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Sample records for 6-mo randomized controlled

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

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

    2016-01-01

    Background: Hormonal fluctuations during the menstrual cycle influence energy intake and expenditure as well as eating preferences and behavior. Objective: We examined the impact of a diet and exercise weightloss program that was designed to target and moderate the effects of the menstrual cycle....... 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...... compared with the effect of simple energy restriction. Design: A total of 60 healthy, overweight, premenopausal women were included in a 6-mo weight-loss program in which each subject consumed a diet of 1600 kcal/d. Subjects were randomly assigned to either a combined diet and exercise program...

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

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

    2008-01-01

    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......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...... changes in adipose tissue. CONCLUSIONS: Diet composition had no major effect on preventing weight regain. However, both the LF and MUFA diets produced less body fat regain than did the control diet, and the dropout rate was lowest in the LF diet group, whereas fasting insulin decreased and the homeostasis...

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

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

    2008-01-01

    performed before and after the 6-mo dietary intervention. All foods were provided by a purpose-built supermarket. RESULTS: After 6 mo, the MUFA diet reduced fasting glucose (-3.0%), insulin (-9.4%), and the homeostasis model assessment of insulin resistance score (-12.1%). Compared with the MUFA diet, the......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...... OGTT, 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...

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

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

    2008-01-01

    control diet increased these variables [1.4% (P = 0.014), 21.2% (P = 0.030), and 22.8% (P = 0.015), respectively], as did the LF diet [1.4% (P = 0.090), 13.1% (P = 0.078), and 15.5% (P = 0.095), respectively]. No significant group differences were detected in glucose or insulin concentrations during the......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...

  5. a randomized, controlled trial

    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...

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

    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.

  7. Random Control over Quantum Open Systems

    Jing, Jun; Bishop, C. Allen; Wu, Lian-Ao

    2014-01-01

    Parametric fluctuations or stochastic signals are introduced into the control pulse sequence to investigate the feasibility of random control over quantum open systems. In a large parameter error region, the out-of-order control pulses work as well as the regular pulses for dynamical decoupling and dissipation suppression. Calculations and analysis are based on a non-perturbative control approach allowed by an exact quantum-state-diffusion equation. When the average frequency and duration of ...

  8. Randomized controlled trials of COX-2 inhibitors

    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...

  9. Nonperturbative dynamical decoupling with random control.

    Jing, Jun; Bishop, C Allen; Wu, Lian-Ao

    2014-01-01

    Parametric fluctuations or stochastic signals are introduced into the rectangular pulse sequence to investigate the feasibility of random dynamical decoupling. In a large parameter region, we find that the out-of-order control pulses work as well as the regular pulses for dynamical decoupling and dissipation suppression. Calculations and analysis are enabled by and based on a nonperturbative dynamical decoupling approach allowed by an exact quantum-state-diffusion equation. When the average frequency and duration of the pulse sequence take proper values, the random control sequence is robust, fault-tolerant, and insensitive to pulse strength deviations and interpulse temporal separation in the quasi-periodic sequence. This relaxes the operational requirements placed on quantum control devices to a great deal. PMID:25169735

  10. 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.

    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

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

    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....

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

    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....

  13. Random Access Game and Medium Access Control Design

    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...

  14. Modeling of Random Delays in Networked Control Systems

    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.

  15. History of the Athens Canadian Random Bred and the Athens Random Bred control populations.

    Collins, K E; Marks, H L; Aggrey, S E; Lacy, M P; Wilson, J L

    2016-05-01

    The University of Georgia maintains two meat-type chicken control strains: the Athens Random Bred (ARB) and the Athens Canadian Random Bred (ACRB). The Athens Random Bred was developed from colored plumage commercial meat chicken strains in 1956. The ACRB is a replicate population of the Ottawa Meat Control strain which was developed in 1955 from white plumage commercial meat-type chickens. These genetic lines have been extremely valuable research resources and have been used extensively to provide comparative context to modern meat-type strains. The ACRB may be the oldest pedigreed control commercial meat-type chicken still in existence today. This paper reviews the history of the breed backgrounds for both control populations and reviews research utilizing the ACRB. PMID:26976904

  16. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

    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.

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

    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.

  18. Multiple input/output random vibration control system

    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.

  19. Randomized algorithms in automatic control and data mining

    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.

  20. 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

    Madsen, Katja Howarth; Rasmussen, Lone Banke; Andersen, Rikke; Mølgaard, Christian; Jakobsen, Jette; Bjerrum, Poul J.; Andersen, Elisabeth Wreford; Mejborn, Heddie; Tetens, Inge

    2013-01-01

    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....../L. Conclusion: Vitamin D fortification of milk and bread reduces the decrease in serum 25(OH)D concentrations during winter and ensures 25(OH)D concentrations >50 nmol/L in children and adults in Denmark. This trial was registered at clinicaltrials.gov as NCT01184716.......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...

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

    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

  2. Stress induced martensite transformation in Co–28Cr–6Mo alloy during room temperature deformation

    The phase transformation and texture change of two Co–28Cr–6Mo alloys during room temperature deformation were studied by using the in-situ synchrotron X-ray diffraction. It is found that a slight difference in chemical compositions can significantly change the phase constitutions and the mechanical properties. For the material with less Ni, C and N (lower α-phase stability), increasing the grain size promotes the athermal martensite transformation during cooling. The kinetics of the Stress Induced Martensite (SIM) phase transformation may be more affected by the athermal martensite instead of the grain size of the α-phase. After deformation, similar textures are produced in samples regardless the differences in the initial structures such as the phase constitution and the grain size; while a relatively strong {111} texture and a weak {100} texture are produced in the α-phase, a {101¯1} fiber texture is gradually developed in the ε-phase during uniaxial tension

  3. Stress induced martensite transformation in Co–28Cr–6Mo alloy during room temperature deformation

    Cai, S., E-mail: song_cai@fwmetals.com [Fort Wayne Metals Research Products Corporation, 9609 Ardmore Avenue, Fort Wayne, IN 46809 (United States); Daymond, M.R. [Department of Mechanical and Materials Engineering, Queen' s University, Nicol Hall, 60 Union Street, Kingston, Ontario, Canada K7L 3N6 (Canada); Ren, Y. [Advanced Photon Source, Argonne National Laboratory, 9700S. Cass Avenue, 433/D008, Argonne, IL 60439 (United States)

    2013-09-15

    The phase transformation and texture change of two Co–28Cr–6Mo alloys during room temperature deformation were studied by using the in-situ synchrotron X-ray diffraction. It is found that a slight difference in chemical compositions can significantly change the phase constitutions and the mechanical properties. For the material with less Ni, C and N (lower α-phase stability), increasing the grain size promotes the athermal martensite transformation during cooling. The kinetics of the Stress Induced Martensite (SIM) phase transformation may be more affected by the athermal martensite instead of the grain size of the α-phase. After deformation, similar textures are produced in samples regardless the differences in the initial structures such as the phase constitution and the grain size; while a relatively strong {111} texture and a weak {100} texture are produced in the α-phase, a {101"¯1} fiber texture is gradually developed in the ε-phase during uniaxial tension.

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

    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.

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

    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.…

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

    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...

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

    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...

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

    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…

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

    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…

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

    Ho, Andrew P; Dahlöf, Carl Gh; Silberstein, Stephen D; Saper, Joel R; Ashina, Messoud; Kost, James T; Froman, Samar; Leibensperger, Heather; Lines, Christopher R; Ho, Tony W

    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...

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

    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...

  12. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Jana Sawynok; Mary Lynch

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks) produces improvements in core domains for fibromyalgia (pai...

  13. Outcomes in Registered, Ongoing Randomized Controlled Trials of Patient Education

    Pino, Cécile; Boutron, Isabelle; Ravaud, Philippe

    2012-01-01

    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 ...

  14. Infinitely dimensional control Markov branching chains in random environments

    HU; Dihe

    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.

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

    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. PMID:26434673

  16. Control with a random access protocol and packet dropouts

    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.

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

    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.

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

    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.

  19. Active subnanometer spectral control of a random laser

    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.

  20. A Quality Analysis of Randomized Controlled Trials about Erectile Dysfunction

    Chung, Jae Hoon; Lee, Jeong Woo; Jo, Jung Ki; Kim, Kyu Shik; Lee, Seung Wook

    2013-01-01

    Purpose A low quality clinical trial could produce errors, and these errors could, in turn, distort the results of the clinical trial. To avoid applying distorted results of trials clinically, a quality analysis of clinical trials is needed. Materials and Methods We selected randomized controlled trials (RCTs) about erectile dysfunction (ED) conducted in Korea using Medline and KoreaMed. Quality assessment of selected RCTs was performed using three assessment tools (Jadad scales, van Tulder s...

  1. STANDARDIZATION FOR SUBGROUP ANALYSIS IN RANDOMIZED CONTROLLED TRIALS

    Varadhan, Ravi; Wang, Sue-Jane

    2014-01-01

    Randomized controlled trials (RCTs) emphasize the average or overall effect of a treatment (ATE) on the primary endpoint. Even though the ATE provides the best summary of treatment efficacy, it is of critical importance to know whether the treatment is similarly efficacious in important, predefined subgroups. This is why the RCTs, in addition to the ATE, also present the results of subgroup analysis for preestablished subgroups. Typically, these are marginal subgroup analysis in the sense tha...

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

    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...

  3. How to Calculate Sample Size in Randomized Controlled Trial?

    ZHONG, Baoliang

    2009-01-01

    To design clinical trials, efficiency, ethics, cost effectively, research duration and sample size calculations are the key things to remember. This review highlights the statistical issues to estimate the sample size requirement. It elaborates the theory, methods and steps for the sample size calculation in randomized controlled trials. It also emphasizes that researchers should consider the study design first and then choose appropriate sample size calculation method.

  4. Optimal Control of Risk Process in Random Environment

    Zhu, Chao

    2010-01-01

    This paper is concerned with cost optimization of an insurance company. The surplus of the insurance company is modeled by a controlled regime switching diffusion, where the regime switching mechanism provides the fluctuations of the random environment. A weaker sufficient condition than that of \\cite[Section V.2]{FlemingS} for the continuity of the value function is obtained. Further, the value function is shown to be a viscosity solution of a Hamilton-Jacobian-Bellman equation.

  5. Shallow Semantic Parsing of Randomized Controlled Trial Reports

    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...

  6. Control and instanton trajectories for random transitions in turbulent flows

    Many turbulent systems exhibit random switches between qualitatively different attractors. The transition between these bistable states is often an extremely rare event, that can not be computed through DNS, due to complexity limitations. We present results for the calculation of instanton trajectories (a control problem) between non-equilibrium stationary states (attractors) in the 2D stochastic Navier-Stokes equations. By representing the transition probability between two states using a path integral formulation, we can compute the most probable trajectory (instanton) joining two non-equilibrium stationary states. Technically, this is equivalent to the minimization of an action, which can be related to a fluid mechanics control problem.

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

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    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 that the......We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance...

  8. Active control of tensegrity structures under random excitation

    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.

  9. Aging behavior and strengthening mechanisms in Tl--6Al--2Sn--4Zr--6Mo alloys

    In Ti--6Al--2Sn--4Zr--6Mo alloys, beta transforms to orthorhombic martensite when quenched from a temperature of 9150C or above. X-ray analysis showed that aging at 500 or 6000C gradually reduces the degree of orthohombicity until a hexagonal structure equivalent to alpha, but having the morphological characteristics of the prior martensite, is produced. The orthorhombicity is reduced by solute rejection to beta which forms as particles both homogeneously and heterogeneously with the martensite structure. The structure at maximum hardness is a fine distribution of Burger's oriented beta particles in a matrix of martensite of greatly reduced orthorhombicity. Overaging appears to occur as a result of coarsening of the homogeneous beta particles. Aging at temperatures from 600 to 8100C results in growth of one particular variant of the beta which is located at the interface between twin related regions composing a martensite lath. This beta along with similarly oriented beta at lath interfaces forms a continuous beta matrix by a gradual growth process. It is shown that this matrix has the identical orientation and shape of the original beta grain prior to quenching. A mechanism is proposed to account for this memory effect. When quenched from 8500C, the resulting structure is a mixture of eqiaxed alpha + retained beta phases. Slip was found to be the only deformation mode and was extremely heterogeneous in nature for the as-quenched structure. Dislocations were found at the leading edge as well as in the vicinity and inside the precipitated alpha. With aging a plate-like alpha structure gradually transforms the retained β into a basket weave structure and the slip characteristics change from heterogeneous to homogeneous both in the primary alpha and the aged beta structure

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

    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

  11. Role of nitrogen addition in stabilizing the γ phase of Biomedical Co–29Cr–6Mo alloy

    Highlights: ► 3-D atomic probe observation + thermodynamic calculations. ► N addition does not change the Gibbs energy of alloy system greatly. ► Generate the energy barrier by formation of N–Cr cluster. ► N addition stabilizes the γ phase of Co–Cr–Mo alloy. ► Phase transition slows down but the transition point does not change with N addition. - Abstract: Three-dimensional atom probe observations and thermodynamic calculations revealed that the mechanism of γ-phase stabilization by N addition in the Co–29Cr–6Mo alloy is different from that in stainless steel: N addition does not lower the free energy of the γ phase in Co–29Cr–6Mo but increases the energy barrier and thus lowers the kinetic rate of the γ → ε transition through the formation of Cr–N short range order.

  12. 19F spin-lattice relaxation in WF6, MoF6, and UF6 gases

    Spin-lattice relaxation times have been measured for the fluorine nuclei in gaseous WF6, MoF6 and UF6 as a function of temperature in the dilute gas region. The measured temperature dependences are as predicted for relaxation resulting from a spin-rotation interaction. Effective cross sections for the transfer of angular momentum to molecular rotation during collisions are deduced. (author)

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

    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

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

    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

  15. Randomized Dynamical Decoupling Techniques for Coherent Quantum Control

    Viola, L; Viola, Lorenza; Santos, Lea F.

    2006-01-01

    The need for strategies able to accurately manipulate quantum dynamics is ubiquitous in quantum control and quantum information processing. We investigate two scenarios where randomized dynamical decoupling techniques become more advantageous with respect to standard deterministic methods in switching off unwanted dynamical evolution in a closed quantum system: when dealing with decoupling cycles which involve a large number of control actions and/or when seeking long-time quantum information storage. Highly effective hybrid decoupling schemes, which combine deterministic and stochastic features are discussed, as well as the benefits of sequentially implementing a concatenated method, applied at short times, followed by a hybrid protocol, employed at longer times. A quantum register consisting of a chain of spin-1/2 particles interacting via the Heisenberg interaction is used as a model for the analysis throughout.

  16. A controllable stitch layout strategy for random needle embroidery

    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.

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

    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

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

    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.

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

    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.

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

    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.

  1. Qigong and fibromyalgia: randomized controlled trials and beyond.

    Sawynok, Jana; Lynch, Mary

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6-8 weeks) produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function) that are maintained at 4-6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6-12 months) indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects. PMID:25477991

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

    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

  3. Prevention of pathological gambling: a randomized controlled trial.

    Doiron, Jason P; Nicki, Richard M

    2007-01-01

    Although the gambling industry is expanding rapidly throughout North America and around the world, there are only a few empirically evaluated programs aimed at the prevention of pathological gambling (PG). The purpose of this study was to measure the effectiveness of a new prevention program aimed at PG. The Stop & Think! program was designed to teach at-risk video lottery terminal (VLT) gamblers cognitive restructuring and problem-solving skills that may help to prevent the development of PG. These skills were taught through a variety of methods - including an automated educational presentation, video and text vignettes, audio training tapes, and skill rehearsal. The program was evaluated using a randomized, 2-group experimental design with a wait-list control group and pre-, post-, and follow-up measures. Results indicated that, compared with the control group, the experimental group was less at risk for developing a gambling problem after the program. The experimental group endorsed fewer gambling-related cognitive distortions, engaged in less VLT gambling, and had lower scores on a measure of PG. The results of this study provide the basis for the implementation of the Stop & Think! program in the province of Prince Edward Island, Canada, and perhaps other jurisdictions too. PMID:17530493

  4. Enhanced Algebraic Error Control for Random Linear Network Coding

    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...

