, corticosteroid injection with physiotherapy or saline injection with physiotherapy. Physiotherapy will comprise 8 sessions of elbow manipulation and exercise over an 8 week period. Blinded follow-up assessments will be conducted at baseline, 4, 8, 12, 26 and 52 weeks after randomisation. The primary outcome will be a participant rating of global improvement, from which measures of success and recurrence will be derived. Analyses will be conducted on an intention-to-treat basis using linear mixed and logistic regression

  18. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial.

    PubMed

    Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; de Freitas, Diego Galace; Fukuda, Thiago Yukio; Monteiro, Renan Lima; Salomão, Evelyn Cassia; de Medeiros, Flávia Cordeiro; Costa, Lucíola da Cunha Menezes

    2016-07-01

    Study Design Randomized controlled trial. Background Many clinical practice guidelines endorse both manual therapy and exercise as effective treatment options for patients with low back pain. To optimize the effects of the treatments recommended by the guidelines, a new intervention known as Kinesio Taping is being widely used in these patients. Objectives To determine the effectiveness of Kinesio Taping in patients with chronic nonspecific low back pain when added to a physical therapy program consisting of exercise and manual therapy. Methods One hundred forty-eight patients with chronic nonspecific low back pain were randomly allocated to receive 10 (twice weekly) sessions of physical therapy, consisting of exercise and manual therapy, or the same treatment with the addition of Kinesio Taping applied to the lower back. The primary outcomes were pain intensity and disability (5 weeks after randomization) and the secondary outcomes were pain intensity, disability (3 months and 6 months after randomization), global perceived effect, and satisfaction with care (5 weeks after treatment). Data were collected by a blinded assessor. Results No between-group differences were observed in the primary outcomes of pain intensity (mean difference, -0.01 points; 95% confidence interval [CI]: -0.88, 0.85) or disability (mean difference, 1.14 points; 95% CI: -0.85, 3.13) at 5 weeks' follow-up. In addition, no between-group differences were observed for any of the other outcomes evaluated, except for disability 6 months after randomization (mean difference, 2.01 points; 95% CI: 0.03, 4.00) in favor of the control group. Conclusion Patients who received a physical therapy program consisting of exercise and manual therapy did not get additional benefit from the use of Kinesio Taping. Level of Evidence Therapy, level 1b. Prospectively registered May 28, 2013 at www.ClinicalTrials.gov (NCT01866332). J Orthop Sports Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016. doi:10.2519/jospt.2016.6590.

  19. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial.

    PubMed

    Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; de Freitas, Diego Galace; Fukuda, Thiago Yukio; Monteiro, Renan Lima; Salomão, Evelyn Cassia; de Medeiros, Flávia Cordeiro; Costa, Lucíola da Cunha Menezes

    2016-07-01

    Study Design Randomized controlled trial. Background Many clinical practice guidelines endorse both manual therapy and exercise as effective treatment options for patients with low back pain. To optimize the effects of the treatments recommended by the guidelines, a new intervention known as Kinesio Taping is being widely used in these patients. Objectives To determine the effectiveness of Kinesio Taping in patients with chronic nonspecific low back pain when added to a physical therapy program consisting of exercise and manual therapy. Methods One hundred forty-eight patients with chronic nonspecific low back pain were randomly allocated to receive 10 (twice weekly) sessions of physical therapy, consisting of exercise and manual therapy, or the same treatment with the addition of Kinesio Taping applied to the lower back. The primary outcomes were pain intensity and disability (5 weeks after randomization) and the secondary outcomes were pain intensity, disability (3 months and 6 months after randomization), global perceived effect, and satisfaction with care (5 weeks after treatment). Data were collected by a blinded assessor. Results No between-group differences were observed in the primary outcomes of pain intensity (mean difference, -0.01 points; 95% confidence interval [CI]: -0.88, 0.85) or disability (mean difference, 1.14 points; 95% CI: -0.85, 3.13) at 5 weeks' follow-up. In addition, no between-group differences were observed for any of the other outcomes evaluated, except for disability 6 months after randomization (mean difference, 2.01 points; 95% CI: 0.03, 4.00) in favor of the control group. Conclusion Patients who received a physical therapy program consisting of exercise and manual therapy did not get additional benefit from the use of Kinesio Taping. Level of Evidence Therapy, level 1b. Prospectively registered May 28, 2013 at www.ClinicalTrials.gov (NCT01866332). J Orthop Sports Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016. doi:10.2519/jospt.2016

  20. Experimental investigations of the swirling flow in the conical diffuser using flow-feedback control technique with additional energy source

    NASA Astrophysics Data System (ADS)

    Tǎnasǎ, C.; Bosioc, A. I.; Susan-Resiga, R. F.; Muntean, S.

    2012-11-01

    The previous experimental and numerical investigations of decelerated swirling flows in conical diffusers have demonstrated that water injection along to the axis mitigates the pressure fluctuations associated to the precessing vortex rope [1]. However, for swirling flows similar to Francis turbines operated at partial discharge, the water jet becomes effective when the jet discharge is larger than 10% from the turbine discharge, leading to large volumetric losses when the jet is supplied from upstream the runner. As a result, it was introduced a new approach for supplying the jet by using a fraction of the discharge collected downstream the conical diffuser [2]. This is called flow-feedback control technique (FFCT) and it was investigated experimentally in order to assess its capability [3]. The FFCT approach not requires additional energy to supply the jet. Consequently, the turbine efficiency is not diminished due to the volumetric losses injected even if around 10% of the main flow is used. However, the equivalent amplitude of the pressure pulsations associated to the vortex rope decreases with 30% if 10% jet discharge is applied [3]. Using 12% water jet discharge from upstream then the equivalent amplitude of the pressure pulsations is mitigated with 70% according to Bosioc et al. [4]. In our case, an extra 2% jet discharge is required in order to obtain similar results with FFCT. This extra discharge is provided using an additional energy source. Therefore, the paper presents experimental investigation performed with FFCT with additional energy source. The experimental results obtained with this technique are compared against FFCT and the swirling flow with vortex rope, respectively.

  1. Frontiers in Microcirculation: Control Processes and Clinical Applications

    PubMed Central

    Segal, Steven S.

    2010-01-01

    This edition of Microcirculation presents five current and emerging perspectives of the microcirculation in development, health and disease. The onset of blood flow and pressure are central to cardiovascular development. These hemodynamic forces are explored in light of underlying molecular signaling pathways that affect vascular and cardiac cell shape and proliferation. Shear-induced strain exerted on the plasma membrane and cytoskeleton is transmitted to cell nuclei and thereby affects gene activation through mechanotransduction. Altered stiffness or disturbed surfaces of aberrant vascular cells may affect an array of vasculopathies through altered gene expression. The endothelium is both a site and source for inflammatory responses triggered by cardiovascular risk factors often mediated through reactive oxygen species and angiotensin II. Tumor microenvironments are disturbed with abnormal growth and remodeling of blood and lymphatic vessels. More effective targeting strategies for delivering anti-angiogenic and cytotoxic agents are being developed through advances in intravital imaging. Blood flow control requires both vasodilation and vasoconstriction to be coordinated along and among arterioles and feed arteries. Evolving insights into signaling pathways between smooth muscle cells and endothelial cells illuminate how such processes can be affected in vasculopathies. These timely reviews provide a novel reference for advancing research frontiers in microcirculation. PMID:20374480

  2. Non-participation in a randomized controlled trial: the effect on clinical and non-clinical variables.

    PubMed

    Vermaire, J H; van Loveren, C; Poorterman, J H G; Hoogstraten, J

    2011-01-01

    Studies reporting clinical and non-clinical parameters of participants and non-participants of clinical trials are scarce. In the available studies non-participants were likely to show less favourable outcomes than participants on both socioeconomic parameters as well as on caries experience. However, the impact of non-participation on the total sample of the research population is not established. In the present study, as part of baseline data collection for a randomized controlled trial on caries-preventive strategies, 346 parents of children 6.0 years (± 3 months) of age were approached to let their child participate. Sixty parents refused, but 56 of them were willing to fill out the same set of questionnaires and to allow their child to be clinically examined once. Parents from participating children had higher socioeconomic status, were more often of autochthonous origin and scored better on knowledge questions than parents of non-participating children. Furthermore, parents of participating children reported a higher willingness to invest, were more likely to hold on to regular meals and their child had lower levels of plaque compared to non-participating children. Surprisingly, the participating children had higher dmfs scores than the non-participating children. Their care index (fs/ds + fs) was higher than that of non-participating children. Based on the findings of this study, the presumption that non-participating children will show less favourable clinical outcomes cannot be supported. Although participants differed from non-participants, they did not differ from the total population. It is suggested that the external validity of a randomized controlled trial on caries-preventive strategies is not necessarily affected by non-participation bias. PMID:21576959

  3. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children.

    PubMed

    Nibhanipudi, Kumara V

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher's exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  4. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children

    PubMed Central

    Nibhanipudi, Kumara V.

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher’s exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  5. Goal-directed and transfer-cue-elicited drug-seeking are dissociated by pharmacotherapy: evidence for independent additive controllers.

    PubMed

    Hogarth, Lee

    2012-07-01

    According to contemporary learning theory, drug-seeking behavior reflects the summation of 2 dissociable controllers. Whereas goal-directed drug-seeking is determined by the expected current incentive value of the drug, stimulus-elicited drug-seeking is determined by the expected probability of the drug independently of its current incentive value, and these 2 controllers contribute additively to observed drug-seeking. One applied prediction of this model is that smoking cessation pharmacotherapies selectively attenuate tonic but not cue-elicited craving because they downgrade the expected incentive value of the drug but leave expected probability intact. To test this, the current study examined whether nicotine replacement therapy (NRT) nasal spray would modify goal-directed tobacco choice in a human outcome devaluation procedure, but leave cue-elicited tobacco choice in a Pavlovian to instrumental transfer (PIT) procedure intact. Smokers (N= 96) first underwent concurrent choice training in which 2 responses earned tobacco or chocolate points, respectively. Participants then ingested either NRT nasal spray (1 mg) or chocolate (147 g) to devalue 1 outcome. Concurrent choice was then tested again in extinction to measure goal-directed control of choice, and in a PIT test to measure the extent to which tobacco and chocolate stimuli enhanced choice of the same outcome. It was found that NRT modified tobacco choice in the extinction test but not the extent to which the tobacco stimulus enhanced choice of the tobacco outcome in the PIT test. This dissociation suggests that the propensity to engage in drug-seeking is determined independently by the expected value and probability of the drug, and that pharmacotherapy has partial efficacy because it selectively effects expected drug value.

  6. Goal-directed and transfer-cue-elicited drug-seeking are dissociated by pharmacotherapy: evidence for independent additive controllers.

    PubMed

    Hogarth, Lee

    2012-07-01

    According to contemporary learning theory, drug-seeking behavior reflects the summation of 2 dissociable controllers. Whereas goal-directed drug-seeking is determined by the expected current incentive value of the drug, stimulus-elicited drug-seeking is determined by the expected probability of the drug independently of its current incentive value, and these 2 controllers contribute additively to observed drug-seeking. One applied prediction of this model is that smoking cessation pharmacotherapies selectively attenuate tonic but not cue-elicited craving because they downgrade the expected incentive value of the drug but leave expected probability intact. To test this, the current study examined whether nicotine replacement therapy (NRT) nasal spray would modify goal-directed tobacco choice in a human outcome devaluation procedure, but leave cue-elicited tobacco choice in a Pavlovian to instrumental transfer (PIT) procedure intact. Smokers (N= 96) first underwent concurrent choice training in which 2 responses earned tobacco or chocolate points, respectively. Participants then ingested either NRT nasal spray (1 mg) or chocolate (147 g) to devalue 1 outcome. Concurrent choice was then tested again in extinction to measure goal-directed control of choice, and in a PIT test to measure the extent to which tobacco and chocolate stimuli enhanced choice of the same outcome. It was found that NRT modified tobacco choice in the extinction test but not the extent to which the tobacco stimulus enhanced choice of the tobacco outcome in the PIT test. This dissociation suggests that the propensity to engage in drug-seeking is determined independently by the expected value and probability of the drug, and that pharmacotherapy has partial efficacy because it selectively effects expected drug value. PMID:22823420

  7. The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. Methods A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale) at 3 weeks. Treatment effects were estimated using linear mixed models. Results One hundred and forty-eight participants were randomized into study groups, of whom 138 (93%) completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1) at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1) at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0) over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care (P = 0.002). Conclusions When added to the currently recommended first-line care of acute

  8. Exploration and classification of chromatographic fingerprints as additional tool for identification and quality control of several Artemisia species.

    PubMed

    Alaerts, Goedele; Pieters, Sigrid; Logie, Hans; Van Erps, Jürgen; Merino-Arévalo, Maria; Dejaegher, Bieke; Smeyers-Verbeke, Johanna; Vander Heyden, Yvan

    2014-07-01

    The World Health Organization accepts chromatographic fingerprints as a tool for identification and quality control of herbal medicines. This is the first study in which the distinction, identification and quality control of four different Artemisia species, i.e. Artemisia vulgaris, A. absinthium, A. annua and A. capillaris samples, is performed based on the evaluation of entire chromatographic fingerprint profiles developed with identical experimental conditions. High-Performance Liquid Chromatography (HPLC) with Diode Array Detection (DAD) was used to develop the fingerprints. Application of factorial designs leads to methanol/water (80:20 (v/v)) as the best extraction solvent for the pulverised plant material and to a shaking bath for 30 min as extraction method. Further, so-called screening, optimisation and fine-tuning phases were performed during fingerprint development. Most information about the different Artemisia species, i.e. the highest number of separated peaks in the fingerprint, was acquired on four coupled Chromolith columns (100 mm × 4.6 mm I.D.). Trifluoroacetic acid 0.05% (v/v) was used as mobile-phase additive in a stepwise linear methanol/water gradient, i.e. 5, 34, 41, 72 and 95% (v/v) methanol at 0, 9, 30, 44 and 51 min, where the last mobile phase composition was kept isocratic till 60 min. One detection wavelength was selected to perform data analysis. The lowest similarity between the fingerprints of the four species was present at 214 nm. The HPLC/DAD method was applied on 199 herbal samples of the four Artemisia species, resulting in 357 fingerprints. The within- and between-day variation of the entire method, as well as the quality control fingerprints obtained during routine analysis, were found acceptable. The distinction of these Artemisia species was evaluated based on the entire chromatographic profiles, developed by a shared method, and visualised in score plots by means of the Principal Component Analysis (PCA) exploratory data

  9. Disciplined Decision Making in an Interdisciplinary Environment: Some Implications for Clinical Applications of Statistical Process Control.

    ERIC Educational Resources Information Center

    Hantula, Donald A.

    1995-01-01

    Clinical applications of statistical process control (SPC) in human service organizations are considered. SPC is seen as providing a standard set of criteria that serves as a common interface for data-based decision making, which may bring decision making under the control of established contingencies rather than the immediate contingencies of…

  10. Nutritional screening; control of clinical undernutrition with analytical parameters.

    PubMed

    de Ulíbarri Pérez, José Ignacio; Fernández, Guillermo; Rodríguez Salvanés, Francisco; Díaz López, Ana María

    2014-01-13

    Objetivo: Actualizar el cribado nutricional. La alta prevalencia del desequilibrio nutricional que genera la Desnutrición Clínica (DC), especialmente en hospitales y residencias asistidas, obliga al uso de herramientas de cribado y a controlar su evolución para combatirla sobre la marcha. La DC deriva menos de la carencia nutricional que de los efectos de la enfermedad y sus tratamientos, pero los actuales sistemas de cribado buscan más la desnutrición ya establecida que el riesgo nutricional existente. Las alteraciones metabólicas del equilibrio nutricional que constituyen la trofopatía se pueden captar en el plasma sin demoras, automáticamente, permitiendo rectificar actitudes terapéuticas demasiado agresivas o complementarlas con el adecuado soporte nutricional. Con los sistemas manuales de cribado, solo pasados días o semanas se evidenciarán, tardíamente, los cambios somáticos expresivos de esa desnutrición. La concentración de la albúmina plasmática es un parámetro muy valioso en el control nutricional. Su disminución, cualquiera que sea la causa, expresa un posible déficit pero también el riesgo nutricional a que se ve sometida la célula, antes de que la desnutrición se manifieste somáticamente. La precocidad de la detección del riesgo nutricional, anticipándose a la desnutrición y su gran capacidad pronóstica hacen de las herramientas basadas en parámetros analíticos, el procedimiento más útil, ergonómico, seguro y eficiente para el cribado y pronóstico nutricional en el entorno clínico. Conclusión: es hora de actualizar conceptos, deshacer mitos y optar por sistemas modernos de cribado eficientes, única manera de alcanzar el sueño de controlar la DC en nuestras poblaciones enfermas y frágiles.

  11. [Planning and data analysis in prospective controlled clinical trials (author's transl)].

    PubMed

    Barth, H

    1978-11-01

    Planning of prospective controlled clinical trials in surgery requires the use of test and control groups, sufficiently frequent repetition of experiments, random allocation of patients to the groups (example), and balancing. The descriptive data analysis should be performed in a stepwise manner (list of new data, rank list, range, median, quartiles, histogram, mean value standard deviation). The advantages of the median-quartile-system and the prerequisites for application of various significance tests are pointed out. In the conduct of controlled clinical trials, the consultative role of experimental surgeons is proposed.

  12. The Clinical Value of Huangqi Injection in the Treatment of Leucopenia: A Meta-Analysis of Clinical Controlled Trials

    PubMed Central

    Zhou, Xifa; Dong, Chunlei; Luo, Judong; Liu, Yongping

    2013-01-01

    Background Huangqi injection is derived from Astragalus membranaceus root. In China, recent reports of Huangqi injection for the treatment of leucopenia have emerged. However, a systematic review of these reports has not been performed. Thus, we conducted a meta-analysis of clinical controlled trials to assess the clinical value of Huangqi injection in the treatment of leucopenia. Methods We searched the Chinese Biomedical Literature Database (CBM), Wanfang Database, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Full-text Database (VIP), as well as PubMed and EMBASE to collect the data about trials of Huangqi injection for treating leucopenia. A meta-analysis was performed using RevMan 5.2 software. Results A total of 13 studies involving 841 patients were included in this study. The overall study quality was lower according to the Jadad scale. The meta-analysis showed that experimentally treated patients experienced greater therapeutic efficacy and lower white blood cell counts than control groups treated with Western medicine (P < 0.05). No publication bias was evident, according to Egger’s test. Conclusions The validity of this meta-analysis was limited by the overall poor quality of the included studies. Huangqi injection may have potential clinical value in the treatment of leucopenia, but confirmation with rigorously well-designed multi-center trials is needed. PMID:24349444

  13. One-year clinical results of Er,Cr:YSGG laser application in addition to scaling and root planing in patients with early to moderate periodontitis.

    PubMed

    Kelbauskiene, Solveiga; Baseviciene, Nomeda; Goharkhay, Kawe; Moritz, Andreas; Machiulskiene, Vita

    2011-07-01

    In 30 patients with periodontitis, a total of 278 teeth exhibiting bleeding on probing, subgingival calculus, and a probing depth between 3-6 mm were examined. For each participant, two treatment types were alternatively applied on the contralateral quadrants: scaling and root planing (SRP) as control, and SRP followed by Er,Cr:YSGG laser application (SRP+laser), as a test method. Five clinical parameters: plaque level, bleeding on probing, probing depth, gingival recession and clinical attachment level were examined at baseline and at 2, 3, 6, 12 months after treatment. Of the total of 1,668 sites examined in all patients, 1,088 sites were found with a probing depth of 3-6 mm. In these sites, differences in clinical parameters between SRP and SRP+laser-treated quadrants were analyzed, assuming the level of p < 0.05 as significant. After 2 months from baseline, the mean probing depth reduction and the clinical attachment level gain were significantly greater in SRP+laser than in SRP quadrants, and remained so throughout the study (p < 0.001). A marked reduction of the bleeding scores occurred in all examined sites, irrespective of the treatment method. However, after 12 months, significantly less teeth exhibited bleeding on probing in SRP+laser quadrants than in SRP quadrants (p < 0.001). The mean plaque and gingival recession levels did not differ between the SRP and SRP+laser quadrants neither before nor after the treatment. The periodontal procedures either using Er,Cr:YSGG laser after SRP or SRP alone, lead to significant improvements in all clinical parameters investigated. However, laser application, as an adjunct to SRP, appeared to be more advantageous.

  14. Early treatment revisions by addition or switch for type 2 diabetes: impact on glycemic control, diabetic complications, and healthcare costs

    PubMed Central

    Schwab, Phil; Saundankar, Vishal; Bouchard, Jonathan; Wintfeld, Neil; Suehs, Brandon; Moretz, Chad; Allen, Elsie; DeLuzio, Antonio

    2016-01-01

    Background The study examined the prevalence of early treatment revisions after glycosylated hemoglobin (HbA1c) ≥9.0% (75 mmol/mol) and estimated the impact of early treatment revisions on glycemic control, diabetic complications, and costs. Research design and methods A retrospective cohort study of administrative claims data of plan members with type 2 diabetes and HbA1c ≥9.0% (75 mmol/mol) was completed. Treatment revision was identified as treatment addition or switch. Glycemic control was measured as HbA1c during 6–12 months following the first qualifying HbA1c ≥9.0% (75 mmol/mol) laboratory result. Complications severity (via Diabetes Complication Severity Index (DCSI)) and costs were measured after 12, 24, and 36 months. Unadjusted comparisons and multivariable models were used to examine the relationship between early treatment revision (within 90 days of HbA1c) and outcomes after controlling for potentially confounding factors measured during a 12-month baseline period. Results 8463 participants were included with a mean baseline HbA1c of 10.2% (75 mmol/mol). Early treatment revision was associated with greater reduction in HbA1c at 6–12 months (−2.10% vs −1.87%; p<0.001). No significant relationship was observed between early treatment revision and DCSI at 12, 24, or 36 months (p=0.931, p=0.332, and p=0.418). Total costs, medical costs, and pharmacy costs at 12, 24, or 36 months were greater for the early treatment revision group compared with the delayed treatment revision group (all p<0.05). Conclusions The findings suggest that in patients with type 2 diabetes mellitus, treatment revision within 90 days of finding an HbA1c ≥9.0% is associated with a greater level of near-term glycemic control and higher cost. The impact on end points such as diabetic complications may not be realized over relatively short time frames. PMID:26925237

  15. Control of hydrogen sulfide production in oil fields by managing microbial communities through nitrate or nitrite addition

    NASA Astrophysics Data System (ADS)

    Hubert, Casey R. J.

    Nitrate or nitrite injection into oil reservoirs during water flooding has the potential to control biological souring, the production of hydrogen sulfide (H2S) by sulfate-reducing bacteria (SRB). Souring control is essential because sulfide is toxic, sulfide precipitates can plug reservoir formations, souring lowers crude oil value, and SRB induce corrosion. Nitrate and nitrite can stimulate heterotrophic nitrate- or nitrite-reducing bacteria (hNRB) and nitrate- or nitrite-reducing, sulfide oxidizing bacteria (NRSOB). Nitrite also inhibits SRB activity by blocking the sulfate reduction pathway. Continuous up-flow packed-bed bioreactors were inoculated with produced water from the Coleville oil field to establish sulfide-producing biofilms similar to those found in sour reservoirs. Nitrate or nitrite addition to bioreactors indicated that the dose required for hNRB or NR-SOB to control souring depended on the concentration of oil organics. Either mechanism mediates the net removal of oil organics (lactate) with nitrate or nitrite, with lower doses of nitrate required due to its greater oxidative power. Microbial community analysis by reverse sample genome probing (RSGP) revealed that NR-SOB mediated sulfide removal at low nitrate or nitrite concentrations when lactate was still available to SRB and the redox potential was low. At high nitrate doses hNRB oxidized lactate directly, produced nitrite and maintained a high redox potential, thus excluding SRB activity. Facultatively chemolithotrophic Campylobacter sp. strains were isolated from the bioreactors and incorporated into RSGP analyses, revealing their dominance in both NR-SOB- and hNRB-containing communities. The metabolic flexibility of these strains may confer a competitive advantage over obligate chemolithotrophs like Thiomicrospira sp. strain CVO or hNRB that do not have NR-SOB activity like newly isolated Thauera sp. and Rhodobacter sp. strains. A single high dose of nitrite resulted in immediate

  16. The effect of student self-video of performance on clinical skill competency: a randomised controlled trial.

    PubMed

    Maloney, Stephen; Storr, Michael; Morgan, Prue; Ilic, Dragan

    2013-03-01

    Emerging technologies and student information technology literacy are enabling new methods of teaching and learning for clinical skill performance. Facilitating experiential practice and reflection on performance through student self-video, and exposure to peer benchmarks, may promote greater levels of skill competency. This study examines the impact of student self-video on the attainment of clinical skills. A total of 60 Physiotherapy students (100%) consented to participate in the randomised controlled trial. One group (50%) was taught a complex clinical skill with regular practical tutoring, whilst the other group (50%) supplemented the tutoring with a self-video task aimed at promoting reflection on performance. Student skill performance was measured in an objective structured clinical examination (OSCE). Students also completed an anonymous questionnaire, which explored their perception of their learning experiences. Students received significantly higher scores in the OSCE when the examined clinical skill had been supplemented with a self-video of performance task (P = 0.048). Descriptive analysis of the questionnaires relating to student perceptions on the teaching methods identified that the self-video of performance task utilised contributed to improvement in their clinical performance and their confidence for future clinical practice. Students identified a number of aspects of the submission process that contributed to this perception of educational value. The novel results of this study demonstrate that greater clinical skill competency is achieved when traditional tutoring methods are supplemented with student self-video of performance tasks. Additional benefits included the ability of staff and students to monitor longitudinal performance, and an increase in feedback opportunities.

  17. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds.

    PubMed

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne; Haase, Lone; Lundquist, Rasmus

    2011-12-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.

  18. The additional value of a night splint to eccentric exercises in chronic midportion Achilles tendinopathy: a randomised controlled trial

    PubMed Central

    de Vos, R J; Weir, A; Visser, R J A; de Winter, ThC; Tol, J L

    2007-01-01

    Aim To assess whether the use of a night splint is of added benefit on functional outcome in treating chronic midportion Achilles tendinopathy. Methods This was a single‐blind, prospective, single centre, randomised controlled trial set in the Sports Medical Department, The Hague Medical Centre, The Netherlands. Inclusion criteria were: age 18–70 years, active participation in sports, and tendon pain localised at 2–7 cm from distal insertion. Exclusion criteria were: insertional disorders, partial or complete ruptures, or systemic illness. 70 tendons were included and randomised into one of two treatment groups: eccentric exercises with a night splint (night splint group, n = 36) or eccentric exercises only (eccentric group, n = 34). Interventions Both groups completed a 12‐week heavy‐load eccentric training programme. One group received a night splint in addition to eccentric exercises. At baseline and follow‐up at 12 weeks, patient satisfaction, Victorian Institute of Sport Assessment–Achilles questionnaire (VISA‐A) score and reported compliance were recorded by a single‐blind trained researcher who was blinded to the treatment. Results After 12 weeks, patient satisfaction in the eccentric group was 63% compared with 48% in the night splint group. The VISA‐A score significantly improved in both groups; in the eccentric group from 50.1 to 68.8 (p = 0.001) and in the night splint group from 49.4 to 67.0 (p<0.001). There was no significant difference between the two groups in VISA‐A score (p = 0.815) and patient satisfaction (p = 0.261). Conclusion A night splint is not beneficial in addition to eccentric exercises in the treatment of chronic midportion Achilles tendinopathy. PMID:17178774

  19. Neural Correlates of Task Cost for Stance Control with an Additional Motor Task: Phase-Locked Electroencephalogram Responses

    PubMed Central

    Hwang, Ing-Shiou; Huang, Cheng-Ya

    2016-01-01

    With appropriate reallocation of central resources, the ability to maintain an erect posture is not necessarily degraded by a concurrent motor task. This study investigated the neural control of a particular postural-suprapostural procedure involving brain mechanisms to solve crosstalk between posture and motor subtasks. Participants completed a single posture task and a dual-task while concurrently conducting force-matching and maintaining a tilted stabilometer stance at a target angle. Stabilometer movements and event-related potentials (ERPs) were recorded. The added force-matching task increased the irregularity of postural response rather than the size of postural response prior to force-matching. In addition, the added force-matching task during stabilometer stance led to marked topographic ERP modulation, with greater P2 positivity in the frontal and sensorimotor-parietal areas of the N1-P2 transitional phase and in the sensorimotor-parietal area of the late P2 phase. The time-frequency distribution of the ERP primary principal component revealed that the dual-task condition manifested more pronounced delta (1–4 Hz) and beta (13–35 Hz) synchronizations but suppressed theta activity (4–8 Hz) before force-matching. The dual-task condition also manifested coherent fronto-parietal delta activity in the P2 period. In addition to a decrease in postural regularity, this study reveals spatio-temporal and temporal-spectral reorganizations of ERPs in the fronto-sensorimotor-parietal network due to the added suprapostural motor task. For a particular set of postural-suprapostural task, the behavior and neural data suggest a facilitatory role of autonomous postural response and central resource expansion with increasing interregional interactions for task-shift and planning the motor-suprapostural task. PMID:27010634

  20. A Serious Videogame as an Additional Therapy Tool for Training Emotional Regulation and Impulsivity Control in Severe Gambling Disorder

    PubMed Central

    Tárrega, Salomé; Castro-Carreras, Laia; Fernández-Aranda, Fernando; Granero, Roser; Giner-Bartolomé, Cristina; Aymamí, Neus; Gómez-Peña, Mónica; Santamaría, Juan J.; Forcano, Laura; Steward, Trevor; Menchón, José M.; Jiménez-Murcia, Susana

    2015-01-01

    Background: Gambling disorder (GD) is characterized by a significant lack of self-control and is associated with impulsivity-related personality traits. It is also linked to deficits in emotional regulation and frequently co-occurs with anxiety and depression symptoms. There is also evidence that emotional dysregulation may play a mediatory role between GD and psychopathological symptomatology. Few studies have reported the outcomes of psychological interventions that specifically address these underlying processes. Objectives: To assess the utility of the Playmancer platform, a serious video game, as an additional therapy tool in a CBT intervention for GD, and to estimate pre-post changes in measures of impulsivity, anger expression and psychopathological symptomatology. Method: The sample comprised a single group of 16 male treatment-seeking individuals with severe GD diagnosis. Therapy intervention consisted of 16 group weekly CBT sessions and, concurrently, 10 additional weekly sessions of a serious video game. Pre-post treatment scores on South Oaks Gambling Screen (SOGS), Barratt Impulsiveness Scale (BIS-11), I7 Impulsiveness Questionnaire (I7), State-Trait Anger Expression Inventory 2 (STAXI-2), Symptom Checklist-Revised (SCL-90-R), State-Trait Anxiety Inventory (STAI-S-T), and Novelty Seeking from the Temperament and Character Inventory-Revised (TCI-R) were compared. Results: After the intervention, significant changes were observed in several measures of impulsivity, anger expression and other psychopathological symptoms. Dropout and relapse rates during treatment were similar to those described in the literature for CBT. Conclusion: Complementing CBT interventions for GD with a specific therapy approach like a serious video game might be helpful in addressing certain underlying factors which are usually difficult to change, including impulsivity and anger expression. PMID:26617550

  1. Engineering of an MBR supernatant fouling layer by fine particles addition: a possible way to control cake compressibility.

