WorldWideScience

Sample records for centre randomized controlled

  1. Improving hand hygiene compliance in child daycare centres: a randomized controlled trial.

    Science.gov (United States)

    Zomer, T P; Erasmus, V; Looman, C W; VAN Beeck, E F; Tjon-A-Tsien, A; Richardus, J H; Voeten, H A C M

    2016-09-01

    Gastrointestinal and respiratory infections in children attending daycare centres (DCCs) are common and compliance with hand hygiene (HH) guidelines to prevent infections is generally low. An intervention was developed to increase HH compliance and reduce infections in DCCs. The objective of this paper was to evaluate the effectiveness of this intervention on HH compliance. The intervention was evaluated in a two-arm cluster randomized controlled trial in 71 DCCs in The Netherlands. Thirty-six DCCs received the intervention including: (1) HH products; (2) training about HH guidelines; (3) two team training sessions aimed at goal setting and formulating HH improvement activities; and (4) reminders and cues for action (posters/stickers). Intervention DCCs were compared to 35 control DCCs that continued usual practice. HH compliance of caregivers and children was observed at baseline and at 1, 3 and 6 months follow-up. Using multilevel logistic regression, odds ratios (ORs) with 95% confidence intervals (CIs) were obtained for the intervention effect. Of 795 caregivers, 5042 HH opportunities for caregivers and 5606 opportunities for supervising children's HH were observed. At 1 month follow-up caregivers' compliance in intervention DCCs was 66% vs. 43% in control DCCs (OR 6·33, 95% CI 3·71-10·80), and at 6 months 59% vs. 44% (OR 4·13, 95% CI 2·33-7·32). No effect of the intervention was found on supervising children's HH (36% vs. 32%; OR 0·64, 95% CI 0·18-2·33). In conclusion, HH compliance of caregivers increased due to the intervention, therefore dissemination of the intervention can be considered. PMID:27193613

  2. Splinting after contracture release for Dupuytren's contracture (SCoRD: protocol of a pragmatic, multi-centre, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chojnowski Adrian J

    2008-04-01

    Full Text Available Abstract Background Splinting as part of the overall post-surgical management of patients after release of Dupuytren's contracture has been widely reported, though there is variation in practice and criteria for using it. The evidence on its effectiveness is sparse, of poor quality and contradictory with studies reporting negative and positive effects. Methods/Design A multi-centre, pragmatic, randomized, controlled trial is being conducted to evaluate the effect of static night splinting for six months on hand function, range of movement, patient satisfaction and recurrence at 1 year after fasciectomy or dermofasciectomy. Using a centrally administered computer randomization system consented patients will be allocated to one of two groups: i splint group who will be given a static splint at approximately 10 to 14 days after surgery to be worn for 6 months at night time only as well as hand therapy; ii non-splint group, who will receive hand therapy only. The primary outcome measure is the patient-reported Disabilities of the Arm, Hand and Shoulder Questionnaire (DASH. Secondary outcomes are total active flexion and extension of fingers, patient satisfaction and recurrence of contracture. Outcome measures will be collected prior to surgery, 3 months, 6 months and 1 year after surgery. Using the DASH as the primary outcome measure, where a difference of 15 points is considered to be a clinically important difference a total of 51 patients will be needed in each group for a power of 90%. An intention-to-treat analysis will be used. Discussion This pragmatic randomized controlled trial will provide much needed evidence on the clinical effectiveness of post-operative night splinting in patients who have undergone fasciectomy or dermofasciectomy for Dupuytren's contracture of the hand. Trial Registration Current Controlled Trials ISRCTN 57079614

  3. Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peerbooms Joost C

    2010-04-01

    Full Text Available Abstract Background If conservative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the attachment of the fascia to the os calcis might induce a healing rate. Methods and design A randomized controlled multi centre trial will be performed. The study population consists of 120 patients of 18 years and older. Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. Data will be collected before the procedure, 4,8,12,26 weeks and 1 year after the procedure. The main outcome measures of this study are pain and function measured with questionnaires. Conclusion Recent literature show positive effects for the treatment of tendinosis with autologous platelet injections. The forthcoming trial will compare treatment for chronic plantar fasciitis with a steroid injection versus an autologous platelet injection. Our results will be published as soon as they become available. Trial Registration Trial registration number: http://www.clinicaltrials.gov NCT00758641.