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

    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.

  6. 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

    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.

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

    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...

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

    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.

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

    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

  10. Role of nitrogen addition in stabilizing the {gamma} phase of Biomedical Co-29Cr-6Mo alloy

    Li, Y.P., E-mail: lyping@imr.tohoku.ac.jp [Institute for Materials Research, Tohoku University, Aoba-ku, Katahira 2-1-1, Sendai, 980-8577 (Japan); Yu, J.S. [Department of Materials Science and Engineering, National University of Defense Technology, Changsha, Hunan (China); Kurosu, S.; Koizumi, Y. [Institute for Materials Research, Tohoku University, Aoba-ku, Katahira 2-1-1, Sendai, 980-8577 (Japan); Matsumoto, H. [Institute for Materials Research, Tohoku University, Aoba-ku, Katahira 2-1-1, Sendai, 980-8577 (Japan); Department of Materials Science and Engineering, National University of Defense Technology, Changsha, Hunan (China); Chiba, A. [Institute for Materials Research, Tohoku University, Aoba-ku, Katahira 2-1-1, Sendai, 980-8577 (Japan)

    2012-03-15

    Highlights: Black-Right-Pointing-Pointer 3-D atomic probe observation + thermodynamic calculations. Black-Right-Pointing-Pointer N addition does not change the Gibbs energy of alloy system greatly. Black-Right-Pointing-Pointer Generate the energy barrier by formation of N-Cr cluster. Black-Right-Pointing-Pointer N addition stabilizes the {gamma} phase of Co-Cr-Mo alloy. Black-Right-Pointing-Pointer Phase transition slows down but the transition point does not change with N addition. - Abstract: Three-dimensional atom probe observations and thermodynamic calculations revealed that the mechanism of {gamma}-phase stabilization by N addition in the Co-29Cr-6Mo alloy is different from that in stainless steel: N addition does not lower the free energy of the {gamma} phase in Co-29Cr-6Mo but increases the energy barrier and thus lowers the kinetic rate of the {gamma} {yields} {epsilon} transition through the formation of Cr-N short range order.

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

    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).

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

    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

  13. Entonox for Labor Pain: A Randomized Placebo Controlled Trial

    H. Talebi

    2009-01-01

    Full Text Available This study aims to investigate the effectiveness of nitrous oxide on pain of labor contractions and on maternal SaO2. The patients were randomized to receive either a pre-prepared mixture of 50% nitrous oxide and oxygen or 50% oxygen by a coin. Study drugs started as early as the onset of pain with each contraction. The patient herself administered gases via a facemask connected to the uni-directional valve which enables the patients to breathe fresh gas in each inspiration. The gas administration was continued to the end of contraction pain at which the patient breathed the room air. Variables such as SaO2, blood pressure, pain and side effects were recorded. 534 ASA I and II parturients, aged from 16 to 35 years, scheduled for elective labor from September 2004 to 2006 were evaluated. Four patients were lost from the study. The mean age of patients was 25.5±4.3 years. During the first three measurements, the SaO2 was significantly higher in control group. In addition, the mean arterial pressure was comparable between groups except two first measurements in which the control group was higher. All the Visual Analogue Scale (VAS values were significantly lower in nitrous oxide group. There were no significant differences in 1st and 5th min apgar scores between groups. All of the side effects were significantly higher among patients in nitrous oxide. In conclusion, our data indicate that using nitrous oxide 50% provides significant pain relief. Nonetheless, it is associated with few side effects, nitrous oxide can be quickly implemented during advanced painful labor.

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

    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

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

    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

  16. Community based intervention to optimize osteoporosis management: randomized controlled trial

    Ciaschini Patricia M

    2010-08-01

    Full Text Available Abstract Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. Methods This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. Results 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40. More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12 and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65. Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387

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

    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...

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

    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.

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

    Jadeja, R.; Ved, A.; S. Chauhan

    2015-01-01

    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 standar...

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

    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.

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

    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; contr...

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

    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

  3. Randomized controlled study of CBT in bronchial asthma

    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.

  4. H∞ Control of Four-Wheel-Independent-Drive Electric Vehicles with Random Time-Varying Delays

    Gang Qin

    2015-01-01

    Full Text Available The random time-varying delays would reduce control performance and even deteriorate the EV system. To deal with random time-varying delays and achieve a real-time steady-state response, considering randomness of delay and a rapid response, an H∞-based delay-tolerant linear quadratic regulator (LQR control method based on Taylor series expansion is proposed in this paper. The results of cosimulations with Simulink and CarSim demonstrate the effectiveness of the proposed controller through the control performance of yaw rate, sideslip angle, and the running track. Moreover, the results of comparison with the other controller illustrate the strength of explicitly.

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

    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

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

    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…

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

    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…

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

    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…

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

    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…

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

    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. 

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

    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...

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

    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...

  13. Prenatal emotion management improves obstetric outcomes: a randomized control study

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-lin

    2015-01-01

    Introduction: Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. Methods: All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartu...

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

    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...

  15. A randomized controlled trial of Telephone Continuing Care

    Godley, Mark D.; Coleman-Cowger, Victoria H.; Titus, Janet C.; Rodney R. Funk; Orndorff, Matthew G.

    2009-01-01

    Telephone continuing care (TCC) was compared to usual continuing care (UCC) on substance use and related problems among adults discharged from residential treatment. Participants were randomly assigned to receive either UCC or TCC. A tapered TCC protocol, initiated by paraprofessional staff and volunteers, was provided during the first three months following discharge. The TCC condition participants reported high satisfaction ratings with the procedure and were more than twice as likely to en...

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

    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

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

    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.

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

    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...

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

    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...

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

    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...

  1. Acupuncture in the Inpatient Acute Care Setting: A Pragmatic, Randomized Control Trial

    Jeannette Painovich; Herman, Patricia M.

    2012-01-01

    Purpose. To evaluate the acceptance and effectiveness of acupuncture in a hospital setting. Methods. This 18-month pragmatic randomized controlled trial used a two-tiered consent process for all patients admitted to the acute care unit by study physician groups. The primary study comparison was between those randomized (using biased-coin randomization after initial consent) to be offered acupuncture or not. The primary outcome was length of stay (LOS). Other measures include costs, self-repor...

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

    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...

  3. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

    Ball T Blake; Ngugi Elizabeth; Estambale Benson; Nguti Rosemary; Barasa Samson; Karanja Sarah; Habyarimana James; Jack William; Chung Michael; Ritvo Paul; Kariri Antony; Mills Edward J; Lester Richard T; Thabane Lehana; Kimani Joshua

    2009-01-01

    Abstract Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to ...

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

    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.

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

    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.

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

    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…

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

    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.

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

    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…

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

    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-…

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

    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

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

    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

  12. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  13. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-01-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients. PMID:27100346

  14. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial.

    Cook, Joan M; Harb, Gerlinde C; Gehrman, Philip R; Cary, Mark S; Gamble, Geraldine M; Forbes, David; Ross, Richard J

    2010-10-01

    One hundred twenty-four male Vietnam War veterans with chronic, severe posttraumatic stress disorder (PTSD) were randomly assigned to imagery rehearsal (n = 61) or a credible active comparison condition (n = 63) for the treatment of combat-related nightmares. There was pre-post change in overall sleep quality and PTSD symptoms for both groups, but not in nightmare frequency. Intent-to-treat analyses showed that veterans who received imagery rehearsal had not improved significantly more than veterans in the comparison condition for the primary outcomes (nightmare frequency and sleep quality), or for a number of secondary outcomes, including PTSD. Six sessions of imagery rehearsal delivered in group format did not produce substantive improvement in Vietnam War veterans with chronic, severe PTSD. Possible explanations for findings are discussed. PMID:20839311

  15. Long-term corrosion investigation of AISI 316L, Co-28Cr-6Mo, and Ti-6Al-4V alloys in simulated body solutions

    The long-term weight loss, ion release and surface composition of AISI 316L, the Co-28Cr-6Mo and Ti-6Al-4V alloys were investigated in phosphate buffered solutions (PBS) with various bovine serum albumin (BSA) concentrations. All the samples lost weight up to 14 weeks and then started to gain weight. This can be explained by precipitation of dissolved ions on the surface after 14 weeks of immersion. The quantities of the dissolved ions were measured in immersed solution for 8, 14 and 22 weeks by induced coupled plasma-optical emission spectrometer (ICP-OES). The amounts of Fe released from 316L, and Co and Mo released from the Co-28Cr-6Mo alloy decreased after 14 weeks of immersion in PBS and BSA solutions. This observation coincides with the weight change of the samples. The oxide layer composition and concentration of the specimens exposed to solutions for 22 weeks were identified by X-ray photoelectron spectroscopy (XPS) analysis. The XPS results revealed that chromium is the main component of the 316L and Co-28Cr-6Mo alloy. The high Cr concentration of the 316L and Co-Cr-Mo oxide layer corresponds with the slow dissolution rate of Cr compared to other alloying elements of the 316L and Co-28Cr-6Mo alloy.

  16. Complementary feeding: a Global Network cluster randomized controlled trial

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

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

    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

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

    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.

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

    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...

  20. Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

    Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

    2013-01-01

    This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstra...

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

    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 ...

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

    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...

  3. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

    Adelaida María Castro-Sánchez; Guillermo A. Matarán-Peñarrocha; Inmaculada Lara-Palomo; Manuel Saavedra-Hernández; Manuel Arroyo-Morales; Carmen Moreno-Lorenzo

    2011-01-01

    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-we...

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

    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...

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

    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...

  6. Balneotherapy for chronic low back pain: a randomized, controlled study.

    Kesiktas, Nur; Karakas, Sinem; Gun, Kerem; Gun, Nuran; Murat, Sadiye; Uludag, Murat

    2012-10-01

    A large number of treatments were used for patients with chronic low back pain. Frequent episodes have been reported very high. Although balneotherapy was found effective in this disease, there are not well-designed studies. We aimed to determine the effectiveness of balneotherapy versus physical therapy in patients with chronic low back pain. Exercise was added to both treatment programs. Sixty patients with chronic low back pain were randomly divided into two groups. Physical modalities plus exercise were applied to group 1, and group 2 was received balneotherapy plus exercise for ten sessions. The following parameters were measured: visual analogue scale at rest and movement for pain, paracetamol dose, manual muscle test for lumber muscles, modified Schoeber' test, Oswestry disability index, and Short-Form 36 at the beginning and end of the therapies and at the 3 months follow-up. The statistical analyses were performed using the SPSS 10.0 program. Both groups achieved significant improvements within themselves. But balneotherapy groups were improved at back extensor muscle test (P pain. PMID:21960048

  7. Controlling transmission eigenchannels in random media by edge reflection

    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. Stochastic Control for a Class of Random Evolution Models

    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

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

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

    2011-01-01

    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....

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

    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…

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

    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 on...

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

    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 ...

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

    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…

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

    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...

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

    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 CO2 baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO2 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.)

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

    A Gholipour; 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...

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

    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,…

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

    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…

  19. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

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

    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…

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

    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...

  2. The Weekend School Effect on Perceived Cognitive and Social Competences: Evidence from a Randomized Controlled Experiment

    Van Klaveren, C.; Terwijn, H.; Meyer, E

    2011-01-01

    This study reports the results of a randomized controlled experiment in the Netherlands that was conducted in 2005 to examine if a Weekend School did positively affect perceived competences. For this purpose, 216 Dutch 7thgraders (aged 10/11) were randomly assigned to a Weekend School program and a waiting list. This study focuses on the following competences: scholastic competence, social acceptance, behavioral conduct, global self-worth and outspokenness. These competences are measured befo...

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

    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 ...

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

    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...

  5. Evaluation of Isosorbide Mononitrate for Preinduction of Cervical Ripening: A Randomized Placebo-Controlled Trial

    Ramya Krishnamurthy; Pallavee, P.; Seetesh Ghose

    2015-01-01

    Objective:To evaluate the safety and efficacy of Isosorbide mononitrate (IMN) as a cervical ripening agent prior to induction of labour in term pregnant women. Materials and methods:A randomized placebo-controlled study was conducted on 100 term singleton pregnancies planned for induction of labour. The participants were randomly assigned to two groups. One group received 40 mg IMN and the other group received 40mg of placebo kept vaginally. The main outcome of this study was to evaluate the ...

  6. Testing a workplace physical activity intervention: a cluster randomized controlled trial

    Jackson Cath; Lawton Rebecca J; McEachan Rosemary RC; Conner Mark; Meads David M; West Robert M

    2011-01-01

    Abstract Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or cont...

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

    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 ...

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

    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...

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

    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...

  10. The effectiveness of lifestyle triple P in the Netherlands : A randomized controlled trial

    Gerards, S.M.P.L.; Dagnelie, P.C.; J. S. Gubbels; van Buuren, S; Hamers, F.J.M.; Jansen, M. W. J.; Goot, O.H.M. van der; de Vries, N. K.; Sanders, M.R.; Kremers, S. P. J.

    2015-01-01

    Introduction Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. Method We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4–8 years old, overweight or obese) were recruited and randomly as...

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

    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...

  12. Oral zolpidem prevents acute mountain sickness: a randomized double-blind placebo controlled study

    Yong-tao HUANG; Qin, Jun; Xu-bin GAO; Chen, Guo-Zhu; Zheng, Cheng-Rong; Yang, Jie; Huang, Lan

    2015-01-01

    Objective To study the prophylactic effect of zolpidem on acute mountain sickness (AMS) after acute high-altitude exposure. Methods A randomized double-blind placebo controlled trial was performed on the plateau. Forty subjects were randomly divided into zolpidem group and placebo group. The general clinical data, heart rate, blood pressure, oxygen saturation, the Pittsburgh Sleep Quality Index (PSQI) scores, AMS scores and physical fitness test of the both groups were collected and assessed ...

  13. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-01-01

    Background The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. Material/Methods This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200...

  14. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial

    Preyde, M

    2000-01-01

    BACKGROUND: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture education), 2 components of massage therapy and placebo in the treatment of subacute (between 1 week and 8 months) low-back pain. METHODS: Subjects with subacute low-back pain were randomly assigned to 1 of 4 groups: comprehensive massage therapy (n = 25), soft-tissue manipul...

  15. Multivitamin and Iron Supplementation to Prevent Periconceptional Anemia in Rural Tanzanian Women: A Randomized, Controlled Trial.

    Gunaratna, Nilupa S.; Masanja, Honorati; Mrema, Sigilbert; Levira, Francis; Spiegelman, Donna; Hertzmark, Ellen; Saronga, Naomi; Irema, Kahema; Shuma, Mary; Elisaria, Ester; Fawzi, Wafaie

    2015-01-01

    Objective: Women’s nutritional status during conception and early pregnancy can influence maternal and infant outcomes. This study examined the efficacy of pre-pregnancy supplementation with iron and multivitamins to reduce the prevalence of anemia during the periconceptional period among rural Tanzanian women and adolescent girls. Design: A double-blind, randomized controlled trial was conducted in which participants were individually randomized to receive daily oral supplements of folic aci...

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

    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...

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

    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...

  18. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial

    Ravindra Arya; Maya Chansoria; Ramesh Konanki; 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...