    PubMed

    Teychene, Benoît; Guigui, Christelle; Cabassud, Corinne

    2011-02-01

    For membrane bioreactors (MBR) applied to wastewater treatment membrane fouling is still the prevalent issue. The main limiting phenomena related to fouling is a sudden jump of the transmembrane pressure (TMP) often attributed to the collapse of the fouling layer. Among existing techniques to avoid or to delay this collapse, the addition of active particles membrane fouling reducers (polymer, resins, powdered activated carbon (PAC), zeolithe...) showed promising results. Thus the main objective of this work is to determine if fouling can be reduced by inclusion of inert particles (500 nm and inert compared to other fouling reducers) and which is the impact on filtration performances of the structuring of the fouling. Those particles were chosen for their different surface properties and their capability to form well structured layer. Results, obtained at constant pressure in dead end mode, show that the presence of particles changes foulant deposition and induces non-compressible fouling (in the range of 0.5-1 bar) and higher rejection values compared to filtration done on supernatant alone. Indeed dead end filtration tests show that whatever interactions between biofluid and particles, the addition of particles leads to better filtration performances (in terms of rejection, and fouling layer compressibility). Moreover results confirm the important role played by macromolecular compounds, during supernatant filtration, creating highly compressible and reversible fouling. In conclusion, this study done at lab-scale suggests the potential benefit to engineer fouling structure to control or to delay the collapse of the fouling layer. Finally this study offers the opportunities to enlarge the choice of membrane fouling reducers by taking into consideration their ability to form more consistent fouling (i.e. rigid, structured fouling). PMID:21232780

  2. Short-chain fatty acids and L-lactate as feed additives to control Campylobacter jejuni infections in broilers.

    PubMed

    Van Deun, Kim; Haesebrouck, Freddy; Van Immerseel, Filip; Ducatelle, Richard; Pasmans, Frank

    2008-08-01

    The usefulness of butyrate, acetate, propionate and l-lactate for the control of Campylobacter jejuni infections in broilers was assessed. For this purpose, the effect of these acids on the growth of C. jejuni in broth and intestinal mucous was determined, as well as their influence on the invasiveness of C. jejuni in intestinal epithelial cells. From these in vitro obtained results, one acid was retained for use as a feed additive in an in vivo trial. Butyrate was the most successful of the short-chain fatty acids, with 12.5 mM being bactericidal for C. jejuni at pH 6.0. Propionate and acetate had a bacteriostatic effect at 50 mM. None of the short-chain fatty acids had a bactericidal effect at pH 7.5 at a maximum concentration of 50 mM. Mucous increased the minimum bactericidal concentration of butyrate, but not the bacteriostatic concentrations of propionate or acetate. When C. jejuni was incubated in growth subinhibitory concentrations of butyrate, acetate or propionate or 25 mM L-lactate, no alteration in the invasive capabilities of C. jejuni in Caco-2 cells was observed. The addition of butyrate-coated micro-beads to the feed was unsuccessful to reduce C. jejuni caecal colonization in a seeder model using 2-week-old broilers. In conclusion, despite the marked bactericidal effect of butyrate towards C. jejuni in vitro, butyrate-coated micro-beads do not protect broilers from caecal colonization with C. jejuni in the applied test conditions. This might be partially ascribed to the protective effect of mucous and the rapid absorption of butyrate by the enterocytes. PMID:18622853

  3. Additional hemodynamic measurements with an esophageal Doppler monitor: a preliminary report of compliance, force, kinetic energy, and afterload in the clinical setting.

    PubMed

    Atlas, Glen; Brealey, David; Dhar, Sunil; Dikta, Gerhard; Singer, Meryvn

    2012-12-01

    The esophageal Doppler monitor (EDM) is a minimally-invasive hemodynamic device which evaluates both cardiac output (CO), and fluid status, by estimating stroke volume (SV) and calculating heart rate (HR). The measurement of these parameters is based upon a continuous and accurate approximation of distal thoracic aortic blood flow. Furthermore, the peak velocity (PV) and mean acceleration (MA), of aortic blood flow at this anatomic location, are also determined by the EDM. The purpose of this preliminary report is to examine additional clinical hemodynamic calculations of: compliance (C), kinetic energy (KE), force (F), and afterload (TSVR(i)). These data were derived using both velocity-based measurements, provided by the EDM, as well as other contemporaneous physiologic parameters. Data were obtained from anesthetized patients undergoing surgery or who were in a critical care unit. A graphical inspection of these measurements is presented and discussed with respect to each patient's clinical situation. When normalized to each of their initial values, F and KE both consistently demonstrated more discriminative power than either PV or MA. The EDM offers additional applications for hemodynamic monitoring. Further research regarding the accuracy, utility, and limitations of these parameters is therefore indicated.

  4. Clinical efficacy and safety of Chinese herbal medicine for Wilson's disease: a systematic review of 9 randomized controlled trials.

    PubMed

    Wang, Yan; Xie, Cheng-long; Fu, Deng-lei; Lu, Lin; Lin, Yan; Dong, Qi-qian; Wang, Xiao-tong; Zheng, Guo-qing

    2012-06-01

    Wilson's disease is an autosomal recessive disorder of copper metabolism. Despite being treatable, there is no universally accepted treatment regimen. Currently, various Chinese herbal medicines (CHMs) are widely used in the treatment of Wilson's disease in China, but there is a lack of reliable scientific evidence for the effectiveness of such therapies. The objective of this systematic review is to assess the clinical efficacy and safety of CHM as an alternative or/and adjuvant therapy for Wilson's disease. A systematic literature search in different medical databases was performed to identify randomized controlled trials comparing CHM as monotherapy or CHM as adjuvant therapy with western conventional medical therapy in the treatment of Wilson's disease. A total of 687 participants were included in nine eligible studies. The main findings are that CHM as monotherapy or adjuvant therapy for Wilson's disease may be able to improve the clinical symptoms, to promote the urinary copper excretion, to ameliorate liver function and/or liver cirrhosis, and has fewer adverse effects in comparison with western conventional medication. Furthermore, CHM generally appeared to be safe and well tolerated in patients with Wilson's disease. However, the evidence presented in this review are insufficient to warrant a clinical recommendation due to the generally low methodological quality of the included studies. In conclusion, CHM seems to be beneficial and safe for Wilson's disease, but high-quality evidences are still needed to further evaluate this therapy. Therefore, additional well-designed, randomized, placebo-controlled clinical trials are needed.

  5. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial

    PubMed Central

    Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-01-01

    Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 PMID:26705327

  6. Single-Amino Acid Modifications Reveal Additional Controls on the Proton Pathway of [FeFe]-Hydrogenase.

    PubMed

    Cornish, Adam J; Ginovska, Bojana; Thelen, Adam; da Silva, Julio C S; Soares, Thereza A; Raugei, Simone; Dupuis, Michel; Shaw, Wendy J; Hegg, Eric L

    2016-06-01

    The proton pathway of [FeFe]-hydrogenase is essential for enzymatic H2 production and oxidation and is composed of four residues and a water molecule. A computational analysis of this pathway in the [FeFe]-hydrogenase from Clostridium pasteurianum revealed that the solvent-exposed residue of the pathway (Glu282) forms hydrogen bonds to two residues outside of the pathway (Arg286 and Ser320), implying that these residues could function in regulating proton transfer. In this study, we show that substituting Arg286 with leucine eliminates hydrogen bonding with Glu282 and results in an ∼3-fold enhancement of H2 production activity when methyl viologen is used as an electron donor, suggesting that Arg286 may help control the rate of proton delivery. In contrast, substitution of Ser320 with alanine reduces the rate ∼5-fold, implying that it either acts as a member of the pathway or influences Glu282 to permit proton transfer. Interestingly, quantum mechanics/molecular mechanics and molecular dynamics calculations indicate that Ser320 does not play a structural role or indirectly influence the barrier for proton movement at the entrance of the channel. Rather, it may act as an additional proton acceptor for the pathway or serve in a regulatory role. While further studies are needed to elucidate the role of Ser320, collectively these data provide insights into the complex proton transport process. PMID:27186945

  7. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

  8. Clinical implementation of a computer controlled milling machine for compensating filter production.

    PubMed

    Partridge, M; Donovan, E; Fenton, N; Reise, S; Blane, S

    1999-11-01

    The procedures required for the clinical implementation of a computer controlled milling machine for producing compensators for breast radiotherapy are described. Moulds are cut in a rigid polymer foam block and filled with stainless-steel granulate. Quality assurance procedures are described for ensuring that the compensators produced are consistent and accurate. Relative and absolute dosimetric measurements are presented showing that the compensators are accurate to better than 1% and demonstrate the technique to be clinically acceptable.

  9. [A trial approach to the ideal control-management and systematization of clinical laboratory].

    PubMed

    Tadano, J

    1993-04-01

    Clinical laboratory examinations have continued to expand with the increase in demand for medical care. However, recent high-technology, medical care has made introduction of a new system of quality control in the clinical laboratory indispensable. First, regarding personnel (clinical laboratory technicians), reducing staff hours led to a drop in the employment of newcomers and subsequent aging of the staff. Next, introducing a system to save labor is extremely expensive, making the cost effectiveness very poor and consequently making it difficult to introduce such a system in many laboratories. This symposium was initiated to assist the search for ways in which the present clinical laboratory can survive despite rising personnel expenses and reagent costs, while reducing medical expenses. And at the same time developing a guide to establishing our ideal for the clinical laboratory of the 21st century.

  10. Development of compression-controlled low-level laser probe system: towards clinical application

    PubMed Central

    Yeo, Changmin; Son, Taeyoon; Park, Junghwan; Lee, Young-Heum; Kwon, Kiwoon; Nelson, J. Stuart

    2011-01-01

    Various physico-chemical tissue optical clearing (TOC) methods have been suggested to maximize photon density in tissue. In order to enhance photon density, a compression-controlled low-level laser probe (CCLLP) system was developed by utilizing the principle of mechanical tissue compression. Negative compression (NC) was applied to the laser probes built in various diameters and simultaneously the laser was irradiated into ex-vivo porcine skin samples. Laser photon density (LPD) was evaluated as a function of NC and probe diameter by analyzing 2D diffusion images of the laser exposures. The CCLLP system resulted in a concentrated laser beam profile, which means enhancement of the LPD. As indicators of LPD, the laser peak intensity increased and the full width at half maximum (FWHM) decreased as a function of NC. The peak intensity at −–30 kPa increased 2.74, 3.22, and 3.64 fold at laser probe diameters of 20, 30, and 40 mm, respectively. In addition, sample temperature was measured with a thermal camera and increased 0.4 K at −30 kPa after 60 s of laser irradiation as a result of enhanced LPD. The CCLLP system effectively demonstrated enhancement of the LPD in tissue and potentially its clinical feasibility. PMID:20393768

  11. EFFECT OF A DENTIFRICE CONTAINING ALOE VERA ON PLAQUE AND GINGIVITIS CONTROL. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

    PubMed Central

    de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

    2008-01-01

    The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) – dentifrice containing Aloe vera - or the control group (n=15) – fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice. PMID:19089263

  12. An Artificial Neural Network Estimation of Gait Balance Control in the Elderly Using Clinical Evaluations

    PubMed Central

    Lugade, Vipul; Lin, Victor; Farley, Arthur; Chou, Li-Shan

    2014-01-01

    The use of motion analysis to assess balance is essential for determining the underlying mechanisms of falls during dynamic activities. Clinicians evaluate patients using clinical examinations of static balance control, gait performance, cognition, and neuromuscular ability. Mapping these data to measures of dynamic balance control, and the subsequent categorization and identification of community dwelling elderly fallers at risk of falls in a quick and inexpensive manner is needed. The purpose of this study was to demonstrate that given clinical measures, an artificial neural network (ANN) could determine dynamic balance control, as defined by the interaction of the center of mass (CoM) with the base of support (BoS), during gait. Fifty-six elderly adults were included in this study. Using a feed-forward neural network with back propagation, combinations of five functional domains, the number of hidden layers and error goals were evaluated to determine the best parameters to assess dynamic balance control. Functional domain input parameters included subject characteristics, clinical examinations, cognitive performance, muscle strength, and clinical balance performance. The use of these functional domains demonstrated the ability to quickly converge to a solution, with the network learning the mapping within 5 epochs, when using up to 30 hidden nodes and an error goal of 0.001. The ability to correctly identify the interaction of the CoM with BoS demonstrated correlation values up to 0.89 (P<.001). On average, using all clinical measures, the ANN was able to estimate the dynamic CoM to BoS distance to within 1 cm and BoS area to within 75 cm2. Our results demonstrated that an ANN could be trained to map clinical variables to biomechanical measures of gait balance control. A neural network could provide physicians and patients with a cost effective means to identify dynamic balance issues and possible risk of falls from routinely collected clinical examinations

  13. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    PubMed Central

    2011-01-01

    Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT) will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE) PMID:21663656

  14. Overview: clinical and physiological comparison of meditation with other self-control strategies.

    PubMed

    Shapiro, D H

    1982-03-01

    In 1977 the American Psychiatric Association called for a critical examination of the clinical effectiveness of meditation. The author provides a review of the literature bearing on clinical and physiological comparisons of meditation with other self-control strategies. He begins by providing a definition of mediation and then cites the literature comparing mediation with such self-regulation strategies as biofeedback, hypnosis, and progressive relaxation. He pays particular attention to the "uniqueness" of mediation as a clinical intervention strategy a well as the adverse effects of meditation. Finally, he offers suggestions and guidelines for future research.

  15. Financial Quality Control of In-Patient Chemotherapy in Germany: Are Additional Payments Cost-Covering for Pharmaco-Oncological Expenses?

    PubMed Central

    Jacobs, Volker R.; Mallmann, Peter

    2011-01-01

    Summary Background Cost-covering in-patient care is increasingly important for hospital providers in Germany, especially with regard to expensive oncological pharmaceuticals. Additional payments (Zusatzentgelte; ZE) on top of flat rate diagnose-related group (DRG) reimbursement can be claimed by hospitals for in-patient use of selected medications. To verify cost coverage of in-patient chemotherapies, the costs of medication were compared to their revenues. Method From January to June 2010, a retrospective cost-revenue study was performed at a German obstetrics/gynecology university clinic. The hospital's pharmacy list of inpatient oncological therapies for breast and gynecological cancer was checked for accuracy and compared with the documented ZEs and the costs and revenues for each oncological application. Results N = 45 in-patient oncological therapies were identified in n = 18 patients, as well as n = 7 bisphosphonate applications; n = 11 ZEs were documented. Costs for oncological medication were € 33,752. The corresponding ZE revenues amounted to only € 13,980, resulting in a loss of € 19,772. All in-patient oncological therapies performed were not cost-covering. Data discrepancy, incorrect documentation and cost attribution, and process aborts were identified. Conclusions Routine financial quality control at the medicine-pharmacy administration interface is implemented, with monthly comparison of costs and revenues, as well as admission status. Non-cost-covering therapies for in-patients should be converted to out-patient therapies. Necessary adjustments of clinic processes are made according to these results, to avoid future losses. PMID:21673822

  16. The basis of clinical tribalism, hierarchy and stereotyping: a laboratory-controlled teamwork experiment

    PubMed Central

    Braithwaite, Jeffrey; Clay-Williams, Robyn; Vecellio, Elia; Marks, Danielle; Hooper, Tamara; Westbrook, Mary; Westbrook, Johanna; Blakely, Brette; Ludlow, Kristiana

    2016-01-01

    Objectives To examine the basis of multidisciplinary teamwork. In real-world healthcare settings, clinicians often cluster in profession-based tribal silos, form hierarchies and exhibit stereotypical behaviours. It is not clear whether these social structures are more a product of inherent characteristics of the individuals or groups comprising the professions, or attributable to a greater extent to workplace factors. Setting Controlled laboratory environment with well-appointed, quiet rooms and video and audio equipment. Participants Clinical professionals (n=133) divided into 35 groups of doctors, nurses and allied health professions, or mixed professions. Interventions Participants engaged in one of three team tasks, and their performance was video-recorded and assessed. Primary and secondary measures Primary: teamwork performance. Secondary, pre-experimental: a bank of personality questionnaires designed to assess participants’ individual differences. Postexperimental: the 16-item Mayo High Performance Teamwork Scale (MHPTS) to measure teamwork skills; this was self-assessed by participants and also by external raters. In addition, external, arm's length blinded observations of the videotapes were conducted. Results At baseline, there were few significant differences between the professions in collective orientation, most of the personality factors, Machiavellianism and conservatism. Teams generally functioned well, with effective relationships, and exhibited little by way of discernible tribal or hierarchical behaviours, and no obvious differences between groups (F (3, 31)=0.94, p=0.43). Conclusions Once clinicians are taken out of the workplace and put in controlled settings, tribalism, hierarchical and stereotype behaviours largely dissolve. It is unwise therefore to attribute these factors to fundamental sociological or psychological differences between individuals in the professions, or aggregated group differences. Workplace cultures are more likely to

  17. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

  18. The ADDITION-Cambridge trial protocol: a cluster – randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients

    PubMed Central

    Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Williams, Kate M; Barling, Roslyn S; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

    2009-01-01

    care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Trial registration Current Controlled trials ISRCTN86769081 PMID:19435491

  19. Design control for clinical translation of 3D printed modular scaffolds.

    PubMed

    Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

    2015-03-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  20. Design Control for Clinical Translation of 3D Printed Modular Scaffolds

    PubMed Central

    Hollister, Scott J.; Flanagan, Colleen L.; Zopf, David A.; Morrison, Robert J.; Nasser, Hassan; Patel, Janki J.; Ebramzadeh, Edward; Sangiorgio, Sophia N.; Wheeler, Matthew B.; Green, Glenn E.

    2015-01-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  1. Design control for clinical translation of 3D printed modular scaffolds.

    PubMed

    Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

    2015-03-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  2. Control of Cr6+ emissions from gas metal arc welding using a silica precursor as a shielding gas additive.

    PubMed

    Topham, Nathan; Wang, Jun; Kalivoda, Mark; Huang, Joyce; Yu, Kuei-Min; Hsu, Yu-Mei; Wu, Chang-Yu; Oh, Sewon; Cho, Kuk; Paulson, Kathleen

    2012-03-01

    Hexavalent chromium (Cr(6+)) emitted from welding poses serious health risks to workers exposed to welding fumes. In this study, tetramethylsilane (TMS) was added to shielding gas to control hazardous air pollutants produced during stainless steel welding. The silica precursor acted as an oxidation inhibitor when it decomposed in the high-temperature welding arc, limiting Cr(6+) formation. Additionally, a film of amorphous SiO(2) was deposited on fume particles to insulate them from oxidation. Experiments were conducted following the American Welding Society (AWS) method for fume generation and sampling in an AWS fume hood. The results showed that total shielding gas flow rate impacted the effectiveness of the TMS process. Increasing shielding gas flow rate led to increased reductions in Cr(6+) concentration when TMS was used. When 4.2% of a 30-lpm shielding gas flow was used as TMS carrier gas, Cr(6+) concentration in gas metal arc welding (GMAW) fumes was reduced to below the 2006 Occupational Safety and Health Administration standard (5 μg m(-3)) and the efficiency was >90%. The process also increased fume particle size from a mode size of 20 nm under baseline conditions to 180-300 nm when TMS was added in all shielding gas flow rates tested. SiO(2) particles formed in the process scavenged nanosized fume particles through intercoagulation. Transmission electron microscopy imagery provided visual evidence of an amorphous film of SiO(2) on some fume particles along with the presence of amorphous SiO(2) agglomerates. These results demonstrate the ability of vapor phase silica precursors to increase welding fume particle size and minimize chromium oxidation, thereby preventing the formation of hexavalent chromium. PMID:22104317

  3. Control of Cr6+ emissions from gas metal arc welding using a silica precursor as a shielding gas additive.

    PubMed

    Topham, Nathan; Wang, Jun; Kalivoda, Mark; Huang, Joyce; Yu, Kuei-Min; Hsu, Yu-Mei; Wu, Chang-Yu; Oh, Sewon; Cho, Kuk; Paulson, Kathleen

    2012-03-01

    Hexavalent chromium (Cr(6+)) emitted from welding poses serious health risks to workers exposed to welding fumes. In this study, tetramethylsilane (TMS) was added to shielding gas to control hazardous air pollutants produced during stainless steel welding. The silica precursor acted as an oxidation inhibitor when it decomposed in the high-temperature welding arc, limiting Cr(6+) formation. Additionally, a film of amorphous SiO(2) was deposited on fume particles to insulate them from oxidation. Experiments were conducted following the American Welding Society (AWS) method for fume generation and sampling in an AWS fume hood. The results showed that total shielding gas flow rate impacted the effectiveness of the TMS process. Increasing shielding gas flow rate led to increased reductions in Cr(6+) concentration when TMS was used. When 4.2% of a 30-lpm shielding gas flow was used as TMS carrier gas, Cr(6+) concentration in gas metal arc welding (GMAW) fumes was reduced to below the 2006 Occupational Safety and Health Administration standard (5 μg m(-3)) and the efficiency was >90%. The process also increased fume particle size from a mode size of 20 nm under baseline conditions to 180-300 nm when TMS was added in all shielding gas flow rates tested. SiO(2) particles formed in the process scavenged nanosized fume particles through intercoagulation. Transmission electron microscopy imagery provided visual evidence of an amorphous film of SiO(2) on some fume particles along with the presence of amorphous SiO(2) agglomerates. These results demonstrate the ability of vapor phase silica precursors to increase welding fume particle size and minimize chromium oxidation, thereby preventing the formation of hexavalent chromium.

  4. Meta-analysis of randomized controlled trials on magnesium in addition to beta-blocker for prevention of postoperative atrial arrhythmias after coronary artery bypass grafting

    PubMed Central

    2013-01-01

    Background Atrial arrhythmia (AA) is the most common complication after coronary artery bypass grafting (CABG). Only beta-blockers and amiodarone have been convincingly shown to decrease its incidence. The effectiveness of magnesium on this complication is still controversial. This meta-analysis was performed to evaluate the effect of magnesium as a sole or adjuvant agent in addition to beta-blocker on suppressing postoperative AA after CABG. Methods We searched the PubMed, Medline, ISI Web of Knowledge, Cochrane library databases and online clinical trial database up to May 2012. We used random effects model when there was significant heterogeneity between trials and fixed effects model when heterogeneity was negligible. Results Five randomized controlled trials were identified, enrolling a total of 1251 patients. The combination of magnesium and beta-blocker did not significantly decrease the incidence of postoperative AA after CABG versus beta-blocker alone (odds ratio (OR) 1.12, 95% confidence interval (CI) 0.86-1.47, P = 0.40). Magnesium in addition to beta-blocker did not significantly affect LOS (weighted mean difference −0.14 days of stay, 95% CI −0.58 to 0.29, P = 0.24) or the overall mortality (OR 0.59, 95% CI 0.08-4.56, P = 0.62). However the risk of postoperative adverse events was higher in the combination of magnesium and beta-blocker group than beta-blocker alone (OR 2.80, 95% CI 1.66-4.71, P = 0.0001). Conclusions This meta-analysis offers the more definitive evidence against the prophylactic administration of intravenous magnesium for prevention of AA after CABG when beta-blockers are routinely administered, and shows an association with more adverse events in those people who received magnesium. PMID:23343189

  5. Utilizing measure-based feedback in control-mastery theory: A clinical error.

    PubMed

    Snyder, John; Aafjes-van Doorn, Katie

    2016-09-01

    Clinical errors and ruptures are an inevitable part of clinical practice. Often times, therapists are unaware that a clinical error or rupture has occurred, leaving no space for repair, and potentially leading to patient dropout and/or less effective treatment. One way to overcome our blind spots is by frequently and systematically collecting measure-based feedback from the patient. Patient feedback measures that focus on the process of psychotherapy such as the Patient's Experience of Attunement and Responsiveness scale (PEAR) can be used in conjunction with treatment outcome measures such as the Outcome Questionnaire 45.2 (OQ-45.2) to monitor the patient's therapeutic experience and progress. The regular use of these types of measures can aid clinicians in the identification of clinical errors and the associated patient deterioration that might otherwise go unnoticed and unaddressed. The current case study describes an instance of clinical error that occurred during the 2-year treatment of a highly traumatized young woman. The clinical error was identified using measure-based feedback and subsequently understood and addressed from the theoretical standpoint of the control-mastery theory of psychotherapy. An alternative hypothetical response is also presented and explained using control-mastery theory. (PsycINFO Database Record PMID:27631857

  6. Clinical Hypnosis in the Treatment of Post-Menopausal Hot Flashes: A Randomized Controlled Trial

    PubMed Central

    Elkins, Gary R.; Fisher, William I.; Johnson, Aimee K.; Carpenter, Janet S.; Keith, Timothy Z.

    2012-01-01

    Objective The use of estrogen and progesterone to manage vasomotor symptoms (i.e., hot flashes, night sweats) has declined due to concerns over their risks and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized, controlled trial of clinical hypnosis in treating vasomotor symptoms among post-menopausal women. Methods Randomized, single-blind, controlled, clinical trial involving 187 post-menopausal women reporting a minimum of seven hot flashes per day, or at least 50 hot flashes a week at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries at weeks 2–6, and 12. Secondary outcomes included measures of hot flash related daily interference, sleep quality and treatment satisfaction. Results In a modified intent-to-treat analysis that included all randomized participants that provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 hot flashes for the clinical hypnosis intervention (74.16%), versus a 12.89 hot flash reduction (17.13%) for the control (p<.001, 95% CI, 36.15–49.67). Mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared to 3.53 (15.38%) for the control (p<.001, 95% CI, 12.60–17.54). At 12 week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and .88 (9.94%) for the control (p<.001, 95% CI, 2.00–5.46). Secondary outcomes were significantly improved compared to control at 12 week follow-up in hot flash related interference (p<.001, 95% CI, 2.74–4.02), sleep quality (p<.001, 95% CI, 3.65–5.84), and treatment satisfaction (p<.001, 95% CI, 7.79–8.59). Conclusion Compared

  7. Role of quantity of additional food to predators as a control in predator-prey systems with relevance to pest management and biological conservation.

    PubMed

    Srinivasu, P D N; Prasad, B S R V

    2011-10-01

    Necessity to understand the role of additional food as a tool in biological control programs is being increasingly felt, particularly due to its eco-friendly nature. A thorough mathematical analysis in this direction revealed the vital role of quality and quantity of the additional food in the controllability of the predator-prey systems. In this article controllability of the additional food--provided predator-prey system is studied from perspectives of pest eradication and biological conservation. Time optimal paths have been constructed to drive the state of the system to a desired terminal state by choosing quantity of the additional food as control variable. The theory developed in this article has been illustrated by solving problems related to pest eradication and biological conservation.

  8. Evaluation of the Clinical and Cost Effectiveness of Intermediate Care Clinics for Diabetes (ICCD): A Multicentre Cluster Randomised Controlled Trial

    PubMed Central

    Hardy, Ainsley; Raymond, Neil; Szczepura, Ala; Crossman, Ric; Baines, Darrin; Khunti, Kamlesh; Kumar, Sudhesh; Saravanan, Ponnusamy

    2014-01-01

    Background Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling off. Community based, intermediate care clinics for diabetes (ICCDs) were considered one solution and are functioning across the UK. However, there is no randomised trial evidence for the effectiveness of such clinics. Trial Design, Methods and Findings This is a cluster-randomised trial, involving 3 primary care trusts, with 49 general practices randomised to usual care (n = 25) or intervention (ICCDs; n = 24). All eligible adult patients with T2D were invited; 1997 were recruited and 1280 followed-up after 18-months intervention. Primary outcome: achievement of all three of the NICE targets [(HbA1c≤7.0%/53 mmol/mol; Blood Pressure <140/80 mmHg; cholesterol <154 mg/dl (4 mmol/l)]. Primary outcome was achieved in 14.3% in the intervention arm vs. 9.3% in the control arm (p = 0.059 after adjustment for covariates). The odds ratio (95% CI) for achieving primary outcome in the intervention group was 1.56 (0.98, 2.49). Primary care and community clinic costs were significantly higher in the intervention group, but there were no significant differences in hospital costs or overall healthcare costs. An incremental cost-effectiveness ratio (ICER) of +£7,778 per QALY gained, indicated ICCD was marginally more expensive at producing health gain. Conclusions Intermediate care clinics can contribute to improving target achievement in patients with diabetes. Further work is needed to investigate the optimal scale and organisational structure of ICCD services and whether, over

  9. The impact of extracellular matrix on the chemoresistance of solid tumors--experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy.

    PubMed

    Baumgartner, G; Gomar-Höss, C; Sakr, L; Ulsperger, E; Wogritsch, C

    1998-09-11

    Chemoresistance is of outstanding importance for the limited results of chemotherapy in solid tumors. Chemoresistance of multicellular tumor tissues is more pronounced than that of single cells in vivo and in vitro. The enzyme hyaluronidase is able to loosen the cell-cell contact and the interstitial connective tissue and as such, in a number of preclinical and clinical trials, was shown to enhance the efficacy of cytostatic agents. Although proven to be very effective as additive to local chemotherapy, the systemic efficacy is not documented as well. We present a randomized trial done in high-grade astrocytomas with combined chemotherapy and radiation therapy with and without hyaluronidase. After very promising pilot results with systemic hyaluronidase in various tumor entities and also astrocytomas, this randomized study failed to show synergy to chemotherapy and radiation therapy in high-grade astrocytomas concerning survival. The promising preclinical data and the rather well documented activity in therapeutic use as additive to local chemotherapy seem to be an adequate motive to further elucidate the complex manner in which hyaluronidase is active in the interstitial tumor matrix and to obtain more information concerning the optimal route of application, the optimal dosage and the spectrum of tumor entities where it is synergistic with cytostatic chemotherapy and perhaps even radiation therapy.

  10. Prenatal Pregnancy Complications and Psychiatric Symptoms: Children with ASD versus Clinic Controls

    ERIC Educational Resources Information Center

    Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.

    2012-01-01

    The current study examined the association between prenatal pregnancy complications (PPC) and childhood psychiatric symptoms in children with an autism spectrum disorder (ASD) and non-ASD children who were referred to a psychiatric clinic (Controls). Parents completed a "DSM-IV"-referenced rating scale and developmental history questionnaire.…

  11. 77 FR 50162 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Correction In notice document 2012-19197 appearing on pages 47109-47110 in the issue...

  12. Wormwood (Artemisia absinthium) suppresses tumour necrosis factor alpha and accelerates healing in patients with Crohn's disease - A controlled clinical trial.

    PubMed

    Krebs, Simone; Omer, Talib N; Omer, Bilal

    2010-04-01

    Suppression of tumour necrosis factor alpha (TNF-alpha) and other interleukins by wormwood (Artemisia absinthium) extracts were reported recently in in vitro studies. The aim of the present study was to find out if this effect can be also be observed in Crohn's Disease (CD) patients where TNF-alpha appears to play an important role. In a controlled trial, 10 randomly selected patients suffering from CD were given in addition to their basic CD therapy 3x750mg dried powdered wormwood for 6 weeks. Ten patients, also randomly selected who met the inclusion criteria served as control group. Minimum score of 200 on Crohn's Disease Activity Index (CDAI) was required at baseline for inclusion in each group. Patients who received infliximab or similar were excluded from the trial. TNF-alpha level in serum were measured at baseline, and after three and six weeks. During this period all concomitant CD medications was maintained at the baseline dose levels. Average serum TNF-alpha level fell from 24.5+/-3.5pg/ml at baseline to 8.0+/-2.5pg/ml after six weeks. The corresponding levels in the control group were 25.7+/-4.6 (week 0), and 21.1+/-3.2 (week 6). On the clinical side, CDAI scores fell from 275+/-15 to below 175+/-12 in wormwood group with remission of symptoms in eight patients (CDAI score below 170 or reduction by 70 points), compared to only two in the placebo group (CDAI of placebo group 282+/-11 at baseline and 230+/-14 on week 6). IBDQ also reflected accelerated clinical response with wormwood. Of clinical significance were the findings that wormwood also improved mood of the CD patients, as reflected in Hamilton's Depression Scale. These findings provide a base to test wormwood in clinical conditions thought to be mediated by increased production of pro-inflammatory cytokines such as TNF-alpha.

  13. Development of Automatic Controller of Brain Temperature Based on the Conditions of Clinical Use

    NASA Astrophysics Data System (ADS)

    Utsuki, Tomohiko; Wakamatsu, Hidetoshi

    A new automatic controller of brain temperature was developed based on the inevitable conditions of its clinical use from the viewpoint of various kinds of feasibility, in particular, electric power consumption of less than 1,500W in ICU. The adaptive algorithm was employed to cope with individual time-varying characteristic change of patients. The controller under water-surface cooling hypothermia requires much power for the frequent regulation of the water temperature of cooling blankets. Thus, in this study, the power consumption of the controller was checked by several kinds of examinations involving the control simulation of brain temperature using a mannequin with thermal characteristics similar to that of adult patients. The required accuracy of therapeutic brain hypothermia, i.e. control deviation within ±0.1C was experimentally confirmed using “root mean square of the control error”, despite the present controller consumes less energy comparing with the one in the case of our conventional controller, where it can still keeps remaining power margin more than 300W even in the full operation. Thereby, the clinically required water temperature was also confirmed within the limit of power supply, thus its practical application is highly expected with less physical burden of medical staff inclusive of more usability and more medical cost performance.