  4. The study protocol for a randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS to reduce respiratory illness in Indigenous infants

    Directory of Open Access Journals (Sweden)

    Segan Catherine

    2010-03-01

    Full Text Available Abstract Background Acute respiratory illness (ARI is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ. Environmental tobacco smoke (ETS from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Māori. Methods/Design This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program. Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants. Discussion Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of

  5. Council celebrates CERN Control Centre

    CERN Multimedia

    2006-01-01

    With the unveiling of its new sign, the CERN Control Centre was officially inaugurated on Thursday 16 March. To celebrate its startup, CERN Council members visited the sleek centre, a futuristic-looking room filled with a multitude of monitoring screens.

  6. EFFECTIVENESS OF BETA-GLUCAN COLLAGEN FOR TREATMENT OF PARTIAL THICKNESS BURNS IN PEDIATRIC AGE GROUP PATIENTS: A RANDOMIZED CONTROLLED TRIAL AT TERTIARY CARE CENTRE

    Directory of Open Access Journals (Sweden)

    Sanjay

    2014-12-01

    Full Text Available SUMMARY: BACKGROUND: Burn injuries present a major public health problem for children. In India this constitutes about one-fourth of total burn injuries. This article deals with situations that need to be addressed in the care of partial thickness wounds in children to provide optimal conditions for wound protection and repair while minimizing the morbidity and complications. AIM: To compare outcomes for pediatric age group patients who were applied beta-glucan collagen or anti-microbial dressing as primary wound covering in respect to pain, infection rate and healing time. DESIGN OF STUDY: Randomized controlled trial. SETTINGS AND DESIGN: Tertiary care hospital of central India from 2008-2010. METHODS: Patients admitted at tertiary care centre with partial thickness burns at first presentation were recruited to randomized controlled trial. Patients in trial were randomly allocated for beta-glucan collagen or anti-microbial dressings. RESULTS: Seventy-two patients were recruited over 28 months. Two were excluded from final analysis due to premature demise. Out of seventy subjects thirty-five were in BGC group while remaining thirty-five were in SSD group. Subjects were in 1-11 age range with majority being in 1-5 age groups. Out of total seventy patients thirty-three were male and thirty-three were females. Flame burns and scald burns were equally distributed in both groups and difference was not significant. Most of the patients presented within 6 hrs of initial injury (54.7%. TBSA% in BGC group was 16.4 while it was 18.2 in control group. Most of the patients in both the groups had burn injury over upper limb followed by anterior trunk. Partial thickness burns in children can be cost effectively treated with BGC with decreased pain, mean healing time and hospital stay with good cosmetic results.

  7. Pulmonary infection control window in treatment of severe respiratory failure of chronic obstructive pulmonary diseases: a prospective, randomized controlled, multi-centred study

    Institute of Scientific and Technical Information of China (English)