  19. Effect of Siguan Acupuncture on Gastrointestinal Motility: A Randomized, Sham-Controlled, Crossover Trial

    Kyung-Min Shin; Ji-Eun Park; Sanghun Lee; Sun-Mi Choi; Yo-Chan Ahn; Jin-Woo Lee; Jin-Hee Kim; Chang-Gue Son

    2013-01-01

    Siguan acupoints have been used to treat gastrointestinal symptoms in acupuncture practices for a long time. This study aimed to investigate the effects of Siguan acupuncture on gastrointestinal motility under accelerated conditions using a randomized, sham-acupuncture-controlled, crossover study. Twenty-one healthy male subjects were hospitalized and randomized into either a real acupuncture group (at Siguan acupoints) or a sham acupuncture group. Subjects were administered with mosapride ci...

  20. 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

    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...

  1. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    Chmiel C

    2014-10-01

    Full Text Available Corinne Chmiel, Oliver Senn, Thomas Rosemann, Valerio Del Prete, Claudia Steurer-Stey Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland Background: Inadequate blood pressure (BP control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP improves BP control and adherence with home BP measurement.Methods: In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg, and adherence with home BP measurement after 6 months.Results: One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7. BP control (treatment target <140/90 mmHg was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5. Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1Conclusion: Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months, but no significant between-group difference was

  2. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    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... others from the general public, about the use of meta-analyses of randomized trials as a tool for...

  3. Effect of Probiotics on Glycemic Control: A Systematic Review and Meta-Analysis of Randomized, Controlled Trials.

    Yuting Ruan

    Full Text Available Previous clinical trials indicate that probiotic consumption may improve blood glucose control, however, results from randomized trials on glycemic control have been inconsistent.To investigate the effects of probiotics on glycemic control in a systematic review and meta-analysis of randomized controlled trials.PubMed, Embase, Cochrane Library, and Clinicaltrial.gov through October 2014.Two independent reviewers extracted relevant data and assessed study quality and risk of bias. Data were pooled using a random-effects model and expressed as mean differences (MD with 95% CI. Heterogeneity was assessed (Cochran Q-statistic and quantified (I2.Seventeen randomized controlled trials were included, in which 17 fasting blood glucose (n = 1105, 11 fasting plasma insulin (n = 788, 8 homeostasis model assessment of insulin resistance (n = 635 comparisons were reported. Probiotic consumption, compared with placebo, significantly reduced fasting glucose (MD = -0.31 mmol/L; 95% CI 0.56, 0.06; p = 0.02, fasting plasma insulin (MD = -1.29 μU/mL; 95% CI -2.17, -0.41; p = 0.004, and HOMA-IR (MD = 0.48; 95% CI -0.83, -0.13; p = 0.007.Probiotic consumption may improve glycemic control modestly. Modification of gut microbiota by probiotic supplementation may be a method for preventing and control hyperglycemia in clinical practice.

  4. Characterization of the Alpha-Beta and Martensitic Transformations en the Ti-6Al-2Sn-4Zr-6Mo Alloy

    Tarín Remohí, Pascual; Alonso, I.; García Simón, Antonio; Badía Pérez, José María; Martín Piris, Nuria

    2008-01-01

    A Ti–6Al–2Sn–4Zr–6Mo (wt.%) alloy has been subjected to different thermal treatments of solution and aging leading to different amounts and distribution of untransformed _-phase, _-phase and martensite. In order to study the _-phase transformation, and thus to evaluate its kinetic behaviour, its characteristics and its influence in subsequent transformations, dilatometric analysis tests, metallographic studies, hardness, and conductivity measurements have been performed.

  5. The determination of the equations of state of gaseous UF6, MoF6, WF6, ClF3 with dielectric method

    The technique for measuring dielectric constants was used to determine the molar polarization, non ideality and dipole moment of UF6, MoF6, WF6, CIF3. Comparisons are made between these non-ideality parameters and those obtained by Magnuson and volumetric method. It is demonstrated that dielectric non-ideality parameters of these gases are unsettled by an adsorption phenomena on the electrodes. (author)

  6. High-dose antioxidants for central serous chorioretinopathy; The randomized placebo-controlled study

    Ratanasukon Mansing; Bhurayanontachai Patama; Jirarattanasopa Pichai

    2012-01-01

    Abstract Background To determine the efficacy of high-dose antioxidants in the acute stage of central serous chorioretinopathy (CSC). Methods This was a randomized placebo-controlled study. The patients with acute CSC (onset within 6 weeks) were randomized to receive either high-dose antioxidant tablets (study group A) or placebo tablets (control group B) for 3 months or until the complete resolution of subretinal fluid. After 3 months, additional treatment with laser or photodynamic therapy ...

  7. A nationwide cluster randomized controlled trial of unanounced versus announced periodic hospital surveys

    Simonsen, Katherina Beltoft

    2016-01-01

    was suggested as an intervention. This cluster-randomized controlled trial (C-RCT) aims at evaluating the effectiveness of unannounced surveys versus announced surveys in detecting non-compliance with a subset of accreditation standards from the DDKM version 2 of public hospitals. METHODS: Study...... design:  Nationwide block and cluster RCT  23 public hospitals (3 university hospitals, 15 general hospitals, and 5 psychiatric hospitals  11 hospitals received announced surveys (control group)  12 hospitals received unannounced surveys (intervention group)  9 surveyors randomly allocated in...

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

    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...

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

    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...

  10. Joint Random Access and Power Control Game in Ad Hoc Networks with Noncooperative Users

    Long, Chengnian; Guan, Xinping

    We consider a distributed joint random access and power control scheme for interference management in wireless ad hoc networks. To derive decentralized solutions that do not require any cooperation among the users, we formulate this problem as non-cooperative joint random access and power control game, in which each user minimizes its average transmission cost with a given rate constraint. Using supermodular game theory, the existence and uniqueness of Nash equilibrium are established. Furthermore, we present an asynchronous distributed algorithm to compute the solution of the game based on myopic best response updates, which converges to Nash equilibrium globally.

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

    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; ·    ...

  12. The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial

    Li Jingdao

    2009-04-01

    Full Text Available Abstract Background Many studies have already reported encouraging results in the prophylactic therapy of migraine by acupuncture, but there seems to be a lack of high quality randomized controlled trials from China. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with flunarizine in the prophylactic therapy of patients with migraine without aura in China. Methods This trial is a multicenter, prospective, randomized controlled clinical trial. The 140 migraine patients are randomly allocated to two different groups. The acupuncture groups (n = 70 is treated with acupuncture and placebo medicine; while the control group (n = 70 is treated with sham acupuncture and medicine (Flunarizine. Both Flunarizine and placebo are taken 10 mg once per night for the first 2 weeks and then 5 mg once per night for the next 2 weeks. Patients in both groups receive 12 sessions of verum/sham acupuncture in 4 weeks. Discussion The study design and the long term clinical practice of acupuncturists guarantee a high external validity for the results. The results of our trial will be helpful to supply the evidence on the efficacy of acupuncture for migraine prophylaxis in China. Trial Registration The trial is registered at Controlled Clinical Trials: ISRCTN49839714.

  13. PDE-based random-valued impulse noise removal based on new class of controlling functions.

    Wu, Jian; Tang, Chen

    2011-09-01

    This paper is concerned with partial differential equation (PDE)-based image denoising for random-valued impulse noise. We introduce the notion of ENI (the abbreviation for "edge pixels, noisy pixels, and interior pixels") that denotes the number of homogeneous pixels in a local neighborhood and is significantly different for edge pixels, noisy pixels, and interior pixels. We redefine the controlling speed function and the controlling fidelity function to depend on ENI. According to our two controlling functions, the diffusion and fidelity process at edge pixels, noisy pixels, and interior pixels can be selectively carried out. Furthermore, a class of second-order improved and edge-preserving PDE denoising models is proposed based on the two new controlling functions in order to deal with random-valued impulse noise reliably. We demonstrate the performance of the proposed PDEs via application to five standard test images, corrupted by random-valued impulse noise with various noise levels and comparison with the related second-order PDE models and the other special filtering methods for random-valued impulse noise. Our two controlling functions are extended to automatically other PDE models. PMID:21435980

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

    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

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

    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…

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

    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…

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

    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

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

    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).

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

    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...

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

    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…

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

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

    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…

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

    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...

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

    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…

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

    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…

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

    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…

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

    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…

  8. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    Andersen, Lars; Jørgensen, Marie Birk; Blangsted, Anne;

    2008-01-01

    PURPOSE:: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS:: A 1-yr randomized controlled intervention trial was done with three groups: specific...

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

    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…

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

    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…

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

    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

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

    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:...

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

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

    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)…

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

    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.

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

    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...

  17. A multisite randomized controlled trial on time to self-support among sickness absence beneficiaries

    Nielsen, Maj Britt D.; Vinsløv Hansen, Jørgen; Aust, Birgit;

    2015-01-01

    sickness absence beneficiaries at high risk for exclusion from the labour market. The aim of this article was to evaluate the effectiveness of the RTW programme on self-support. METHODS: Beneficiaries from three municipalities (denoted M1, M2 and M3) participated in a randomized controlled trial. We...

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

    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

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

    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…

  20. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  1. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

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

    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.

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

    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.

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

    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.

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

    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

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

    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)…

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

    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.…

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

    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

  9. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

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

    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…

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

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

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

    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

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

    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…

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

    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...

  15. SMALL INCISION CATARACT SURGERY VERSUS PHACOEMULSIFICATION FOR IMMATURE CATARACT: A SINGLE BLIND RANDOMIZED CONTROLLED TRIAL

    Md. Jawed; Himadri; De, Abhijit; Rathindra; Deshmukh Md Saudmiya

    2014-01-01

    BACKGROUND: Manual small incision cataract surgery (SICS) has given visual results almost equivalent to Phacoemulsification but limited studies are available regarding the efficacy of small incision cataract surgery in phaco suitable immature cataracts. OBJECTIVE: To compare manual small incision cataract surgery and Phacoemulsification in immature cataracts. MATERIALS AND METHODS: A single blind randomized controlled trial was conducted with 105 eyes each for small incisi...

  16. Quantum randomness can be controlled by free will -a consequence of the before-before experiment

    Suarez, Antoine

    2008-01-01

    The before-before experiment demonstrates that quantum randomness can be controlled by influences from outside spacetime, and therefore by immaterial free will. Rather than looking at quantum physics as the model for explaining free will, one should look at free will as a primitive principle for explaining why the laws of Nature are quantum.

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

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

    2006-01-01

    . 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...

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

    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…

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

    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…

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

    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.

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

    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…

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

    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...... 200 patients with mild AD to a supervised exercise group (60-min sessions three times a week for 16 weeks) or to a control group. Primary outcome was changed from baseline in cognitive performance estimated by Symbol Digit Modalities Test (SDMT) in the intention-to-treat (ITT) group. Secondary...... baseline in SDMT as compared with the control group (mean: 4.2, 95% CI 0.5 to 7.9, p = 0.028), suggesting a dose-response relationship between exercise and cognition. Conclusions: This is the first randomized controlled trial with supervised moderate-to-high intensity exercise in patients with mild AD...

  3. Efficacy of nonsurgical periodontal therapy on glycaemic control in type II diabetic patients: a randomized controlled clinical trial

    Telgi, Ravishankar Lingesha; Tandon, Vaibhav; Tangade, Pradeep Shankar; Tirth, Amit; Kumar, Sumit; Yadav, Vipul

    2013-01-01

    Purpose Diabetes and periodontal disease are two common diseases with high prevalence rates. Recent evidence has shown a bidirectional relationship between diabetes and periodontitis. The aim of this study was to investigate the effects of nonsurgical periodontal therapy on glycemic control in type 2 diabetes mellitus patients. Methods Sixty subjects aged 35-45 years with blood sugar controlled by oral hypoglycaemic agents were randomly divided equally among 3 groups: group A (scaling, mouthw...

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

    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 ...

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

    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...

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

    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...

  7. The effect of antenatal exercise on women’s experience of labor: A randomized controlled trial

    Austad, Åshild; Forså, Marianne Inngjerdingen

    2013-01-01

    Objective: To assess whether following a standardized exercise program during pregnancy affects women’s experience of labor.Methods: 855 healthy pregnant women were randomized to an intervention or a control group. The intervention group followed a 12 weeks standardized exercise program between gestational weeks 20 and 36. The program included aerobic and strengthening exercises of moderate to high-intensity. The control group followed standard antenatal care. At inclusion and three months po...

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

    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 ...

  9. The Effect of Telephone Support on Postpartum Depression: A Randomized Controlled Trial

    Sakineh Mohammad-Alizadeh-Charandabi; Jamileh Malakoti; Faramarz Sohrabi; Nafiseh Shokranian

    2013-01-01

    Introduction: Postpartum depression is a common disorder. Systematic reviews emphasized the need to conduct more trials about interventions to prevent postpartum depression. The aim of this study was to determine the effect of postpartum telephone support on maternal depression. Methods: 366 postpartum women with no history of known depression were randomly assigned into control (244 subjects) and intervention (122 subjects) groups. The control group received only routine po...

  10. Effect of Chewing Gum on Oral Mucositis in Children Undergoing Chemotherapy: A Randomized Controlled Study

    Eghbali, A.; Taherkhanchi, B; Bagheri, B; Sadeghi Sedeh, B

    2016-01-01

    Background Oral mucositis is an adverse effect of chemotherapy. Type of chemotherapy regimen is the most important factor causing mucositis. Oral mucositis is usually associated with transient decrease in saliva production. The goal was to study effects of gum consumption on oral mucositis in children undergoing chemotherapy. Materials and Method This randomized controlled trial was done in Amir Kabir Hospital, Arak, Iran. 130 children 5 to 15 years of age were studied. Control group was comp...

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

    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...

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

    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...

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

    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...

  14. Effects of a Telephone-Based Exercise Intervention for Dementia Caregiving Wives: A Randomized Controlled Trial

    Connell, Cathleen M; Janevic, Mary R

    2009-01-01

    Despite the importance of self-care for dementia caregivers, few interventions have included a focus on health behaviors. The current study reports outcomes of a telephone-based exercise intervention designed for women caring for a spouse with dementia. Caregivers (N = 137) were randomized to intervention or control conditions. Participants with at or below-median exercise scores at baseline had a significantly greater increase in exercise at six-month follow-up compared to their control coun...

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

    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

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

    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

  18. Brief Report: Staged-informed Consent in the Cohort Multiple Randomized Controlled Trial Design.

    Young-Afat, Danny A; Verkooijen, Helena A M; van Gils, Carla H; van der Velden, Joanne M; Burbach, Johannes P; Elias, Sjoerd G; van Delden, Jonannes J; Relton, Clare; van Vulpen, Marco; van der Graaf, Rieke

    2016-05-01

    The "cohort multiple randomized controlled trial," a new design for pragmatic trials, embeds multiple trials within a cohort. The cohort multiple RCT is an attractive alternative to conventional RCTs in fields where recruitment is slow, multiple new (competing) interventions for the same condition have to be tested, new interventions are highly preferred by patients and doctors, and the risk of disappointment bias, cross-over, and contamination is considerable. To prevent these unwanted effects, the cohort multiple RCT provides information on randomization to the intervention group/arm only, and only after randomization (i.e., prerandomization). To some, especially in a clinical setting, this is not ethically acceptable. In this article, we argue that prerandomization in the cohort multiple randomized controlled trial (cmRCT) can be avoided by adopting a staged-informed consent procedure. In the first stage, at entry into the cohort, all potential participants are asked for their informed consent to participate in a cohort study and broad consent to be either randomly selected to be approached for experimental interventions or to serve as control without further notice during participation in the cohort. In a second stage, at the initiation of an RCT within the cohort, informed consent to receive the intervention is then only sought in those randomly selected for the intervention arm. At the third stage, after completion of each RCT, all cohort participants receive aggregate disclosure of trial results. This staged-informed consent procedure avoids prerandomization in cmRCT and aims to keep participants actively engaged in the research process. PMID:27035689

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

    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...

