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Sample records for 6-mo randomized controlled

  1. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: A 6-mo randomized, controlled trial

    DEFF Research Database (Denmark)

    Due, Anette; Larsen, Thomas M; Mu, Huiling;

    2008-01-01

    BACKGROUND: The optimal dietary content and type of fat and carbohydrate for weight management has been debated for decades. OBJECTIVE: The objective was to compare the effects of 3 ad libitum diets on the maintenance of an initial weight loss of >or=8% and risk factors for CVD and diabetes during...... as monounsaturated fatty acids (MUFA diet; n = 54), to a low-fat (20-30% of energy) diet (LF diet; n = 51), or to a control diet (35% of energy as fat; n = 26). Protein constituted 10-20% of energy in all 3 diets. All foods were provided free of charge from a purpose-built supermarket. RESULTS: More subjects dropped...... a 6-mo controlled dietary intervention. DESIGN: Nondiabetic overweight or obese [mean +/- SD body mass index (in kg/m(2)): 31.5 +/- 2.6] men (n = 55) and women (n = 76) aged 28.2 +/- 4.8 y were randomly assigned to a diet providing a moderate amount of fat (35-45% of energy) and >20% of fat...

  2. Small-quantity, lipid-based nutrient supplements provided to women during pregnancy and 6 mo postpartum and to their infants from 6 mo of age increase the mean attained length of 18-mo-old children in semi-urban Ghana: a randomized controlled trial12

    Science.gov (United States)

    Arimond, Mary; Vosti, Stephen; Dewey, Kathryn G

    2016-01-01

    Background: Childhood stunting usually begins in utero and continues after birth; therefore, its reduction must involve actions across different stages of early life. Objective: We evaluated the efficacy of small-quantity, lipid-based nutrient supplements (SQ-LNSs) provided during pregnancy, lactation, and infancy on attained size by 18 mo of age. Design: In this partially double-blind, individually randomized trial, 1320 women at ≤20 wk of gestation received standard iron and folic acid (IFA group), multiple micronutrients (MMN group), or SQ-LNS (LNS group) daily until delivery, and then placebo, MMNs, or SQ-LNS, respectively, for 6 mo postpartum; infants in the LNS group received SQ-LNS formulated for infants from 6 to 18 mo of age (endline). The primary outcome was child length by 18 mo of age. Results: At endline, data were available for 85% of 1228 infants enrolled; overall mean length and length-for-age z score (LAZ) were 79.3 cm and −0.83, respectively, and 12% of the children were stunted (LAZ supplement provided at enrollment, stunting prevalences were 8.9% compared with 15.1% and 11.5%, respectively (P = 0.045). Conclusion: Provision of SQ-LNSs to women from pregnancy to 6 mo postpartum and to their infants from 6 to 18 mo of age may increase the child’s attained length by age 18 mo in similar settings. This trial was registered at clinicaltrials.gov as NCT00970866. PMID:27534634

  3. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets

    DEFF Research Database (Denmark)

    Due, Anette; Larsen, Thomas M; Hermansen, Kjeld;

    2008-01-01

    BACKGROUND: The effect of dietary fat and carbohydrate on glucose metabolism has been debated for decades. OBJECTIVE: The objective was to compare the effect of 3 ad libitum diets, different in type and amount of fat and carbohydrate, on insulin resistance and glucose tolerance subsequent to weight...... in monounsaturated fatty acids ( > 20% of energy); 2) LF diet (n = 18): low-fat diet (20-30% of energy), and 3) control diet (n = 12): 35% of energy as fat ( > 15% of energy as saturated fatty acids). Protein accounted for 15% of energy in all 3 diets. A 2-h oral-glucose-tolerance test (OGTT) was performed before......, in the Matsudas index, in body weight, or in body composition. CONCLUSION: A diet high in monounsaturated fat has a more favorable effect on glucose homeostasis than does the typical Western diet in the short term and may also be more beneficial than the official recommended low-fat diet during a period of weight...

  4. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  5. A weight-loss program adapted to the menstrual cycle increases weight loss in healthy, overweight, premenopausal women: a 6-mo randomized controlled trial

    DEFF Research Database (Denmark)

    Geiker, Nina Rica Wium; Ritz, Christian; Pedersen, Sue D;

    2016-01-01

    . Conclusion: A differentiated diet and exercise program that is tailored to counteract food cravings and metabolic changes throughout the menstrual cycle may increase weight loss above that achieved with a traditional diet and exercise program in women who can comply with the program. This trial...

  6. Mechanical alloying of biocompatible Co-28Cr-6Mo alloy.

    Science.gov (United States)

    Sánchez-De Jesús, F; Bolarín-Miró, A M; Torres-Villaseñor, G; Cortés-Escobedo, C A; Betancourt-Cantera, J A

    2010-07-01

    We report on an alternative route for the synthesis of crystalline Co-28Cr-6Mo alloy, which could be used for surgical implants. Co, Cr and Mo elemental powders, mixed in an adequate weight relation according to ISO Standard 58342-4 (ISO, 1996), were used for the mechanical alloying (MA) of nano-structured Co-alloy. The process was carried out at room temperature in a shaker mixer mill using hardened steel balls and vials as milling media, with a 1:8 ball:powder weight ratio. Crystalline structure characterization of milled powders was carried out by X-ray diffraction in order to analyze the phase transformations as a function of milling time. The aim of this work was to evaluate the alloying mechanism involved in the mechanical alloying of Co-28Cr-6Mo alloy. The evolution of the phase transformations with milling time is reported for each mixture. Results showed that the resultant alloy is a Co-alpha solid solution, successfully obtained by mechanical alloying after a total of 10 h of milling time: first Cr and Mo are mechanically prealloyed for 7 h, and then Co is mixed in for 3 h. In addition, different methods of premixing were studied. The particle size of the powders is reduced with increasing milling time, reaching about 5 mum at 10 h; a longer time promotes the formation of aggregates. The morphology and crystal structure of milled powders as a function of milling time were analyzed by scanning electron microscopy and XR diffraction. PMID:20364362

  7. A New Family of Ce6MoO15 as Fast Oxide Ion Conductor

    Institute of Scientific and Technical Information of China (English)

    Feng Jing; Meng Jian; Bo Qibing; Che Ping; Wang Jingping; Liu Jianfen; Lu Minfeng; Zhang Deping; Fang Daqing; Cao Xueqiang

    2004-01-01

    A novel solid solution Ce6MoO15 was achieved. Their structure and oxide ionic conductivity were studied.Based on Ce6MoO15, rare earth element substitution on cerium site shows that all resulting oxides enhance the conductivity further, and have high oxide-ion conductivity, which may be a kind of promising material for SOFCs.

  8. Dynamic Output Feedback Control for Nonlinear Networked Control Systems with Random Packet Dropout and Random Delay

    Directory of Open Access Journals (Sweden)

    Shuiqing Yu

    2013-01-01

    Full Text Available This paper investigates the dynamic output feedback control for nonlinear networked control systems with both random packet dropout and random delay. Random packet dropout and random delay are modeled as two independent random variables. An observer-based dynamic output feedback controller is designed based upon the Lyapunov theory. The quantitative relationship of the dropout rate, transition probability matrix, and nonlinear level is derived by solving a set of linear matrix inequalities. Finally, an example is presented to illustrate the effectiveness of the proposed method.

  9. Randomized control of open quantum systems

    CERN Document Server

    Viola, L

    2006-01-01

    The problem of open-loop dynamical control of generic open quantum systems is addressed. In particular, I focus on the task of effectively switching off environmental couplings responsible for unwanted decoherence and dissipation effects. After revisiting the standard framework for dynamical decoupling via deterministic controls, I describe a different approach whereby the controller intentionally acquires a random component. An explicit error bound on worst-case performance of stochastic decoupling is presented.

  10. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J;

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...

  11. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

    Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

  12. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  13. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  14. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    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. Random transitions and cell cycle control.

    Science.gov (United States)

    Brooks, R F

    1981-01-01

    Differences between the cycle times of sister cells are exponentially distributed, which means that these differences can be explained entirely by the existence of a single critical step in the cell cycle which occurs at random. Cycle times as a whole are not exponentially distributed, indicating an additional source of variation in the cell cycle. It follows that this additional variation must affect sister cells identically; ie, sister cell cycle times are correlated. This correlation and the overall distribution of cycle times can be predicted quantitatively by a model that was developed initially in order to explain certain problematic features of the response of quiescent cells to mitogenic stimulation - in particular, the significance of the lag that almost invariably occurs between stimulation and the onset of DNA synthesis. This model proposes that each cell cycle depends not on one but two random transitions, one of which (at reasonably high growth rates) occurs in the mother cell, its effects being inherited equally by the two daughter cells. The fundamental timing element in the cell cycle is proposed to be a lengthy process, called L, which accounts for most of the lag on mitogenic stimulation and also for the minimum cycle time in growing cultures. One of the random transitions is concerned with the initiation of L, whereas the other becomes possible on completion of L. The latter transition has two consequences: the first is the initiation of a sequence of events which includes S, G2 and M; the second is the restoration of the state from which L may be initiated once more. As a result, L may begin (at random) at any stage of the conventional cycle, ie, S, G2, M, or G1. There are marked similarities between the hypothetical process L and the biogenesis of mitotic centres - the structures responsible for organising the spindle poles. PMID:7312875

  16. A study of corrosion electrochemical properties of martensite-austenite steel Cr15Ni6Mo

    Energy Technology Data Exchange (ETDEWEB)

    Cihal, V.; Hubackova, J.; Kubelka, J.; Mezanec, K.

    1985-11-01

    The steel Cr15Ni6Mo (UHB 119) exhibits a very satisfactory corrosion resistance. However, its superior passivating ability depends on the heat treatment method used. The use of two-step tempering leads primarily to an improved resistance to reactivation and optimum properties are achieved when the basic matrix contains about 40% stable austenite in fine form. This structural state requires the use of tempering temperatures from 625 to 650/sup 0/C in Step 1, and 525/sup 0/C in Step 2 of tempering.

  17. Risks and Benefits of Nalmefene in the Treatment of Adult Alcohol Dependence: A Systematic Literature Review and Meta-Analysis of Published and Unpublished Double-Blind Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Clément Palpacuer

    2015-12-01

    Full Text Available Nalmefene is a recent option in alcohol dependence treatment. Its approval was controversial. We conducted a systematic review and meta-analysis of the aggregated data (registered as PROSPERO 2014:CRD42014014853 to compare the harm/benefit of nalmefene versus placebo or active comparator in this indication.Three reviewers searched for published and unpublished studies in Medline, the Cochrane Library, Embase, ClinicalTrials.gov, Current Controlled Trials, and bibliographies and by mailing pharmaceutical companies, the European Medicines Agency (EMA, and the US Food and Drug Administration. Double-blind randomized clinical trials evaluating nalmefene to treat adult alcohol dependence, irrespective of the comparator, were included if they reported (1 health outcomes (mortality, accidents/injuries, quality of life, somatic complications, (2 alcohol consumption outcomes, (3 biological outcomes, or (4 treatment safety outcomes, at 6 mo and/or 1 y. Three authors independently screened the titles and abstracts of the trials identified. Relevant trials were evaluated in full text. The reviewers independently assessed the included trials for methodological quality using the Cochrane Collaboration tool for assessing risk of bias. On the basis of the I2 index or the Cochrane's Q test, fixed or random effect models were used to estimate risk ratios (RRs, mean differences (MDs, or standardized mean differences (SMDs with 95% CIs. In sensitivity analyses, outcomes for participants who were lost to follow-up were included using baseline observation carried forward (BOCF; for binary measures, patients lost to follow-up were considered equal to failures (i.e., non-assessed patients were recorded as not having responded in both groups. Five randomized controlled trials (RCTs versus placebo, with a total of 2,567 randomized participants, were included in the main analysis. None of these studies was performed in the specific population defined by the EMA approval

  18. Synthesis and Crystal Structure of [Ca(DMF)6][Mo6Br8Cl6

    Institute of Scientific and Technical Information of China (English)

    LIU Xi; CAI Li-Zhen; GUO Guo-Cong; LI Qiang; HUANG Jin-Shun

    2006-01-01

    The reaction of MoBr2 with CaCl2 in DMF (N, N'-dimethylformamide) gives the cluster complex [Ca(DMF)6][Mo6Br8Cl6] 1 by using standard Schlenk techniques. This cluster complex crystallizes in triclinic, space group (P1) with a = 10.329(4), b = 10.349(4), c = 12.510(5) (A), α = 103.793(5), β = 98.562(3), γ = 98.268(5)°, V = 1261.5(9)(A)3, Dc = 2.509 g/cm3, Z = 1, C18H42Br8CaCl6Mo6N6O6, Mr = 1906.28, μ = 8.236 mm-1, λ(MoKα) = 0.71073(A)and F(000) = 894. The final R = 0.0589 and wR = 0.1458 for 2759 observed reflections with I > 2σ(I). The structure is composed of isolated octahedral coordination cations and discrete cluster anions, and these two kinds of ions connect each other to form a 3-D framework with similar packing patterns as CsCl through weak C-H…X (X = Br, Cl) hydrogen bonds.

  19. Cognitive rehabilitation in patients with gliomas : a randomized, controlled trial

    NARCIS (Netherlands)

    Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H.; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K

    2009-01-01

    PURPOSE: Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients

  20. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  1. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  2. Random Access Game and Medium Access Control Design

    OpenAIRE

    Chen, Lijun; Low, Steven H.; Doyle, John C.

    2010-01-01

    Motivated partially by a control-theoretic viewpoint, we propose a game-theoretic model, called random access game, for contention control. We characterize Nash equilibria of random access games, study their dynamics, and propose distributed algorithms (strategy evolutions) to achieve Nash equilibria. This provides a general analytical framework that is capable of modeling a large class of system-wide quality-of-service (QoS) models via the specification of per-node util...

  3. Modeling of Random Delays in Networked Control Systems

    Directory of Open Access Journals (Sweden)

    Yuan Ge

    2013-01-01

    Full Text Available In networked control systems (NCSs, the presence of communication networks in control loops causes many imperfections such as random delays, packet losses, multipacket transmission, and packet disordering. In fact, random delays are usually the most important problems and challenges in NCSs because, to some extent, other problems are often caused by random delays. In order to compensate for random delays which may lead to performance degradation and instability of NCSs, it is necessary to establish the mathematical model of random delays before compensation. In this paper, four major delay models are surveyed including constant delay model, mutually independent stochastic delay model, Markov chain model, and hidden Markov model. In each delay model, some promising compensation methods of delays are also addressed.

  4. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

    Directory of Open Access Journals (Sweden)

    SOFIA VON HUMBOLDT

    2013-01-01

    Full Text Available El objetivo del estudio que se informa fue ex- plorar si una intervención individual de terapia centrada en la persona (TCP en personas adul- tas mayores puede promover su sentido de cohe- rencia, en comparación con un grupo control (lista de espera. Se plantea que los participantes asignados al azar a TCP informarían mejoras en SDC de pre y post-intervención en comparación con el grupo control. Un grupo de 87 participantes de 65 a 86 años (M = 72.4; DE = 5.15 fue evaluado con la Escala de Sentido de Coherencia (ESDC y el cuestio- nario sociodemográfico en tres momentos dife- rentes: al inicio del estudio (t1, post-tratamiento (t2 y a los 12 meses de seguimiento (t3. Los resultados indicaron que los participan- tes en TCP evidenciaron un aumento significa- tivo en cuanto a su SDC (16.7%, mientras que en el grupo control se encontró una disminu- ción significativa (-2.7%, entre el inicio del es- tudio y el momento de seguimiento. El tamaño del efecto en el grupo TCP fue alto (η2p = .776. En concreto, tanto en la post-intervención como en el momento del seguimiento, los participan- tes que se sometieron a TCP tenían un SDC sig- nificativamente mayor (M = 3.84, DE = .219 Se encontraron diferencias significativas entre el grupo de intervención y el grupo control en la post-intervención y en el seguimiento. Se concluye que los cambios en SDC fueron positivos y mantenidos, por lo tanto, los resul- tados sugieren que la TCP es favorable a la me- jora de SDC. Por otra parte, ya que la SDC se asocia con el bienestar relacionado con la salud de las poblaciones de mayor edad, hay que en- fatizar el desarrollo de SDC en la vejez.

  5. Retinal vessels caliber changes after strabismus surgery: results of 6mo follow-up

    Science.gov (United States)

    Li, Ji-Peng; Fu, Jing; Zhou, Jin-Qiong; Wang, Xiao-Zhen; Wang, Wen-Ying; Liu, Ning-Pu

    2016-01-01

    AIM To evaluate the effect of strabismus surgery on retinal vessels calibers with digital color fundus photographs. METHODS Two hundred consecutive strabismus patients underwent surgery, and 118 patients (female/male, 55/63) who finished 6-month follow-up were finally included in this study. Optic disc-centered digital color fundus photographs of both eyes of all patients were taken prior to surgery and 6mo post surgery. The retinal vascular caliber of 116 operated eyes were measured using the computer program IVAN. The operated eyes were divided into 3 groups according to the surgical methods, recession of one muscle, one muscle recession and one muscle folding, one muscle resection and one muscle recession. The effect of number of altered muscles on retinal vessels was analyzed using statistic software SPSS 16.0. RESULTS The mean age was 12.4±8.6y. Averaged central retinal artery equivalent (CRAE) of all patients was 120.31±23.02 µm preoperatively, and 122.87±15.93 µm six months after surgery. Averaged central retinal vein equivalent (CRVE) was 171.11±31.73 µm preoperatively and 175.02±21.00 µm postoperatively. There was no significant difference of averaged CRAE (P=0.22) or CRVE (P=0.19) before and after operation. Averaged arteriole to venule ratio (AVR) was 0.71±0.07 before surgery and 0.70±0.07 after surgery. Comparison of preoperative and postoperative retinal vessels calibers among different surgical groups did not show significant differences. Also, there was no advantage of rectus muscle folding to muscle resection. CONCLUSION Up to 6mo after strabismus surgery, the retinal vascular calibers were not altered. No more than two muscles in one surgery are safe for retinal perfusion. PMID:27672600

  6. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    , agility, endurance, and sensor-motoric reaction. A population of 12 elderly (average age: 79) with balancing problems (DGI average score: 18.7) was randomly assigned to control group or tiles training group, and tested before and after intervention. The tiles training group had statistical significant...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...

  7. Multiple input/output random vibration control system

    Science.gov (United States)

    Unruh, James F.

    1988-01-01

    A multi-input/output random vibration control algorithm was developed based on system identification concepts derived from random vibration spectral analysis theory. The unique features of the algorithm are: (1) the number of input excitors and the number of output control responses need not be identical; (2) the system inverse response matrix is obtained directly from the input/output spectral matrix; and (3) the system inverse response matrix is updated every control loop cycle to accommodate system amplitude nonlinearities. A laboratory demonstration case of two imputs with three outputs is presented to demonstrate the system capabilities.

  8. Taming random lasers through active spatial control of the pump.

    Science.gov (United States)

    Bachelard, N; Andreasen, J; Gigan, S; Sebbah, P

    2012-07-20

    Active control of the spatial pump profile is proposed to exercise control over random laser emission. We demonstrate numerically the selection of any desired lasing mode from the emission spectrum. An iterative optimization method is employed, first in the regime of strong scattering where modes are spatially localized and can be easily selected using local pumping. Remarkably, this method works efficiently even in the weakly scattering regime, where strong spatial overlap of the modes precludes spatial selectivity. A complex optimized pump profile is found, which selects the desired lasing mode at the expense of others, thus demonstrating the potential of pump shaping for robust and controllable single mode operation of a random laser.

  9. Taming random lasers through active spatial control of the pump

    CERN Document Server

    Bachelard, Nicolas; Gigan, Sylvain; Sebbah, Patrick

    2012-01-01

    Active control of the pump spatial profile is proposed to exercise control over random laser emission. We demonstrate numerically the selection of any desired lasing mode from the emission spectrum. An iterative optimization method is employed, first in the regime of strong scattering where modes are spatially localized and can be easily selected using local pumping. Remarkably, this method works efficiently even in the weakly scattering regime, where strong spatial overlap of the modes precludes spatial selectivity. A complex optimized pump profile is found, which selects the desired lasing mode at the expense of others, thus demonstrating the potential of pump shaping for robust and controllable singlemode operation of a random laser.

  10. Randomized algorithms in automatic control and data mining

    CERN Document Server

    Granichin, Oleg; Toledano-Kitai, Dvora

    2015-01-01

    In the fields of data mining and control, the huge amount of unstructured data and the presence of uncertainty in system descriptions have always been critical issues. The book Randomized Algorithms in Automatic Control and Data Mining introduces the readers to the fundamentals of randomized algorithm applications in data mining (especially clustering) and in automatic control synthesis. The methods proposed in this book guarantee that the computational complexity of classical algorithms and the conservativeness of standard robust control techniques will be reduced. It is shown that when a problem requires "brute force" in selecting among options, algorithms based on random selection of alternatives offer good results with certain probability for a restricted time and significantly reduce the volume of operations.

  11. Sub-threshold micro-pulse diode laser treatment in diabetic macular edema: A Meta-analysis of randomized controlled trials

    Science.gov (United States)

    Qiao, Gang; Guo, Hai-Ke; Dai, Yan; Wang, Xiao-Li; Meng, Qian-Li; Li, Hui; Chen, Xiang-Hui; Chen, Zhong-Lun

    2016-01-01

    AIM To examine possible differences in clinical outcomes between sub-threshold micro-pulse diode laser photocoagulation (SDM) and traditional modified Early Treatment Diabetic Retinopathy Study (mETDRS) treatment protocol in diabetic macular edema (DME). METHODS A comprehensive literature search using the Cochrane Collaboration methodology to identify RCTs comparing SDM with mETDRS for DME. The participants were type I or type II diabetes mellitus with clinically significant macular edema treated by SDM from previously reported randomized controlled trials (RCTs). The primary outcome measures were the changes in the best corrected visual acuity (BCVA) and the central macular thickness (CMT) as measured by optical coherence tomography (OCT). The secondary outcomes were the contrast sensitivity and the damages of the retina. RESULTS Seven studies were identified and analyzed for comparing SDM (215 eyes) with mETDRS (210 eyes) for DME. There were no statistical differences in the BCVA after treatment between the SDM and mETDRS based on the follow-up: 3mo (MD, -0.02; 95% CI, -0.12 to 0.09; P=0.77), 6mo (MD, -0.02; 95% CI, -0.12 to 0.09; P=0.75), 12mo (MD, -0.05; 95% CI, -0.17 to 0.07; P=0.40). Likewise, there were no statistical differences in the CMT after treatment between the SDM and mETDRS in 3mo (MD, -9.92; 95% CI, -28.69 to 8.85; P=0.30), 6mo (MD, -11.37; 95% CI, -29.65 to 6.91; P=0.22), 12mo (MD, 8.44; 95% CI, -29.89 to 46.77; P=0.67). Three RCTs suggested that SDM laser results in good preservation of contrast sensitivity as mETDRS, in two different follow-up evaluations: 3mo (MD, 0.05; 95% CI, 0 to 0.09; P=0.04) and 6mo (MD, 0.02; 95% CI, -0.10 to 0.14; P=0.78). Two RCTs showed that the SDM laser treatment did less retinal damage than that mETDRS did (OR, 0.05; 95% CI, 0.02 to 0.13; P<0.01). CONCLUSION SDM laser photocoagulation shows an equally good effect on visual acuity, contrast sensitivity, and reduction of DME as compared to conventional mETDRS protocol

  12. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  13. Clonal Selection Algorithm Based Iterative Learning Control with Random Disturbance

    Directory of Open Access Journals (Sweden)

    Yuanyuan Ju

    2013-01-01

    Full Text Available Clonal selection algorithm is improved and proposed as a method to solve optimization problems in iterative learning control. And a clonal selection algorithm based optimal iterative learning control algorithm with random disturbance is proposed. In the algorithm, at the same time, the size of the search space is decreased and the convergence speed of the algorithm is increased. In addition a model modifying device is used in the algorithm to cope with the uncertainty in the plant model. In addition a model is used in the algorithm cope with the uncertainty in the plant model. Simulations show that the convergence speed is satisfactory regardless of whether or not the plant model is precise nonlinear plants. The simulation test verify the controlled system with random disturbance can reached to stability by using improved iterative learning control law but not the traditional control law.

  14. Ultrasonically assisted turning of Ti-6Al-2Sn-4Zr-6Mo

    Science.gov (United States)

    Muhammad, R.; Maurotto, A.; Roy, A.; Silberschmidt, V. V.

    2012-08-01

    Titanium alloys are widely used in the aerospace and offshore industries due to their high strength-to-weight ratio sustained at elevated temperatures, their fracture-resistance features and exceptionally good corrosion-resistance properties. However, poor thermal conductivity and high chemical affinity of these alloys to tool materials severely impair their machinability. As a result the machining processes of titanium alloys are typically characterized by low cutting feeds and speeds making production of components uneconomical. Recently, a non-conventional hybrid machining technique, namely, ultrasonically assisted turning has been shown to significantly improve the machinability of intractable alloys with a concomitant improvement in material removal rates, thus improving machining economics. In the current work, a 3D finite element model of turning of Ti-6Al-2Sn-4Zr-6Mo is developed in the commercial software, MSC Marc/Mentat. A constitutive behaviour of the workpiece material under large deformations and elevated temperatures is adequately represented by a Johnson-Cook material model. For validation of the developed numerical model, experimental tests were carried out. The numerical and experimental results were found to be in good agreement.

  15. A Systematic Review of Randomized Controlled Studies of Art Therapy

    Science.gov (United States)

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  16. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten;

    2009-01-01

    with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  17. Levetiracetam in spinal cord injury pain: a randomized controlled trial

    DEFF Research Database (Denmark)

    Finnerup, N B; Grydehøj, J; Bing, J;

    2009-01-01

    STUDY DESIGN: A randomized, double-blind, placebo-controlled, crossover, multicenter trial. A 1-week baseline period was followed by two treatment periods of 5 weeks duration with levetiracetam increased from 500 mg b.i.d. to a maximum of 1500 mg b.i.d. separated by a 1-week washout period...

  18. Randomized, controlled trial of telcagepant over four migraine attacks

    DEFF Research Database (Denmark)

    Ho, Andrew P; Dahlöf, Carl Gh; Silberstein, Stephen D;

    2010-01-01

    This study evaluated the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant (tablet formulation) for treatment of a migraine attack and across four attacks. Adults with migraine were randomized, double-blind, to telcagepant 140 mg, telcagepant 280 mg, or control treatment sequ...

  19. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

    Science.gov (United States)

    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  20. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  1. Teacher Awareness Program on Child Abuse: A Randomized Controlled Trial.

    Science.gov (United States)

    McGrath, Patrick; And Others

    1987-01-01

    Because teachers lack knowledge of the law, of school board policies, and of issues regarding child abuse and neglect, a professional development workshop was developed and presented to all teachers in the Ottawa Public Schools. Evaluation by a randomized controlled trial showed the workshop effective in increasing and maintaining knowledge.…

  2. Virtual Patients in Undergraduate Surgery Education: A Randomized Controlled Study

    OpenAIRE

    Mohammad Shariati; Masuod Yunesian; Iraj Harirchi; Ahmad Khosravi

    2008-01-01

    Introduction: This study aims to clarify the effects of implementing a series of virtual patients in undergraduate surgery education on various dimensions of skills as applied to clinical problems. Methods: In a randomized controlled trial 48 surgery clerks were assigned to an intervention group who worked on 14 simulated cases of abdominal pain during 7 weeks in a computer lab and a control group without access to software. At the end of the intervention, both groups were tested by a structu...

  3. Filtering, control and fault detection with randomly occurring incomplete information

    CERN Document Server

    Dong, Hongli; Gao, Huijun

    2013-01-01

    This book investigates the filtering, control and fault detection problems for several classes of nonlinear systems with randomly occurring incomplete information. It proposes new concepts, including RVNs, ROMDs, ROMTCDs, and ROQEs. The incomplete information under consideration primarily includes missing measurements, time-delays, sensor and actuator saturations, quantization effects and time-varying nonlinearities. The first part of this book focuses on the filtering, control and fault detection problems for several classes of nonlinear stochastic discrete-time systems and

  4. Infinitely dimensional control Markov branching chains in random environments

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    First of all we introduce the concepts of infinitely dimensional control Markov branching chains in random environments (β-MBCRE) and prove the existence of such chains, then we introduce the concepts of conditional generating functionals and random Markov transition functions of such chains and investigate their branching property. Base on these concepts we calculate the moments of the β-MBCRE and obtain the main results of this paper such as extinction probabilities, polarization and proliferation rate. Finally we discuss the classification ofβ-MBCRE according to the different standards.

  5. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors.

    Science.gov (United States)

    Johnson, Jillian A; Rash, Joshua A; Campbell, Tavis S; Savard, Josée; Gehrman, Philip R; Perlis, Michael; Carlson, Linda E; Garland, Sheila N

    2016-06-01

    This review examined the efficacy of cognitive behavior therapy for insomnia (CBT-I) in people diagnosed with cancer. Studies were identified through November 2014 using multiple databases, clinical trial records, and bibliography searches. Inclusion was limited to randomized controlled trials of CBT-I conducted in individuals with a cancer diagnosis who had clinically relevant insomnia. The primary outcome variable was sleep efficiency (SE) as measured by sleep diary. Eight studies including data from 752 cancer survivors met inclusion criteria. CBT-I resulted in a 15.5% improvement in SE relative to control conditions (6.1%) from pre- to post-intervention, with a medium effect size (ES: d = 0.53). Overall, sleep latency was reduced by 22 min with an ES of d = 0.43, compared to a reduction of 8 min in the control conditions. Wake after sleep onset was reduced by 30 min with an ES of d = 0.41, compared to 13 min in the control conditions. Large effect sizes were observed for self-reported insomnia severity (d = 0.77) for those patients who received CBT-I, representing a clinically relevant eight point reduction. Effects were durable up to 6 mo. The quality of the evidence supports a strong recommendation for the use of CBT-I among cancer survivors.

  6. Control with a random access protocol and packet dropouts

    Science.gov (United States)

    Wang, Liyuan; Guo, Ge

    2016-08-01

    This paper investigates networked control systems whose actuators communicate with the controller via a limited number of unreliable channels. The access to the channels is decided by a so-called group random access protocol, which is modelled as a binary Markov sequence. Data packet dropouts in the channels are modelled as independent Bernoulli processes. For such systems, a systematic characterisation for controller synthesis is established and stated in terms of the transition probabilities of the Markov protocol and the packet dropout probabilities. The results are illustrated via a numerical example.

  7. Active subnanometer spectral control of a random laser

    CERN Document Server

    Leonetti, Marco; 10.1063/1.4792759

    2013-01-01

    We demonstrate an experimental technique that allows to achieve a robust control on the emission spectrum of a micro random laser and to select individual modes with sub-nanometer resolution. The presented approach relies on an optimization protocol of the spatial profile of the pump beam. Here we demonstrate not only the possibility to increase the emission at a wavelength, but also that we can isolate an individual peak suppressing unwanted contributions form other modes.

  8. Improving aerobic capacity through active videogames: A randomized controlled trial

    OpenAIRE

    Jorge Luiz de Brito-Gomes; Raphael José Perrier-Melo; Erik Anders Wikstrom; Manoel da Cunha Costa

    2015-01-01

    AbstractThe rate of peak workload improvement between different types of Active Video Games (AVG) in young sedentary adults was investigated. Aerobic capacity improvement after a 6-week intervention between AVG types was also compared. Twenty participants, after baseline assessments, were randomized into one of three parallel groups: structured AVG (n= 6), unstructured AVG (n= 7) and a control group (n= 7). Participants played their respective AVG 3 times a week for 6-weeks (30 minutes-sessio...

  9. Shallow Semantic Parsing of Randomized Controlled Trial Reports

    OpenAIRE

    Paek, Hyung; Kogan, Yacov; Thomas, Prem; Codish, Seymour; Krauthammer, Michael

    2006-01-01

    In this work, we are measuring the performance of Propbank-based Machine Learning (ML) for automatically annotating abstracts of Randomized Controlled Trials (RCTs) with semantically meaningful tags. Propbank is a resource of annotated sentences from the Wall Street Journal (WSJ) corpus, and we were interested in assessing performance issues when porting this resource to the medical domain. We compare intra-domain (WSJ/WSJ) with cross-domain (WSJ/medical abstracts) performance. Although the i...

  10. Active control of tensegrity structures under random excitation

    Science.gov (United States)

    Ganesh Raja, M.; Narayanan, S.

    2007-06-01

    In this paper we consider vibration control of tensegrity structures under stationary and nonstationary random excitations. These excitations may be representative of many physical loading conditions, such as earthquake, wind, aerodynamic and acoustic excitations. The optimal control theory based on H2 and \\mathrm {H}_{\\infty } controller with full state and limited state feedback is used for the control. The response of the tensegrity structure is represented by the zero lag covariance matrix and the same is obtained by solving the matrix Lyapunov equation. The force generated by the electro-mechanical coupling of the piezoelectric actuator is used in the formulation. A tensegrity structure of class-1 comprising of two modules, with 24 pretension cables and six struts with piezoelectric actuators, is considered.

  11. Fabrication, tribological and corrosion behaviors of ultra-fine grained Co-28Cr-6Mo alloy for biomedical applications.

    Science.gov (United States)

    Ren, Fuzeng; Zhu, Weiwei; Chu, Kangjie

    2016-07-01

    Nickel and carbides free Co-28Cr-6Mo alloy was fabricated by combination of mechanical alloying and warm pressing. The microstructure, mechanical properties, pin-on-disk dry sliding wear and corrosion behavior in simulated physiological solution were investigated. The produced Co-28Cr-6Mo alloy has elongated ultra-fine grained (UFG) structure of ε-phase with average grain size of 600nm in length and 150nm in thickness. The hardness and modulus were determined to be 8.87±0.56GPa and 198.27±7.02GPa, respectively. The coefficient of friction upon dry sliding against alumina is pretty close to that of the forged Co-29Cr-6Mo alloy. The initial ε-phase and UFG microstructure contribute to reduce the depth of severe plastic deformation region during wear and enable the alloy with excellent wear resistance. The corrosion potential of such UFG Co-Cr-Mo alloy has more positive corrosion potential and much lower corrosion current density than those of ASTM alloy. PMID:26807770

  12. Genetic susceptibility testing and readiness to control weight: results from a randomized controlled trial

    OpenAIRE

    S. Meisel; Beeken, R. J.; van Jaarsveld, C H M; Wardle, J

    2015-01-01

    Objective To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. Methods Individually randomized controlled trial comparing the effect of: (i) simple weight control advice plus FTO feedback (FA) and (ii) simple weight control advice only (AO) on readiness to engage with weight control. Differences in stage of change by genotype and differential weight con...

  13. Genetic susceptibility testing and readiness to control weight: Results from a randomized controlled trial

    NARCIS (Netherlands)

    Meisel, S.F.; Beeken, R.J.; Jaarsveld, C.H.M. van; Wardle, J.

    2015-01-01

    OBJECTIVE: To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. METHODS: Individually randomized controlled trial comparing the effect of: (i) simple weight c

  14. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  15. Coblation tonsillectomy: a double blind randomized controlled study.

    Science.gov (United States)

    Timms, M S; Temple, R H

    2002-06-01

    Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.

  16. Enhancing antiepileptic drug adherence: a randomized controlled trial.

    Science.gov (United States)

    Brown, Ian; Sheeran, Paschal; Reuber, Markus

    2009-12-01

    Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (Pintention intervention may be an easy-to-administer and effective means of promoting AED adherence. PMID:19864187

  17. Cognitive Stimulation in Patients with Dementia: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Daniela Mapelli

    2013-08-01

    Full Text Available Background/Aims: This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs, using a randomized controlled clinical trial. Methods: Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation, placebo (treated with occupational therapy, and control (continuing with the usual activities of the nursing home. Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results: Only the experimental group improved its performance in cognitive tests (p Conclusions: The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms.

  18. A controllable stitch layout strategy for random needle embroidery

    Institute of Scientific and Technical Information of China (English)

    Jie ZHOU; Zheng-xing SUN; Ke-wei YANG

    2014-01-01

    Random needle embroidery (RNE) is a graceful art enrolled in the world intangible cultural heritage. In this paper, we study the stitch layout problem and propose a controllable stitch layout strategy for RNE. Using our method, a user can easily change the layout styles by adjusting several high-level layout parameters. This approach has three main features:firstly, a stitch layout rule containing low-level stitch attributes and high-level layout parameters is designed;secondly, a stitch neighborhood graph is built for each region to model the spatial relationship among stitches;thirdly, different stitch attributes (orientations, lengths, and colors) are controlled using different reaction-diffusion processes based on a stitch neighborhood graph. Moreover, our method supports the user in changing the stitch orientation layout by drawing guide curves interactively. The experimental results show its capability for reflecting various stitch layout styles and flexibility for user interaction.

  19. Standards of Reporting of Randomized Controlled Trials in General Surgery

    Science.gov (United States)

    Balasubramanian, Sabapathy P.; Wiener, Martin; Alshameeri, Zeiad; Tiruvoipati, Ravindranath; Elbourne, Diana; Reed, Malcolm W.