    Collaborating Research Group for Noninvasive Mecha

    2005-01-01

    Background Early withdraw from invasive mechanical ventilation (MV) followed by noninvasive MV is a new strategy for changing modes of treatment. This study was conducted to estimate the feasibility and the efficacy of early extubation and sequential noninvasive MV commenced at beginning of pulmonary infection control window in patients with exacerbated hypercapnic respiratory failure caused by chronic obstructive pulmonary diseases (COPD). Methods A prospective, randomized controlled study was conducted in eleven teaching hospitals' respiratory or medical intensive care units in China. Ninety intubated COPD patients with severe hypercapnic respiratory failure triggered by pulmonary infection (pneumonia or purulent bronchitis) were involved in the study. When the pulmonary infection had been controlled by antibiotics and comprehensive therapy, the "pulmonary infection control window (PIC window)" has been reached. Each case was randomly assigned to study group (extubation and noninvasive MV via facial mask immediately) or control group (invasive MV was received continuously after PIC window by using conventional weaning technique).Results Study group (n=47) and control group (n=43) had similar clinical characteristics initially and at the time of PIC window. Compared with control group, study group had shorter duration of invasive MV [(6.4±4.4) days vs (11.3±6.2) days, P=0.000], lower rate of ventilator associated pneumonia (VAP) (3/47 vs 12/43, P=0.014), fewer days in ICU [(12±8) days vs (16±11) days, P=0.047] and lower hospital mortality (1/47 vs 7/43, P=0.025).Conclusions In COPD patients requiring intubation and invasive MV for hypercapnic respiratory failure, which is exacerbated by pulmonary infection, early extubation followed by noninvasive MV initiated at the start of PIC window may decrease significantly the duration of invasive MV, the risk of VAP and hospital mortality.

  8. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed.

  9. The new AMS control centre

    CERN Multimedia

    Anaïs Schaeffer

    2011-01-01

    Construction work for the future AMS control room began in November 2010 and should be finished this June. The new building, which will have been completed in record time thanks to the professionalism of the project team, will soon be ready to receive the initial data from the AMS experiment.     Luigi Scibile and Michael Poehler, from the GS department, at the AMS control centre construction site.   The Alpha Magnetic Spectrometer (AMS) is due to wing its way towards the International Space Station (ISS) on board the shuttle Discovery in April. Mainly intended for research on antimatter and dark matter, the data collected by AMS will be sent to Houston in the United States and then directly to CERN’s new Building 946. Construction work for the AMS control centre building on the Route Gentner at CERN’s Prévessin site started in November 2010 and must be completed in time to receive the first data from the spectrometer in June. “It normall...

  10. Management based on exhaled nitric oxide levels adjusted for atopy reduces asthma exacerbations in children: A dual centre randomized controlled trial.

    Science.gov (United States)

    Petsky, Helen L; Li, Albert M; Au, Chun T; Kynaston, Jennifer A; Turner, Catherine; Chang, Anne B

    2015-06-01

    While several randomized control trials (RCTs) have evaluated the use of fractional exhaled nitric oxide (FeNO) to improve asthma outcomes, none used FeNO cut-offs adjusted for atopy, a determinant of FeNO levels. In a dual center RCT, we assessed whether a treatment strategy based on FeNO levels, adjusted for atopy, reduces asthma exacerbations compared with the symptoms-based management (controls). Children with asthma from hospital clinics of two hospitals were randomly allocated to receive an a-priori determined treatment hierarchy based on symptoms or FeNO levels. There was a 2-week run-in period and they were then reviewed 10 times over 12-months. The primary outcome was the number of children with exacerbations over 12-months. Sixty-three children were randomized (FeNO = 31, controls = 32); 55 (86%) completed the study. Although we did achieve our planned sample size, significantly fewer children in the FeNO group (6 of 27) had an asthma exacerbation compared to controls (15 of 28), P = 0.021; number to treat for benefit = 4 (95% CI 3-24). There was no difference between groups for any secondary outcomes (quality of life, symptoms, FEV1 ). The final daily inhaled corticosteroids (ICS) dose was significantly (P = 0.037) higher in the FeNO group (median 400 µg, IQR 250-600) compared to the controls (200, IQR100-400). Taking atopy into account when using FeNO to tailor asthma medications is likely beneficial in reducing the number of children with severe exacerbations at the expense of increased ICS use. However, the strategy is unlikely beneficial for improving asthma control. A larger study is required to confirm or refute our findings.