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

    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...

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

    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...

  2. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent Versus Sequential Intervention.

    Spring, Bonnie; Pagoto, Sherry; Pingitore, Regina; Doran, Neal; Schneider, Kristin; Hedeker, Don

    2004-01-01

    The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

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

    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.

  4. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study

    Nielsen, Maria Mærsk; Sparre, Anita Belza; Stødkilde-Jørgensen, Hans;

    2012-01-01

    The consumption of sucrose-sweetened soft drinks (SSSDs) has been associated with obesity, the metabolic syndrome, and cardiovascular disorders in observational and short-term intervention studies. Too few long-term intervention studies in humans have examined the effects of soft drinks....

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

    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

  6. 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

    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...

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

    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

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

    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

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

    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.

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

    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.

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

    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

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

    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...

  13. Effectiveness of an Interactive Website Aimed at Empowerment of Disability Benefit Claimants: Results of a Pragmatic Randomized Controlled Trial

    Samoocha, D.; Snels, I.A.K.; Bruinvels, D.J.; Anema, J. R.; Beek, van der, A.J.

    2011-01-01

    Introduction The aim of this study was to investigate the effectiveness of an interactive website aimed at empowerment of disability claimants, prior to the assessment of disability by an insurance physician. Methods A randomized controlled trial was conducted. Claimants applying for a work disability pension after being sick-listed for 104 weeks, were randomized into either an intervention group or control group. Participants who were randomized into the intervention group were able to logon...

  14. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Yu Zhang; Hao-Ping Zhu; Jian-Xia Fan; Hong Yu; Li-Zhou Sun; Lian Chen; Qing Chang; Nai-Qing Zhao; Wen Di

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized...

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

    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...

  16. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study

    de Seigneux Sophie

    2012-10-01

    Full Text Available Abstract Background Experimentally, erythropoietin (EPO has nephroprotective as well as immunomodulatory properties when administered after ischemic renal injury. We tested the hypothesis that different doses of recombinant human EPO administered to patients after cardiac surgery would minimize kidney lesions and the systemic inflammatory response, thereby decreasing acute kidney injury (AKI incidence. Methods In this double-blinded randomized control study, 80 patients admitted to the ICU post-cardiac surgery were randomized by computer to receive intravenously isotonic saline (n = 40 versus α-Epoetin (n = 40: either 40000 IU (n = 20 or 20000 IU (n = 20. The study lasted one year. The primary outcome was the change in urinary NGAL concentration from baseline and 48 h after EPO injection. Creatinine, cystatine C and urinary NGAL levels were measured on the day of randomization and 2–4 days after EPO injection. To assess acute inflammatory response, serum cytokines (IL6 and IL8 were measured at randomization and four days after r-HuEPO injection. Patients and care-takers were blinded for the assignment. Results No patient was excluded after randomization. Patient groups did not differ in terms of age, gender, comorbidities and renal function at randomization. The rate of AKI assessed by AKIN criteria was 22.5% in our population. EPO treatment did not significantly modify the difference in uNGAl between 48 hours and randomization compared to placebo [2.5 ng/ml (−17.3; 22.5 vs 0.7 ng/ml (−31.77; 25.15, p = 0.77] and the incidence of AKI was similar. Inflammatory cytokines levels were not influenced by EPO treatment. Mortality and hospital stays were similar between the groups and no adverse event was recorded. Conclusion In this randomized-controlled trial, α-Epoetin administrated after cardiac surgery, although safe, demonstrated neither nephroprotective nor anti-inflammatory properties. Trial registration number NCT

  17. A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

    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…

  18. The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

    Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

    2015-01-01

    This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

  19. The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women : a randomized controlled trial

    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

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

    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.

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

    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

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

    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

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

    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.

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

    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

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

    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.

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

    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

  7. Acupoint Stimulation on Weight Reduction for Obesity: A Randomized Sham-Controlled Study.

    Yeh, Mei-Ling; Chu, Nain-Feng; Hsu, Man-Ying F; Hsu, Chin-Che; Chung, Yu-Chu

    2015-12-01

    Auricular acupoint stimulation has become a popular weight loss method. However, its efficacy for obesity treatment has not been fully studied. This study aimed to investigate the effect of a 10-week intervention of auricular electrical stimulation combined with auricular acupressure on weight reduction in obese outpatients. In this single-blind randomized sham-controlled study, 134 participants were randomly assigned to an experimental group receiving stimulation at true acupoints, or a sham group receiving stimulation delivered in the same manner but at sham acupoints. Each participant received nutrition counseling by a nutritionist weekly. The results showed significant differences in body mass index, blood pressure, total cholesterol, triglyceride, and leptin or adiponectin over time within the group, but not between the groups. This study could not exclude the effect of placebo and dietary consultation. Further study that adds a control group receiving no treatment is therefore needed to confirm the effects of auricular acupressure. PMID:25183702

  8. Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

    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...... bleeding. At 31 hospitals in an emergency setting, 256 patients (Child-Pugh > 8; Child-Pugh B = 26%, C = 74%) were randomized equally to: placebo; 600 microg/kg rFVIIa (200 + 4x 100 microg/kg); or 300 microg/kg rFVIIa (200 + 100 microg/kg). Dosing was intravenous at 0, 2, 8, 14, and 20 hours after...... endoscopy, in addition to standard vasoactive, prophylactic antibiotic, and endoscopic treatment. The primary composite endpoint consisted of failure to control 24-hour bleeding, or failure to prevent rebleeding or death at day 5. Secondary endpoints included adverse events and 42-day mortality. Baseline...

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

    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 searches of PubMed. METHODS: Twenty-two residents and specialists working at the Radboud University Nijmegen Medical Centre were trained in formulating PICO queries and then presented with a randomi...

  10. Dramatic reduction of read disturb through pulse width control in spin torque random access memory

    Wang, Zihui; Wang, Xiaobin; Gan, Huadong; Jung, Dongha; Satoh, Kimihiro; Lin, Tsann; Zhou, Yuchen; Zhang, Jing; Huai, Yiming; Chang, Yao-Jen; Wu, Te-ho

    2013-09-01

    Magnetizations dynamic effect in low current read disturb region is studied both experimentally and theoretically. Dramatic read error rate reduction through read pulse width control is theoretically predicted and experimentally observed. The strong dependence of read error rate upon pulse width contrasts conventional energy barrier approach and can only be obtained considering detailed magnetization dynamics at long time thermal magnetization reversal region. Our study provides a design possibility for ultra-fast low current spin torque random access memory.

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

    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...

  12. The effect of compression socks on balance skills : randomized controlled trial

    Kiikka, Daniel

    2015-01-01

    TIIVISTELMÄ Kiikka, Daniel. 2015. The effect of compression socks on balance skills - randomized controlled trial. Jyväskylän yliopisto. Liikuntakasvatuksen laitos. Liikuntapedagogiikan pro gradu -tutkielma, 71s., 11 liitettä. Urheilusuoritusta parantavat kompressiomateriaalit ovat nopeasti nousseet polttavaksi puheenaiheeksi nykyurheilussa sekä -liikunnassa, minkä takia monet urheiluvaatemerkit ovat alkaneet kehittää omia versioitaan kompressiovaatteista, joita on alun perin käytett...

  13. Randomized, Double-Blind, and Placebo-Controlled Trial of Clenbuterol in Denervated Muscle Atrophy

    Jiang, Guang-Liang; Gu, Yu-Dong; Zhang, Li-Yin; Shen, Li-Ying; Yu, Cong; Xu, Jian-Guang

    2011-01-01

    Objectives. 2 -adrenergic agonists, such as clenbuterol, have been shown to promote the hypertrophy of healthy skeletal muscles and to ameliorate muscle wasting in a few pathological conditions in both animals and humans. We intended to investigate the clinical efficacy of clenbuterol on attenuating denervation-induced muscle atrophy. Methods. A double-blind, placebo-controlled, parallel, and randomized trial was employed. 71 patients, suffering from brachial plexus injuries, were given eit...

  14. Improving participation rates by providing choice of participation mode: two randomized controlled trials

    Heijmans, N.; Van Lieshout, J.; Wensing, M.J.

    2015-01-01

    BACKGROUND: Low participation rates reduce effective sample size, statistical power and can increase risk for selection bias. Previous research suggests that offering choice of participation mode can improve participation rates. However, few head-to-head trials compared choice of participation mode using telephone interviews and postal questionnaires as modes of interest. Aiming to explore effects of choice of participation, two randomized controlled trials were performed comparing participat...

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

    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...

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

    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-...

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

    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...

  18. Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial

    Fariba Jaffary; Gita Faghihi; Arghavan Mokhtarian; Sayed Mohsen Hosseini

    2015-01-01

    Background: The pathogenesis of atopic dermatitis (AD) remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE) in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. Materials and Methods: This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-...

  19. Intravenous lidocaine for postmastectomy pain treatment: randomized, blind, placebo controlled clinical trial

    2015-01-01

    BACKGROUND AND OBJECTIVE: Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. METHODS: After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was cond...

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

    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...

  1. Aspirin and Serum Estrogens in Postmenopausal Women: a Randomized Controlled Clinical Trial

    Duggan, Catherine; Wang, Ching-Yun; Xiao, Liren; McTiernan, Anne

    2014-01-01

    Epidemiologic studies suggest a reduced risk of breast cancer among women who use aspirin. A plausible mechanism is through aspirin’s effect on estrogens, possibly mediated through interference with estrogen synthesis via reduction in inflammation, which is increased in adipose tissues including breast. In a randomized placebo-controlled trial, we evaluated the effects of 6-months administration of 325 mg/day aspirin on serum estrogens (estradiol, estrone, free estradiol, bioavailable estradi...

  2. A Randomized Controlled Trial of Patient-Reported Outcomes With Tai Chi Exercise in Parkinson's Disease

    Li, Fuzhong; Harmer, Peter; Liu, Yu; Eckstrom, Elizabeth; Fitzgerald, Kathleen; Stock, Ronald; Chou, Li-Shan

    2013-01-01

    A previous randomized, controlled trial of tai chi showed improvements in objectively measured balance and other motor-related outcomes in patients with Parkinson's disease. This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence. In a secondary analysis of the tai chi trial, patient-reported and clinical outcomes and exercise adherence measures were compared ...

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

    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...

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

    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.

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

    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...

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

    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...

  7. Physical activity and anxiety in adolescents : a systematic review of randomized controlled trials

    Shi, Shitian; 石诗田

    2014-01-01

    Background Anxiety disorders are among the most prevalent psychological disorders experienced during adolescence. Studies have suggested that physical activity may contribute to a beneficial role for anxiety including the prevention and reduction of anxiety symptoms among adolescents. This systematic review aims to explore the possible relationship between physical activity and anxiety. Methods A systematic search was performed to locate randomized-controlled trials (RCT)from 1980t...

  8. Prevention of Generalized Anxiety Disorder Using a Web Intervention, iChill: Randomized Controlled Trial

    Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin A; Gosling, John; Bennett, Kylie

    2014-01-01

    Background Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. Objective The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone an...

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

    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. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    Arija Victoria; Martín Núria; Canela Teresa; Anguera Carme; Castelao Ana I; García-Barco Montserrat; García-Campo Antoni; González-Bravo Ana I; Lucena Carme; Martínez Teresa; Fernández-Barrés Silvia; Pedret Roser; Badia Waleska; Basora Josep

    2012-01-01

    Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of t...

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

    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

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

    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...

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

    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...

  15. The 40-Something randomized controlled trial to prevent weight gain in mid-age women

    Williams, Lauren T.; Hollis, Jenna L; Collins, Clare E.; Morgan, Philip J

    2013-01-01

    Background Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity inte...

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

    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...

  17. Overcoming the funding challenge: the cost of randomized controlled trials in the next decade.

    Shore, Benjamin J; Nasreddine, Adam Y; Kocher, Mininder S

    2012-07-18

    Randomized controlled trials (RCTs) represent the gold standard of evidence-based medicine. However, over the last several decades, the cost associated with conducting RCTs has increased dramatically. Several factors contribute to higher costs associated with clinical trials. This paper describes important barriers to conducting surgical RCTs, identifies funding sources available to finance RCTs, and suggests strategies to maintain cost-efficient study practices as we move into the next decade. PMID:22810458

  18. Short coherent control pulse with small random errors in its direction

    Zhi-Kun, Su; Shao-Ji, Jiang

    2012-01-01

    The finite-amplitude short coherent control pulse with small random errors in its direction is considered. We derive the conditions for it to approximate an ideal delta-shaped pulse up to an error in the second order of pulse duration. Whether the symmetric and asymmetric pulse shapes would fulfill these conditions is also analyzed. The result shows that, under one of these conditions, all symmetric pulse shapes can fulfill this condition but not for all asymmetric ones..

  19. Saving and empowering young lives in Europe (SEYLE): a randomized controlled trial.

    Nemes Bogdan; Marusic Dragan; Keeley Helen; Kaess Michael; Kahn Jean-Pierre; Haring Christian; Guillemin Francis; Gadoros Julia; Feldman Dana; Durkee Tony; Cosman Doina; Corcoran Paul; Bursztein-Lipsicas Cendrine; Brunner Romuald; Bracale Renata

    2010-01-01

    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...

  20. Neural Mobilization: A Systematic Review of Randomized Controlled Trials with an Analysis of Therapeutic Efficacy

    Ellis, Richard F.; Hing, Wayne A

    2008-01-01

    Neural mobilization is a treatment modality used in relation to pathologies of the nervous system. It has been suggested that neural mobilization is an effective treatment modality, although support of this suggestion is primarily anecdotal. The purpose of this paper was to provide a systematic review of the literature pertaining to the therapeutic efficacy of neural mobilization. A search to identify randomized controlled trials investigating neural mobilization was conducted using the key w...

  1. Effects of a physical education intervention on cognitive function in young children: randomized controlled pilot study

    Watson Christine; Tomporowski Phillip; Paton James Y; Boyle James ME; Fisher Abigail; McColl John H; Reilly John J

    2011-01-01

    Abstract Background Randomized controlled trials (RCT) are required to test relationships between physical activity and cognition in children, but these must be informed by exploratory studies. This study aimed to inform future RCT by: conducting practical utility and reliability studies to identify appropriate cognitive outcome measures; piloting an RCT of a 10 week physical education (PE) intervention which involved 2 hours per week of aerobically intense PE compared to 2 hours of standard ...

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

    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...

  3. Automated confidence ranked classification of randomized controlled trial articles: an aid to evidence-based medicine

    Cohen, Aaron M; Smalheiser, Neil R.; McDonagh, Marian S; Yu, Clement; Adams, Clive E.; Davis, John M.; PHILIP S. YU

    2015-01-01

    Objective: For many literature review tasks, including systematic review (SR) and other aspects of evidence-based medicine, it is important to know whether an article describes a randomized controlled trial (RCT). Current manual annotation is not complete or flexible enough for the SR process. In this work, highly accurate machine learning predictive models were built that include confidence predictions of whether an article is an RCT. Materials and Methods: The LibSVM classifier was used wit...

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

    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...

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

    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...

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

    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...

  7. Effects of Lornoxicam on Anastomotic Healing: A Randomized, Blinded, Placebo-Control Experimental Study

    Drakopoulou, Stamatoula; Kontis, Elissaios; Pantiora, Eirini; Vezakis, Antonios; Karandrea, Despoina; Aravidou, Eftychia; Konti-Paphiti, Agathi; Argyra, Erifili; Voros, Dionisios; Polydorou, Andreas A.; Fragulidis, Georgios P.