    2006-01-01

    Objective: To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality. Summary Background Data: Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels. Methods: Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose. Results: Of the 69 RCTs analyzed, only 37.7% had a Jadad score of ≥3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022). Conclusion: The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. PMID:17060756

  20. Vitamin E treatment for children with chronic hepatitis B: A randomized placebo controlled trial

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    AIM: To evaluate the safety and efficacy of vitamin E in children with chronic hepatitis B. METHODS: We randomly assigned patients with chronic hepatitis B, positive for hepatitis B e antigen (HBeAg), to receive either vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner. The primary end point was HBeAg seroconversion, defined as the loss of HBeAg, undetectable levels of serum hepatitis B virus DNA, and the appearance of antibodies against HBeAg 12 rno after therapy. RESULTS: At baseline visit, 49 patients had normal and 43 had increased serum aminotransferase levels. Twenty-nine patients did not respond to previous treatment with interferon-α or lamivudine. Seventy-six children completed the study; 16 were non-compliant (n = 7), lost to follow-up (n = 7), or started another antiviral treatment (n = 3). Intention-to-treat analysis showed HBeAg seroconversion in 16 children (23.2%) treated with vitamin E and two (8.7%) in the placebo group (P = 0.13). Vitamin E was well tolerated. CONCLUSION: There is only a tendency that vitamin E may promote HBeAg seroconversion. Erefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis B.

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

    Science.gov (United States)

    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.

  2. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  3. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  4. Microstructures and mechanical properties of Co-29Cr-6Mo alloy fabricated by selective laser melting process for dental applications.

    Science.gov (United States)

    Takaichi, Atsushi; Suyalatu; Nakamoto, Takayuki; Joko, Natsuka; Nomura, Naoyuki; Tsutsumi, Yusuke; Migita, Satoshi; Doi, Hisashi; Kurosu, Shingo; Chiba, Akihiko; Wakabayashi, Noriyuki; Igarashi, Yoshimasa; Hanawa, Takao

    2013-05-01

    The selective laser melting (SLM) process was applied to a Co-29Cr-6Mo alloy, and its microstructure, mechanical properties, and metal elution were investigated to determine whether the fabrication process is suitable for dental applications. The microstructure was evaluated using scanning electron microscopy with energy-dispersed X-ray spectroscopy (SEM-EDS), X-ray diffractometry (XRD), and electron back-scattered diffraction pattern analysis. The mechanical properties were evaluated using a tensile test. Dense builds were obtained when the input energy of the laser scan was higher than 400 J mm⁻³, whereas porous builds were formed when the input energy was lower than 150 J mm⁻³. The microstructure obtained was unique with fine cellular dendrites in the elongated grains parallel to the building direction. The γ phase was dominant in the build and its preferential orientation was confirmed along the building direction, which was clearly observed for the builds fabricated at lower input energy. Although the mechanical anisotropy was confirmed in the SLM builds due to the unique microstructure, the yield strength, UTS, and elongation were higher than those of the as-cast alloy and satisfied the type 5 criteria in ISO22764. Metal elution from the SLM build was smaller than that of the as-cast alloy, and thus, the SLM process for the Co-29Cr-6Mo alloy is a promising candidate for fabricating dental devices.

  5. Hydrothermal synthesis of Yb3+, Tm3+ co-doped Gd6MoO12 and its upconversion properties

    Science.gov (United States)

    Di, Qiu-Mei; Sun, Yu-Mei; Xu, Qi-Guang; Han, Liu; Xue, Bing; Sun, Jia-Yue

    2015-06-01

    Yb3+, Tm3+ co-doped Gd6MoO12 phosphors with different morphologies are prepared by the hydrothermal method. The dendrites present different morphologies (including hexagonal prisms, spindles, and spheres) after changing the pH value and edetate disodium (EDTA) usage. It is found that each of the two factors plays a crucial role in forming different morphologies. The up-conversion (UC) luminescence is studied. Under 980-nm semiconductor laser excitation, relatively strong blue emission and weak red emission are observed. Finally, the effect of pumping power on the UC luminescence properties and the level diagram mechanism of Gd6MoO12:Yb3+/Tm3+ phosphor are also discussed. Project supported by the National Natural Science Foundation of China (Grant No. 20976002), the Beijing Natural Science Foundation, China (Grant No. 2122012), the Key Projects for Science and Technology of Beijing Education Commission, China (Grant No. KZ201310011013), and the Education and Research Fund of Guangdong Province, China (Grant No. 2011B090400100).

  6. Microstructures and mechanical properties of Co-29Cr-6Mo alloy fabricated by selective laser melting process for dental applications.

    Science.gov (United States)

    Takaichi, Atsushi; Suyalatu; Nakamoto, Takayuki; Joko, Natsuka; Nomura, Naoyuki; Tsutsumi, Yusuke; Migita, Satoshi; Doi, Hisashi; Kurosu, Shingo; Chiba, Akihiko; Wakabayashi, Noriyuki; Igarashi, Yoshimasa; Hanawa, Takao

    2013-05-01

    The selective laser melting (SLM) process was applied to a Co-29Cr-6Mo alloy, and its microstructure, mechanical properties, and metal elution were investigated to determine whether the fabrication process is suitable for dental applications. The microstructure was evaluated using scanning electron microscopy with energy-dispersed X-ray spectroscopy (SEM-EDS), X-ray diffractometry (XRD), and electron back-scattered diffraction pattern analysis. The mechanical properties were evaluated using a tensile test. Dense builds were obtained when the input energy of the laser scan was higher than 400 J mm⁻³, whereas porous builds were formed when the input energy was lower than 150 J mm⁻³. The microstructure obtained was unique with fine cellular dendrites in the elongated grains parallel to the building direction. The γ phase was dominant in the build and its preferential orientation was confirmed along the building direction, which was clearly observed for the builds fabricated at lower input energy. Although the mechanical anisotropy was confirmed in the SLM builds due to the unique microstructure, the yield strength, UTS, and elongation were higher than those of the as-cast alloy and satisfied the type 5 criteria in ISO22764. Metal elution from the SLM build was smaller than that of the as-cast alloy, and thus, the SLM process for the Co-29Cr-6Mo alloy is a promising candidate for fabricating dental devices. PMID:23500549

  7. The electrically and magnetically controllable random laser from dye-doped liquid crystals

    Science.gov (United States)

    Ye, Lihua; Liu, Bo; Zhao, Chong; Wang, Yan; Cui, Yiping; Lu, Yanqing

    2014-08-01

    The electrically and magnetically controllable random laser from dye-doped liquid crystals (LCs) was studied. The rubbing-alignment of the polyimide in the LC cell influenced the threshold voltage and the response time of the electrically controllable random laser. When the applied electric field was increased, the response time of the random laser decreased. The magnetically controllable random laser was studied in the hollow fiber structure, of which the response time was less than 1 s.

  8. Virtual Patients in Undergraduate Surgery Education: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Mohammad Shariati

    2008-01-01

    Full Text Available Introduction: This study aims to clarify the effects of implementing a series of virtual patients in undergraduate surgery education on various dimensions of skills as applied to clinical problems. Methods: In a randomized controlled trial 48 surgery clerks were assigned to an intervention group who worked on 14 simulated cases of abdominal pain during 7 weeks in a computer lab and a control group without access to software. At the end of the intervention, both groups were tested by a structured, seven-part paper-based exam evaluating certain areas of competence. Results: In this study, from 48 medical students, forty-five students took the exam. Results showed a significant improvement in history taking (P < 0.001 and no improvement in scores related to appropriate use of radiology and lab tests, proposing differential diagnoses and management plans and factual knowledge. From the intervention group, 20 students completed a virtual case exam whose results had a poor correlation with the written exam. Conclusion: Overall, our findings indicate that virtual patients are strong tools in enhancing history-taking skills of students, but they do not affect other areas of competence significantly. Educators are recommended to be sceptical about enthusiastic reports on various computer applications and avoid falling into false expectations of their implementation

  9. Improving aerobic capacity through active videogames: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jorge Luiz de Brito-Gomes

    2015-09-01

    Full Text Available AbstractThe rate of peak workload improvement between different types of Active Video Games (AVG in young sedentary adults was investigated. Aerobic capacity improvement after a 6-week intervention between AVG types was also compared. Twenty participants, after baseline assessments, were randomized into one of three parallel groups: structured AVG (n= 6, unstructured AVG (n= 7 and a control group (n= 7. Participants played their respective AVG 3 times a week for 6-weeks (30 minutes-session. The control group maintained normal activities. Both structured and unstructured AVG improved peak workload after four weeks but only the structured group maintained this improvement through week five and six. Aerobic capacity improved in the unstructured (Pre: 36.0 ± 5.2ml.kg.min-¹,Post: 39.7 ± 4.9ml.kg.min-¹, p = .038 and structured AVG (Pre: 39.0 ± 5.9ml.kg.min-¹,Post: 47.8 ± 4.3ml.kg.min-¹, p = .006 groups. Structured AVG provide greater health benefits to aerobic capacity and peak workload in young sedentary but otherwise healthy males relative to unstructured AVG.

  10. Enhanced Algebraic Error Control for Random Linear Network Coding

    CERN Document Server

    Yan, Zhiyuan

    2012-01-01

    Error control is significant to network coding, since when unchecked, errors greatly deteriorate the throughput gains of network coding and seriously undermine both reliability and security of data. Two families of codes, subspace and rank metric codes, have been used to provide error control for random linear network coding. In this paper, we enhance the error correction capability of these two families of codes by using a novel two-tier decoding scheme. While the decoding of subspace and rank metric codes serves a second-tier decoding, we propose to perform a first-tier decoding on the packet level by taking advantage of Hamming distance properties of subspace and rank metric codes. This packet-level decoding can also be implemented by intermediate nodes to reduce error propagation. To support the first-tier decoding, we also investigate Hamming distance properties of three important families of subspace and rank metric codes, Gabidulin codes, Kotter--Kschischang codes, and Mahdavifar--Vardy codes. Both the...

  11. A Double-Blind, Placebo Controlled, Randomized Trial to Assess the Impact of a Monthly Administration of 50,000 IU of Vitamin D3 for 6 Months on Serum Levels of 25-Hydroxyvitamin D in Healthy Young Adults

    Directory of Open Access Journals (Sweden)

    E. Brunel

    2013-01-01

    Full Text Available In this double blind, unicentre, randomized, placebo controlled study, we evaluated the changes in 25-hydroxyvitamin D (25(OHD serum levels in 150 young Belgian adults (18–30 years, monthly supplemented with 50,000 IU of vitamin D (VTD or placebo for 6 months, from November 2010 to May 2011. At T0, 30% of the population presented 25(OHD serum levels below 20 ng/mL. In the VTD-treated group, mean serum levels increased from 21.2 ± 8.2 to 30.6 ± 8.8 ng/mL (P<0.001 at T3mo and to 36.0 ± 9.2 ng/mL (P<0.001 at T6mo. Despite documented VTD intake, no changes in serum levels were, however, observed in 10% of the treated group. In the placebo group, mean 25(OHD serum levels decreased from 22.8 ± 8.5 to 14.0 ± 6.9 ng/mL at T3mo (P<0.001 but returned to values not significantly different from those observed at T0 (23.5 ± 8.6 ng/mL at T6mo. No difference between serum calcium levels was observed between the groups throughout the study. In conclusion, monthly supplementation with 50,000 UI of VTD in winter can warrant serum 25(OHD levels above 20 ng/mL in 96.2% of those healthy young adults without inducing unacceptably high 25(OHD concentration. This supplementation is safe and may be proposed without 25(OHD testing.

  12. The Effectiveness of Pregabalin for Post-Tonsillectomy Pain Control: A Randomized Controlled Trial

    OpenAIRE

    Soo Seog Park; Dong-Hyun Kim; In-Chul Nam; Il-Hwan Lee; Jae-Woong Hwang

    2015-01-01

    Background Although various analgesics have been used, postoperative pain remains one of the most troublesome aspects of tonsillectomy for patients. Objective The aim of the present study was to evaluate the effectiveness of premedication using pregabalin compared with placebo (diazepam) on postoperative pain control in patients undergoing tonsillectomy. Methods Forty-eight adult patients were randomly divided into a control group and a pregabalin group. Preoperatively, patients in the contro...

  13. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yulian Jin

    2015-01-01

    Full Text Available In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD, patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group versus acupuncture at nonacupoints without manipulation (control group once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups and secondary (in the eight patients of the treatment group outcomes as compared with baseline (P=0.0078 to <0.0001; treatment group has better outcomes in all primary outcome measures (P<0.0001 except for SDS (P=0.0005. Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group. Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion.

  14. Evaluating cognitive effort in a randomized controlled trial.

    Science.gov (United States)

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Carnosine treatment for gulf war illness: a randomized controlled trial.

    Science.gov (United States)

    Baraniuk, James Nicholas; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib; Timbol, Christian

    2013-05-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (B-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  16. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  17. Randomized controlled trial of the effects of vitamin D–fortified milk and bread on serum 25-hydroxyvitamin D concentrations in families in Denmark during winter: the VitmaD study1-3

    DEFF Research Database (Denmark)

    Madsen, Katja Howarth; Rasmussen, Lone Banke; Andersen, Rikke;

    2013-01-01

    starting in September. The milk and bread replaced the participants’ usual consumptions of products. Results: Median (IQR) vitamin D intakes (habitual diet plus fortified products) were 9.4 μg/d (6.5, 12.3 μg/d) and 2.2 μg/d (1.5, 3.0 μg/d) in fortification and control groups, respectively. Geometric mean......Background: Vitamin D intakes are lower than dietary recommendations in most populations, and thus, a low vitamin D status is widespread, especially during winter. Objective: We investigated the effects of increasing vitamin D intake to the recommended amount by fortification of milk and bread...... on serum 25-hydroxyvitamin D [25(OH)D] concentrations in families during winter in Denmark. Design: The study was a randomized controlled trial in 782 children and adults (4–60 y old) recruited as 201 families. Families were randomly assigned to vitamin D–fortified or nonfortified milk and bread for 6 mo...

  18. Spinal cord stimulation with interleaved pulses: a randomized, controlled trial.

    Science.gov (United States)

    North, Richard B; Kidd, David H; Olin, John; Sieracki, Jeffrey M; Boulay, Marc

    2007-10-01

    Objectives.  The development of multicontact electrodes and programmable, implanted pulse generators has increased the therapeutic success of spinal cord stimulation (SCS) by enhancing the ability to capture and maintain pain/paresthesia overlap. This study sought to determine if interleaved stimulation and/or frequency doubling improves pain/paresthesia overlap in patients with failed back surgery syndrome. Methods.  Using a patient-interactive computer system that quantifies SCS performance and presents stimulation settings in randomized, double-blind fashion, we compared the effect on pain/paresthesia overlap of interleaved stimulation (rapidly interleaved pulse trains using two different contact combinations) vs. standard treatment with a single contact combination, controlling for frequency doubling. Stimulation amplitude (charge per phase, as determined by varying pulse voltage or width) was adjusted to a subjectively comfortable intensity (usage amplitude), which was maintained for all trials in each patient. The number of percutaneous spinal electrodes used (one or two) and the phase angle between interleaved pulses were additional study variables. Results.  Multivariate analysis of 266 test results from 15 patients revealed a statistically significant (p ≤ 0.05) association between increased computer-calculated pain/paresthesia overlap and 1) high- and low-frequency interleaved stimulation using two combinations of contacts and 2) frequency doubling using one combination. We found no significant effect for electrode configuration (single or dual), pulse width matching, or phase angle. Conclusions.  The statistically significant advantages we observed for SCS with interleaved stimulation are explained, at least in part, by the effects of frequency doubling. These findings have important implications for the design and adjustment of pulse generators. PMID:22150894

  19. Synthesis for robust synchronization of chaotic systems under output feedback control with multiple random delays

    Energy Technology Data Exchange (ETDEWEB)

    Wen Guilin [Key Laboratory of Advanced Technology for Vehicle Body Design and Manufactory, M.O.E, College of Mechanical and Automotive Engineering, Hunan University, Changsha, Hunan 410082 (China); Wang Qingguo [Department of Electrical and Computer Engineering, National University of Singapore, 10 Kent Ridge Crescent, Singapore 119260 (Singapore)]. E-mail: elewqg@nus.edu.sg; Lin Chong [Department of Electrical and Computer Engineering, National University of Singapore, 10 Kent Ridge Crescent, Singapore 119260 (Singapore); Han Xu [Key Laboratory of Advanced Technology for Vehicle Body Design and Manufactory, M.O.E, College of Mechanical and Automotive Engineering, Hunan University, Changsha, Hunan 410082 (China); Li Guangyao [Key Laboratory of Advanced Technology for Vehicle Body Design and Manufactory, M.O.E, College of Mechanical and Automotive Engineering, Hunan University, Changsha, Hunan 410082 (China)

    2006-09-15

    Synchronization under output feedback control with multiple random time delays is studied, using the paradigm in nonlinear physics-Chua's circuit. Compared with other synchronization control methods, output feedback control with multiple random delay is superior for a realistic synchronization application to secure communications. Sufficient condition for global stability of delay-dependent synchronization is established based on the LMI technique. Numerical simulations fully support the analytical approach, in spite of the random delays.

  20. Pre-randomization decisions and group stratification in a randomized controlled trial to improve prescribing

    NARCIS (Netherlands)

    van Eijk, Martine E C; Paes, Arsenio H P; Porsius, Arijan; Avorn, Jerry; de Boer, Anthonius

    2004-01-01

    OBJECTIVE: To select and evaluate characteristics of primary care practice groups relevant for stratification prior to randomization. METHOD: Structured telephone interviews and pre- and post-intervention prescription data. SETTING: Additional study in an RCT to rationalize prescribing in primary ca

  1. An Investigation on the Performance of Random PWM Controlled Converters

    Directory of Open Access Journals (Sweden)

    R. Jadeja

    2015-12-01

    Full Text Available This paper provides an insight on various random pulse width modulation techniques and their effect on spreading the harmonic spectrum for various applications like drives, hybrid electric vehicles and renewable energy sources, for two level as well as three level inverter. Acoustic noise reduction, electromagnetic interference conducted and torque ripple are obvious advantages of random pulse width modulation (PWM. PWM converters with multilevel topology can meet with global quality standards for power supplies. The random PWM technique provides additional advantages. Among others, it may be implemented to achieve switching loss equalization in power switches for cascaded H-Bridge multilevel inverters. This paper provides in depth understanding for different random PWM techniques and their applications.

  2. Research on PCC Control Method for Ribbon-free Random Winding

    Institute of Scientific and Technical Information of China (English)

    WEI Jian; WANG Ming-hong; TANG Yi-fan; LU Wen-hua; WU Wen-ying

    2004-01-01

    Based on analyzing the overlap appearance of random winding, basic principles of ribbon-free random winding and parametric selections for anti-overlap are discussed. The ribbon-free random winding control system and its related hardware construction as well as its software design are introduced by applying PCC technology to high speed spinning machine of synthetic filament.

  3. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    OpenAIRE

    Jing-Yu Tan; Lorna K P Suen; Tao Wang; Alexander Molassiotis

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from in...

  4. Study on the Tribological Properties and Composition of W6Mo5Cr4V2 High Speed Steel Implanted by Boron

    Institute of Scientific and Technical Information of China (English)

    CAI Zhi-hai; XIONG Wan-quan; ZHANG Ping; TAN Jun; ZAHO Jun-jun

    2004-01-01

    Boron atoms were implanted into W6Mo5Cr4V2 high-speed steel (HSS) in CC-60 ion implantation machine to improve its tribological properties. The influence of boron implantation dose on the microhardness, friction coefficient and wear resistance of HSS were investigated. The experiment results showed that the implantation of boron can improve the tribological properties of W6Mo5Cr4V2 steel greatly. Then the phase and composition of implanted layer were analyzed by XRD and XPS. The analysisresult revealed that the interface between the implantation layer and substrate appeared to be mixed.With the increase of boron dose, the compound of δ-WB, CrB, BFe3 are the main additive phases, which supposed to be the main reason to improve the tribological properties of W6Mo5Cr4V2 steel.

  5. W6Mo5Cr4V2钢制大规格机用丝锥的热处理%Heat Treatment of Large-Sized Machine Tap of W6Mo5Cr4V2 Steel

    Institute of Scientific and Technical Information of China (English)

    陈顺民; 董向阳

    2015-01-01

    Carbides in large-sized machine tap of high speed steel are difficult to be uniformly distributed,which will have an effect on its heat treatment quality.The large-sized machine tap made of W6Mo5Cr4V2 steel should be heat treated by being successively preheated at 500 to 600 ℃,800 to 850 ℃ and 950 to 1000 ℃ prior to austenitizing;quenched from austenitizing temperature on the low side,i.e.,1200 to 1225 ℃ and at rates of more than 7 ℃/s(preferably,subjected to multiple stage cooling);and sufficiently tempered,thus making certain that the tap conforms with property requirements.Furthermore,the handle of a tap is to be hardened by being first quenched in water then cooled in air instead of by first being quenched in water then cooled in oil to render possibility of the tap cracking less.%高速钢大规格机用丝锥由于尺寸较大,碳化物分布难以均匀,将影响丝锥的热处理质量。对于大规格 W6Mo5Cr4V2钢机用丝锥,为确保其性能达到要求,应按下列工艺进行热处理:淬火加热前,依次于500~600℃、800~850℃和950~1000℃进行预热;淬火温度取下限,即1200~1225℃;以大于7℃/s 的速度进行淬火冷却,最好进行多次分级冷却;充分回火。此外,为减小丝锥的开裂倾向,柄部应采用水淬空冷而不是水淬油冷工艺淬火。

  6. Variable Voltage Source Inverter with controlled frequency spectrum based on Random Pulse Width Modulation

    Directory of Open Access Journals (Sweden)

    Muhammad Farrukh Yaqub

    2012-01-01

    Full Text Available This paper presents a new method for single phase variable voltage inverter based on Random Pulse Width Modulation. In Random Pulse Width Modulation based inverter, the frequency spectrum of the output current and voltage waveforms becomes continuous because of the randomization of the switching function of the devices controlling the output voltages. This paper establishes a theory that if the distributions of the random numbers generated by the random source are kept within certain limit with respect to the peak value of reference sinusoidal waveform, the frequency spectrum can be controlled. On the basis of the results, a novel drive using variable tap changing transformer (optional and adaptive random number generator, to control the ratio between the numbers generated by the random source and the reference waveform has been suggested that will guarantee a better power quality profile for a broad range of output voltages.

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

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available 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.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.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.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, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  8. Fluoxetine for poststroke depression A randomized placebo controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    Yan Kong; Wanli Dong; Chunfeng Liu

    2007-01-01

    BACKGROUND: Studies have demonstrated that poststroke depression(PSD) may be related with the disequilibrium between noradrenaline and 5-hydroxytryptamine (5-HT) caused by cerebral injury. The injured regions involve noradrenergic and 5-hydroxytryptaminergic neurons as well as conduction pathway.The levels of noradrenaline and 5-HT would be decreased.OBJECTIVE: To observe the effect of fluoxetine on preventing against PSD and recovery of neurologic function, and analyze the relationship of fluoxetine and the 5-HT level.DESIGN: A randomized controlled clinical trial.SETTING: Department of Neurology, First Hospital Affiliated to Soochow University.PARTICIPANTS: Ninety consecutive patients, 47 female and 43 male, were recruited who admitted to hospital for recent stroke in the Department of Neurology, First Affiliated Hospital of Soochow University between September 2003 and February 2005. Subjects were aged (64±7) years, ranging from 47 to 79 years old. They all met the diagnosis criteria of various cerebrovascular diseases formulated in the 4th National Cerebrovascular Disease Conference and confirmed as stroke by skull CT or MRI; The time from onset to tentative administration was less than 7 days; The patients had clear consciousness, without obvious language disorder. They were randomized into treatment group (n =48) and placebo group (n =42).METHODS: ①All the patients were given routine treatment according to treatment guideline of cerebrovascular disease after admission. Patients in the treatment group and placebo group received 20 mg/d fluoxetine and placebo (component: vitamin C) for 8 weeks, respectively. ② Neurologic deficit was assessed according to 24-item Hamilton Rating Scale for Depression (HAMD) and Activity of Daily Living Scale (ADL) before and at 2,4 and 8 weeks after test, separately; Meanwhile, the levels of platelet 5-HT and plasma 5-HT were determined. Grading criteria of HAMD intergral depression: non-depression < 8 points

  9. Randomized controlled study of CBT in bronchial asthma

    Directory of Open Access Journals (Sweden)

    Grover Naveen

    2007-01-01

    Full Text Available The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured interview schedule, Asthma Symptom Checklist, Asthma di-ary, Asthma Bother Profile, Hospital Anxiety & Depression Scale, AQLQ and Peak Expiratory Flow Rate. Within group comparison showed significant improvement in both groups at the post assessment. Between group comparisons showed that CBT group reported significantly greater change than that of SM group. Cognitive behavior therapy helps in improving the managment of asthma.

  10. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    Science.gov (United States)

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  11. Adaptive randomized algorithms for analysis and design of control systems under uncertain environments

    Science.gov (United States)

    Chen, Xinjia

    2015-05-01

    We consider the general problem of analysis and design of control systems in the presence of uncertainties. We treat uncertainties that affect a control system as random variables. The performance of the system is measured by the expectation of some derived random variables, which are typically bounded. We develop adaptive sequential randomized algorithms for estimating and optimizing the expectation of such bounded random variables with guaranteed accuracy and confidence level. These algorithms can be applied to overcome the conservatism and computational complexity in the analysis and design of controllers to be used in uncertain environments. We develop methods for investigating the optimality and computational complexity of such algorithms.

  12. Randomized Controlled Trial on Physical Therapy for TMJ Closed Lock

    NARCIS (Netherlands)

    Craane, B.; Dijkstra, P. U.; Stappaerts, K.; De Laat, A.

    2012-01-01

    This study evaluated the one-year effect of physical therapy on pain and mandibular dysfunction associated with anterior disc displacement without reduction of the temporomandibular joint (closed lock). Forty-nine individuals were randomly assigned to either a physical therapy group [n = 23, mean ag

  13. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    Science.gov (United States)

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  14. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    Science.gov (United States)

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  15. The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study

    NARCIS (Netherlands)

    Sturkenboom, I.H.W.M.; Graff, M.J.L.; Borm, G.F.; Veenhuizen, Y.; Bloem, B.R.; Munneke, M.; Nijhuis-Van der Sanden, M.W.G.

    2013-01-01

    AIM: To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. DESIGN: Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at

  16. Is the randomized controlled drug trial in Europe lagging behind the USA?

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo J.; Knol, Mirjam J.; Tijssen, Robert J. W.; van Leeuwen, Thed N.; Grobbee, Diederick E.; de Zeeuw, Dick

    2008-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? center dot The USA, UK and Germany have a strong position in performance of drug and nondrug randomized controlled trials. center dot Europe's position in the quantitative and qualitative performance in drug randomized controlled trials in particular, and fa

  17. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  18. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    Science.gov (United States)

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  19. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial. 

  20. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    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 cort

  1. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: the Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

    OpenAIRE

    Wild, Sarah; Hanley, Janet; Lewis, Stephanie; McKnight, John; McCloughan, Catherine; Padfield, Paul; Parker, Richard; Paterson, Mary; Pinnock, Hilary; Sheikh, Aziz; McKinstry, Brian

    2016-01-01

    Abstract Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.Methods and Findings We performed a randomized, parallel, investigator-blind controlled trial with centralised randomization in fami...

  2. Solid Solution Nitriding Technology of 15Cr-7.5Mn-2.6Mo Duplex Stainless Steel

    Institute of Scientific and Technical Information of China (English)

    FU Rui-dong; ZHAO Pin; WANG Chun-Yu; QIU Liang; ZHENG Yang-zeng

    2004-01-01

    Solid solution nitriding technologies of 15Cr-7.5Mn-2.6Mo duplex stainless steel were investigated by using of orthogonal tests. The results show that the best technology would be the processes of 1050℃× 2h + 1150℃× 3h +1050℃× 2h + 1150℃× 4h under pure N2 with PN2=0.15MPa. The high nitrogen austenitic case with the depth of1.62mm can be obtained. Orthogonal tests show that the type of atmosphere has the most notable effect on solid solution nitriding process; the pressure in the furnace and the nitriding processes has a notable effect. X-ray diffraction analyses results indicate that the main phases in the cases of the solution-nitrided samples cooled in the furnace are high nitrogen austenite, CrN, Fe3O4 and nitrogen containing ferrite. In the other samples experienced solid solution nitriding and solution treatment the obtained phase in the cases is high nitrogen austenite only. The results show that solid solution nitriding is a process that nitrogen absolutely diffuses in the austenite. The diffusing activation energy in the conditions of PN2 = 0.15MPa and 1050℃~ 1200℃ is 186.6K J/mol.

  3. A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

    OpenAIRE

    Chan, Diana Man Ka; Cheung, Ka Wang; Yung, Sofie Shuk Fei; Lee, Vivian Chi Yan; Li, Raymond Hang Wun; Ng, Ernest Hung Yu

    2016-01-01

    Background Miscarriage is a common complication of pregnancy occurring in 15–20 % of all clinically recognized pregnancies. Currently, there is still no good scientific evidence to support the routine use of progestogens for the treatment of threatened miscarriage because the existing studies were not large enough to show a significant difference and some of them were not randomized or double-blind. Methods This is a double-blind, randomized controlled trial. A total of 400 patients presentin...

  4. Controlling Random Lasing with Three-Dimensional Plasmonic Nanorod Metamaterials.

    Science.gov (United States)

    Wang, Zhuoxian; Meng, Xiangeng; Choi, Seung Ho; Knitter, Sebastian; Kim, Young L; Cao, Hui; Shalaev, Vladimir M; Boltasseva, Alexandra

    2016-04-13

    Plasmonics has brought revolutionary advances to laser science by enabling deeply subwavelength nanolasers through surface plasmon amplification. However, the impact of plasmonics on other promising laser systems has so far remained elusive. Here, we present a class of random lasers enabled by three-dimensional plasmonic nanorod metamaterials. While dense metallic nanostructures are usually detrimental to laser performance due to absorption losses, here the lasing threshold keeps decreasing as the volume fraction of metal is increased up to ∼0.07. This is ∼460 times higher than the optimal volume fraction reported thus far. The laser supports spatially confined lasing modes and allows for efficient modulation of spectral profiles by simply tuning the polarization of the pump light. Full-field speckle-free imaging at micron-scales has been achieved by using plasmonic random lasers as the illumination sources. Our findings show that plasmonic metamaterials hold potential to enable intriguing coherent optical sources.

  5. GENDER-RESPONSIVE DRUG COURT TREATMENT: A Randomized Controlled Trial

    OpenAIRE

    Messina, Nena; Calhoun, Stacy; Warda, Umme

    2012-01-01

    This pilot study compared outcomes for 94 women offenders in San Diego County, California, who participated in four drug court programs. Women were randomized to gender-responsive (GR) programs using Helping Women Recover and Beyond Trauma or standard mixed-gender treatment. Data were collected at program entry, during treatment, and approximately 22 months after treatment entry. Bivariate and multivariate analyses were conducted. Results showed that GR participants had better in-treatment pe...

  6. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty

    DEFF Research Database (Denmark)

    Mathiesen, O.; Jacobsen, L.S.; Holm, H.E.;

    2008-01-01

    randomly allocated to either Group A (placebo), Group B (pregabalin 300 mg), or Group C (pregabalin 300 mg+dexamethasone 8 mg). The medication and acetaminophen 1 g were given before operation. Spinal anaesthesia was performed. Postoperative pain treatment was with acetaminophen 1 g three times daily and...... patient-controlled i.v morphine, 2.5 mg bolus. Nausea was treated with ondansetron. Morphine consumption, pain intensity at rest and during mobilization, nausea and vomiting, sedation, dizziness, and consumption of ondansetron were recorded 2, 4, and 24 h after operation. P < 0.05 was considered...

  7. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  8. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.

    Science.gov (United States)

    Viera, Anthony J; Bangdiwala, Shrikant I

    2007-02-01

    Randomization in randomized controlled trials involves more than generation of a random sequence by which to assign subjects. For randomization to be successfully implemented, the randomization sequence must be adequately protected (concealed) so that investigators, involved health care providers, and subjects are not aware of the upcoming assignment. The absence of adequate allocation concealment can lead to selection bias, one of the very problems that randomization was supposed to eliminate. Authors of reports of randomized trials should provide enough details on how allocation concealment was achieved so the reader can determine the likelihood of success. Fortunately, a plan of allocation concealment can always be incorporated into the design of a randomized trial. Certain methods minimize the risk of concealment failing more than others. Keeping knowledge of subjects' assignment after allocation from subjects, investigators/health care providers, or those assessing outcomes is referred to as masking (also known as blinding). The goal of masking is to prevent ascertainment bias. In contrast to allocation concealment, masking cannot always be incorporated into a randomized controlled trial. Both allocation concealment and masking add to the elimination of bias in randomized controlled trials.

  9. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meisel Susanne F

    2012-12-01

    Full Text Available Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice in a situation where weight gain is relatively common. Methods/design First-year university students (n = 800 will be randomized to receive either 1 their personal genetic test result for a gene (FTO related to weight gain susceptibility in addition to a leaflet with simple weight control advice (‘Feedback + Advice’ group, FA, or 2 only the leaflet containing simple weight control advice (‘Advice Only’ group, AO. Motivation to avoid weight gain and active use of weight control strategies will be assessed one month after receipt of the leaflet with or without genetic test feedback. Weight and body fat will be measured at baseline and eight months follow-up. We will also assess short-term psychological reactions to the genetic test result. In addition, we will explore interactions between feedback condition and gene test status. Discussion We hope to provide a first indication of the clinical utility of weight-related genetic test feedback in the prevention context. Trial registration Current controlled trials ISRCTN91178663

  10. A Novel Algorithm of Quantum Random Walk in Server Traffic Control and Task Scheduling

    Directory of Open Access Journals (Sweden)

    Dong Yumin

    2014-01-01

    Full Text Available A quantum random walk optimization model and algorithm in network cluster server traffic control and task scheduling is proposed. In order to solve the problem of server load balancing, we research and discuss the distribution theory of energy field in quantum mechanics and apply it to data clustering. We introduce the method of random walk and illuminate what the quantum random walk is. Here, we mainly research the standard model of one-dimensional quantum random walk. For the data clustering problem of high dimensional space, we can decompose one m-dimensional quantum random walk into m one-dimensional quantum random walk. In the end of the paper, we compare the quantum random walk optimization method with GA (genetic algorithm, ACO (ant colony optimization, and SAA (simulated annealing algorithm. In the same time, we prove its validity and rationality by the experiment of analog and simulation.

  11. A Cluster-Randomized Trial of Insecticide-Treated Curtains for Dengue Vector Control in Thailand

    OpenAIRE

    Lenhart, Audrey; Trongtokit, Yuwadee; Alexander, Neal; Apiwathnasorn, Chamnarn; Satimai, Wichai; Vanlerberghe, Veerle; Van der Stuyft, Patrick; Philip J McCall

    2013-01-01

    The efficacy of insecticide-treated window curtains (ITCs) for dengue vector control was evaluated in Thailand in a cluster-randomized controlled trial. A total of 2,037 houses in 26 clusters was randomized to receive the intervention or act as control (no treatment). Entomological surveys measured Aedes infestations (Breteau index, house index, container index, and pupae per person index) and oviposition indices (mean numbers of eggs laid in oviposition traps) immediately before and after in...

  12. Effect of Rosa aromatherapy on anxiety before cardiac catheterization: A randomized controlled trial

    OpenAIRE

    Atye Babaii; Mohammad Abbasinia; Seyed Fakhreddin Hejazi; Seyyed Reza Seyyed Tabaei; Fariba Dehghani

    2015-01-01

    Background and Objectives: Most patients experience moderate to severe anxiety before cardiac catheterization. This study aimed to investigate the effect of Rosa aromatherapy on anxiety before cardiac catheterization. Methods: In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received rou...

  13. Analysis and Design of Networked Control Systems with Random Markovian Delays and Uncertain Transition Probabilities

    OpenAIRE

    2013-01-01

    This paper focuses on the stability issue of discrete-time networked control systems with random Markovian delays and uncertain transition probabilities, wherein the random time delays exist in the sensor-to-controller and controller-to-actuator. The resulting closed-loop system is modeled as a discrete-time Markovian delays system governed by two Markov chains. Using Lyapunov stability theory, a result is established on the Markovian structure and ensured that the closed-loop system is st...

  14. The effectiveness of pregabalin for post-tonsillectomy pain control: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Soo Seog Park

    Full Text Available Although various analgesics have been used, postoperative pain remains one of the most troublesome aspects of tonsillectomy for patients.The aim of the present study was to evaluate the effectiveness of premedication using pregabalin compared with placebo (diazepam on postoperative pain control in patients undergoing tonsillectomy.Forty-eight adult patients were randomly divided into a control group and a pregabalin group. Preoperatively, patients in the control group received 4 mg diazepam orally as placebo, whereas those in the pregabalin group received 300 mg pregabalin orally. All participants were provided with patient-controlled analgesia using fentanyl for 24 hours after surgery. Postoperative pain treatment included acetaminophen 650 mg three times daily for 8 postoperative days. The primary outcome measure was the total amount of patient-controlled fentanyl consumption after tonsillectomy. Secondary outcome measures were the number of injections of ketorolac tromethamine (each 30 mg requested by patients, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting after the surgery. P < 0.05 was considered statistically significant.The total amount of fentanyl demanded decreased significantly in the pregabalin group (P < 0.001. There were no significant differences in the number of ketorolac tromethamine injections, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting between the two groups.Administration of 300 mg pregabalin prior to tonsillectomy decreases fentanyl consumption compared with that after 4 mg diazepam, without an increased incidence of adverse effects.KCT0001215.

  15. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    OpenAIRE

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Roya KELISHADI

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were rand...