  14. Somatostatin plus isosorbide 5-mononitrate versus somatostatin in the control of acute gastro-oesophageal variceal bleeding: a double blind, randomised, placebo controlled clinical trial

    PubMed Central

    Junquera, F; Lopez-Talavera, J; Mearin, F; Saperas, E; Videla, S; Armengol, J; Esteban, R; Malagelada, J

    2000-01-01

    BACKGROUND—Variceal bleeding is a severe complication of portal hypertension. Somatostatin reduces portal pressure by decreasing splanchnic blood flow, and nitrates by diminishing intrahepatic resistance. Experimental studies have shown that the combination of somatostatin and nitrates has an additive effect in decreasing portal pressure.
AIM—To compare the therapeutic efficacy of either intravenous infusion of somatostatin plus oral isosorbide 5-mononitrate or somatostatin alone in gastro-oesophageal variceal bleeding associated with liver cirrhosis.
METHODS—A unicentre, double blind, placebo controlled, clinical trial was conducted. Sixty patients bleeding from oesophageal or gastric varices were randomised to receive intravenous infusion of somatostatin (250 µg/hour) plus oral isosorbide 5-mononitrate (40 mg/12 hours) (group I) or somatostatin infusion plus placebo (group II) for 72 hours.
RESULTS—The two groups of patients had similar clinical, endoscopic, and haematological characteristics. Control of bleeding was achieved in 18 out of 30 patients (60%) in group I and 26 out of 30 patients (87%) in group II (p<0.05). There was no significant difference in mean transfusion requirements between the two groups: 2.6 (2.2) v 1.8 (1.6) respectively; means (SD). Mortality and side effects were similar in the two groups, but development of ascites was higher in group I (30%) than in group II (7%) (p<0.05).
CONCLUSION—In cirrhotic patients with acute gastro-oesophageal variceal bleeding, addition of isosorbide 5-mononitrate to somatostatin does not improve therapeutic efficacy, induces more adverse effects, and should not be used.


Keywords: gastro-oesophageal bleeding; haemorrhage; portal hypertension; clinical trial; isosorbide 5-mononitrate; somatostatin PMID:10601068

  15. Efficacy and Safety Assessment of the Addition of Bevacizumab to Adjuvant Therapy Agents in Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Ahmadizar, Fariba; Onland-Moret, N. Charlotte; de Boer, Anthonius; Liu, Geoffrey; Maitland-van der Zee, Anke H.

    2015-01-01

    Aim To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. Methods & Design/ Results PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials comparing bevacizumab and adjuvant therapy with adjuvant therapy alone published from January 1966 to 7th of May 2014. Progression free survival, overall survival, overall response rate, safety and quality of life were analyzed using random- or fixed-effects models according to the PRISMA guidelines. We obtained data from 44 randomized controlled trials (30,828 patients). Combining bevacizumab with different adjuvant therapies resulted in significant improvement of progression free survival (log hazard ratio, 0.87; 95% confidence interval (CI), 0.84–0.89), overall survival (log hazard ratio, 0.96; 95% CI, 0.94–0.98) and overall response rate (relative risk, 1.46; 95% CI: 1.33–1.59) compared to adjuvant therapy alone in all studied tumor types. In subgroup analyses, there were no interactions of bevacizumab with baseline characteristics on progression free survival and overall survival, while overall response rate was influenced by tumor type and bevacizumab dose (p-value: 0.02). Although bevacizumab use resulted in additional expected adverse drug reactions except anemia and fatigue, it was not associated with a significant decline in quality of life. There was a trend towards a higher risk of several side effects in patients treated by high-dose bevacizumab compared to the low-dose e.g. all grade proteinuria (9.24; 95% CI: 6.60–12.94 vs. 2.64; 95% CI: 1.29–5.40). Conclusions Combining bevacizumab with different adjuvant therapies provides a survival benefit across all major subsets of patients, including by tumor type, type of adjuvant therapy, and duration and dose of bevacizumab therapy. Though bevacizumab was associated with increased risks of some adverse drug

  16. Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms

    PubMed Central

    2013-01-01

    Background Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient. Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma. Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. Methods/design The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later. The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0–10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment. In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed. The statistical analysis of the primary outcome will be performed

  17. Field Testing of a Wet FGD Additive for Enhanced Mercury Control - Task 3 Full-scale Test Results

    SciTech Connect

    Gary Blythe

    2007-05-01

    This Topical Report summarizes progress on Cooperative Agreement DE-FC26-04NT42309, 'Field Testing of a Wet FGD Additive'. The objective of the project is to demonstrate the use of a flue gas desulfurization (FGD) additive, Degussa Corporation's TMT-15, to prevent the reemission of elemental mercury (Hg{sup 0}) in flue gas exiting wet FGD systems on coal-fired boilers. Furthermore, the project intends to demonstrate whether the additive can be used to precipitate most of the mercury (Hg) removed in the wet FGD system as a fine TMT salt that can be separated from the FGD liquor and bulk solid byproducts for separate disposal. The project is conducting pilot- and full-scale tests of the TMT-15 additive in wet FGD absorbers. The tests are intended to determine required additive dosages to prevent Hg{sup 0} reemissions and to separate mercury from the normal FGD byproducts for three coal types: Texas lignite/Power River Basin (PRB) coal blend, high-sulfur Eastern bituminous coal, and low-sulfur Eastern bituminous coal. The project team consists of URS Group, Inc., EPRI, TXU Generation Company LP, Southern Company, and Degussa Corporation. TXU Generation has provided the Texas lignite/PRB cofired test site for pilot FGD tests, Monticello Steam Electric Station Unit 3. Southern Company is providing the low-sulfur Eastern bituminous coal host site for wet scrubbing tests, as well as the pilot- and full-scale jet bubbling reactor (JBR) FGD systems to be tested. IPL, an AES company, provided the high-sulfur Eastern bituminous coal full-scale FGD test site and cost sharing. Degussa Corporation is providing the TMT-15 additive and technical support to the test program as cost sharing. The project is being conducted in six tasks. Of the six project tasks, Task 1 involves project planning and Task 6 involves management and reporting. The other four tasks involve field testing on FGD systems, either at pilot or full scale. The four tasks include: Task 2 - Pilot Additive Testing

  18. Klebsiella pneumoniae liver abscess in diabetic patients: association of glycemic control with the clinical characteristics

    PubMed Central

    2013-01-01

    Background Klebsiella pneumoniae liver abscess (KPLA) has been reported with increasing frequency in East Asian countries in the past 3 decades, especially in Taiwan and Korea. Diabetes is a well-known risk factor for KPLA and highly associated with septic metastatic complications from KPLA. We investigated the association of glycemic control in diabetic patients with the clinical characteristics of KPLA in Taiwan. Methods Adult diabetic patients with KPLA were identified retrospectively in a medical center from January 2007 to January 2012. Clinical characteristics were compared among patients with different levels of current hemoglobin A1c (HbA1c). Risk factors for metastatic infection from KPLA were analyzed. Results Patients with uncontrolled glycemia (HbA1c ≥ 7%) were significantly younger than those with controlled glycemia (HbA1c < 7%). Patients with uncontrolled glycemia had the trend to have a higher rate of gas-forming liver abscess, cryptogenic liver abscess, and metastatic infection than those with controlled glycemia. Cryptogenic liver abscess and metastatic infection were more common in the poor glycemic control group (HbA1c value >; 10%) after adjustment with age. HbA1c level and abscess < 5 cm were independent risk factors for metastatic complications from KPLA. Conclusions Glycemic control in diabetic patients played an essential role in the clinical characteristics of KPLA, especially in metastatic complications from KPLA. PMID:23363608

  19. Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

    PubMed

    Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

    2011-11-01

    This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

  20. Electroacupuncture in the treatment of chronic lameness in horses and ponies: a controlled clinical trial.

    PubMed Central

    Steiss, J E; White, N A; Bowen, J M

    1989-01-01

    Electroacupuncture was used to treat lameness in horses and ponies with chronic laminitis (n = 10) or navicular disease (n = 10). A clinical trial was conducted with random allocation of equal numbers of animals to control and treatment groups. Acupuncture was performed three times per week for four consecutive weeks. The degree of lameness was assessed by 1) a grading scheme, 2) measurement of stride lengths and 3) analysis of weight distribution using a force plate. Although seven out of ten animals with chronic laminitis improved clinically during the trial, there were no statistically significant differences between treatment and control groups. Six out of ten horses with navicular disease improved, but there were no significant differences between treatment and control groups. PMID:2653599

  1. Riposte to Guest Commentaries on 'Problems associated with randomized controlled clinical trials in breast cancer.

    PubMed

    Johnson, A E

    1998-08-01

    This paper addresses the objections of Professor M. Baum and Mr W. J. Cunliffe to my thesis that the randomized controlled clinical trial is a poor tool for the investigation of the treatment of breast cancer, argued in a discussion paper entitled 'Problems associated with randomized controlled clinical trials in breast cancer' (A.E. Johnson, 1998, Journal of Evaluation in Clinical Practice 4, 119-126). The objections range from those that have a philosophical basis, through those founded on differing concepts of the classification of primary tumours and the nature of the metastatic tumour, to those that question the reliability and usefulness of the clinical evaluation of response to treatment in terms of histological grade and rate of tumour shrinkage. An alternative approach to research through primary systemic therapy with selection of treatment according to predicted tumour behaviour was severely criticized, both on the preceding grounds and because it was assumed that the alternative to randomization is management by anecdote. These objections are examined and evidence in support of reliable and useful clinical measurement of response is presented in some detail. The problems associated with randomization as a technique for the evaluation of treatments, when the intrinsic variability of tumours is very large without the intervention of treatment, remain unsolved.

  2. Albumin in Burn Shock Resuscitation: A Meta-Analysis of Controlled Clinical Studies

    PubMed Central

    Greenhalgh, David G.; Wilkes, Mahlon M.

    2016-01-01

    Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07–0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed. PMID:25426807

  3. Child Effortful Control, Teacher-Student Relationships, and Achievement in Academically At-Risk Children: Additive and Interactive Effects

    ERIC Educational Resources Information Center

    Liew, Jeffrey; Chen, Qi; Hughes, Jan N.

    2010-01-01

    The joint contributions of child effortful control (using inhibitory control and task accuracy as behavioral indices) and positive teacher-student relationships at first grade on reading and mathematics achievement at second grade were examined in 761 children who were predominantly from low-income and ethnic minority backgrounds and assessed to…

  4. Integrated Autopilot/Autothrottle Based on a Total Energy Control Concept: Design and Evaluation of Additional Autopilot Modes

    NASA Technical Reports Server (NTRS)

    Bruce, Kevin R.

    1988-01-01

    An integrated autopilot/autothrottle system was designed using a total energy control design philosophy. This design ensures that the system can differentiate between maneuvers requiring a change in thrust to accomplish a net energy change, and those maneuvers which only require elevator control to redistribute energy. The system design, the development of the system, and a summary of simulation results are defined.

  5. Cancer Control Research Training for Native Researchers: A Model for Development of Additional Native Researcher Training Programs

    ERIC Educational Resources Information Center

    Becker, Thomas M.; Dunn, Esther; Tom-Orme, Lillian; Joe, Jennie

    2005-01-01

    Several social and biological scientists who have Native status are engaged in productive research careers, but the encouragement that has been offered to Native students to formulate career goals devoted to cancer etiology or cancer control in Native peoples has had limited success. Hence, the Native Researchers' Cancer Control Training Program…

  6. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial

    PubMed Central

    Cella, D.; Ivanescu, C.; Holmstrom, S.; Bui, C. N.; Spalding, J.; Fizazi, K.

    2015-01-01

    Background To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial. Patients and methods Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was completed before randomization, at weeks 13, 17, 21, and 25, and every 12 weeks thereafter while on study treatment. Longitudinal changes in FACT-P scores from baseline to 25 weeks were analyzed using a mixed effects model for repeated measures (MMRM), with a pattern mixture model (PMM) applied as secondary analysis to address non-ignorable missing data. Cumulative distribution function (CDF) plots were generated and different methodological approaches and models for handling missing data were applied. Due to the exploratory nature of the analyses, adjustments for multiple comparisons were not made. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311. Results The intention-to-treat FACT-P population included 938 patients (enzalutamide, n = 674; placebo n = 264) with evaluable FACT-P assessments at baseline and ≥1 post-baseline assessment. After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001). In addition, significant treatment differences at week 25 favoring enzalutamide were evident for all FACT-P subscales and indices, whether analyzed by MMRM or PMM. CDF plots revealed differences favoring enzalutamide compared with placebo across the full range of possible response levels for FACT-P total and all disease- and symptom-specific subscales/indices. Conclusion In men with progressive mCRPC after docetaxel-based chemotherapy, enzalutamide is superior to placebo in health-related quality-of-life outcomes, regardless of analysis model or threshold selected for meaningful response. Clinical

  7. Intrasession reliability and influence of breathing during clinical assessment of lumbar spine postural control.

    PubMed

    Lafond, Danik; Dimmock, Mathilde; Champagne, Annick; Descarreaux, Martin

    2009-04-01

    The aims of this study were to evaluate the influence of breathing when measuring lumbar postural control during a clinical progressive lumbar stabilization test (LST) and to estimate the intrasession reliability of the LST. The lumbar postural control index was calculated by using a biofeedback pressure unit. The LST was performed in two different positions (crook lying and upright) and two respiratory conditions (apnea and breathing) by 20 healthy individuals. The intrasession reliability of the lumbar postural control index of one trial was estimated with intraclass correlation coefficient (ICC) based on an Anova model. The results showed that the lumbar postural control index is similar between testing positions. There is an increase of the lumbar postural control index during breathing compared to the apnea. The reliability of the lumbar postural control index was fair to good (ICC 0.28-0.58). We also found that for the apnea, three trials had to be averaged to attain an ICC of 0.80 for both positions. The results of the present study indicate that the progressive LST can be similarly conducted in either supine or upright posture. Clinicians should be aware of the influence of breathing during LST. However, breathing could also serve as a clinical strategy to challenge lumbar spine postural control and stability during bracing therapeutic exercises. PMID:19384740

  8. Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Yousefichaijan, Parsa; Cyrus, Ali; Dorreh, Fatemeh; Rafeie, Mohammad; Sharafkhah, Mojtaba; Frohar, Faryar; Safi, Fatemeh

    2015-01-01

    Background: Nephrolithiasis in children is associated with a high rate of complications and recurrence. Objectives: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. Patients and Methods: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. Results: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001) in a way that the decrease in the intervention group showed no difference with the control group. Conclusions: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field. PMID:26635934

  9. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial.

    PubMed

    Hashem, D; Mannocci, F; Patel, S; Manoharan, A; Brown, J E; Watson, T F; Banerjee, A

    2015-04-01

    The aims of this study were to assess the effectiveness of calcium silicate cement (Biodentine) versus glass ionomer cement (GIC; control group) as indirect pulp capping materials in patients with reversible pulpitis and to compare the effectiveness of cone beam computed tomography (CBCT) versus periapical (PA) radiographs in detecting PA changes at baseline (T0) and at 12 mo (T12) postoperatively. Seventy-two restorations (36 Biodentine, 36 Fuji IX) were placed randomly in 53 patients. CBCT/PA radiographs were taken at T0 and T12. Two calibrated examiners assessed the presence/absence and increase/decrease in the size of existing PA radiolucencies under standardized conditions. The Kappa coefficient evaluated statistically the effectiveness of CBCT versus PA radiographs in detecting PA changes. Chi-square/Mann-Whitney tests were used to evaluate the association between PA changes in CBCT with various clinical measures. Significance was predetermined at α = 0.05. Clinical success rates for Biodentine and Fuji IX GIC were 83.3%. CBCT was significantly more effective in detecting PA radiolucencies compared with radiographs (P = 0.0069). Of the teeth, 65.4% and 90.4% were deemed healthy using CBCT and PA radiographs, respectively, at T12. Healing/healed rates were 17.3%/0%, while new/progressed radiolucency were 30.8%/9.6% with CBCT/PA radiographs, respectively. Seventy-one percent of healed lesions had received Biodentine; 88% of new/progressed lesions received Fuji IX GIC. Teeth presenting with an initial CBCT PA lesion had a failure rate of 63%, whereas teeth with no initial lesion had a failure rate of 16%. Although no statistically significant difference was detected in the clinical efficacy of Biodentine/Fuji IX when used as indirect pulp capping materials in patients with reversible pulpitis, CBCT showed a significant difference in that most healed CBCT lesions had received Biodentine while most that did not heal received Fuji IX. Longer-term follow-up is

  10. High-dose intravenous immunoglobulin in inflammatory myopathies: experience based on controlled clinical trials.

    PubMed

    Dalakas, M C

    2003-10-01

    Controlled clinical trials with high-dose intravenous immunoglobulin (IVIg) have been conducted in patients with DM and IBM, but not PM. A double-blind placebo-controlled study in DM patients, resistant or partially responsive to conventional therapies, showed that IVIg is very effective in improving both the muscle strength and the skin rash. The clinical benefit, which was impressive in patients with early disease, was associated with improvement in the muscle cytoarchitecture. Quantitative histological studies in repeated muscle biopsies showed a statistically significant increased in the size of muscle fibers and the number of capillaries with normalization of the capillary diameter. Resolution of the aberrant immunopathological parameters including interception of complement activation products and downregulation of T cells, ICAM-I, VCAM, TGF-beta and MHC-I molecules was also noted. In IBM, IVIg showed marginal, and non statistically significant, improvements in muscle strength. Up to 20% of patients however, demonstrated clinical improvement with increased activities of daily living while certain muscle groups, such as the muscles of swallowing, showed significant improvements compared to placebo implying mild regional benefits. In PM, small uncontrolled series have shown improvements in muscle strength in up to 70% of the IVIg-treated patients. Because PM, as a stand-alone clinical entity, is a very rare disease, completion of controlled trials will be very difficult.

  11. [Construction and implementation of quality control index for clinical safety of Chinese medicine injection].

    PubMed

    Jiang, Jun-jie; Xie, Yan-ming

    2015-12-01

    In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference. PMID:27245020

  12. Field Testing of a Wet FGD Additive for Enhanced Mercury Control - Task 5 Full-Scale Test Results

    SciTech Connect

    Gary Blythe; MariJon Owens

    2007-12-01

    This Topical Report summarizes progress on Cooperative Agreement DE-FC26-04NT42309, 'Field Testing of a Wet FGD Additive'. The objective of the project is to demonstrate the use of two flue gas desulfurization (FGD) additives, Evonik Degussa Corporation's TMT-15 and Nalco Company's Nalco 8034, to prevent the re-emission of elemental mercury (Hg{sup 0}) in flue gas exiting wet FGD systems on coal-fired boilers. Furthermore, the project intends to demonstrate whether the additive can be used to precipitate most of the mercury (Hg) removed in the wet FGD system as a fine salt that can be separated from the FGD liquor and bulk solid byproducts for separate disposal. The project is conducting pilot- and full-scale tests of the additives in wet FGD absorbers. The tests are intended to determine required additive dosages to prevent Hg{sup 0} re-emissions and to separate mercury from the normal FGD byproducts for three coal types: Texas lignite/Powder River Basin (PRB) coal blend, high-sulfur Eastern bituminous coal, and low-sulfur Eastern bituminous coal. The project team consists of URS Group, Inc., EPRI, Luminant Power (was TXU Generation Company LP), Southern Company, IPL (an AES company), Evonik Degussa Corporation and the Nalco Company. Luminant Power has provided the Texas lignite/PRB co-fired test site for pilot FGD tests and cost sharing. Southern Company has provided the low-sulfur Eastern bituminous coal host site for wet scrubbing tests, as well as the pilot- and full-scale jet bubbling reactor (JBR) FGD systems tested. IPL provided the high-sulfur Eastern bituminous coal full-scale FGD test site and cost sharing. Evonik Degussa Corporation is providing the TMT-15 additive, and the Nalco Company is providing the Nalco 8034 additive. Both companies are also supplying technical support to the test program as in-kind cost sharing. The project is being conducted in six tasks. Of the six project tasks, Task 1 involves project planning and Task 6 involves management

  13. Saccharomyces cerevisiae Thg1 Uses 5′-Pyrophosphate Removal To Control Addition of Nucleotides to tRNAHis

    PubMed Central

    2015-01-01

    In eukaryotes, the tRNAHis guanylyltransferase (Thg1) catalyzes 3′–5′ addition of a single guanosine residue to the −1 position (G–1) of tRNAHis, across from a highly conserved adenosine at position 73 (A73). After addition of G–1, Thg1 removes pyrophosphate from the tRNA 5′-end, generating 5′-monophosphorylated G–1-containing tRNA. The presence of the 5′-monophosphorylated G–1 residue is important for recognition of tRNAHis by its cognate histidyl-tRNA synthetase. In addition to the single-G–1 addition reaction, Thg1 polymerizes multiple G residues to the 5′-end of tRNAHis variants. For 3′–5′ polymerization, Thg1 uses the 3′-end of the tRNAHis acceptor stem as a template. The mechanism of reverse polymerization is presumed to involve nucleophilic attack of the 3′-OH from each incoming NTP on the intact 5′-triphosphate created by the preceding nucleotide addition. The potential exists for competition between 5′-pyrophosphate removal and 3′–5′ polymerase reactions that could define the outcome of Thg1-catalyzed addition, yet the interplay between these competing reactions has not been investigated for any Thg1 enzyme. Here we establish transient kinetic assays to characterize the pyrophosphate removal versus nucleotide addition activities of yeast Thg1 with a set of tRNAHis substrates in which the identity of the N–1:N73 base pair was varied to mimic various products of the N–1 addition reaction catalyzed by Thg1. We demonstrate that retention of the 5′-triphosphate is correlated with efficient 3′–5′ reverse polymerization. A kinetic partitioning mechanism that acts to prevent addition of nucleotides beyond the −1 position with wild-type tRNAHis is proposed. PMID:24548272

  14. 40 CFR 82.18 - Availability of production in addition to baseline production allowances for class II controlled...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... permitted under the Montreal Protocol or to receive from the person for the current control period some... production quantities: (A) The maximum production that the nation is allowed under the Protocol minus...

  15. Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

    PubMed

    Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming

    2014-04-30

    The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually <2. In contrast to the Cp value for cholesterol, Cpk of cholesterol was lower than 2, indicating a systematic error that should be further investigated. This finding suggests a degree of variation or failure to meet specifications that should be corrected. The study indicated that Cp and Cpk could be applied not only for monitoring variations in quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

  16. Age-Matched, Case-Controlled Comparison of Clinical Indicators for Development of Entropion and Ectropion

    PubMed Central

    Michels, Kevin S.; Czyz, Craig N.; Cahill, Kenneth V.; Foster, Jill A.; Burns, John A.; Everman, Kelly R.

    2014-01-01

    Purpose. To analyze the clinical findings associated with involutional entropion and ectropion and compare them to each other and to age-matched controls. Methods. Prospective, age-matched cohort study involving 30 lids with involutional entropion, 30 lids with involutional ectropion, and 52 age-matched control lids. Results. The statistically significant differences associated with both the entropion and ectropion groups compared to the control group were presence of a retractor dehiscence, presence of a “white line,” occurrence of orbital fat prolapse in the cul-de-sac, decreased lower lid excursion, increased lid laxity by the snapback test, and an increased lower lid distraction. Entropion also differed from the control group with an increased lid crease height and decreased lateral canthal excursion. Statistically significant differences associated with entropion compared to ectropion were presence of a retractor dehiscence, decreased lateral canthal excursion, and less laxity in the snapback test. Conclusion. Entropic and ectropic lids demonstrate clinically and statistically significant anatomical and functional differences from normal, age-matched lids. Many clinical findings associated with entropion are also present in ectropion. Entropion is more likely to develop with a pronounced retractor deficiency. Ectropion is more likely to develop with diminished elasticity as measured by the snapback test. PMID:24734167

  17. Parenting clinically anxious versus healthy control children aged 4-12 years.

    PubMed

    van der Sluis, C M; van Steensel, F J A; Bögels, S M

    2015-05-01

    This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child. PMID:25819172

  18. Parenting clinically anxious versus healthy control children aged 4-12 years.

    PubMed

    van der Sluis, C M; van Steensel, F J A; Bögels, S M

    2015-05-01

    This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child.

  19. Randomized, controlled clinical study to evaluate efficacy of novel indigenously designed controlled release flurbiprofen gel system for management of periodontal diseases

    PubMed Central

    Deshpande, Neeraj C.; Bhat, K. M.; Bhat, G. S.; Deshpande, Anshula N.

    2013-01-01

    Background: This randomized, controlled clinical study was planned to evaluate the use of anti-inflammatory drug flurbiprofen in the form of locally delivered controlled release gel in the treatment of periodontal disease. Materials and Methods: The flurbiprofen gel was indigenously prepared in the concentration of 0.3%. The 30 patients with localized periodontal pockets measuring ≥5 mm were randomly divided into three groups. The groups received flurbiprofen gel, flurbiprofen gel after prophylaxis, and placebo gel after oral prophylaxis, respectively. The clinical parameters for plaque and gingival inflammation were evaluated at baseline, 7th day, and 14th day. Results: The results of the study suggested the statistically significant (P < 0.05) improvement in the gingival status of the patients with the use of flurbiprofen gel as an adjunct to scaling and root planing as compared to oral prophylaxis or gel alone. Conclusion: The data demonstrated that the additional use of local drug delivery of flurbiprofen through gel media enhances the positive effects of scaling and root planing and helps in faster resolution of the inflammation. PMID:23853449

  20. Clinical comparison of two tartar control dentifrices: a twelve-week study.

    PubMed

    Sowinski, J; Petrone, D M; Battista, G; Petrone, M E; DeVizio, W; Volpe, A R

    1998-01-01

    The objective of this double-blind clinical study was to investigate the anticalculus efficacy of a new improved tartar control dentifrice formulation containing tetrasodium pyrophosphate, sodium tripolyphosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals) as the test dentifrice, compared to a previously marketed, American Dental Association-accepted, tartar control dentifrice formulation containing tetrasodium pyrophosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals), as the positive control dentifrice. Adult male and female subjects were entered into the study based on a pre-test (baseline) Volpe-Manhold calculus index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for the formation of supragingival dental calculus were performed after twelve-weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol and completed the entire study. At the 12-week examination, the test dentifrice group exhibited a statistically significant (p < 0.0008) 44.1% reduction in the mean Volpe-Manhold calculus index score compared to the mean calculus scores of the previously marketed, positive control dentifrice group. Thus, the results of this clinical study support the conclusion that the New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals is more efficacious in controlling the development of supragingival calculus formation than the previously marketed Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals.

  1. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    PubMed Central

    Venekamp, Roderick P.; Bonten, Marc J.M.; Rovers, Maroeska M.; Verheij, Theo J.M.; Sachs, Alfred P.E.

    2012-01-01

    Background: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic corticosteroid monotherapy for clinically diagnosed, uncomplicated acute rhinosinusitis. Methods: We conducted a block-randomized, double-blind, placebo-controlled clinical trial at 54 primary care practices (68 family physicians) in the Netherlands between Dec. 30, 2008, and Apr. 28, 2011. Adult patients with clinically diagnosed acute rhinosinusitis were randomly assigned to receive either prednisolone 30 mg/d or placebo for 7 days and asked to complete a symptom diary for 14 days. The primary outcome measure was the proportion of patients with resolution of facial pain or pressure on day 7. Results: Of the 185 patients included in the trial (93 in the treatment group, 92 in the placebo group), 2 withdrew from the study and 9 were excluded from the primary analysis because of incomplete symptom reporting. The remaining 174 patients (88 in the treatment group, 86 in the placebo group) were included in the intention-to-treat analysis. The proportions of patients with resolution of facial pain or pressure on day 7 were 62.5% (55/88) in the prednisolone group and 55.8% (48/86) in the placebo group (absolute risk difference 6.7%, 95% confidence interval −7.9% to 21.2%). The groups were similar with regard to the decrease over time in the proportion of patients with total symptoms (combined symptoms of runny nose, postnasal discharge, nasal congestion, cough and facial pain) and health-related quality of life. Adverse events were mild and did not differ significantly between the groups. Interpretation: Systemic corticosteroid monotherapy had no clinically relevant beneficial effects among patients with clinically diagnosed acute rhinosinusitis. Netherlands Trial Register

  2. A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

    PubMed Central

    2010-01-01

    Background Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised

  3. Lipid-lowering therapies, glucose control and incident diabetes: evidence, mechanisms and clinical implications.

    PubMed

    Zafrir, Barak; Jain, Mohit

    2014-08-01

    Lipid-lowering therapies constitute an essential part in the treatment and prevention of cardiovascular diseases and are consistently shown to reduce adverse cardiovascular outcomes in wide-scale populations. Recently, there is increased awareness of the possibility that lipid-lowering drugs may affect glucose control and insulin resistance. This phenomenon is reported in all classes of lipid-modifying agents, with differential effects of distinct drugs. Since the prevalence of metabolic syndrome and diabetes is rising, and lipid-modifying therapies are widely used to reduce the cardiovascular burden in these populations, it is of importance to examine the relationship between lipid-lowering drugs, glycemic control and incident diabetes. In the current review we discuss the evidence, ranging from experimental studies to randomized controlled clinical trials and meta-analyses, of how lipid-modifying therapies affect glycemic control and insulin sensitivity. Cumulative data suggest that both statins and niacin are associated with increased risk of impaired glucose control and development of new-onset diabetes, as opposed to bile-acid sequestrants which display concomitant moderate lipid and glucose lowering effects, and fibrates (particularly the pan-PPAR agonist bezafibrate) which may produce beneficial effects on glucose metabolism and insulin sensitivity. Ezetimibe is implied to ameliorate metabolic markers such as hepatic steatosis and insulin resistance, with yet little support from clinical trials, while fish oils which in experimental studies produce favorable effects on insulin sensitivity, although studied extensively, continue to show inconclusive effects on glucose homeostasis in patients with diabetes. Suggested mechanisms of how lipid-modifying agents affect glucose control and their clinical implications in this context, are summarized. PMID:24952127

  4. Cognitive Behavioral Therapy for Early Adolescents with Autism Spectrum Disorders and Clinical Anxiety: A Randomized, Controlled Trial

    PubMed Central

    Wood, Jeffrey J.; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C.; De Nadai, Alessandro S.; Arnold, Elysse; Lewin, Adam B.; Murphy, Tanya K.; Storch, Eric A.

    2014-01-01

    Background Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009), was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Method Thirty-three adolescents (11–15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and post-treatment/post-waitlist. Results In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators’ ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. Conclusions The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  5. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed.

  6. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  7. Copper-Catalyzed Enantioselective Addition of Styrene-Derived Nucleophiles to Imines Enabled by Ligand-Controlled Chemoselective Hydrocupration.

    PubMed

    Yang, Yang; Perry, Ian B; Buchwald, Stephen L

    2016-08-10

    The copper-catalyzed intermolecular enantioselective addition of styrenes to imines has been achieved under mild conditions at ambient temperature. This process features the use of styrenes as latent carbanion equivalents via the intermediacy of catalytically generated benzylcopper derivatives, providing an effective means for accessing highly enantiomerically enriched amines bearing contiguous stereocenters. Mechanistic studies shed light on the origin of the preferential styrene hydrocupration in the presence of an imine with the Ph-BPE-derived copper catalyst. PMID:27454393

  8. 78 FR 14217 - Control of Alcohol and Drug Use: Addition of Post-Accident Toxicological Testing for Non...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... certain non-controlled substances with potentially impairing side effects (77 FR 29307). As discussed in..., chlorpheniramine, bromenphiramine, and doxylamine'' (77 FR at 29308, emphasis added). As explained below, the... suspicion and post-accident testing, 50 FR 31508, August 2, 1985), and the Supreme Court upheld...

  9. 40 CFR 82.18 - Availability of production in addition to baseline production allowances for class II controlled...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... quantity of production that the nation is permitted under the Montreal Protocol or to receive from the... allowances, for a specified control period through trades with another Party to the Protocol as set forth in... that is also listed in Appendix C, Annex 1 of the Protocol as having ratified the Beijing...

  10. 40 CFR 82.18 - Availability of production in addition to baseline production allowances for class II controlled...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... quantity of production that the nation is permitted under the Montreal Protocol or to receive from the... allowances, for a specified control period through trades with another Party to the Protocol as set forth in... that is also listed in Appendix C, Annex 1 of the Protocol as having ratified the Beijing...

  11. 40 CFR 82.18 - Availability of production in addition to baseline production allowances for class II controlled...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... quantity of production that the nation is permitted under the Montreal Protocol or to receive from the... allowances, for a specified control period through trades with another Party to the Protocol as set forth in... that is also listed in Appendix C, Annex 1 of the Protocol as having ratified the Beijing...

  12. Controlled challenge experiment demonstrates substantial additive genetic variation in resistance of Nile tilapia (Oreochromis niloticus) to Streptococcus iniae

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Streptococcus iniae is an etiologic agent of streptococcal disease in tilapia and is one of several Streptococcus spp. that negatively impact worldwide tilapia production. Methods for the prevention and control of S. iniae include vaccines, management strategies, and antibiotics. A complimentary pre...