    2016-01-01

    Introduction and Aim. With the implementation of multimodal analgesia regimens, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are often administered for optimal pain control and reduction of opioid use. The aim of the study was to examine the effects of lornoxicam, a NSAID, on anastomotic healing employing an animal model. Materials and Methods. A total of 28 Wistar rats were randomly assigned in two groups. All animals underwent ascending colonic transection followed by an end-to-end hand se...

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

    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...

  9. Functional Stretching Exercise Submitted for Spastic Diplegic Children: A Randomized Control Study

    Mohamed Ali Elshafey; Adel Abd-Elaziem; Rana Elmarzouki Gouda

    2014-01-01

    Objective. Studying the effect of the functional stretching exercise in diplegic children. Design. Children were randomly assigned into two matched groups. Setting. Outpatient Clinic of the Faculty of Physical Therapy, Cairo University. Participants. Thirty ambulant spastic diplegic children, ranging in age from five to eight years, participated in this study. Interventions. The control group received physical therapy program with traditional passive stretching exercises. The study group rece...

  10. Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: a randomized controlled trial

    Zhao-wei CHEN; Chen, Yong-Qiang

    2010-01-01

    Background: In China, patients with rheumatoid arthritis (RA) are often treated with traditional Chinese herbal medicine. There are certain advantages of traditional Chinese medicine therapy in treatment of RA.Objective: To assess the efficacy and adverse reaction of Shenshi Qianghuo Dihuang Decoction (SQDD), a compound traditional Chinese herbal medicine, in treatment of RA.Design, setting, participants and interventions: This was a 24-week prospective, randomized, controlled trial. Ninety R...

  11. Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial

    Verhaeghe, Nick; Clays, Els; Vereecken, Carine; De Maeseneer, Jan; Maes, Lea; van Heeringen, Cornelis; De Bacquer, Dirk; Annemans, Lieven

    2013-01-01

    Background: The existing literature on weight management interventions targeting physical activity and healthy eating in mental health care appears to provide only limited evidence. The aim of the study was to examine the effectiveness of a 10-week health promotion intervention, followed by a 6-month follow-up period in individuals with mental disorders living in sheltered housing in the Flanders region (Belgium). Methods: The study had a cluster preference randomized controlled design. Tw...

  12. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    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.

  13. Effectiveness of adjuvant occupational therapy in employees with depression: design of a randomized controlled trial

    Hees Hiske L; Koeter Maarten WJ; de Vries Gabe; Ooteman Wendy; Schene Aart H

    2010-01-01

    Abstract Background Major depressive disorder is among the medical conditions with the highest negative impact on work outcome. However, little is known regarding evidence-based interventions targeting the improvement of work outcomes in depressed employees. In this paper, the design of a randomized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression. This occupational intervention is based on an earlier interventi...

  14. Control-Variate Models of Common Random Numbers for Multiple Comparisons with the Best

    Barry L. Nelson; Hsu, Jason C.

    1993-01-01

    Using common random numbers (CRN) in simulation experiment design is known to reduce the variance of estimators of differences in system performance. However, when more than two systems are compared, exact simultaneous statistical inference in conjunction with CRN is typically impossible. We introduce control-variate models of CRN that permit exact statistical inference, specifically multiple comparisons with the best. These models explain the effect of CRN via a linear regression of the simu...

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

    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...

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

    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 ...

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

    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...

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

    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...

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

    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...

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

    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. Helicobacter pylori eradication in dyspeptic primary care patients: a randomized controlled trial of a pharmacy intervention

    STEVENS, Victor J; Shneidman, Robert J; Johnson, Richard E; Boles, Myde; Steele, Paul E.; Lee, Nancy L

    2002-01-01

    Objective To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen. Design Randomized controlled clinical trial. Setting Nonprofit group-practice health maintenance organization (HMO). Participants HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing (UBT). Interventions Those whose tests were positive for H pylori (23.3%) were provided...

  2. A randomized controlled trial of an antenatal intervention to increase exclusive breastfeeding

    Wong Cheung, Ka-lun; 黃張嘉倫

    2014-01-01

    In Hong Kong, while around 85% of mothers choose to breastfeed their infants, most discontinue within the first one to two months postpartum. This indicates that there is room for improving the current breastfeeding education. A randomized controlled trial was conducted to evaluate the effectiveness of a professional one-to-one antenatal breastfeeding support and education intervention on the exclusivity and duration of breastfeeding. A total of 469 primiparous women who attended the ante...

  3. Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial

    Wang, Yan; Gao, Yun-xian; Sun, Qi; Bu, Qian; Shi, Jing; Zhang, Ya-ni; Xu, Qin; Ji, Yan; Tong, Min; Jiang, Guang-li

    2014-01-01

    Background Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months. Methods/Design A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A tot...

  4. Cyclical iron supplementation to reduce anemia among Brazilian preschoolers: a randomized controlled trial

    Coutinho, Geraldo GPL; Patrícia M. Cury; José A Cordeiro

    2013-01-01

    Background Iron-deficiency anemia is the most common type of nutritional disorder. New strategies for the treatment of anemia are very important for its reduction. The aim of this study was to assess the efficacy and feasibility of cyclical iron supplementation as a strategy to reduce the prevalence of anemia among preschoolers. Methods A randomized controlled trial was performed in the entire population of under five-year-old children who attended government daycare centers in a small town i...

  5. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial.

    Claustrat Bruno; Roy Pascal; Feugier-Favier Nathalie; Nicolas Alain; Noel-Baron Florence; Remontet Laurent; Cornu Catherine; Saadatian-Elahi Mitra; Kassaï Behrouz

    2010-01-01

    Abstract Background To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders. Methods Randomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention...

  6. Fish Oil and Atrial Fibrillation after Cardiac Surgery: A Meta-Analysis of Randomized Controlled Trials

    Xin, Wei; Wei, Wei; Lin, Zhiqin; Zhang, Xiaoxia; Yang, Hongxia; Zhang, Tao; Li, Bin; Mi, Shuhua

    2013-01-01

    Background Influence of fish oil supplementation on postoperative atrial fibrillation (POAF) was inconsistent according to published clinical trials. The aim of the meta-analysis was to evaluate the effects of perioperative fish oil supplementation on the incidence of POAF after cardiac surgery. Methods Pubmed, Embase and the Cochrane Library databases were searched. Randomized controlled trials (RCTs) assessing perioperative fish oil supplementation for patients undergoing cardiac surgery we...

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

    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.

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

    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...

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

    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...

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

    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...

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

    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 ...

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

    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...

  13. A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education

    Day, Melissa A; Thorn, Beverly E.; Kapoor, Shweta

    2011-01-01

    Cognitive Behavioral Therapy (CBT) is a widely accepted psychosocial treatment for chronic pain. However, the efficacy of CBT has not been investigated within a rural setting. Furthermore, few studies have utilized first-person accounts to qualitatively investigate the key treatment elements and processes of change underlying the well-documented quantitative improvements associated with CBT. To address these gaps, we conducted a randomized controlled trial (RCT) investigating the efficacy of ...

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

    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...

  15. Randomized pilot study to disseminate caries-control services in dentist offices

    Reynolds Debra; Anderson Maxwell; del Aguila Michael A; Spiekerman Charles; Grembowski David; Ellersick Allison; Foster James; Choate Leslie

    2006-01-01

    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–...

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

    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)...

  17. Aerobic exercise in obese diabetic patients with chronic kidney disease: a randomized and controlled pilot study

    Cooper Cheryl; Jelinek Christine S; Qureshi Shahzad; Bast Joseph P; Moinuddin Irfan; Leehey David J; Edwards Lonnie C; Smith Bridget M; Collins Eileen G

    2009-01-01

    Abstract Background Patients with obesity, diabetes, and chronic kidney disease (CKD) are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. Methods We performed a 24-week randomized controlled feasibility study comparing aerobic exercise plus optimal medical management to medical management alone in patients with type 2 diabetes, obesity (body mass index [BMI] > 30 kg/m2), and stage 2-4 CKD (estimated glomerular filtration rate [eGFR] 15-90 m...

  18. Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial

    Jones, R B; L Goldsmith; Hewson, P; Williams, C. J.

    2013-01-01

    Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues....

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

    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...

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

    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...

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

    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...

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

    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...

  3. Hypnosis can reduce pain in hospitalized older patients: a randomized controlled study

    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...

  4. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

    O Cathain, A.; Goode, J.; Drabble, S J; Thomas, K.J.; Rudolph, A; Hewison, J.

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the...

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

    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...

  6. The Use of Propensity Scores and Observational Data to Estimate Randomized Controlled Trial Generalizability Bias

    Pressler, Taylor R.; Kaizar, Eloise E.

    2013-01-01

    While randomized controlled trials (RCT) are considered the “gold standard” for clinical studies, the use of exclusion criteria may impact the external validity of the results. It is unknown whether estimators of effect size are biased by excluding a portion of the target population from enrollment. We propose to use observational data to estimate the bias due to enrollment restrictions, which we term generalizability bias. In this paper we introduce a class of estimators for the generalizabi...

  7. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial

    Mhalu, Grace; Hella, Jerry; Doulla, Basra; Mhimbira, Francis; Mtutu, Hawa; Hiza, Helen; Sasamalo, Mohamed; Rutaihwa, Liliana; Rieder, Hans L; Seimon, Tamsyn; Mutayoba, Beatrice; Mitchell G Weiss; Fenner, Lukas

    2015-01-01

    OBJECTIVE We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video. TRIAL DESIGN Randomized controlled trial. METHODS We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Ta...

  8. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

    Mhalu, Grace; Hella, Jerry; Doulla, Basra; Mhimbira, Francis; Mtutu, Hawa; Hiza, Helen; Sasamalo, Mohamed; Rutaihwa, Liliana; Rieder, Hans L; Seimon, Tamsyn; Mutayoba, Beatrice; Mitchell G Weiss; Fenner, Lukas

    2015-01-01

    OBJECTIVE We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video. TRIAL DESIGN Randomized controlled trial. METHODS We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Da...

  9. The Effect of The Cognitive Behavioral Therapy and Pharmacotherapy on Infertility Stress: A Randomized Controlled Trial

    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 ...

  10. Stress and Fatigue Management Using Balneotherapy in a Short-Time Randomized Controlled Trial

    Lolita Rapolienė; Artūras Razbadauskas; Jonas Sąlyga; Arvydas Martinkėnas

    2016-01-01

    Objective. To investigate the influence of high-salinity geothermal mineral water on stress and fatigue. Method. 180 seamen were randomized into three groups: geothermal (65), music (50), and control (65). The geothermal group was administered 108 g/L salinity geothermal water bath for 2 weeks five times a week. Primary outcome was effect on stress and fatigue. Secondary outcomes were the effect on cognitive function, mood, and pain. Results. The improvements after balneotherapy were a reduct...

  11. 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

    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.

  12. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    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

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

    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

  14. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

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

    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.

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

    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

  18. Effectiveness of the home-based alcohol prevention program "In control: No alcohol!": study protocol of a randomized controlled trial

    Verdurmen Jacqueline EE; Schulten Ingrid; Lichtwarck-Aschoff Anna; van der Vorst Haske; Mares Suzanne HW; Otten Roy; Engels Rutger CME

    2011-01-01

    Abstract Background In the Netherlands, children start to drink at an early age; of the Dutch 12-year olds, 40% reports lifetime alcohol use, while 9.7% reports last-month drinking. Starting to drink at an early age puts youth at risk of developing several alcohol-related problems later in life. Recently, a home-based prevention program called "In control: No alcohol!" was developed to delay the age of alcohol onset in children. The main aim of this project is to conduct a Randomized Controll...

  19. A Randomized Controlled Trial of Hospital-based Case Management in Cancer Care

    Wulff, Christian N; Vedsted, Peter; Søndergaard, Jens

    2012-01-01

    BACKGROUND: Case management (CM) models based on experienced nurses are increasingly used to improve coordination and continuity of care for patients with complex health care needs. Anyway, little is known about the effects of hospital-based CM in cancer care.Aim.To analyse the effects of hospital......-based CM on (i) GPs' evaluation of information from the hospital and collaboration with the hospital staff and (ii) patients' contacts with GPs during daytime and out of hours. DESIGN: A randomized controlled trial allocated 280 colorectal cancer patients 1:1 to either a control group or CM intervention...

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

    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. Use of remifentanil in comparison with sodium nitroprusside for controlled hypotension during rhinoplasty: Randomized controlled trail

    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...

  2. Treatment of chronic idiopathic urticaria with levamisole: a multicentre, randomized, double-blind, controlled trial.

    Zhang, H; Shan, C; Hua, Z; Zhao, P; Zhang, H

    2009-01-01

    The objective of this study was to evaluate the efficacy of treating chronic idiopathic urticaria (CIU) with levamisole in combination with levocetirizine. This was a multicentre, randomized, double-blind, controlled trial that included 132 patients with active CIU who were treated for 6 weeks with either levocetirizine alone (control group; n = 65) or levamisole plus levocetirizine (treatment group; n = 67). Response to therapy was evaluated by measuring the efficacy rate. After 2 weeks of treatment, there was no significant difference in the efficacy rate between the treatment and control groups (54.84% and 42.37%, respectively). After 6 weeks of treatment, a statistically significant difference in the efficacy rate was observed between the groups (76.27% and 54.39% for the treatment and control groups, respectively). This study demonstrated that a combination of levamisole plus levocetirizine is more effective than levocetirizine alone and potentially provides a new, promising approach to the treatment of CIU. PMID:19761700

  3. Suboptimal feedback control of TCP flows in computer network using random early discard (RED mechanism

    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.

  4. Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

    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

  5. Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

    Shi Guang-Xia

    2012-11-01

    Full Text Available Abstract Background Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the theory of traditional Chinese medicine, acupoints located on both the adjacent and distal area of the disease can be needled to treat disease. Furthermore, the way of combining acupoints is for strengthening the curative effect. We aim to evaluate the efficacy of acupuncture at local points in combination with distal points in subjective tinnitus patients. Method This trial is a randomized, single-blind, controlled study. A total of 112 participants will be randomly assigned to one of four treatment groups receiving acupuncture treatment for 4 weeks. The primary outcome measure is subjective tinnitus loudness and annoyance perception, which is graded using the Visual Analogue Scale (VAS. The assessment is at baseline (before treatment initiation, 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion Completion of this trial will help to identify whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN29230777

  6. Perioperative Continuous Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

    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

  7. Herbal medicines for Parkinson's disease: a systematic review of randomized controlled trials.

    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.

  8. The differential influences of positive affect, random reward, and performance-contingent reward on cognitive control.

    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

  9. Effect of Fruit Juice on Glucose Control and Insulin Sensitivity in Adults: A Meta-Analysis of 12 Randomized Controlled Trials

    Bin WANG; Liu, Kai; Mi, Mantian; Jian WANG

    2014-01-01

    Background Diabetes mellitus has become a worldwide health problem. Whether fruit juice is beneficial in glycemic control is still inconclusive. This study aimed to synthesize evidence from randomized controlled trials on fruit juice in relationship to glucose control and insulin sensitivity. Methods A strategic literature search of PubMed, EMBASE, and the Cochrane Library (updated to March, 2014) was performed to retrieve the randomized controlled trials that evaluated the effects of fruit j...

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

    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.