  11. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  12. Randomized, blind, parallel-controlled and multiple-centre clinical trial on the efficacy and safety of sustained-released leuprolide acetate in the treatment of endometriosis

    Institute of Scientific and Technical Information of China (English)

    Bian Mei-lu; Qiao Jie; Lin Jin-fang; Zhang Zhen-yu; Zuo Yue-wei; Chen Qing-yun

    2011-01-01

    Objective:To evaluate the efficacy and safety of leuprolide acetate in the treatment of endometriosis.Methods:The patients with endometriosis were randomly divided into leuprolide (n=75) and control (n=74)groups.They were treated with either sustained-release injection of leuprolide acetate or Enatntone injection (control) for 3 times totally.After treatment,the ovarian mass volume was measured under B ultrasound.The changes in hormone levels of estrodial (E2),FSH and LH,the pelvic signs,the scores of the patient's subjective symptoms during menstruation and non-menstrual days were observed.Results:The rate of changes in ovarian mass volume had no statistically significant difference between the two groups (P=0.495-0.965).The average reduction of ovarian mass volume was 47.91% in leuprolide group,and 53.51% in the control group 12 weeks after first medication.The distinct improvement rate and improvement rate of total symptom scores during menstruation and non-menstrual days had no significant difference between the two groups.The hormone levels of E2,FSH and LH were not significantly different between the two groups.The differences in the incidence of adverse reactions were not significant between the two groups.Conclusion:Leuprolide acetate produced by Livzon China is effective and safe in the treatment of endometriosis.

  13. A day in the CERN Control Centre

    CERN Multimedia

    Rosaria Marraffino

    2015-01-01

    The CERN Control Centre (CCC) is the nerve centre of the CERN beam systems. From this room, the experts prepare, monitor, adjust, and control the particle beams that circulate throughout the accelerator complex while ensuring that the services and the technical infrastructure work flawlessly. Buttons, screens, telephones, lights (but no sound): in the CCC, everything is ready to make it possible for the LHC to reach the unprecedented energies expected at Run 2.   Seen from above, the CERN Control Centre resembles the shape of a quadrupole magnet. The consoles are distributed in four circles, called “islands”, dedicated to the LHC, the SPS, the PS Complex and the Technical Infrastructure (TI) respectively. Spread between TI and LHC are the Cryogenics consoles. Being in the same room allows the 24h-manned islands to be constantly in touch with one another, thus ensuring the best performance of the machines. At the LHC island, operators are currently busy training the magnet...

  14. Enhancing Safety at Airline Operations Control Centre

    Directory of Open Access Journals (Sweden)

    Lukáš Řasa

    2015-04-01

    Full Text Available In recent years a new term of Safety Management System (SMS has been introduced into aviation legislation. This system is being adopted by airline operators. One of the groundbased actors of everyday operations is Operations Control Centre (OCC. The goal of this article has been to identify and assess risks and dangers which occur at OCC and create a template for OCC implementation into SMS.

  15. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

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

  16. Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2011-02-01

    Full Text Available Abstract Background Cognitive behaviour therapy (CBT is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. Methods/Design This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. Discussion This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have

  17. The CERN Control Centre is up and running!

    CERN Multimedia

    Maximilien Brice

    2006-01-01

    The CERN Control Centre (CCC) that combines all the control rooms for the accelerators, the cryogenic system and the technical infrastructure came into operation on 1st February. On 1st February, at 2.00 p.m., Patrick Villeton Pachot started the first Technical Infrastructure shift at the brand new CERN Control Centre.

  18. Evolution of the CANDU control centre design process

    International Nuclear Information System (INIS)

    The design of the CANDU NPP control centre and the associated control centre design process has evolved considerably over several generations of plants, from Douglas Point through Darlington, and beyond, to new designs like CANDU 3. In the early plants, the control centre configuration had to be based on designers' projections of control interface requirements. With succeeding generations of designs, along with the introduction of advancing computer control technology, a larger based of operational experience has been factored into the control interface design, and increasing attention has been given to more formal requirements definition, and more systematic consideration of human factors aspects of the design