  13. Effects of drying control chemical additive on properties of Li 4Ti 5O 12 negative powders prepared by spray pyrolysis

    NASA Astrophysics Data System (ADS)

    Ju, Seo Hee; Kang, Yun Chan

    High-density Li 4Ti 5O 12 powders comprising spherical particles are prepared by spray pyrolysis from a solution containing dimethylacetamide (drying control chemical additive) and citric acid and ethylene glycol (organic additives). The prepared powders have high discharge capacities and good cycle properties. The optimum concentration of dimethylacetamide is 0.5 M. The addition of dimethylacetamide to the polymeric spray solutions containing citric acid and ethylene glycol helps in the effective control of the morphology of the Li 4Ti 5O 12 powders. At a constant current density of 0.17 mA g -1, the initial discharge capacities of the powders obtained from the spray solution with and without the organic additives are 171 and 167 mAh g -1, respectively.

  14. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Meta-Analyses of Randomized Controlled Clinical Trials (RCTs... constructive discussion and information-sharing about best practices in meta-analyses of clinical trial data... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled...

  15. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review

    PubMed Central

    Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

    2015-01-01

    While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and

  16. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

    PubMed

    Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

    2015-01-01

    While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and

  17. The added value of using mutational profiling in addition to cytology in diagnosing aggressive pancreaticobiliary disease: review of clinical cases at a single center

    PubMed Central

    2014-01-01

    Background This study aimed to better understand the supporting role that mutational profiling (MP) of DNA from microdissected cytology slides and supernatant specimens may play in the diagnosis of malignancy in fine-needle aspirates (FNA) and biliary brushing specimens from patients with pancreaticobiliary masses. Methods Cytology results were examined in a total of 30 patients with associated surgical (10) or clinical (20) outcomes. MP of DNA from microdissected cytology slides and from discarded supernatant fluid was analyzed in 26 patients with atypical, negative or indeterminate cytology. Results Cytology correctly diagnosed aggressive disease in 4 patients. Cytological diagnoses for the remaining 26 were as follows: 16 negative (9 false negative), 9 atypical, 1 indeterminate. MP correctly determined aggressive disease in 1 false negative cytology case and confirmed a negative cytology diagnosis in 7 of 7 cases of non-aggressive disease. Of the 9 atypical cytology cases, MP correctly diagnosed 7 as positive and 1 as negative for aggressive disease. One specimen that was indeterminate by cytology was correctly diagnosed as non-aggressive by MP. When first line malignant (positive) cytology results were combined with positive second line MP results, 12/21 cases of aggressive disease were identified, compared to 4/21 cases identified by positive cytology alone. Conclusions When first line cytology results were uncertain (atypical), questionable (negative), or not possible (non-diagnostic/indeterminate), MP provided additional information regarding the presence of aggressive disease. When used in conjunction with first line cytology, MP increased detection of aggressive disease without compromising specificity in patients that were difficult to diagnose by cytology alone. PMID:25084836

  18. Food additives

    PubMed Central

    Spencer, Michael

    1974-01-01

    Food additives are discussed from the food technology point of view. The reasons for their use are summarized: (1) to protect food from chemical and microbiological attack; (2) to even out seasonal supplies; (3) to improve their eating quality; (4) to improve their nutritional value. The various types of food additives are considered, e.g. colours, flavours, emulsifiers, bread and flour additives, preservatives, and nutritional additives. The paper concludes with consideration of those circumstances in which the use of additives is (a) justified and (b) unjustified. PMID:4467857

  19. Graphene oxide as a high-performance fluid-loss-control additive in water-based drilling fluids.

    PubMed

    Kosynkin, Dmitry V; Ceriotti, Gabriel; Wilson, Kurt C; Lomeda, Jay R; Scorsone, Jason T; Patel, Arvind D; Friedheim, James E; Tour, James M

    2012-01-01

    Graphene oxide (GO) performs well as a filtration additive in water-based drilling fluids at concentrations as low as 0.2 % (w/w) by carbon content. Standard American Petroleum Institute (API) filtration tests were conducted on pH-adjusted, aqueous dispersions of GO and xanthan gum. It was found that a combination of large-flake GO and powdered GO in a 3:1 ratio performed best in the API tests, allowing an average fluid loss of 6.1 mL over 30 min and leaving a filter cake ~20 μm thick. In comparison, a standard suspension (~12 g/L) of clays and polymers used in the oil industry gave an average fluid loss of 7.2 mL and a filter cake ~280 μm thick. Scanning electron microscopy imaging revealed the extreme pliability of well-exfoliated GO, as the pressure due to filtration crumpled single GO sheets, forcing them to slide through pores with diameters much smaller than the flake's flattened size. GO solutions also exhibited greater shear thinning and higher temperature stability compared to clay-based fluid-loss additives, demonstrating potential for high-temperature well applications.

  20. Graphene oxide as a high-performance fluid-loss-control additive in water-based drilling fluids.

    PubMed

    Kosynkin, Dmitry V; Ceriotti, Gabriel; Wilson, Kurt C; Lomeda, Jay R; Scorsone, Jason T; Patel, Arvind D; Friedheim, James E; Tour, James M

    2012-01-01

    Graphene oxide (GO) performs well as a filtration additive in water-based drilling fluids at concentrations as low as 0.2 % (w/w) by carbon content. Standard American Petroleum Institute (API) filtration tests were conducted on pH-adjusted, aqueous dispersions of GO and xanthan gum. It was found that a combination of large-flake GO and powdered GO in a 3:1 ratio performed best in the API tests, allowing an average fluid loss of 6.1 mL over 30 min and leaving a filter cake ~20 μm thick. In comparison, a standard suspension (~12 g/L) of clays and polymers used in the oil industry gave an average fluid loss of 7.2 mL and a filter cake ~280 μm thick. Scanning electron microscopy imaging revealed the extreme pliability of well-exfoliated GO, as the pressure due to filtration crumpled single GO sheets, forcing them to slide through pores with diameters much smaller than the flake's flattened size. GO solutions also exhibited greater shear thinning and higher temperature stability compared to clay-based fluid-loss additives, demonstrating potential for high-temperature well applications. PMID:22136134

  1. Case-control studies in clinical research: mechanism and prevention of selection bias.

    PubMed

    Morabia, A

    1997-01-01

    The mechanism by which selection bias occurs in case-control studies is explained to an audience of clinicians using a simple conceptual framework and a graphical presentation. A case-control study consists in comparing the frequency of exposure in a group of subjects having the studied disease (the cases) relative to another group free of that disease (the controls). Cases and controls can be thought of as arising from a hypothetical cohort study. Thus, enrolled cases are a fraction F1 of the exposed who developed the disease plus a fraction F3 of the unexposed who developed the disease during a given period. Similarly, enrolled controls are a fraction F2 of the exposed who did not develop disease plus a fraction F4 of the unexposed who did not develop the disease. A selection process is inherent to the design of case-control studies but it leads to selection bias only when the ratio of F1 x F4/F2 x F3 is not equal to unity. Examples demonstrate the implication of sampling fractions for designing and interpreting case-control studies performed in clinical settings.

  2. Group sequential control of overall toxicity incidents in clinical trials - non-Bayesian and Bayesian approaches.

    PubMed

    Yu, Jihnhee; Hutson, Alan D; Siddiqui, Adnan H; Kedron, Mary A

    2016-02-01

    In some small clinical trials, toxicity is not a primary endpoint; however, it often has dire effects on patients' quality of life and is even life-threatening. For such clinical trials, rigorous control of the overall incidence of adverse events is desirable, while simultaneously collecting safety information. In this article, we propose group sequential toxicity monitoring strategies to control overall toxicity incidents below a certain level as opposed to performing hypothesis testing, which can be incorporated into an existing study design based on the primary endpoint. We consider two sequential methods: a non-Bayesian approach in which stopping rules are obtained based on the 'future' probability of an excessive toxicity rate; and a Bayesian adaptation modifying the proposed non-Bayesian approach, which can use the information obtained at interim analyses. Through an extensive Monte Carlo study, we show that the Bayesian approach often provides better control of the overall toxicity rate than the non-Bayesian approach. We also investigate adequate toxicity estimation after the studies. We demonstrate the applicability of our proposed methods in controlling the symptomatic intracranial hemorrhage rate for treating acute ischemic stroke patients.

  3. Optimal design of clinical trials comparing several treatments with a control.

    PubMed

    Marschner, Ian C

    2007-01-01

    Clinical trials are often designed to compare several treatments with a common control arm in pairwise fashion. In this paper we study optimal designs for such studies, based on minimizing the total number of patients required to achieve a given level of power. A common approach when designing studies to compare several treatments with a control is to achieve the desired power for each individual pairwise treatment comparison. However, it is often more appropriate to characterize power in terms of the family of null hypotheses being tested, and to control the probability of rejecting all, or alternatively any, of these individual hypotheses. While all approaches lead to unbalanced designs with more patients allocated to the control arm, it is found that the optimal design and required number of patients can vary substantially depending on the chosen characterization of power. The methods make allowance for both continuous and binary outcomes and are illustrated with reference to two clinical trials, one involving multiple doses compared to placebo and the other involving combination therapy compared to mono-therapies. In one example a 55% reduction in sample size is achieved through an optimal design combined with the appropriate characterization of power. PMID:17323312

  4. An Additional Approach to Model Current Followers and Amplifiers with Electronically Controllable Parameters from Commercially Available ICs

    NASA Astrophysics Data System (ADS)

    Sotner, R.; Kartci, A.; Jerabek, J.; Herencsar, N.; Dostal, T.; Vrba, K.

    2012-12-01

    Several behavioral models of current active elements for experimental purposes are introduced in this paper. These models are based on commercially available devices. They are suitable for experimental tests of current- and mixed-mode filters, oscillators, and other circuits (employing current-mode active elements) frequently used in analog signal processing without necessity of onchip fabrication of proper active element. Several methods of electronic control of intrinsic resistance in the proposed behavioral models are discussed. All predictions and theoretical assumptions are supported by simulations and experiments. This contribution helps to find a cheaper and more effective way to preliminary laboratory tests without expensive on-chip fabrication of special active elements.

  5. Dual Release Paracetamol in Osteoarthritis of Knee: A Randomized Controlled Clinical Trial

    PubMed Central

    Raj, D. Gokul; Sharma, Ateet B.; Swami B., Mallikarjun; Batra, Sumit; Acharya, Apurv; Maroo, Sanjaykumar H.; Patel, Ketan R.; Prajapati, Vipul

    2014-01-01

    Background: Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing. Objective: To evaluate the efficacy and safety of Paracetamol 650 mg dual release tablet twice daily (PCM 650 dual release) compared to paracetamol 500mg immediate release tablet thrice daily (PCM 500 IR) in the treatment of Knee OA. Materials and Methods: In this randomized, open label, parallel, active controlled clinical study, 250 patients of OA knee meeting inclusion criteria were randomized to receive either PCM 650 dual release two times daily or PCM 500 IR three times daily for 6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks. Primary efficacy measures were severity of pain (Visual Analogue Scale) and Knee injury and osteoarthritis outcome score (KOOS) subscale for pain at week 2, 4 and 6. Other KOOS subscales (symptoms other than pain, function in daily living, function in sport and recreation, quality of life) and patient’s and physicians global assessment of therapy were included as secondary endpoints. Results: Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving PCM 650 dual release showed significant improvement of pain in both primary endpoints at each study visit compared to patients receiving PCM 500 IR (p<0.001). PCM 650 dual release was significantly superior to PCM 500 IR for improvement in all KOOS subscales at each study visit (p<0.01). Less number of patients required additional rescue analgesics in PCM 650 dual release group (16% patients vs 26%, PCM 500 IR; p>0.05). Adverse effects were significantly less in PCM 650 dual release group (6% vs. 14% in PCM 500 IR; p<0.05). Patient’s and physician’s global assessment of therapy favoured PCM 650 dual release than PCM 500 IR (p<0.001). Conclusion: Patients with

  6. Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training.

    PubMed

    Warschburger, Petra; Kroeller, Katja; Haerting, Johannes; Unverzagt, Susanne; van Egmond-Fröhlich, Andreas

    2016-08-01

    Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects.

  7. Informed Conditioning on Clinical Covariates Increases Power in Case-Control Association Studies

    PubMed Central

    Zaitlen, Noah; Lindström, Sara; Pasaniuc, Bogdan; Cornelis, Marilyn; Genovese, Giulio; Pollack, Samuela; Barton, Anne; Bickeböller, Heike; Bowden, Donald W.; Eyre, Steve; Freedman, Barry I.; Friedman, David J.; Field, John K.; Groop, Leif; Haugen, Aage; Heinrich, Joachim; Henderson, Brian E.; Hicks, Pamela J.; Hocking, Lynne J.; Kolonel, Laurence N.; Landi, Maria Teresa; Langefeld, Carl D.; Le Marchand, Loic; Meister, Michael; Morgan, Ann W.; Raji, Olaide Y.; Risch, Angela; Rosenberger, Albert; Scherf, David; Steer, Sophia; Walshaw, Martin; Waters, Kevin M.; Wilson, Anthony G.; Wordsworth, Paul; Zienolddiny, Shanbeh; Tchetgen, Eric Tchetgen; Haiman, Christopher; Hunter, David J.; Plenge, Robert M.; Worthington, Jane; Christiani, David C.; Schaumberg, Debra A.; Chasman, Daniel I.; Altshuler, David; Voight, Benjamin; Kraft, Peter; Patterson, Nick; Price, Alkes L.

    2012-01-01

    Genetic case-control association studies often include data on clinical covariates, such as body mass index (BMI), smoking status, or age, that may modify the underlying genetic risk of case or control samples. For example, in type 2 diabetes, odds ratios for established variants estimated from low–BMI cases are larger than those estimated from high–BMI cases. An unanswered question is how to use this information to maximize statistical power in case-control studies that ascertain individuals on the basis of phenotype (case-control ascertainment) or phenotype and clinical covariates (case-control-covariate ascertainment). While current approaches improve power in studies with random ascertainment, they often lose power under case-control ascertainment and fail to capture available power increases under case-control-covariate ascertainment. We show that an informed conditioning approach, based on the liability threshold model with parameters informed by external epidemiological information, fully accounts for disease prevalence and non-random ascertainment of phenotype as well as covariates and provides a substantial increase in power while maintaining a properly controlled false-positive rate. Our method outperforms standard case-control association tests with or without covariates, tests of gene x covariate interaction, and previously proposed tests for dealing with covariates in ascertained data, with especially large improvements in the case of case-control-covariate ascertainment. We investigate empirical case-control studies of type 2 diabetes, prostate cancer, lung cancer, breast cancer, rheumatoid arthritis, age-related macular degeneration, and end-stage kidney disease over a total of 89,726 samples. In these datasets, informed conditioning outperforms logistic regression for 115 of the 157 known associated variants investigated (P-value = 1×10−9). The improvement varied across diseases with a 16% median increase in χ2 test statistics and a

  8. Photodynamic therapy as adjunct to non-surgical periodontal treatment in patients on periodontal maintenance: a randomized controlled clinical trial.

    PubMed

    Chondros, Panos; Nikolidakis, Dimitris; Christodoulides, Nicos; Rössler, Ralf; Gutknecht, Norbert; Sculean, Anton

    2009-09-01

    Recent preclinical and clinical data have suggested the potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, currently, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of the present study was to evaluate the clinical and microbiological effects of the adjunctive use of PDT in non-surgical periodontal treatment in patients receiving supportive periodontal therapy. Twenty-four patients receiving regularly supportive periodontal therapy were randomly treated with either subgingival scaling and root planing followed by a single episode of PDT (test) or subgingival scaling and root planing alone (control). The following parameters were evaluated at baseline and at 3 months and 6 months after therapy: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), bleeding on probing (BOP) at experimental sites, probing pocket depth (PPD), gingival recession (REC), and clinical attachment level (CAL). Primary outcome variables were changes in PPD and CAL. Microbiological evaluation of Aggregatibacter actinomycetemcomitans (A.a.), Porphyromonas gingivalis (P.g.), Prevotella intermedia (P.i.), Tannerella forsythensis (T.f.), Treponema denticola (T.d.), Peptostreptococcus micros (P.m.), Fusobacterium nucleatum (F.n.), Campylobacter rectus (C.r.), Eubacterium nodatum (E.n.), Eikenella corrodens (E.c.), and Capnocytophaga species (C.s.) was also performed at baseline and at 3 months and 6 months after therapy, using a commercially available polymerase chain reaction test. No differences in any of the investigated parameters were observed at baseline between the two groups. At 3 months and 6 months after treatment, there were no statistically significant differences between the groups in terms of PPD, CAL and FMPS. At 3 months and 6 months, a statistically significantly higher improvement of BOP was found in the test group. At 3 months after therapy

  9. Statistical process control for referrals by general practitioner at Health Insurance Organization clinics in Alexandria.

    PubMed

    Abdel Wahab, Moataza M; Nofal, Laila M; Guirguis, Wafaa W; Mahdy, Nehad H

    2004-01-01

    Quality control is the application of statistical techniques to a process in an effort to identify and minimize both random and non-random sources of variation. The present study aimed at the application of Statistical Process Control (SPC) to analyze the referrals by General Practitioners (GP) at Health Insurance Organization (HIO) clinics in Alexandria. Retrospective analysis of records and cross sectional interview to 180 GPs were done. Using the control charts (p chart), the present study confirmed the presence of substantial variation in referral rates from GPs to specialists; more than 60% of variation was of the special cause, which revealed that the process of referral in Alexandria (HIO) was completely out of statistical control. Control charts for referrals by GPs classified by different GP characteristics or organizational factors revealed much variation, which suggested that the variation was at the level of individual GPs. Furthermore, the p chart for each GP separately; which yielded a fewer number of points out of control (outliers), with an average of 4 points. For 26 GPs, there was no points out of control, those GPs were slightly older than those having points out of control. Otherwise, there was no significant difference between them. The revised p chart for those 26 GPs together yielded a centerline of 9.7%, upper control limit of 12.0% and lower control limit of 7.4%. Those limits were in good agreement with the limits specified by HIO; they can be suggested to be the new specification limits after some training programs. PMID:17265609

  10. Clinical relevance of surgical site infection as defined by the criteria of the Centers for Disease Control and Prevention.

    PubMed

    Henriksen, N A; Meyhoff, C S; Wetterslev, J; Wille-Jørgensen, P; Rasmussen, L S; Jorgensen, L N

    2010-07-01

    Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant (CRSSI) and whether there is agreement between evaluations according to the CDC criteria, the ASEPSIS score (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of Stay) and CRSSI. We included 54 patients diagnosed with SSI and a matched control group (N=46) without SSI according to the CDC criteria after laparotomy. Two blinded experienced surgeons evaluated the hospital records and determined whether patients had CRSSI, based on the following criteria: antibiotic treatment, surgical intervention, prolonged hospital stay or referral to an intensive care unit for SSI. The rate of CRSSI was 38 of 54 (70%) in patients with CDC-diagnosed SSI and none in patients without a CDC-diagnosed SSI. Sixty-one percent of the CDC-diagnosed SSIs were superficial, of which 48% were considered clinically relevant. There was substantial agreement between the CDC criteria and CRSSI [kappa=0.69; 95% confidence interval (CI): 0.55-0.83] and fair agreement between the ASEPSIS score and the CDC criteria (kappa=0.23; 95% CI: 0-0.49) and between the ASEPSIS score and CRSSI (kappa=0.39; 95% CI: 0.17-0.61). The CDC criteria represent a suitable standard definition for monitoring and identifying SSI, even if some cases of less clinically significant superficial SSI are included.

  11. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial

    PubMed Central

    2011-01-01

    Background High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). Methods Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second. Results Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. Conclusions HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. Trial Registration ClinicalTrials.gov: NCT00181285 PMID:21906390

  12. Clinical effect of a gel containing Lippia sidoides on plaque and gingivitis control

    PubMed Central

    Pereira, Sérgio Luis da Silva; Praxedes, Yuri Carvalho Machado; Bastos, Thiago Catunda; Alencar, Phillipe Nogueira Barbosa; da Costa, Flávio Nogueira

    2013-01-01

    Objective: This parallel controlled clinical trial evaluated the effect of a gel containing Lippia sidoides essential oil on plaque and gingivitis control. Methods: Thirty patients (n=30) were randomly selected and allocated into three groups: Lippia sidoides (LS, n=10), chlorhexidine (CLX, n=10) or placebo (control, n=10). Plaque and bleeding index were recorded at baseline and after three months. All volunteers were instructed to brush with the gel three times a day throughout the experiment period. Results: There was a significant reduction on plaque and gingivitis in the test groups (P<.05), but no statistically significant difference was observed between them (P>.05). Conclusion: A gel preparation containing 10% Lippia sidoides essential oil was an efficient herbal antiplaque and antigingivitis agent. PMID:23408652

  13. Including xpc® feed additive in the diet of inoculated broilers during grow-out helps control salmonella associated with their carcasses after processing

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The objective of this study was to test XPC® feed additive for control of Salmonella in poultry meat products. Day of hatch broiler chicks were gavaged with 106 cells of a nalidixic acid resistant marker strain of Salmonella Typhimurium and placed on clean pine shavings in 9 separate floor pens (25 ...

  14. Assessment of hypertension control and clinical course of patients excluded from the SYMPLICITY HTN-3 trial.

    PubMed

    Yerasi, Charan; Baker, Nevin C; Jonnalagadda, Anil K; Torguson, Rebecca; Singh, Suman; Vies, Judith; Waksman, Ron

    2015-12-01

    The screening of patients referred for the Symplicity Renal-Denervation Catheter Therapy on Resistant Hypertension (SYMPLICITY HTN-3) trial was rigorous, with many found not eligible to participate. We investigate patients who were not included in the trial and evaluate their current hypertensive (HTN) therapy, control and clinical status. A retrospective review and telephone interview was performed 8-10 months postscreening on 45 patients and their referring providers who were ultimately not included. Patients were grouped into 4 categories: (1) noninterest; (2) excluded (not meeting inclusion criteria); (3) screen failure (excluded during screening visits due to adequate blood pressure control guided by HTN specialist); or (4) referred after enrollment closure. Primary outcomes evaluated included current anti-HTN management and clinical outcomes. This population consisted of 42% males, mean age 65 ± 5 years, 78% African American, 64% diabetic, and 21% chronic kidney disease. Primary referral basis included cardiology (44%), nephrology (30%), and primary care (26%). At time of follow-up, 20% had continued resistant HTN while most of the patients had controlled HTN (60%); with highest success rates among the screen failure group (88%) who also had the lowest average systolic blood pressure (137 ± 11 mm of Hg) when compared to other groups (P = .04). Average number of medications was lowest in the screen failure group (2.8 ± 1.6, P = .07). Resistant and/or uncontrolled HTN was most prevalent in the noninterest or excluded groups, as were hospitalization for cardiovascular and HTN urgency/emergency. This study highlights the disparity of HTN control and treatment in daily practice compared with clinical trials, and confirms a need for vigilant screening of those considered candidates for renal denervation.

  15. Molecular analysis of sarcoidosis lymph nodes for microorganisms: a case–control study with clinical correlates

    PubMed Central

    Robinson, Lary A; Smith, Prudence; SenGupta, Dhruba J; Prentice, Jennifer L; Sandin, Ramon L

    2013-01-01

    Introduction Sarcoidosis is an incurable, chronic granulomatous disease primarily involving the lungs and lymph nodes of unknown aetiology, treated with non-specific anti-inflammatory/immunosuppressive drugs. Persistently symptomatic patients worsen with a disabling, potentially fatal clinical course. To determine a possible infectious cause, we correlated in a case-control study the clinical information with the presence of bacterial DNA in sarcoidosis mediastinal lymph nodes compared with control lymph nodes resected during cancer surgery. Methods We retrospectively studied formalin-fixed, paraffin-embedded, mediastinal lymph nodes from 30 patients with sarcoidosis and 30 control patients with lung cancer. Nucleic acids were extracted from nodes, evaluated by ribosomal RNA PCR for bacterial 16S ribosomal DNA and the results were sequenced and compared with a bacterial sequence library. Clinical information was correlated. Results 11/30 (36.7%) of lymph nodes from patients with sarcoidosis had detectable bacterial DNA, significantly more than control patient lymph nodes (2/30, 6.7%), p=0.00516. At presentation, 19/30 (63.3%) patients with sarcoidosis were symptomatic including all patients with detectable bacterial DNA. Radiographically, there were 18 stage I and 12 stage II patients. All stage II patients were symptomatic and 75% had PCR-detectable bacteria. After a mean follow-up of 52.8±32.8 months, all patients with PCR-detectable bacteria in this series were persistently symptomatic requiring treatment. Discussion 36.6% of patients with sarcoidosis had detectable bacterial DNA on presentation, all of these patients were quite symptomatic and most were radiographically advanced stage II. These findings suggest that bacterial DNA-positive, symptomatic patients have more aggressive sarcoidosis that persists long term and might benefit from antimicrobial treatment directed against this presumed chronic granulomatous infection. PMID:24366580

  16. Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

    PubMed

    Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

    2013-02-01

    Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

  17. Effect of clinical parameters on the control of myoelectric robotic prosthetic hands.

    PubMed

    Atzori, Manfredo; Gijsberts, Arjan; Castellini, Claudio; Caputo, Barbara; Hager, Anne-Gabrielle Mittaz; Elsig, Simone; Giatsidis, Giorgio; Bassetto, Franco; Müller, Henning

    2016-01-01

    Improving the functionality of prosthetic hands with noninvasive techniques is still a challenge. Surface electromyography (sEMG) currently gives limited control capabilities; however, the application of machine learning to the analysis of sEMG signals is promising and has recently been applied in practice, but many questions still remain. In this study, we recorded the sEMG activity of the forearm of 11 male subjects with transradial amputation who were mentally performing 40 hand and wrist movements. The classification performance and the number of independent movements (defined as the subset of movements that could be distinguished with >90% accuracy) were studied in relationship to clinical parameters related to the amputation. The analysis showed that classification accuracy and the number of independent movements increased significantly with phantom limb sensation intensity, remaining forearm percentage, and temporal distance to the amputation. The classification results suggest the possibility of naturally controlling up to 11 movements of a robotic prosthetic hand with almost no training. Knowledge of the relationship between classification accuracy and clinical parameters adds new information regarding the nature of phantom limb pain as well as other clinical parameters, and it can lay the foundations for future "functional amputation" procedures in surgery. PMID:27272750

  18. Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials.

    PubMed

    Stanworth, S J; Brunskill, S J; Hyde, C J; McClelland, D B L; Murphy, M F

    2004-07-01

    Summary Randomized controlled trials of good quality are a recognized means to robustly assess the efficacy of interventions in clinical practice. A systematic identification and appraisal of all randomized trials involving fresh frozen plasma (FFP) has been undertaken in parallel to the drafting of the updated British Committee for Standards in Haematology guidelines on the use of FFP. A total of 57 trials met the criteria for inclusion in the review. Most clinical uses of FFP, currently recommended by practice guidelines, are not supported by evidence from randomized trials. In particular, there is little evidence for the effectiveness of the prophylactic use of FFP. Many published trials on the use of FFP have enrolled small numbers of patients, and provided inadequate information on the ability of the trial to detect meaningful differences in outcomes between the two patient groups. Other concerns about the design of the trials include the dose of FFP used, and the potential for bias. No studies have taken adequate account of the extent to which adverse effects might negate the clinical benefits of treatment with FFP. There is a need to consider how best to develop new trials to determine the efficacy of FFP in different clinical scenarios to provide the evidence base to support national guidelines for transfusion practice. Trials of modified FFP (e.g. pathogen inactivated) are of questionable value when there is little evidence that the standard product is an effective treatment. PMID:15198745

  19. Pharmacogenetics of controlled ovarian hyperstimulation: time to corroborate the clinical utility of FSH receptor genetic markers.

    PubMed

    Morón, Francisco Jesús; Ruiz, Agustín

    2010-11-01

    Several studies have shown high variability in clinical outcome among women undergoing follicle-stimulating hormone treatment. Pharmacogenetic studies have revealed a series of genetic markers involved in controlled ovarian hyperstimulation (COH) response. FSHR gene-associated SNPs, including the N680S missense variant, are the most promising genetic markers available to date. In this paper the state of the art pharmacogenetic analysis of COH outcome is reviewed and a meta-analysis is conducted with available data that confirms that the N680S marker is associated with poor response during COH. Thus, we propose that by pooling together available information, it is possible to go one step further with this biomarker to definitively validate its utility in the clinical field. We propose to conduct clinical trials, to look for algorithms integrating the N680S genotype and to test if such clinical protocols can optimize recombinant follicle-stimulating hormone dose and detect women at risk of a poor response during a COH cycle.

  20. Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial

    PubMed Central

    Simmons, Rebecca K; Echouffo-Tcheugui, Justin B; Sharp, Stephen J; Sargeant, Lincoln A; Williams, Kate M; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

    2012-01-01

    Summary Background The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality. Methods In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20 184 individuals aged 40–69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA1c) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to-screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081. Findings Of 16 047 high-risk individuals in screening practices, 15 089 (94%) were invited for screening during 2001–06, 11 737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184 057 person-years of follow up (median duration 9·6 years [IQR 8·9–9·9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1·06, 95% CI 0·90–1·25

  1. Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training.

    PubMed

    Warschburger, Petra; Kroeller, Katja; Haerting, Johannes; Unverzagt, Susanne; van Egmond-Fröhlich, Andreas

    2016-08-01

    Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects. PMID:27074374

  2. Effect of posture-control insoles on function in children with cerebral palsy: Randomized controlled clinical trial

    PubMed Central

    2012-01-01

    Introduction Cerebral palsy (CP) is a posture and movement disorder and different therapeutic modalities, such as the use of braces, have sought to favor selective motor control and muscle coordination in such patients. The aim of the proposed study is to determine the effect of the combination of posture-control insoles and ankle-foot orthoses (AFOs) improving functional limitation in children with CP. Methods/Design The sample will be composed of 24 children with CP between four and 12 years of age. After the signing of the statement of informed consent, the children will be randomly allocated to two groups: a control group using AFOs alone and an experimental group using both posture-control insoles and AFOs. Evaluations will be performed on five occasions: without any accessory (insoles or AFOs), immediately after, one month after, six months after and one year after AFOs or insole and AFOs use. The evaluation will involve the analysis of gait, static and functional balance, mobility and hypertonia. The three-dimensional assessment of gait will involve the eight-camera SMART-D SMART-D 140® system (BTS Engineering), two Kistler force plates (model 9286BA) and an eight-channel, wireless FREEEMG® electromyography (BTS Engineering). Static balance will be assessed using a Kistler force plate (model 9286BA). Clinical functional balance and mobility will be assessed using the Berg Balance Scale, Timed Up-and-Go Test and Six-Minute Walk Test. The posture-control insoles will be made of ethylene vinyl acetate, with thermal molding for fixation. The fixed orthoses will be made of polypropylene and attached to the ankle region (AFO). The results will be analyzed statistically, with the level significance set to 5% (p < 0.05). Trial Registration Trial Registration Number: RBR6d342s (http://www.ensaiosclinicos.gov.br/news/) PMID:23033863

  3. Addition of ferrocene controls polymorphism and enhances charge mobilities in poly(3-hexylthiophene) thin-film transistors

    NASA Astrophysics Data System (ADS)

    Smith, Brandon; Clark, Michael; Grieco, Christopher; Larsen, Alec; Asbury, John; Gomez, Enrique

    2015-03-01

    Crystalline organic molecules often exhibit the ability to form multiple crystal structures depending on the processing conditions. Exploiting this polymorphism to optimize molecular orbital overlap between adjacent molecules within the unit lattice of conjugated polymers is an approach to enhance charge transport within the material. We have demonstrated the formation of tighter π- π stacking poly(3-hexylthiophene-2,5-diyl) polymorphs in films spin coated from ferrocene-containing solutions using grazing incident X-ray diffraction. As a result, we found that the addition of ferrocene to casting solutions yields thin-film transistors which exhibit significantly higher source-drain current and charge mobilities than neat polymer devices. Insights gleaned from ferrocene/poly(3-hexylthiophene) mixtures can serve as a template for selection and optimization of next generation small molecule/polymer systems possessing greater baseline charge mobilities. Ultimately, the development of such techniques to enhance the characteristics of organic transistors without imparting high costs or loss of advantageous properties will be a critical factor determining the future of organic components within the electronics market.