  11. Effect of visual biofeedback to acquire supraglottic swallow in healthy individuals: a randomized-controlled trial.

    Imada, Miho; Kagaya, Hitoshi; Ishiguro, Yuriko; Kato, Miho; Inamoto, Yoko; Tanaka, Takashi; Shibata, Seiko; Saitoh, Eiichi

    2016-06-01

    The aim of this study is to evaluate the effect of visual biofeedback therapy in acquiring supraglottic swallow (SGS) in a randomized-controlled trial with healthy individuals. Eighteen individuals (mean age, 26 years) who could not close or keep closed the vocal folds before and during the swallow in SGS were allocated randomly to either a visual biofeedback group (eight individuals) or a nonbiofeedback group (10 individuals). A videoendoscope was inserted intranasally and an SGS exercise, using 4 ml of green-colored water, was performed 30 times per day up to 5 days. When the participant failed to perform SGS, the result was provided only to the participants in the visual biofeedback group. The median length of time until acquiring SGS was 1.5 days in the visual biofeedback group and 3.5 days in the nonbiofeedback group (P=0.040). We concluded that visual biofeedback effectively enabled participants to acquire SGS earlier. PMID:26795716

  12. Controlling dispersion forces between small particles with artificially created random light fields

    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...

  13. Healing Touch with Guided Imagery for PTSD in returning active duty military: a randomized controlled trial.

    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

  14. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    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...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted of...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  15. Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial

    Hedayati-Hajikand, Trifa; Lundberg, Ulrika; Eldh, Catarina;

    2015-01-01

    .8 (p close to five. No differences were displayed between the groups concerning presence of visible plaque or bleeding-on-brushing. No side effects were reported. CONCLUSIONS: The results suggested that early......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...... healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test group were instructed to give their child one chewing tablet per day containing three strains of live probiotic...

  16. A Random-Walk Based Privacy-Preserving Access Control for Online Social Networks

    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.

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

    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

  18. Efficacy of a triclosan formula in controlling early subgingival biofilm formation: a randomized trial

    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.

  19. Multidisciplinary rehabilitation and steroids in the management of multiple sclerosis relapses: a randomized controlled trial

    Dackovic, Jelena; Tepavcevic, Darija Kisic; Basuroski, Irena Dujmovic; Mesaros, Sarlota; Pekmezovic, Tatjana; Drulovic, Jelena

    2015-01-01

    Introduction Periodic relapses are one of the main characteristics of multiple sclerosis (MS), from which recovery is often incomplete despite high-dose methylprednisolone (HDMP) treatment. The aim of our study was to evaluate the potential benefits of short-term HDMP combined with multidisciplinary rehabilitation (MDR) in persons with MS in relapse in order to assess whether combination of steroid therapy with MDR is more beneficial than steroid therapy alone. Material and methods This investigation was conducted as a randomized controlled trial. The MS patients were eligible if they had an established diagnosis and relapse requiring application of HDMP. Forty-nine patients were included in the study and randomized to control and treatment groups, and 37 completed the study. High-dose methylprednisolone was administered to all patients. The treatment group additionally underwent an MDR program over a 3-week period. All outcome measures were completed at baseline and 1 and 3 months later. Results The Expanded Disability Status Scale (EDSS) and Functional Independence Measure (FIM) motor scores improved statistically significantly 1 month after HDMP, in both treatment and control groups. During the study period, in the treatment group, a sustained large effect size (ES) was found for both physical and mental composite scores of Multiple Sclerosis Quality of Life-54 (MSQoL-54), while in the controls, a sustained moderate ES was demonstrated only for physical composite score. Conclusions Our findings suggest that MDR improves MS relapse outcome.

  20. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    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

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

    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.

  2. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    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.

  3. Effects of kettlebell training on postural coordination and jump performance: a randomized controlled trial.

    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

  4. Adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia: meta-analysis of randomized controlled trials.

    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.

  5. Evaluation of Co-Q10 anti-gingivitis effect on plaque induced gingivitis: A randomized controlled clinical trial

    Anirban Chatterjee; Abhishek Kandwal; Nidhi Singh; Amit Singh

    2012-01-01

    Background: Deficiency of Co-Q10 has been found to be responsible for periodontal destruction; therefore, this study was undertaken to evaluate the anti-gingivitis effect of Co-Q10 on plaque induced gingivitis. Materials and Methods: Thirty subjects with plaque induced gingivitis were enrolled in a split mouth randomized controlled trial. For each subject, scaling was randomly performed for any two quadrants, followed by the topical application of Co-Q10 randomly in a previously scaled and as...

  6. Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

    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.

  7. Sealing caries in primary molars: randomized control trial, 5-year results.

    Innes, N P T; Evans, D J P; Stirrups, D R

    2011-12-01

    The Hall Technique (HT) is a method for managing carious primary molars. Decay is sealed under pre-formed metal crowns without any caries removal, tooth preparation, or local anesthesia. The aim of this study was to compare HT clinical/radiographic failure rates with General Dental Practitioners' (GDPs) standard (control) restorations. We conducted a split-mouth, randomized control trial (132 children, aged 3-10 yrs, GDPs n = 17) in Scotland. There were 264 study teeth with initial lesions, 42% of which were radiographically > half-way into dentin, and 67% of which had Class II restorations. Teeth were randomized to HT (intervention) or GDPs' usual treatment (control). Annual clinical/radiographic follow-up data were recorded. Ninety-one patients (69%) had 48 months' minimum follow-up. At 60 months, 'Major' failures (irreversible pulpitis, loss of vitality, abscess, or unrestorable tooth) were recorded: HT, 3 (3%); control restorations, 15 (16.5%) (p = 0.000488; NNT 8); and 'Minor' failures (reversible pulpitis, restoration loss/wear/fracture; or secondary caries): HT, 4 (5%); control restorations, 38 (42%) (p < 0.000001; NNT 3). Overall, there were follow-up data for 130 patients (2-60 mos): 'Major' failures: HT, 3 (2%); control restorations, 22 (17%) (p = 0.000004; NNT 7); and 'Minor' failures, HT, 7 (5%); control restorations, 60 (46%) (p < 0.000001; NNT 3). Sealing in caries by the Hall Technique statistically, and clinically, significantly outperformed GDPs' standard restorations in the long term (Trial registration no. ISRCTN 47267892). PMID:21921249

  8. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    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

  9. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    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

  10. Can sedentary behavior be made more active? A randomized pilot study of TV commercial stepping versus walking

    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

  11. Interval-walking training for the treatment of type 2 diabetes: a randomized, controlled trial

    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......: 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...... [CGM]). Resultater: Training adherence was high (89 + 4%), and training energy expenditure and mean intensity were comparable between training groups. Nine and four of the subjects reported “Improved Health” in the IWT and CWT group, respectively. VO2max increased 16.1 + 3.7% in the IWT group (P<0...

  12. A stochastic control approach to Slotted-ALOHA random access protocol

    Pietrabissa, Antonio

    2013-12-01

    ALOHA random access protocols are distributed protocols based on transmission probabilities, that is, each node decides upon packet transmissions according to a transmission probability value. In the literature, ALOHA protocols are analysed by giving necessary and sufficient conditions for the stability of the queues of the node buffers under a control vector (whose elements are the transmission probabilities assigned to the nodes), given an arrival rate vector (whose elements represent the rates of the packets arriving in the node buffers). The innovation of this work is that, given an arrival rate vector, it computes the optimal control vector by defining and solving a stochastic control problem aimed at maximising the overall transmission efficiency, while keeping a grade of fairness among the nodes. Furthermore, a more general case in which the arrival rate vector changes in time is considered. The increased efficiency of the proposed solution with respect to the standard ALOHA approach is evaluated by means of numerical simulations.

  13. A randomized controlled trial of aquatic and land-based exercise in patients with knee osteoarthritis

    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...

  14. The prevention of depressive symptoms in rural school children: a randomized controlled trial.

    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

  15. Intravenous chemotherapy for resected gastric cancer: meta-analysis of randomized controlled trials

    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

  16. Use of remifentanil in comparison with sodium nitroprusside for controlled hypotension during rhinoplasty: Randomized controlled trail

    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.

  17. A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-01-01

    Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

  18. Effect of fish oil on heart rate in humans. A meta-analysis of randomized controlled trials

    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

  19. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    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)…

  20. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

    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.

  1. Effects of warm acupuncture on breast cancer–related chronic lymphedema: a randomized controlled trial

    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

  2. A randomized controlled trial on therapeutic efficacy and safety of No. 1 Decoction for common cold

    Xiao-rong HUO

    2012-12-01

    Full Text Available Objective  To assess therapeutic efficacy and safety of No. 1 Decoction for common cold in patients. Methods  A randomized controlled trial was conducted to study 225 male military officers and soldiers who were suffering from common cold, while 6 of them who showed positive results in the colloidal gold immunochromatography assay (GICA for detecting Flu A/ B or LP were excluded. The remaining 219 patients were randomly allocated either to receive No. 1 Decoction (study group, n=111 or Ganmao Qingre Keli (control group, n=108 for 3 days. Grading quantization form for symptoms of common cold were filled for all patients. Clinical response rate, significant response rate and complete cure rate were analyzed. Adverse events were also observed and recorded. Results  In this trial, 2 patients in test group and 1 in study group were lost in follow-up, 13 cases with incomplete data were excluded (5 in study group, 8 in control group. 219 patients were included in FAS set and SS set, and data of 203 cases were observed in the PP set. In FAS set, the study group had a higher clinical recovery rate and effective rate than the control group (14.41% vs12.96%, P=0.755; 72.97% vs64.81%, P=0.192, and had a lower significant effective rate than control group (36.94% vs43.52%, P=0.321. The 95% confidence interval for the difference between the effective rates of study group and control group was (–4.06%-20.38%, Δ=–10%, suggesting No.1 Decoction might be as effective as Ganmao Qingre Keli. The results of PP set were similar to that of FAS set. Conclusion  No. 1 Decoction is a safe and effective drug for common cold.

  3. Effect of early vitamin A supplementation on cell-mediated immunity in infants younger than 6 mo.

    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

  4. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    Cain Kevin C

    2004-07-01

    Full Text Available Abstract 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.

  5. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

    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.

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

    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.

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

    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.

  8. Do motion controllers make action video games less sedentary? A randomized experiment.

    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

  9. Effect of pre-treatment with chlorhexidine on the retention of restorations: a randomized controlled trial.

    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

  10. Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India

    Sujha Subramanian

    2009-03-01

    Full Text Available OBJECTIVE: To evaluate oral cancer screening by visual inspection. METHODS: A cluster randomized controlled trial was initiated in Trivandrum district, Kerala, India. Of 13 population clusters, seven were randomly allocated to three rounds of screening between 1996 and 2004, while standard care was provided in six (control arm. An activity-based approach was employed to calculate costs associated with various components of the screening trial. Information on the resources used and on clinical events in each trial arm was derived from trial databases. Total costs for each cluster were estimated in 2004 United States dollars (US$. The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals (i.e. tobacco or alcohol users. FINDINGS: The proportion of oral cancers detected at an early stage (i.e. stage I or II was higher in the intervention arm than the control arm (42% versus 24%, respectively. The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals. Oral cancer screening by visual inspection was performed for under US$ 6 per person. CONCLUSION: The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population. Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-resource setting.

  11. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial

    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.

  12. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    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

  13. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    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

  14. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial

    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.

  15. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    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

  16. Short-term effects of a randomized controlled worksite relaxation intervention in Greece

    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

  17. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials.

    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

  18. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial

    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

  19. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

    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.

  20. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    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.

  1. Kinetics of volatile fluoride desorption from granular sodium fluoride. Part II. Desorption of WF6, MoF6, and HF

    Desorption of tungsten hexafluoride, molybdenum hexafluoride and hydrogen fluoride sorbed on granulated sodium fluoride was studied in the temperature ranges 563-583 K, 463-483 K and 460-490 K respectively. It was ascertained that the process of WF6 and MoF6 desorption is limited by diffusion of the sorbate molecules from the bulk of sodium fluoride granules and it takes place in two stages. Chemical reaction of NaF · HF complex decomposition is the limiting stage of HF desorption. The values of apparent activation energy of WF6, MoF6 and HF desorption amounted to 95200 ± 2000 J/mol, 55000 ± 2500 J/mol and 88500 ± 1500 J/mol, respectively

  2. Infrared spectra of UF6, WF6, MoF6, and SF6 complexes with hydrogen fluoride in solid argon

    UF6, WF6, MoF6, and SF6 have been codeposited with hydrogen fluoride in excess argon at 12 K. The FTIR spectra of UF6 and HF revealed a strong UF6-HF complex absorption at 3,848 cm-1 along with a weak, broad band at 3,903 cm-1 due to the UF6-FH complex. Only one 1:2 complex with a UF6-HaF-HbF arrangement was detected at higher HF concentrations and sample annealings. Similarly, the HF interaction with tungsten hexafluoride formed two 1:1 complexes. However, the 3,884-cm-1 band due to the anti-hydrogen-bonded complex WF6-FH was considerably stronger than the WF6-FHb-FHa structure. The band positions and relative intensities for the MoF6 complexes with HF and DF were very comparable to their WF6 counterparts

  3. Molecular beam study of the reactions of K and Cs with UF6, WF6, MoF6, TeF6, and SeF6

    The reactions of K and Cs with UF6, WF6, MoF6, TeF6, SeF6, and SF6 at thermal energies have been investigated using crossed molecular beams. Except for SF6, these hexafluorides have remarkably high electron affinities. In fact, the electron affinities of MoF6, WF6, and UF6 exceed the ionization potentials of K and Cs so that spontaneous ion pair formation is energetically possible. In no case was a significant ion current observed. Instead, exchange reactions to form MF (and possibly MAF5) are observed. The measured product angular distributions were in all cases found to be consistent with the model of complex formation. However, substantial differences in the nature of the complex disintegration were noted

  4. Evaluation of HIP-plus-forged Ti--6Al--2Sn--4Zr--6Mo discs made from REP power preforms

    An investigation was undertaken to evaluate the forgeability, the structural characteristics, and the mechanical properties of Ti--6Al--2Sn--4Zr--6Mo disk forgings processed from rotating electrode process-hot isostatic pressing (REP-HIP) powder preforms. It was shown that the powder preforms exhibited excellent forgeability in both (α+β) and β ranges. Among various processing conditions examined, the as (α+β) forged powder preforms gave the best room temperature and high temperature tensile properties. However, the optimum combination of tensile properties, creep strength and stability, and fracture toughness was obtained for as β-forged disks. The results also demonstrated that the powder forgings are very sensitive to heat treatment, and the tensile ductility varies significantly with specimen orientation. Additional observations are made on the die-chilled surface layers in the β-processed forgings

  5. Fractional Nonablative 1540 nm Laser Resurfacing for Thermal Burn Scars: A Randomized Controlled Trial

    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 adve......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...... fractional laser treatments and (ii) no treatment. Blinded on-site response evaluations were performed 4 and 12 weeks after final treatment. Primary endpoints were change in skin texture (0-10 categorical scale), pain and adverse effects. Secondary endpoints were change in skin color and patient satisfaction...

  6. Prospective randomized controlled trial investigating the type of sutures used during hepatectomy

    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.

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

    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

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

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

    2010-01-01

    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 (±4.8) points in the omega-3 group compared to 0.3 (±7.2) points in the placebo group (p = 0.40; effect size = 0.38). Correlations were found between decreases in f...

  9. Quality of randomized controlled trials reporting in the treatment of melasma conducted in china

    Chen, Zhiwei; CHEN, YUCHI; Zeng, Jingchun; Wang, Yang; Ye, Teng; Zhou, Qiaochu; Du, Xiaojing; Su, Wenting; Ding, Zhishan

    2015-01-01

    Background There is no existing report on the quality of randomized controlled trials (RCTs) of melasma treatment currently conducted in China. This study aims to assess the quality of RCT- reporting in the treatment of melasma conducted in China. Methods Several databases were searched from their inception through to August 2014. In order to rate the report quality, we scored 1 for the item if it was reported in CONSORT 2010 and 0 for the item if it was not definitely stated or was not clear...

  10. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

    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...