  16. Robust Fault-Tolerant Control for Uncertain Networked Control Systems with State-Delay and Random Data Packet Dropout

    Directory of Open Access Journals (Sweden)

    Xiaomei Qi

    2012-01-01

    Full Text Available A robust fault-tolerant controller design problem for networked control system (NCS with random packet dropout in both sensor-to-controller link and controller-to-actuator link is investigated. A novel stochastic NCS model with state-delay, model uncertainty, disturbance, probabilistic sensor failure, and actuator failure is proposed. The random packet dropout, sensor failures, and actuator failures are characterized by a binary random variable. The sufficient condition for asymptotical mean-square stability of NCS is derived and the closed-loop NCS satisfies H∞ performance constraints caused by the random packet dropout and disturbance. The fault-tolerant controller is designed by solving a linear matrix inequality. A numerical example is presented to illustrate the effectiveness of the proposed method.

  17. Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: A randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    Jing You; Virasakdi Chongsuvivatwong; Hutcha Sriplung; Alan Geater; Yan-Wei Qiao; Rong-Xue Wu; Lin Zhuang; Hong-Ying Cheng; Shou-Ming Yan; Lan Yu; Jun-Hua Huang; Bao-Zhang Tang; Meng-Ling Huang; Yong-Liang Ma

    2006-01-01

    AIM: To observe the efficiency and safety of thymosin-α1treatment in patients with hepatitis B e antigen (HBeAg)and HBV DNA positive chronic hepatitis.METHODS: Sixty-two patients were randomly divided into groups A and B. The patients in group A received subcutaneous injection of 1.6 mg thymosin-α1, twice a week (T-α1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-α) each day for fifteen days, then three times weekly (IFN-α group)for six months. The results between two groups treated with and the group untreated with IFN-α which was followed up for 12 mo (historical control group consisting of 30 patients) were compared, and three groups were comparable between each other (P > 0.05) at baseline (age, sex, clinical history, biochemical, and serological parameters).RESULTS: At the end of treatment, complete response,which was defined as alanine aminotransferase (ALT)normalization and HBV DNA and HBeAg loss, occurred in 9 of 29 (31.0%) patients in the T-α1 group and in 15 of 33 (45.5%) patients in the IFN-α group (x2= 1.36, P >0.05). After a follow-up period of six months, a complete response was observed in 14 of 29 (48.3%) patients in the T-α1 group and in 9 of 33 (27.3%) patients in the IFN-α group (x2= 2.93, P > 0.05). Compared with the results observed in the historical control (HC) group untreated with IFN-α which was followed up for 12 mo,the rate of complete response was significantly higher in IFN-α group at the end of therapy (1 of 30 vs 15 of 33,x2 = 14.72, P < 0.001) and in the T-α1 group at the end of follow-up (1 of 30 vs 14 of 29, x2 = 15.71, P < 0.001).In T-α1 and IFN-α treatment groups, the area under (the plasma concentration time) curve (AUC) of negative HBV DNA and HBeAg was 34%, 17%, 31% and 19% smaller than that in the HC group. By the end of the followup period, the proportions of ALT normalization and negative HBV DNA in the T-α1 group were significantly higher than those in the

  18. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

    Full Text Available Abstract Background The practice of evidence-based medicine (EBM requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs, a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are

  19. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  20. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    NARCIS (Netherlands)

    Haren, F.M.P. van; Sleigh, J.; Boerma, E.C.; Pine, M. La; Bahr, M.; Pickkers, P.; Hoeven, J.G. van der

    2012-01-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% N

  1. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  2. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    Science.gov (United States)

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  3. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  4. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    Science.gov (United States)

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  5. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    Science.gov (United States)

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  6. Content-Specificity in Verbal Recall: A Randomized Controlled Study

    OpenAIRE

    Jan Zirk-Sadowski; Denes Szucs; Joni Holmes

    2013-01-01

    In this controlled experiment we examined whether there are content effects in verbal short-term memory and working memory for verbal stimuli. Thirty-seven participants completed forward and backward digit and letter recall tasks, which were constructed to control for distance effects between stimuli. A maximum-likelihood mixed-effects logistic regression revealed main effects of direction of recall (forward vs backward) and content (digits vs letters). There was an interaction between type o...

  7. Controlling transmission eigenchannels in random media by edge reflection

    CERN Document Server

    Zhao, Liyi; Bliokh, Yury P; Freilikher, Valentin

    2015-01-01

    Transmission eigenchannels and associated eigenvalues, that give a full account of wave propagation in random media, have recently emerged as a major theme in theoretical and applied optics. Here we demonstrate, both analytically and numerically, that in quasi one-dimensional ($1$D) diffusive samples, their behavior is governed mostly by the asymmetry in the reflections of the sample edges rather than by the absolute values of the reflection coefficients themselves. We show that there exists a threshold value of the asymmetry parameter, below which high transmission eigenchannels exist, giving rise to a singularity in the distribution of the transmission eigenvalues, $\\rho({\\cal T}\\rightarrow 1)\\sim(1-{\\cal T})^{-\\frac{1}{2}}$. At the threshold, $\\rho({\\cal T})$ exhibits critical statistics with a distinct singularity $\\sim(1-{\\cal T})^{-\\frac{1}{3}}$; above it the high transmission eigenchannels disappear and $\\rho({\\cal T})$ vanishes for ${\\cal T}$ exceeding a maximal transmission eigenvalue. We show that s...

  8. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    2014-01-01

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified accor

  9. Systematic care for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial

    NARCIS (Netherlands)

    Spijker, A.; Wollersheim, H.C.H.; Teerenstra, S.; Graff, M.J.L.; Adang, E.M.M.; Verhey, F.; Vernooij-Dassen, M.J.F.J.

    2011-01-01

    OBJECTIVE: To evaluate the effectiveness of the Systematic Care Program for Dementia (SCPD) on patient institutionalization and to determine the predictors of institutionalization. DESIGN: Single-blind, multicenter, cluster-randomized, controlled trial. SETTING: Six community mental health services

  10. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  11. Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris - PEMPULS trial

    NARCIS (Netherlands)

    Mentink, LF; Mackenzie, MW; Toth, GG; Laseur, M; Lambert, FPG; Veeger, NJGM; Cianchini, G; Pavlovic, MD; Jonkman, MF

    2006-01-01

    Objective: To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris. Design: A randomized, placebo-controlled trial. Setting: International European, multicenter outpatient and inpatient study. Patients: Of the

  12. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Engers, A.J.; Wensing, M.J.P.; Tulder, M.W. van; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.

    2005-01-01

    STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to

  13. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  14. Stochastic Control for a Class of Random Evolution Models

    International Nuclear Information System (INIS)

    We construct the explicit connection existing between a solvable model of the discrete velocities non-linear Boltzmann equation and the Hamilton-Bellman-Jacobi equation associated with a simple optimal control of a piecewise deterministic process. This study extends the known relation that exists between the Burgers equation and a simple controlled diffusion problem. In both cases the resulting partial differential equations can be linearized via a logarithmic transformation and hence offer the possibility to solve physically relevant non-linear field models in full generality

  15. Prayer and healing: A medical and scientific perspective on randomized controlled trials

    OpenAIRE

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect...

  16. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

    OpenAIRE

    Usman Anju; Logerquist Sally; Schneider Cindy; Smith Scott; Rossignol Lanier W; Rossignol Daniel A; Neubrander Jim; Madren Eric M; Hintz Gregg; Grushkin Barry; Mumper Elizabeth A

    2009-01-01

    Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21), were randomly assigned to 40 hourly treatments ...

  17. Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention

    OpenAIRE

    Fox, Caroline S; Gurary, Ellen B.; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

    2016-01-01

    Background: A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30‐day page views. Whether insufficient social media intensity contributed to these results is uncertain. Methods and Results: Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journa...

  18. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    OpenAIRE

    Luke Perraton; Zuzana Machotka; Saravana Kumar

    2009-01-01

    Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Onl...

  19. Computer-Aided Diabetes Education: A Synthesis of Randomized Controlled Trials

    OpenAIRE

    Boren, Suzanne Austin; Gunlock, Teira L.; Krishna, Santosh; Kramer, Teresa C.

    2006-01-01

    Computer-aided diabetes education is the application of technology to provide information on diabetes self-management as well as test the users’ knowledge and provide feedback. The objective of this paper was to evaluate the impact of computer-aided diabetes education in improving health outcomes. We identified reports of randomized controlled trials through systematic electronic database searches. Three eligibility criteria were applied: randomized controlled trial; evaluation of a computeri...

  20. Does Playworks Work? Findings from a Randomized Controlled Trial

    Science.gov (United States)

    James-Burdumy, Susanne; Bleeker, Martha; Beyler, Nicholas; London, Rebecca A.; Westrich, Lisa; Stokes-Guinan, Katie; Castrechini, Sebastian

    2013-01-01

    Most school principals believe recess has a positive impact on the development of students' social skills and academic achievement. Research also suggests that physical activity and play during recess may be linked to improvements in both academic and prosocial behaviors (Centers for Disease Control and Prevention 2010). Recess, however, has been…

  1. Dronabinol in severe, enduring anorexia nervosa: A randomized controlled trial

    DEFF Research Database (Denmark)

    Andries, Alin; Frystyk, Jan; Flyvbjerg, Allan;

    2013-01-01

    The evidence for pharmacological treatment of severe, longstanding anorexia nervosa (AN) is sparse and the few controlled pharmacologic studies have focused on a narrow range of drugs. The aim of the present study was to investigate the effects of treatment with a synthetic cannabinoid agonist...

  2. Partner randomized controlled trial: study protocol and coaching intervention

    OpenAIRE

    Garbutt Jane M; Highstein Gabrielle; Yan Yan; Strunk Robert C

    2012-01-01

    Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes ...

  3. Intermittent preventive treatment for malaria in Papua New Guinean infants exposed to Plasmodium falciparum and P. vivax: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Nicolas Senn

    Full Text Available BACKGROUND: Intermittent preventive treatment in infants (IPTi has been shown in randomized trials to reduce malaria-related morbidity in African infants living in areas of high Plasmodium falciparum (Pf transmission. It remains unclear whether IPTi is an appropriate prevention strategy in non-African settings or those co-endemic for P. vivax (Pv. METHODS AND FINDINGS: In this study, 1,121 Papua New Guinean infants were enrolled into a three-arm placebo-controlled randomized trial and assigned to sulfadoxine-pyrimethamine (SP (25 mg/kg and 1.25 mg/kg plus amodiaquine (AQ (10 mg/kg, 3 d, n = 374, SP plus artesunate (AS (4 mg/kg, 3 d, n = 374, or placebo (n = 373, given at 3, 6, 9 and 12 mo. Both participants and study teams were blinded to treatment allocation. The primary end point was protective efficacy (PE against all episodes of clinical malaria from 3 to 15 mo of age. Analysis was by modified intention to treat. The PE (compared to placebo against clinical malaria episodes (caused by all species was 29% (95% CI, 10-43, p ≤ 0.001 in children receiving SP-AQ and 12% (95% CI, -11 to 30, p = 0.12 in those receiving SP-AS. Efficacy was higher against Pf than Pv. In the SP-AQ group, Pf incidence was 35% (95% CI, 9-54, p = 0.012 and Pv incidence was 23% (95% CI, 0-41, p = 0.048 lower than in the placebo group. IPTi with SP-AS protected only against Pf episodes (PE = 31%, 95% CI, 4-51, p = 0.027, not against Pv episodes (PE = 6%, 95% CI, -24 to 26, p = 0.759. Number of observed adverse events/serious adverse events did not differ between treatment arms (p > 0.55. None of the serious adverse events were thought to be treatment-related, and the vomiting rate was low in both treatment groups (1.4%-2.0%. No rebound in malaria morbidity was observed for 6 mo following the intervention. CONCLUSIONS: IPTi using a long half-life drug combination is efficacious for the prevention of malaria and anemia in infants

  4. Do Motion Controllers Make Action Video Games Less Sedentary? A Randomized Experiment

    OpenAIRE

    Lyons, Elizabeth J.; Tate, Deborah F; Ward, Dianne S; Ribisl, Kurt M.; J. Michael Bowling; Sriram Kalyanaraman

    2012-01-01

    Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100) were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12). An interaction was found such that in one pair, motion control (mean [SD] 0....

  5. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  6. Radonexposure with the treatment of rheumatic diseases - randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Falkenbach, A. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria)]|[Forschungsinstitut Gastein, Bad Gastein (Austria); Kovac, J.; Brandmaier, P. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria); Soto, J. [Dept. of Medical Physics, Univ. of Cantabria (Spain)

    2001-07-01

    The objective was to investigate whether there is evidence for the effectiveness of radon therapy in the treatment of rheumatic diseases. Method: Medline and MedKur databases were searched for randomised controlled clinical trials. Radon therapy centres and experts in the field were contacted, proceedings were hand-searched and bibliographies were checked for references of potential impact. Four clinical trials evaluating the effect of radon in patients suffering from rheumatic diseases with no or only a small number of drop-outs met the inclusion criteria. In patients with degenerative disease of the spine and large joints, two trials [1,2] reported less pain on pressure of painful paraspinal muscle points after a series of radon baths at a concentration of 0.8 kBq/L and 3 kBq/L, respectively. The alleviation of pain was most pronounced in the weeks following the treatment period. [3]. At six months follow-up serial immersion in combined radon and CO{sub 2} baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO{sub 2} only. [4] In 130 patients with ankylosing spondylitis a complex rehabilitation program at a health resort (group 1 and 2) showed greater and longer-lasting differences to a control group staying at home (group 3), if speleotherapeutic radon exposure (group 1) was added (as compared to an added sauna treatment, group 2). Conclusion: The four trials meeting the inclusion criteria showed beneficial effects of radon therapy compared to interventions without radon exposure. Up to nine months after the treatment period significantly better results were observed, if radon therapy is added. (orig.)

  7. The Effect of Educational and Modifying Intervention on Asthma Control among Adolescents: a Randomized Clinical Trial

    OpenAIRE

    Zarei, Soheila; Valizadeh, Leila; BILAN, Nemat

    2013-01-01

    Introduction: Controlling over allergens and environmental irritants is one of the essential elements of controlling asthma. Asthma control in adolescents is a challenge. The current study was performed with the goal of investigating the effect of an educational and modifying intervention about asthma triggers on asthma control among adolescents. Methods: The current study was a randomized clinical trial. 60 adolescents of 12-18 years of age participated in this study. The p...

  8. End-to-end rate-based congestion control with random loss: convergence and stability

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    The convergence and stability analysis for two end-to-end rate-based congestion control algorithms with unavoidable random loss in packets are presented, which can be caused by, for example, errors on wireless links. The convergence rates of these two algorithms are analyzed by linearizing them around their equilibrium points, since they are globally stable and can converge to their unique equilibrium points. Some sufficient conditions for local stability in the presence of round-trip delay are obtained based on the general Nyquist criterion of stability. The stability conditions can be considered to be more general. If random loss in the first congestion control algorithm is not considered, they reduce to the local stability conditions which have been obtained in some literatures. Furthermore, sufficient conditions for local stability of a new congestion control algorithm have also been obtained if random loss is not considered in the second congestion control algorithm.

  9. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    Science.gov (United States)

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  10. Effectiveness of "Primary Bereavement Care" for Widows: A Cluster Randomized Controlled Trial Involving Family Physicians

    Science.gov (United States)

    García, Jesus A.; Landa, Victor; Grandes, Gonzalo; Pombo, Haizea; Mauriz, Amaia

    2013-01-01

    Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 15 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary…

  11. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    Science.gov (United States)

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  12. Effectiveness in practice-based research: Looking for alternatives to the randomized controlled trial (RCT)

    NARCIS (Netherlands)

    L. Tavecchio

    2015-01-01

    Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings a

  13. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    Science.gov (United States)

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  14. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    Science.gov (United States)

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  15. Token reinforcement therapeutic approach is more effective than exercise for controlling negative symptoms of schizophrenic patients: A randomized controlled trial

    OpenAIRE

    Gholipour, A; S H Abolghasemi; K Gholinia; Saeed Taheri

    2012-01-01

    Introduction: This study aimed to evaluate the effectiveness of exercise and token-behavior therapy on the negative symptoms of schizophrenic patients. Objective: Comparison of the effectiveness of exercise and token-behavior therapy on the negative symptoms of schizophrenic patients. Methods: This research was a randomized controlled clinical trial that was done on 45 schizophrenic patients, hospitalized in Rasht, Iran. Through systematic random allocation, the samples were placed in one con...

  16. Preventing College Women's Sexual Victimization Through Parent Based Intervention: A Randomized Controlled Trial

    OpenAIRE

    Testa, Maria; Hoffman, Joseph H.; Livingston, Jennifer A.; Turrisi, Rob

    2010-01-01

    A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n=305), Enhanced Alco...

  17. Effects of adjunctive daily phototherapy on chronic periodontitis: a randomized single-blind controlled trial

    OpenAIRE

    Jung, Gyu-Un; Kim, Jin-Woo; Kim, Sun-Jong; Pang, Eun-Kyoung

    2014-01-01

    Purpose The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT ...

  18. Oral Doxycycline Reduces Pterygium Lesions; Results from a Double Blind, Randomized, Placebo Controlled Clinical Trial

    OpenAIRE

    Oscar Rúa; Larráyoz, Ignacio M; Barajas, María T.; Sara Velilla; Alfredo Martínez

    2012-01-01

    PURPOSE: To determine whether oral doxycycline treatment reduces pterygium lesions. DESIGN: Double blind, randomized, placebo controlled clinical trial. PARTICIPANTS: 98 adult patients with primary pterygium. METHODS: Patients were randomly assigned to receive 100 mg oral doxycycline twice a day (49 subjects), or placebo (49 subjects), for 30 days. Photographs of the lesion were taken at the time of recruitment and at the end of the treatment. Follow-up sessions were performed 6 and 12 months...

  19. Transcutaneous electric acupoint stimulation at Jiaji points reduce abdominal pain after colonoscopy: a randomized controlled trial

    OpenAIRE

    Chen, Yanqing; Wu, Weilan; Yao, Yusheng; Yang, Yang; Zhao, Qiuyan; Qiu, Liangcheng

    2015-01-01

    Background: Transcutaneous electric acupoint stimulation (TEAS) at Jiaji acupuncture points has therapeutic potential for relieving viscera pain and opioid-related side effects. This prospective, randomized, triple-blinded, placebo-controlled trial was to investigate the efficacy of TEAS on abdominal pain after colonoscopy. Methods: Consecutive outpatients with American Society of Anesthesiologists (ASA) physical status I or II underwent selective colonoscopy were randomly assigned into two g...

  20. Effect of the Cardio First Angel™ device on CPR indices: a randomized controlled clinical trial

    OpenAIRE

    Vahedian-Azimi, Amir; Hajiesmaeili, Mohammadreza; Amirsavadkouhi, Ali; Jamaati, Hamidreza; Izadi, Morteza; Madani, Seyed J.; Hashemian, Seyed M. R.; Miller, Andrew C

    2016-01-01

    Background A number of cardiopulmonary resuscitation (CPR) adjunct devices have been developed to improve the consistency and quality of manual chest compressions. We investigated whether a CPR feedback device would improve CPR quality and consistency, as well as patient survival. Methods We conducted a randomized controlled study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical intensive care units of four academic teaching hospitals. Patients were randomized to re...

  1. Noninvasive Ventilation for Preterm Twin Neonates with Respiratory Distress Syndrome: A Randomized Controlled Trial

    OpenAIRE

    Long Chen; Li Wang; Jie Li; Nan Wang; Yuan Shi

    2015-01-01

    Noninvasive ventilation has been proven to be effective strategies for reducing the need for endotracheal ventilation in preterm infant with respiratory distress syndrome (RDS), however the best option needs to be further determined. A single center, paired design, randomized, controlled trial was conducted between Jan 2011 and July 2014. Preterm twins with RDS were included. One of a pair was randomized to NIPPV, while another to NCPAP. Surfactant was administrated as rescue treatment. The p...

  2. Randomized Controlled Trial of Ondansetron vs. Prochlorperazine in Adults in the Emergency Department

    OpenAIRE

    Patka, John; Wu, Daniel T.; Abraham, Prasad; Sobel, Richard M.

    2011-01-01

    Objective: To compare the effectiveness of ondansetron and prochlorperazine to treat vomiting. Secondary objectives were the effectiveness of ondansetron and prochlorperazine to treat nausea and their tolerability. Methods: This was a prospective, randomized, active controlled, double-blinded study. Using a convenience sample, patients were randomized to either intravenous ondansetron 4mg (n=32) or prochlorperazine 10mg (n=32). The primary outcome was the percentage of patients with ...

  3. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial

    OpenAIRE

    Zwan, van der, G.; Vente, de, W.; Huizink, A.C.; Bögels, S.M.; Bruin, de, B.

    2015-01-01

    In contemporary western societies stress is highly prevalent, therefore the need for stress-reducing methods is great. This randomized controlled trial compared the efficacy of self-help physical activity (PA), mindfulness meditation (MM), and heart rate variability biofeedback (HRV-BF) in reducing stress and its related symptoms. We randomly allocated 126 participants to PA, MM, or HRV-BF upon enrollment, of whom 76 agreed to participate. The interventions consisted of psycho-education and a...

  4. Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

    OpenAIRE

    Quinn, Charlene C.; Shardell, Michelle D; Terrin, Michael L.; Barr, Erik A.; Ballew, Shoshana H.; Gruber-Baldini, Ann L.

    2011-01-01

    OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled...

  5. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities

    OpenAIRE

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R.; Platt, Robert; Toh, Sengwee

    2015-01-01

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up...

  6. Chaos Control in Random Boolean Networks by Reducing Mean Damage Percolation Rate

    Institute of Scientific and Technical Information of China (English)

    JIANG Nan; CHEN Shi-Jian

    2011-01-01

    Chaos control in random Boolean networks is implemented by freezing part of the network to drive it from chaotic to ordered phase. However, controlled nodes are only viewed as passive blocks to prevent perturbation spread. We propose a new control method in which controlled nodes can exert an active impact on the network.Controlled nodes and frozen values are deliberately selected according to the information of connection and Boolean functions. Simulation results showy that the number of nodes needed to achieve control is largely reduced compared to the previous method. Theoretical analysis is also given to estimate the least fraction of nodes needed to achieve control.%Chaos control in random Boolean networks is implemented by freezing part of the network to drive it from chaotic to ordered phase.However, controlled nodes are only viewed as passive blocks to prevent perturbation spread.We propose a new control method in which controlled nodes can exert an active impact on the network.Controlled nodes and frozen values are deliberately selected according to the information of connection and Boolean functions.Simulation results show that the number of nodes needed to achieve control is largely reduced compared to the previous method.Theoretical analysis is also given to estimate the least fraction of nodes needed to achieve control

  7. Pain after microlaparoscopic cholecystectomy. A randomized double-blind controlled study

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R;

    2000-01-01

    BACKGROUND: Laparoscopic cholecystectomy (LC) is traditionally performed with two 10-mm and two 5-mm trocars. The effect of smaller port incisions on pain has not been established in controlled studies. METHODS: In a double-blind controlled study, patients were randomized to LC or cholecystectomy......: The study was discontinued after inclusion of 26 patients because five of the 13 patients (38%) randomized to micro-LC were converted to LC. In the remaining 21 patients, overall pain and incisional pain intensity during the first 3 h postoperatively increased in the LC group (n = 13) compared...

  8. A randomized trial of ethyl lauroyl arginate‐containing mouthrinse in the control of gingivitis

    OpenAIRE

    Gallob, John T.; Lynch, Michael; Charles, Christine; Ricci‐Nittel, Danette; Mordas, Carolyn; Gambogi, Robert; Revankar, Ratna; Mutti, Bruna; Labella, Roberto

    2015-01-01

    Abstract Aim This 4‐week, single‐centre, randomized, examiner‐blind, controlled study investigated the efficacy and safety of 0.15% ethyl lauroyl arginate (LAE)‐containing mouthrinse in adults with mild‐to‐moderate gingivitis. Material and Methods Subjects were randomized to use 0.15% LAE‐containing mouthrinse or 5% hydroalcohol‐negative control twice daily after brushing with standard fluoride toothpaste. Plaque, gingivitis and bleeding were assessed at baseline and Weeks 2 and 4. The oral m...

  9. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique.

    Directory of Open Access Journals (Sweden)

    Jing-Yu Tan

    Full Text Available To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method.Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes.Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and "non-acupoint" stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes.A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes cannot be derived because of

  10. Randomized Algorithms for Analysis and Control of Uncertain Systems With Applications

    CERN Document Server

    Tempo, Roberto; Dabbene, Fabrizio

    2013-01-01

    The presence of uncertainty in a system description has always been a critical issue in control. The main objective of Randomized Algorithms for Analysis and Control of Uncertain Systems, with Applications (Second Edition) is to introduce the reader to the fundamentals of probabilistic methods in the analysis and design of systems subject to deterministic and stochastic uncertainty. The approach propounded by this text guarantees a reduction in the computational complexity of classical  control algorithms and in the conservativeness of standard robust control techniques. The second edition has been thoroughly updated to reflect recent research and new applications with chapters on statistical learning theory, sequential methods for control and the scenario approach being completely rewritten.   Features: ·         self-contained treatment explaining Monte Carlo and Las Vegas randomized algorithms from their genesis in the principles of probability theory to their use for system analysis; ·    ...

  11. Optimally controlling the internal dynamics of a randomly oriented ensemble of molecules

    Science.gov (United States)

    Turinici, Gabriel; Rabitz, Herschel

    2004-12-01

    The ultrafast control of large polyatomic molecules in the gas and condensed phases entails working with a randomly oriented ensemble. During the short control period, little reorientation may occur, especially for cases in the condensed phases. This paper addresses the degree to which all members of the ensemble may be simultaneously controlled with respect to their internal motion by a single laser pulse. It is shown that all members of the ensemble are fully controllable if any one member is. Numerical optimal control simulations also show that excellent quality full ensemble control can be achieved even with reasonable constraints placed on the control fields. Although the full ensemble may be controlled to a high degree, the control mechanism is likely to differ for each ensemble member.

  12. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yan Jie

    2009-08-01

    Full Text Available Abstract Background Acupuncture is widely used in China to treat functional dyspepsia (FD. However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control group. The four acupoint treatment groups will focus on: (1 specific acupoints of the stomach meridian; (2 non-specific acupoints of the stomach meridian; (3 specific acupoints of alarm and transport points; and (4 acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system, a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials

  13. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick s

  14. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    Science.gov (United States)

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  15. Effects of Folic Acid Supplementation on Hearing in Older Adults: a Randomized, Controlled Trial

    NARCIS (Netherlands)

    Durga, J.; Verhoef, P.; Anteunis, L.J.C.; Schouten, E.G.; Kok, F.J.

    2007-01-01

    Background: Age-related hearing loss is a common chronic condition of elderly persons. Low folate status has been associated with poor hearing. Objective: To determine whether folic acid supplementation slows age-related hearing loss. Design: Double-blind, randomized, placebo-controlled trial conduc

  16. Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

    OpenAIRE

    Harrison, R; Dey, P.; Slevin, N J; Eardley, A; Gibbs, A; Cowan, R.; Logue, J P; Leidecker, V; Hopwood, P

    2001-01-01

    In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed. © 2001 Cancer Research Campaign http://www.bjcancer.com

  17. Is Personality a Key Predictor of Missing Study Data? An Analysis From a Randomized Controlled Trial

    OpenAIRE

    Jerant, Anthony; Chapman, Benjamin P.; Duberstein, Paul; Franks, Peter

    2009-01-01

    PURPOSE Little is known regarding the effects of psychological factors on data collection in research studies. We examined whether Five Factor Model (FFM) personality factors—Neuroticism, Extraversion, Openness, Agreeableness, and Conscientiousness—predicted missing data in a randomized controlled trial (RCT).

  18. Randomized controlled trial on collagen/oxidized regenerated cellulose/silver treatment

    DEFF Research Database (Denmark)

    Gottrup, Finn; Cullen, Breda Mary; Karlsmark, Tonny;

    2013-01-01

    ). Patients with diabetic foot ulcers were randomized to either collagen/ORC/silver (24) or control treatment (15). Wound area measurements and wound fluid samples were taken weekly. Protease levels were measured in wound fluid samples to investigate differences between responders (≥50% reduction in wound...

  19. Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

    Science.gov (United States)

    Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

    2010-01-01

    Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

  20. Randomized controlled trial of the effect of medical audit on AIDS prevention in general practice

    DEFF Research Database (Denmark)

    Sandbæk, Annelli

    1999-01-01

    OBJECTIVE: We aimed to evaluate the effect of a medical audit on AIDS prevention in general practice. METHODS: We conducted a prospective randomized controlled study performed as 'lagged intervention'. At the time of comparison, the intervention group had completed 6 months of audit including...

  1. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    Science.gov (United States)

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  2. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  3. RANDOMIZED CONTROLLED TRIALS OF MATERNAL-FETAL SURGERY : A CHALLENGE TO CLINICAL EQUIPOISE

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; van den Berg, P. P.

    2014-01-01

    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

  4. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    Science.gov (United States)

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  5. A Randomized Controlled Study of Brief Interventions To Teach Residents about Domestic Violence.

    Science.gov (United States)

    Coonrod, Dean V.; Bay, R. Curtis; Rowley, Beverley D.; Del Mar, Nancy B.; Gabriele, Laura; Tessman, Terrie D.; Chambliss, Linda R.

    2000-01-01

    Medical residents were randomly assigned to either a 20-minute session on the importance of screening for domestic violence or to an unrelated topic. Subsequently, 71 percent of the trained residents diagnosed at least one case of domestic violence compared to 52 percent of residents in the control group. Rates of diagnosis also differed by…

  6. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    Science.gov (United States)

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  7. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    Science.gov (United States)

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  8. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis

    NARCIS (Netherlands)

    Sheffler, L.R.; Taylor, P.N.; Gunzler, D.D.; Buurke, J.H.; IJzerman, M.J.; Chae, J.

    2013-01-01

    Objective: To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors. Design: Single-blinded randomized controlled trial. Setting: Teaching hospital of

  9. A neurofeedback video game (MindLight) to prevent anxiety in children: A randomized controlled trial

    NARCIS (Netherlands)

    Schoneveld, E.A.; Malmberg, M.; Lichtwarck-Aschoff, A.; Verheijen, G.P.; Engels, R.C.M.E.; Granic, I.

    2016-01-01

    Background Childhood anxiety is a global mental health concern. Interventions are needed that are effective, but also cost less, are more accessible and engage children long enough to build emotional resilience skills through practice. Methods The present randomized controlled study aimed to examine

  10. Sunbed radiation provokes cutaneous vitamin D synthesis in humans--a randomized controlled trial

    DEFF Research Database (Denmark)

    Thieden, Elisabeth; Jørgensen, Henrik L; Jørgensen, Niklas Rye;

    2008-01-01

    We wanted to investigate whether the use of sunbeds with sunlamps emitting mainly UVA and only 0.5% or 1.4% UVB will increase the level of serum 25-hydroxyvitamin D (25(OH)D). In a randomized, controlled, open study on healthy, Caucasian females (> 50 years) sunbed radiation was given as follows:...

  11. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    Science.gov (United States)

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  12. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  13. Exercise and micronutrient enriched foods for functional improvement in frail elderly? A randomized controlled trail

    NARCIS (Netherlands)

    Chin a Paw, J.M.M.; Jong, de N.; Schouten, E.G.; Hiddink, G.J.; Kok, F.J.

    2001-01-01

    Objective: To examine the effects of an exercise program and an enriched food regimen on physical functioning of frail elderly persons. Design: A 17-week randomized, placebo-controlled trial. Setting: Community. Participants: One hundred fifty-seven independently living frail elderly (mean age, 78.7

  14. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    2008-01-01

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and Stat

  15. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    Science.gov (United States)

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  16. Working Memory Training in Young Children with ADHD: A Randomized Placebo-Controlled Trial

    Science.gov (United States)

    Dongen-Boomsma, Martine; Vollebregt, Madelon A.; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training…

  17. Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Hoffmann, Kristine; Sobol, Nanna A; Frederiksen, Kristian S;

    2015-01-01

    Background: Studies of physical exercise in patients with Alzheimer’s disease (AD) are few and results have been inconsistent. Objective: To assess the effects of a moderate-to-high intensity aerobic exercise program in patients with mild AD. Methods: In a randomized controlled trial, we recruited...

  18. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials*

    OpenAIRE

    Wu, Yan; Robinson, Nicola; Hardiman, Paul J.; Taw, Malcolm B.; Zhou, Jue; Wang, Fang-Fang; Qu, Fan

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

  19. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    Science.gov (United States)

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  20. Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    LI Ting-qian; MAO Bing; WANG Gang; CHANG Jing; WANG Lei

    2008-01-01

    @@ Evidence obtained from randomized controlled trials (RCTs) has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully understand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner.

  1. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    2015-01-01

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff tea

  2. Melatonin for chronic sleep onset insomnia in children: A Randomized placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.G.; Nagtegaal, J.E.; Heijden, J.A.M. van der; Coenen, A.M.L.; Kerkhof, G.A.

    2001-01-01

    To establish the efficacy of melatonin treatment in childhood sleep onset insomnia, 40 elementary school children, 6 to 12 years of age, who suffered more than 1 year from chronic sleep onset insomnia, were studied in a double-blind, placebo-controlled study. The children were randomly assigned to r

  3. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    Science.gov (United States)

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  4. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention

    DEFF Research Database (Denmark)

    Ho, Tony W; Connor, Kathryn M; Zhang, Ying;

    2014-01-01

    OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3-14 migra...

  5. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    Science.gov (United States)

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  6. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    Science.gov (United States)

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  7. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Science.gov (United States)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  8. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    Science.gov (United States)

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  9. Methylprednisolone in the management of spinal cord injuries: Lessons from randomized, controlled trials

    Directory of Open Access Journals (Sweden)

    Vincent Cheung

    2015-01-01

    Full Text Available The efficacy of glucocorticoid for treatment of acute spinal cord injuries remains a controversial topic. Differing medical societies have issued conflicting recommendations in this regard. Here we review the available randomized, controlled trial (RCT data on this subject and offer a synthesis of these data sets.

  10. Double-blind randomized controlled study of coblation tonsillotomy versus coblation tonsillectomy on postoperative pain.

    Science.gov (United States)

    Arya, A; Donne, A J; Nigam, A

    2003-12-01

    This double-blind randomized controlled trial of coblation tonsillotomy versus coblation tonsillectomy uses visual analogue scoring to compare the pain experienced in the 24h postoperative period. No statistically significant difference in pain is demonstrated in the group of 14 patients studied. Tonsillectomy is recommended over tonsillotomy.

  11. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  12. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    Science.gov (United States)

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  13. Regional specificity of exercise and calcium during skeletal growth in girls : A randomized controlled trial

    NARCIS (Netherlands)

    Iuliano-Burns, S; Saxon, L; Naughton, G; Gibbons, K; Bass, SL

    2003-01-01

    Combining exercise with calcium supplementation may produce additive or multiplicative effects at loaded sites; thus, we conducted a single blind, prospective, randomized controlled study in pre- and early-pubertal girls to test the following hypotheses. (1) At the loaded sites, exercise and calcium

  14. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial

    NARCIS (Netherlands)

    J.E. van der Zwan; W. de Vente; A.C. Huizink; S.M. Bögels; E.I. de Bruin

    2015-01-01

    In contemporary western societies stress is highly prevalent, therefore the need for stress-reducing methods is great. This randomized controlled trial compared the efficacy of self-help physical activity (PA), mindfulness meditation (MM), and heart rate variability biofeedback (HRV-BF) in reducing

  15. The Efficiency and Efficacy of Equivalence-Based Learning: A Randomized Controlled Trial

    Science.gov (United States)

    Zinn, Tracy E.; Newland, M. Christopher; Ritchie, Katie E.

    2015-01-01

    Because it employs an emergent-learning framework, equivalence-based instruction (EBI) is said to be highly efficient, but its presumed benefits must be compared quantitatively with alternative techniques. In a randomized controlled trial, 61 college students attempted to learn 32 pairs of proprietary and generic drug names using computer-based…

  16. Computerized Training of Working Memory in Children with ADHD-A Randomized, Controlled Trial

    Science.gov (United States)

    Klingberg, Torkel; Fernell, Elisabeth; Olesen, Pernille J.; Johnson, Mats; Gustafsson, Per; Dahlstrom, Kerstin; Gillberg, Christopher G.; Forssberg, Hans; Westerberg, Helena

    2005-01-01

    Objective: Deficits in executive functioning, including working memory (WM) deficits, have been suggested to be important in attention-deficit/hyperactivity disorder (ADHD). During 2002 to 2003, the authors conducted a multicenter, randomized, controlled, double-blind trial to investigate the effect of improving WM by computerized, systematic…

  17. Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

    Science.gov (United States)

    Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

    2009-01-01

    The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

  18. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    Science.gov (United States)

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  19. The effectiveness of integrated care for patients with hand eczema: Results of a randomized, controlled trial

    NARCIS (Netherlands)

    Gils, R.F. van; Boot, C.R.L.; Knol, D.L.; Rustemeyer, T.; Mechelen, W. van; Valk, P.G.M. van der; Anema, J.R.

    2012-01-01

    Objectives. To evaluate the effectiveness of integrated, multidisciplinary care as compared with usual care for patients with moderate to severe, chronic hand eczema after 26 weeks of follow-up. Background. This study was designed as a randomized, controlled trial. Methods. Patients who visited one

  20. Multichannel active control of random noise in a small reverberant room

    DEFF Research Database (Denmark)

    Laugesen, Søren; Elliott, Stephen J.