  4. Control of ordering and structure in soft templated mesoporous carbon films by use of selective solvent additives.

    PubMed

    Qiang, Zhe; Xue, Jiachen; Stein, Gila E; Cavicchi, Kevin A; Vogt, Bryan D

    2013-07-01

    The structure of ordered mesoporous carbons fabricated using poly(styrene-block-N,N,-dimethyl-n-octadecylamine p-styrenesulfonate) (PS-b-PSS-DMODA) as the template and phenolic resin (resol) as the carbon source can be easily manipulated by inclusion of low concentrations of low volatility selective solvents in the casting solution. Casting from neat methyl ethyl ketone yields a disordered structure even upon thermal annealing. However, addition of both dioctyl phthalate (DOP, PS selective) and dimethyl sulfoxide (DMSO, resol and PSS-DMODA selective) at modest concentrations to this casting solution provides sufficient mobility to produce highly ordered films with cylindrical mesopores. The DOP acts to swell the hydrophobic domain and can more than double the mesopore size, while the DMSO acts to swell the resol phase. Moreover, the surface area of the mesoporous carbons increases significantly as the meosopore size increases. This is a result of the decrease in wall thickness, which can be ascertained by the constant d-spacing of the mesostructure as the pore size increases. This behavior is counter to the typical effect of pore swelling agents that increase the pore size and decrease the surface area. Moreover, with only 4 wt % DOP/DMSO in the solution (20 wt % relative to solids), the scattering profiles exhibit many orders of diffraction, even upon carbonization, which is not typically observed for soft templated films. Variation in the concentration of DOP and DMSO during casting enables facile tuning of the structure of mesoporous carbon films. PMID:23738851

  5. Developing a quality control protocol for diffusion imaging on a clinical MRI system.

    PubMed

    Delakis, Ioannis; Moore, Elizabeth M; Leach, Martin O; De Wilde, Janet P

    2004-04-21

    This work describes the development of a quality control protocol, which can be implemented to assess the accuracy, precision and reproducibility of the apparent diffusion coefficient (ADC) measurement on a clinical magnetic resonance imaging (MRI) system. The precision and accuracy of the ADC measurement are analysed with regard to MRI system noise, signal reproducibility and differences between nominal and effective b values. Two aqueous test-solutions of CuSO4 and sucrose are prepared for the quality control protocol. ADC measurement with the CuSO4 solution is more sensitive to differences between nominal and effective b values, on account of the solution's high ADC. ADC measurement with the sucrose solution is more sensitive to signal reproducibility due to the solution's low baseline signal intensity. The ADC of the test-solutions is measured on an MRI system at our centre with a sequence used for clinical studies using diffusion imaging. Two parameters, Q and R, are defined for the analysis of the quality control ADC values. The Q parameter is the ratio of the standard deviation of the quality control mean ADC values over time to the optimal standard deviation, as derived from the effect of thermal noise on the ADC measurement uncertainty. Analysis with the Q parameter indicates that signal reproducibility errors contribute to ADC variations on our MRI system when imaging with high b values (b > 500 mm s(-2)), whereas differences between nominal and effective b values have a greater impact on the ADC measurement when imaging with low b values (b < 500 mm s(-2)). The R parameter is defined as the ratio of the directional variation of the ADC quality control values to the uncertainty of the ADC measurement. Analysis with the R parameter shows that the effect of directional variation of the ADC measurement on our MRI system is more pronounced when imaging with low b values. The quality control protocol identified a systematic error, which introduced a small

  6. The default network and self-generated thought: component processes, dynamic control, and clinical relevance

    PubMed Central

    Andrews-Hanna, Jessica R.; Smallwood, Jonathan; Spreng, R. Nathan

    2014-01-01

    Though only a decade has elapsed since the default network was first emphasized as being a large-scale brain system, recent years have brought great insight into the network’s adaptive functions. A growing theme highlights the default network as playing a key role in internally-directed—or self-generated—thought. Here, we synthesize recent findings from cognitive science, neuroscience, and clinical psychology to focus attention on two emerging topics as current and future directions surrounding the default network. First, we present evidence that self-generated thought is a multi-faceted construct whose component processes are supported by different subsystems within the network. Second, we highlight the dynamic nature of the default network, emphasizing its interaction with executive control systems when regulating aspects of internal thought. We conclude by discussing clinical implications of disruptions to the integrity of the network, and consider disorders when thought content becomes polarized or network interactions become disrupted or imbalanced. PMID:24502540

  7. Controlled clinical evaluations of chlorine dioxide, chlorite and chlorate in man.

    PubMed Central

    Lubbers, J R; Chauan, S; Bianchine, J R

    1982-01-01

    To assess the relative safety of chronically administered chlorine water disinfectants in man, a controlled study was undertaken. The clinical evaluation was conducted in the three phases common to investigational drug studies. Phase I, a rising dose tolerance investigation, examined the acute effects of progressively increasing single doses of chlorine disinfectants to normal healthy adult male volunteers. Phase II considered the impact on normal subjects of daily ingestion of the disinfectants at a concentration of 5 mg/l. for twelve consecutive weeks. Persons with a low level of glucose-6-phosphate dehydrogenase may be expected to be especially susceptible to oxidative stress; therefore, in Phase III, chlorite at a concentration of 5 mg/l. was administered daily for twelve consecutive weeks to a small group of potentially at-risk glucose-6-phosphate dehydrogenase-deficient subjects. Physiological impact was assessed by evaluation of a battery of qualitative and quantitative tests. The three phases of this controlled double-blind clinical evaluation of chlorine dioxide and its potential metabolites in human male volunteer subjects were completed uneventfully. There were no obvious undesirable clinical sequellae noted by any of the participating subjects or by the observing medical team. In several cases, statistically significant trends in certain biochemical or physiological parameters were associated with treatment; however, none of these trends was judged to have physiological consequence. One cannot rule out the possibility that, over a longer treatment period, these trends might indeed achieve proportions of clinical importance. However, by the absence of detrimental physiological responses within the limits of the study, the relative safety of oral ingestion of chlorine dioxide and its metabolites, chlorite and chlorate, was demonstrated. PMID:6961033

  8. The effects of nanoparticles and organic additives with controlled dispersion on dielectric properties of polymers: Charge trapping and impact excitation

    NASA Astrophysics Data System (ADS)

    Huang, Yanhui; Wu, Ke; Bell, Michael; Oakes, Andrew; Ratcliff, Tyree; Lanzillo, Nicholas A.; Breneman, Curt; Benicewicz, Brian C.; Schadler, Linda S.

    2016-08-01

    This work presents a comprehensive investigation into the effects of nanoparticles and organic additives on the dielectric properties of insulating polymers using reinforced silicone rubber as a model system. TiO2 and ZrO2 nanoparticles (d = 5 nm) were well dispersed into the polymer via a bimodal surface modification approach. Organic molecules with the potential of voltage stabilization were further grafted to the nanoparticle to ensure their dispersion. These extrinsic species were found to provide deep traps for charge carriers and exhibited effective charge trapping properties at a rather small concentration (˜1017 cm-3). The charge trapping is found to have the most significant effect on breakdown strength when the electrical stressing time is long enough that most charges are trapped in the deep states. To establish a quantitative correlation between the trap depth and the molecular properties, the electron affinity and ionization energy of each species were calculated by an ab initio method and were compared with the experimentally measured values. The correlation however remains elusive and is possibly complicated by the field effect and the electronic interactions between different species that are not considered in this computation. At high field, a super-linear increase of current density was observed for TiO2 filled composites and is likely caused by impact excitation due to the low excitation energy of TiO2 compared to ZrO2. It is reasoned that the hot charge carriers with energies greater than the excitation energy of TiO2 may excite an electron-hole pair upon collision with the NP, which later will be dissociated and contribute to free charge carriers. This mechanism can enhance the energy dissipation and may account for the retarded electrical degradation and breakdown of TiO2 composites.

  9. Clinical and Immunological Changes of Immunotherapy in Patients with Atopic Dermatitis: Randomized Controlled Trial

    PubMed Central

    Sánchez Caraballo, Jorge Mario; Cardona Villa, Ricardo

    2012-01-01

    Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients. PMID:23724240

  10. [From Nebuchadnezzar to the randomized controlled trial--milestones in the development of clinical research].

    PubMed

    Oberbaum, Menachem; Lysy, Joseph; Gropp, Cornelius

    2011-08-01

    The first clinical experiment is described in the bible: The prophet Daniel is reported being nourished during ten days by seeds and water only, in order to check if his physical state would deteriorate as a result of this minimal nutrition. In the 15th century, French surgeon Ambroise Parí experimented with a mixture of turpentine, egg protein and rose oil to treat combat wounds, which is thought to be the first clinical study to be reported. In the 19th century British scientist James Lind designed the first controlled prospective study with parallel groups, proving that ingesting citrus fruit prevents scurvy. A short time afterwards British scientist John Haygarth was the first to use a placebo drug in a clinical study. Important work on placebo was conducted by the American scientists Austin Flint and later by Henry K. Beecher, who showed that placebo itself has biological properties. The importance of comparative studies was first understood by French psychologist CLaude Bernard. He is considered the founder of the modern scientific method based on observation, analysis of data and examination of hypotheses. Bernard's work was based on the work of fellow Frenchman Pierre Charles Alexandre Louis, who is justly considered a founding father of modern epidemiology, and who was the first to use statistics in clinical experiments. Random distributions in clinical studies were reported even before this time, for instance in the work of the Flemish physician Johannes Baptista van Helmont. Danish Nobel prize winner Johannes Fibiger pioneered the use of selection bias in his work with diphtheria serum. PMID:21939122

  11. [From Nebuchadnezzar to the randomized controlled trial--milestones in the development of clinical research].

    PubMed

    Oberbaum, Menachem; Lysy, Joseph; Gropp, Cornelius

    2011-08-01

    The first clinical experiment is described in the bible: The prophet Daniel is reported being nourished during ten days by seeds and water only, in order to check if his physical state would deteriorate as a result of this minimal nutrition. In the 15th century, French surgeon Ambroise Parí experimented with a mixture of turpentine, egg protein and rose oil to treat combat wounds, which is thought to be the first clinical study to be reported. In the 19th century British scientist James Lind designed the first controlled prospective study with parallel groups, proving that ingesting citrus fruit prevents scurvy. A short time afterwards British scientist John Haygarth was the first to use a placebo drug in a clinical study. Important work on placebo was conducted by the American scientists Austin Flint and later by Henry K. Beecher, who showed that placebo itself has biological properties. The importance of comparative studies was first understood by French psychologist CLaude Bernard. He is considered the founder of the modern scientific method based on observation, analysis of data and examination of hypotheses. Bernard's work was based on the work of fellow Frenchman Pierre Charles Alexandre Louis, who is justly considered a founding father of modern epidemiology, and who was the first to use statistics in clinical experiments. Random distributions in clinical studies were reported even before this time, for instance in the work of the Flemish physician Johannes Baptista van Helmont. Danish Nobel prize winner Johannes Fibiger pioneered the use of selection bias in his work with diphtheria serum.

  12. The Effect of Melatonin on Climacteric Symptoms in Menopausal Women; A Double-Blind, Randomized Controlled, Clinical Trial

    PubMed Central

    PARANDAVAR, Nehleh; ABDALI, Khadijeh; KESHTGAR, Sara; EMAMGHOREISHI, Maasoumeh; AMOOEE, Seddegheh

    2014-01-01

    Abstract Background Menopause is one of the most critical periods of woman’s life. With reducing of ovarian estrogen; women are more prone to psychological and physical symptoms. The present study aimed to investigate the effect of melatonin on the climacteric symptoms. Methods The present double blind, placebo randomized controlled clinical trial was conducted on 240 menopausal women (40 - 60 years old) referring to the gynecology clinics of Shiraz University of Medical Sciences (January - November 2012). The participants were randomly divided into two groups through sortition. Demographic characteristics, Goldberg’s general health questionnaire (GHQ), Greene Climacteric Scale and level of Follicle Stimulating Hormone (FSH) were determined for both groups before the intervention. The intervention group received one 3mg melatonin tablet each night for 3 months and the control group received the placebo in the same period. Changes of climacteric symptoms and drug complications were measured 1, 2 and 3 months after the intervention Results We analyzed the data of 99 postmenopausal women in the intervention group and 101 postmenopausal women in the control group. In the melatonin group, the climacteric symptoms score decreased from 35.73+11.6 to 17.09+10.22 during the 3-month study period and regardless of time, a significant difference was observed between the two groups (P<0.001). In addition, a significant difference was found between the two groups regarding various dimensions of the climacteric symptoms over time (P<0.001). No significant difference was found regarding side effects between the two groups (P= 0.135). Conclusion The study findings showed that using melatonin improved the climacteric symptoms. PMID:26060703

  13. Design of clinical trials of antidepressants: should a placebo control arm be included?

    PubMed

    Fritze, J; Möller, H J

    2001-01-01

    There is no doubt that available antidepressants are efficacious and effective. Nevertheless, more effective drugs with improved tolerability are needed. With this need in mind, some protagonists claim that future antidepressants should be proved superior to, or at least as effective as, established antidepressants, making placebo control methodologically dispensable in clinical trials. Moreover, the use of placebo control is criticised as unethical because it might result in effective treatment being withheld. There are, however, a number of methodological reasons why placebo control is indispensable for the proof of efficacy of antidepressants. Comparing investigational antidepressants only with standard antidepressants and not placebo yields ambiguous results that are difficult to interpret, be it in superiority or equivalence testing, and this method of assessment requires larger sample sizes than those required with the use of placebo control. Experimental methodology not adhering to the optimal study design is ethically questionable. Restricting the testing of investigational antidepressants only to superiority over standard antidepressants is an obstacle to therapeutic progress in terms of tolerability and the detection of innovative mechanisms of action from which certain subgroups of future patients might benefit. The use of a methodology that requires larger samples for testing of superiority or equivalence is also ethically questionable. In view of the high placebo response rates in trials of antidepressants, placebo treatment does not mean withholding effective treatment. Accepting the necessity of the clinical evaluation of new, potentially ineffective antidepressants implicitly means accepting placebo control as ethically justified. Three- or multi-arm comparisons including placebo and an active reference represent the optimal study design. PMID:11602002

  14. Controlled clinical trial of oral and topical diethylcarbamazine in treatment of onchocerciasis.

    PubMed

    Taylor, H R; Greene, B M; Langham, M E

    1980-05-01

    In a double-blind controlled clinical trial comparing the safety and efficacy of oral diethylcarbamazine citrate (DEC) with topical DEC for the treatment of onchocerciasis twenty men with moderate skin-snip microfilarial counts received daily therapy for 1 week, then weekly therapy for the rest of 6 months. The number of microfilariae per skin snip dropped quickly to 2% of initial levels and remained at low levels in those receiving oral DEC, and to 20% of initial levels in patients treated with DEC lotion. Side-effects in both groups included lymphadenopathy, fever, pruritus, rash, proteinuria, and chorioretinitis; they were commoner with topical DEC.

  15. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2016-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14-65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood. PMID:26870678

  16. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2016-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14-65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood.

  17. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2015-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14–65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood. PMID:26870678

  18. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial.

    PubMed

    Carcuac, O; Derks, J; Charalampakis, G; Abrahamsson, I; Wennström, J; Berglundh, T

    2016-01-01

    The aim of the present randomized controlled clinical trial was to investigate the adjunctive effect of systemic antibiotics and the local use of chlorhexidine for implant surface decontamination in the surgical treatment of peri-implantitis. One hundred patients with severe peri-implantitis were recruited. Surgical therapy was performed with or without adjunctive systemic antibiotics or the local use of chlorhexidine for implant surface decontamination. Treatment outcomes were evaluated at 1 y. A binary logistic regression analysis was used to identify factors influencing the probability of treatment success, that is, probing pocket depth ≤5 mm, absence of bleeding/suppuration on probing, and no additional bone loss. Treatment success was obtained in 45% of all implants but was higher in implants with a nonmodified surface (79%) than those with a modified surface (34%). The local use of chlorhexidine had no overall effect on treatment outcomes. While adjunctive systemic antibiotics had no impact on treatment success at implants with a nonmodified surface, a positive effect on treatment success was observed at implants with a modified surface. The likelihood for treatment success using adjunctive systemic antibiotics in patients with implants with a modified surface, however, was low. As the effect of adjunctive systemic antibiotics depended on implant surface characteristics, recommendations for their use in the surgical treatment of peri-implantitis should be based on careful assessments of the targeted implant (ClinicalTrials.gov NCT01857804).

  19. Quality control of software in dissimilar systems using a common clinical data base

    SciTech Connect

    Erickson, J. J.; Price, R. R.; Touya, J. J.; Kronenberg, M. W.; Pederson, R.; Rollo, F. D.

    1980-01-01

    For a long time there has been widespread interest in the quality control of diagnostic instrumentation. The increasing dependence on computational systems for clinical results makes it imperative that methods for quality control of diagnostic software be developed. This paper proposes a method based on the use of a collection of patient studies for which the results have been corroborated by independent methods. The data set will be distributed in a format requiring no special handling by the system being tested and will appear identical to studies actually collected by the host system. An example of the use of a preliminary version of the data set for comparison of two systems is shown. The comparison shows that analyses performed on the two systems agree very well and can be reliably compared for follow-up studies of a patient.

  20. EMD in periodontal regenerative surgery modulates cytokine profiles: A randomised controlled clinical trial

    PubMed Central

    Villa, Oscar; Wohlfahrt, Johan C.; Koldsland, Odd Carsten; Brookes, Steven J.; Lyngstadaas, Staale P.; Aass, Anne M.; Reseland, Janne E.

    2016-01-01

    The enamel matrix derivative (EMD) contains hundreds of peptides in different levels of proteolytic processing that may provide a range of biological effects of importance in wound healing. The aim of the present study was to compare the effect of EMD and its fractions on the cytokine profiles from human gingival fibroblasts in vitro and in gingival crevicular fluid (GCF) in a randomized controlled split-mouth clinical study (n = 12). Levels of cytokines in cell culture medium and in GCF were measured by Luminex over a 2-week period. In the clinical study, levels of pro-inflammatory cytokines and chemokines were increased, whereas the levels of transforming growth factor-α (TGF-α) and platelet-derived growth factor-BB (PDGF-BB) were reduced. The in vitro study showed that EMD and its high and low molecular weight fractions reduced the secretion of pro-inflammatory cytokines and chemokines compared to untreated cells. EMD had an effect on levels of cytokines related to fibroplasia, angiogenesis, inflammation and chemotaxis both in vitro and in vivo, however, the anti-inflammatory effect induced by EMD observed in the in vitro study could not be confirmed clinically. PMID:26976446

  1. Randomized controlled trials of maternal-fetal surgery: a challenge to clinical equipoise.

    PubMed

    Rodrigues, H C M L; van den Berg, P P

    2014-10-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable.

  2. Two phase randomised controlled clinical trial of postoperative oral dietary supplements in surgical patients.

    PubMed Central

    Keele, A M; Bray, M J; Emery, P W; Duncan, H D; Silk, D B

    1997-01-01

    BACKGROUND: Previous work has shown that the administration of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinically significant short term benefits. AIMS: This study aimed firstly to re-evaluate these short term effects, and secondly to establish whether there are any long term benefits. SUBJECTS: One hundred patients admitted for elective moderate or major gastrointestinal surgery. METHODS: In the inpatient phase, patients were randomised to receive a normal ward diet postoperatively, or the same diet supplemented with an oral dietary supplement. In the outpatient phase, patients were further randomised to receive their home diet, or their home diet supplemented with the oral dietary supplement for four months. RESULTS: During the inpatient phase, patients treated with oral supplements had a significantly improved nutritional intake and lost less weight (2.2, 95% confidence interval (95% CI) 0.9 kg) compared with control patients (4.2 (0.78) kg, p < 0.001). Supplemented patients maintained their hand grip strength whereas control patients showed a significant reduction in grip strength (p < 0.01). Subjective levels of fatigue increased significantly above preoperative levels in control patients (p < 0.01) but not in the supplemented group. Twelve patients in the control group developed complications compared with four in the supplemented group (p < 0.05). In the outpatient phase, supplemented patients had improved nutrient intakes but there were no significant differences in indices of nutritional status or wellbeing between the groups. CONCLUSIONS: The prescription of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinically significant benefits. These benefits, however, are restricted to the inpatient phase. PMID:9135531

  3. Clinically Apparent Internal Mammary Nodal Metastasis in Patients With Advanced Breast Cancer: Incidence and Local Control

    SciTech Connect

    Zhang Yujing; Oh, Julia L.; Whitman, Gary J.

    2010-07-15

    Purpose: To investigate the incidence and local control of internal mammary lymph node metastases (IMN+) in patients with clinical N2 or N3 locally advanced breast cancer. Methods and Materials: We retrospectively reviewed the records of 809 breast cancer patients diagnosed with advanced nodal disease (clinical N2-3) who received radiation treatment at our institution from January 2000 December 2006. Patients were considered IMN+ on the basis of imaging studies. Results: We identified 112 of 809 patients who presented with IMN+ disease (13.8%) detected on ultrasound, computed tomography (CT), positron emission tomography/CT (PET/CT), and/or magnetic resonance imaging (MRI) studies. All 112 patients with IMN+ disease received anthracycline and taxane-based chemotherapy. Neoadjuvant chemotherapy (NCT) resulted in a complete response (CR) on imaging studies of IMN disease in 72.1% of patients. Excluding 16 patients with progressive disease, 96 patients received adjuvant radiation to the breast or the chest wall and the regional lymphatics including the IMN chain with a median dose of 60 Gy if the internal mammary lymph nodes normalized after chemotherapy and 66 Gy if they did not. The median follow-up of surviving patients was 41 months (8-118 months). For the 96 patients able to complete curative therapy, the actuarial 5-year IMN control rate, locoregional control, overall survival, and disease-free survival were 89%, 80%, 76%, and 56%. Conclusion: Over ten percent of patients with advanced nodal disease will have IMN metastases on imaging studies. Multimodality therapy including IMN irradiation achieves excellent rates of control in the IMN region and a DFS of more than 50% after curative treatment.

  4. The need for annual echocardiography to detect cabergoline-associated valvulopathy in patients with prolactinoma: a systematic review and additional clinical data.

    PubMed

    Caputo, Carmela; Prior, David; Inder, Warrick J

    2015-11-01

    Present recommendations by the US Food and Drug Administration advise that patients with prolactinoma treated with cabergoline should have an annual echocardiogram to screen for valvular heart disease. Here, we present new clinical data and a systematic review of the scientific literature showing that the prevalence of cabergoline-associated valvulopathy is very low. We prospectively assessed 40 patients with prolactinoma taking cabergoline. Cardiovascular examination before echocardiography detected an audible systolic murmur in 10% of cases (all were functional murmurs), and no clinically significant valvular lesion was shown on echocardiogram in the 90% of patients without a murmur. Our systematic review identified 21 studies that assessed the presence of valvular abnormalities in patients with prolactinoma treated with cabergoline. Including our new clinical data, only two (0·11%) of 1811 patients were confirmed to have cabergoline-associated valvulopathy (three [0·17%] if possible cases were included). The probability of clinically significant valvular heart disease is low in the absence of a murmur. On the basis of these findings, we challenge the present recommendations to do routine echocardiography in all patients taking cabergoline for prolactinoma every 12 months. We propose that such patients should be screened by a clinical cardiovascular examination and that echocardiogram should be reserved for those patients with an audible murmur, those treated for more than 5 years at a dose of more than 3 mg per week, or those who maintain cabergoline treatment after the age of 50 years.

  5. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    NASA Astrophysics Data System (ADS)

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  6. Bacterial colonization of the ovarian bursa in dogs with clinically suspected pyometra and in controls.

    PubMed

    Rubio, Alejandro; Boyen, Filip; Tas, Olaf; Kitshoff, Adriaan; Polis, Ingeborgh; Van Goethem, Bart; de Rooster, Hilde

    2014-10-15

    Septic peritonitis occurs relatively commonly in dogs. Secondary septic peritonitis is usually associated with perforation of intestines or infected viscera, such as the uterus in pyometra cases. The aim of this study was to evaluate the bacterial flora in the ovarian bursae of intact bitches as a potential source of contamination. One hundred forty dogs, clinically suspected of pyometra, were prospectively enrolled. The control group consisted of 26 dogs that underwent elective ovariohysterectomies and 18 dogs with mammary gland tumors that were neutered at the time of mastectomy. Bacteriology samples were taken aseptically at the time of surgery from the bursae and the uterus in all dogs. Twenty-two dogs that were clinically suspected of pyometra had sterile uterine content ("mucometra" cases); the remaining 118 had positive uterine cultures ("pyometra" cases) and septic peritoneal fluid was present in 10% of these cases. Of the 118 pyometra cases, 9 had unilateral and 15 had bilateral bacterial colonization of their ovarian bursae. However, the bacteria from the ovarian bursa were similar to those recovered from the uterine pus in only half of the cases. Furthermore, positive bursae were also seen in one mucometra dog (unilateral) and in four control dogs (two unilateral and two bilateral). The data illustrate that the canine ovarian bursa can harbor bacteria. The biological importance of these isolations remains unclear.

  7. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

    PubMed

    Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

    2013-01-15

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

  8. Bacterial colonization of the ovarian bursa in dogs with clinically suspected pyometra and in controls.

    PubMed

    Rubio, Alejandro; Boyen, Filip; Tas, Olaf; Kitshoff, Adriaan; Polis, Ingeborgh; Van Goethem, Bart; de Rooster, Hilde

    2014-10-15

    Septic peritonitis occurs relatively commonly in dogs. Secondary septic peritonitis is usually associated with perforation of intestines or infected viscera, such as the uterus in pyometra cases. The aim of this study was to evaluate the bacterial flora in the ovarian bursae of intact bitches as a potential source of contamination. One hundred forty dogs, clinically suspected of pyometra, were prospectively enrolled. The control group consisted of 26 dogs that underwent elective ovariohysterectomies and 18 dogs with mammary gland tumors that were neutered at the time of mastectomy. Bacteriology samples were taken aseptically at the time of surgery from the bursae and the uterus in all dogs. Twenty-two dogs that were clinically suspected of pyometra had sterile uterine content ("mucometra" cases); the remaining 118 had positive uterine cultures ("pyometra" cases) and septic peritoneal fluid was present in 10% of these cases. Of the 118 pyometra cases, 9 had unilateral and 15 had bilateral bacterial colonization of their ovarian bursae. However, the bacteria from the ovarian bursa were similar to those recovered from the uterine pus in only half of the cases. Furthermore, positive bursae were also seen in one mucometra dog (unilateral) and in four control dogs (two unilateral and two bilateral). The data illustrate that the canine ovarian bursa can harbor bacteria. The biological importance of these isolations remains unclear. PMID:25127745

  9. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    ERIC Educational Resources Information Center

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  10. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  11. Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

    PubMed Central

    Rosen, Sydney; Maskew, Mhairi; Fox, Matthew P.; Nyoni, Cynthia; Mongwenyana, Constance; Sanne, Ian; Sauls, Celeste; Long, Lawrence

    2016-01-01

    Background High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit. Methods and Findings RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study (“rapid arm”) received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study (“standard arm”) followed standard clinic procedures (three to five additional clinic visits over 2–4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis

  12. Clinical results of renal artery embolization to control postoperative hemorrhage after partial nephrectomy

    PubMed Central

    Jeon, Chang Ho; Yoon, Chang Jin; Byun, Seok-Soo; Lee, Sang Eun

    2016-01-01

    Background With the wider application of nephron-sparing surgery, there has been an increase in the occurrence of postoperative hemorrhage. However, despite such an increase, there are only a limited number of reports regarding renal artery embolization (RAE) for the management of postoperative bleeding after nephron-sparing surgery, especially after robot-assisted laparoscopic partial nephrectomy (RALPN). Purpose To evaluate the safety and clinical efficacy of transcatheter RAE for postoperative hemorrhage after open partial nephrectomy (OPN) and RALPN. Material and Methods A total of 29 patients (17 men, 12 women; age range, 31–70 years) who were referred to our hospital for postoperative hemorrhage after partial nephrectomy, between December 2003 and December 2014, were selected. We retrospectively reviewed patients’ clinical data, angiographic findings, embolization details, and clinical outcomes. Results Embolization was performed in patients who underwent OPN (25/29) and RALPN (4/29). The angiographic findings were as follows: renal artery pseudoaneurysm (n = 18), contrast extravasation (n = 8), and arteriovenous fistula (n = 3). Fiber-coated microcoil and n-butyl-2-cyanoacrylate (NBCA) was administered to the targeted bleeding renal arteries in 12 and 11 patients, respectively. In six patients, fiber-coated microcoil and NBCA were used concurrently. Technical and clinical successes were achieved in all patients (100%). Bleeding cessation was achieved in all patients, and no further relevant surgeries or interventions were required for hemorrhage control. There were no episodes of hemorrhagic recurrence during the follow-up period (median, 20 days; range, 7–108 days). Conclusion Angiography and RAE identified the origin of bleeding and could successfully preserve the residual renal function. PMID:27570638

  13. The Effect of Emphasizing Mathematical Structure in the Acquisition of Whole Number Computation Skills (Addition and Subtraction) By Seven- and Eight-Year Olds: A Clinical Investigation.

    ERIC Educational Resources Information Center

    Uprichard, A. Edward; Collura, Carolyn

    This investigation sought to determine the effect of emphasizing mathematical structure in the acquisition of computational skills by seven- and eight-year-olds. The meaningful development-of-structure approach emphasized closure, commutativity, associativity, and the identity element of addition; the inverse relationship between addition and…

  14. Nigella sativa Improves Glycemic Control and Ameliorates Oxidative Stress in Patients with Type 2 Diabetes Mellitus: Placebo Controlled Participant Blinded Clinical Trial

    PubMed Central

    Kaatabi, Huda; Bamosa, Abdullah Omar; Badar, Ahmed; Al-Elq, Abdulmohsen; Abou-Hozaifa, Bodour; Lebda, Fatma; Al-Khadra, Akram; Al-Almaie, Sameeh

    2015-01-01

    Background and Objective Oxidative stress plays an important role in pathogenesis of diabetes mellitus and its complications. Our previous study has shown glucose lowering effect produced by 3 months supplementation of Nigella sativa (NS) in combination with oral hypoglycemic drugs among type 2 diabetics. This study explored the long term glucose lowering effect (over one year) of NS in patients with type 2 diabetes mellitus on oral hypoglycemic drugs and to study its effect on redox status of such patients. Methods 114 type 2 diabetic patients on standard oral hypoglycemic drugs were assigned into 2 groups by convenience. The control group (n = 57) received activated charcoal as placebo and NS group (n = 57) received 2g NS, daily, for one year in addition to their standard medications. Fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), C- peptide, total antioxidant capacity (TAC), superoxide dismutase (SOD), catalase (CAT), glutathione and thiobarbituric acid reactive substances (TBARS) at the baseline, and every 3 months thereafter were determined. Insulin resistance and β-cell activity were calculated using HOMA 2 calculator. Results Comparison between the two groups showed a significant drop in FBG (from 180±5.75 to 180±5.59 in control Vs from 195±6.57 to 172 ±5.83 in NS group), HbA1c (from 8.2±0.12 to 8.5±0.14 in control VS from 8.6±0.13 to 8.2±0.14 in NS group), and TBARS (from 48.3±6.89 to 52.9 ±5.82 in control VS from 54.1±4.64 to 41.9 ±3.16 in NS group), in addition to a significant elevation in TAC, SOD and glutathione in NS patients compared to controls. In NS group, insulin resistance was significantly lower, while β-cell activity was significantly higher than the baseline values during the whole treatment period. Conclusion Long term supplementation with Nigella sativa improves glucose homeostasis and enhances antioxidant defense system in type 2 diabetic patients treated with oral hypoglycemic drugs. Trial Registration

  15. Adaptive control of drug dosage regimens: basic foundations, relevant issues, and clinical examples.

    PubMed

    Jelliffe, R W; Maire, P; Sattler, F; Gomis, P; Tahani, B

    1994-06-01

    In this paper we examine several of the fundamental foundations and relevant clinical issues in adaptive control of drug dosage regimens for patients. Truly individualized therapy with drugs having narrow margins of safety first requires a practical pharmacokinetic/dynamic model of the behavior of a drug. Past experience with a drug is stored in the form of a population model. Next, using the information in such a model and its relationship to the incidence of adverse reactions, a specific, explicit therapeutic goal must be selected by the responsible clinician, based on the patient's need for the drug and the risk of adverse reactions felt to be justified by each patient's need, small, moderate, or great. Individualized drug therapy thus begins with the selection of individualized therapeutic goals (low, moderate, or high) for each patient. Using subsequent feedback from the patient's serum drug levels, and using Bayesian fitting, the model is then linked to each patient as a patient-specific model. Control of the model by the dosage regimen increasingly controls the patient, to better obtain the desired explicit therapeutic goals. This process is essentially similar to that of a flight control or missile guidance system.

  16. Clinical efficacy of trivalent oral poliomyelitis vaccine: a case-control study.

    PubMed Central

    Deivanayagam, N.; Nedunchelian, K.; Ahamed, S. S.; Rathnam, S. R.