  19. The CERN Control Centre is up and running!

    CERN Multimedia

    2006-01-01

    The CERN Control Centre (CCC) that combines all the control rooms for the accelerators, the cryogenic system and the technical infrastructure came into operation on 1st February. This is not a mock-up but the real thing! The CERN Control Centre has been built and put into operation in only 15 months.On 1st February, at 2.00 p.m., Patrick Villeton Pachot started the first Technical Infrastructure shift at the brand new CERN Control Centre. From now on, when you dial 72201 to report a leak or an electrical fault, your call will ring out in the brand new CERN Control Centre. The much anticipated CCC came on line on 1st February, exactly as planned. The 2.00 p.m. shift by the operators of the former Technical Control Room (TCR), now renamed TI for Technical Infrastructure, marked the start of operations at the Centre. The PCR, MCR, TCR and QCR are no more, and all the individual control rooms have been merged into one. And what a control room it is! True to the streamlined image announced when the project was f...

  20. Operational improvements in the CANDU 9 control centre

    International Nuclear Information System (INIS)

    AECL has adopted an evolutionary approach to the design of the CANDU 9 control centre. Several factors have contributed to this decision including the desire to build on the successes of the current generation of CANDU stations, the changing roles and responsibilities of operations staff, an improved understanding of human error in operational situations, the opportunity for improved plant performance through the introduction of new technologies, and evolving customer and regulatory requirements. Underlying this approach is a refined engineering design process that cost-effectively integrates operational feedback and human factors engineering to define the operating staff information and information presentation requirements. Based on this approach, the CANDU 9 control centre will provide utility operating staff with a layout and information organization that is better matched to operational tasks, thereby leading to reduced operations, maintenance and administration (OM and A) costs. Significant design features that contribute to the improved operational capabilities of the CANDU 9 control centre include: a control centre layout with improved functionality; a new Plant Display System that is separated from the digital control computer system; and an enhanced computerized reactor shutdown system. The paper will present a summary of the design process, a detailed description of the CANDU 9 control centre layout and features, a description of the plant control and display systems design, including findings from a regulatory review, and other improvements to enhance operability. (author)

  1. Internal communications for the control centres

    Science.gov (United States)

    Leroy, Jean-Marie

    1990-10-01

    The control centers' internal communication requirements are reviewed, outlining the types of messages and further defining the internal communication functions to be performed. A brief local area network (LAN) tradeoff analysis is performed, concluding that most of the communication services can be covered by a modern high speed LAN (HSLN) or broadband metropolitan area network (MAN), such as the emerging fiber distributed data interface (FDDI-2) or the queued packet synchronous switch/distributed queue dual bus (QPSX/DQDB).

  2. A computer simulation of the new Control Centre (CCC)

    CERN Multimedia

    2004-01-01

    In a development crucial for the success of the LHC, CERN will build a Control Centre (CCC) for the operation of all its beams and accelerators. The CCC will be an extension of the existing PCR building at Prévessin and is due to be operational by 1 February 2006.

  3. Evolution of the CANDU control centre retrofit and new stations

    International Nuclear Information System (INIS)

    Significant event data from operating nuclear plants in many countries consistently indicates human errors are the root cause for 40-60% of operating station significant events. Because so much information is already in digital form, opportunities exist to improve the CANDU control centre with retrofits that exploit this information. These opportunities are enhanced because of rapid technological development in computers and electronics, coupled with significant progress in the behavioural sciences that greatly increases our knowledge of the cognitive strengths and weaknesses of human beings. CANDU control rooms are undergoing retrofits and for future CANDU stations, a new concept of the control centre is emerging. The objective is to significantly reduce the incidence of human error, reduce operations and maintenance costs and improve both reliability and safety

  4. Improved operability of the CANDU 9 control centre

    Energy Technology Data Exchange (ETDEWEB)

    Macbeth, M. J.; Webster, A. [Atomic Energy of Canada Limited, Saskatoon (Canada)