    1993-01-01

    An algorithm for multichannel adaptive IIR (infinite impulse response) filtering is presented and applied to the active control of broadband random noise in a small reverberant room. Assuming complete knowledge of the primary noise, the theoretically optimal reductions of acoustic energy are init...

  1. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    Science.gov (United States)

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

  2. Working memory training in young children with ADHD: a randomized placebo-controlled trial

    NARCIS (Netherlands)

    Dongen-Boomsma, M. van; Vollebregt, M.A.; Buitelaar, J.; Slaats-Willemse, D.I.E.

    2014-01-01

    BACKGROUND: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the

  3. Completion report : Effect of Comprehensive Yogic Breathing program on type 2 diabetes: A randomized control trial

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2014-01-01

    Full Text Available Background: Yoga has been shown to be benefi cial in diabetes in many studies, though randomized control trials are few. The aim of this randomized control trial was to see the effect of Sudarshan Kriya and related practices (comprehensive yogic breathing program on quality of life, glycemic control, and cardiac autonomic functions in diabetes. Diabetes mellitus is a risk factor for sudden cardiac death. Cardiac autonomic neuropathy has been implicated in the causation of sudden cardiac death. Therefore, a maneuver to prevent progression of cardiac autonomic neuropathy holds signifi cance. Materials and Methods: A total of 120 patients of diabetes on oral medication and diet and exercise advice were randomized into two groups: (1 Continued to receive standard treatment for diabetes. (2 Patients administered comprehensive yogic breathing program and monitored to regularly practice yoga in addition to standard treatment of diabetes. At 6 months, quality of life and postprandial plasma glucose signifi cantly improved in the group practicing yoga compared to baseline, but there was no significant improvement in the fasting plasma glucose and glycated hemoglobin. Results: On per protocol analysis, sympathetic cardiac autonomic functions signifi cantly improved from baseline in the group practicing comprehensive yogic breathing. Conclusion: This randomized control trial points towards the beneficial effect of yogic breathing program in preventing progression of cardiac neuropathy. This has important implications as cardiac autonomic neuropathy has been considered as one of the factors for sudden cardiac deaths.Keywords: comprehensive yogic breathing program, diabetes mellitus, cardiac autonomic function

  4. Mupirocin for the reduction of colonization of internal jugular cannulae: a randomized controlled trial

    NARCIS (Netherlands)

    R.L.R. Hill; A. P. Fisher; R. J. Ware; S. Wilson; M. W. Casewell

    1990-01-01

    textabstractIn a prospective study, 218 cardiothoracic patients, in whom 'Abbocath-T' cannulae had been inserted preoperatively into the internal jugular vein, were randomized to receive skin preparation of the insertion site with tincture of iodine (108 controls) or tincture of iodine followed by a

  5. Psychological distress because of asking about suicidal thoughts: a randomized controlled trial among students.

    NARCIS (Netherlands)

    Beurs, D.P. de; Ghoncheh, R.; Geraedts, A.S.; Kerkhof, A.J.F.M.

    2016-01-01

    The aim of this study was to investigate the effect of the questions from the Beck Scale for Suicide Ideation on psychological well-being among healthy participants. In a randomized controlled study, 301 participants completed the same 4 questionnaires on psychopathology. The experimental group addi

  6. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    Science.gov (United States)

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  7. 77 FR 26789 - Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and...

    Science.gov (United States)

    2012-05-07

    ... violation of section 337 in the infringement of certain patents. 73 FR 75131. The principal respondent was... order. 75 FR 44989-90 (July 30, 2010). The Commission also issued cease and desist orders against those... COMMISSION Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers...

  8. Melatonin for Chronic Insomnia in Angelman Syndrome: A Randomized Placebo-Controlled Trial

    NARCIS (Netherlands)

    Braam, W.J.; Didden, H.C.M.; Smits, M.G.; Curfs, L.M.G

    2008-01-01

    Previous studies suggested that melatonin improves sleep in insomniac patients with Angelman syndrome. To assess the efficacy of melatonin, a randomized placebo-controlled study was conducted in 8 children with Angelman syndrome with idiopathic chronic insomnia. After a 1-week baseline period, patie

  9. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    Science.gov (United States)

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  10. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2008-01-01

    The transversus abdominis plane (TAP) block is an effective method of providing postoperative analgesia in patients undergoing midline abdominal wall incisions. We evaluated its analgesic efficacy over the first 48 postoperative hours after cesarean delivery performed through a Pfannensteil incision, in a randomized controlled, double-blind, clinical trial.

  11. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  12. Acupuncture-Point Stimulation for Postoperative Pain Control: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    Xian-Liang Liu; Jing-Yu Tan; Alex Molassiotis; Suen, Lorna K P; Yan Shi

    2015-01-01

    The purpose of this study was to evaluate the effectiveness of Acupuncture-point stimulation (APS) in postoperative pain control compared with sham/placebo acupuncture or standard treatments (usual care or no treatment). Only randomized controlled trials (RCTs) were included. Meta-analysis results indicated that APS interventions improved VAS scores significantly and also reduced total morphine consumption. No serious APS-related adverse effects (AEs) were reported. There is Level I evidence ...

  13. Physician–Pharmacist Cooperation Program for Blood Pressure Control in Patients With Hypertension: A Randomized-Controlled Trial

    OpenAIRE

    Tobari, Hiroko; Arimoto, Takanori; SHIMOJO, NOBUTAKE; Yuhara, Kiyomi; Noda, Hiroyuki; Yamagishi, Kazumasa; ISO, Hiroyasu

    2010-01-01

    BackgroundThe aim of the trial was to evaluate the effectiveness of a program of cooperation between physician and pharmacist to reduce cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure (BP) control, appropriate changes in antihypertensive medications, and beneficial changes in lifestyle.MethodsThe 132 subjects in this randomized, controlled trial were in the age range of 40–79 years. The inclusion criteria were: systolic BP (SBP) ra...

  14. The Effects of Implementation Intentions on Volunteer Firefighter Exercise Behavior: A Randomized Controlled Study

    OpenAIRE

    Hammer, Rodney L.

    2010-01-01

    The current study used a randomized control design to determine if an implementation intention intervention based on the Health Action Process Approach would increase exercise behavior in volunteer firefighters. One hundred forty-seven male and female volunteer firefighters from nine fire departments participated. The treatment group received a survey that prompted them to create exercise implementation intentions by describing "where," "when," and "how" they will exercise, while the control ...

  15. Omega-3 Supplementation Lowers Inflammation and Anxiety in Medical Students: A Randomized Controlled Trial

    OpenAIRE

    Kiecolt-Glaser, Janice K.; Belury, Martha A.; Andridge, Rebecca; Malarkey, William B.; Glaser, Ronald

    2011-01-01

    Observational studies have linked lower omega-3 (n-3) polyunsaturated fatty acids (PUFAs) and higher omega-6 (n-6) PUFAs with inflammation and depression, but randomized controlled trial (RCT) data have been mixed. To determine whether n-3 decreases proinflammatory cytokine production and depressive and anxiety symptoms in healthy young adults, this parallel group, placebo-controlled, double-blind 12-week RCT compared n-3 supplementation with placebo. The participants, 68 medical students, pr...

  16. Parent Training for Young Children With Developmental Disabilities: Randomized Controlled Trial

    OpenAIRE

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group (n = 23) received usual care, including early childhood education and related services. Results suggest that this parent training intervention was su...

  17. Intrapartum Amnioinfusion in Meconium Stained Amniotic Fluid- A Randomized Control Study In a Tertiary Care Hospital

    OpenAIRE

    Ashvin D Vachhani, Jitesh M Shah, Garima S Goel, Meghana N Mehta, Archish I Desai, Malati T Dalal

    2015-01-01

    "Objectives: The study was un-dertaken to evaluate maternal and Perinatal outcomes follow-ing transcervical intrapartum amnioinfusion in women with moderate to thick meconium stained amniotic fluid. Methods: A randomized control study was conducted on 200 women with moderate to thick meconium stained amniotic flu-id during labor. Group A (study group) of 100 cases received am-nioinfusion. Group B (control group) of 100 cases received standard obstetric care. Fetal heart rate monitori...

  18. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation

    OpenAIRE

    Nilsson Robert; Antić Ruza; Spasojević-Tišma Vera; Joksić Gordana; Rutqvist Lars E

    2011-01-01

    Abstract Background Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials. Methods We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enr...

  19. Antidepressants for bipolar disorder: A meta-analysis of randomized, double-blind, controlled trials

    OpenAIRE

    Zhang, Yingli; Yang, Huan; Yang, Shichang; Liang, Wei; DAI, Ping; Wang, Changhong; Zhang, Yalin

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepressants in the treatment of bipolar disorder. DATA SOURCES: A literature search of randomized, double-blind, controlled trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Controlled Trials databases. The keywords “bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed ma...

  20. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    OpenAIRE

    Dawson Church; De Asis, Midanelle A.; Brooks, Audrey J.

    2012-01-01

    Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI). Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques), a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were cond...

  1. Randomized controlled trials in relapsed/refractory follicular lymphoma: a systematic review and meta-analysis.

    Science.gov (United States)

    Police, Rachel L; Trask, Peter C; Wang, Jianmin; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Colosia, Ann; Njue, Annete; Sherril, Beth; Ruiz-Soto, Rodrigo; Kaye, James A; Hamadani, Mehdi

    2016-10-01

    This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, 1.2-23.2 months). Six of ten trials reported objective response rate (range, 9-93%). Meta-analysis showed only one statistically significant result: rituximab + bortezomib yielded a significantly higher objective response rate than rituximab monotherapy (relative risk, 1.28; 95% confidence interval, 1.11-1.47). Otherwise, there were no discernable differences in overall survival or progression-free survival, partly due to insufficient reporting of results in the clinical trials. The relatively small number of randomized controlled trials, few overlapping treatment arms, and variability in the randomized controlled trial features and in the endpoints studied complicate the formal comparison of therapies for relapsed/refractory follicular lymphoma. Additional well-designed randomized controlled trials are needed to fully understand the relative outcomes of older and more recently developed therapies. PMID:26320127

  2. o-ZrWl.6Mo0.408: A Novel Orthorhombic Intermediate Phase Formed During the Synthesis of the Negative Thermal Expansion Cubic ZrWl.6Mo0.4O8 Material by the Precursor Dehydration Route

    Institute of Scientific and Technical Information of China (English)

    赵新华; 黄令; 刘鹏辉; 马辉

    2003-01-01

    The mechanism of the precursor dehydration route was revealed for the synthesis of NTE c-ZrW1.6Mo0.4O8. The hydrate precursor was dehydrated at 473 K and transformed to a NTE cubic compound above 800 K. A novel intermediate phase o-ZrWl.6Mo0.4O8 occurs between the temperature range of 573-800 K. The XRD pattern of novel intermediate was refined with the structural model of LT-ZrMo2O8 by using Rietveld method.The residuals are Rwp=7.80% and Rp=5.79%. The space group is Pmn21 and the lattice parameters are α=0.5917(4)nm, b=0.7273(4) nm, c =0.9148(6) nm, and Z=2.

  3. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    OpenAIRE

    Akhtari, Elham; Raisi, Firoozeh; Keshavarz, Mansoor; Hosseini, Hamed; Sohrabvand, Farnaz; Bioos, Soodabeh; Kamalinejad, Mohammad; Ghobadi, Ali

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. De...

  4. Control of random Boolean networks via average sensitivity of Boolean functions

    Institute of Scientific and Technical Information of China (English)

    Chen Shi-Jian; Hong Yi-Guang

    2011-01-01

    In this paper, we discuss how to transform the disordered phase into an ordered phase in random Boolean networks. To increase the effectiveness, a control scheme is proposed, which periodically freezes a fraction of the network based on the average sensitivity of Boolean functions of the nodes. Theoretical analysis is carried out to estimate the expected critical value of the fraction, and shows that the critical value is reduced using this scheme compared to that of randomly freezing a fraction of the nodes. Finally, the simulation is given for illustrating the effectiveness of the proposed method.

  5. Impact of Seed Voucher System on Rice Farmers’ Welfare in Nigeria: A Randomized Control Trial Approach

    OpenAIRE

    Awotide, Bola Amoke; Awoyemi, Taiwo Timothy; Diagne, Aliou; Ojehomon, Vivian E.T.

    2012-01-01

    This study adopted Randomized Control Trial to examine the impact of seed voucher system on farming households’ welfare in Nigeria using cross-sectional data of 600 rice farmers randomly selected from the three major rice ecologies of Nigeria. The WALD estimate reveals that the use of seed voucher increased household Per Capita Expenditure (PCE) by N14705.91. While the result of the Local Average Treatment Effect (LATE), shows a positive and significant impact of N7928.15 on PCE. Therefore, t...

  6. Effects of nutrition education on weight gain prevention: a randomized controlled trial

    OpenAIRE

    Metzgar, Catherine J.; Nickols-Richardson, Sharon M.

    2016-01-01

    Background Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity. Methods This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18–45 y, with a body mass index (BMI) of >18.5 kg/m2. Eighty-seven women were randomized to a weight gain prevention intervention del...

  7. Unicursal random maze tool path for computer-controlled optical surfacing.

    Science.gov (United States)

    Wang, Chunjin; Wang, Zhenzhong; Xu, Qiao

    2015-12-01

    A novel unicursal random maze tool path is proposed in this paper, which can not only implement uniform coverage of the polishing surfaces, but also possesses randomness and multidirectionality. The simulation experiments along with the practical polishing experiments are conducted to make the comparison of three kinds of paths, including maze path, raster path, and Hilbert path. The experimental results validate that the maze path can warrant uniform polishing and avoid the appearance of the periodical structures in the polished surface. It is also more effective than the Hilbert path in restraining the mid-spatial frequency error in computer-controlled optical surfacing process. PMID:26836670

  8. Unicursal random maze tool path for computer-controlled optical surfacing.

    Science.gov (United States)

    Wang, Chunjin; Wang, Zhenzhong; Xu, Qiao

    2015-12-01

    A novel unicursal random maze tool path is proposed in this paper, which can not only implement uniform coverage of the polishing surfaces, but also possesses randomness and multidirectionality. The simulation experiments along with the practical polishing experiments are conducted to make the comparison of three kinds of paths, including maze path, raster path, and Hilbert path. The experimental results validate that the maze path can warrant uniform polishing and avoid the appearance of the periodical structures in the polished surface. It is also more effective than the Hilbert path in restraining the mid-spatial frequency error in computer-controlled optical surfacing process.

  9. Clinical Effect of Acupuncture on Endemic Skeletal Fluorosis: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Zhou Jincao

    2013-01-01

    Full Text Available Objective. To evaluate the effect of acupuncture on endemic skeletal fluorosis (ESF through the randomized controlled trial. Methods. Ninety-nine cases were divided into the treatment group (68 cases and the control group (31 cases randomly. Normal acupuncture combined with electroacupuncture was used in treatment group, while Caltrate with vitamin D tablets were applied in control group. After 2 courses, the VAS, urinary fluoride, serum calcium, and serum phosphate were evaluated before and after treatment. Results. Both of these two methods could relieve pain effectively and the effect of acupuncture was better (P<0.05. In treatment group, the content of urinary fluoride after treatment was higher than before (P<0.05, while the content of serum calcium and phosphate was lower (P<0.05. Conclusion. The effect of acupuncture on relieving pain and promoting discharge of urinary fluoride is better than that of western medicine. Acupuncture can reduce the content of serum calcium and phosphate.

  10. Study on semi-active control of mega-sub controlled structure by MR damper subject to random wind loads

    Institute of Scientific and Technical Information of China (English)

    Qin Xiangjun; Zhang Xun'an; Sheldon Cherry

    2008-01-01

    The recently proposed mega-sub controlled structure (MSCS), a new type of structure associated with the design and construction of super-tall buildings, has attracted the attention of designers for use in enhancing the control effectiveness in mega-fi'ame buildings. In this paper, a dynamic equation and method to assemble parameter matrixes for a mega-sub controlled structure under random wind loads is presented. Semi-active control using magnetorheological dampers for the MSCS under random wind loads is investigated, and is compared with a corresponding system without dampers. A parametric study of the relative stiffness ratio and relative mass ratio between the mega-frame and the substructures, as well as the additional column stiffness ratio that influences the response control effectiveness of the MSCS, is discussed. The studies reveal, for the first time, that different control mechanisms exist. The results indicate that the proposed structure employing semi-active control can offer an effective control mechanism. Guidelines for selecting parameters are provided based on the analytical study.

  11. One-step receding horizon H(∞) control for networked control systems with random delay and packet disordering.

    Science.gov (United States)

    Liu, Andong; Yu, Li; Zhang, Wen-An

    2011-01-01

    The receding horizon H(∞) control (RHHC) problem is investigated in this paper for a class of networked control systems (NCSs) with random delay and packet disordering. A new model is proposed to describe the NCS with random delay which may be larger than one sampling period. The random delay is modeled as a Markov chain while the closed-loop system is described as a Markovian jump system. Sufficient conditions for the closed-loop NCS to be stochastically stable and the performance index to be upper bounded are derived by using the receding optimization principle. Furthermore, by solving a semi-definite programming (SDP) with linear matrix inequalities (LMIs) constraint, a piecewise-constant receding horizon H(∞) controller is obtained, and the designed piecewise-constant controller ensures that the closed-loop NCS achieves a prescribed H(∞) disturbance attenuation level. Finally, an illustrative example is given to demonstrate the effectiveness of the proposed method. PMID:21036353

  12. Application of dietary fiber in clinical enteral nutrition: A meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Gang Yang; Xiao-Ting Wu; Yong Zhou; Ying-Li Wang

    2005-01-01

    AIM: To evaluate the effects of dietary fiber (DF) as a part of enteral nutrition (EN) formula on diarrhea, infection, and length of hospital stay.METHODS: Following electronic databases were searched for randomized controlled trials about DF: Chinese Biomedicine Database (CBM), MEDLINE, EMBASE and Cochrane Controlled Trials Register. RevMan 4.1 was used for statistical analysis.RESULTS: Seven randomized controlled trials with 400pat-ients were included. The supplement of DF in EN was compared with standard enteral formula in five trials.Combined analysis did not show a significant reduction in occurrence of diarrhea, but there were valuable results for non-critically iii patients. Combined analysis of two trials observing the infection also did not show any valid evidence that DF could decrease the infection rate, though the length of hospital stay was reduced significantly.CONCLUSION: Based on the current eligible randomized controlled trials, there is no evidence that the value of DF in the diarrhea can be proved. Though length of hospital stay was shortened by the use of DF, there is no available evidence in preventing infection by DF. Further studies are needed for evaluating the value of DF in EN.

  13. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

  14. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Bindu John

    2016-01-01

    Full Text Available Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n=34; control group, n=24. Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

  15. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

    Directory of Open Access Journals (Sweden)

    Francesco Cerritelli

    Full Text Available Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes.The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group or osteopathic manipulative treatment (study group. The primary outcome was the mean difference in length of hospital stay between groups.A total of 695 newborns were randomly assigned to either the study group (n= 352 or the control group (n=343. A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31. Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001. Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001 but not in daily weight gain. There were no complications associated to the intervention.Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

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

    Science.gov (United States)

    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.

  17. Comparison of two purification products of shankha bhasma: A prospective randomized control trial

    Science.gov (United States)

    Ranade, Manjiri; Chary, Dingari Laxmana

    2013-01-01

    Background: Shankha bhasma is widely used in the treatment of gastroesophageal reflux disease (GERD) patients. Aim: To compare the efficacy of two purification methods of shankha bhasma in relieving GERD symptoms. In method A, purification was done with lemon juice and method B with sour gruel. Materials and Methods: Patients with heartburn since at least four days/week but who did undergo endoscopy to assess esophageal mucosa could participate. In this single-phase, single-center, prospective, randomized control trial, the patients were randomized to receive either shankha bhasma purified by method A or by method B. The primary efficacy variable was the proportion of patients with resolution of heartburn at week 4 and week 8. Design: Single-phase, single-center, prospective, randomized control trial in a hospital setting. Results: Of the total 70 patients who received samples A and B in a randomized double-blind manner, 65% of the patients showed resolution of symptoms in sample A and 28% in sample B at the end of four weeks, whereas, 71% of the patients showed resolution of symptoms in sample A and 31% in sample B at the end of eight weeks; P value was statistically significant for resolution of symptoms (P <0.005). Conclusion: Purification of shankha bhasma by lemon juice method is better than sour gruel method in terms of clinical outcome in GERD patients and is hence recommended. PMID:23633854

  18. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  19. Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial

    OpenAIRE

    Andersson, Neil; Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

    2015-01-01

    Objective To test whether community mobilization adds effectiveness to conventional dengue control. Design Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Setting Random sam...

  20. LA Sprouts Randomized Controlled Nutrition, Cooking and Gardening Program Reduces Obesity and Metabolic Risk in Latino Youth

    OpenAIRE

    Gatto, Nicole M.; Martinez, Lauren C.; Spruijt-Metz, Donna; Davis, Jaimie N.

    2015-01-01

    Objective To assess the effects of a 12-week gardening, nutrition, and cooking intervention (“LA Sprouts”) on dietary intake, obesity parameters and metabolic disease risk among low-income, primarily Hispanic/Latino youth in Los Angeles. Methods Randomized control trial involving four elementary schools [2 schools randomized to intervention (172, 3rd–5th grade students); 2 schools randomized to control (147, 3rd–5th grade students)]. Classes were taught in 90-minute sessions once a week to ea...

  1. Speed synchronization control for integrated automotive motor-transmission powertrain system with random delays

    Science.gov (United States)

    Zhu, Xiaoyuan; Zhang, Hui; Fang, Zongde

    2015-12-01

    This paper presents a robust speed synchronization controller design for an integrated motor-transmission powertrain system in which the driving motor and multi-gearbox are directly coupled. As the controller area network (CAN) is commonly used in the vehicle powertrain system, the possible network-induced random delays in both feedback and forward channel are considered and modeled by using two Markov chains in the controller design process. For the application perspective, the control law adopted here is a generalized proportional-integral (PI) control. By employing the system-augmentation technique, a delay-free stochastic closed-loop system is obtained and the generalized PI controller design problem is converted to a static output feedback (SOF) controller design problem. Since there are external disturbances involved in the closed-loop system, the energy-to-peak performance is considered to guarantee the robustness of the controller. And the controlled output is chosen as the speed synchronization error. To further improve the transient response of the closed-loop system, the pole placement is also employed in the energy-to-peak performance based speed synchronization control. The mode-dependent control gains are obtained by using an iterative linear matrix inequality (LMI) algorithm. Simulation results show the effectiveness of the proposed control approach.

  2. Comparative efficacy of aloe vera mouthwash and chlorhexidine on periodontal health: A randomized controlled trial

    Science.gov (United States)

    Jha, Abhishek; Bhashyam, Mamtha

    2016-01-01

    Background With introduction of many herbal medicines, dentistry has recently evidenced shift of approach for treating many inflammatory oral diseases by using such modalities. Aloe vera is one such product exhibiting multiple benefits and has gained considerable importance in clinical research recently. Aim To compare the efficacy of Aloevera and Chlorhexidine mouthwash on Periodontal Health. Material and Methods Thirty days randomized controlled trial was conducted among 390 dental students. The students were randomized into two intervention groups namely Aloe Vera (AV) chlorhexidine group (CHX) and one control (placebo) group. Plaque index and gingival index was recorded for each participant at baseline, 15 days and 30 days. The findings were than statistically analyzed, ANOVA and Post Hoc test were used. Results There was significant reduction (pAloe Vera (AV) and chlorhexidine group. Post hoc test showed significant difference (paloe Vera and placebo and chlorhexidine and placebo group. No significant difference (pAloe vera, chlorhexidine, dental plaque, gingivitis. PMID:27703614

  3. Prayer and healing: A medical and scientific perspective on randomized controlled trials.

    Science.gov (United States)

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect on outcomes, to worsen outcomes and to have retrospective healing effects. For a multitude of reasons, research on the healing effects of prayer is riddled with assumptions, challenges and contradictions that make the subject a scientific and religious minefield. We believe that the research has led nowhere, and that future research, if any, will forever be constrained by the scientific limitations that we outline.

  4. Prevention of low back pain in female eldercare workers: randomized controlled work site trial

    DEFF Research Database (Denmark)

    Jensen, Lone Donbæk; Gonge, Henrik Gjesing; Jørs, Erik;

    2006-01-01

    Study Design. Randomized controlled trial. Objective. To evaluate the effectiveness of an ergonomic and psychosocial intervention in reducing low back pain (LBP) among health care workers. Summary of Background Data. LBP and injuries are reported frequently among health care workers worldwide...... arms over the study period. Conclusion. The study showed no effect of a transfer technique or stress management program targeting LBP. Thus, there is a need for discussing other priorities in the prevention of LBP among health care workers........ Improvement of person-transfer techniques is the preferred tool in the prevention of both. Although popular, to our knowledge, any effect has not been documented in controlled trials. Methods. Study participants were eldercare workers from 19 eldercare groups randomly assigned to the transfer technique...

  5. Building social resilience in soldiers: A double dissociative randomized controlled study.

    Science.gov (United States)

    Cacioppo, John T; Adler, Amy B; Lester, Paul B; McGurk, Dennis; Thomas, Jeffrey L; Chen, Hsi-Yuan; Cacioppo, Stephanie

    2015-07-01

    Can social resilience be trained? We report results of a double-dissociative randomized controlled study in which 48 Army platoons were randomly assigned to social resilience training (intervention condition) or cultural awareness training (active control group). The same surveys were administered to all platoons at baseline and after the completion of training to determine the short-term training effects, generalization effects beyond training, and possible adverse effects. Multilevel modeling analyses indicated that social resilience, compared with cultural awareness, training produced small but significant improvements in social cognition (e.g., increased empathy, perspective taking, & military hardiness) and decreased loneliness, but no evidence was found for social resilience training to generalize beyond these training foci nor to have adverse effects. Moreover, as predicted, cultural awareness, compared with social resilience, training produced increases in knowledge about and decreases in prejudice toward Afghans. Additional research is warranted to determine the long-term durability, safety, and generalizability of social resilience training. PMID:26098588

  6. ALCOHOLIC VERSUS NONALCOHOLIC CIRRHOSIS IN A RANDOMIZED CONTROLLED TRIAL OF EMERGENCY THERAPY OF BLEEDING VARICES

    Science.gov (United States)

    Orloff, Marshall J.; Isenberg, Jon I.; Wheeler, Henry O.; Haynes, Kevin S.; Jinich-Brook, Horacio; Rapier, Roderick; Vaida, Florin; Hye, Robert J.; Orloff, Susan L.

    2010-01-01

    Background It has been proposed that portal-systemic shunts be avoided in alcoholic cirrhotics because survival rate is allegedly lower in alcoholics than in nonalcoholics. We examined this issue in a randomized controlled trial. Methods 211 unselected, consecutive patients with cirrhosis and bleeding esophageal varices were randomized to endoscopic sclerotherapy (EST) (n=106) or emergency portacaval shunt (EPCS) (105). Treatment was initiated within 8 hours. EST failure was treated by rescue PCS. 10-yr follow-up was 96%. Results Results strongly favored EPCS over EST (p<0.001). Among EPCS patients, 83% were alcoholic and 17% nonalcoholic. Outcomes were (1) permanent control of bleeding 100% vs. 100%; (2) 5-yr survival 71% vs.78%; (3) encephalopathy 14% vs. 19%; (4) yearly charges $38,300 vs. $43,000. Conclusions EPCS results were similar in alcoholic and nonalcoholic cirrhotics. EPCS is an effective first line emergency treatment in all forms of cirrhosis, including alcoholic. PMID:21195430

  7. Filtering random matrices: the effect of incomplete channel control in multiple scattering.

    Science.gov (United States)

    Goetschy, A; Stone, A D

    2013-08-01

    We present an analytic random matrix theory for the effect of incomplete channel control on the measured statistical properties of the scattering matrix of a disordered multiple-scattering medium. When the fraction of the controlled input channels, m1, and output channels, m2, is decreased from unity, the density of the transmission eigenvalues is shown to evolve from the bimodal distribution describing coherent diffusion, to the distribution characteristic of uncorrelated Gaussian random matrices, with a rapid loss of access to the open eigenchannels. The loss of correlation is also reflected in an increase in the information capacity per channel of the medium. Our results have strong implications for optical and microwave experiments on diffusive scattering media. PMID:23971574

  8. Feasibility, Safety, and Compliance in a Randomized Controlled Trial of Physical Therapy for Parkinson's Disease

    Directory of Open Access Journals (Sweden)

    Jennifer L. McGinley

    2012-01-01

    Full Text Available Both efficacy and clinical feasibility deserve consideration in translation of research outcomes. This study evaluated the feasibility of rehabilitation programs within the context of a large randomized controlled trial of physical therapy. Ambulant participants with Parkinson's disease (PD (n=210 were randomized into three groups: (1 progressive strength training (PST; (2 movement strategy training (MST; or (3 control (“life skills”. PST and MST included fall prevention education. Feasibility was evaluated in terms of safety, retention, adherence, and compliance measures. Time to first fall during the intervention phase did not differ across groups, and adverse effects were minimal. Retention was high; only eight participants withdrew during or after the intervention phase. Strong adherence (attendance >80% did not differ between groups (P=.435. Compliance in the therapy groups was high. All three programs proved feasible, suggesting they may be safely implemented for people with PD in community-based clinical practice.

  9. Affective-Cognitive Behavioral Therapy for Fibromyalgia: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Robert L. Woolfolk

    2012-01-01

    Full Text Available A randomized controlled trial was conducted to assess the efficacy of an individually administered form of cognitive behavioral treatment for fibromyalgia. In an additive design, 76 patients diagnosed with fibromyalgia were randomly assigned to either the experimental treatment (affective-cognitive behavioral therapy, 10 individual sessions, one per week administered concurrently with treatment-as-usual or to an unaugmented treatment-as-usual condition. Statistical analysis conducted at the end of treatment (3 months after the baseline assessment and at a followup (9 months after the baseline assessment indicated that the patients receiving the experimental treatment reported less pain and overall better functioning than control patients, both at posttreatment and at followup. The implications of these findings for future research are discussed.

  10. Study designs of randomized controlled trials not based on Chinese medicine theory are improper

    Directory of Open Access Journals (Sweden)

    Jiao Yan

    2009-02-01

    Full Text Available Abstract Current biomedical research methods to evaluate the efficacy of Chinese medicine interventions are often conceptually incompatible with the theory and clinical practice of Chinese medicine. In this commentary, we (1 highlight the theory and principles underlying Chinese medicine clinical practice; (2 use ginseng as an example to describe clinical indications in Chinese medicine; (3 propose a framework guided by Chinese medicine theory for the evaluation of study designs in Chinese medicine research; and (4 evaluate 19 randomized, double-blind, placebo-controlled trials of ginseng. Our analysis indicates that all 19 trials with both positive and negative results confirm the specific effects of ginseng indicated by Chinese medicine theory. Study designs guided by Chinese medicine theory are necessary to validate and improve future randomized controlled clinical trials in Chinese medicine.

  11. Estimating optimal treatment regimes via subgroup identification in randomized control trials and observational studies.

    Science.gov (United States)

    Fu, Haoda; Zhou, Jin; Faries, Douglas E

    2016-08-30

    With new treatments and novel technology available, personalized medicine has become an important piece in the new era of medical product development. Traditional statistics methods for personalized medicine and subgroup identification primarily focus on single treatment or two arm randomized control trials. Motivated by the recent development of outcome weighted learning framework, we propose an alternative algorithm to search treatment assignments which has a connection with subgroup identification problems. Our method focuses on applications from clinical trials to generate easy to interpret results. This framework is able to handle two or more than two treatments from both randomized control trials and observational studies. We implement our algorithm in C++ and connect it with R. Its performance is evaluated by simulations, and we apply our method to a dataset from a diabetes study. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26892174

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

    Science.gov (United States)

    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

  13. Preventive home visits to older people in Denmark: methodology of a randomized controlled study

    DEFF Research Database (Denmark)

    Vass, Mikkel; Avlund, Kirsten; Hendriksen, Carsten;

    2002-01-01

    BACKGROUND AND AIMS: Preventive home visits were introduced by legislation in Denmark in 1998. This ongoing randomized controlled intervention study introduces a model where preventive home visits to elderly people are carried out in a standardized way, focusing on early signs of disability...... of the study. METHODS: The design was a prospective, controlled, follow-up study conducted over a 3-year period (1999-2001) with randomization and intervention at the community level, and outcomes measured at an individual level among people living in those communities. The study included 17 pairs...... comparable. The intervention was well accepted and feasible. CONCLUSIONS: When results become available, the study should reveal the most important factors for preventive home visits to elderly people....

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

    Science.gov (United States)

    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.

  15. Magnesium carbonate for phosphate control in patients on hemodialysis. A randomized controlled trial

    OpenAIRE

    Tzanakis, Ioannis P.; Papadaki, Antonia N.; Wei, Mingxin; Kagia, Stella; Spadidakis, Vlassios V.; Kallivretakis, Nikolaos E.; Oreopoulos, Dimitrios G

    2008-01-01

    Background Magnesium salts bind dietary phosphorus, but their use in renal patients is limited due to their potential for causing side effects. The aim of this study was to evaluate the efficacy and safety of magnesium carbonate (MgCO3) as a phosphate-binder in hemodialysis patients. Methods Forty-six stable hemodialysis patients were randomly allocated to receive either MgCO3 (n = 25) or calcium carbonate (CaCO3), (n = 21) for 6 months. The concentration of Mg in the dialysate bath was 0.30 ...

  16. Citalopram controls phobic symptoms in patients with panic disorder: randomized controlled trial.

    OpenAIRE

    Leinonen, E.; Lepola, U; Koponen, H; Turtonen, J; Wade, A; Lehto, H

    2000-01-01

    OBJECTIVE: To examine the effects of long-term treatment with citalopram or clomipramine on subjective phobic symptoms in patients with panic disorder. DESIGN: Double-blind, parallel-group, five-arm study. PATIENTS: Patients aged 18 to 65 years with panic disorder (DMS-III-R diagnosis) and with no major depressive symptoms. INTERVENTIONS: Four hundred and seventy-five patients were randomized to 8 weeks of treatment with either citalopram (10 to 15 mg per day; 20 to 30 mg per day; or 40 to 60...

  17. A critical appraisal of the evidence for using cardiotocography plus ECG ST interval analysis for fetal surveillance in labor. Part I: The randomized controlled trials

    OpenAIRE

    Olofsson, Per; Ayres-de-Campos, Diogo; Kessler, Jörg; Tendal, Britta; Yli, Branislava Markovic; Devoe, Lawrence

    2014-01-01

    We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis (CTG+ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in ope...

  18. Mixed methods evaluation of a randomized control pilot trial targeting sugar-sweetened beverage behaviors

    OpenAIRE

    Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul

    2013-01-01

    This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER)...

  19. New drugs with novel therapeutic characteristics. Have they been subject to randomized controlled trials?

    OpenAIRE

    Lexchin, Joel

    2002-01-01

    OBJECTIVE: To determine how many randomized controlled trials on the safety or efficacy of new drugs are published when these drugs are first marketed in Canada, and to determine the quality of the information in those trials. DESIGN: A MEDLINE search was conducted on each drug identified as having novel therapeutic characteristics and first marketed between 1990 and 2000. MAIN OUTCOME MEASURES: Number of trials dealing with the safety or efficacy of each drug published at the time the drug w...

  20. Randomized Controlled Trials: A Systematic Review of Laparoscopic Surgery and Simulation-Based Training

    OpenAIRE

    2014-01-01

    Introduction This systematic review was conducted to analyze the impact and describe simulation-based training and the acquisition of laparoscopic surgery skills during medical school and residency programs. Methods This systematic review focused on the published literature that used randomized controlled trials to examine the effectiveness of simulation-based training to develop laparoscopic surgery skills. Searching PubMed from the inception of the databases to May 1, 2014 and specific hand...

  1. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    OpenAIRE

    Marie Pirotta; Roberta Chow; Ian Relf

    2008-01-01

    Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or b...

  2. Engaging rural women in healthy lifestyle programs: insights from a randomized controlled trial

    OpenAIRE

    Kozica, Samantha L.; Harrison, Cheryce L; Teede, Helena J.; Ng, Sze; Moran, Lisa J.; Lombard, Catherine B

    2015-01-01

    Background The obesity epidemic is well established, particularly in rural settings. Programs promoting healthy lifestyles for rural women are urgently needed; however, participant engagement is challenging. In the context of a large randomized controlled trial targeting the prevention of weight gain in rural women, we explored successful recruitment strategies and aimed to understand participants’ barriers, enablers and reasons for program participation. Methods We recruited women (aged 18–5...

  3. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    OpenAIRE

    Ceren Acarturk; Emre Konuk; Mustafa Cetinkaya; Ibrahim Senay; Marit Sijbrandij; Pim Cuijpers; Tamer Aker

    2015-01-01

    Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-...

  4. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    OpenAIRE

    Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

    2015-01-01

    Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population.Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees.Method: Twenty-ni...

  5. Randomized Controlled Trial of Brief Interventions to Reduce College Students’ Drinking and Risky Sex

    OpenAIRE

    Dermen, Kurt H.; Thomas, Sherilyn N.

    2011-01-01

    The present study tested the proposition that an intervention to reduce alcohol use among college students will also reduce their risky sexual behavior. In a randomized, controlled trial, 154 heavy-drinking, predominantly White, heterosexual college students at behavioral risk for infection with HIV and other STDs were assigned to receive no intervention or a two-session, in-person, motivational interviewing-based intervention focused on either: (a) reducing alcohol risk behavior, (b) reducin...