    1993-01-01

    A case-control study was carried out between May 1988 and May 1989 to assess the effectiveness of three doses of trivalent oral poliomyelitis vaccine (TOPV3) in children aged 6-35 months in Madras city. All the cases were patients with acute paralytic poliomyelitis who were residing in Madras city and were hospitalized in the Institute of Child Health; they represented 95% of such cases in the city. The diagnosis was based on clinical grounds and confirmed by stool culture which was positive in 60%. Age- and sex-matched controls, all residing in the city of Madras, were recruited concurrently from the Institute's outpatient department. There were 78 cases and 315 controls. Vaccine efficacy observed for TOPV3 was 81% (95% CI, 58-91%) for the 6-35-month age group and 86% (95% CI, 67-94%) for the 6-23-month age group. Vaccine efficacy, after controlling for age using the Mantel-Haenszel method, was 83% (95% CI, 67-91%). An unimmunized child was at 5 times greater risk of developing acute paralytic poliomyelitis than a fully immunized child. PMID:8324848

  17. Neuro Emotional Technique for the treatment of trigger point sensitivity in chronic neck pain sufferers: A controlled clinical trial

    PubMed Central

    Bablis, Peter; Pollard, Henry; Bonello, Rod

    2008-01-01

    Background Trigger points have been shown to be active in many myofascial pain syndromes. Treatment of trigger point pain and dysfunction may be explained through the mechanisms of central and peripheral paradigms. This study aimed to investigate whether the mind/body treatment of Neuro Emotional Technique (NET) could significantly relieve pain sensitivity of trigger points presenting in a cohort of chronic neck pain sufferers. Methods Sixty participants presenting to a private chiropractic clinic with chronic cervical pain as their primary complaint were sequentially allocated into treatment and control groups. Participants in the treatment group received a short course of Neuro Emotional Technique that consists of muscle testing, general semantics and Traditional Chinese Medicine. The control group received a sham NET protocol. Outcome measurements included pain assessment utilizing a visual analog scale and a pressure gauge algometer. Pain sensitivity was measured at four trigger point locations: suboccipital region (S); levator scapulae region (LS); sternocleidomastoid region (SCM) and temporomandibular region (TMJ). For each outcome measurement and each trigger point, we calculated the change in measurement between pre- and post- treatment. We then examined the relationships between these measurement changes and six independent variables (i.e. treatment group and the above five additional participant variables) using forward stepwise General Linear Model. Results The visual analog scale (0 to 10) had an improvement of 7.6 at S, 7.2 at LS, 7.5 at SCM and 7.1 at the TMJ in the treatment group compared with no improvement of at S, and an improvement of 0.04 at LS, 0.1 at SCM and 0.1 at the TMJ point in the control group, (P < 0.001). Conclusion After a short course of NET treatment, measurements of visual analog scale and pressure algometer recordings of four trigger point locations in a cohort of chronic neck pain sufferers were significantly improved when

  18. An examination of the origin and evolution of additional tandem repeats in the mitochondrial DNA control region of Japanese sika deer (Cervus Nippon).

    PubMed

    Ba, Hengxing; Wu, Lang; Liu, Zongyue; Li, Chunyi

    2016-01-01

    Tandem repeat units are only detected in the left domain of the mitochondrial DNA control region in sika deer. Previous studies showed that Japanese sika deer have more tandem repeat units than its cousins from the Asian continent and Taiwan, which often have only three repeat units. To determine the origin and evolution of these additional repeat units in Japanese sika deer, we obtained the sequence of repeat units from an expanded dataset of the control region from all sika deer lineages. The functional constraint is inferred to act on the first repeat unit because this repeat has the least sequence divergence in comparison to the other units. Based on slipped-strand mispairing mechanisms, the illegitimate elongation model could account for the addition or deletion of these additional repeat units in the Japanese sika deer population. We also report that these additional repeat units could be occurring in the internal positions of tandem repeat regions, possibly via coupling with a homogenization mechanism within and among these lineages. Moreover, the increased number of repeat units in the Japanese sika deer population could reflect a balance between mutation and selection, as well as genetic drift.

  19. Using historical control information for the design and analysis of clinical trials with overdispersed count data.

    PubMed

    Gsteiger, Sandro; Neuenschwander, Beat; Mercier, Francois; Schmidli, Heinz

    2013-09-20

    Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting provide valuable information for designing a new trial. For the analysis, however, the use of trial-external information is challenging and therefore controversial, although it seems attractive from an ethical or efficiency perspective. Here, we consider the formal use of historical control data on lesion counts in a multiple sclerosis trial. The approach to incorporating historical data is Bayesian, in that historical information is captured in a prior that accounts for between-trial variability and hence leads to discounting of historical data. We extend the meta-analytic-predictive approach, a random-effects meta-analysis of historical data combined with the prediction of the parameter in the new trial, from normal to overdispersed count data of individual-patient or aggregate-trial format. We discuss the prior derivation for the lesion mean count in the control group of the new trial for two populations. For the general population (without baseline enrichment), with 1936 control patients from nine historical trials, between-trial variability was moderate to substantial, leading to a prior effective sample size of about 45 control patients. For the more homogenous population (with enrichment), with 412 control patients from five historical trials, the prior effective sample size was approximately 63 patients. Although these numbers are small relative to the historical data, they are fairly typical in settings where between-trial heterogeneity is moderate. For phase II, reducing the number of control patients by 45 or by 63 may be an attractive option in many multiple sclerosis trials.

  20. Clinical significance of determining plasma homocysteine: case-control study on arterial and venous thrombotic patients

    PubMed Central

    Vučković, Biljana A.; Čabarkapa, Velibor S.; Ilić, Tatjana A.; Salatić, Iva R.; Lozanov-Crvenković, Zagorka S.; Mitić, Gorana P.

    2013-01-01

    Aim To determine the differences in plasma homocysteine levels between three MTHFR 677 genotype subgroups in patients with thrombosis and in controls, as well as between patients with thrombosis and controls with the same MTHFR 677 genotype. Methods This case-control study was conducted in Clinical Center of Vojvodina, Novi Sad, from June to December 2011. We included 65 patients with either arterial or venous thrombosis (mean age, 40.97 ± 11.38 years) and 65 controls with no history or clinical evidence of any thrombotic event (mean age, 41.23 ± 11.12 years). Patients and controls were age- and sex-matched. Results In comparison with controls, thrombotic patients had significantly higher homocysteine levels (12.81 ± 4.94 µmol/L vs 9.82 ± 3.68 µmol/L; P < 0.001) and significantly higher incidence of hyperhomocysteinemia (55% vs 22%; P < 0.001; odds ratio [OR] = 4.521). There were no significant differences in homocysteine levels between homozygous carriers, heterozygous carriers, and non-carriers of the MTHFR 677 mutation in either thrombotic patients (12.97 ± 5.40 µmol/L vs 12.55 ± 5.71 µmol/L vs 13.27 ± 1.71 µmol/L; P = 0.100) or controls (10.07 ± 2.50 µmol/L vs 10.25 ± 4.84 µmol/L vs 9.20 ± 2.44 µmol/L; P = 0.651). However, in comparison with controls, homozygous carriers in thrombotic patient group did not have significantly higher levels of homocysteine (12.97 ± 5.40 µmol/L vs 10.07 ± 2.50 µmol/L; P = 0.072), but heterozygous carriers (12.55 ± 5.71 µmol/L vs 10.25 ± 4.84 µmol/L; P = 0.020) and non-carriers (13.27 ± 1.71 µmol/L vs 9.20 ± 2.44 µmol/L; P < 0.001) did. There was no significant difference in homocysteine levels between patients with arterial and venous thrombosis (12.76 ± 3.60 µmol/L vs 12.86 ± 5.51 µmol/L; P = 0.990) and between patients with one thrombotic event and those with recurrent thrombotic events

  1. A twelve-week clinical comparison of two tartar control dentifrices.

    PubMed

    Sowinski, J; Battista, G; Petrone, D M; Petrone, M E; DeVizio, W; Volpe, A R; Proskin, H M

    2000-01-01

    The objective of this double-blind clinical study, conducted using the Volpe-Manhold evaluation method for dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after twelve weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol, and completed the entire study. At the twelve-week examination, the Test Dentifrice group exhibited a statistically significant 43.5% reduction in mean Volpe-Manhold Calculus Index scores compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base.

  2. Impaired fetal thymic growth precedes clinical preeclampsia: a case-control study.

    PubMed

    Eviston, David P; Quinton, Ann E; Benzie, Ron J; Peek, Michael J; Martin, Andrew; Nanan, Ralph K

    2012-06-01

    In preeclampsia the maternal adaptive immune system undergoes specific changes, which are different from the physiological processes associated with healthy pregnancy. Whether preeclampsia also affects the fetal immune system is difficult to investigate, due to limited access to the fetus. We hypothesized that if preeclampsia affects the fetal adaptive immune system this might be associated with early changes in thymic growth. In this case-control study, 53 preeclamptic and 120 healthy control pregnancies were matched for maternal age, gestational age and smoking. Fetal thymus diameter was measured as the greatest width perpendicular to a line connecting sternum and spine based on ultrasound images taken at 17-21 weeks gestation. Independent of fetal and maternal anthropometric measures, thymuses were found to be smaller in preeclamptic pregnancies than healthy controls (16.2 mm versus 18.3 mm, respectively, mean difference=2.1 mm, 95% CI: 0.8-3.3, p<0.001), and the odds of developing preeclampsia was estimated to be 0.72 (95% CI: 0.60-0.86, p<0.001) lower for each 1 mm increase in thymus diameter. There was no correlation between the onset of preeclampsia and fetal thymus size. This is the first study to suggest that fetal thymus growth is reduced before the clinical onset of preeclampsia and precedes any described fetal anomalies or maternal immunological changes associated with preeclampsia. We propose that the fetal adaptive immune system is either passively affected by maternal processes preceding clinical preeclampsia or is actively involved in initiating preeclampsia in later pregnancy.

  3. [Cost-effectiveness analysis of preventive methods for occlusal surface according to caries risk: results of a controlled clinical trial].

    PubMed

    Tagliaferro, Elaine Pereira da Silva; Marinho, Daniel Savignon; Pereira, Claudia Cristina de Aguiar; Pardi, Vanessa; Ambrosano, Gláucia Maria Bovi; Meneghim, Marcelo de Castro; Pereira, Antonio Carlos

    2013-11-01

    This study presents the results of a cost-effectiveness analysis in a controlled clinical trial on the effectiveness of a modified glass ionomer resin sealant ( Vitremer, 3M ESPE) and the application of fluoride varnish (Duraphat, Colgate) on occlusal surfaces of first permanent molars in children 6-8 years of age (N = 268), according to caries risk (high versus low). Children were examined semiannually by the same calibrated dentist for 24 months after allocation in six groups: high and low risk controls (oral health education every three months); high and low risk with varnish (oral health education every three months + varnish biannually); and high and low risk with sealant (oral health education every three months + a single application of sealant). Economic analysis showed that sealing permanent first molars of high-risk schoolchildren showed a C/E ratio of US$ 119.80 per saved occlusal surface and an incremental C/E ratio of US$ 108.36 per additional saved occlusal surface. The study concluded that sealing permanent first molars of high-risk schoolchildren was the most cost-effective intervention.

  4. [Cost-effectiveness analysis of preventive methods for occlusal surface according to caries risk: results of a controlled clinical trial].

    PubMed

    Tagliaferro, Elaine Pereira da Silva; Marinho, Daniel Savignon; Pereira, Claudia Cristina de Aguiar; Pardi, Vanessa; Ambrosano, Gláucia Maria Bovi; Meneghim, Marcelo de Castro; Pereira, Antonio Carlos

    2013-11-01

    This study presents the results of a cost-effectiveness analysis in a controlled clinical trial on the effectiveness of a modified glass ionomer resin sealant ( Vitremer, 3M ESPE) and the application of fluoride varnish (Duraphat, Colgate) on occlusal surfaces of first permanent molars in children 6-8 years of age (N = 268), according to caries risk (high versus low). Children were examined semiannually by the same calibrated dentist for 24 months after allocation in six groups: high and low risk controls (oral health education every three months); high and low risk with varnish (oral health education every three months + varnish biannually); and high and low risk with sealant (oral health education every three months + a single application of sealant). Economic analysis showed that sealing permanent first molars of high-risk schoolchildren showed a C/E ratio of US$ 119.80 per saved occlusal surface and an incremental C/E ratio of US$ 108.36 per additional saved occlusal surface. The study concluded that sealing permanent first molars of high-risk schoolchildren was the most cost-effective intervention. PMID:25402241

  5. Phosphazene additives

    DOEpatents

    Harrup, Mason K; Rollins, Harry W

    2013-11-26

    An additive comprising a phosphazene compound that has at least two reactive functional groups and at least one capping functional group bonded to phosphorus atoms of the phosphazene compound. One of the at least two reactive functional groups is configured to react with cellulose and the other of the at least two reactive functional groups is configured to react with a resin, such as an amine resin of a polycarboxylic acid resin. The at least one capping functional group is selected from the group consisting of a short chain ether group, an alkoxy group, or an aryloxy group. Also disclosed are an additive-resin admixture, a method of treating a wood product, and a wood product.

  6. Potlining Additives

    SciTech Connect

    Rudolf Keller

    2004-08-10

    In this project, a concept to improve the performance of aluminum production cells by introducing potlining additives was examined and tested. Boron oxide was added to cathode blocks, and titanium was dissolved in the metal pool; this resulted in the formation of titanium diboride and caused the molten aluminum to wet the carbonaceous cathode surface. Such wetting reportedly leads to operational improvements and extended cell life. In addition, boron oxide suppresses cyanide formation. This final report presents and discusses the results of this project. Substantial economic benefits for the practical implementation of the technology are projected, especially for modern cells with graphitized blocks. For example, with an energy savings of about 5% and an increase in pot life from 1500 to 2500 days, a cost savings of $ 0.023 per pound of aluminum produced is projected for a 200 kA pot.

  7. Limitations of student-driven formative assessment in a clinical clerkship. A randomised controlled trial

    PubMed Central

    Palmer, Edward J; Devitt, Peter G

    2008-01-01

    Background Teachers strive to motivate their students to be self-directed learners. One of the methods used is to provide online formative assessment material. The concept of formative assessment and use of these processes is heavily promoted, despite limited evidence as to their efficacy. Methods Fourth year medical students, in their first year of clinical work were divided into four groups. In addition to the usual clinical material, three of the groups were provided with some form of supplementary learning material. For two groups, this was provided as online formative assessment. The amount of time students spent on the supplementary material was measured, their opinion on learning methods was surveyed, and their performance in summative exams at the end of their surgical attachments was measured. Results The performance of students was independent of any educational intervention imposed by this study. Despite its ready availability and promotion, student use of the online formative tools was poor. Conclusion Formative learning is an ideal not necessarily embraced by students. If formative assessment is to work students need to be encouraged to participate, probably by implementing some form of summative assessment. PMID:18471324

  8. The Reduction of Distress Using Therapeutic Geothermal Water Procedures in a Randomized Controlled Clinical Trial

    PubMed Central

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P < 0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P = 0.01). Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine. PMID:25866680

  9. Neuroimaging in clinical studies of craving: importance of reward and control networks.

    PubMed

    Thayer, Rachel E; Hutchison, Kent E

    2013-06-01

    Research on neurobiological mechanisms, especially the function of networks that underlie reward and cognitive control, may offer an opportunity to explore how existing treatments work and provide means for developing new treatments for substance use disorders. In this respect, the special issue of Psychology of Addictive Behaviors highlights efforts to integrate translational neuroimaging with clinical research by actively linking neuroimaging measures with psychosocial treatment mechanisms. Based on several of the articles in this special issue, mindfulness-based approaches appear poised to make rapid progress in terms of integrating neuroimaging with research on mechanisms that mediate treatment success. This commentary briefly discusses research on incentive salience and cognitive control networks in the context of addiction, followed by a discussion of specific studies within this special issue that address the integration of neuroimaging assessments in the context of mindfulness approaches. Future work may be able to leverage measures of changes in networks and regions that underlie reward processing and cognitive control to better understand how treatments work, especially for mindfulness-based approaches. PMID:23815450

  10. [An outpatient clinic measure and control system for anticoagulation levels, CoaguChek XS].

    PubMed

    Romero Guardeño, Araceli; Pérez Lucena, Dolores Amalia

    2009-03-01

    A significant increase during recent years in the number of patients who need Oral Anticoagulant Treatment has meant a greater role for nurses, especially in Primary Health Care Centers, since nurses, along with doctors, are the professionals responsible for treating those patients. This control is carried out by measuring the levels of anticoagulants in the blood, regulating the anticoagulant medicine doses, and providing patients with the essential health education so patients participate in the treatment of their illness. To a large degree, the preponderance of Primary Health Care Centers in the aforementioned control has developed hand-in-hand with the availability of portable, simple and low cost coagulation measuring systems which permit a direct reading of a patient's anticoagulation level with one drop of capillary blood. The objective of this article is introduce the reader to a measuring system appropriate for outpatient clinic control of anticoagulant levels in blood by mans of the CoaguChek XS System, which is described. The authors specify the sample extraction procedure, how to measure coagulant levels, and recommendations to keep in mind while carrying out this procedure. The authors sketch the importance of health education and finally, they describe some advantages and inconveniences this system has.

  11. The reduction of distress using therapeutic geothermal water procedures in a randomized controlled clinical trial.

    PubMed

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P < 0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P = 0.01). Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine.

  12. [Rethinking clinical research in surgical oncology. From comic opera to quality control].

    PubMed

    Evrard, Serge

    2016-01-01

    The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.

  13. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    PubMed

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  14. A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. Methods/Design This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion. Discussion This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of

  15. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    PubMed Central

    Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

    2011-01-01

    A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe. PMID:20953383

  16. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial

    PubMed Central

    Valizadeh, Leila; Seyyedrasooli, Alehe; Zamanazadeh, Vahid; Nasiri, Khadijeh

    2015-01-01

    Background: Sleep disorders are common mental disorders reported among the elderly in all countries, and with nonpharmacological interventions, they could be helped to improve their sleep quality. Objectives: The aim of this study was to compare the effects of two interventions, foot reflexology and foot bath, on sleep quality in elderly people. Patients and Methods: This three-group randomized clinical trial (two experimental groups and a control group) was conducted on 69 elderly men. The two experimental groups had reflexology (n = 23) and foot bath (n = 23) interventions for 6 weeks. The reflexology intervention was done in the mornings, once a week for ten minutes on each foot. The participants in the foot bath group were asked to soak their feet in 41°C to 42°C water one hour before sleeping. The pittsburgh sleep quality index (PSQI) was completed before and after the intervention through an interview process. Results: The results showed that the PSQI scores after intervention compared to before it in the reflexology and foot bath groups were statistically significant (P = 0.01 , P = 0.001); however, in the control group did not show a statistically significant difference (P = 0.14). In addition, the total score changes among the three groups were statistically significant (P = 0.01). Comparing the score changes of quality of sleep between the reflexology and foot bath groups showed that there was no significant difference in none of the components and the total score (P = 0.09). The two interventions had the same impact on the quality of sleep. Conclusions: It is suggested that the training of nonpharmacological methods to improve sleep quality such as reflexology and foot bath be included in the elderly health programs. In addition, it is recommended that the impact of these interventions on subjective sleep quality using polysomnographic recordings be explored in future research. PMID:26734475

  17. Comparison of Neurofeedback and Transcutaneous Electrical Nerve Stimulation Efficacy on Treatment of Primary Headaches: A Randomized Controlled Clinical Trial

    PubMed Central

    Moshkani Farahani, Davood; Tavallaie, Seyed Abbas; Ahmadi, Khodabakhsh; Fathi Ashtiani, Ali

    2014-01-01

    Background: Headache is one of the most prevalent investigated complaints in the neurology clinics and is the most common pain-related complaint worldwide. Stress is a significant factor that causes and triggers headaches. Since healthcare practitioners experience a lot of stress in their careers, they are more prone to headaches. Objectives: This study was designed to evaluate and compares the efficacy of neurofeedback behavioural therapy (NFB) and transcutaneous electrical nerve stimulation (TENS) in the treatment of primary headaches in healthcare providers. Patients and Methods: The current study was a clinical trial, performed in Teheran, IR Iran, with two experimental groups and a control group. Convenient sampling method was used to recruit patients. Independent variables were NFB and TENS and dependent variables were frequency, severity, and duration of headache. Blanchard headache diary was used for assessment. Hence, 45 healthcare providers with primary headache were selected and randomly allocated to one of the NFB, TENS, and control groups by block random assignment method. All three groups completed the headache diary during one week before and after the treatment period as pretest and posttests, respectively. The NFB group was treated in the period between pretest and posttest with fifteen 30-minute treatment sessions three times a week and the TENS group was treated with fifteen 20-minute daily sessions. The control group received none of these treatments. Results: The results from the analysis of covariance showed that treatment with NFB and TENS had caused significant decrease in the frequency, severity, and duration of headache in experimental groups. The results of the LSD post-hoc test indicated that there were significant differences in the frequency, severity, and duration of pain among experimental groups and the control group. Moreover, there were significant differences between pain frequencies in experimental groups. Conclusions: According

  18. Traditional endodontic surgery versus modern technique: a 5-year controlled clinical trial.

    PubMed

    Tortorici, Silvia; Difalco, Paolo; Caradonna, Luigi; Tetè, Stefano

    2014-05-01

    In this study, we compared outcomes of traditional apicoectomy versus modern apicoectomy, by means of a controlled clinical trial with a 5-year follow-up. The study investigated 938 teeth in 843 patients. On the basis of the procedure performed, the teeth were grouped in 3 groups. Differences between the groups were the method of osteotomy (type of instruments used), type of preparation of retrograde cavity (different apicoectomy angles and instruments used for root-end preparation), and root-end filling material used (gray mineral trioxide aggregate or silver amalgam). Outcome (tooth healing) was estimated after 1 and 5 years, postoperatively. Clinical success rates after 1 year were 67% (306 teeth), 90% (186 teeth), and 94% (256 teeth) according to traditional apicoectomy (group 1), modern microsurgical apicoectomy using burns for osteotomy (group 2) or using piezo-osteotomy (group 3), respectively. After 1 year, group comparison results were statistically significant (P < 0.0001). Linear trend test was also statistically significant (P < 0.0001), pointing out larger healing from group 1 to group 3. After 5 years, teeth were classified into 2 groups on the basis of root-end filling material used. Clinical success was 90.8% (197 teeth) in the silver amalgam group versus 96% (309 teeth) in the mineral trioxide aggregate group (P < 0.00214). Multiple logistic regression analysis found that surgical technique was independently associated to tooth healing. In conclusion, modern apicoectomy resulted in a probability of success more than 5 times higher (odds ratio, 5.20 [95% confidence interval, 3.94-6.92]; P < 0.001) compared with the traditional technique. PMID:24469371

  19. Nonsurgical treatment of moderate and advanced periimplantitis lesions: a controlled clinical study.

    PubMed

    Schwarz, Frank; Bieling, Katrin; Bonsmann, Martin; Latz, Thilo; Becker, Jürgen

    2006-12-01

    The aim of this controlled, parallel design clinical study was to evaluate the effectiveness of an Er:YAG (erbium-doped:yttrium, aluminum, and garnet) laser for nonsurgical treatment of periimplantitis lesions. Twenty patients, each of whom displayed at least one implant with (a) moderate and (b) advanced periimplantitis (n=40 implants; IMZ, ITI, Spline Twist, ZL-Duraplant, Camlog), were randomly instrumented nonsurgically using either (1) an Er:YAG laser (100 mJ/pulse, 10 Hz) device (LAS) or (2) mechanical debridement using plastic curettes and antiseptic therapy with chlorhexidine digluconate (0.2%) (C). The following clinical parameters were measured at baseline, 3, 6, and 12 months after treatment: plaque index, bleeding on probing (BOP), probing depth, gingival recession, and clinical attachment level (CAL). Mean BOP improved significantly in both groups at 3, 6, and 12 months (a- lesions: P<0.001 and b- lesions: P<0.01, respectively). After 3 and 6 months, the mean reduction of BOP was significantly higher in the LAS group when compared to the C group (a- and b- lesions: P<0.01 and P<0.05, respectively). At 3 and 6 months, both groups revealed significant CAL gains at a- and b- lesions (P<0.01, respectively). In both groups, however, the mean CAL at a- and b- lesions was not significantly different from the respective baseline values at 12 months (P>0.05, respectively). Although treatment of periimplantitis lesions with LAS resulted in a significantly higher BOP reduction than C, its effectiveness seemed to be limited to a period of 6 months, particularly at b- lesions.

  20. Blood pressure control in treated hypertensive patients: clinical performance of general practitioners.

    PubMed Central

    Frijling, B D; Spies, T H; Lobo, C M; Hulscher, M E; van Drenth, B B; Braspenning, J C; Prins, A; van der Wouden, J C; Grol, R P

    2001-01-01

    BACKGROUND: The blood pressure of many treated hypertensive patients remains above recommended target levels. This discrepancy may be related to general practitioners' (GPs') actions. AIM: To assess clinical performance of GPs in blood pressure control in treated hypertensive patients and to explore the influence of patient and GP characteristics on clinical performance. DESIGN OF STUDY: Cross-sectional study conducted on 195 GPs with invitations to participate made via bulletins and by letter. SETTING: One hundred and thirty-two practices in the southern half of The Netherlands from November 1996 to April 1997. METHOD: Performance criteria were selected from Dutch national hypertension guidelines for general practice. GPs completed self-report forms immediately after follow-up visits of hypertensive patients treated with antihypertensive medication. RESULTS: The GPs recorded 3526 follow-up visits. In 63% of these consultations the diastolic blood pressure (DBP) was 90 mmHg or above. The median performance rates of the GPs were less than 51% for most of the recommended actions, even at a DBP of > or = 100 mmHg. Performance of non-pharmacological actions increased gradually with increasing DBP; prescribing an increase in antihypertensive medication and making a follow-up appointment scheduled within six weeks rose steeply at a DBP of > or = 100 mmHg. Patient and GP characteristics contributed little to clinical performance. Action performance rates varied considerably between GPs. CONCLUSION: GPs seem to target their actions at a DBP of below 100 mmHg, whereas guidelines recommend targeting at a DBP of below 90 mmHg. PMID:11271892

  1. Heat treatment and the use of additives to improve the stability of paralytic shellfish poisoning toxins in shellfish tissue reference materials for internal quality control and proficiency testing.

    PubMed

    Burrell, Stephen; Clion, Valentin; Auroy, Virginie; Foley, Barry; Turner, Andrew D

    2015-06-01

    The need for homogenous reference materials stable for paralytic shellfish toxins is vital for the monitoring and quality assurance of these potent neurotoxins in shellfish. Two stabilisation techniques were investigated, heat treatment through autoclaving and the addition of preserving additives into the tissue matrix. Short and long-term stability experiments as well as homogeneity determination were conducted on materials prepared by both techniques in comparison with an untreated control using two LC-FLD methods. Both techniques improved the stability of the matrix and the PSP toxins present compared to the controls. A material was prepared using the combined techniques of heat treatment followed by spiking with additives and data is presented from this optimised reference material as used over a two year period in the Irish national monitoring program and in a development exercise as part of a proficiency testing scheme operated by QUASIMEME (Quality Assurance of Information for Marine Environmental Monitoring in Europe) since 2011. The results were indicative of the long-term stability of the material as evidenced through consistent assigned values in the case of the proficiency testing scheme and a low relative standard deviation of 10.5% for total toxicity data generated over 24 months.

  2. Temperature-controlled laser-soldering system and its clinical application for bonding skin incisions.

    PubMed

    Simhon, David; Gabay, Ilan; Shpolyansky, Gregory; Vasilyev, Tamar; Nur, Israel; Meidler, Roberto; Hatoum, Ossama Abu; Katzir, Abraham; Hashmonai, Moshe; Kopelman, Doron

    2015-01-01

    Laser tissue soldering is a method of repairing incisions. It involves the application of a biological solder to the approximated edges of the incision and heating it with a laser beam. A pilot clinical study was carried out on 10 patients who underwent laparoscopic cholecystectomy. Of the four abdominal incisions in each patient, two were sutured and two were laser soldered. Cicatrization, esthetical appearance, degree of pain, and pruritus in the incisions were examined on postoperative days 1, 7, and 30. The soldered wounds were watertight and healed well, with no discharge from these wounds or infection. The total closure time was equal in both methods, but the net soldering time was much shorter than suturing. There was no difference between the two types of wound closure with respect to the pain and pruritus on a follow-up of one month. Esthetically, the soldered incisions were estimated as good as the sutured ones. The present study confirmed that temperature-controlled laser soldering of human skin incisions is clinically feasible, and the results obtained were at least equivalent to those of standard suturing. PMID:26720882

  3. Temperature-controlled laser-soldering system and its clinical application for bonding skin incisions

    NASA Astrophysics Data System (ADS)

    Simhon, David; Gabay, Ilan; Shpolyansky, Gregory; Vasilyev, Tamar; Nur, Israel; Meidler, Roberto; Hatoum, Ossama Abu; Katzir, Abraham; Hashmonai, Moshe; Kopelman, Doron

    2015-12-01

    Laser tissue soldering is a method of repairing incisions. It involves the application of a biological solder to the approximated edges of the incision and heating it with a laser beam. A pilot clinical study was carried out on 10 patients who underwent laparoscopic cholecystectomy. Of the four abdominal incisions in each patient, two were sutured and two were laser soldered. Cicatrization, esthetical appearance, degree of pain, and pruritus in the incisions were examined on postoperative days 1, 7, and 30. The soldered wounds were watertight and healed well, with no discharge from these wounds or infection. The total closure time was equal in both methods, but the net soldering time was much shorter than suturing. There was no difference between the two types of wound closure with respect to the pain and pruritus on a follow-up of one month. Esthetically, the soldered incisions were estimated as good as the sutured ones. The present study confirmed that temperature-controlled laser soldering of human skin incisions is clinically feasible, and the results obtained were at least equivalent to those of standard suturing.

  4. Endoscopic shuffling, infection control, and the clinical practice of push enteroscopy.

    PubMed

    Muscarella, Lawrence F

    2007-01-01

    Failure to identify and diagnose the site and cause of obscure bleeding or some other gastrointestinal disorder may be an indication for push enteroscopy. During this procedure, a long, narrow, flexible gastrointestinal endoscope, known as a push enteroscope, is advanced into the upper gastrointestinal tract to examine and evaluate the proximal section (first one third) of the small bowel. Because of limited funding and inadequate instrument availability, some gastrointestinal endoscopy units may perform this procedure using a colonoscope instead of a push enteroscope. Although not specifically designed for push enteroscopy, colonoscopes are less expensive than push enteroscopes and readily available for clinical use in virtually every gastrointestinal endoscopy unit. The use of a colonoscope or other lower gastrointestinal endoscope to perform push enteroscopy or another upper gastrointestinal procedure (or the use of an upper gastrointestinal endoscope to perform a lower gastrointestinal procedure) is defined in this article as endoscopic shuffling. Although it is arguably efficient and cost effective (and in some instances may improve clinical outcomes), endoscopic shuffling raises a number of economic, legal, medical, and ethical questions and concerns, several of which are discussed in this article, with a particular focus on infection control. PMID:17440313

  5. Control of ACTH secretion by excitatory amino acids: functional significance and clinical implications.

    PubMed

    Jezova, Daniela

    2005-12-01

    The involvement of excitatory amino acids in the control of ACTH release is well established. Activation of ionotropic glutamate receptors has a stimulatory effect on ACTH release, while the role of metabotropic receptors is not yet understood in detail. Glutamatergic regulation of ACTH release has a clear significance for the stress response and neuroendocrine functions during development. A dysregulation of the hypothalamic-pituitary-adrenocortical (HPA) axis has been reported in several psychiatric and neurological disorders. So far, only fractional indices on the clinical importance of the interaction between glutamate and ACTH secretion have been obtained in both preclinical and clinical studies. Some antidepressant drugs, such as tianeptine, which were found to modulate ACTH release, appear to interfere with brain glutamatergic system. Changes in ACTH and cortisol release may be of importance for mood stabilizing effects of antiepileptic drugs modulating glutamate release, such as lamotrigine. Brain glutamate and HPA axis interaction seems to be of importance in alcohol and drug abuse. Little information is available on ACTH release in response to glutamate-modulating drugs used in the treatment of schizophrenia and Alzheimer disease. Nevertheless, pharmacological interventions influencing interaction between glutamate and the HPA axis are promising treatment possibilities in psychiatry and neurology.

  6. An empirical evaluation of devolving administrative control to Costa Rican hospital and clinic directors.

    PubMed

    Lee, Theodore; McKee, Douglas

    2015-01-01

    In the early 2000s, Costa Rica implemented comprehensive reforms of its health care system, including devolving administrative power from the central government to some providers that remain part of the national system. In this article, we evaluate how this aspect of the reform affected clinic efficiency and population health by analyzing administrative data on regional providers and mortality rates in local areas. We compare changes in outcomes across time between areas that signed performance contracts with the central government and received limited budgetary control to those that continued to be managed directly by the central government. We believe the reform created opportunities for providers to become more efficient and effective. Our results suggest that the reform significantly decreased costs without adversely affecting quality of care or population health.