  11. Saving and Empowering Young Lives in Europe (SEYLE: a randomized controlled trial

    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

  12. Qing-Yi decoction in participants with severe acute pancreatitis: a randomized controlled trial

    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...

  13. Inappropriate statistical method in a parallel-group randomized controlled trial results in unsubstantiated conclusions.

    Dimova, Rositsa B; Allison, David B

    2016-01-01

    The conclusions of Cassani et al. in the January 2015 issue of Nutrition Journal (doi: 10.1186/1475-2891-14-5 ) cannot be substantiated by the analysis reported nor by the data themselves. The authors ascribed the observed decrease in inflammatory markers to the components of flaxseed and based their conclusions on within-group comparisons made between the final and the baseline measurements separately in each arm of the randomized controlled trial. However, this is an improper approach and the conclusions of the paper are invalid. A correct analysis of the data shows no such effects. PMID:27265269

  14. Does Peer Use Influence Adoption of Efficient Cookstoves? Evidence from a Randomized Controlled Trial in Uganda

    Beltramo, Theresa; Blalock, Garrick; Levine, David; Simons, Andrew

    2014-01-01

    We examine the effect of peer usage on consumer demand for efficient cookstoves with a randomized controlled trial in rural Uganda. We testifthe neighbors of buyers who ordered and received a stove are more likely to purchase an efficient cookstove than the neighbors of buyers who ordered but have not yet received a stove. We find that neighbors of buyers who have experience with the stove are not detectably more likely to purchase a stove than neighbors of buyers who have not yet received th...

  15. Saving and Empowering Young Lives in Europe (SEYLE): a randomized controlled trial

    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

  16. Effectiveness of a Self-Guided Web-Based Cannabis Treatment Program: Randomized Controlled Trial

    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...

  17. Effects of Aerobic Exercise on Overweight Children’s Cognitive Functioning: A Randomized Controlled Trial

    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...

  18. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial

    ABBASKHANIAN, Ali; Sara EHTESHAMI; Sadegh SAJJADI; Mohammad Sadegh REZAI

    2012-01-01

    How to cite this article:Abbaskhanian A, Ehteshami S, Sajjadi S, Rezai MS. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial. Iran J Child Neurol Autumn 2012; 6(4): 9-15. Abstarct:Objective Breath holding spells (BHS) are common paroxysmal non-epileptic eventsin the pediatric population which are very stressfull despite their harmlessnature. There has been no specific treatment found for the spells yet. The aimof this study was to evaluate the...

  19. Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

    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...

  20. A randomized controlled trial of Minnesota day clinic treatment of alcoholics

    Grønbaek, Morten; Nielsen, Bent

    2007-01-01

    AIM: To compare the Minnesota day clinic treatment with the traditional public psychosocial treatment. DESIGN: Randomized controlled trial. SETTING: Public out-patient alcohol clinic and privately funded Minnesota day clinic in Denmark. PARTICIPANTS: A total of 148 individuals with alcohol...... dependence were included in a 1-year clinical trial. MEASUREMENTS: Self-reported drinking pattern and the seven composite scores from the addiction severity index (ASI). FINDINGS: A total of 42 (57%) and 45 (61%) patients (P > 0.05) completed the Minnesota treatment and public treatment, respectively...

  1. Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial

    Bernhard, Molly C.; Li, Peng; Allison, David B.; Gohlke, Julia M.

    2015-01-01

    Background We hypothesized that exposure to temperatures above the thermoneutral zone (TNZ) would decrease food intake in young adults in a sedentary office environment over a 2-h period. Methods Participants wearing standardized clothing were randomized to perform routine office work in the TNZ, considered control (19–20°C), or above the TNZ considered warmer (26–27°C) using a parallel-group design (n = 11 and 9, respectively). Thermal images of the inner canthus of their eye and ...

  2. Exercise Effects on Depressive Symptoms and Self-Worth in Overweight Children: A Randomized Controlled Trial*

    Petty, Karen H.; Davis, Catherine L.; Tkacz, Joseph; Young-Hyman, Deborah; Waller, Jennifer L.

    2009-01-01

    Objective To test the dose–response effects of an exercise program on depressive symptoms and self-worth in children. Method Overweight, sedentary children (N = 207, 7–11 years, 58% male, 59% Black) were randomly assigned to low or high dose (20 or 40 min/day) aerobic exercise programs (13 ± 1.6 weeks), or control group. Children completed the Reynolds Child Depression Scale and Self-Perception Profile for Children at baseline and posttest. Results A dose–response benefit of exercise was dete...

  3. Aspirin, Calcitriol, and Calcium Do Not Prevent Adenoma Recurrence in a Randomized Controlled Trial

    Pommergaard, Hans Christian; Burcharth, Jakob; Rosenberg, Jacob;

    2016-01-01

    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, and...... current smokers OR, 1.70; 95% CI, 0.70-4.09; P value interaction < .05). However, the overall interaction was not significant. CONCLUSIONS: In a prospective study, the combination of calcitriol, aspirin, and calcium carbonate did not prevent recurrence of colorectal adenomas over a 3-year period. The...

  4. Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial

    Andresen, Sven Robert; Bing, Jette; Hansen, Rikke Bod Middelhede;

    2015-01-01

    Introduction  Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA) is a fatty acid that isproduced in many cells in the body, and it is thought to potentiate endocannabinoids. PEA is suggested to reduce pain and inflammation but....... 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...

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

    Becker, Stéphanie J.E.; Thierry Guitton; David Ring

    2014-01-01

    Background:  The primary aim of this study was to determine predictors of missed research appointments in a prospective  andomized placebo injection-controlled trial with evaluations 1 to 3 and 5 to 8 months after enrollment.   Methods:  This study represents a secondary use of data from 104 patients that were enrolled in a prospective randomized  ontrolled trial of dexamethasone versus lidocaine (placebo) injection for various diagnoses. Patients were enrolled between June 2003 and ...

  6. A pilot randomized controlled trial comparing prenatal yoga to perinatal health education for antenatal depression.

    Uebelacker, Lisa A; Battle, Cynthia L; Sutton, Kaeli A; Magee, Susanna R; Miller, Ivan W

    2016-06-01

    We conducted a pilot randomized controlled trial (RCT) comparing a prenatal yoga intervention to perinatal-focused health education in pregnant women with depression. Findings document acceptability and feasibility of the yoga intervention: no yoga-related injuries were observed, instructors showed fidelity to the yoga manual, and women rated interventions as acceptable. Although improvements in depression were not statistically different between groups, they favored yoga. This study provides support for a larger scale RCT examining prenatal yoga to improve mood during pregnancy. PMID:26385456

  7. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    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

  8. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

    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.

  9. Computer decision support software safely improves glycemic control in the burn intensive care unit: a randomized controlled clinical study

    Mann, Elizabeth A.; Jones, John A.; Wolf, Steven E.; Wade, Charles E.

    2011-01-01

    Objective The optimal method for glycemic control in the critically burned patient is unknown. The purpose of this randomized controlled study was to determine the safety and efficacy of computer decision support software (CDSS) to control serum glucose concentration in a burn intensive care unit. Methods Eighteen adult burn/trauma patients receiving continuous insulin infusion were initially randomized to receive glucose management via a traditional paper-based protocol (PP) or a computer protocol (CP) for 72 hours, then crossed over to the alternate method for an additional 72 hours. Results Time in target glucose range (80-110 mg/dl) was higher in the CP group (47 ± 17% versus 41 ± 16.6%; p ≤ 0.05); time over target range was not significantly reduced in the CP group (49 ± 17.8% versus 54 ± 17.1; p = 0.08); and no difference was noted in time under target range of 80 mg/dl (CP 4.5 ± 2.8, PP 4.8 ± 3.3%; p = 0.8), under 60 mg/dl (p = 0.7), and under 40 mg/dl (p = 1.0). Severe hypoglycemic events (< 40 mg/dl) did not differ from the CP group compared to historical controls for patients receiving no insulin (p = 0.6). More glucose measurements were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions Glycemic control using CDSS is safe and effective for the critically burned patient. Time in target range improved without increase in hypoglycemic events. CDSS enhanced consistency in practice, providing standardization among nursing staff. PMID:21240001

  10. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    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

  11. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

    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.

  12. EEG Neurofeedback treatments in children with ADHD: An updated meta-analysis of Randomized Controlled Trials

    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.

  13. Effect of Telephone-Based Support on Postpartum Depression: A Randomized Controlled Trial

    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.

  14. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

    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

  15. Treatment of brain metastases: Review of phase III randomized controlled trials

    The optimal management of brain metastases remains controversial. Both whole brain radiotherapy (WBRT) and local treatment [surgery (S) or radiosurgery (RS)] are the cornerstones of treatment. The role of systemic therapy is also being explored. Randomized controlled trials (RCT) have tried to assess the individual and combined effects of different therapeutic strategies. (1) RCT in oligometastatic patients: WBRT alone vs. local treatment + WBRT. Combined treatment may improve both overall survival and local control in patients with a single metastasis, but it also leads to a local control benefit in patients with two to four lesions. Exclusive local treatment vs. WBRT plus local treatment. The addition of WBRT to local treatment may result in improved local control, improved freedom from new brain metastases and improved overall brain control. S + WBRT vs. RS + WBRT. There is no evidence of superiority of a combined treatment over the other one. (2) RCT addressing the point of improving WBRT outcome: differences in WBRT fractionation do not significantly alter outcome of treatments. Only a few systemic drugs may cause some significant advantages. (3) RCT that assessed neurocognitive impairment and quality of life: the baseline cognitive performance of most patients is significantly impaired. Intracranial tumor control is an essential factor in stabilizing neurocognitive function. The data on neurocognitive toxicity related to WBRT are still contradictory. Impairment of both neurocognitive function and quality of life of patients with brain metastases needs to be further addressed in RCT.

  16. Randomized pilot study to disseminate caries-control services in dentist offices

    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.

  17. A Pilot Randomized Controlled Trial of Brief Cognitive-Behavioral Therapy for Anxiety in Patients with Terminal Cancer

    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.

  18. Implementing Randomized Controlled Trials in Preschool Settings That Include Young Children with Disabilities: Considering the Context of Strain and Bovey

    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.

  19. Effect of Chromium Supplementation on Glucose Metabolism and Lipids: A Systematic Review with Meta-Analysis of Randomized Controlled Trials

    Objective. A systematic review of the effect of chromium supplementation on glucose metabolism and lipid levels. Research Design and Methods. Literature search conducted in MEDLINE and Commonwealth Agricultural Bureau. Eligible studies were English language randomized controlled trials of chromium ...

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

    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

  1. Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial

    Fariba Jaffary

    2015-01-01

    Full Text Available Background: The pathogenesis of atopic dermatitis (AD remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. Materials and Methods: This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-to-moderate AD, based on the Hanifin and Rajka diagnostic criteria. The patients were randomly selected from teaching skin clinics in Isfahan, Iran. They were randomly assigned to two groups of equal number, receiving vitamin E (400 IU/day and placebo for four 4 months. Each month, the extent, severity, and subjective symptoms including itch and sleeplessness were measured by SCORAD index. Three months after the end of intervention, the recurrence rate was assessed. Results: The improvement in all symptoms, except sleeplessness, was significantly higher in the group receiving vitamin E than in controls (-1.5 vs. 0.218 in itching, -10.85 vs. -3.54 in extent of lesion, and -11.12 vs. -3.89 in SCORAD index, respectively, P 0.05. Conclusion: This study suggests that vitamin E can improve the symptoms and the quality of life in patients with AD. As vitamin E has no side effects with a dosage of 400 IU/day, it can be recommended for the treatment of AD.

  2. Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial

    Mamtani Manju

    2009-05-01

    Full Text Available Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl, zinc (Zn only, and zinc and copper (Zn+Cu together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383.

  3. Safety data from randomized controlled trials: applying models for recurrent events.

    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

  4. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

    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.

  5. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    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

  6. Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol

    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

  7. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    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. PMID:26764156

  8. Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

    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

  9. Auricular Acupressure for Managing Postoperative Pain and Knee Motion in Patients with Total Knee Replacement: A Randomized Sham Control Study

    Ling-hua Chang; Chung-Hua Hsu; Gwo-Ping Jong; Shungtai Ho; Shiow-luan Tsay; Kuan-Chia Lin

    2012-01-01

    Background. Postoperative pain management remains a significant challenge for all healthcare providers. A randomized controlled trial was conducted to examine the adjuvant effects of auricular acupressure on relieving postoperative pain and improving the passive range of motion in patients with total knee replacement (TKR). Method. Sixty-two patients who had undergone a TKR were randomly assigned to the acupressure group and the sham control group. The intervention was delivered three times a...

  10. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study

    Teughels, Wim; Durukan, Andaç; Ozcelik, Onur; Pauwels, Martine; Quirynen, Marc; Haytac, Mehmet Cenk

    2013-01-01

    Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol 2013; 40: 1025–1035. doi: 10.1111/jcpe.12155. AimThe aim of this randomized placebo-controlled clinical trial was to evaluate the effects of Lactobacillus reuteri-containing probiotic lozenges as an adjunct to scaling and root planing (SRP). Material and ...

  11. Dietary Soy Supplement on Fibromyalgia Symptoms: A Randomized, Double-Blind, Placebo-Controlled, Early Phase Trial

    Wahner-Roedler, Dietlind L; Thompson, Jeffrey M; Luedtke, Connie A; King, Susan M.; Cha, Stephen s; Elkin, Peter L.; Barbara K. Bruce; Townsend, Cynthia O.; Bergeson, Jody R.; Eickhoff, Andrea L.; Laura L. Loehrer; Amit Sood; Bauer, Brent A.

    2011-01-01

    Most patients with fibromyalgia use complementary and alternative medicine (CAM). Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein) shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemio...

  12. The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial

    Vizza, Lisa; Smith, Caroline A.; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S.

    2016-01-01

    Background To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Methods Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and com...

  13. The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults 1 2

    Chowdhury, Enhad A.; Richardson, Judith D; Holman, Geoffrey D; Tsintzas, Kostas; Thompson, Dylan; Betts, James A

    2016-01-01

    Background: The causal nature of associations between breakfast and health remain unclear in obese individuals. Objective: We sought to conduct a randomized controlled trial to examine causal links between breakfast habits and components of energy balance in free-living obese humans. Design: The Bath Breakfast Project is a randomized controlled trial with repeated measures at baseline and follow-up among a cohort in South West England aged 21–60 y with dual-energy X-ray absorptiometry–derived...

  14. Exercise during pregnancy reduces the rate of cesarean and instrumental deliveries: results of a randomized controlled trial

    Barakat Carballo, Ruben; Peláez Puente, Mireia; Coteron Lopez, Francisco Javier

    2012-01-01

    Objective: In this study, the authors assessed the effects of a structured, moderate-intensity exercise program during the entire length of pregnancy on a woman’s method of delivery. Methods: A randomized controlled trial was conducted with 290 healthy pregnant Caucasian (Spanish) women with a singleton gestation who were randomly assigned to either an exercise (n=138) or a control (n=152) group. Pregnancy outcomes, including the type of delivery, were measured at the end ...

  15. Effect of Hibiscus sabdariffa Calices on Dyslipidemia in Obese Adolescents: A Triple-masked Randomized Controlled Trial

    Sabzghabaee, Ali Mohammad; Ataei, Ehsan; Kelishadi, Roya; Ghannadi, Alireza; Soltani, Rasool; Badri, Shirinsadat; Shirani, Shahin

    2013-01-01

    Conflict of interest: none declared. Objective We aimed to evaluate the effects of Hibiscus sabdariffa (HS) calices on controlling dyslipidemia in obese adolescents. Methodology In this triple blind randomized placebo-controlled clinical trial which was registered in the Iranian registry for clinical trials (IRCT201109122306N2), 90 obese adolescents aged 12-18 years with documented dyslipidemia were randomly assigned in two groups of cases who received 2 grams of fine powdered calices of Hibi...