  6. Self-administered acupressure for treating adult psychiatric patients with constipation: a randomized controlled trial

    OpenAIRE

    Wong, Wai Kit; Chien, Wai Tong; Lee, Wai Ming

    2015-01-01

    Background Constipation has a high prevalence rate (>30 %) in psychiatric patients with psychotropic drugs. Common pharmacological and non-pharmacological interventions for constipation might have longer-term negative and adverse effects that would outweigh their short-term efficacy in symptom reduction. This randomized controlled trial aims to investigate the effect of self-administered acupressure for the management of constipation, in hospitalized psychiatric patients. Methods Seventy-eigh...

  7. Acupuncture for the treatment of urinary incontinence: A review of randomized controlled trials

    OpenAIRE

    PAIK, SUN-HO; HAN, SU-RYUN; Kwon, Oh-Jun; AHN, YOUNG-MIN; Lee, Byung-Cheol; AHN, SE-YOUNG

    2013-01-01

    The aim of this study was to examine the effects of acupuncture on urinary incontinence and to discuss why these acupoints were selected. Seven databases were searched for any randomized controlled trials (RCTs) that investigated the use of acupuncture or acupressure as a treatment for urinary incontinence, and the Cochrane risk of bias tool was utilized to evaluate the risk of bias in each study. Four RCTs met all the inclusion criteria. The results from the selected RCTs failed to demonstra...

  8. Acupressure, reflexology, and auricular acupressure for insomnia: A systematic review of randomized controlled trials

    OpenAIRE

    Chung, KF; Zhang, ZJ; Poon, MMK; Ho, FYY; Zhang, SP; Ziea, ETC; Wong, VT; Yeung, WF

    2012-01-01

    Previous randomized controlled trials (RCTs) have shown that acupuncture may be efficacious for insomnia. Instead of needling, acupressure, reflexology, and auricular acupressure are procedures involving physical pressure on acupoints or reflex areas. These variants of acupuncture are gaining popularity, perhaps due to their non-invasive nature. A systematic review has therefore been conducted to examine their efficacy and safety for insomnia. Two independent researchers searched five English...

  9. Effects of yoga exercises for headaches: a systematic review of randomized controlled trials

    OpenAIRE

    Kim, Sang-Dol

    2015-01-01

    [Purpose] To assess the evidence for the effectiveness of yoga exercises in the management of headaches. [Subjects and Methods] A search was conducted of six electronic databases to identify randomized controlled trials (RCTs) reporting the effects of yogic intervention on headaches published in any language before January 2015. Quality assessment was conducted using the Cochrane risk of bias tool. [Results] One potential trial was identified and included in this review. The quality critical ...

  10. Critical appraisal skills training for health care professionals: a randomized controlled trial [ISRCTN46272378

    OpenAIRE

    Ewings Paul E; Reeves Barnaby C; Taylor Rod S; Taylor Rebecca J

    2004-01-01

    Abstract Introduction Critical appraisal skills are believed to play a central role in an evidence-based approach to health practice. The aim of this study was to evaluate the effectiveness and costs of a critical appraisal skills educational intervention aimed at health care professionals. Methods This prospective controlled trial randomized 145 self-selected general practitioners, hospital physicians, professions allied to medicine, and healthcare managers/administrators from the South West...

  11. Effect of Head Covering on Phototherapy-Induced Hypocalcaemia in Icterus Newborns; A Randomized Controlled Trial

    OpenAIRE

    Kargar, Marzieh; Jamshidi, Zahra; Beheshtipour, Nooshin; Pishva, Narjes; Jamali, Maryam

    2014-01-01

    Background: Although phototherapy has been used for more than 60 years it has some complications. The light waves produced from phototherapy reduce melatonin concentration in newborns with subsequent hypocalcemia. We aimed to assess the effect of head covering on calcium and magnesium levels in full term newborns during phototherapy. Methods: In this randomized controlled trial, 72 full-term icterus newborns weighing >2500 gr with indirect hyperbillirubinemia who received phototherapy at the ...

  12. Effects of Saccharomyces boulardii on Neonatal Hyperbilirubinemia: A Randomized Controlled Trial

    OpenAIRE

    GÜRSOY, Tuğba; Ovalı, Fahri; Karatekin, Güner

    2015-01-01

    Objective Since probiotics modulate intestinal functions and enterohepatic circulation; they might have an effect on neonatal hyperbilirubinemia treatment. The objective of this study was to investigate the efficacy of Saccharomyces boulardii supplementation on hyperbilirubinemia. Study Design A prospective, double-blind, placebo controlled trial was performed on 35 to 42 gestational weeks' neonates. They were randomized either to receive feeding supplementation with S. boulardii 125 mg every...

  13. Cognitive Benefits of Social Dancing and Walking in Old Age: The Dancing Mind Randomized Controlled Trial

    OpenAIRE

    Merom, Dafna; Grunseit, Anne; Eramudugolla, Ranmalee; Jefferis, Barbara; McNeill, Jade; Anstey, Kaarin J

    2016-01-01

    Background A physically active lifestyle has the potential to prevent cognitive decline and dementia, yet the optimal type of physical activity/exercise remains unclear. Dance is of special interest as it complex sensorimotor rhythmic activity with additional cognitive, social, and affective dimensions. Objectives To determine whether dance benefits executive function more than walking, an activity that is simple and functional. Methods Two-arm randomized controlled trial a...

  14. Reading and solving arithmetic problems improves cognitive functions of normal aged people: a randomized controlled study

    OpenAIRE

    UCHIDA, Shinya; Kawashima, Ryuta

    2008-01-01

    The relationship between mental exercise and mental aging is a controversial issue. People generally believe the so-called mental-exercise hypothesis, that is, the age-related decline in cognitive function is less pronounced for people who are mentally active, yet there is insufficient scientific evidence supporting this hypothesis. Previous randomized controlled trial studies showed convincing beneficial effects of cognitive training on directly targeted cognitive functions. In this study, w...

  15. The Anxiolytic Effect of Aromatherapy on Patients Awaiting Ambulatory Surgery: A Randomized Controlled Trial

    OpenAIRE

    Cheng-Hua Ni; Wen-Hsuan Hou; Ching-Chiu Kao; Ming-Li Chang; Lee-Fen Yu; Chia-Che Wu; Chiehfeng Chen

    2013-01-01

    The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil) and control (water vapor) conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromath...

  16. A systematic mapping review of Randomized Controlled Trials (RCTs in care homes

    Directory of Open Access Journals (Sweden)

    Gordon Adam L

    2012-06-01

    Full Text Available Abstract Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated.

  17. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

    OpenAIRE

    Paul Ratanasiripong; Nop Ratanasiripong; Duangrat Kathalae

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on h...

  18. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

    Science.gov (United States)

    Schmidt, Stefan; Grossman, Paul; Schwarzer, Barbara; Jena, Susanne; Naumann, Johannes; Walach, Harald

    2011-02-01

    Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P=0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P=0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences. In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness

  19. Randomized Controlled Trials on Complementary and Traditional Medicine in the Korean Literature

    OpenAIRE

    Chang-Kyu Kim; Da-Hee Kim; Myeong Soo Lee; Jong-In Kim; L. Susan Wieland; Byung-Cheul Shin

    2014-01-01

    Objective. This study aimed to identify all of the features of complementary and alternative (CAM) randomized controlled trials (RCTs) in the Korean literature and then introduce English-speaking researchers to the bibliometric and risk of bias characteristics of this literature. Methods. Eleven electronic databases and sixteen Korean journals were searched to August 2013 for RCTs of CAM therapies. Key study characteristics were extracted and risk of bias was assessed using the Cochrane Colla...

  20. The Reduction of Distress Using Therapeutic Geothermal Water Procedures in a Randomized Controlled Clinical Trial

    OpenAIRE

    Lolita Rapolienė; Artūras Razbadauskas; Antanas Jurgelėnas

    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 i...

  1. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials

    OpenAIRE

    Jang, Soobin; Jang, Bo-Hyoung; Ko, Youme; Sasaki, Yui; Park, Jeong-Su; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keyw...

  2. Multimedia-based training on Internet platforms improves surgical performance: a randomized controlled trial

    OpenAIRE

    Pape-Koehler, Carolina; Immenroth, Marc; Sauerland, Stefan; Lefering, Rolf; Lindlohr, Cornelia; Toaspern, Jens; Heiss, Markus

    2013-01-01

    Background Surgical procedures are complex motion sequences that require a high level of preparation, training, and concentration. In recent years, Internet platforms providing surgical content have been established. Used as a surgical training method, the effect of multimedia-based training on practical surgical skills has not yet been evaluated. This study aimed to evaluate the effect of multimedia-based training on surgical performance. Methods A 2 × 2 factorial, randomized controlled tria...

  3. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    OpenAIRE

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2013-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was hig...

  4. Testing for Placebo Effects Using Data from Blinded, Randomized Controlled Trials

    OpenAIRE

    Anup Malani

    2004-01-01

    This paper proposes a test for the existence of placebo effects, as described by the so-called expectancy theory. This theory, which is the dominant medical theory of how placebo effects operate, posits that health outcomes rise in individuals' beliefs about the probability that they are getting a beneficial treatment and their beliefs about the efficacy of that treatment. Blinded, randomized, controlled trials provide near-perfect environments in which to test this theory because they offer ...

  5. Efficacy of 5-nitroimidazoles for the treatment of giardiasis: a systematic review of randomized controlled trials.

    OpenAIRE

    Vinay Pasupuleti; Angel Arturo Escobedo; Abhishek Deshpande; Priyaleela Thota; Yuani Roman; Adrian V Hernandez

    2014-01-01

    BACKGROUND: Giardiasis is one of the most common causes of diarrheal disease worldwide and 5-nitroimidazoles (5-NI) are the most commonly prescribed drugs for the treatment of giardiasis. We evaluated the efficacy of 5-nitroimidazoles (5-NI) in the treatment of giardiasis in a systematic review of randomized controlled trials (RCTs). METHODOLOGY/PRINCIPAL FINDINGS: We conducted a comprehensive literature search in PubMed-Medline, Scopus, Web of Science and Cochrane Library for RCTs evaluating...

  6. Efficacy of 5-Nitroimidazoles for the Treatment of Giardiasis: A Systematic Review of Randomized Controlled Trials

    OpenAIRE

    Pasupuleti, Vinay; Escobedo, Angel Arturo; Deshpande, Abhishek; Thota, Priyaleela; Roman, Yuani; Adrian V Hernandez

    2014-01-01

    Background Giardiasis is one of the most common causes of diarrheal disease worldwide and 5-nitroimidazoles (5-NI) are the most commonly prescribed drugs for the treatment of giardiasis. We evaluated the efficacy of 5-nitroimidazoles (5-NI) in the treatment of giardiasis in a systematic review of randomized controlled trials (RCTs). Methodology/Principal Findings We conducted a comprehensive literature search in PubMed-Medline, Scopus, Web of Science and Cochrane Library for RCTs evaluating t...

  7. The Effect of Acupressure on Sleep Quality in Menopausal Women: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Zahra Abedian

    2015-07-01

    Full Text Available Background: One of the common problems in menopausal women is sleep disorder. Traditional Chinese acupressure is a noninvasive and safe technique. Menopausal women can easily learn the technique and a self-care method to manage their sleep disorder. This study was carried out to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women in Mashhad during 2009. Methods: This double blind, randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65 years. Their sleep quality was measured according to the Pittsburgh Sleep Quality Index (PSQI. Participants were randomly assigned to an acupressure group (n=37, a sham acupressure group (n=36 and a control group (n=32 by two time randomized method (systematic and simple randomized. These interventions were carried out for four consecutive weeks. The participants in the acupressure and sham acupressure groups learned to carry out the acupressure technique as a self-care at home with simultaneous massage techniques that were to be performed 2 hours before sleep, whereas only conversation was used in the control group. The data were analyzed by the SPSS software version 17. Results: The results indicated significant differences in total PSQI scores among the three groups (P<0.001. Tukey’s test revealed that there were significant differences between the acupressure group and the control group (P<0.001, the acupressure group and sham acupressure group (P<0.001, and the sham acupressure and the control group (P<0.001. Conclusion: Acupressure can be used as a complementary treatment to relieve sleep disorders in menopausal women; and is offered as an efficient method to manage sleep quality. Trial Registration Number: IRCT2013100614910N1.

  8. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    OpenAIRE

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C.; Thurston, Wilfreda E.; Newby-Clark, Ian R.; Radtke, H Lorraine; Hobden, Karen L

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program c...

  9. Recruiting and Retaining Family Caregivers to a Randomized Controlled Trial on Mindfulness-Based Stress Reduction

    OpenAIRE

    Whitebird, Robin R; Kreitzer, Mary Jo; Lewis, Beth A.; Hanson, Leah R.; Crain, A Lauren; Enstad, Chris J; Mehta, Adele

    2011-01-01

    Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind-body based complementary therapies. Our pilot study is the first of its kind to successfully recruit caregivers for a family member with dementia to a randomized controlled pilot study of mindfulness-based stre...

  10. Sublingual buprenorphine for acute renal colic pain management: a double-blind, randomized controlled trial

    OpenAIRE

    Payandemehr, Pooya; Jalili, Mohammad; Mostafazadeh Davani, Babak; Dehpour, Ahmad Reza

    2014-01-01

    Background The aim of this study was to compare the efficacy and safety of sublingual buprenorphine with intravenous morphine sulfate for acute renal colic in the emergency department. Methods In this double-dummy, randomized controlled trial, we enrolled patients aged 18 to 55 years who had a clinical diagnosis of acute renal colic. Patients received either 2 mg sublingual buprenorphine with an IV placebo, or 0.1 mg/kg IV morphine sulfate with a sublingual placebo. Subjects graded their pain...

  11. Ondansetron reducing pain on injection of etomidate: a controlled randomized study

    OpenAIRE

    Omid Azimaraghi; Yasaman Aghajani; Maziar Molaghadimi; Malihe Khosravi; Kobra Eslami; Fatemeh Ghadimi; Ali Movafegh

    2014-01-01

    Introduction: Etomidate causes pain when injected intravenously. In this study we sought to determine if pretreatment by ondansetron reduces the pain on injection of etomidate. Methods: In this randomized, double blinded, placebo-controlled clinical trial, 20 patients of both sexes aged between 18 and 50 years of American Society of Anesthesiologists (ASA) physical status class I or II, whom were candidates for various elective surgical procedures and need more than one intravenous acces...

  12. Continuous terlipressin versus vasopressin infusion in septic shock (TERLIVAP): a randomized, controlled pilot study

    OpenAIRE

    Morelli, Andrea; Ertmer, Christian; Rehberg, Sebastian; Lange, Matthias; Orecchioni, Alessandra; Cecchini, Valeria; Bachetoni, Alessandra; D'Alessandro, Mariadomenica; Van Aken, Hugo; Pietropaoli, Paolo; Westphal, Martin

    2009-01-01

    Introduction Recent clinical data suggest that early administration of vasopressin analogues may be advantageous compared to a last resort therapy. However, it is still unknown whether vasopressin and terlipressin are equally effective for hemodynamic support in septic shock. The aim of the present prospective, randomized, controlled pilot trial study was, therefore, to compare the impact of continuous infusions of either vasopressin or terlipressin, when given as first-line therapy in septic...

  13. Remifentanil for endotracheal intubation in premature infants: A randomized controlled trial

    OpenAIRE

    Badiee, Zohreh; Vakiliamini, Mazyar; Mohammadizadeh, Majid

    2013-01-01

    Objective: Endotracheal intubation is a common procedure in neonatal care. The objective of this study was to determine whether the premedication with remifentanil before intubation has analgesic effects in newborn infants. Methods: A total of 40 premature infants who needed endotracheal intubation for intubation-surfactant-extubation method were randomly assigned in two groups of an equal number at two university hospitals. The control group was given 10 μg/kg atropine IV infusions in 1 min ...

  14. Quantifying Bias in Randomized Controlled Trials in Child Health: A Meta-Epidemiological Study

    OpenAIRE

    Lisa Hartling; Hamm, Michele P.; Fernandes, Ricardo M; Dryden, Donna M.; Ben Vandermeer

    2014-01-01

    OBJECTIVE: To quantify bias related to specific methodological characteristics in child-relevant randomized controlled trials (RCTs). DESIGN: Meta-epidemiological study. DATA SOURCES: We identified systematic reviews containing a meta-analysis with 10-40 RCTs that were relevant to child health in the Cochrane Database of Systematic Reviews. DATA EXTRACTION: Two reviewers independently assessed RCTs using items in the Cochrane Risk of Bias tool and other study factors. We used meta-epidemiolog...

  15. Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    R Rahmani

    2012-11-01

    Full Text Available Background: Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes.Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87 or control (N=90 group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3-4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure.Results: There was significant difference in the length of second stage of labor (P <.05. The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes.Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women.

  16. Treadmill training as an augmentation treatment for Alzheimer?s disease: a pilot randomized controlled study

    OpenAIRE

    Cynthia Arcoverde; Andrea Deslandes; Helena Moraes; Cloyra Almeida; Narahyana Bom de Araujo; Paulo Eduardo Vasques; Heitor Silveira; Jerson Laks

    2014-01-01

    Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD) patients. Method Elderly (n=20) with mild dementia (NINCDS-ADRDA/CDR1) were randomly assigned to an exercise group (EG) on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max) and control group (GC) 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG). Specifics instruments were also appli...

  17. Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial

    OpenAIRE

    Briken, S.; Gold, S M; S. Patra; Vettorazzi, E; Harbs, D.; Tallner, Alexander; Ketels, G.; Schulz, K. H.; Heesen, C.

    2014-01-01

    Background: Exercise may have beneficial effects on both well-being and walking ability in multiple sclerosis (MS). Exercise is shown to be neuroprotective in rodents and may also enhance cognitive function in humans. It may, therefore, be particularly useful for MS patients with pronounced neurodegeneration. Objective: To investigate the potential of standardized exercise as a therapeutic intervention for progressive MS, in a randomized-controlled pilot trial. Methods: Patients with pr...

  18. An Eight Month Randomized Controlled Exercise Intervention Alters Resting State Synchrony in Overweight Children

    OpenAIRE

    Krafft, Cynthia E.; Pierce, Jordan E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Rodrigue, Amanda L.; Camchong, Jazmin; Allison, Jerry D.; Yanasak, Nathan E.; Liu, Tianming; Davis, Catherine L.; McDowell, Jennifer E.

    2013-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥ 85th percentile) children 8–11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional...

  19. Assessment and Management of Patients with Chronic Cough by Certified Respiratory Educators: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stephen K Field

    2009-01-01

    Full Text Available BACKGROUND: The value of other health care professionals is increasingly being recognized to compensate for the shortage of physicians in Canada. Chronic cough is one of the most common reasons for consultation with a respirologist. In the present study, a prospective, randomized, controlled study was undertaken to determine whether Certified Respiratory Educators (CREs could manage screened patients with chronic cough as effectively as respirologists.

  20. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    OpenAIRE

    Tadjerbashi, Kamelia; Rosales, Roberto S; Atroshi, Isam

    2014-01-01

    Background: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arth...

  1. Hypnosis can reduce pain in hospitalized older patients: a randomized controlled study

    OpenAIRE

    Ardigo, Sheila; Herrmann, François; Moret, Véronique; Derame, Laurence; Giannelli, Sandra Véronique; Gold, Gabriel; Pautex, Sophie Marie

    2016-01-01

    Background: Chronic pain is a common and serious health problem in older patients. Treatment often includes non pharmacological approaches despite a relatively modest evidence base in this population. Hypnosis has been used in younger adults with positive results. The main objective of this study was to measure the feasibility and efficacy of hypnosis (including self hypnosis) in the management of chronic pain in older hospitalized patients. Methods: A single center randomized controlled tria...

  2. The Effect of The Cognitive Behavioral Therapy and Pharmacotherapy on Infertility Stress: A Randomized Controlled Trial

    OpenAIRE

    Mahbobeh Faramarzi; Hajar Pasha; Seddigheh Esmailzadeh; Farzan Kheirkhah; Shima Heidary; Zohreh Afshar

    2013-01-01

    Background: Infertility has been described as creating a form of stress leading to a variety of psychological problems. Both psychotherapy and pharmacotherapy are effective treatments for infertility stress. The aim of this study was to evaluate the effectiveness of cognitive behavioral therapy along with fluoxetine for improvement infertility stress in infertile women. Materials and Methods: In a randomized controlled clinical trial, 89 infertile women with mild to moderate depression (Beck ...

  3. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  4. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge;

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  5. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no P

  6. Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy: a meta-analysis of 16 randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Bing Pang

    2016-01-01

    Conclusion: HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities. Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy. However, the methodological quality of the randomized controlled trials was generally low. Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.

  7. The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women : a randomized controlled trial

    NARCIS (Netherlands)

    Hak, AE; Bak, AAA; Lindemans, J; Planellas, J; Bennink, HJTC; Hofman, A; Grobbee, DE; Witteman, JCM

    2001-01-01

    Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine

  8. A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

    Science.gov (United States)

    O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

    2015-01-01

    A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

  9. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Science.gov (United States)

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Meta-Analyses of Randomized Controlled Clinical Trials (RCTs... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled clinical trials (RCTs) to evaluate safety risks associated with the use of human drugs or biological...

  10. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    Science.gov (United States)

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  11. Effects of vacuum-compression therapy on healing of diabetic foot ulcers: randomized controlled trial.

    Science.gov (United States)

    Akbari, Asghar; Moodi, Hesam; Ghiasi, Fatemeh; Sagheb, Hamidreza Mahmoudzadeh; Rashidi, Homayra

    2007-01-01

    A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.

  12. Stability and Stabilization of Networked Control System with Forward and Backward Random Time Delays

    Directory of Open Access Journals (Sweden)

    Ye-Guo Sun

    2012-01-01

    Full Text Available This paper deals with the problem of stabilization for a class of networked control systems (NCSs with random time delay via the state feedback control. Both sensor-to-controller and controller-to-actuator delays are modeled as Markov processes, and the resulting closed-loop system is modeled as a Markovian jump linear system (MJLS. Based on Lyapunov stability theorem combined with Razumikhin-based technique, a new delay-dependent stochastic stability criterion in terms of bilinear matrix inequalities (BMIs for the system is derived. A state feedback controller that makes the closed-loop system stochastically stable is designed, which can be solved by the proposed algorithm. Simulations are included to demonstrate the theoretical result.

  13. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    Science.gov (United States)

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

  14. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    International Nuclear Information System (INIS)

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

  15. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    Directory of Open Access Journals (Sweden)

    Luke Perraton

    2009-11-01

    Full Text Available Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS. The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery were analyzed.Results: Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery.Conclusions: Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.Keywords: hydrotherapy, fibromyalgia syndrome, exercise, effective, components

  16. Antidepressants for bipolar disorder A meta-analysis of randomized, double-blind, controlled trials

    Institute of Scientific and Technical Information of China (English)

    Yingli Zhang; Huan Yang; Shichang Yang; Wei Liang; Ping Dai; Changhong Wang; Yalin Zhang

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepres-sants in the treatment of bipolar disorder. DATA SOURCES:A literature search of randomized, double-blind, control ed trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Control ed Trials databases. The keywords“bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed mania and depression, rapid cycling and bipolar disorder”, AND “antidepressant agent, antidepressive agents second-generation, antidepressive agents tricyclic, monoamine oxidase inhibitor, noradrenaline uptake in-hibitor, serotonin uptake inhibitor, and tricyclic antidepressant agent” were used. The studies that were listed in the reference list of the published papers but were not retrieved in the above-mentioned databases were supplemented. STUDY SELECTION: Studies selected were double-blind randomized control ed trials assessing the efficacy and safety of antidepressants in patients with bipolar disorder. Al participants were aged 18 years or older, and were diagnosed as having primary bipolar disorder. Antidepressants or antidepressants combined with mood stabilizers were used in experimental interventions. Placebos, mood stabilizers, antipsychotics and other antide pressants were used in the control interventions. Studies that were quasi-randomized studies, or used antidepressants in combination with antipsy-chotics in the experimental group were excluded. Al analyses were conducted using Review Man-ager 5.1 provided by the Cochrane Col aboration. MAIN OUTCOME MEASURES:The primary outcome was the response and switching to mania. The secondary outcomes included remission, discontinuation rate, and suicidality. RESULTS: Among 5 001 treatment studies published, 14 double-blind randomized control ed trials involving 1 244 patients were included in the meta

  17. Use of remifentanil in comparison with sodium nitroprusside for controlled hypotension during rhinoplasty: Randomized controlled trail

    OpenAIRE

    Eman Mohammed Kamal Aboseif; Sameh Mohammed Osman

    2015-01-01

    Objective: To evaluate the clinical efficacy of remifentanil infusion in comparison with sodium nitroprusside regarding controlled hypotension during rhinoplasty. Background: Controlled hypotension is a well-known technique used in many operations to reduce blood loss and need for blood transfusion and to provide satisfactory bloodless surgical field. Many pharmacological agents are used to perform controlled hypotension intraoperatively. Patients and methods: A total of 130 adult conse...

  18. Effect of early vitamin A supplementation on cell-mediated immunity in infants younger than 6 mo.

    Science.gov (United States)

    Rahman, M M; Mahalanabis, D; Alvarez, J O; Wahed, M A; Islam, M A; Habte, D

    1997-01-01

    One hundred twenty infants were randomly assigned to receive either 15 mg vitamin A or placebo with each of three DPT/OPV (diphtheria, pertussis, tetanus/oral polio vaccine) immunizations at monthly intervals. Sixty-two received vitamin A and 58 received placebo. One month after the third supplementation dose, the response to the delayed cutaneous hypersensitivity test [multitest cell-mediated immunity (CMI) skin evaluation] for tetanus, diphtheria, and tuberculin (purified protein derivative, PPD) was the same in the vitamin A and placebo infants. The number of anergic infants was 17 (27%) and 19 (33%) in the vitamin A and placebo groups, respectively. The number of positive tests among well-nourished infants was significantly higher than that in malnourished infants irrespective of supplementation (P 0.7 mumol/L) after supplementation, the vitamin A-supplemented infants had a significantly higher proportion of positive CMI tests than the placebo infants (chi-square test: 8.99, P = 0.008). Among the infants with low serum retinol concentrations ( 0.7 mumol/L) at the time of the CMI test. CMI was consistently better in well-nourished infants irrespective of supplementation. PMID:8988926

  19. Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Seitsalo Seppo

    2007-12-01

    Full Text Available Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS. As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28, treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28, treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs to assess activity-related symptoms. We also estimated the direct healthcare costs. Results Both groups showed marked improvement during the follow-up. The mean improvement in the Kujala score was 12.9 (95% confidence interval (CI 8.2–17.6 in the arthroscopy group and 11.4 (95% CI 6.9–15.8 in the control group. However, there was no difference between the groups in mean improvement in the Kujala score (group difference 1.1 (95% CI -7.4 - 5.2 or in any of the VAS scores. Total direct healthcare costs in the arthroscopy group were estimated to exceed on average those of the control group by €901 per patient (p Conclusion In this controlled trial involving patients with chronic PFPS, the outcome when arthroscopy was used in addition to a home exercise program was no better than when the home exercise program was used alone. Trial registration Current Controlled Trials ISRCTN 41800323

  20. The Anxiolytic Effect of Aromatherapy on Patients Awaiting Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Cheng-Hua Ni

    2013-01-01

    Full Text Available The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil and control (water vapor conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromatherapy showed a greater reduction in preoperative anxiety than those in the control groups. Aromatherapy may be a useful part of a holistic approach to reducing preoperative anxiety before ambulatory surgery.

  1. Congruence Couple Therapy for Pathological Gambling: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Bonnie K; Awosoga, Olu

    2015-09-01

    A multi-site pilot randomized controlled trial of Congruence Couple Therapy (CCT) for problem gambling was conducted in Ontario and Alberta, Canada from 2009 to 2011. The purpose was to assess the feasibility of a full trial and to identify methodological modifications to enhance future trials. The sample (N = 30; 15 couples) consisted of 66% male gamblers and 34% female. Mean age of sample was 49.1 years. Baseline mean DSM-IV gambling score was 8.7/10. Retention of the treatment couples was 89% at 2-month follow-up. Retention of control couples was 78%. A randomized controlled design compared the status of couples in treatment condition to control condition. Treatment couples received 12-week CCT while control couples received three brief check-ins over 12 weeks. No significant difference was found between treatment and control group at baseline on all measures. At (1) week 12 post-treatment, and (2) week 20 follow-up, significant treatment effects were found for gambling symptoms (p = 0.008; p = 0.041), mental distress (p = 0.001; p = 0.035), and family systems function (p = 0.023; p = 0.054) between treatment and control group. Within group changes for treatment couples over time were significant for mental distress (p = 0.000), dyadic adjustment (p = 0.002), and family systems function (p = 0.000). On similar measures, control group showed non-significant improvement. Future methodological changes, advantages and disadvantages of multi-site partnerships with community treatment agencies are discussed. Of interest is that control participants showed unintended improvement. CCT as a treatment was favourably accepted by counselors, problem gamblers and their spouses. Positive outcome trends ranging from small to large effect size on key measures indicate that a full-scaled trial will require approximately 140 couples and is an investment worth pursuing.

  2. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program

    Science.gov (United States)

    2016-01-01

    Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. PMID:27689502

  3. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  4. Suboptimal feedback control of TCP flows in computer network using random early discard (RED mechanism

    Directory of Open Access Journals (Sweden)

    Ahmed N. U.

    2005-01-01

    Full Text Available We consider a dynamic model that simulates the interaction of TCP sources with active queue management system (AQM. We propose a modified version of an earlier dynamic model called RED. This is governed by a system of stochastic differential equations driven by a doubly stochastic point process with intensity as the control. The feedback control law proposed observes the router (queue status and controls the intensity by sending congestion signals (warnings to the sources for adjustment of their transmission rates. The (feedback control laws used are of polynomial type (including linear with adjustable coefficients. They are optimized by use of genetic algorithm (GA and random recursive search (RRS technique. The numerical results demonstrate that the proposed model and the method can improve the system performance significantly.

  5. Interval-walking training for the treatment of type 2 diabetes: a randomized, controlled trial

    DEFF Research Database (Denmark)

    Karstoft, Kristian; Winding, Kamilla; Knudsen, Sine H.;

    Formål: To evaluate the feasibility of free-living walking training in type 2 diabetes patients, and to investigate the effects of interval-walking training (IWT) versus continuous-walking training (CWT) upon self reported health, physical fitness, body composition and glycemic control. Metoder...... alternated 3-min repetitions at low and high intensity. Before and after the 4-month intervention, the following variables were measured: Self-reported health, Physical fitness (VO2max), body composition, and glycemic control (fasting glucose, HbA1c, oral glucose tolerance test, continuous glucose monitoring......: Subjects with type 2 diabetes were randomized to a control (n = 8), CWT (n = 12), or IWT group (n = 12). Training groups were prescribed five sessions per week (60 min/session) and were controlled with an accelerometer and a heart-rate monitor. CWT performed all training at moderate intensity, whereas IWT...

  6. Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies

    Directory of Open Access Journals (Sweden)

    Shobana Balasingam

    2016-08-01

    Conclusions: Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events.

  7. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    OpenAIRE

    Meisel Susanne F; Beeken Rebecca J; van Jaarsveld Cornelia HM; Wardle Jane

    2012-01-01

    Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice i...

  8. Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Yong-Suk

    2011-03-01

    Full Text Available Abstract Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010

  9. Herbal medicines for Parkinson's disease: a systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Tae-Hun Kim

    Full Text Available OBJECTIVE: We conducted systematic review to evaluate current evidence of herbal medicines (HMs for Parkinson's disease (PD. METHODS: Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs, quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. RESULTS: From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. CONCLUSION: Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future.

  10. Single- versus two- layer intestinal anastomosis: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Taji Yoshinori

    2006-01-01

    Full Text Available Abstract Background To compare single- with two- layer intestinal anastomosis after intestinal resection: a meta-analysis of randomized controlled trials. Methods Randomized controlled trials comparing single- with two-layer intestinal anastomosis were identified using a systematic search of Medline, Embase and the Cochrane Library Databases covering articles published from 1966 to 2004. Outcome of primary interest was postoperative leak. A risk ratio for trial outcomes and weighted pooled estimates for data were calculated. A fixed-effect model weighted using Mantel-Haenszel methods and a random-effect model using DerSimonian-Laird methods were employed. Results Six trials were analyzed, comprising 670 participants (single-layer group, n = 299; two-layer group, n = 371. Data on leaks were available from all included studies. Combined risk ratio using DerSimonian-Laird methods was 0.91 (95% CI = 0.49 to 1.69, and indicated no significant difference. Inter-study heterogeneity was significant (χ2 = 10.5, d.f. = 5, p = 0.06. Conclusion No evidence was found that two-layer intestinal anastomosis leads to fewer post-operative leaks than single layer. Considering duration of the anastomosis procedure and medical expenses, single-layer intestinal anastomosis appears to represent the optimal choice for most surgical situations.

  11. Perioperative Continuous Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

    Science.gov (United States)

    Fassoulaki, Argyro; Vassi, Emilia; Korkolis, Dimitrios; Zotou, Marianna

    2016-02-01

    Wound infusion with local anesthetics has been used for postoperative pain relief with variable results. This randomized, controlled, double-blind clinical trial examines the effect of ropivacaine infusion on pain after laparoscopic cholecystectomy. A total of 110 patients were randomly assigned to 2 groups. After induction of anesthesia a 75-mm catheter was inserted subcutaneously and connected to an elastomeric pump containing either 0.75% ropivacaine (ropivacaine group) or normal saline (control group) for 24 hours postoperatively. Before skin closure, each hole was infiltrated with 2 mL of 0.75% ropivacaine or normal saline according to randomization. Pain at rest, pain during cough, and analgesic consumption were recorded in the postanesthesia care unit and at 2, 4, 8, 24, and 48 hours postoperatively. Analgesic requirements and pain scores were recorded 1 and 3 months after surgery. The ropivacaine group reported less pain during cough (P=0.044) in the postanesthesia care unit (P=0.017) and 4 hours postoperatively (P=0.038). Ropivacaine wound infusion had no effect on late and chronic pain. PMID:26679680

  12. The differential influences of positive affect, random reward, and performance-contingent reward on cognitive control.

    Science.gov (United States)

    Fröber, Kerstin; Dreisbach, Gesine

    2014-06-01

    Growing evidence suggests that positive affect and reward have differential effects on cognitive control. So far, however, these effects have never been studied together. Here, the authors present one behavioral study investigating the influences of positive affect and reward (contingent and noncontingent) on proactive control. A modified version of the AX-continuous performance task, which has repeatedly been shown to be sensitive to reward and affect manipulations, was used. In a first phase, two experimental groups received either neutral or positive affective pictures before every trial. In a second phase, the two halves of a given affect group additionally received, respectively, performance-contingent or random rewards. The results replicated the typical affect effect, in terms of reduced proactive control under positive as compared to neutral affect. Also, the typical reward effects associated with increased proactive control were replicated. Most interestingly, performance-contingent reward counteracted the positive affect effect, whereas random reward mirrored that effect. In sum, this study provides first evidence that performance-contingent reward, on the one hand, and positive affect and performance-noncontingent reward, on the other hand, have oppositional effects on cognitive control: Only performance-contingent reward showed a motivational effect in terms of a strategy shift toward increased proactive control, whereas positive affect alone and performance-noncontingent reward reduced proactive control. Moreover, the integrative design of this study revealed the vulnerability of positive affect effects to motivational manipulations. The results are discussed with respect to current neuroscientific theories of the effects of dopamine on affect, reward, and cognitive control. PMID:24659000

  13. Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol

    Directory of Open Access Journals (Sweden)

    Leatherdale Scott T

    2011-09-01

    Full Text Available Abstract Background Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered - do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. Methods/Design A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months. Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000. Eligible subjects interested in free NRT will be determined at baseline (N = 1,000 and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco at 6-month follow-up as compared to subjects who do not

  14. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Shawn D Aaron

    Full Text Available BACKGROUND: Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF. METHODS: We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18 or placebo (N = 17 for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1 and quality of life. RESULTS: Over the 24 week treatment period, 4 of 18 (22% patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31% placebo treated patients, P = 0.70. FEV(1 declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34. Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. CONCLUSION: We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00528190.

  15. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    Directory of Open Access Journals (Sweden)

    Ian Relf

    2008-01-01

    Full Text Available Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

  16. Protocol for Shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Christoffer H; Andersen, Lars L; Mortensen, Ole S;

    2011-01-01

    ABSTRACT: BACKGROUND: Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Such musculoskeletal pain - which is often associated with restricted range of motion and loss of muscle strength - is one of the most common conditions...... training of the painful area. Our study investigates the effect of the latter approach. METHODS/DESIGN: A randomized controlled trial of 10 weeks duration is currently being conducted. Employed office workers with severe neck-shoulder pain are randomized to 3 × 20 min shoulder function training...... including jobs characterized by intensive computer work. The first 100 positive replies entered the study. Among these inclusion criteria were pain intensity in the neck/shoulder of at least 3 on a 0-9 scale. Exclusion criteria were cardiovascular disease, trauma, hypertension, or serious chronic disease...