  7. Chemotherapy of onchocerciasis: a controlled clinical trial of topical diethylcarbamazine (DEC) in Guatemala.

    PubMed

    Taylor, H R; Langham, M E; de Stahl, E M; Figueroa, L N; Beltranena, F

    1980-09-01

    A double-masked, controlled clinical trial was conducted in Guatemala to assess the safety and efficacy of diethylcarbamazine (DEC) lotion as compared to placebo lotion in the treatment of onchocerciasis. One hundred eighty-seven people were enrolled in this study and were followed for two months. Lotion was applied daily for seven days, then weekly for seven weeks. The decrease in mean microfilarial counts per skin snip was significantly greater in those receiving DEC lotion than for those receiving placebo lotion. The proportionate reduction in microfilarial counts was similar for people with light, moderate, or heavy microfilarial loads. Side effects were mainly related to skin changes, fever, and malaise, and occurred in nearly one-third of the people receiving DEC lotion. These reactions occurred almost as commonly in those people who were lightly infected as in those who had moderate or heavy infections.

  8. The case for randomized controlled trials to assess the impact of clinical information systems

    PubMed Central

    Wyatt, Jeremy C

    2011-01-01

    There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

  9. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

    PubMed Central

    Wiljer, David; Cafazzo, Joseph A

    2016-01-01

    Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study

  10. An empirical evaluation of devolving administrative control to Costa Rican hospital and clinic directors.

    PubMed

    Lee, Theodore; McKee, Douglas

    2015-01-01

    In the early 2000s, Costa Rica implemented comprehensive reforms of its health care system, including devolving administrative power from the central government to some providers that remain part of the national system. In this article, we evaluate how this aspect of the reform affected clinic efficiency and population health by analyzing administrative data on regional providers and mortality rates in local areas. We compare changes in outcomes across time between areas that signed performance contracts with the central government and received limited budgetary control to those that continued to be managed directly by the central government. We believe the reform created opportunities for providers to become more efficient and effective. Our results suggest that the reform significantly decreased costs without adversely affecting quality of care or population health. PMID:25813506

  11. People v. Stockton Pregnancy Control Medical Clinic, Inc., 28 July 1988.

    PubMed

    1988-01-01

    The defendants, a pregnancy control clinic and physicians, appealed a decision enjoining them from violating a California statute that required them to report as child abuse instances where minors under the age of 14 were diagnosed as being pregnant, as having a sexually transmitted disease, or as suffering from the complications of an abortion. The Court reversed part of the lower court decision and held that the defendants did not have to report voluntary sexual contact where the parties are of similar age. However, it also ruled that where the parties were of disparate age, such a reporting requirement did not violate the constitutional right to privacy of minors and served the compelling state interest of preventing child abuse. PMID:12289577

  12. Nutraceuticals and Blood Pressure Control: Results from Clinical Trials and Meta-Analyses.

    PubMed

    Cicero, Arrigo F G; Colletti, Alessandro

    2015-09-01

    Beyond the well-known effects on blood pressure (BP) of the dietary approaches to stop hypertension (DASH) and the Mediterranean diets, a large number of studies has investigated the possible BP lowering effect of different dietary supplements and nutraceuticals, the most part of them being antioxidant agents with a high tolerability and safety profile. In particular relatively large body of evidence support the use of potassium, L-arginine, vitamin C, cocoa flavonoids, beetroot juice, coenzyme Q10, controlled-release melatonin, and aged garlic extract. However there is a need for data about the long-term safety of a large part of the above discussed products. Moreover further clinical research is advisable to identify between the available active nutraceuticals those with the best cost-effectiveness and risk-benefit ratio for a large use in general population with low-added cardiovascular risk related to uncomplicated hypertension. PMID:25788027

  13. Risk factors and clinical features of ovarian pregnancy: a case–control study

    PubMed Central

    Zhu, Qian; Li, Cheng; Zhao, Wei-Hong; Yuan, Jiang-Jing; Yan, Ming-Xing; Qin, Guo-Juan; Zhang, Jian

    2014-01-01

    Objective To identify risk factors for ovarian pregnancy (OP) and compare clinical features between OP and tubal pregnancy (TP) patients. Design Case–control study. Setting University hospital. Participants A case–control study was conducted from January 2005 to May 2014. Women diagnosed with OP were recruited as the case group (n=71), 145 women with TP and 146 with intrauterine pregnancy (IUP) were matched as controls at a ratio of 1:2:2. Women who refused interviews or provided incomplete information were excluded. Results OP risk was lower than TP risk in women with serological evidence of Chlamydia trachomatis infection (adjusted OR1 0.17, 95% CI 0.06 to 0.52), previous adnexal surgery (adjusted OR1 0.25, 95% CI 0.07 to 0.95), and current levonorgestrel emergency contraceptive use (adjusted OR1 0.24, 95% CI 0.07 to 0.78). In vitro fertilisation-embryo transfer (IVF-ET) carried a higher risk of OP (adjusted OR1 12.18, 95% CI 2.23 to 66.58) than natural conception. When Controlled by IUP women, current users of intrauterine devices (IUDs) carried a higher risk of OP than non-users of any contraceptives (adjusted OR2 9.60, 95% CI 1.76 to 42.20). β-Human chorionic gonadotropin (hCG) levels on the day of surgery were higher in OP patients than in TP patients (p<0.01). Women with OP were less likely to initially present with vaginal bleeding than those with TP (p=0.02). Moreover, shock (p=0.02), rupture (p<0.01), haemoperitoneum (p<0.01) and emergency laparotomy (p<0.01) were more common in the OP group than in the TP group. Conclusions IVF-ET and IUD use may be risk factors for OP, and OP patients tend to have high β-hCG levels and a poor clinical outcome (shock, rupture, haemoperitoneum and need for emergency laparotomy). Our findings may contribute to the prevention and early diagnosis of OP. PMID:25472658

  14. Self-hypnosis for intrapartum pain management in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness

    PubMed Central

    Downe, S; Finlayson, K; Melvin, C; Spiby, H; Ali, S; Diggle, P; Gyte, G; Hinder, S; Miller, V; Slade, P; Trepel, D; Weeks, A; Whorwell, P; Williamson, M

    2015-01-01

    Objective (Primary) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use. Design Multi-method randomised control trial (RCT). Setting Three NHS Trusts. Population Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness. Methods Randomisation at 28–32 weeks’ gestation to usual care, or to usual care plus brief self-hypnosis training (two × 90-minute groups at around 32 and 35 weeks’ gestation; daily audio self-hypnosis CD). Follow up at 2 and 6 weeks postnatal. Main outcome measures Primary: epidural analgesia. Secondary: associated clinical and psychological outcomes; cost analysis. Results Six hundred and eighty women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 [95% confidence interval (CI): 0.64–1.24], or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and 2 weeks post natal (anxiety: mean difference −0.72, 95% CI −1.16 to −0.28, P = 0.001); fear (mean difference −0.62, 95% CI −1.08 to −0.16, P = 0.009) [Correction added on 7 July 2015, after first online publication: ‘Mean difference’ replaced ‘Odds ratio (OR)’ in the preceding sentence.]. Postnatal response rates were 67% overall at 2 weeks. The additional cost in the intervention arm per woman was £4.83 (CI −£257.93 to £267.59). Conclusions Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women's anxiety and fear about childbirth needs further investigation. Tweetable abstract Going to 2 prenatal self-hypnosis groups didn't reduce labour epidural use but did

  15. Promising New Wart Treatment: A Randomized, Placebo-Controlled, Clinical Trial

    PubMed Central

    Zandi, Shokrollah; Ahmad Zadeh, Razyeh; Yousefi, Sayedeh Reyhaneh; Gharibi, Fardin

    2016-01-01

    Background Warts are common dermatological lesion caused by skin epithelial cells’ infection with human Papillomavirus (HPV). Objectives This study aimed to assess the efficacy of a new method for the treatment of dermal warts. Patients and Methods In this clinical trial study, 60 patients (older than 10 years) with dermal warts living in Baneh city, west of Iran, were allocated into the intervention and control groups using the block randomized method in 2012. In the intervention group, outer layers of the dermal wart carved using scalpel and HD tablet set on it and covered with adhesive. In the second and third days, it was repeated again. All stages in the intervention group were similar to the placebo group. Placebo was prepared by a pharmacologist, which was similar to the HD tablet. In both groups, patients were examined one week and one month after taking the last tablet by the physician in terms of improvement or lack of improvement. Data were analyzed by SPSS software version 18 using chi-square test, Fisher’s exact test, Mann-Whitney test and ANOVA for repeated measures. Results In the first week after the intervention, warts were changed in 93.3% of the cases; however, no changes were recorded in the control group. One month after follow-up, the mean was 0.4 ± 0.7 in the intervention group and 5.5 ± 4.9 in the control group (P = 0.0001). Based on ANOVA for repeated measures and t-test, the average number of warts, before, one week and one month after the intervention was statistically significant for both intervention (P = 0.009) and control groups (P = 0.0001). Conclusions This method is recommended for the treatment of dermal warts, owing to the effectiveness, short duration of treatment, and low cost of topical treatment for dermal warts using HD tablets. PMID:27761268

  16. Does the addition of specific acupuncture to standard swallowing training improve outcomes in patients with dysphagia after stroke? a randomized controlled trial

    PubMed Central

    Xia, Wenguang; Zheng, Chanjuan; Zhu, Suiqiang; Tang, Zhouping

    2015-01-01

    Objective: To assess the effect of adding acupuncture to standard swallowing training for patients with dysphagia after stroke. Design: Single-blind randomized controlled trial. Setting: Inpatient and outpatient clinics. Subjects: A total of 124 patients with dysphagia after stroke were randomly divided into two groups: acupuncture and control. Interventions: The acupuncture group received standard swallowing training and acupuncture treatment. In comparison, the control group only received standard swallowing training. Participants in both groups received six days of therapy per week for a four-week period. Main measures: The primary outcome measures included the Standardized Swallowing Assessment and the Dysphagia Outcome Severity Scale. The secondary outcome measures included the Modified Barthel Index and Swallowing-Related Quality of Life, which were assessed before and after the four-week therapy period. Results: A total of 120 dysphagic subjects completed the study (60 in acupuncture group and 60 in control group). Significant differences existed in the Standardized Swallowing Assessment, Dysphagia Outcome Severity Scale, Modified Barthel Index, and Swallowing-Related Quality of Life scores of each group after the treatment (P < 0.01). After the four-week treatment, the Standardized Swallowing Assessment (mean difference − 2.9; 95% confidence interval (CI) – 5.0 to − 0.81; P < 0.01), Dysphagia Outcome Severity Scale (mean difference 2.3; 95% CI 0.7 to 1.2; P < 0.01), Modified Barthel Index (mean difference 17.2; 95% CI 2.6 to 9.3; P < 0.05) and Swallowing-Related Quality of Life scores (mean difference 31.4; 95% CI 3.2 to 11.4; P < 0.01) showed more significant improvement in the acupuncture group than the control group. Conclusions: Acupuncture combined with the standard swallowing training may be beneficial for dysphagic patients after stroke. PMID:25819076

  17. Towards the synthesis of hydroxyapatite/protein scaffolds with controlled porosities: bulk and interfacial shear rheology of a hydroxyapatite suspension with protein additives.

    PubMed

    Maas, Michael; Bodnar, Pedro Marcus; Hess, Ulrike; Treccani, Laura; Rezwan, Kurosch

    2013-10-01

    The synthesis of porous hydroxyapatite scaffolds is essential for biomedical applications such as bone tissue engineering and replacement. One way to induce macroporosity, which is needed to support bone in-growth, is to use protein additives as foaming agents. Another reason to use protein additives is the potential to introduce a specific biofunctionality to the synthesized scaffolds. In this work, we study the rheological properties of a hydroxyapatite suspension system with additions of the proteins bovine serum albumin (BSA), lysozyme (LSZ) and fibrinogen (FIB). Both the rheology of the bulk phase as well as the interfacial shear rheology are studied. The bulk rheological data provides important information on the setting behavior of the thixotropic suspension, which we find to be faster with the addition of FIB and LSZ and much slower with BSA. Foam bubble stabilization mechanisms can be rationalized via interfacial shear rheology and we show that it depends on the growth of interfacial films at the suspension/air interface. These interfacial films support the stabilization of bubbles within the ceramic matrix and thereby introduce macropores. Due to the weak interaction of the protein molecules with the hydroxyapatite particles of the suspension, we find that BSA forms the most stable interfacial films, followed by FIB. LSZ strongly interacts with the hydroxyapatite particles and thus only forms thin films with very low elastic moduli. In summary, our study provides fundamental rheological insights which are essential for tailoring hydroxyapatite/protein suspensions in order to synthesize scaffolds with controlled porosities.

  18. A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials.

    PubMed

    Arandjelović, Ognjen

    2012-01-01

    It is well known that the outcome of an intervention is affected both by the inherent effects of the intervention and the patient's expectations. For this reason in comparative clinical trials an effort is made to conceal the nature of the administered intervention from the participants in the trial i.e. to blind the trial. Yet, in practice perfect blinding is impossible to ensure or even verify post hoc. The current clinical standard is to follow up the trial with an auxiliary questionnaire, which allows trial participants to express in closed form their belief concerning the intervention, i.e. trial group assignment (treatment or control). Auxiliary questionnaire responses are then used to compute the extent of blinding in the trial in the form of a blinding index. If the estimated extent of blinding exceeds a particular threshold the trial is deemed sufficiently blinded; otherwise, the strength of evidence of the trial is brought into question. This may necessitate that the trial is repeated. In this paper we make several contributions. Firstly, we identify a series of problems of the aforesaid clinical practice and discuss them in context of the most commonly used blinding indexes. Secondly, we formulate a novel approach for handling imperfectly blinded trials. We adopt a feedback questionnaire of the same form as that which is currently in use, but interpret the collected data using a novel statistical method, significantly different from that proposed in the previous work. Unlike the previously proposed approaches, our method is void of any ad hoc free parameters and robust to small changes in the participants' feedback responses. Our method also does not discard any data and is not predicated on any strong assumptions used to interpret participants' feedback. The key idea behind the present method is that it is meaningful to compare only the corresponding treatment and control participant sub-groups, that is, sub-groups matched by their auxiliary responses

  19. Ethnic differences in control of cardiovascular risk factors in patients with type 2 diabetes attending an Inner London diabetes clinic

    PubMed Central

    Chowdhury, T A; Lasker, S S; Mahfuz, R

    2006-01-01

    Background South Asians have higher risk of diabetic complications compared with white Europeans. The aim of this study was to compare management of cardiovascular risk factors between Bangladeshis and white Europeans. Methods A retrospective survey of all diabetic patients attending an Inner London hospital diabetic clinic over one year was undertaken. Data were obtained from the hospital diabetes database: presence of macrovascular (myocardial infarction, angina, stroke, transient ischaemic attack, cardiac intervention) and microvascular disease (neuropathy, retinopathy, and nephropathy), glycated haemoglobin, blood pressure, lipids, smoking, and body mass index (BMI) were all determined. Results A total of 1162 white European and 912 Bangladeshi patients with full data available were included in the analyses. The groups were equivalent in age, sex, duration of diabetes. Compared with white Europeans, Bangladeshis had more macrovascular disease (19.5% v 11.9% p<0.01), sight threatening retinopathy (7.2% v 3.8%, p<0.01), and nephropathy (15.3% v 9.1%, p<0.01). In addition, Bangladeshis had significantly more male smokers (28.1% v 22.1%, p<0.01), poorer glycaemic control (mean HbA1c 8.6% v 8.1%, p = 0.039), greater proportion with uncontrolled hypercholesterolaemia (total cholesterol >5.0 mmol/l, 31.6% v 26% p = 0.05), and poorer control of blood pressure (proportion with BP >140/80 mm Hg, 43.2% v 32.1%, p<0.01). Conclusions South Asians with type 2 diabetes have poorer glycaemic, blood pressure, and lipid control than white Europeans. The reasons for this are probably multifactorial. PMID:16517804

  20. The Effect of Lemon Inhalation Aromatherapy on Nausea and Vomiting of Pregnancy: A Double-Blinded, Randomized, Controlled Clinical Trial

    PubMed Central

    Yavari kia, Parisa; Safajou, Farzaneh; Shahnazi, Mahnaz; Nazemiyeh, Hossein

    2014-01-01

    Background: Nausea and vomiting of pregnancy are amongst the most common complaints that effects on both the physical and mental conditions of the pregnant women. Due to the increasing tendency of women to use herbal medications during pregnancy, the effect of lemon inhalation aromatherapy on nausea and vomiting of pregnancy was investigated in this study. Objectives: The aim of this study was to determine the effect of lemon inhalation aromatherapy on nausea and vomiting during pregnancy. Materials and Methods: This was a randomized clinical trial in which 100 pregnant women with nausea and vomiting who had eligibility criteria were randomly divided into intervention and control groups based on four- and six-random block sampling method. Lemon essential oil and placebo were given to the intervention and control groups, respectively, to inhale it as soon as they felt nausea. The nausea, vomiting, and retch intensity were investigated 24 hours before and during the four days of treatment by means of PUQE-24 (24-hour Pregnancy Unique Quantification of Emesis). Results: There was a statistically significant difference between the two groups in the mean scores of nausea and vomiting on the second and fourth days (P = 0.017 and P = 0.039, respectively). The means of nausea and vomiting intensity in the second and fourth days in the intervention group were significantly lower than the control group. In addition, in intragroup comparison with ANOVA with repeated measures, the nausea and vomiting mean in the five intervals, showed a statistically significant difference in each group (P < 0.001 and P = 0.049, respectively). Conclusions: Lemon scent can be effective in reducing nausea and vomiting of pregnancy. PMID:24829772

  1. Bingel-Hirsch addition on non-isolated-pentagon-rule Gd3N@C2n (2n = 82 and 84) metallofullerenes: products under kinetic control.

    PubMed

    Alegret, Núria; Salvadó, Patricia; Rodríguez-Fortea, Antonio; Poblet, Josep M

    2013-10-01

    Bingel-Hirsch reactions on fullerenes take place under kinetic control. We here predict, by means of DFT methodology, the products of the Bingel-Hirsch addition on non-isolated-pentagon-rule (non-IPR) metallofullerenes Gd3N@C2n (2n = 82, 84), as modeled by closed-shell Y3N@C2n systems. Adducts on [6,6] B-type bonds placed near the pentalene unit are predicted for the two cages, as found for other non-IPR endohedral fullerenes such as Sc3N@C68.

  2. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

    PubMed

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-03-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

  3. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

    PubMed Central

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-01-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

  4. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

    PubMed

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-03-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

  5. Virtual Reality for Enhanced Ecological Validity and Experimental Control in the Clinical, Affective and Social Neurosciences.

    PubMed

    Parsons, Thomas D

    2015-01-01

    An essential tension can be found between researchers interested in ecological validity and those concerned with maintaining experimental control. Research in the human neurosciences often involves the use of simple and static stimuli lacking many of the potentially important aspects of real world activities and interactions. While this research is valuable, there is a growing interest in the human neurosciences to use cues about target states in the real world via multimodal scenarios that involve visual, semantic, and prosodic information. These scenarios should include dynamic stimuli presented concurrently or serially in a manner that allows researchers to assess the integrative processes carried out by perceivers over time. Furthermore, there is growing interest in contextually embedded stimuli that can constrain participant interpretations of cues about a target's internal states. Virtual reality environments proffer assessment paradigms that combine the experimental control of laboratory measures with emotionally engaging background narratives to enhance affective experience and social interactions. The present review highlights the potential of virtual reality environments for enhanced ecological validity in the clinical, affective, and social neurosciences.

  6. Clinical consultations in an aboriginal community-controlled health service: a comparison with general practice.

    PubMed

    Thomas, D P; Heller, R F; Hunt, J M

    1998-02-01

    Clinical consultation at Danila Dilba, an Aboriginal community-controlled health service in Darwin, were compared with consultations in Australian general practice. We described 583 consultations, using a questionnaire based on the International Classification of Primary Care. The methods were similar to those of the Australian Morbidity and Treatment Survey (AMTS) of consultations in Australian general practice undertaken by the University of Sydney Family Medicine Research Unit. Compared with Australian general practice consultations, consultations with Danila Dilba were more complex: more young patients, more new patients, more home visits, more problems managed, more new problems and more consultations leading to emergency hospital admission. Skin infections, diabetes mellitus, chronic alcohol abuse, rheumatic heart disease (or rheumatic fever) and chronic suppurative otitis media were much more commonly managed at study consultations at Danila Dilba than at consultations with general practitioners in the AMTS. Nearly all patients saw an Aboriginal health worker first, and nearly half the consultations were with Aboriginal health workers alone. The results suggest possible limitations of fee-for-item Medicare funding of Aboriginal community-controlled health services compared with existing block grant funding. PMID:9599858

  7. Virtual Reality for Enhanced Ecological Validity and Experimental Control in the Clinical, Affective and Social Neurosciences

    PubMed Central

    Parsons, Thomas D.

    2015-01-01

    An essential tension can be found between researchers interested in ecological validity and those concerned with maintaining experimental control. Research in the human neurosciences often involves the use of simple and static stimuli lacking many of the potentially important aspects of real world activities and interactions. While this research is valuable, there is a growing interest in the human neurosciences to use cues about target states in the real world via multimodal scenarios that involve visual, semantic, and prosodic information. These scenarios should include dynamic stimuli presented concurrently or serially in a manner that allows researchers to assess the integrative processes carried out by perceivers over time. Furthermore, there is growing interest in contextually embedded stimuli that can constrain participant interpretations of cues about a target’s internal states. Virtual reality environments proffer assessment paradigms that combine the experimental control of laboratory measures with emotionally engaging background narratives to enhance affective experience and social interactions. The present review highlights the potential of virtual reality environments for enhanced ecological validity in the clinical, affective, and social neurosciences. PMID:26696869

  8. Alpha lipoic acid efficacy in burning mouth syndrome. A controlled clinical trial

    PubMed Central

    Palacios-Sánchez, Begoña; Cerero-Lapiedra, Rocío; Llamas-Martínez, Silvia; Esparza-Gómez, Germán

    2015-01-01

    Background A double-blind placebo-controlled trial was conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease. Material and Methods 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with follow up of 2 months. Results 64% of ALA patients reported some level of improvement, with a level of maintenance of 68.75% one month after treatment. 27.6% of the placebo group also demonstrated some reduction in BMS symptoms. Conclusions Long-term evolution and the intensity of symptoms are variables that reduce the probability of improvement with ALA treatment. Key words: Burning mouth syndrome, neuropathy, alpha lipoic acid. PMID:26034927

  9. Clinical study of yoga techniques in university students with asthma: a controlled study.

    PubMed

    Vedanthan, P K; Kesavalu, L N; Murthy, K C; Duvall, K; Hall, M J; Baker, S; Nagarathna, S

    1998-01-01

    Adult asthmatics, ranging from 19 to 52 years from an asthma and allergy clinic in a university setting volunteered to participate in the study. The 17 students were randomly divided into yoga (9 subjects) and nonyoga control (8 subjects) groups. The yoga group was taught a set of breathing and relaxation techniques including breath slowing exercises (pranayama), physical postures (yogasanas), and meditation. Yoga techniques were taught at the university health center, three times a week for 16 weeks. All the subjects in both groups maintained daily symptom and medication diaries, collected A.M. and P.M. peak flow readings, and completed weekly questionnaires. Spirometry was performed on each subject every week. Analysis of the data showed that the subjects in the yoga group reported a significant degree of relaxation, positive attitude, and better yoga exercise tolerance. There was also a tendency toward lesser usage of beta adrenergic inhalers. The pulmonary functions did not vary significantly between yoga and control groups. Yoga techniques seem beneficial as an adjunct to the medical management of asthma.

  10. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    PubMed Central

    Ferreira, Luciano Ambrosio; Grossmann, Eduardo; Januzzi, Eduardo; Gonçalves, Rafael Tardin Rosa Ferraz; Mares, Fernando Antonio Guedes; de Paula, Marcos Vinicius Queiroz; Carvalho, Antonio Carlos Pires

    2015-01-01

    Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p < 0.05). However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term. PMID:26351510

  11. Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Myocardial infarction causes irreversible loss of cardiomyocytes and may lead to loss of ventricular function, morbidity and mortality. Infarct size is a major prognostic factor and reduction of infarct size has therefore been an important objective of strategies to improve outcomes. In experimental studies, glucagon-like peptide 1 and exenatide, a long acting glucagon-like peptide 1 receptor agonist, a novel drug introduced for the treatment of type 2 diabetes, reduced infarct size after myocardial infarction by activating pro-survival pathways and by increasing metabolic efficiency. Methods The EXAMI trial is a multi-center, prospective, randomized, placebo controlled trial, designed to evaluate clinical outcome of exenatide infusion on top of standard treatment, in patients with an acute myocardial infarction, successfully treated with primary percutaneous coronary intervention. A total of 108 patients will be randomized to exenatide (5 μg bolus in 30 minutes followed by continuous infusion of 20 μg/24 h for 72 h) or placebo treatment. The primary end point of the study is myocardial infarct size (measured using magnetic resonance imaging with delayed enhancement at 4 months) as a percentage of the area at risk (measured using T2 weighted images at 3-7 days). Discussion If the current study demonstrates cardioprotective effects, exenatide may constitute a novel therapeutic option to reduce infarct size and preserve cardiac function in adjunction to reperfusion therapy in patients with acute myocardial infarction. Trial registration ClinicalTrials.gov: NCT01254123 PMID:22067476

  12. Local bupivacaine for postoperative pain management in thyroidectomized patients: A prospective and controlled clinical study

    PubMed Central

    Dumlu, Ersin Gürkan; Tokaç, Mehmet; Öcal, Haydar; Durak, Doğukan; Kara, Halil; Kılıç, Mehmet; Yalçın, Abdussamed

    2016-01-01

    Objective We aimed to evaluate the effect of bupivacaine and to compare the routes of administration of bupivacaine in the management of postoperative incision site pain after thyroidectomy. Material and Methods Consecutive patients who were planned for thyroidectomy surgery were randomized into three groups of 30 patients each: Group 1 (control group): standard thyroidectomy surgery without additional intervention; Group 2 (paratracheal infiltration with bupivacaine): following thyroidectomy, 0.25% bupivacaine was applied on the surgical area; Group 3 (subcutaneous infiltration with bupivacaine): following thyroidectomy, 0.25% bupivacaine was injected into the cutaneous, subcutaneous region and fascia of the surgical area. Postoperative pain was evaluated by a visual analog scale (VAS) at 1st, 4th, and 12th hours after thyroidectomy. Total daily requirement for additional analgesia was recorded. Results The mean age of 90 patients was 44.37±13.42 years, and the female:male ratio was 62:28. There was no difference between study groups in terms of age, thyroid volume, TSH and T4 levels. VAS score of patients in paratracheal infiltration with bupivacaine group was significantly lower than control group patients at 1st, 4th and 12th hours following thyroidectomy (p=0.030, p=0.033, p=0.039, respectively). The need for analgesics was significantly lower in both paratracheal infiltration and subcutaneous infiltration groups than the control group (86.7%, 83.0%, and 73.3%, respectively, p=0.049). Conclusions Intraoperative local bupivacaine application is effective in decreasing postoperative pain in patients with thyroidectomy. PMID:27528810

  13. A comparative, randomized, controlled study on clinical efficacy and dental staining reduction of a mouthwash containing Chlorhexidine 0.20% and Anti Discoloration System (ADS)

    PubMed Central

    Marrelli, Massimo; Amantea, Massimiliano; Tatullo, Marco

    2015-01-01

    Summary Introduction A good control of bacterial plaque is an essential factor for the success of periodontal therapy, therefore it is the main objective that the clinician together with the patient must get to have a healthy periodontium. The plaque control with mouthwashes is the most important home therapy as it helps to reduce the formation of plaque between the mechanical removal with a toothbrush. Aim Authors analyzed the clinical data from a trial carried out with 3 different mouthwashes containing 0.2% Chlorhexidine (CHX). In addition, the ADS (Anti Discoloration System - Curaden Healthcare) was tested in comparison with the other mouthwashes without this system. Materials and methods We tested antiplaque activity showed by 3 of the most commercialized mouthwashes, moreover, we tested the ability in reducing the dental staining related to the oral assumption of Chlorhexidine. Discussion and conclusion Our results demonstrated the clinical efficacy of the 3 mouthwashes with CHX. Particularly performing was the anti discoloration system (Curaden Healthcare), with a clinical detection of dental stainings significantly less than the others tested. This study demonstrated the clinical efficacy of ADS system in the reduction of tooth staining, without a loss of antiplaque activity with respect to the competing mouthwashes containing CHX. PMID:26330902

  14. The clinical use of Kampo medicines (traditional Japanese herbal treatments) for controlling cancer patients’ symptoms in Japan: a national cross-sectional survey

    PubMed Central

    2012-01-01

    Background Kampo medicines are traditional Japanese medicines produced from medicinal plants and herbs. Even though the efficacy of Kampo medicines for controlling cancer-related symptoms is being reported, their actual nationwide clinical use has not been comprehensively investigated. We aimed to investigate physicians’ recognition of Kampo medicines and their clinical use for cancer patients in the field of palliative care. Methods A cross-sectional self-administered anonymous questionnaire was distributed to 549 physicians working in palliative care teams at 388 core cancer treatment hospitals and 161 certified medical institutions that have palliative care units (PCUs). Results Valid responses were obtained from 311 physicians (response rate, 56.7%) who were evenly distributed throughout the country without significant geographical biases. Kampo medicines were prescribed for controlling cancer-related symptoms by 64.3% of the physicians. The symptoms treated with Kampo medicines were numbness/hypoesthesia (n = 99, 49.5%), constipation (n = 76, 38.0%), anorexia/weight loss (n = 72, 36%), muscle cramps (n = 71, 35.5%) and languor/fatigue (n = 64, 32.0%). Regarding open issues about prescription, 60.7% (n = 173) of the physicians raised the issue that the dosage forms need to be better devised. Conclusions To increase the clinical use of Kampo medicines, more evidence from clinical studies is necessary. In addition, their mechanisms of action should be clarified through laboratory studies. PMID:23167528

  15. Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

    PubMed Central

    Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

    2016-01-01

    Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

  16. Clinical features of kidney cancer in primary care: a case-control study using primary care records

    PubMed Central

    Shephard, Elizabeth; Neal, Richard; Rose, Peter; Walter, Fiona; Hamilton, William T

    2013-01-01

    Background Kidney cancer accounts for over 4000 UK deaths annually, and is one of the cancer sites with a poor mortality record compared with Europe. Aim To identify and quantify all clinical features of kidney cancer in primary care. Design Case-control study, using General Practice Research Database records. Method A total of 3149 patients aged ≥40 years, diagnosed with kidney cancer between 2000 and 2009, and 14 091 age, sex and practice-matched controls, were selected. Clinical features associated with kidney cancer were identified, and analysed using conditional logistic regression. Positive predictive values for features of kidney cancer were estimated. Results Cases consulted more frequently than controls in the year before diagnosis: median 16 consultations (interquartile range 10–25) versus 8 (4–15): P<0.001. Fifteen features were independently associated with kidney cancer: visible haematuria, odds ratio 37 (95% confidence interval [CI] = 28 to 49), abdominal pain 2.8 (95% CI = 2.4 to 3.4), microcytosis 2.6 (95% CI = 1.9 to 3.4), raised inflammatory markers 2.4 (95% CI = 2.1 to 2.8), thrombocytosis 2.2 (95% CI = 1.7 to 2.7), low haemoglobin 1.9 (95% CI = 1.6 to 2.2), urinary tract infection 1.8 (95% CI = 1.5 to 2.1), nausea 1.8 (95% CI = 1.4 to 2.3), raised creatinine 1.7 (95% CI = 1.5 to 2.0), leukocytosis 1.5 (95% CI = 1.2 to 1.9), fatigue 1.5 (95% CI = 1.2 to 1.9), constipation 1.4 (95% CI = 1.1 to 1.7), back pain 1.4 (95% CI = 1.2 to 1.7), abnormal liver function 1.3 (95% CI = 1.2 to 1.5), and raised blood sugar 1.2 (95% CI = 1.1 to 1.4). The positive predictive value for visible haematuria in patients aged ≥60 years was 1.0% (95% CI = 0.8 to 1.3). Conclusion Visible haematuria is the commonest and most powerful single predictor of kidney cancer, and the risk rises when additional symptoms are present. When considered alongside the risk of bladder cancer, the overall risk of urinary tract cancer from haematuria warrants referral. PMID:23540481

  17. THE ROLE OF METABOLIC SURGERY FOR PATIENTS WITH OBESITY GRADE I AND TYPE 2 DIABETES NOT CONTROLLED CLINICALLY

    PubMed Central

    CAMPOS, Josemberg; RAMOS, Almino; SZEGO, Thomaz; ZILBERSTEIN, Bruno; FEITOSA, Heládio; COHEN, Ricardo

    2016-01-01

    ABSTRACT Introduction Even considering the advance of the medical treatment in the last 20 years with new and more effective drugs, the outcomes are still disappointing as the control of obesity and type 2 Diabetes Mellitus (T2DM) with a large number of patients under the medical treatment still not reaching the desired outcomes. Objective: To present a Metabolic Risk Score to better guide the surgical indication for T2DM patients with body mass index (BMI) where surgery for obesity is still controversial. Method: Research was conducted in Pubmed, Medline, Pubmed Central, Scielo and Lilacs between 2003-2015 correlating headings: metabolic surgery, obesity and type 2 diabetes mellitus. In addition, representatives of the societies involved, as an expert panel, issued opinions. Results: Forty-five related articles were analyzed by evidence-based medicine criteria. Grouped opinions sought to answer the following questions: Why metabolic and not bariatric surgery?; Mechanisms involved in glycemic control; BMI as a single criterion for surgical indication for uncontrolled T2DM; Results of metabolic surgery studies in BMI<35 kg/m2; Safety of metabolic surgery in patients with BMI<35 kg/m2; Long-term effects of surgery in patients with baseline BMI<35 kg/m2 and Proposal for a Metabolic Risk Score. Conclusion: Metabolic surgery has well-defined mechanisms of action both in experimental and human studies. Gastrointestinal interventions in T2DM patients with IMC≤35 kg/m2 has similar safety and efficacy when compared to groups with greater BMIs, leading to the improvement of diabetes in a superior manner than clinical treatment and lifestyle changes, in part through weight loss independent mechanisms . There is no correlation between baseline BMI and weight loss in the long term with the success rate after any surgical treatment. Gastrointestinal surgery treatment may be an option for patients with T2DM without adequate clinical control, with a BMI between 30 and 35, after

  18. Single Nucleotide Polymorphisms in Regulator-Encoding Genes Have an Additive Effect on Virulence Gene Expression in a Vibrio cholerae Clinical Isolate.