  16. Resistance training does not have an effect on cognition or related serum biomarkers in nonagenarians: a randomized controlled trial

    Ruiz, Jonatan R.; Gil Bea, Francisco; Bustamante-Ara, Natalia; Rodríguez Romo, Gabriel; Fiuza Luces, María del Carmen; Serra-Rexach, José A.; Cedazo-Mínguez, Ángel; Lucía Mulas, Alejandro

    2015-01-01

    The aim of this randomized controlled trial was to determine the effects of 8-week exercise-intervention on cognition and related serum biochemical markers in nonagenarians. We also studied the effects of a 4-week training cessation ('detraining') period on our study variables. Participants were randomly allocated to a standard-care (control) or intervention (exercise) group [n=20 (16 women)/group]. The intervention focused on supervised, light-to-moderate-intensity aerobic and resistance exe...

  17. Effect of green tea consumption on blood pressure: A meta-analysis of 13 randomized controlled trials

    Xiaoli Peng; Rui Zhou; Bin Wang; Xiaoping Yu; Xiaohong Yang; Kai Liu; Mantian Mi

    2014-01-01

    The studies investigating the effects of green tea on blood pressure (BP) have generated inconsistent results. The aim of this study is to quantitatively evaluate the effects of green tea on BP control. PubMed, Embase, and the Cochrane Library (updated to March 2014) were searched for randomized controlled trials evaluating the effects of green tea on BP. Pooled effect of green tea consumption on BP was evaluated using fixed-effects or random-effects model. Thirteen trials comprising a total ...

  18. Do Functional Keratin Dressings Accelerate Epithelialization in Human Partial Thickness Wounds? A Randomized Controlled Trial on Skin Graft Donor Sites

    Davidson, Andrew; Jina, N. Hamesh; Marsh, Clive; Than, Martin; Simcock, Jeremy W.

    2013-01-01

    Objective: To determine if the experimental (keratin-based) dressing accelerates epithelialization rates during healing of partial-thickness wounds, relative to a Standard Care dressing. Method: A randomized control trial was conducted using a Standard Care dressing side by side with the experimental dressing on a sample (n=26) of partial-thickness donor site wounds. The proximal/distal placement of the control and treatment was randomized. Percentage epithelialization after approximately 7 d...

  19. A randomized, placebo-controlled trial to determine the course of aminotransferase elevation during prolonged acetaminophen administration

    Heard, Kennon; Green, Jody L; Anderson, Victoria; Bucher-Bartelson, Becki; Dart, Richard C.

    2014-01-01

    Background Acetaminophen administration for more than 4 days causes aminotransferase elevation in some subjects. The objective of this randomized, placebo-controlled trial is to describe the course of alanine aminotransferase (ALT) elevation in subjects administered 4 g/day of acetaminophen for at least 16 days. Methods A randomized, placebo controlled trial of acetaminophen (4 g/day) vs placebo. Subjects were healthy volunteers with normal liver enzymes. The primary outcome was the course of...

  20. One Year Effects of a Workplace Integrated Care Intervention for Workers with Rheumatoid Arthritis: Results of a Randomized Controlled Trial

    Boot, C.R.L.; Twisk, J.W.R.; Steenbeek, R.; Voskuyl, A E; Schaardenburg. D. van; Anema, J.R.

    2016-01-01

    Purpose To evaluate the effectiveness of a workplace integrated care intervention on at-work productivity loss in workers with rheumatoid arthritis (RA) compared to usual care. Methods In this randomized controlled trial, 150 workers with RA were randomized into either the intervention or control group. The intervention group received an integrated care and participatory workplace intervention. Outcome measures were the Work Limitations Questionnaire, Work Instability Scale for RA, pain, fati...

  1. The effectiveness of using misoprostol with and without letrozole for successful medical abortion: A randomized placebo-controlled clinical trial

    Elham Naghshineh; Zahra Allame; Faezah Farhat

    2015-01-01

    Background: In developing countries it is important to the exploration of available and safe regimens for medical abortion. The present study was designed to assess the effect of letrozole compared to placebo pretreatment followed by sublingual misoprostol for therapeutic abortion in eligible women with gestational age less than 17 weeks. Materials and Methods: In this randomized control trail, 130 women eligible for legal abortions were randomly divided into two groups of case and controls. ...

  2. Guided internet-delivered cognitive behavior therapy for post-traumatic stress disorder: A randomized controlled trial

    David Ivarsson; Marie Blom; Hugo Hesser; Per Carlbring; Pia Enderby; Rebecca Nordberg; Gerhard Andersson

    2014-01-01

    The aim of this randomized controlled trial was to investigate the effects of guided internet-based cognitive behavior therapy (ICBT) for posttraumatic stress disorder (PTSD). Sixty-two participants with chronic PTSD, as assessed by the Clinician-administered PTSD Scale, were recruited via nationwide advertising and randomized to either treatment (n= 31) or delayed treatment attention control (n= 31). The ICBT treatment consisted of 8 weekly text-based modules containing psychoeducation, brea...

  3. Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up.

    Lyonne N L Zonneveld

    Full Text Available BACKGROUND: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. METHODOLOGY/PRINCIPAL FINDINGS: The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002, but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01, emotional (Cohen's d = 0.44;p = 0.01, and social (Cohen's d = 0.36;p = 0.01 functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p =

  4. Topical Tacrolimus versus Hydrocortisone on Atopic Dermatitis in Paediatric Patients: A Randomized Controlled Trial.

    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

  5. Just-in-time information improved decision-making in primary care: a randomized controlled trial.

    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. Is DBM Beneficial for the Enhancement of Bony Consolidation in Distraction Osteogenesis? A Randomized Controlled Trial

    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.

  7. Long-Term Propranolol Use in Severely Burned Pediatric Patients: A Randomized Controlled Study

    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

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

    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.

  9. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    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.

  10. Merocel versus Nasopore for nasal packing: a meta-analysis of randomized controlled trials.

    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.

  11. Functional electrical stimulation therapy for grasping in traumatic incomplete spinal cord injury: randomized control trial.

    Kapadia, Naaz M; Zivanovic, Vera; Furlan, Julio C; Craven, B Cathy; McGillivray, Colleen; Popovic, Milos R

    2011-03-01

    The purpose of this single-site randomized control trial was to assess the short-term and long-term efficacy of functional electrical stimulation (FES) therapy over conventional occupational therapy in improving voluntary hand function in incomplete C4-C7 spinal cord injury individuals. All 22 participants recruited in this randomized control trial received treatment for both the left and right upper extremities. Every participant, irrespective of group allocation, received one dose (60 min per day, 5 days per week for the duration of 8 weeks) of conventional occupational therapy for hand function. Of the 22 participants, 12 individuals received an additional dose of conventional occupational therapy, while the remaining 10 participants received a dose of FES hand therapy. The primary outcome measure was Functional Independence Measure (FIM) self-care subscore. The secondary outcome measures were Spinal Cord Independence Measure (SCIM) self-care subscore and Toronto Rehabilitation Institute Hand Function Test (TRI-HFT). The participants who received FES therapy showed significantly greater improvements in hand function at discharge, and were able to maintain their gains at long-term follow-up as assessed using FIM self-care subscore, SCIM self-care subscore, and TRI-HFT. The FES therapy effectively increased independence and thereby improved quality of life of individuals with tetraplegia when compared with conventional occupational therapy. PMID:21401662

  12. Adjunctive mirror exposure for eating disorders: a randomized controlled pilot study.

    Hildebrandt, Tom; Loeb, Katharine; Troupe, Sara; Delinsky, Sherrie

    2012-12-01

    Mirror exposure therapy has proven efficacious in improving body image among individuals with shape/weight concerns and eating disorders. No randomized controlled trials have examined the effect of mirror exposure in a healthy-weight clinical sample of eating disordered individuals. The purpose of the current study was to test the efficacy of a five-session acceptance based mirror exposure therapy (A-MET) versus a non directive body image therapy (ND) control as an adjunctive treatment to outpatient eating disorder treatment. Thirty-three males and females aged 14-65 with a body mass index of 18.5-29.9 were randomized to five sessions of A-MET or ND with a 1-month follow-up. Results indicated large to moderate effect size differences for efficacy of A-MET across measures of body checking, body image dissatisfaction, and eating disorder symptoms (d = -0.38 to -1.61) at end of treatment and follow-up. Baseline measures of social comparison and history of appearance-related teasing were predictive of treatment response. There were also differential effects of treatment on participants' perceived homework quality, but no differences in therapeutic alliance. Results suggest that A-MET is a promising adjunctive treatment for residual body image disturbance among normal and overweight individuals undergoing treatment for an eating disorder. Future research and clinical implications are discussed. PMID:23089085

  13. Effect of Mozart music on heel prick pain in preterm infants: a pilot randomized controlled trial

    Cristina Cavaiuolo

    2015-02-01

    Full Text Available Objective: The aim of this pilot study was to determine the effect of music by Mozart on heel prick procedural pain in premature infants.Background: Painful procedures are routinely performed in the setting of neonatal intensive care unit (NICU. Pain may exert short- and long-term deleterious effects on premature babies. Many non-pharmacological interventions have been proven efficacious for blunting neonatal pain.Study design: Randomized, controlled trial.Methods: The study was carried out in the NICU of the “G. Rummo” Hospital in Benevento, Italy. The sample consisted of 42 preterm infants, with no hearing loss or significant cerebral lesions on cranial ultrasound. They were randomized to receive heel lance during a music condition or a no-music control condition. We set strict criteria for selecting and delivering the music. Baseline and postprocedural heart rate and transcutaneous oxygen saturation were manually recorded. The Premature Infant Pain Profile (PIPP score was used to measure the behavioral response to prick. An unpaired t-test was performed for the intergroup comparisons.Results: There were significant differences between groups on heart rate increase, oxygen saturation reduction and PIPP score following the procedure.Conclusions: Listening to Mozart music during heel prick is a simple and inexpensive tool for pain alleviating in preterm stable neonates.

  14. Pregnancy rates among juvenile justice girls in two randomized controlled trials of multidimensional treatment foster care.

    Kerr, David C R; Leve, Leslie D; Chamberlain, Patricia

    2009-06-01

    Preventing adolescent pregnancy is a national research priority that has had limited success. In the present study, the authors examined whether Multidimensional Treatment Foster Care (MTFC) relative to intervention services as usual (group care [GC]) decreased pregnancy rates among juvenile justice girls mandated to out-of-home care. Girls (13-17 years of age) with histories of criminal referrals (Mdn = 10) were randomly assigned to MTFC (n = 81) or GC (n = 85) as part of 2 randomized controlled trials. Pregnancy histories were assessed from baseline through 24 months. Fewer postbaseline pregnancies were reported for MTFC girls (26.9%) than for GC girls (46.9%)--an effect that remained significant after controlling for baseline criminal referrals, pregnancy history, and sexual activity. MTFC has previously been shown to decrease arrest and lock-up rates. The present findings support the long-term preventive effects of MTFC on adolescent girls' pregnancy rates. Findings are consistent with the notion that programs that target delinquency by impacting general risk behavior pathways and contexts may more successfully prevent teen pregnancy than those that directly target sexual behaviors. PMID:19485598

  15. Immunomodulatory effects of kimchi in chinese healthy college students: a randomized controlled trial.

    Lee, Hansongyi; Kim, Do Yeon; Lee, Mi Ae; Jang, Ja-Young; Choue, Ryowon

    2014-07-01

    This study examined the potential immunomodulatory effects of Kimchi, a traditional fermented Korean vegetable, in healthy Chinese college students. The four-week clinical-trial (randomized, open-label, prospective, controlled) was followed by a one week wash-out period. Healthy Chinese college students (over 20 years of age with a body mass index of 18.5-23.0 kg/m(2)) volunteered for this study. Forty-three students were randomly classified into two groups, Kimchi (n = 21, supplemented with 100 g of Kimchi per day) or non-Kimchi (n = 22, supplemented with 100 g of radish per day, control) groups. During the four-week intervention period, students were asked to maintain their usual diet and activity, and instructed not to take any medications, functional food products, or dietary supplements. Anthropometrics, nutritional intake, and blood immune parameters (lymphocyte subsets, cytokines, and immunoglobulins) were measured before and after the four weeks of intervention. Thirty-nine students (19 in the Kimchi group, 20 in the non-Kimchi group) finished the study. After the intervention, no significant changes were observed in lymphocyte subsets (T-cell, B-cell, NK cell), pro-inflammatory cytokines (IL-6, TNF-α), anti-inflammatory cytokines (IL-4 and IL-10), and immunoglobulins (Ig A, G, and M) between groups in either the Kimchi or non-Kimchi. These results suggest that the short-term consumption of Kimchi has no immunomodulatory effects in healthy Chinese college students. PMID:25136537

  16. High-dose antioxidants for central serous chorioretinopathy; The randomized placebo-controlled study

    Ratanasukon Mansing

    2012-07-01

    Full Text Available Abstract Background To determine the efficacy of high-dose antioxidants in the acute stage of central serous chorioretinopathy (CSC. Methods This was a randomized placebo-controlled study. The patients with acute CSC (onset within 6 weeks were randomized to receive either high-dose antioxidant tablets (study group A or placebo tablets (control group B for 3 months or until the complete resolution of subretinal fluid. After 3 months, additional treatment with laser or photodynamic therapy (PDT was considered if any fluorescein leakage persisted. The outcomes measured were the changes in visual acuity (VA and central macular thickness (CMT, the number of patients with subretinal fluid at each follow-up time, the number of patients with fluorescein leakage at the end of the 3rd month and patients who received additional treatments. Results Fifty-one of 58 patients (88% completed the follow-up criteria. The baseline demographic data were comparable in both groups. At the end of the 3rd month, the VA and CMT showed no statistical difference between the groups but the patients in group A has less fluorescein leakage and additional treatments than in group B (p = 0.027 and 0.03. Conclusion The high-dose antioxidants for acute CSC did not show any benefits in VA and CMT. However, the drugs might decrease the chance for fluorescein leakage and additional treatments at the end of the 3rd month.

  17. Arginine and antioxidant supplement on performance in elderly male cyclists: a randomized controlled trial

    Carpenter Catherine L

    2010-03-01

    Full Text Available Abstract Background Human exercise capacity declines with advancing age. These changes often result in loss of physical fitness and more rapid senescence. Nitric oxide (NO has been implicated in improvement of exercise capacity through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as well as via independent mechanisms. Antioxidants may prevent nitric oxide inactivation by oxygen free radicals. The purpose of this study was to investigate the effects of an L-arginine and antioxidant supplement on exercise performance in elderly male cyclists. Methods This was a two-arm prospectively randomized double-blinded and placebo-controlled trial. Sixteen male cyclists were randomized to receive either a proprietary supplement (Niteworks®, Herbalife International Inc., Century City, CA or a placebo powder. Exercise parameters were assessed by maximal incremental exercise testing performed on a stationary cycle ergometer using breath-by-breath analysis at baseline, week one and week three. Results There was no difference between baseline exercise parameters. In the supplemented group, anaerobic threshold increased by 16.7% (2.38 ± 0.18 L/min, p 2 max between control and intervention groups at either week 1 or week 3 by comparison to baseline. Conclusion An arginine and antioxidant-containing supplement increased the anaerobic threshold at both week one and week three in elderly cyclists. No effect on VO2 max was observed. This study indicated a potential role of L-arginine and antioxidant supplementation in improving exercise performance in elderly.

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

    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. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    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

  20. Comparison of Ondansetron and Meperidine for Treatment of Postoperative Shivering: A Randomized Controlled Clinical Trial

    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