  17. Healing Touch with Guided Imagery for PTSD in returning active duty military: a randomized controlled trial.

    Science.gov (United States)

    Jain, Shamini; McMahon, George F; Hasen, Patricia; Kozub, Madelyn P; Porter, Valencia; King, Rauni; Guarneri, Erminia M

    2012-09-01

    Post-traumatic stress disorder (PTSD) remains a significant problem in returning military and warrants swift and effective treatment. We conducted a randomized controlled trial to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery [HT+GI]) reduced PTSD symptoms as compared to treatment as usual (TAU) returning combat-exposed active duty military with significant PTSD symptoms. Active duty military (n = 123) were randomized to 6 sessions (within 3 weeks) of HT+GI vs. TAU. The primary outcome was PTSD symptoms; secondary outcomes were depression, quality of life, and hostility. Repeated measures analysis of covariance with intent-to-treat analyses revealed statistically and clinically significant reduction in PTSD symptoms (p biofield therapy approaches for mitigating PTSD in military populations is warranted.

  18. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Krebs, Teri S; Johansen, Pål-Ørjan

    2012-07-01

    Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

  19. A randomized controlled study of exposure therapy as aftercare for alcohol use disorder

    DEFF Research Database (Denmark)

    Mellentin, Angelina Isabella; Nielsen, Bent; Nielsen, Anette Søgaard;

    2016-01-01

    Background It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses...... on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphone or in group sessions increases the effect of Cognitive Behavioural Treatment in groups of alcohol dependent...... as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized into one of the three following aftercare groups after concluding primary treatment: (1) CET as a smartphone application; (2...

  20. Personal view: randomized controlled trials in epilepsy specialist nursing: the seduction of content by form.

    Science.gov (United States)

    Brown, Stephen

    2002-04-01

    Research into the effectiveness of epilepsy specialist nursing needs to take into account a number of factors, which have not been adequately addressed in previous studies. Nursing outcome measures are different to medical ones and it is inappropriate to confuse these. Specialist nurses affect the whole culture of a service, and their impact on service quality may go beyond that of their individual patient contacts. Thus randomized studies within a service that already has specialist nurses may not give valid results. Some service users will benefit more from direct contact with a specialist nurse than others, and people who give informed consent to take part in randomized controlled trials might not be representative of those who would benefit most from specialist nurse access. The stampede for level one evidence risks failing to address the issues properly by overvaluing research process (form) against its appropriateness (content), yet there remain great opportunities for good quality research in this area.

  1. Aspirin, Calcitriol, and Calcium Do Not Prevent Adenoma Recurrence in a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Pommergaard, Hans Christian; Burcharth, Jakob; Rosenberg, Jacob;

    2016-01-01

    , and calcium carbonate could prevent colorectal adenoma recurrence. METHODS: We included 1107 patients with 1 or more sporadic adenoma(s) removed from the colon or rectum at centers in Europe, Russia, or the United States, from 2004 through 2010. Inclusion criteria were 1 adenoma greater than 1 cm in diameter......BACKGROUND & AIMS: Chemopreventive strategies might be used to reduce the recurrence of colorectal adenomas and the incidence of colorectal cancer. We performed a randomized, double-blind, placebo-controlled trial to determine whether a combination of acetylsalicylic acid (aspirin), calcitriol......, more than 1 adenoma of any size, or an adenoma of any size and first-degree relatives with colorectal cancer. Subjects were assigned randomly to groups given 0.5 μg calcitriol, 75 mg acetylsalicylic acid, and 1250 mg calcium carbonate (n = 209), or placebo (n = 218), each day for 3 years. The primary...

  2. Healing Touch with Guided Imagery for PTSD in returning active duty military: a randomized controlled trial.

    Science.gov (United States)

    Jain, Shamini; McMahon, George F; Hasen, Patricia; Kozub, Madelyn P; Porter, Valencia; King, Rauni; Guarneri, Erminia M

    2012-09-01

    Post-traumatic stress disorder (PTSD) remains a significant problem in returning military and warrants swift and effective treatment. We conducted a randomized controlled trial to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery [HT+GI]) reduced PTSD symptoms as compared to treatment as usual (TAU) returning combat-exposed active duty military with significant PTSD symptoms. Active duty military (n = 123) were randomized to 6 sessions (within 3 weeks) of HT+GI vs. TAU. The primary outcome was PTSD symptoms; secondary outcomes were depression, quality of life, and hostility. Repeated measures analysis of covariance with intent-to-treat analyses revealed statistically and clinically significant reduction in PTSD symptoms (p biofield therapy approaches for mitigating PTSD in military populations is warranted. PMID:23025129

  3. Controlling dispersion forces between small particles with artificially created random light fields

    CERN Document Server

    Bruegger, Georges; Scheffold, Frank; Saenz, Juan Jose

    2015-01-01

    Appropriate combinations of laser beams can be used to trap and manipulate small particles with "optical tweezers" as well as to induce significant "optical binding" forces between particles. These interaction forces are usually strongly anisotropic depending on the interference landscape of the external fields. This is in contrast with the familiar isotropic, translationally invariant, van der Waals and, in general, Casimir-Lifshitz interactions between neutral bodies arising from random electromagnetic waves generated by equilibrium quantum and thermal fluctuations. Here we show, both theoretically and experimentally, that dispersion forces between small colloidal particles can also be induced and controlled using artificially created fluctuating light fields. Using optical tweezers as gauge, we present experimental evidence for the predicted isotropic attractive interactions between dielectric microspheres induced by laser-generated, random light fields. These light induced interactions open a path towards...

  4. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia.

    Science.gov (United States)

    Carson, James W; Carson, Kimberly M; Jones, Kim D; Bennett, Robert M; Wright, Cheryl L; Mist, Scott D

    2010-11-01

    A mounting body of literature recommends that treatment for fibromyalgia (FM) encompass medications, exercise and improvement of coping skills. However, there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping. The aim of this randomized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping. A sample of 53 female FM patients were randomized to the 8-week Yoga of Awareness program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, group discussions) or to wait-listed standard care. Data were analyzed by intention to treat. At post-treatment, women assigned to the yoga program showed significantly greater improvements on standardized measures of FM symptoms and functioning, including pain, fatigue, and mood, and in pain catastrophizing, acceptance, and other coping strategies. This pilot study provides promising support for the potential benefits of a yoga program for women with FM.

  5. Fractional Nonablative 1540 nm Laser Resurfacing for Thermal Burn Scars: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Haedersdal, M.; Moreau, K.E.R.; Beyer, D.M.;

    2009-01-01

    Background and Objective: Burn scars cause permanent and disfiguring problems for many patients and limited treatments are available. Nonablative fractional lasers induce a wound healing response, which may lead to remodeling of burn sear texture. This randomized trial evaluates efficacy...... and adverse effects of 1540 nm fractional laser versus untreated control for burn scars. Materials and Methods: Seventeen adult patients with burn scars of 1 year or older and Fitzpatrick skin types I-III were included in the study. Side-by-side test areas were randomized to (i) three monthly 1540 nm.......0015; 12 weeks: 4 (2-5), P = 0.0007). Patients were satisfied with treatments (week 12: 7 (4-8.5)) and 8/17 patients evaluated burn scars to be moderately or significantly improved. Skin redness increased transiently from laser treatments. No significant differences were found in skin pigmentation...

  6. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R;

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... of three outpatient clinic visits. The three-visit cycle was repeated until study end point. The study end points were defined as complete ulcer healing, amputation, or death. RESULTS: One hundred ninety-three individuals were randomized to telemedical monitoring and 181 to standard care. Demographics were...... similar in both groups. A cause-specific Cox proportional hazard model showed no difference in individuals monitored through telemedicine regarding wound healing (hazard ratio 1.11 [95% CI 0.87, 1.42], P = 0.42) or amputation (0.87 [0.54, 1.42], P = 0.59). We found a higher mortality incidence...

  7. Differential Effect of Taekwondo Training on Knee Muscle Strength and Reactive and Static Balance Control in Children with Developmental Coordination Disorder: A Randomized Controlled Trial

    Science.gov (United States)

    Fong, Shirley S. M.; Chung, Joanne W. Y.; Chow, Lina P. Y.; Ma, Ada W. W.; Tsang, William W. N.

    2013-01-01

    This randomized controlled trial aimed to investigate the effect of short-term intensive TKD training on the isokinetic knee muscle strength and reactive and static balance control of children with developmental coordination disorder (DCD). Among the 44 children with DCD (mean age: 7.6 plus or minus 1.3 years) recruited, 21 were randomly assigned…

  8. Effects of kettlebell training on postural coordination and jump performance: a randomized controlled trial.

    Science.gov (United States)

    Jay, Kenneth; Jakobsen, Markus D; Sundstrup, Emil; Skotte, Jørgen H; Jørgensen, Marie B; Andersen, Christoffer H; Pedersen, Mogens T; Andersen, Lars L

    2013-05-01

    The aim of this study was to investigate the effectiveness of a worksite intervention using kettlebell training to improve postural reactions to perturbation and jump performance. This single-blind randomized controlled trial involved 40 adults (n = 40) from occupations with a high prevalence of musculoskeletal pain and discomfort (mean age 44 years, body mass index 23 kg·m, 85% women). A blinded examiner took measures at baseline and follow-up. Participants were randomly assigned to a training group-doing kettlebell swings 3 times a week for 8 weeks-or to a control group. The outcome measures were postural reactions to sudden perturbation and maximal countermovement jump height. Compared with the control group, the training group had a significant decreased stopping time after perturbation (-109 ms, 95% confidence interval [-196 to -21]). Jump height increased significantly in the training group (1.5 cm, 95% confidence interval [0.5 to 2.5]), but this was nonsignificantly different from control. Kettlebell training improves postural reactions to sudden perturbation. Future studies should investigate whether kettlebell training can reduce the risk of low back injury in occupations with manual material handling or patient handling where sudden perturbations often occur. PMID:22843044

  9. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

    Directory of Open Access Journals (Sweden)

    Usman Anju

    2009-03-01

    Full Text Available Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21, were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm and 24% oxygen ("treatment group", n = 33 or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29. Outcome measures included Clinical Global Impression (CGI scale, Aberrant Behavior Checklist (ABC, and Autism Treatment Evaluation Checklist (ATEC. Results After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008, receptive language (p Conclusion Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air. Trial Registration clinicaltrials.gov NCT00335790

  10. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  11. Effect of Rosa aromatherapy on anxiety before cardiac catheterization: A randomized controlled trial

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    Atye Babaii

    2015-09-01

    Full Text Available Background and Objectives: Most patients experience moderate to severe anxiety before cardiac catheterization. This study aimed to investigate the effect of Rosa aromatherapy on anxiety before cardiac catheterization. Methods: In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa aromatherapy for eighteen minutes. The level of anxiety was measured immediately before, and after the treatment. Results: In the stages before and after the study, there were no significant differences between the two groups in the terms of the mean scores of state and total anxiety. However, the mean score of trait anxiety in the experimental group was significantly lower than the control group. Furthermore, there was no significant difference between pre- and post-treatment in both groups. Conclusion: Most of the patients experience moderate to severe anxiety before cardiac catheterization. The findings of this study demonstrate that aromatherapy, as administered in this study, is not beneficial.

  12. A Random-Walk Based Privacy-Preserving Access Control for Online Social Networks

    Directory of Open Access Journals (Sweden)

    You-sheng Zhou

    2016-02-01

    Full Text Available Online social networks are popularized with people to connect friends, share resources etc. Meanwhile, the online social networks always suffer the problem of privacy exposure. The existing methods to prevent exposure are to enforce access control provided by the social network providers or social network users. However, those enforcements are impractical since one of essential goal of social network application is to share updates freely and instantly. To better the security and availability in social network applications, a novel random walking based access control of social network is proposed in this paper. Unlike using explicit attribute based match in the existing schemes, the results from random walking are employed to securely compute L1 distance between two social network users in the presented scheme, which not only avoids the leakage of private attributes, but also enables each social network user to define access control policy independently. The experimental results show that the proposed scheme can facilitate the access control for online social network.

  13. Efficacy of a triclosan formula in controlling early subgingival biofilm formation: a randomized trial

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    Ernesto ANDRADE

    2015-01-01

    Full Text Available The aim of this study was to determine the efficacy of rinses with slurries of a dentifrice containing triclosan (TCS, as compared with rinses with slurries from a control dentifrice, in controlling early subgingival biofilm formation. A double-blind, randomized and cross-over clinical trial was designed, and 26 dental students were included. In the first period, participants were randomized to rinse with a TCS slurry or a control slurry, in a 12 h interval, and to refrain from mechanical cleaning. A Plaque Free Zone Index was assessed at 24 h, 48 h, 72 h and 96 h. After a washout period of 10 days, the second experimental period was conducted, following the same protocol as the first period, except that the slurry groups were switched. Use of the TCS slurry resulted in a significantly higher percentage of plaque-free surfaces, both at 24 h and at 72 h (p < 0.01. In the of 48-72 h interval, the triclosan slurry showed a lower percentage of sites converted to a score of 2 (38.1% for the testversus 40% for the control product, p = 0.015. In conclusion, rinsing with slurries of dentifrice containing TCS retards the down growth of bacterial biofilms from the supra- to the subgingival environment.

  14. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    Science.gov (United States)

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  15. Efficacy of a triclosan formula in controlling early subgingival biofilm formation: a randomized trial.

    Science.gov (United States)

    Andrade, Ernesto; Weidlich, Patricia; Angst, Patrícia Daniela Melchiors; Gomes, Sabrina Carvalho; Oppermann, Rui Vicente

    2015-01-01

    The aim of this study was to determine the efficacy of rinses with slurries of a dentifrice containing triclosan (TCS), as compared with rinses with slurries from a control dentifrice, in controlling early subgingival biofilm formation. A double-blind, randomized and cross-over clinical trial was designed, and 26 dental students were included. In the first period, participants were randomized to rinse with a TCS slurry or a control slurry, in a 12 h interval, and to refrain from mechanical cleaning. A Plaque Free Zone Index was assessed at 24 h, 48 h, 72 h and 96 h. After a washout period of 10 days, the second experimental period was conducted, following the same protocol as the first period, except that the slurry groups were switched. Use of the TCS slurry resulted in a significantly higher percentage of plaque-free surfaces, both at 24 h and at 72 h (p < 0.01). In the of 48-72 h interval, the triclosan slurry showed a lower percentage of sites converted to a score of 2 (38.1% for the test versus 40% for the control product, p = 0.015). In conclusion, rinsing with slurries of dentifrice containing TCS retards the down growth of bacterial biofilms from the supra- to the subgingival environment. PMID:26039907

  16. The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jochems EC

    2015-12-01

    Full Text Available Eline C Jochems,1,2 Christina M van der Feltz-Cornelis,1–3 Arno van Dam,3,4 Hugo J Duivenvoorden,5 Cornelis L Mulder1,6 1Department of Psychiatry, Epidemiological and Social Psychiatric Research Institute, Erasmus MC University Medical Center, Rotterdam, the Netherlands; 2GGz Breburg, Top Clinical Center for Body, Mind and Health, Tilburg, the Netherlands; 3Tilburg University, Faculty of Social Sciences, Tranzo Department, Tilburg, the Netherlands; 4GGZ Westelijk Noord Brabant, Bergen op Zoom, the Netherlands; 5Erasmus MC University Medical Center, Rotterdam, the Netherlands; 6BavoEuropoort, Parnassia Psychiatric Institute, Rotterdam, the Netherlands Objective: To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness.Methods: Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968. Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF generated by clinicians additional to treatment as usual (TAU and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment.Results: The 294 randomized patients (148 MF, 146 TAU and 57 clinicians (29 MF, 28 TAU of 12 teams (6 MF, 6 TAU were analyzed according to the intention-to-treat principle. No statistically significant differences

  17. Cognitive effects of calligraphy therapy for older people: a randomized controlled trial in Hong Kong

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    Kwok TCY

    2011-10-01

    Full Text Available Timothy CY Kwok1,2, Xue Bai1,3, Henry SR Kao4,5, Jessie CY Li1, Florence KY Ho11Jockey Club Centre for Positive Ageing; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong; 3Department of Social Work and Social Administration; 4Department of Psychology, The University of Hong Kong, Hong Kong; 5Department of Psychology, Fu Jen Catholic University, TaiwanBackground: This pilot study investigated the effects of calligraphy therapy on cognitive function in older Hong Kong Chinese people with mild cognitive impairment.Methods: A single-blind, randomized controlled trial was carried out in a sample of 31 adults aged 65 years or older with mild cognitive impairment. They were randomly assigned to receive either intensive calligraphy training led by a trained research assistant for eight weeks (calligraphy group, n = 14 or no calligraphy treatment (control group, n = 17. Participants' cognitive function was assessed by the Chinese version of the Mini-Mental State Examination (CMMSE before and after calligraphy treatment. Repeated measures analysis of variance and paired samples t-tests were used to analyze the data.Results: A significant interaction effect of time and intervention was detected [F (1, 29 = 9.11, P = 0.005, η2= 0.24]. The calligraphy group was found to have a prominent increase in CMMSE global score, and scores in the cognitive areas of orientation, attention, and calculation after two months (∆M = 2.36, P < 0.01, whereas their counterparts in the control group experienced a decline in CMMSE score (∆M = -0.41, P < 0.05.Conclusion: Calligraphy therapy was effective for enhancing cognitive function in older people with mild cognitive impairment and should be incorporated as part of routine programs in both community and residential care settings.Keywords: calligraphy therapy, Chinese elderly, mild cognitive impairment, cognitive function, randomized controlled trial

  18. Automated Internet-based pain coping skills training to manage osteoarthritis pain: a randomized controlled trial.

    Science.gov (United States)

    Rini, Christine; Porter, Laura S; Somers, Tamara J; McKee, Daphne C; DeVellis, Robert F; Smith, Meredith; Winkel, Gary; Ahern, David K; Goldman, Roberta; Stiller, Jamie L; Mariani, Cara; Patterson, Carol; Jordan, Joanne M; Caldwell, David S; Keefe, Francis J

    2015-05-01

    Osteoarthritis (OA) places a significant burden on worldwide public health because of the large and growing number of people affected by OA and its associated pain and disability. Pain coping skills training (PCST) is an evidence-based intervention targeting OA pain and disability. To reduce barriers that currently limit access to PCST, we developed an 8-week, automated, Internet-based PCST program called PainCOACH and evaluated its potential efficacy and acceptability in a small-scale, 2-arm randomized controlled feasibility trial. Participants were 113 men and women with clinically confirmed hip or knee OA and associated pain. They were randomized to a group completing PainCOACH or an assessment-only control group. Osteoarthritis pain, pain-related interference with functioning, pain-related anxiety, self-efficacy for pain management, and positive and negative affect were measured before intervention, midway through the intervention, and after intervention. Findings indicated high acceptability and adherence: 91% of participants randomized to complete PainCOACH finished all 8 modules over 8 to 10 weeks. Linear mixed models showed that, after treatment, women who received the PainCOACH intervention reported significantly lower pain than that in women in the control group (Cohen d = 0.33). Intervention effects could not be tested in men because of their low pain and small sample size. Additionally, both men and women demonstrated increases in self-efficacy from baseline to after intervention compared with the control group (d = 0.43). Smaller effects were observed for pain-related anxiety (d = 0.20), pain-related interference with functioning (d = 0.13), negative affect (d = 0.10), and positive affect (d = 0.24). Findings underscore the value of continuing to develop an automated Internet-based approach to disseminate this empirically supported intervention.

  19. Adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia: meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Xianbin Li

    Full Text Available OBJECTIVE: To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia. METHODS: POPULATION: adult patients presenting with antipsychotic-induced hyperprolactinemia diagnosed by prolactin level with or without prolactin-related symptoms. INTERVENTIONS: adjunctive aripiprazole vs. adjunctive placebo. OUTCOME MEASURES: adverse events and efficacy of treatment. STUDIES: randomized controlled trials. RESULTS: Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158 prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed -0.05 to 0.04 (95% confidence interval -0.13 to 0.16; I(2 =0% to 68%, P=0.20 to 0.70. However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random 0.76 (95% confidence interval 0.67 to 0.85; I(2 =43%, P<0.00001. The subgroup analysis confirmed that the subjects who received adjunctive aripiprazole 5 mg/day showed a degree of prolactin normalization similar to that of all participants. No significant differences between groups in discontinuation and improvements of psychiatric symptoms. CONCLUSION: Adjunctive aripiprazole is both safe and effective as a reasonable choice treatment for patients with antipsychotic-induced hyperprolactinemia. The appropriate dose of adjunctive aripiprazole may be 5 mg/day.

  20. Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

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    Caroline A. Smith

    2011-01-01

    Full Text Available We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture =46 and control =46. At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR 0.72, 95% confidence interval (CI 0.53–1.00, =.05. Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, =.04, and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, =.03, but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

  1. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

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    Overgaard Hans J

    2012-10-01

    Full Text Available Abstract Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA; dengue interventions (DEN; combined diarrhea and dengue interventions (DIADEN; and control (C. Schools were allocated publicly in each municipality (strata at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de

  2. Intensive glycemic control and macrovascular events in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    WU Hong; XU Mao-jin; ZOU Da-jin; HAN Qiao-jun; HU Xue

    2010-01-01

    Background There is no agreement as to whether intensive glucose control in type 2 diabetes can reduce the incidence of macrovascular events in these patients. We performed a meta-analysis comparing intensive glucose control or conventional glucose control in randomized controlled trials.Methods Databases including MEDLINE, EMBASE, and Cochrane controlled trials register, the Cochrane Library, and Science Citation Index were searched to find relevant trials. Outcome measures were the incidence of major macrovascular events.Results Six trials involving 28 065 patients were included. Analysis suggested that there was an obviously decreased incidence of major macrovascular events in patients having intensive glucose treatment vs. Controls (RR 0.92; 95% Cl 0.87, 0.98; P=0.005). However, intensive glycemia control strategies in type 2 diabetes showed no significant impact on the incidence of death from any cause compared with conventional glycemia control strategies, intensive 14.7%, controls 12.0% (RR 0.95; 95% Cl 0.80, 1.12; P=0.55), as well as on the incidence of cardiovascular death, intensive 3.7%,controls 3.6% (RR 1.10, 95% Cl 0.79, 1.53; P=0.57).Conclusions Control of glycemia to normal (or near normal levels) in type 2 diabetes appears to be effective in reducing the incidence of major macrovascular events, but there were no significant differences of either the mortality from any cause or from cardiovascular death between the two glycemia-control strategies.

  3. Use of remifentanil in comparison with sodium nitroprusside for controlled hypotension during rhinoplasty: Randomized controlled trail

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    Eman Mohammed Kamal Aboseif

    2015-10-01

    Conclusion: This study confirmed that remifentanil infusion with dose of 0.25–0.5 μg/kg/min. induced desired controlled hypotension intraoperatively during rhinoplasty with no complications occurred either intra- or postoperative with advantage of rapid recovery from anesthesia.

  4. Can sedentary behavior be made more active? A randomized pilot study of TV commercial stepping versus walking

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    Steeves Jeremy A

    2012-08-01

    Full Text Available Abstract Background There is a growing problem of physical inactivity in America, and approximately a quarter of the population report being completely sedentary during their leisure time. In the U.S., TV viewing is the most common leisure-time activity. Stepping in place during TV commercials (TV Commercial Stepping could increase physical activity. The purpose of this study was to examine the feasibility of incorporating physical activity (PA into a traditionally sedentary activity, by comparing TV Commercial Stepping during 90 min/d of TV programming to traditional exercise (Walking. Methods A randomized controlled pilot study of the impact of 6 months of TV Commercial Stepping versus Walking 30 min/day in adults was conducted. 58 sedentary, overweight (body mass index 33.5 ± 4.8 kg/m2 adults (age 52.0 ± 8.6 y were randomly assigned to one of two 6-mo behavioral PA programs: 1 TV Commercial Stepping; or 2 Walking 30 min/day. To help facilitate behavior changes participants received 6 monthly phone calls, attended monthly meetings for the first 3 months, and received monthly newsletters for the last 3 months. Using intent-to-treat analysis, changes in daily steps, TV viewing, diet, body weight, waist and hip circumference, and percent fat were compared at baseline, 3, and 6 mo. Data were collected in 2010–2011, and analyzed in 2011. Results Of the 58 subjects, 47 (81% were retained for follow-up at the completion of the 6-mo program. From baseline to 6-mo, both groups significantly increased their daily steps [4611 ± 1553 steps/d vs. 7605 ± 2471 steps/d (TV Commercial Stepping; 4909 ± 1335 steps/d vs. 7865 ± 1939 steps/d (Walking; P  Conclusions Participants in both the TV Commercial Stepping and Walking groups had favorable changes in daily steps, TV viewing, diet, and anthropometrics. PA can be performed while viewing TV commercials and this may be a feasible alternative to traditional approaches for

  5. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

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    Stout Lydia

    2007-12-01

    Full Text Available Abstract Background The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma, tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12. Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12 to determine subsequent fracture rates. Our co

  6. Effects of a communication course for clinicians on parents' perception of care - a randomized controlled trial

    DEFF Research Database (Denmark)

    Ammentorp, Jette; Sabroe, Svend; Kofoed, Poul-Erik;

    2009-01-01

    in communication skills training has primarily focused on the behavioural changes of clinicians, and only few studies have investigated the effect from the perspective of the user. Method: A randomized controlled trial including medical doctors and nurses from paediatric outpatients' clinics was carried out....... The intervention group completed a 5-day communication course, whereas the control group had no intervention. The intervention was evaluated using questionnaires measuring parents' perception of the communication and their satisfaction. The questionnaires were filled out by parents to children consulting....... There were no significant differences between the satisfaction of parents visiting clinicians from the intervention group and those visiting clinicians from the control group; however, the proportion of parents who had a positive perception of the communication was up to 9.8% higher in the intervention group...

  7. A randomized controlled trial of aquatic and land-based exercise in patients with knee osteoarthritis

    DEFF Research Database (Denmark)

    Lund, H.; Weile, U.; Christensen, R.;

    2008-01-01

    patients reported adverse events (i.e. discomfort) in land-based exercise, while only 3 reported adverse events in the aquatic exercise. Conclusion: Only land-based exercise showed some improvement in pain and muscle strength compared with the control group, while no clinical benefits were detectable after......Objective: To compare the efficacy of aquatic exercise and a land-based exercise programme vs control in patients with knee osteoarthritis. Methods: Primary outcome was change in pain, and in addition Knee Injury and Osteoarthritis Outcome Score questionnaire (KOOS). Standing balance and strength...... was also measured after and at 3-month follow-up. Seventy-nine patients (62 women), with a mean age of 68 years (age range 40-89 years) were randomized to aquatic exercise (n = 27), land-based exercise (n = 25) or control (n = 27). Results: No effect was observed immediately after exercise cessation...

  8. The prevention of depressive symptoms in rural school children: a randomized controlled trial.

    Science.gov (United States)

    Roberts, Clare; Kane, Robert; Thomson, Helen; Bishop, Brian; Hart, Bret

    2003-06-01

    A controlled trial was conducted to evaluate a prevention program aimed at reducing depressive and anxious symptoms in rural school children. Seventh-grade children with elevated depression were selected. Nine primary schools (n = 90) were randomly assigned to receive the program, and 9 control schools (n = 99) received their usual health education classes. Children completed questionnaires on depression, anxiety, explanatory style, and social skills. Parents completed the Child Behavior Checklist (T. M. Achenbach, 1991). No intervention effects were found for depression. Intervention group children reported less anxiety than the control group after the program and at 6-month follow-up and more optimistic explanations at postintervention. Intervention group parents reported fewer child internalizing and externalizing symptoms at postintervention only. PMID:12795585

  9. Intravenous chemotherapy for resected gastric cancer: meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Jian-Kun Hu; You-Ping Li; Zhi-Xin Chen; Zong-Guang Zhou; Bo Zhang; Jing Tian; Jia-Ping Chen; Li Wang; Chao-Hua Wang; Hong-Yan Chen

    2002-01-01

    AIM: To assess the safety and efficacy of different intravenous chemotherapeutic regimens in patients with gastric carcinomas who had undergone gastrectomy.METHODS: A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Language was restricted to Chinese and English. RCTs were identified from Medline and Embase (1980-2001/4), and Chinese Biowere checked at the same time. We included randomized and quasi-randomized trials comparing the efficacy of intravenous chemotherapy after gastrectomy with that of surgery alone in patients with confirmed gastric carcinomas who had undergone gastrectomy. Selection criteria were: randomized or quasi-randomized trials with following-up results; Trials could be double-blind, single-blind or not blind; Chemotherapy groups were given intravenous chemotherapy after gastrectomy without neo-adjuvant chemotherapy, intraperitoneal hyperthermic perfusion, radiotherapy or chemoimmunotherapy; Controlled group included those receiving gastrectomy alone. The following data were extracted: the number of survival and death by the end of the follow-up; the different agents and doses of the intravenous chemotherapy; the baseline of the chemotherapy group and the controlled arm; the serious adverse events; the statistical consideration; cost-effectiveness analysis. The statistical analysis was performed by RevMan4.1 software which was provided by the Cochrane Collaboration. A Pvalue of <0.05 was considered statistically significant. Metaanalysis was done with random effects model. Heterogeneity was checked by chi-square test. Sensitivity analysis was performed by excluding the trials in which Jadad-scale was only 1 score. The result was expressed with odds ratio (OR) for the categorical variable.RESULTS: Fourteen trials involving 4543 patients were included. Meta-analysis was done with random effects model. Heterogeneity and sensitivity analysis were performed also. The effect of intravenous chemotherapy after

  10. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

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    Grøndahl Jan

    2008-09-01

    Full Text Available Abstract Background Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP. Methods The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests. Results The treatment group improved from their symptoms, (change from 62.5 to 55.4, while the control group deteriorated, (change from 37.2 to 45.1, (p = 0,045. The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046. One year later the corresponding result was 41.3, indicating a persisting improvement. Conclusion The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results. Trial Registration The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001.

  11. Effects of warm acupuncture on breast cancer–related chronic lymphedema: a randomized controlled trial

    Science.gov (United States)

    Yao, C.; Xu, Y.; Chen, L.; Jiang, H.; Ki, C.S.; Byun, J.S.; Bian, W.

    2016-01-01

    Background Effective treatment for breast cancer–related chronic lymphedema (bcrl) remains a clinical challenge. Acupuncture and moxibustion treatments have been shown to be beneficial and safe for treating bcrl. In the present randomized controlled trial, we compared the effectiveness of combined acupuncture and moxibustion (“warm acupuncture”) with that of diosmin in bcrl. Methods Breast cancer patients who met the inclusion and exclusion criteria (n = 30) were randomized to experimental and control groups (15 per group). On alternate days, patients in the experimental group received 30 minutes of acupuncture at 6 acupoints, with 3 of the needles each being topped by a 3-cm moxa stick. The control treatment was diosmin 900 mg 3 times daily. The control and experimental treatments were administered for 30 days. Outcome measures included arm circumferences (index of effectiveness), range of motion [rom (shoulder joint function)], quality of life, clinical safety, and adverse events. Results Measured by the index of effectiveness, bcrl improved by 51.46% in the experimental group and by 26.27% in the control group (p < 0.00001). Effects were greatest at 10 cm above the elbow and at the wrist, where the warm needling was provided. Impairments in shoulder joint rom were minimal at baseline in both treatment groups. However, the roms of rear protraction, abduction, intorsion, and extorsion in the experimental group improved significantly; they did not change in the control group. Self-reported quality of life was significantly better with warm acupuncture than with diosmin. No adverse effects were reported during the treatment period, and laboratory examinations for clinical safety fell within the normal ranges. Conclusions Compared with diosmin, warm acupuncture treatment can effectively reduce the degree of bcrl at the specific acupoints treated and can promote quality of life. Warm acupuncture showed good clinical safety, without any adverse effects on blood

  12. Do motion controllers make action video games less sedentary? A randomized experiment.

    Science.gov (United States)

    Lyons, Elizabeth J; Tate, Deborah F; Ward, Dianne S; Ribisl, Kurt M; Bowling, J Michael; Kalyanaraman, Sriram

    2012-01-01

    Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100) were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12). An interaction was found such that in one pair, motion control (mean [SD] 0.96 [0.20] kcal · kg(-1) · hr(-1)) produced 0.10 kcal · kg(-1) · hr(-1) (95% confidence interval 0.03 to 0.17) greater energy expenditure than traditional control (0.86 [0.17] kcal · kg(-1) · hr(-1), P = .048). All games were sedentary. As currently implemented, motion control is unlikely to produce moderate intensity physical activity in action games. However, some games produce small but significant increases in energy expenditure, which may benefit health by decreasing sedentary behavior. PMID:22028959

  13. Do Motion Controllers Make Action Video Games Less Sedentary? A Randomized Experiment

    Directory of Open Access Journals (Sweden)

    Elizabeth J. Lyons

    2012-01-01

    Full Text Available Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100 were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12. An interaction was found such that in one pair, motion control (mean [SD] 0.96 [0.20] kcal ⋅ kg-1 ⋅ hr-1 produced 0.10 kcal ⋅ kg-1 ⋅ hr-1 (95% confidence interval 0.03 to 0.17 greater energy expenditure than traditional control (0.86 [0.17] kcal ⋅ kg-1 ⋅ hr-1, P = .048. All games were sedentary. As currently implemented, motion control is unlikely to produce moderate intensity physical activity in action games. However, some games produce small but significant increases in energy expenditure, which may benefit health by decreasing sedentary behavior.

  14. Do motion controllers make action video games less sedentary? A randomized experiment.

    Science.gov (United States)

    Lyons, Elizabeth J; Tate, Deborah F; Ward, Dianne S; Ribisl, Kurt M; Bowling, J Michael; Kalyanaraman, Sriram

    2012-01-01

    Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100) were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12). An interaction was found such that in one pair, motion control (mean [SD] 0.96 [0.20] kcal · kg(-1) · hr(-1)) produced 0.10 kcal · kg(-1) · hr(-1) (95% confidence interval 0.03 to 0.17) greater energy expenditure than traditional control (0.86 [0.17] kcal · kg(-1) · hr(-1), P = .048). All games were sedentary. As currently implemented, motion control is unlikely to produce moderate intensity physical activity in action games. However, some games produce small but significant increases in energy expenditure, which may benefit health by decreasing sedentary behavior.

  15. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Dawson Church

    2012-01-01

    Full Text Available Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI. Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques, a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N=18. The EFT group (n=9 had significantly more depression at baseline than the control group (n=9 (EFT BDI mean=23.44, SD=2.1 versus control BDI mean=20.33, SD=2.1. After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P=.001; EFT BDI mean=6.08, SE=1.8 versus control BDI mean=18.04, SE=1.8. Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment.

  16. Study protocol: optimization of complex palliative care at home via telemedicine. A cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hasselaar Jeroen

    2011-08-01

    Full Text Available Abstract Background Due to the growing number of elderly with advanced chronic conditions, healthcare services will come under increasing pressure. Teleconsultation is an innovative approach to deliver quality of care for palliative patients at home. Quantitative studies assessing the effect of teleconsultation on clinical outcomes are scarce. The aim of this present study is to investigate the effectiveness of teleconsultation in complex palliative homecare. Methods/Design During a 2-year recruitment period, GPs are invited to participate in this cluster randomized controlled trial. When a GP refers an eligible patient for the study, the GP is randomized to the intervention group or the control group. Patients in the intervention group have a weekly teleconsultation with a nurse practitioner and/or a physician of the palliative consultation team. The nurse practitioner, in cooperation with the palliative care specialist of the palliative consultation team, advises the GP on treatment policy of the patient. The primary outcome of patient symptom burden is assessed at baseline and weekly using the Edmonton Symptom Assessment Scale (ESAS and at baseline and every four weeks using the Hospital Anxiety and Depression Scale (HADS. Secondary outcomes are self-perceived burden from informal care (EDIZ, patient experienced continuity of medical care (NCQ, patient and caregiver satisfaction with the teleconsultation (PSQ, the experienced problems and needs in palliative care (PNPC-sv and the number of hospital admissions. Discussion This is one of the first randomized controlled trials in palliative telecare. Our data will verify whether telemedicine positively affects palliative homecare. Trial registration The Netherlands National Trial Register NTR2817

  17. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

    Directory of Open Access Journals (Sweden)

    Thomson Denise

    2010-12-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. Methods We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. Results Most studies (83% were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008. Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25. Among survey respondents (50% response rate, the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. Conclusions More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.

  18. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    Science.gov (United States)

    Ersek, Mary; Turner, Judith A; Cain, Kevin C; Kemp, Carol A

    2004-01-01

    Background Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. Methods/Design This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of .50 for the primary outcome. Discussion Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range. PMID:15285783

  19. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy.

    Science.gov (United States)

    Klopstock, Thomas; Yu-Wai-Man, Patrick; Dimitriadis, Konstantinos; Rouleau, Jacinthe; Heck, Suzette; Bailie, Maura; Atawan, Alaa; Chattopadhyay, Sandip; Schubert, Marion; Garip, Aylin; Kernt, Marcus; Petraki, Diana; Rummey, Christian; Leinonen, Mika; Metz, Günther; Griffiths, Philip G; Meier, Thomas; Chinnery, Patrick F

    2011-09-01

    Major advances in understanding the pathogenesis of inherited metabolic disease caused by mitochondrial DNA mutations have yet to translate into treatments of proven efficacy. Leber's hereditary optic neuropathy is the most common mitochondrial DNA disorder causing irreversible blindness in young adult life. Anecdotal reports support the use of idebenone in Leber's hereditary optic neuropathy, but this has not been evaluated in a randomized controlled trial. We conducted a 24-week multi-centre double-blind, randomized, placebo-controlled trial in 85 patients with Leber's hereditary optic neuropathy due to m.3460G>A, m.11778G>A, and m.14484T>C or mitochondrial DNA mutations. The active drug was idebenone 900 mg/day. The primary end-point was the best recovery in visual acuity. The main secondary end-point was the change in best visual acuity. Other secondary end-points were changes in visual acuity of the best eye at baseline and changes in visual acuity for both eyes in each patient. Colour-contrast sensitivity and retinal nerve fibre layer thickness were measured in subgroups. Idebenone was safe and well tolerated. The primary end-point did not reach statistical significance in the intention to treat population. However, post hoc interaction analysis showed a different response to idebenone in patients with discordant visual acuities at baseline; in these patients, all secondary end-points were significantly different between the idebenone and placebo groups. This first randomized controlled trial in the mitochondrial disorder, Leber's hereditary optic neuropathy, provides evidence that patients with discordant visual acuities are the most likely to benefit from idebenone treatment, which is safe and well tolerated.