    PubMed

    Carignan, Bailey M; Brumfield, Kyle D; Son, Mike S

    2016-01-01

    Vibrio cholerae is the etiological agent of the infectious disease cholera, which is characterized by vomiting and severe watery diarrhea. Recently, V. cholerae clinical isolates have demonstrated increased virulence capabilities, causing more severe symptoms with a much higher rate of disease progression than previously observed. We have identified single nucleotide polymorphisms (SNPs) in four virulence-regulatory genes (hapR, hns, luxO, and vieA) of a hypervirulent V. cholerae clinical isolate, MQ1795. Herein, all SNPs and SNP combinations of interest were introduced into the prototypical El Tor reference strain N16961, and the effects on the production of numerous virulence-related factors, including cholera toxin (CT), the toxin-coregulated pilus (TCP), and ToxT, were analyzed. Our data show that triple-SNP (hapR hns luxO and hns luxO vieA) and quadruple-SNP combinations produced the greatest increases in CT, TCP, and ToxT production. The hns and hns luxO SNP combinations were sufficient for increased TCP and ToxT production. Notably, the hns luxO vieA triple-SNP combination strain produced TCP and ToxT levels similar to those of MQ1795. Certain SNP combinations (hapR and hapR vieA) had the opposite effect on CT, TCP, and ToxT expression. Interestingly, the hns vieA double-SNP combination strain increased TCP production while decreasing CT production. Our findings suggest that SNPs identified in the four regulatory genes, in various combinations, are associated with increased virulence capabilities observed in V. cholerae clinical isolates. These studies provide insight into the evolution of highly virulent strains. IMPORTANCE Cholera, an infectious disease of the small intestine caused by the aquatic bacterium Vibrio cholerae, often results in vomiting and acute watery diarrhea. If left untreated or if the response is too slow, the symptoms can quickly lead to extreme dehydration and ultimately death of the patient. Recent anecdotal evidence of cholera

  19. Single Nucleotide Polymorphisms in Regulator-Encoding Genes Have an Additive Effect on Virulence Gene Expression in a Vibrio cholerae Clinical Isolate

    PubMed Central

    Carignan, Bailey M.; Brumfield, Kyle D.

    2016-01-01

    ABSTRACT Vibrio cholerae is the etiological agent of the infectious disease cholera, which is characterized by vomiting and severe watery diarrhea. Recently, V. cholerae clinical isolates have demonstrated increased virulence capabilities, causing more severe symptoms with a much higher rate of disease progression than previously observed. We have identified single nucleotide polymorphisms (SNPs) in four virulence-regulatory genes (hapR, hns, luxO, and vieA) of a hypervirulent V. cholerae clinical isolate, MQ1795. Herein, all SNPs and SNP combinations of interest were introduced into the prototypical El Tor reference strain N16961, and the effects on the production of numerous virulence-related factors, including cholera toxin (CT), the toxin-coregulated pilus (TCP), and ToxT, were analyzed. Our data show that triple-SNP (hapR hns luxO and hns luxO vieA) and quadruple-SNP combinations produced the greatest increases in CT, TCP, and ToxT production. The hns and hns luxO SNP combinations were sufficient for increased TCP and ToxT production. Notably, the hns luxO vieA triple-SNP combination strain produced TCP and ToxT levels similar to those of MQ1795. Certain SNP combinations (hapR and hapR vieA) had the opposite effect on CT, TCP, and ToxT expression. Interestingly, the hns vieA double-SNP combination strain increased TCP production while decreasing CT production. Our findings suggest that SNPs identified in the four regulatory genes, in various combinations, are associated with increased virulence capabilities observed in V. cholerae clinical isolates. These studies provide insight into the evolution of highly virulent strains. IMPORTANCE Cholera, an infectious disease of the small intestine caused by the aquatic bacterium Vibrio cholerae, often results in vomiting and acute watery diarrhea. If left untreated or if the response is too slow, the symptoms can quickly lead to extreme dehydration and ultimately death of the patient. Recent anecdotal evidence of

  20. Single Nucleotide Polymorphisms in Regulator-Encoding Genes Have an Additive Effect on Virulence Gene Expression in a Vibrio cholerae Clinical Isolate

    PubMed Central

    Carignan, Bailey M.; Brumfield, Kyle D.

    2016-01-01

    ABSTRACT Vibrio cholerae is the etiological agent of the infectious disease cholera, which is characterized by vomiting and severe watery diarrhea. Recently, V. cholerae clinical isolates have demonstrated increased virulence capabilities, causing more severe symptoms with a much higher rate of disease progression than previously observed. We have identified single nucleotide polymorphisms (SNPs) in four virulence-regulatory genes (hapR, hns, luxO, and vieA) of a hypervirulent V. cholerae clinical isolate, MQ1795. Herein, all SNPs and SNP combinations of interest were introduced into the prototypical El Tor reference strain N16961, and the effects on the production of numerous virulence-related factors, including cholera toxin (CT), the toxin-coregulated pilus (TCP), and ToxT, were analyzed. Our data show that triple-SNP (hapR hns luxO and hns luxO vieA) and quadruple-SNP combinations produced the greatest increases in CT, TCP, and ToxT production. The hns and hns luxO SNP combinations were sufficient for increased TCP and ToxT production. Notably, the hns luxO vieA triple-SNP combination strain produced TCP and ToxT levels similar to those of MQ1795. Certain SNP combinations (hapR and hapR vieA) had the opposite effect on CT, TCP, and ToxT expression. Interestingly, the hns vieA double-SNP combination strain increased TCP production while decreasing CT production. Our findings suggest that SNPs identified in the four regulatory genes, in various combinations, are associated with increased virulence capabilities observed in V. cholerae clinical isolates. These studies provide insight into the evolution of highly virulent strains. IMPORTANCE Cholera, an infectious disease of the small intestine caused by the aquatic bacterium Vibrio cholerae, often results in vomiting and acute watery diarrhea. If left untreated or if the response is too slow, the symptoms can quickly lead to extreme dehydration and ultimately death of the patient. Recent anecdotal evidence of

  1. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy: a randomised, double-blind, placebo-controlled clinical trial

    PubMed Central

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    2012-01-01

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN or placebo patch in combination with eccentric squats on a decline board. Measurements were performed at baseline, 6, 12 and 24 weeks. Primary outcome measure was the Victorian Institute of Sports Assessment-Patella (VISA-P) questionnaire. Secondary outcome measures were patient satisfaction and pain scores during sports. Generalised estimated equation was used to analyse the treatment, time and treatment×time effect. Analyses were performed following the intention-to-treat principle. Results VISA-P scores for both groups improved over the study period to 75.0±16.2 and 80.7±22.1 at 24 weeks. Results showed a significant effect for time (p<0.01) but no effect for treatment×time (p=0.80). Mean Visual Analogue Scores pain scores during sports for both groups increased over the study period to 6.6±3 and 7.8±3.1. Results showed a significant effect for time (p<0.01) but no effect for treatment×time (p=0.38). Patient satisfaction showed no difference between GTN and placebo groups (p=0.25) after 24 weeks, but did show a significant difference over time (p=0.01). Three patients in the GTN group reported some rash. Conclusion It seems that continuous topical GTN treatment in addition to an eccentric exercise programme does not improve clinical outcome compared to placebo patches and an eccentric exercise programme in patients with chronic patellar tendinopathy. PMID:22930695

  2. Bifunctional heterogeneous catalysis of silica-alumina-supported tertiary amines with controlled acid-base interactions for efficient 1,4-addition reactions.

    PubMed

    Motokura, Ken; Tanaka, Satoka; Tada, Mizuki; Iwasawa, Yasuhiro

    2009-10-19

    We report the first tunable bifunctional surface of silica-alumina-supported tertiary amines (SA-NEt(2)) active for catalytic 1,4-addition reactions of nitroalkanes and thiols to electron-deficient alkenes. The 1,4-addition reaction of nitroalkanes to electron-deficient alkenes is one of the most useful carbon-carbon bond-forming reactions and applicable toward a wide range of organic syntheses. The reaction between nitroethane and methyl vinyl ketone scarcely proceeded with either SA or homogeneous amines, and a mixture of SA and amines showed very low catalytic activity. In addition, undesirable side reactions occurred in the case of a strong base like sodium ethoxide employed as a catalytic reagent. Only the present SA-supported amine (SA-NEt(2)) catalyst enabled selective formation of a double-alkylated product without promotions of side reactions such as an intramolecular cyclization reaction. The heterogeneous SA-NEt(2) catalyst was easily recovered from the reaction mixture by simple filtration and reusable with retention of its catalytic activity and selectivity. Furthermore, the SA-NEt(2) catalyst system was applicable to the addition reaction of other nitroalkanes and thiols to various electron-deficient alkenes. The solid-state magic-angle spinning (MAS) NMR spectroscopic analyses, including variable-contact-time (13)C cross-polarization (CP)/MAS NMR spectroscopy, revealed that acid-base interactions between surface acid sites and immobilized amines can be controlled by pretreatment of SA at different temperatures. The catalytic activities for these addition reactions were strongly affected by the surface acid-base interactions.

  3. Clinical and social determinants of diarrhoeal disease in a rural HIV/AIDS clinic, South Africa: a case-control study.

    PubMed

    Moshabela, M; MacPherson, P; Ezard, N; Frean, E; Mashimbye, L; Elliott, J H; Oldenburg, B

    2012-05-01

    Diarrhoeal diseases are a common cause of morbidity and are associated with mortality in HIV-infected populations. Little is known about the contribution of clinical and socio-environmental factors to the risk of diarrhoea in these populations in rural sub-Saharan Africa. We conducted a case-control study of people attending a rural HIV clinic with an episode of diarrhoea in Bushbuckridge, South Africa. Cases were defined as HIV-positive adults with symptoms of diarrhoea before or after initiation of antiretroviral therapy (ART). Controls without diarrhoea were randomly selected from clinic attendees. Structured questionnaires and case-file reviews were undertaken to describe clinical and socioenvironmental risk factors. We recruited 103 cases of diarrhoea from 121 patients meeting case definitions. Cases were more likely to be women (P = 0.013), aged over 45 years (P = 0.002), divorced or separated (P = 0.006), have limited formal education (P = 0.003), have inadequate access to sanitation facilities (P = 0.045), have water access limited to less than three days per week (P = 0.032) and not yet initiated on ART (P < 0.001). In multivariate analysis, diarrhoea remained associated with female gender (adjusted odds ratio [aOR]: 2.02, 95% CI 1.10-3.73), older age (aOR: 6.31, 95% CI 1.50-26.50), limited access to water (aOR: 2.66, 95% CI 1.32-5.35) and pre-ART status (aOR: 5.87, 95% CI 3.05-11.27). Clinical and socio-environmental factors are associated with occurrence of diarrhoeal disease among rural HIV patients in South Africa. Further intervention research is urgently needed, combining community- and clinic-based approaches, to improve access to water, sanitation and ART for rural areas with high HIV prevalence, along with structural interventions to address gender inequities.

  4. Donor-derived West Nile virus infection in solid organ transplant recipients: report of four additional cases and review of clinical, diagnostic, and therapeutic features.

    PubMed

    Winston, Drew J; Vikram, Holenarasipur R; Rabe, Ingrid B; Dhillon, Gundeep; Mulligan, David; Hong, Johnny C; Busuttil, Ronald W; Nowicki, Marek J; Mone, Thomas; Civen, Rachel; Tecle, Selam A; Trivedi, Kavita K; Hocevar, Susan N

    2014-05-15

    We describe four solid-organ transplant recipients with donor-derived West Nile virus (WNV) infection (encephalitis 3, asymptomatic 1) from a common donor residing in a region of increased WNV activity. All four transplant recipients had molecular evidence of WNV infection in their serum and/or cerebrospinal fluid (CSF) by reverse transcription polymerase chain reaction (RT-PCR) testing. Serum from the organ donor was positive for WNV IgM but negative for WNV RNA, whereas his lymph node and spleen tissues tested positive for WNV by RT-PCR. Combination therapy included intravenous immunoglobulin (4 cases), interferon (3 cases), fresh frozen plasma with WNV IgG (2 cases), and ribavirin (1 case). Two of the four transplant recipients survived.Review of the 20 published cases of organ-derived WNV infection found that this infection is associated with a high incidence of neuroinvasive disease (70%) and severe morbidity and mortality (30%). Median time to onset of symptomatic WNV infection was 13 days after transplantation (range 5-37 days). Initial unexplained fever unresponsive to antibiotic therapy followed by rapid onset of neurologic deficits was the most common clinical presentation. Confirmation of infection was made by testing serum and CSF for both WNV RNA by RT-PCR and WNV IgM by serological assays. Treatment usually included supportive care, reduction of immunosuppression, and frequent intravenous immunoglobulin. The often negative results for WNV by current RT-PCR and serological assays and the absence of clinical signs of acute infection in donors contribute to the sporadic occurrence of donor-derived WNV infection. Potential organ donors should be assessed for unexplained fever and neurological symptoms, particularly if they reside in areas of increased WNV activity.

  5. Clinical Evaluation of the Use of a Multifunctional Remotely Controlled Insulin Pump

    PubMed Central

    Pinget, Michel; Lachgar, Karim; Parkin, Christopher G.; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-01-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system’s advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. PMID:25107708

  6. Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

    PubMed Central

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2015-01-01

    Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

  7. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial.

    PubMed

    El-Gammal, Mona Y; Salem, Ahmed S; Anees, Mohamed M; Tawfik, Mohamed A

    2016-04-01

    Immediate loading of dental implants in situations where low bone density exist, such as the posterior maxillary region, became possible recently after the introduction of biomimetic agents. This 1-year preliminary clinical trial was carried out to clinically and radiographically evaluate immediate-loaded 1-piece implants with local application of melatonin in the osteotomy site as a biomimetic material. 14 patients with missing maxillary premolars were randomized to receive 14 implants of 1-piece type that were subjected to immediate loading after 2 weeks of initial placement. Group I included 7 implants with acid-etched surface while group II included 7 implants with acid-etched surface combined with local application of melatonin gel at the osteotomy site. Patients were recalled for follow up at 1, 3, 6, and 12 months after loading. All implants were considered successful after 12 months of follow-up. Significant difference (P < 0.05) was found between both groups at 1 month of implant loading when considering the implant stability. At 1 and 3 months there were significant differences in the marginal bone level between the 2 groups. These results suggest that the local application of melatonin at the osteotomy site is associated with good stability and minimal bone resorption. However, more studies for longer follow-up periods are required to confirm the effect of melatonin hormone on osseointegration of dental implants.

  8. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade.

    PubMed

    Flohr-Madsen, S; Ytrebø, L M; Valen, K; Wilsgaard, T; Klaastad, Ø

    2016-08-01

    Some surgeons believe that infraclavicular brachial plexus blocks tends to result in supination of the hand/forearm, which may make surgical access to the dorsum of the hand more difficult. We hypothesised that this supination may be reduced by the addition of a suprascapular nerve block. In a double-blind, randomised, placebo-controlled study, our primary outcome measure was the amount of supination (as assessed by wrist angulation) 30 min after infraclavicular brachial plexus block, with (suprascapular group) or without (control group) a supplementary suprascapular block. All blocks were ultrasound-guided. The secondary outcome measure was an assessment by the surgeon of the intra-operative position of the hand. Considering only patients with successful nerve blocks, mean (SD) wrist angulation was lower (33 (27) vs. 61 (44) degrees; p = 0.018) and assessment of the hand position was better (11/11 vs. 6/11 rated as 'good'; p = 0.04) in the suprascapular group. The addition of a suprascapular nerve block to an infraclavicular brachial plexus block can provide a better hand/forearm position for dorsal hand surgery. PMID:27396247

  9. Is telephone counselling a useful addition to physician advice and nicotine replacement therapy in helping patients to stop smoking? A randomized controlled trial

    PubMed Central

    Reid, R D; Pipe, A; Dafoe, W A

    1999-01-01

    BACKGROUND: The authors evaluated the incremental efficacy of telephone counselling by a nurse in addition to physician advice and nicotine replacement therapy in helping patients to stop smoking. METHODS: The trial was conducted at the University of Ottawa Heart Institute. A total of 396 volunteers who smoked 15 or more cigarettes daily were randomly assigned to either of 2 groups: usual care (control group) and usual care plus telephone counselling (intervention group); the groups were stratified by sex and degree of nicotine dependence. Usual care involved the receipt of physician advice on 3 occasions, self-help materials and 12 weeks of nicotine replacement therapy. Telephone counselling was provided by a nurse at 2, 6 and 13 weeks after the target quit date. Point-prevalent quit rates were determined at 52 weeks after the target quit date. RESULTS: The point-prevalent quit rates at 52 weeks did not differ significantly between the control and intervention groups (24.1% v. 23.4% respectively). The quit rates did not differ significantly at the secondary measurement points of 4, 12 and 26 weeks. INTERPRETATION: Brief physician assistance, along with nicotine replacement therapy, can help well-motivated smokers to quit. Three additional sessions of telephone counselling by a nurse were ineffective in increasing quit rates. This form of assistance may be useful in the absence of physician advice or when self-selected by patients. PMID:10373999

  10. Randomized controlled clinical trial of 2 types of hydroxyapatite-coated implants on moderate periodontitis patients

    PubMed Central

    2016-01-01

    Purpose The aim of this study was to compare and analyze the peri-implant tissue conditions and prospective clinical outcomes associated with 2 types of hydroxyapatite (HA)-coated implants: (1) fully HA-coated implants and (2) partially HA-coated implants with resorbable blast medium on the coronal portion of the threads. Methods Forty-four partially edentulous patients were randomly assigned to undergo the placement of 62 HA-coated implants, and were classified as the control group (partially HA-coated, n=30) and the test group (fully HA-coated, n=32). All patients had chronic periodontitis with moderate crestal bone loss around the edentulous area. The stability and clinical outcomes of the implants were evaluated using the primary and secondary implant stability quotient (ISQ), as well as radiographic, mobility, and peri-implant soft tissue assessments around the implants. The Wilcoxon signed-rank test and the Mann-Whitney test were used to evaluate differences between and within the 2 groups, with P values <0.05 considered to indicate statistical significance. Results The fully HA-coated implants displayed good retention of crestal bone, and insignificant differences were found in annual marginal bone loss between the 2 types of HA-coated implants (P>0.05). No significant differences were found in the survival rate (group I, 100%; group II, 100%) or the success rate (group I, 93.3%; group II, 93.8%). The fully HA-coated implants also did not significantly increase the risk of peri-implantitis (P>0.05). Conclusions The fully HA-coated implants did not lead to an increased risk of peri-implantitis and showed good retention of the crestal bone, as well as good survival and success rates. Our study suggests that fully HA-coated implants could become a reliable treatment alternative for edentulous posterior sites and are capable of providing good retention of the crestal bone. PMID:27800216

  11. Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Methods for ATMP Release.

    PubMed

    Radrizzani, Marina; Soncin, Sabrina; Lo Cicero, Viviana; Andriolo, Gabriella; Bolis, Sara; Turchetto, Lucia

    2016-01-01

    Mesenchymal stromal/stem cells (MSC) are promising candidates for the development of cell-based therapies for various diseases and are currently being evaluated in a number of clinical trials (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014). MSC for therapeutic applications are classified as advanced therapy medicinal products (ATMP) (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004) and must be prepared according to good manufacturing practices ( http://ec.europa.eu/health/documents/eudralex/vol-4 ). They may be derived from different starting materials (mainly bone marrow (BM), adipose tissue, or cord blood) and applied as fresh or cryopreserved products, in the autologous as well as an allogeneic context (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014; Sensebé and Bourin, Transplantation 87(9 Suppl):S49-S53, 2009). In any case, they require an approved and well-defined panel of assays in order to be released for clinical use.This chapter describes analytical methods implemented and performed in our cell factory as part of the release strategy for an ATMP consisting of frozen autologous BM-derived MSC. Such methods are designed to assess the safety (sterility, endotoxin, and mycoplasma assays) and identity/potency (cell count and viability, immunophenotype and clonogenic assay) of the final product. Some assays are also applied to the biological starting material (sterility) or carried out as in-process controls (sterility, cell count and viability, immunophenotype, clonogenic assay).The validation strategy for each analytical method is described in the accompanying Chapter 20 .

  12. Hyperproteic hypocaloric enteral nutrition in the critically ill patient: A randomized controlled clinical trial

    PubMed Central

    Rugeles, Saúl-Javier; Rueda, Juan-David; Díaz, Carlos-Eduardo; Rosselli, Diego

    2013-01-01

    Introduction: Our aim was to evaluate the impact of hyperproteic hypocaloric enteral feeding on clinical outcomes in critically ill patients, particularly on severity of organic failure measured with the Sequential Organ Failure Assessment (SOFA). Materials and Methods: In a double blind clinical trial, 80 critically ill adult patients were randomized to hyperproteic hypocaloric or to isocaloric enteral nutrition; all patients completed follow-up of at least 4 days. Prescribed caloric intake was: Hyperproteic hypocaloric enteral nutrition (15 kcal/kg with 1.7 g/kg of protein) or isocaloric enteral nutrition (25 kcal/kg with 20% of the calories as protein). The main outcome was the differences in delta SOFA at 48 h. Secondary outcomes were intensive care unit (ICU) length of stay, days on ventilator, hyperglycemic events, and insulin requirements. Results: There were no differences in SOFA score at baseline (7.5 (standard deviation (SD) 2.9) vs 6.7 (SD 2.5) P = 0.17). The total amount of calories delivered was similarly low in both groups (12 kcal/kg in intervention group vs 14 kcal/kg in controls), but proteic delivery was significantly different (1.4 vs 0.76 g/kg, respectively P ≤ 0.0001). The intervention group showed an improvement in SOFA score at 48 h (delta SOFA 1.7 (SD 1.9) vs 0.7 (SD 2.8) P = 0.04) and less hyperglycemic episodes per day (1.0 (SD 1.3) vs 1.7 (SD 2.5) P = 0.017). Discussion: Enteral hyperproteic hypocaloric nutrition therapy could be associated with a decrease in multiple organ failure measured with SOFA score. We also found decreased hyperglycemia and a trend towards less mechanical ventilation days and ICU length of stay. PMID:24501485

  13. Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Methods for ATMP Release.

    PubMed

    Radrizzani, Marina; Soncin, Sabrina; Lo Cicero, Viviana; Andriolo, Gabriella; Bolis, Sara; Turchetto, Lucia

    2016-01-01

    Mesenchymal stromal/stem cells (MSC) are promising candidates for the development of cell-based therapies for various diseases and are currently being evaluated in a number of clinical trials (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014). MSC for therapeutic applications are classified as advanced therapy medicinal products (ATMP) (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004) and must be prepared according to good manufacturing practices ( http://ec.europa.eu/health/documents/eudralex/vol-4 ). They may be derived from different starting materials (mainly bone marrow (BM), adipose tissue, or cord blood) and applied as fresh or cryopreserved products, in the autologous as well as an allogeneic context (Sharma et al., Transfusion 54:1418-1437, 2014; Ikebe and Suzuki, Biomed Res Int 2014:951512, 2014; Sensebé and Bourin, Transplantation 87(9 Suppl):S49-S53, 2009). In any case, they require an approved and well-defined panel of assays in order to be released for clinical use.This chapter describes analytical methods implemented and performed in our cell factory as part of the release strategy for an ATMP consisting of frozen autologous BM-derived MSC. Such methods are designed to assess the safety (sterility, endotoxin, and mycoplasma assays) and identity/potency (cell count and viability, immunophenotype and clonogenic assay) of the final product. Some assays are also applied to the biological starting material (sterility) or carried out as in-process controls (sterility, cell count and viability, immunophenotype, clonogenic assay).The validation strategy for each analytical method is described in the accompanying Chapter 20 . PMID:27236681

  14. The effect of thyme honey nasal spray on chronic rhinosinusitis: a double-blind randomized controlled clinical trial.

    PubMed

    Hashemian, Farnaz; Baghbanian, Neda; Majd, Zahra; Rouini, Mohammad-Reza; Jahanshahi, Javaneh; Hashemian, Farshad

    2015-06-01

    Chronic rhinosinusitis is a common disease which causes persisting inflammatory conditions of one or more sinuses. This study was designed to evaluate the effect of thyme honey nasal spray as an adjunctive medication on chronic rhinosinusitis after functional endoscopic sinus surgery. This was a randomized, placebo controlled, double-blind clinical study. 64 patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery were enrolled in this study. Patients were randomized and blinded to receive either placebo or thyme honey nasal spray in addition to the standard regimen postoperatively. Patients were visited on postoperative days 7, 30 and 60. The sino-nasal outcome test, endoscopic grading system and sinus CT-scan were scored before operation and on the day 60 after surgery. 54 patients completed the study. Significant improvement was observed in both treatment groups. There were no significant changes in SNOT-22, endoscopy and CT-scan scores between the two study groups. However, a greater reduction in endoscopic scores was shown in thyme honey group. The incidence of adverse effects was not significantly different between the groups, but synechiae formation and epistaxis were lower in treatment group. Thyme honey nasal spray seems to be a low-priced potential adjuvant remedy with excellent safety profile, to reduce inflammation and polyp formation and also fostering mucosal healing for patients suffering from chronic rhinosinusitis. However, further studies are recommended.

  15. Quality control guidelines for National Committee for Clinical Laboratory Standards recommended broth macrodilution testing of amphotericin B, fluconazole, and flucytosine.

    PubMed Central

    Pfaller, M A; Bale, M; Buschelman, B; Lancaster, M; Espinel-Ingroff, A; Rex, J H; Rinaldi, M G; Cooper, C R; McGinnis, M R

    1995-01-01

    Amphotericin B, fluconazole, and flucytosine (5FC) were tested in a multilaboratory study to establish quality control (QC) guidelines for yeast antifungal susceptibility testing. Ten candidate QC strains were tested in accordance with National Committee for Clinical Laboratory Standards M27-P guidelines against the three antifungal agents in each of six laboratories. Each laboratory was assigned a unique lot of RPMI 1640 broth medium as well as a lot of RPMI 1640 common to all of the laboratories. The candidate QC strains were tested 20 times each against the three antifungal agents in both unique and common lots of RPMI 1640. A minimum of 220 MICs per drug per organism were generated during the study. Overall, 95% of the MICs of amphotericin B, fluconazole, and 5FC fell within the desired 3 log2-dilution range (mode +/- 1 log2 dilution). Excellent performance with all three drugs was observed for Candida parapsilosis ATCC 22019 and C. krusei ATCC 6258. With these strains, on-scale 3 log2-dilution ranges encompassing 96 to 99% of the MICs of all three drugs were established. These two strains are recommended for QC testing of amphotericin B, fluconazole, and 5FC. Reference ranges were also established for an additional four strains for use in method development and for training. Four strains failed to perform adequately for recommendation as either QC or reference strains. PMID:7615713

  16. Moxifloxacin versus Clindamycin/Ceftriaxone in the management of odontogenic maxillofacial infectious processes: A preliminary, intrahospital, controlled clinical trial

    PubMed Central

    Gómez-Arámbula, Hansel; Hidalgo-Hurtado, Antonio; Rodríguez-Flores, Rosaura; González-Amaro, Ana-María; Garrocho-Rangel, Arturo

    2015-01-01

    Background The aim of this study was to compare the days of hospitalization length between patients treated with Moxifloxacin with that of patients treated with a Clindamycin/Ceftriaxone combination and additionally, to isolate and identify the oral pathogens involved in orofacial odontogenic infections. Material and Methods A pilot-controlled-clinical-trial was carried out on hospitalized patients with cervicofacial odontogenic abscesses or cellulitis, who were randomly asigned to two study groups: 1) patients who received Moxifloxacin, and 2) patients receiving Clindamycin/Ceftriaxone combination. Infiltrate samples were collected through transdermic or transmucosal punction and later cultured on a media specific for aerobic and anaerobic microorganisms. Mean hospitalization duration in days until hospital discharge and susceptibility assessment in rates were established. Results Mean hospitalization time in days of patients treated with Moxifloxacin was 7.0 ± 1.6 days, while in the Clindamycin/Ceftriaxone group, this was 8.4 ± 1.8 days, although significant difference could not be demonstrated (p=0.074). A total of 43 strains were isolated, all of these Gram-positive. These strains appeared to be highly sensitive to Moxifloxacin (97.5%) and Ceftriaxone (92.5%). Conclusions Moxifloxacin and Ceftriaxone appear to be potential convenient and rational alternatives to traditional antibiotics, for treating severe odontogenic infections, in conjunction with surgical extraoral incision, debridement, and drainage. Key words:Orofacial odontogenic infections, antimicrobial susceptibility, antimicrobial resistance. PMID:26644841

  17. Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

    PubMed Central

    Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

    2015-01-01

    Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

  18. Neuro-hormonal control of food intake: basic mechanisms and clinical implications.

    PubMed

    Konturek, P C; Konturek, J W; Cześnikiewicz-Guzik, M; Brzozowski, T; Sito, E; Konturek, S J

    2005-12-01

    Obesity is one of the most common metabolic diseases and the greatest threats of the health because of possibility of numerous complications. In order to design effective drugs or apply the helpful surgical procedure it is essential to understand physiology of appetite control and pathophysiology of obesity. According to the first law of thermodynamics, the energy input in the form of food, equals energy expenditure through exercise, basal metabolism, thermogenesis and fat biosynthesis. The control of body weight actually concerns the control of adipose tissue with the key role of hypothalamus, possessing several neuronal centers such as that in lateral hypothalamic nuclei considered to be "hunger" center and in ventromedial nuclei serving as the "satiety" center. In addition, paraventricular and arcuate hypothalamic nuclei (ARC) are the sites where multiple hormones, released from the gut and adipose tissue, converge to regulate food intake and energy expenditure. There are two distinct types of neurons in ARC that are important in control of food intake; (1) preopiomelanocortin (POMC) neurons activated by an orexigenic hormones and releasing alpha-melanocyte-stimulating hormone (alpha-MSH) in satiety center and (2) neurons activated by orexigenic peptides such as ghrelin that release the substances including neuropeptide Y (NPY) and Agouti-Related Peptide (AgRP) in hunger center. ARC integrates neural (mostly vagal) and humoral inputs such as enteropeptides including orexigenic (ghrelin and orexins) and an orexigenic peptides (cholecystokinin, polypeptide YY, glucagon-like peptide-1, oxyntomodulin, leptin and others) that exert a physiological role in regulating appetite and satiety. The peripherally (gut, adipose tissue) and centrally expressed modulators of appetitive behavior act through specific receptors in the afferent (mostly vagal) nerves and hypothalamic neurons implicated in adiposity signaling and regulation of food intake.

  19. Meal replacements and fibre supplement as a strategy for weight loss. Proprietary PGX® meal replaceme