  20. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    Zhang-Jin Zhang

    Full Text Available BACKGROUND: Previous studies suggest that electroacupuncture possesses therapeutic benefits for depressive disorders. The purpose of this study was to determine whether dense cranial electroacupuncture stimulation (DCEAS could enhance the antidepressant efficacy in the early phase of selective serotonin reuptake inhibitor (SSRI treatment of major depressive disorder (MDD. METHODS: In this single-blind, randomized, controlled study, patients with MDD were randomly assigned to 9-session DCEAS or noninvasive electroacupuncture (n-EA control procedure in combination with fluoxetine (FLX for 3 weeks. Clinical outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17, Clinical Global Impression-severity (CGI-S, and Self-rating Depression Scale (SDS as well as the response and remission rates. RESULTS: Seventy-three patients were randomly assigned to n-EA (n = 35 and DCEAS (n = 38, of whom 34 in n-EA and 36 in DCEAS group were analyzed. DCEAS-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores at Day 3 through Day 21 and in SDS scores at Day 3 and Day 21 compared to patients receiving n-EA. DCEAS intervention also produced a higher rate of clinically significant response compared to n-EA procedure (19.4% (7/36 vs. 8.8% (3/34. The incidence of adverse events was similar in the two groups. CONCLUSIONS: DCEAS is a safe and effective intervention that augments the antidepressant efficacy. It can be considered as an additional therapy in the early phase of SSRI treatment of depressed patients. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88008690.

  1. Short-term effects of a randomized controlled worksite relaxation intervention in Greece

    Directory of Open Access Journals (Sweden)

    Evangelos C Alexopoulos

    2014-06-01

    Full Text Available objective. To evaluate the short-term benefits of simple relaxation techniques in white-collar employees. materials and methods. The study was a two-arm parallel group randomized controlled trial. 152 employees were randomly assigned to receive the 8-week programme (N=80 (relaxation breathing and progressive muscle relaxation, twice a day or not (wait-list group N=72. Self-reported validated measures were used to evaluate perceived stress, health locus of control, job and lifestyle related variables. Saliva cortisol were also sampled and measured. Adjusted mean changes on outcomes were estimated by linear mixed model analysis. 127 employees were finally analyzed (68 in the intervention and 59 in the control group. results. Specific stress-related symptoms, psychological job demands and cortisol levels were found to be significantly decreased after 8-weeks in the intervention group. The result was probably affected by the general socio-economic condition during the study period. Cortisol levels were also significantly related with age, family situation, gender and sampling time. conclusions. Simple relaxation training (diaphragmatic breathing and progressive muscle relaxation could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings

  2. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    Science.gov (United States)

    Flaugnacco, Elena; Lopez, Luisa; Terribili, Chiara; Montico, Marcella; Zoia, Stefania; Schön, Daniele

    2015-01-01

    There is some evidence for a role of music training in boosting phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development. Poor performance in tasks requiring temporal processing, rhythm perception and sensorimotor synchronization seems to be a crucial factor underlying dyslexia in children. Interestingly, children with dyslexia show deficits in temporal processing, both in language and in music. Within this framework, we test the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test (ID NCT02316873). After rehabilitation, the music group (N = 24) performed better than the control group (N = 22) in tasks assessing rhythmic abilities, phonological awareness and reading skills. This is the first randomized control trial testing the effect of music training in enhancing phonological and reading abilities in children with dyslexia. The findings show that music training can modify reading and phonological abilities even when these skills are severely impaired. Through the enhancement of temporal processing and rhythmic skills, music might become an important tool in both remediation and early intervention programs.Trial Registration: ClinicalTrials.gov NCT02316873 PMID:26407242

  3. Can orthotic insoles prevent lower limb overuse injuries? A randomized-controlled trial of 228 subjects.

    Science.gov (United States)

    Mattila, V M; Sillanpää, P J; Salo, T; Laine, H-J; Mäenpää, H; Pihlajamäki, H

    2011-12-01

    Lower limb overuse injuries are common among people who are exposed to physical stress. Orthotic shoe insoles are widely used to prevent lower limb overuse injuries. Here, we conducted a randomized-controlled study to examine whether the use of orthotic insoles prevents lower limb overuse injuries. Participants (n=228) were randomly assigned to use (n=73) or not to use (n=147) orthotic insoles. The insoles were molded to the shape of the foot to provide support during physical activity. The main outcome measure in the present study was the physician-diagnosed lower limb overuse injury. Thirty-four (46.6%) subjects in the insole group were diagnosed with a lower limb overuse injury compared with 56 (38.1%) in the control group (P=0.29) during the 6-month study period. When body mass index and the results of a 12-min running test and muscle strength were adjusted in a Cox's regression model, the hazard ratio for lower limb overuse injury in the insole group was 1.3 (95% confidence intervals: 0.8-2.1) compared with the control group. Use of orthotic insoles was not associated with a decrease in lower limb overuse injuries. Our findings suggest that routine use of orthotic insoles does not prevent physical-stress-related lower limb injuries in healthy young male adults.

  4. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kim, Sang-Dol

    2016-07-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  5. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ravindra Arya

    2012-01-01

    Full Text Available Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS. Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19–29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm or standard care only (control arm. Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329. Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82–1.44, <0.0001 and habituation (ES 1.05, 95% CI 0.53–1.57, =0.0001. Conclusion. Prenatal music exposure to mother significantly and favourably influences neonatal behaviour.

  6. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  7. Effect of pre-treatment with chlorhexidine on the retention of restorations: a randomized controlled trial.

    Science.gov (United States)

    Montagner, Anelise Fernandes; Perroni, Ana Paula; Corrêa, Marcos Britto; Masotti, Alexandre Severo; Pereira-Cenci, Tatiana; Cenci, Maximiliano Sérgio

    2015-01-01

    This study aimed to evaluate the effect of chlorhexidine (CHX) application on etched dentin on the 6-month retention of restorations placed on non-carious cervical lesions (NCCLs). A randomized controlled split-mouth and triple blind trial was carried out. Patients (n=42) with at least two non-carious cervical lesions were included. NCCLs were randomly assigned to two groups: control (placebo solution) or test group (2% CHX solution for 60 s after acid etching and before the adhesive application). Class V restorations (n=169) were performed with an etch-and-rinse adhesive system and composite resin by 10 trained operators. A calibrated examiner evaluated the restorations at 1 week (baseline) and at 6 months using the FDI criteria. The primary outcome was retention of the restorations. The analysis of factors associated to failure of restorations was carried out by Fisher's exact test (α=0.05). After 6 months of follow-up, 3.4% (CI 95% 1.3-7.3) of the restorations failed. There was no statistically significant difference between control and CHX (p=0.920). Regarding the cavity variables, deeper (p=0.04), wider (p=0.004) and wedge-shaped (p=0.033) cavities failed more. Both treatments provided acceptable clinical performance of the restorations. The use of CHX as a adjuvant in dentin adhesion did not influence the retention of Class V restorations after 6 months of follow-up. PMID:26200146

  8. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    Directory of Open Access Journals (Sweden)

    Elena Flaugnacco

    Full Text Available There is some evidence for a role of music training in boosting phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development. Poor performance in tasks requiring temporal processing, rhythm perception and sensorimotor synchronization seems to be a crucial factor underlying dyslexia in children. Interestingly, children with dyslexia show deficits in temporal processing, both in language and in music. Within this framework, we test the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test (ID NCT02316873. After rehabilitation, the music group (N = 24 performed better than the control group (N = 22 in tasks assessing rhythmic abilities, phonological awareness and reading skills. This is the first randomized control trial testing the effect of music training in enhancing phonological and reading abilities in children with dyslexia. The findings show that music training can modify reading and phonological abilities even when these skills are severely impaired. Through the enhancement of temporal processing and rhythmic skills, music might become an important tool in both remediation and early intervention programs.Trial Registration: ClinicalTrials.gov NCT02316873

  9. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    Science.gov (United States)

    Flaugnacco, Elena; Lopez, Luisa; Terribili, Chiara; Montico, Marcella; Zoia, Stefania; Schön, Daniele

    2015-01-01

    There is some evidence for a role of music training in boosting phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development. Poor performance in tasks requiring temporal processing, rhythm perception and sensorimotor synchronization seems to be a crucial factor underlying dyslexia in children. Interestingly, children with dyslexia show deficits in temporal processing, both in language and in music. Within this framework, we test the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test (ID NCT02316873). After rehabilitation, the music group (N = 24) performed better than the control group (N = 22) in tasks assessing rhythmic abilities, phonological awareness and reading skills. This is the first randomized control trial testing the effect of music training in enhancing phonological and reading abilities in children with dyslexia. The findings show that music training can modify reading and phonological abilities even when these skills are severely impaired. Through the enhancement of temporal processing and rhythmic skills, music might become an important tool in both remediation and early intervention programs.Trial Registration: ClinicalTrials.gov NCT02316873

  10. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

    Directory of Open Access Journals (Sweden)

    Kevin Sweet

    2014-01-01

    Full Text Available We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF or hypertension (HTN, managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC. Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®. OSUWMC patient participants with chronic disease (CD receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1 change in risk perception; (2 knowledge retention; (3 perceived personal control; (4 health behavior change; and, for the active arm (5, overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.

  11. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Adelaida María Castro-Sánchez

    2012-01-01

    Full Text Available Background. Multiple sclerosis (MS is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P<0.028 and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients.

  12. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    A R Pradeep

    2012-01-01

    Full Text Available Background: The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF as the active ingredient on gingivitis. Materials and Methods: Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided in three groups: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. Results: AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. Conclusions: AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  13. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Giovanni E. Ferreira

    2016-01-01

    Full Text Available ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed, EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  14. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial

    Science.gov (United States)

    Arya, Ravindra; Chansoria, Maya; Konanki, Ramesh; Tiwari, Dileep K.

    2012-01-01

    Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19–29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm) or standard care only (control arm). Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329). Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82–1.44, P music exposure to mother significantly and favourably influences neonatal behaviour. PMID:22518187

  15. Noninvasive Ventilation for Preterm Twin Neonates with Respiratory Distress Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Long; Wang, Li; Li, Jie; Wang, Nan; Shi, Yuan

    2015-01-01

    Noninvasive ventilation has been proven to be effective strategies for reducing the need for endotracheal ventilation in preterm infant with respiratory distress syndrome (RDS), however the best option needs to be further determined. A single center, paired design, randomized, controlled trial was conducted between Jan 2011 and July 2014. Preterm twins with RDS were included. One of a pair was randomized to NIPPV, while another to NCPAP. Surfactant was administrated as rescue treatment. The primary outcome was the need for endotracheal ventilation. The secondary outcomes were the complications. 143 pairs were randomized and 129 pairs finished the trial. The rates of endotracheal ventilation did not differ significantly between NIPPV and NCPAP groups (11.9% vs 19.6%, P = 0.080). This difference was not observed in the subgroup of infants who received surfactant therapy (11.1% vs 19.7%, P = 0.087). No secondary outcomes also differed significantly between the two groups. NIPPV did not result in a significantly lower incidence of intubation as compared with NCPAP in preterm twins with RDS. PMID:26399752

  16. Prospective randomized controlled trial investigating the type of sutures used during hepatectomy

    Institute of Scientific and Technical Information of China (English)

    Norifumi Harimoto; Ken Shirabe; Tomoyuki Abe; Takafumi Yukaya; Eiji Tsujita; Tomonobu Gion; Kiyoshi Kajiyama; Takashi Nagaie

    2011-01-01

    AIM: To determine whether absorbable sutures or non-absorbable sutures are better in preventing surgical site infection (SSI), in this paper we discuss the results of a randomized clinical trial which examined the type of sutures used during hepatectomy. METHODS: All hepatic resections performed from January 2007 to November 2008 at the Department of Surgery at Iizuka Hospital in Japan were included in this study. There were 125 patients randomly assigned to an absorbable sutures (Vicryl) group or non-absorbable sutures (Silk) group. RESULTS: SSI was observed in 13.6% (17/125) patients participating in this study, 11.3% in the Vicryl group and 15.8% in the Silk group. Incisional SSI including superficial and deep SSI, was observed in 8% of the Vicryl group and 9.5% of the Silk group. Organ/ space SSI was observed in 3.2% of the Vicryl group and 6.0% of the Silk group. There were no significant differences, but among the patients with SSI, the period for recovery was significantly shorter for the Vicryl group compared to the Silk group. CONCLUSION: The incidence of SSI in patients receiving absorbable sutures and silk sutures is not significantly different in this randomized controlled study; however, the period for recovery in patients with SSI was significantly shorter for absorbable sutures.

  17. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  18. Working alliance and its relationship to outcomes in a randomized controlled trial (RCT of antipsychotic medication

    Directory of Open Access Journals (Sweden)

    Wykes Til

    2013-01-01

    Full Text Available Abstract Background Long acting injections (LAI have been associated with perceptions of coercion in cross sectional studies but there have been no longitudinal studies of the effects on clinical relationships with newer depot medications. Method Randomized controlled trial with (50 participants with a diagnosis of schizophrenia randomized to risperidone LAI or oral atypical antipsychotic medication. The main outcome was the Working Alliance Inventory (WAI with background variables (symptoms, side effect, social functioning, quality of life measured before randomization and at two years. Results At follow-up (14 risperidone LAI and 16 oral medication analyses including predictors of missing data and baseline score showed a trend for those on risperidone LAI to reduce WAI score and those on oral medication showing no change. Sensitivity analyses showed (i a significant detrimental effect of LAI on WAI and (ii the pattern of results was not affected by change in symptoms over the study. Conclusion This is the first study to show that the prescription of depot atypical depot medication is associated with detrimental effects on clinical relationships after 2 years of continual treatment.

  19. Saving and Empowering Young Lives in Europe (SEYLE: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nemes Bogdan

    2010-04-01

    Full Text Available Abstract Background There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health. The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. Methods and design The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR, awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. Discussion Although it has been reported that

  20. Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

    DEFF Research Database (Denmark)

    Marckmann, Peter; Agerskov, Hanne; Thineshkumar, Sasikala;

    2012-01-01

    BackgroundHypovitaminosis D is common in chronic kidney disease (CKD). Effects of 25-hydroxyvitamin D replenishment in CKD are not well described.MethodsAn 8-week randomized, placebo-controlled, double-blind parallel intervention study was conducted in haemodialysis (HD) and non-HD CKD patients...... biomarkers related to cardiovascular disease (plasma D-dimer, plasma fibrinogen, plasma von Willebrand factor antigen and activity, plasma interleukin 6, plasma C-reactive protein, blood pressure, aortic augmentation index, aortic pulse wave velocity and 24-h urinary protein loss). Objective and subjective...

  1. Qing-Yi decoction in participants with severe acute pancreatitis: a randomized controlled trial

    OpenAIRE

    Chen, Weiwei; Yang, Xiaonan; Huang, Lei; Xue, Ping; Wan, Meihua; Guo, Jia; Zhu, Lin; Jin, Tao; Huang, Zongwen; Chen, Guangyuan; Tang, Wenfu; Xia, Qing

    2015-01-01

    Background Qing-Yi Decoction (QYD) has been used for severe acute pancreatitis (SAP) patients in China for many years. There were two kinds of QYD: Num 1. QYD (QYD1) which is used in the acute response stage of SAP and Num 2. QYD (QYD2) which is used in the second stage of SAP. This study aims to evaluate the therapeutic efficacy of QYD in participants with SAP. Methods In this prospective, randomized, double-blind, placebo-controlled trial, participants aged 18–70 years within the first 7 da...

  2. Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial

    DEFF Research Database (Denmark)

    Hedayati-Hajikand, Trifa; Lundberg, Ulrika; Eldh, Catarina;

    2015-01-01

    BACKGROUND: To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area. METHODS: The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138...... daily with fluoride toothpaste. RESULTS: The groups were balanced at baseline and the attrition rate was 20%. Around 2/3 of the children in both groups reported an acceptable compliance. The caries increment (Δds) was significantly lower in the test group when compared with the placebo group, 0.2 vs. 0.......8 (p effects were reported. CONCLUSIONS: The results suggested that early...

  3. Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andresen, Sven Robert; Bing, Jette; Hansen, Rikke Bod Middelhede;

    2015-01-01

    . Methods  A randomized, double-blind, placebo-controlled parallel multicenter study. Study population of at least 66 patients must complete the 12 week trial.Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment. A numeric...... is 55.3 (±9.5) years and average time since injury is 8.8 (±8.9)years. Causes of injury are 31% transport, 27% fall, 21% non-traumatic SCI, 14% other traumatic cause and 7% sports injuries. No major side effectshave been reported. Further results will be presented at the meeting...

  4. Effectiveness of a Self-Guided Web-Based Cannabis Treatment Program: Randomized Controlled Trial

    OpenAIRE

    Rooke, Sally; Copeland, Jan; Norberg, Melissa; Hine, Donald; McCambridge, Jim

    2013-01-01

    Background Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems. Objectives The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully s...

  5. Saving and Empowering Young Lives in Europe (SEYLE): a randomized controlled trial

    LENUS (Irish Health Repository)

    Wasserman, Danuta

    2010-04-13

    Abstract Background There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people\\'s mental health. The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. Methods and design The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. Discussion Although it has been reported that suicide

  6. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

    OpenAIRE

    Steinan, Mette Kvisten; Krane-Gartiser, Karoline; Langsrud, Knut; Sand, Trond; Kallestad, Håvard; Morken, Gunnar

    2014-01-01

    Background Patients with bipolar disorder experience sleep disturbance, even in euthymic phases. Changes in sleep pattern are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for primary insomnia, but there are no published results on the effects of CBT-I in patients with bipolar disorder. In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to...

  7. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    Science.gov (United States)

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety. PMID:23362335

  8. Effects of Aerobic Exercise on Overweight Children’s Cognitive Functioning: A Randomized Controlled Trial

    OpenAIRE

    Davis, Catherine L.; Tomporowski, Phillip D.; Boyle, Colleen A; Waller, Jennifer L.; Miller, Patricia H.; Naglieri, Jack A.; Gregoski, Mathew

    2007-01-01

    The study tested the effect of aerobic exercise training on executive function in overweight children. Ninety-four sedentary, overweight but otherwise healthy children (mean age = 9.2 years, body mass index ≥ 85th percentile) were randomized to a low-dose (20 min/day exercise), high-dose (40 min/day exercise), or control condition. Exercise sessions met 5 day/wk for 15 weeks. The Cognitive Assessment System (CAS), a standardized test of cognitive processes, was administered individually befor...

  9. Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

    DEFF Research Database (Denmark)

    Bosch, Jaime; Thabut, Dominique; Albillos, Agustín;

    2008-01-01

    A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal...... events, were comparable between groups. CONCLUSION: Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo. Therefore, decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered, because results of this study do...

  10. A randomized controlled trial on a multicomponent intervention for overweight school-aged children - Copenhagen, Denmark

    DEFF Research Database (Denmark)

    Harder-Lauridsen, Nina Majlund; Birk, Nina Marie; Ried-Larsen, Mathias;

    2014-01-01

    BACKGROUND: Obesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance...... intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group. METHODS: School children from Copenhagen were randomly...

  11. Randomized Controlled Trials to Define Viral Load Thresholds for Cytomegalovirus Pre-Emptive Therapy

    Science.gov (United States)

    Griffiths, Paul D.; Rothwell, Emily; Raza, Mohammed; Wilmore, Stephanie; Doyle, Tomas; Harber, Mark; O’Beirne, James; Mackinnon, Stephen; Jones, Gareth; Thorburn, Douglas; Mattes, Frank; Nebbia, Gaia; Atabani, Sowsan; Smith, Colette; Stanton, Anna; Emery, Vincent C.

    2016-01-01

    Background To help decide when to start and when to stop pre-emptive therapy for cytomegalovirus infection, we conducted two open-label randomized controlled trials in renal, liver and bone marrow transplant recipients in a single centre where pre-emptive therapy is indicated if viraemia exceeds 3000 genomes/ml (2520 IU/ml) of whole blood. Methods Patients with two consecutive viraemia episodes each below 3000 genomes/ml were randomized to continue monitoring or to immediate treatment (Part A). A separate group of patients with viral load greater than 3000 genomes/ml was randomized to stop pre-emptive therapy when two consecutive levels less than 200 genomes/ml (168 IU/ml) or less than 3000 genomes/ml were obtained (Part B). For both parts, the primary endpoint was the occurrence of a separate episode of viraemia requiring treatment because it was greater than 3000 genomes/ml. Results In Part A, the primary endpoint was not significantly different between the two arms; 18/32 (56%) in the monitor arm had viraemia greater than 3000 genomes/ml compared to 10/27 (37%) in the immediate treatment arm (p = 0.193). However, the time to developing an episode of viraemia greater than 3000 genomes/ml was significantly delayed among those randomized to immediate treatment (p = 0.022). In Part B, the primary endpoint was not significantly different between the two arms; 19/55 (35%) in the less than 200 genomes/ml arm subsequently had viraemia greater than 3000 genomes/ml compared to 23/51 (45%) among those randomized to stop treatment in the less than 3000 genomes/ml arm (p = 0.322). However, the duration of antiviral treatment was significantly shorter (p = 0.0012) in those randomized to stop treatment when viraemia was less than 3000 genomes/ml. Discussion The results illustrate that patients have continuing risks for CMV infection with limited time available for intervention. We see no need to alter current rules for stopping or starting pre-emptive therapy. PMID:27684379

  12. Effect of fish oil on heart rate in humans. A meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Mozaffarian, D.; Geelen, A.; Brouwer, I.A.; Geleijnse, J.M.; Katan, M.B.; Zock, P.L.

    2005-01-01

    Background - The effect of fish oil on heart rate (HR), a major risk factor for sudden death, is not well established. We calculated this effect in a meta-analysis of randomized, double-blind, placebo- controlled trials in humans. Methods and Results - Randomized trials of fish oil that evaluated HR

  13. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    Science.gov (United States)

    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)…

  14. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  15. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Winstein Carolee J

    2013-01-01

    Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary

  16. Supramolecular assembly based on a heteropolyanion: Synthesis and crystal structure of Na3(H2O)6[Al(OH)6Mo6O18]$\\cdot$2H2O

    Indian Academy of Sciences (India)

    Vaddypally Shivaiah; Samar K Das

    2005-05-01

    Synthesis and structural characterization of a polyoxometalate compound Na3(H2O)6 [Al(OH)6Mo6O18]$\\cdot$2H2O (1) have been described. Compound 1 exhibits three-dimensional network structure in the solid state, which is assembled by Anderson-type heteropolyanions, [Al(OH)6Mo6O18]$_n^{3n-}$, as building blocks sharing sodium cations. 1 possesses ``sinuous" channels occupied by supramolecular water dimers as guests. Anderson anions, sodium-coordinated water and crystal water are additionally involved in an intricate hydrogen-bonding network in the crystal of 1.

  17. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Agnes S Chan

    Full Text Available Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD, which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group or PMR (control group twice per week for four weeks. The participants' self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants' brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org.

  18. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chuan Zou

    Full Text Available To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD patients with insomnia.Sixty three (63 eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32, or sham AA (SAA group received AA on points irrelevant to insomnia treatment (n=31 for eight weeks. All participants were followed up for 12 weeks after treatments. The primary outcome was clinical response at eight weeks after randomization, defined as a reduction of Pittsburgh Sleep Quality Index (PSQI global score by 3 points and more.Fifty-eight (58 participants completed the trial and five dropped out. Twenty participants in AA group (62.5% and ten in SAA group (32.3% responded to the eight-week interventions (χ2 = 5.77, P = 0.02. PSQI global score declined 3.75 ± 4.36 (95%CI -5.32, -2.18 and 2.26 ± 3.89 (95%CI -3.68, -0.83 in AA group and SAA group respectively. Three participants died during the follow-up period. No evidence supported their deaths were related to the AA intervention. No other adverse event was observed.Feasibility and logistics of patient recruitment, randomization procedure, blinding approach, interventions application and outcome assessment had been tested in this pilot trial. The preliminary data appeared to show a favorable result on AA treatment. A full-scale trial is warranted.Chinese Clinical Trial Registry ChiCTR-TRC-12002272.

  19. Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial

    Science.gov (United States)

    Umasunthar, T; Procktor, A; Hodes, M; Smith, J G; Gore, C; Cox, H E; Marrs, T; Hanna, H; Phillips, K; Pinto, C; Turner, P J; Warner, J O; Boyle, R J

    2015-01-01

    Background Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices. Methods We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events. Results We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful – RR 1.00 (95% CI 0.68–1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001). Conclusions AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q. PMID:25850463

  20. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2016-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  1. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John F. Emerson

    2015-12-01

    Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention

  2. EEG Neurofeedback treatments in children with ADHD: An updated meta-analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jean-Arthur eMicoulaud Franchi

    2014-11-01

    Full Text Available Objective We undertook a meta-analysis of published Randomized Controlled Trials (RCT with semi-active control and sham-NF groups to determine whether EEG-NF significantly improves the overall symptoms, inattention and hyperactivity/impulsivity dimensions for probably unblinded assessment (parent assessment and probably blinded assessment (teacher assessment in children with Attention Deficit Hyperactivity Disorder (ADHD.Data Sources A systematic review identified independent studies that were eligible for inclusion in a random effects meta-analysis.Data Extraction Effect sizes for ADHD symptoms were expressed as standardized mean differences (SMD with 95% confidence intervals.ResultsFive identified studies met eligibility criteria, 263 patients with ADHD were included, 146 patients were trained with EEG-NF. On parent assessment (probably unblinded assessment, the overall ADHD score (SMD=-0.49 [-0.74, -0.24], the inattention score (SMD=-0.46 [-0.76, -0.15] and the hyperactivity/impulsivity score (SMD=-0.34 [-0.59, -0.09] were significantly improved in patients receiving EEG-NF compared to controls. On teacher assessment (probably blinded assessment, only the inattention score was significantly improved in patients receiving EEG-NF compared to controls (SMD=-0.30 [-0.58, -0.03]. ConclusionsThis meta-analysis of EEG-NF in children with ADHD highlights improvement in the inattention dimension of ADHD symptoms. Future investigations should pay greater attention to adequately blinded studies and EEG-NF protocols that carefully control the implementation and embedding of training.

  3. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

    Energy Technology Data Exchange (ETDEWEB)

    Tuomi, Lisa, E-mail: lisa.tuomi@vgregion.se [Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden); Andréll, Paulin [Department of Molecular and Clinical Medicine/Multidisciplinary Pain Center, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden); Finizia, Caterina [Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden)

    2014-08-01

    Background: Patients treated with radiation therapy for laryngeal cancer often experience voice problems. The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist. Methods and Materials: Sixty-nine male patients irradiated for laryngeal cancer participated. Voice recordings and self-assessments of communicative dysfunction were performed 1 and 6 months after radiation therapy. Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and 36 to a control group. Furthermore, comparisons with 23 healthy control individuals were made. Acoustic analyses were performed for all patients, including the healthy control individuals. The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function. Results: The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation. Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function, whereas the control group did not. Conclusion: Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements. The patients experienced better voice function after rehabilitation. Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes. Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy, particularly for patients with supraglottic tumors.

  4. Effect of Telephone-Based Support on Postpartum Depression: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hourieh Shamshiri Milani

    2015-08-01

    Full Text Available Background: Postpartum depression (PPD is one public health issue that affects both maternal and child health. This research studies the effect of health volunteers’ telephonebased support on decreasing PPD. Materials and Methods: This randomized controlled trial evaluated 203 women who had uncomplicated deliveries. The women completed the Edinburg Postnatal Depression Scale (EPDS, 10 to 15 days after childbirth in order to be assessed for pre-trial depression scores. The cut-off point for depression was considered to be a score of >10. We randomly assigned 54 eligible mothers (n=27 per group with mild and moderate depression to the intervention and control groups. In both groups, mothers received routine postpartum care. The intervention group additionally received telephone support from health volunteers. A questionnaire was used to gather demographic and obstetric information. By the end of the 6th week, mothers completed the EPDS to be reassessed for depression after intervention. Data were analyzed using the chi-square, Fisher’s exact, t- and paired t tests. Results: The mean depression scores before intervention (10 to 15 days after childbirth in the intervention and control groups did not significantly differ (P=0.682. Depression scores of the intervention and control groups showed a significant difference after 6 weeks (P=0.035. In addition, there was a significant decrease in depression for the intervention and control groups (P=0.045. Conclusion: Health volunteer telephone-based support effectively decreased PPD and may be beneficial to women with symptoms of mild and moderate PPD (Registration number: IRCT201202159027N1.

  5. Effect of Telephone-Based Support on Postpartum Depression: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hourieh Shamshiri Milani

    2015-07-01

    Full Text Available Background: Postpartum depression (PPD is one public health issue that affects both maternal and child health. This research studies the effect of health volunteers’ telephonebased support on decreasing PPD. Materials and Methods: This randomized controlled trial evaluated 203 women who had uncomplicated deliveries. The women completed the Edinburg Postnatal Depression Scale (EPDS, 10 to 15 days after childbirth in order to be assessed for pre-trial depression scores. The cut-off point for depression was considered to be a score of >10. We randomly assigned 54 eligible mothers (n=27 per group with mild and moderate depression to the intervention and control groups. In both groups, mothers received routine postpartum care. The intervention group additionally received telephone support from health volunteers. A questionnaire was used to gather demographic and obstetric information. By the end of the 6th week, mothers completed the EPDS to be reassessed for depression after intervention. Data were analyzed using the chi-square, Fisher’s exact, t- and paired t tests. Results: The mean depression scores before intervention (10 to 15 days after childbirth in the intervention and control groups did not significantly differ (P=0.682. Depression scores of the intervention and control groups showed a significant difference after 6 weeks (P=0.035. In addition, there was a significant decrease in depression for the intervention and control groups (P=0.045. Conclusion: Health volunteer telephone-based support effectively decreased PPD and may be beneficial to women with symptoms of mild and moderate PPD (Registration number: IRCT201202159027N1.

  6. Randomized pilot study to disseminate caries-control services in dentist offices

    Directory of Open Access Journals (Sweden)

    Reynolds Debra

    2006-05-01

    Full Text Available Abstract Background To determine whether education and financial incentives increased dentists' delivery of fluoride varnish and sealants to at risk children covered by capitation dental insurance in Washington state (U.S.. Methods In 1999, 53 dental offices in Washington Dental Service's capitation dental plan were invited to participate in the study, and consenting offices were randomized to intervention (n = 9 and control (n = 10 groups. Offices recruited 689 capitation children aged 6–14 and at risk for caries, who were followed for 2 years. Intervention offices received provider education and fee-for-service reimbursement for delivering fluoride varnish and sealants. Insurance records were used to calculate office service rates for fluoride, sealants, and restorations. Parents completed mail surveys after follow-up to measure their children's dental utilization, dental satisfaction, dental fear and oral health status. Regression models estimated differences in service rates between intervention and control offices, and compared survey measures between groups. Results Nineteen offices (34% consented to participate in the study. Fluoride and sealant rates were greater in the intervention offices than the control offices, but the differences were not statistically significant. Restoration rates were lower in the intervention offices than the control offices. Parents in the intervention group reported their children had less dental fear than control group parents. Conclusion Due to low dentist participation the study lacked power to detect an intervention effect on dentists' delivery of caries-control services. The intervention may have reduced children's dental fear.

  7. Effectiveness of Treadmill Training on Balance Control in Elderly People: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Soraya Pirouzi

    2014-11-01

    Full Text Available Physical exercise would improve postural stability, which is an essential factor in preventing accidental fall among the elderly population. The aim of this study is to examine the effectiveness of treadmill walking on balance improvement among the elderly people. A total of 30 community dwelling older adults with a Berg Balance Scale score of 36-48 and the ability to walk without aid were considered and divided into control (n=15 and experimental (n=15 groups. Individuals in the experimental group participated in 30 minutes of forward and backward treadmill training based on three times a week interval for a period of four weeks. Individuals in the control group were instructed to continue with their daily routine activity. Before and after training, gait speed was measured by six-minute walk test and balance ability was evaluated by Fullerton Advanced Balance Scale (FABS and Berg Balance Scale (BBS tests. Postural sway items such as the Center of Pressure (COP, average displacement and velocity were evaluated by using a force platform system. Data were collected in quiet standing, tandem position and standing on foam pads before and after intervention. After intervention, balance variables in the experimental group indicated a significant improvement in quiet standing on firm and foam surfaces, but no considerable improvement was shown in tandem position. A between-group comparison showed a significant reduction in COP velocity in the sagittal plane (P=0.030 during quiet standing and in the frontal plane (P=0.001 during standing on foam, whereas no significant reduction in COP parameters during tandem position was found. It is recommended that twelve sessions of forward and backward treadmill walk are effective in balance improvement in elderly people. Trial Registration Number: IRCT201209199440N2

  8. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sarah H Wild

    2016-07-01

    Full Text Available Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD HbA1c at follow-up was 63.0 (15.5 mmol/mol in the intervention group and 67.8 (14.7 mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007. For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017 and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006 among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified

  9. Structure and Tensile Properties of 32Mn-7Cr-0.6Mo-0.3N Austenitic Cryogenic Steel%32Mn-7Cr-0.6Mo-0.3N奥氏体低温钢的组织和拉伸性能

    Institute of Scientific and Technical Information of China (English)

    付瑞东; 任一宾; 郑炀曾

    2001-01-01

    用材料试验机、SEM、TEM和X-射线分析研究了32Mn-7Cr-0.6Mo-0.3N奥氏体钢的组织和从室温到77K的拉伸性能。结果表明:随着温度的降低,屈服强度(σ0.2)和抗拉强度(σb)显著上升,延伸率(δ5)和断面收缩率(Ψ)略有减少;77K温度变形前后均为单相奥氏体组织,韧窝断口占主导并混有少量准解理小刻面的韧性断裂特征。%The tensile properties from 293K to 77K and structure ofaustenitic cryogenic steel 32Mn-7Cr-0.6Mo-0.3N by tensile test, SEM, TEM and X-ray analysis have been studied. The results showed that with the temperature decreasing, the yield and tensile strength increased appreciably, and the elongation and reduction of area decreased slightly. The structure of steel was single austenitic phase in deforming at 77K, and the fracture at 77K was tough feature with minor quasi-cleavage plane.

  10. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yan-hui Li

    Full Text Available BACKGROUND: Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM, the role of massage therapy in the management of FM remained controversial. OBJECTIVE: The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. METHODS: Electronic databases (up to June 2013 were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD and 95% confidence intervals (CI were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2 statistic. RESULTS: Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03, anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01, and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005 in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52. CONCLUSION: Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.

  11. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  12. Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

    Science.gov (United States)

    Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

    2016-01-01

    OBJECTIVE To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). METHODS Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. RESULTS Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD:15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of grow thin adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. CONCLUSIONS This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism. PMID:19948568

  13. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    Science.gov (United States)

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  14. Safety data from randomized controlled trials: applying models for recurrent events.

    Science.gov (United States)

    Hengelbrock, Johannes; Gillhaus, Johanna; Kloss, Sebastian; Leverkus, Friedhelm

    2016-07-01

    Simple descriptive listings and inference statistics based on 2×2 tables are still the most common way of summarizing and reporting adverse events data from randomized controlled trials, although these methods do not account for differences in observation times between treatment groups. Using standard methods from survival analysis such as the Cox model or Kaplan-Meier estimates would overcome this problem but limit the analysis to the first safety-related event of each subject. As an alternative, we discuss two models for recurrent events data-the Andersen-Gill and Prentice-Williams-Peterson model-regarding their applicability to safety data from randomized controlled trials. We argue that these models can be used to estimate two different quantities: a direct treatment effect on the risk of an event (Prentice-Williams-Peterson) and a total treatment effect as sum of the direct effect and the treatment's indirect effect via the event history (Anderson-Gill). Using simulated data, we illustrate the difference between these treatment effects and analyze the performance of both models in different scenarios. Because both models are limited to the analysis of cause-specific hazards if competing risks are present, we suggest to incorporate estimates of the mean frequency of events in the analysis to additionally allow the comparison of treatment effects on absolute event probabilities. We demonstrate the application of both models and the mean frequency function to safety endpoints with an illustrative analysis of data from a randomized phase-III study. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27291933

  15. Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol

    Directory of Open Access Journals (Sweden)

    Janssen Patricia A

    2012-12-01

    Full Text Available Abstract Background The prevalence of maternal drug use during pregnancy in North America has been estimated to be as high as 6-10%. The consequences for the newborn include increased risk for perinatal mortality and ongoing physical, neurobehavioral, and psychosocial problems. Methadone is frequently used to wean women off street drugs but is implicated as a cause of adverse fetal/neonatal outcomes itself. The purpose of our study was to test the ability of maternal acupuncture treatment among mothers who use illicit drugs to reduce the frequency and severity of withdrawal symptoms among their newborns. Methods We randomly assigned chemically dependent pregnant women at BC Women’s Hospital in Vancouver, British Columbia to daily acupuncture treatments versus usual care. By necessity, neither our participants nor acupuncturists were blinded as to treatment allocation. Our primary outcome was days of neonatal morphine treatment for symptoms of neonatal withdrawal. Secondary neonatal outcomes included admission to a neonatal ICU and transfer to foster care. Results We randomized 50 women to acupuncture and 39 to standard care. When analyzed by randomized groups, we did not find benefit of acupuncture; the average length of treatment with morphine for newborns in the acupuncture group was 2.7 (6.3 compared to 2.8 (7.0 in the control group. Among newborns of women who were compliant with the acupuncture regime, we observed a reduction of 2.1 and 1.5 days in length of treatment for neonatal abstinence syndrome compared to the non-compliant and control groups, respectively. These differences were not statistically significant. Conclusions Acupuncture may be a safe and feasible treatment to assist mothers to reduce their dosage of methadone. Our results should encourage ongoing studies to test the ability of acupuncture to mitigate the severity of neonatal abstinence syndrome among their newborns. Clinical Trial Registration http

  16. A Pilot Randomized Controlled Trial of Brief Cognitive-Behavioral Therapy for Anxiety in Patients with Terminal Cancer

    OpenAIRE

    Greer, Joseph A.; Traeger, Lara; Bemis, Heather; Solis, Jessica; Hendriksen, Ellen S.; Park, Elyse R; Pirl, William F.; Temel, Jennifer S.; Prigerson, Holly G.; Safren, Steven A.

    2012-01-01

    This article presents a pilot randomized controlled trial that examined the feasibility and potential efficacy of brief cognitive-behavioral therapy to reduce anxiety in patients with terminal cancer.

  17. Implementing Randomized Controlled Trials in Preschool Settings That Include Young Children with Disabilities: Considering the Context of Strain and Bovey

    Science.gov (United States)

    Snyder, Patricia

    2011-01-01

    In this commentary, developments related to conducting randomized controlled trials in authentic preschool settings that include young children with disabilities are discussed in relation to the Strain and Bovey study.

  18. Integrative psychotherapeutic nursing home program to reduce multiple psychiatric symptoms of cognitively impaired patients and caregiver burden: randomized controlled trial

    NARCIS (Netherlands)

    Bakker, T.J.; Duivenvoorden, H.J.; Lee, J. van der; Olde Rikkert, M.G.M.; Beekman, A.T.; Ribbe, M.W.

    2011-01-01

    OBJECTIVE: To test the effectiveness of an integrative psychotherapeutic nursing home program (integrative reactivation and rehabilitation [IRR]) to reduce multiple neuropsychiatry symptoms (MNPS) of cognitively impaired patients and caregiver burden (CB). DESIGN: Randomized controlled trial. SETTIN

  19. Treating adolescents with cannabis use disorder with Multidimensional Family Therapy (MDFT): Main results of a Randomized Controlled Trial (RCT)

    NARCIS (Netherlands)

    P. Tossmann (Peter); B. Jonas (Benjamin); H. Rigter (Henk); A. Gantner (Andreas)

    2012-01-01

    textabstractAims: To determine the effectiveness of Multidimensional Family Therapy (MDFT) among adolescents with cannabis use disorder in Germany. Methods: In a randomized controlled trial (RCT), MDFT was compared with Youth Psychotherapy (JUP), an individual intervention including Cognitive Behavi

  20. Milder ovarian stimulation for in-vitro fertilization reduces aneuploidy in the human preimplantation embryo: A randomized controlled trial

    NARCIS (Netherlands)

    E.B. Baart (Esther); E. Martini (Elena); M.J.C. Eijkemans (René); D. van Opstal (Diane); N.G.M. Beckers (Nicole); A. Verhoeff (Arie); N.S. Macklon (Nick); B.C.J.M. Fauser (Bart)

    2007-01-01

    textabstractBACKGROUND: To test whether ovarian stimulation for in-vitro fertilization (IVF) affects oocyte quality and thus chromosome segregation behaviour during meiosis and early embryo development, preimplantation genetic screening of embryos was employed in a prospective, randomized controlled

  1. Internet-based cognitive bias modification for obsessive compulsive disorder : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Williams, Alishia D; Pajak, Rosanna; O'Moore, Kathleen; Andrews, Gavin; Grisham, Jessica R

    2014-01-01

    BACKGROUND: Cognitive bias modification (CBM) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology. The current randomized controlled trial (RCT) will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification intervention

  2. Effects of a stepwise multidisciplinary intervention for challenging behavior in advanced dementia: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Pieper, M.J.C.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    Objectives: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. Design: Cluster randomized controlled trial. Setting: Twenty-one clusters (single independe

  3. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders

    NARCIS (Netherlands)

    L.L.M. Bamelis; S.M.A.A. Evers; P. Spinhoven; A. Arntz

    2014-01-01

    Objective: The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. Method: A multicenter randomized controlled trial, with

  4. Selective decontamination of the digestive tract to prevent postoperative infection : A randomized placebo-controlled trial in liver transplant patients

    NARCIS (Netherlands)

    Zwaveling, JH; Maring, JK; Klompmaker, IJ; Haagsma, EB; Bottema, JT; Winter, Heinrich L.J.; van Enckevort, PJ; TenVergert, EM; Metselaar, HJ; Bruining, HA; Slooff, MJH

    2002-01-01

    Objective., To determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver. Design: Randomized, double-blind, placebo-controlled study. Setting. Two academic teaching hospitals. Patients. Adult patients undergoing elec

  5. Just-in-time information improved decision-making in primary care: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Jessie McGowan

    Full Text Available BACKGROUND: The "Just-in-time Information" (JIT librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. METHODS AND FINDING: A randomized controlled trial (RCT was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information and control (no librarian information groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service, additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98. The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86. Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses of participants scored the service as having a positive impact on care and 72% (52/72 indicated that they would use the service frequently if it were continued. CONCLUSIONS: In this study, providing timely information to clinical questions had a highly positive impact on

  6. Topical Tacrolimus versus Hydrocortisone on Atopic Dermatitis in Paediatric Patients: A Randomized Controlled Trial.

    Science.gov (United States)

    Rahman, M F; Nandi, A K; Kabir, S; Kamal, M; Basher, M S; Banu, L A

    2015-07-01

    Atopic dermatitis (AD) is a chronic, inflammatory skin disease in early childhood. Atopic dermatitis is familial disease, often coexists with other atopic diseases with multiple risk factors associated with atopic eczema. The disease is more frequent in urban areas compared with rural areas. Changes in nutrition and a decrease in infant breast-feeding and respiratory allergies are contributory factors for the condition. A Randomized Controlled Trial (RCT) was carried to compare the efficacy and safety of Tacrolimus ointment with a topical corticosteroid reference therapy. A total 60 patients aged between 2 to 10 years, having atopic dermatitis for at least one year and comply Hanifin-Rajka criteria were selected using random number table and allocated into study and control groups through randomization. Study group was treated with topical Tacrolimus 0.03% twice daily for three weeks, while the control group was treated with 1% Hydrocortisone acetate for the same period. Both groups had a washed out phase for 2 weeks with a follow up period of 6 weeks. Eczema Area and Severity lndex (EASI) was assessed at baseline and three weeks after treatment. Efficacy was evaluated at each visit by six clinical signs of atopic dermatitis through measurement of the affected surface area and the EASI score in each of four body regions. Before intervention, in study group mean EASI score was 11.29 with a SD of 2.14, while in control group it was 11.05 with a SD of 2.46. Difference was statistically insignificant (p>0.05). At the end of the treatment, in study group mean EASI score was 4.86 with a SD of 1.01, while in control group it was 7.97 with a SD of 1.80. Statistically high significant difference was observed between EASI scores of two groups before and after the treatment (pHydrocortisone, median reduction of EASI score was 27.16. Difference was highly significant (p<0.001). It is evidenced that Tacrolimus ointment (0.03%) acts as an effective as well as safe non

  7. Adaptive control of the propagation of ultrafast light through random and nonlinear media

    Science.gov (United States)

    Moores, Mark David

    2001-12-01

    Ultrafast light sources generate coherent pulses with durations of less than one picosecond, and represent the next generation of illuminators for medical imaging and optical communications applications. Such sources are already widely used experimentally. Correction of temporal widths or pulse envelopes after traversal of optically non-ideal materials is critical for the delivery of optimal ultrashort pulses. It is important to investigate the physical mechanisms that distort pulses and to develop and implement methods for minimizing these effects. In this work, we investigate methods for characterizing and manipulating pulse propagation dynamics in random (scattering) and nonlinear optical media. In particular, we use pulse shaping to manipulate the light field of ultrashort infrared pulses. Application of spectral phase by a liquid crystal spatial light modulator is used to control the temporal pulse shape. The applied phase is controlled by a genetic algorithm that adaptively responds to the feedback from previous phase profiles. Experiments are detailed that address related aspects of the character of ultrafast pulses-the short timescales and necessarily wide frequency bandwidths. Material dispersion is by definition frequency dependent. Passage through an inhomogeneous system of randomly situated boundaries (scatterers) causes additional distortion of ballistic pulses due to multiple reflections. The reflected rays accumulate phase shifts that depend on the separation of the reflecting boundaries and the photon frequency. Ultrafast bandwidths present a wide range of frequencies for dispersion and interaction with macroscopic dielectric structure. The shaper and adaptive learning algorithm are used to reduce these effects, lessening the impact of the scattering medium on propagating pulses. The timescale of ultrashort pulses results in peak intensities that interact with the electronic structure of optical materials to induce polarization that is no longer

  8. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  9. Long-Term Propranolol Use in Severely Burned Pediatric Patients: A Randomized Controlled Study

    Science.gov (United States)

    Herndon, David N.; Rodriguez, Noe A.; Diaz, Eva C.; Hegde, Sachin; Jennings, Kristofer; Mlcak, Ronald P.; Suri, Jaipreet S.; Lee, Jong O.; Williams, Felicia N.; Meyer, Walter; Suman, Oscar E.; Barrow, Robert E.; Jeschke, Marc G.; Finnerty, Celeste C.

    2012-01-01

    Objective To determine the safety and efficacy of propranolol given for 1 year on cardiac function, resting energy expenditure, and body composition in a prospective randomized single-center controlled study in pediatric patients with large burns. Summary Background Data Severe burns trigger a hypermetabolic response that persists for up to 2 years after burn. Propranolol given for 1 month post burn blunts this response. Whether propranolol administration for 1 year after injury provides a continued benefit is currently unclear. Methods One-hundred seventy nine pediatric patients with >30% total body surface area burns were randomized to receive control (n = 89) or 4 mg/kg/d propranolol (n = 90) for 12 months after burn. Changes in resting energy expenditure, cardiac function, and body composition were measured acutely at 3, 6, 9, and 12 months postburn. Statistical analyses included techniques that adjust for non-normality, repeated measures, and regression analyses. P <0.05 was considered significant. Results Long-term propranolol treatment significantly reduced the percent of the predicted heart rate and percent of the predicted resting energy expenditure, decreased accumulation of central mass and central fat, prevented bone loss, and improved lean body mass accretion. There were very few adverse effects from the dose of propranolol used. Conclusions Propranolol treatment for 12 months, following thermal injury, ameliorates the hyperdynamic, hypermetabolic, hypercatabolic, and osteopenic responses in pediatric patients. This study is registered at clinicaltrials.gov, NCT00675714. PMID:22895351

  10. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ceren Acarturk

    2015-05-01

    Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

  11. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Orla Doyle

    Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

  12. Enhanced tuberculosis case detection among substitution treatment patients: a randomized controlled trial

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    McNutt Louise-Anne

    2011-06-01

    Full Text Available Abstract Background Historically, HIV, TB (tuberculosis and illegal drug treatment services in Estonia have been developed as vertical structures. Related health care services are often provided by different health care institutions and in different locations. This may present obstacles for vulnerable groups, such as injecting drug users (IDU, to access the needed services. We conducted a small scale randomized controlled trial to evaluate a case management intervention aimed at increasing TB screening and treatment entry among IDUs referred from a methadone drug treatment program in Jõhvi, North-Eastern Estonia. Findings Of the 189 potential subjects, 112 (59% participated. HIV prevalence was 86% (n = 96 and 7.4% (n = 8 of participants were interferon gamma release assay (IGRA positive (6.5% were both HIV and IGRA-positive, n = 7. Overall, 44% of participants (n = 49 attended TB clinic, 17 (30% from control group and 32 (57% from case management group (p = 0.004. None of the participants were diagnosed with TB. In a multivariate model, those randomized to case management group were more likely to access TB screening services. Conclusions These findings demonstrate the urgent need for scaling up TB screening among IDUs and the value of more active approach in referring substitution treatment patients to TB services. Trial registration ClinicalTrials.gov: NCT01290081

  13. Operating Room Time Savings with the Use of Splint Packs: A Randomized Controlled Trial

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    Tyler Gonzalez

    2016-01-01

    Full Text Available Background: The most expensive variable in the operating room (OR is time. Lean Process Management is being used in the medical field to improve efficiency in the OR. Streamlining individual processes within the OR is crucial to a comprehensive time saving and cost-cutting health care strategy. At our institution, one hour of OR time costs approximately $500, exclusive of supply and personnel costs. Commercially prepared splint packs (SP contain all components necessary for plaster-of-Paris short-leg splint application and have the potential to decrease splint application time and overall costs by making it a more lean process. We conducted a randomized controlled trial comparing OR time savings between SP use and bulk supply (BS splint application. Methods: Fifty consecutive adult operative patients on whom post-operative short-leg splint immobilization was indicated were randomized to either a control group using BS or an experimental group using SP. One orthopaedic surgeon (EMB prepared and applied all of the splints in a standardized fashion. Retrieval time, preparation time, splint application time, and total splinting time for both groups were measured and statistically analyzed. Results: The retrieval time, preparation time and total splinting time were significantly less (p

  14. Is DBM Beneficial for the Enhancement of Bony Consolidation in Distraction Osteogenesis? A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Sang-Heon Song

    2015-01-01

    Full Text Available The aim of the present study was to compare the radiographic and clinical outcomes of DBM injection and conventional treatment during tibial lengthening over an intramedullary nail in adult patients with short stature. Twenty-nine patients were randomized to receive DBM injection (n=14 or conventional treatment without any injection (n=15 and evaluated. The outcome was measured on the basis of the pixel value ratio (PVR in the digital radiographs during the consolidation period; healing index; clinical assessment; and the rate of complications. In the DBM group, the mean PVR of 1 (mineral density of the callus is comparable to the adjacent bone was reached by 40 weeks in anterior and medial cortices which was significantly different than that in the control group (P=0.03 for anterior cortex; P=0.04 for medial cortex. The average healing index in the DBM group was 39.8 ± 5.3 days/cm compared to 44.3 ± 5.8 days/cm in the control group (P=0.05. There were no significant differences in clinical outcomes (P=0.23 and functional status (P=0.47 including complications (P=0.72 between two groups. In this randomized clinical trial, injection of DBM at the time of initial operation enhanced consolidation of regenerate callus without interfering with clinical outcomes compared to that with conventional treatment.

  15. Effects of resistance training on sarcopenic obesity index in older women: A randomized controlled trial.

    Science.gov (United States)

    Gadelha, André Bonadias; Paiva, Flávio Macedo Lahud; Gauche, Rafael; de Oliveira, Ricardo Jacó; Lima, Ricardo Moreno

    2016-01-01

    The purpose of this study was to examine the effects of resistance training (RT) on sarcopenic obesity (SO) in older women. 243 older women underwent body composition measurement using dual-energy X-ray absorptiometry, and the SO index was calculated. This randomized controlled trial adopted from the baseline sample, 113 volunteers (67.0±5.2years) were randomly assigned to a control group (CG, n=64) or an experimental group (EG, n=69). The EG took part in a 24-week RT program, conducted three times per week. Body composition measurements were repeated at the end of the training program. RT induced a significant increase in fat-free mass (P<0.01), but not decrease in fat mass in the EG. Moreover, the SO index was also significantly improved in the EG (P<0.01), while it decreased significantly in the CG (P<0.01). It is concluded that RT is an effective approach to promote body composition alterations in older women, and it might improve SO-related phenotypes. PMID:27057600

  16. Comparison of Ondansetron and Meperidine for Treatment of Postoperative Shivering: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Mahoori, Alireza; Noroozinia, Heydar; Hasani, Ebrahim; Soltanahmadi, Maryam

    2014-01-01

    Background: The involved neurotransmitter pathways in the postoperative shivering (POS) are poorly understood. Recently, 5-hydroxytryptamine 3 (5-HT3) receptor antagonists have been reported to prevent POS. We investigated the effect of ondansetron, a 5-HT3 antagonist that is used to treat postoperative nausea and vomiting, on shivering. Objectives: This study aimed to compare the efficacy of ondansetron and meperidine in the treatment of shivering after general anesthesia. Patients and Methods: In this double-blinded randomized clinical trial, 83 patients (age range, 18-60 years) who had shivering after general anesthesia were randomly allocated to any of these three groups: Group A, (number = 27) received 4 mg of intravenous ondansetron, Group B, (number = 27) received 8 mg of intravenous ondansetron, and Group C, (number = 29) received 0.4 mg/kg of intravenous meperidine at recovery room. The surface temperatures and the incidence as well as intensity of shivering were recorded. Results: Shivering was controlled in 16 patients (59%) in Group A, 22 (81%) in Group B, and 25 (86%) in Group C (P = 0.01). Within each group, there were no significant differences among the surface temperature in recovery room. Patients in groups A and B had significantly lower incidence of nausea and vomiting than group C (P = 0.01). Conclusions: Ondansetron and meperidine have similar effects on shivering. We concluded that 8 mg of intravenous ondansetron can control shivering and this is the dose of choice, especially in patients with POS with nausea and vomiting. PMID:25389473

  17. Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Pirbaglou, Meysam; Katz, Joel; de Souza, Russell J; Stearns, Jennifer C; Motamed, Mehras; Ritvo, Paul

    2016-09-01

    Gastrointestinal microbiota, consisting of microbial communities in the gastrointestinal tract, play an important role in digestive, metabolic, and immune functioning. Preclinical studies on rodents have linked behavioral and neurochemical changes in the central nervous system with deficits or alterations in these bacterial communities. Moreover, probiotic supplementation in rodents has been shown to markedly change behavior, with correlated changes in central neurochemistry. While such studies have documented behavioral and mood-related supplementation effects, the significance of these effects in humans, especially in relation to anxiety and depression symptoms, are relatively unknown. Thus, the purpose of this paper was to systematically evaluate current literature on the impact of probiotic supplementation on anxiety and depression symptoms in humans. To this end, multiple databases, including Medline, PsycINFO, PubMed, Scopus, and Web of Science were searched for randomized controlled trials published between January 1990 and January 2016. Search results led to a total of 10 randomized controlled trials (4 in clinically diagnosed and 6 in non-clinical samples) that provided limited support for the use of some probiotics in reducing human anxiety and depression. Despite methodological limitations of the included trials and the complex nature of gut-brain interactions, results suggest the detection of apparent psychological benefits from probiotic supplementation. Nevertheless a better understanding of developmental, modulatory, and metagenomic influences on the GI microbiota, specifically as they relate to mood and mental health, represent strong priorities for future research in this area. PMID:27632908

  18. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Jang, Soobin; Jang, Bo-Hyoung; Ko, Youme; Sasaki, Yui; Park, Jeong-Su; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were "Chinese herbal medicines", "metabolic syndrome", and "randomized controlled trials". Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's "Risk of Bias" tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome. PMID:27413388

  19. Cancer risk in older people receiving statin therapy: a meta-analysis of randomized controlled trials

    Science.gov (United States)

    Liu, Hong-Wei; Bian, Su-Yan; Zhu, Qi-Wei; Zhao, Yue-Xiang

    2016-01-01

    Background Although statins are well tolerated by most aged people, their potential carcinogenicity is considered as one of the biggest factors limiting the use of statins. The aim of the present study was to determine the risk of cancer in people aged over 60 years receiving statin therapy. Methods A comprehensive search for articles published up to December 2015 was performed, reviews of each randomized controlled trials (RCTs) that compared the effects of statin mono-therapy with placebo on the risk of cancer in people aged > 60 years were conducted and data abstracted. All the included studies were evaluated for publication bias and heterogeneity. Pooled odds ratios (OR) estimates and 95% confidence intervals (CIs) were calculated using the random effects model. Results A total of 12 RCTs, involving 62,927 patients (31,517 in statin therapy group and 31,410 in control group), with a follow-up duration of 1.9–5.4 years, contributed to the analysis. The statin therapy did not affect the overall incidence of cancer (OR = 1.03, 95% CI: 0.94–1.14, P = 0.52); subgroup analyses showed that neither the variety nor the chemical properties of the statins accounted for the incidence of cancer in older people. Conclusions Our meta-analysis findings do not support a potential cancer risk of statin treatment in people over 60 years old. Further targeted researches with a longer follow-up duration are warranted to confirm this issue.

  20. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. PMID:26121535

  1. Merocel versus Nasopore for nasal packing: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Jianzhang Wang

    Full Text Available OBJECTIVE: To compare the clinical outcomes, including efficacy and complications, of Merocel versus Nasopore as a nasal packing material after nasal surgery. METHODS: Relevant randomized controlled trials were identified from electronic databases (The Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure and Chinese Biomedical Database. Conference proceedings and references from identified trials and review articles were also searched. Outcome measures were pain during nasal packing, pain and bleeding upon packing removal, pressure sensation, nasal blockage, formation of synechiae, mucosal healing, and patients' general satisfaction. RESULTS: Seven randomized controlled trials met criteria for analysis. Compared with Merocel, Nasopore significantly reduced patients' subjective symptoms including in situ pain (pain experienced while packing is in place, nasal pressure, pain and bleeding during packing removal, and increased patients' general satisfaction with nasal packing. There were no significant differences in nasal obstruction, adhesion and mucosal healing between the Merocel and Nasopore groups. CONCLUSIONS: Preliminary evidence suggests that Nasopore may be superior to Merocel as a nasal packing material with regard to in situ pain, pain and bleeding upon removal, pressure, and general satisfaction and does not differ from Merocel in terms of nasal obstruction, tissue adhesion, and long-term mucosal healing.

  2. Acupuncture in treatment of carpal tunnel syndrome: A randomized controlled trial study

    Directory of Open Access Journals (Sweden)

    Saeid Khosrawi

    2012-01-01

    Full Text Available BACKGROUND: Carpal tunnel syndrome (CTS is the most preva lent form of peripheral neuropathy. The efficacy of acupuncture in management of mild to moderate CTS has been investigated in limited studies with controversial results. The aim of this study was to assess the short-term effects of acupuncture in treatment of mild to moderate carpal tunnel syndrome. METHODS: In a randomized controlled trial study, participants were randomly assigned to either control group which night splinting, vitamin B1, B6 and sham acupuncture for four weeks were administered, or intervention group that un-derwent acupuncture in 8 sessions over 4 weeks and night splinting. The clinical symptoms using global symptom score (GSS and electrophysiological parameters were assessed at baseline and four weeks after the intervention. RESULTS: Of 72 patients met the inclusion criteria, 64 patients actually completed the 4 week intervention and were evaluated for the outcome. There was a statistically significant difference in GSS between two arms of treatment after the intervention (p 0.05. CONCLUSIONS: Our findings indicated that the acupuncture can improve the overall subjective symptoms of carpal tun-nel syndrome and could be adopted in comprehensive care programs of these patients.

  3. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

    Science.gov (United States)

    Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

    2016-01-01

    This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

  4. Effect of management training in organizational justice: a randomized controlled trial.

    Science.gov (United States)

    Nakamura, Saki; Somemura, Hironori; Sasaki, Norio; Yamamoto, Megumi; Tanaka, Mika; Tanaka, Katsutoshi

    2016-06-10

    Organizational justice (OJ) influences the well-being of employees of organizations. We conducted a randomized controlled trial to examine whether or not brief management training increases OJ for subordinates. Study participants were managers and subordinates working in the private manufacturing sector. Randomization at the departmental level generated an intervention group of 23 departments (93 managers and 248 subordinates) and a control group of 23 departments (91 managers and 314 subordinates). Managers in the intervention group received a 90-min training session to investigate the attitudes and behavior of managers and help increase OJ. Subordinates completed self-administered OJ questionnaire surveys on procedural, interpersonal, and informational justice before and 3 months after intervention. For all subordinates, the interaction between group and time in OJ scores obtained before and 3 months after intervention were not significant. However, in subgroup analyses of the lowest tertile group in relation to the baseline of each of the three OJ subscales and total scores, the lowest tertile group of the interpersonal justice subscale showed significant improvement. The results of this study suggest that brief management training in OJ for managers significantly improves a low rating from subordinates in interpersonal justice. Further studies are required to develop a specific intervention method to increase OJ. PMID:26860786

  5. Video-Assisted Thoracoscopic Sympathectomy for Palmar Hyperhidrosis: A Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Zhang, Wenxiong; Yu, Dongliang; Jiang, Han; Xu, Jianjun; Wei, Yiping

    2016-01-01

    Objectives Video-assisted thoracoscopic sympathectomy (VTS) is effective in treating palmar hyperhidrosis (PH). However, it is no consensus over which segment should undergo VTS to maximize efficacy and minimize the complications of compensatory hyperhidrosis (CH). This study was designed to compare the efficiency and side effects of VTS of different segments in the treatment of PH. Methods A comprehensive search of PubMed, Ovid MEDLINE, EMBASE, Web of Science, ScienceDirect, the Cochrane Library, Scopus and Google Scholar was performed to identify studies comparing VTS of different segments for treatment of PH. The data was analyzed by Revman 5.3 software and SPSS 18.0. Results A total of eight randomized controlled trials (RCTs) involving 1200 patients were included. Meta-analysis showed that single segment/low segments VTS could reduce the risk of moderate/severe CH compared with multiple segments/high segments. The risk of total CH had a similar trend. In the subgroup analysis of single segment VTS, no significant differences were found between T2/T3 VTS and other segments in postoperative CH and degree of CH. T4 VTS showed better efficacy in limiting CH compared with other segments. Conclusions T4 appears to be the best segment for the surgical treatment of PH. Our findings require further validation in more high-quality, large-scale randomized controlled trials. PMID:27187774

  6. Video-Assisted Thoracoscopic Sympathectomy for Palmar Hyperhidrosis: A Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Wenxiong Zhang

    Full Text Available Video-assisted thoracoscopic sympathectomy (VTS is effective in treating palmar hyperhidrosis (PH. However, it is no consensus over which segment should undergo VTS to maximize efficacy and minimize the complications of compensatory hyperhidrosis (CH. This study was designed to compare the efficiency and side effects of VTS of different segments in the treatment of PH.A comprehensive search of PubMed, Ovid MEDLINE, EMBASE, Web of Science, ScienceDirect, the Cochrane Library, Scopus and Google Scholar was performed to identify studies comparing VTS of different segments for treatment of PH. The data was analyzed by Revman 5.3 software and SPSS 18.0.A total of eight randomized controlled trials (RCTs involving 1200 patients were included. Meta-analysis showed that single segment/low segments VTS could reduce the risk of moderate/severe CH compared with multiple segments/high segments. The risk of total CH had a similar trend. In the subgroup analysis of single segment VTS, no significant differences were found between T2/T3 VTS and other segments in postoperative CH and degree of CH. T4 VTS showed better efficacy in limiting CH compared with other segments.T4 appears to be the best segment for the surgical treatment of PH. Our findings require further validation in more high-quality, large-scale randomized controlled trials.

  7. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer.

    Science.gov (United States)

    Monti, Daniel A; Peterson, Caroline; Kunkel, Elisabeth J Shakin; Hauck, Walter W; Pequignot, Edward; Rhodes, Lora; Brainard, George C

    2006-05-01

    The purpose of this study was to gather data on the efficacy of a newly developed psychosocial group intervention for cancer patients, called mindfulness-based art therapy (MBAT). One hundred and eleven women with a variety of cancer diagnoses were paired by age and randomized to either an eight-week MBAT intervention group or a wait-list control group. Ninety-three participants (84%) completed both the pre- and post-study measurements. As compared to the control group, the MBAT group demonstrated a significant decrease in symptoms of distress (as measured by the Symptoms Checklist-90-Revised) and significant improvements in key aspects of health-related quality of life (as measured by the Medical Outcomes Study Short-Form Health Survey). This investigation of MBAT provides initial encouraging data that support a possible future role for the intervention as a psychosocial treatment option for cancer patients.

  8. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction.

    Science.gov (United States)

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C

    2016-07-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard classroom settings, (b) improves students' mathematical abilities (beyond standard math curricula), and (c) is related to changes in basic cognitive capacities like working memory. MA students outperformed controls on arithmetic tasks, suggesting that MA expertise can be achieved by children in standard classrooms. MA training did not alter basic cognitive abilities; instead, differences in spatial working memory at the beginning of the study mediated MA learning. PMID:27062391

  9. A Randomized Controlled Trial of Relationship Education in the U.S. Army: 2-Year Outcomes.

    Science.gov (United States)

    Stanley, Scott M; Rhoades, Galena K; Loew, Benjamin A; Allen, Elizabeth S; Carter, Sarah; Osborne, Laura J; Prentice, Donnella; Markman, Howard J

    2014-10-01

    This study examined the effectiveness of an evidence-based, community-delivered adaptation of couple relationship education (CRE; specifically, PREP, The Prevention and Relationship Enhancement Program) delivered at two Army installations. The study is a randomized controlled trial with two years of follow-up, examining marital quality and stability. Sample composition was 662 married couples with a spouse in the U.S. Army. Analyses yielded no evidence of overall enduring intervention effects on relationship quality but couples assigned to intervention at the higher risk site were significantly less likely than controls to be divorced at the two-year follow-up (8.1% vs. 14.9%, p divorce was strongest for minority couples. The findings add to the literature on who may benefit most from CRE.

  10. Needle catheter jejunostomy: a controlled, prospective, randomized trial in patients with gynecologic malignancy.

    Science.gov (United States)

    Spirtos, N M; Ballon, S C

    1988-06-01

    Sixty patients with gynecologic cancer entered a prospective, randomized study of immediate postoperative feeding. Thirty-three women in the study group received an elemental diet (Vivonex HN) delivered through a needle catheter jejunostomy. Twenty-seven patients in the control group were given standard 5% dextrose and electrolyte solutions. Patients in both groups were stratified according to nutritional status as determined by anthropometric evaluation and levels of serum albumin, total protein, and transferrin. These parameters also were measured at intervals throughout the study. Only one catheter-related complication occurred. Patients in the study group received significantly more calories (p = 0.01) and were better able to maintain serum levels of transferrin (p = 0.05) than those in the control group. An elemental diet administered through the needle catheter jejunostomy effectively maintains postoperative nutrition and is associated with few complications. PMID:3132853

  11. A national study of the psychological impact of bank robbery with a randomized control group

    DEFF Research Database (Denmark)

    Hansen, Maj; Armour, Cherie; Shevlin, Mark;

    of bank employees exposed to robbery (response rate: 73.6 %). Several related factors were also investigated including prior traumatic exposure, anxiety, and general traumatic symptoms. The results were compared to a randomized control group of bank employees never exposed to robbery (N= 303......Despite, numerous annual bank robberies worldwide, research on the psychological sequelae of bank robberies is limited. We studied the prevalence of Acute Stress Disorder (ASD) (N = 458) and the prevalence of Posttraumatic Stress Disorder (PTSD) (n = 378) in a Danish national questionnaire survey......). The estimated ASD rate was 11.1 % (n = 41), and the estimated PTSD rate was 6.2 % (n = 23). Both prevalence rates were limited by the avoidance diagnostic criteria. Preliminary results indicated that the control group scored significantly lower than the acute robbery group on general traumatization and anxiety...

  12. Acupuncture on the day of embryo transfer: a randomized controlled trial of 635 patients

    DEFF Research Database (Denmark)

    Andersen, Dorthe; Løssl, Kristine; Nyboe Andersen, Anders;

    2010-01-01

    This prospective, randomized, controlled and double-blinded trial studied whether acupuncture in relation to embryo transfer could increase the ongoing pregnancy rates and live birth rates in women undergoing assisted reproductive therapy. A total of 635 patients undergoing IVF or intracytoplasmic...... sperm injection (ICSI) were included. In 314 patients, embryo transfer was accompanied by acupuncture according to the principles of traditional Chinese medicine. In the control group, 321 patients received placebo acupuncture using a validated placebo needle. In the acupuncture group and the placebo...... group, the ongoing pregnancy rates were 27% (95% CI 22-32) and 32% (95% CI 27-37), respectively. Live birth rates were 25% (95% CI 20-30) in the acupuncture group and 30% (95% CI 25-30) in the placebo group. The differences were not statistically significant. These results suggest that acupuncture...

  13. School-based humanistic counseling for psychological distress in young people: pilot randomized controlled trial.

    Science.gov (United States)

    McArthur, Katherine; Cooper, Mick; Berdondini, Lucia

    2013-01-01

    School-based humanistic counseling (SBHC) is a widely delivered intervention for psychological distress in young people, particularly in the UK. This study piloted a set of procedures for evaluating SBHC and obtaining indications of effect. Psychologically distressed young people (aged 13-16) were randomized to either 12 weeks of SBHC or a waiting list control. The primary outcome was psychological distress at the 12-week endpoint, as measured by the Young Person's CORE. Those allocated to counseling (n=16) showed significantly greater reductions in psychological distress than participants in the control group (n=17), with an effect size (ES) (g) of 1.14 on the primary outcome and a mean ES across all four outcome measures of 0.73 at endpoint. The findings indicate that SBHC may be an effective means of reducing psychological distress in young people.

  14. Treadmill training as an augmentation treatment for Alzheimer?s disease: a pilot randomized controlled study

    Directory of Open Access Journals (Sweden)

    Cynthia Arcoverde

    2014-03-01

    Full Text Available Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD patients. Method Elderly (n=20 with mild dementia (NINCDS-ADRDA/CDR1 were randomly assigned to an exercise group (EG on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max and control group (GC 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG. Specifics instruments were also applied to evaluate executive function, memory, attention and concentration, cognitive flexibility, inhibitory control and functional capacity. Results After 16 weeks, the EG showed improvement in cognition CAMCOG whereas the CG declined. Compared to the CG, the EG presented significant improvement on the functional capacity. The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables. Conclusion Walking on treadmill may be recommended as an augmentation treatment for patients with AD.

  15. Motivational interviewing as a mechanism for change in men who batter: a randomized controlled trial.

    Science.gov (United States)

    Kistenmacher, Barbara R; Weiss, Robert L

    2008-01-01

    The present study reports on the potential effectiveness of motivational interviewing (MI) in changing the way batterers think about their violent behavior. Thirty-three domestic violence offenders who were court-mandated to treatment were randomly assigned to MI or a control condition before attending their first mandated treatment group. Consistent with predictions, the MI group demonstrated generally more improvement on stages of change subscales than the control group. Further, the MI group demonstrated a significantly greater decrease in the extent to which they blamed their violence on external factors. Current data indicate that MI has the potential to increase batterers' motivation to change, although validation trials with larger sample sizes and more refined measures are required.

  16. Building psychosocial assets and wellbeing among adolescent girls: A randomized controlled trial.

    Science.gov (United States)

    Leventhal, Katherine Sachs; Gillham, Jane; DeMaria, Lisa; Andrew, Gracy; Peabody, John; Leventhal, Steve

    2015-12-01

    We conducted a randomized controlled trial of a 5-month resilience-based program (Girls First Resilience Curriculum or RC) among 2308 rural adolescent girls at 57 government schools in Bihar, India. Local women with at least a 10th grade education served as group facilitators. Girls receiving RC improved more (vs. controls) on emotional resilience, self-efficacy, social-emotional assets, psychological wellbeing, and social wellbeing. Effects were not detected on depression. There was a small, statistically significant negative effect on anxiety (though not likely clinically significant). Results suggest psychosocial assets and wellbeing can be improved for girls in high-poverty, rural schools through a brief school-day program. To our knowledge, this is one of the largest developing country trials of a resilience-based school-day curriculum for adolescents. PMID:26547145

  17. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Farah Jindani

    2015-01-01

    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  18. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Science.gov (United States)

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  19. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction.

    Science.gov (United States)

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C

    2016-07-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard classroom settings, (b) improves students' mathematical abilities (beyond standard math curricula), and (c) is related to changes in basic cognitive capacities like working memory. MA students outperformed controls on arithmetic tasks, suggesting that MA expertise can be achieved by children in standard classrooms. MA training did not alter basic cognitive abilities; instead, differences in spatial working memory at the beginning of the study mediated MA learning.

  20. Building psychosocial assets and wellbeing among adolescent girls: A randomized controlled trial.

    Science.gov (United States)

    Leventhal, Katherine Sachs; Gillham, Jane; DeMaria, Lisa; Andrew, Gracy; Peabody, John; Leventhal, Steve

    2015-12-01

    We conducted a randomized controlled trial of a 5-month resilience-based program (Girls First Resilience Curriculum or RC) among 2308 rural adolescent girls at 57 government schools in Bihar, India. Local women with at least a 10th grade education served as group facilitators. Girls receiving RC improved more (vs. controls) on emotional resilience, self-efficacy, social-emotional assets, psychological wellbeing, and social wellbeing. Effects were not detected on depression. There was a small, statistically significant negative effect on anxiety (though not likely clinically significant). Results suggest psychosocial assets and wellbeing can be improved for girls in high-poverty, rural schools through a brief school-day program. To our knowledge, this is one of the largest developing country trials of a resilience-based school-day curriculum for adolescents.