    1996-04-15

    The next generation CANDU nuclear power plant being designed by AECL is the 900 MWe class CANDU 9 station. It is based upon the Darlington CANDU station design which is among the world leaders in capacity factor with low Operation, Maintenance and Administration (OM and A) costs. This Control Centre design includes the proven functionality of existing CANDU control centres (including the Wolsong 2,3, and 4 control centre improvements, such as the Emergency Core Cooling panels), the characteristics identified by systematic design with human factors analysis of operations requirements and the advanced features needed to improve station operability which is made possible by the application of new technology. The CANDU 9 Control Centre provides plant staff with an improved operability capability due to the combination of proveness, systematic design with human factors engineering and enhanced operating features. Significant features which contribute to this improved operability include: {center_dot} Standard NSP, BOP and F/H panels with controls and indicators integrated by a standard display/presentation philosophy. {center_dot} Common plant parameter signal database for extensive monitoring, checking, display and annunciation. {center_dot} Powerful annunciation system allowing alarm filtering, prioritizing and interrogation to enhance staff recognition of events, plant state and required corrective procedural actions. {center_dot} The use of an overview display to present immediate and uncomplicated plant status information to facilitate operator awareness of unit status in a highly readable and recognizable format. {center_dot} Extensive cross checking of similar process parameters amongst themselves, with the counterpart safety system parameters and as well as with 'signature' values obtained from known steady state conditions. {center_dot} Powerful calculation capabilities, using the plant wide database, providing immediate recognizable and readable and

  5. Integrated control centre concepts for CANDU power plants

    International Nuclear Information System (INIS)

    The size and complexity of nuclear power plants has increased significantly in the last 20 years. There is general agreement that plant safety and power production can be enhanced if more operational support systems that are significantly different from the ones based on the more conventional technologies used in plant control rooms. In particular, artificial intelligence and related technologies will play a major role in the development of innovative methods for information processing and presentation. These technologies must be integrated into the overall management and control philosophy of the plant and not be treated as vehicles to implement point solutions. The underlying philosophy behind our approach is discussed in this paper. Operator support systems will integrate into the overall control philosophy by complementing the operator. Four support systems are described; each is a prototype of a system being considered for the CANDU 3 control centre

  6. {\\pi}-Control: A Personal Cloud Control Centre

    CERN Document Server

    Spillner, Josef

    2012-01-01

    Consumption of online services and cloud computing offerings is on the rise, largely due to compelling advantages over traditional local applications. From a user perspective, these include zero-maintenance of software, the always-on nature of such services, mashups of different applications and the networking effect with other users. Associated disadvantages are known, but effective means and tools to limit their effect are not yet well-established and not yet generally available to service users. We propose (1) a user-centric model of cloud elements beyond the conventional aaS layers, including activities across trust zones, and (2) a personal control console for all individual and collaborative user activities in the cloud.

  7. Nanoscale magnetometry through quantum control of nitrogen-vacancy centres in rotationally diffusing nanodiamonds

    CERN Document Server

    Maclaurin, D; Martin, A M; Hollenberg, L C L

    2012-01-01

    The confluence of quantum physics and biology is driving a new generation of quantum-based sensing and imaging technology capable of harnessing the power of quantum effects to provide tools to understand the fundamental processes of life. One of the most promising systems in this area is the nitrogen-vacancy centre in diamond - a natural spin qubit which remarkably has all the right attributes for nanoscale sensing in ambient biological conditions. Typically the nitrogen-vacancy qubits are fixed in tightly controlled/isolated experimental conditions. In this work quantum control principles of nitrogen-vacancy magnetometry are developed for a randomly diffusing diamond nanocrystal. We find that the accumulation of geometric phases, due to the rotation of the nanodiamond plays a crucial role in the application of a diffusing nanodiamond as a bio-label and magnetometer. Specifically, we show that a freely diffusing nanodiamond can offer real-time information about local magnetic fields and its own rotational beh...

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

    Directory of Open Access Journals (Sweden)

    Shuiqing Yu

    2013-01-01

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

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

    OpenAIRE

    Luke Perraton; Zuzana Machotka; Saravana Kumar

    2009-01-01

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

  10. Random transitions and cell cycle control.

    Science.gov (United States)

    Brooks, R F

    1981-01-01

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

  11. Randomized control of open quantum systems

    CERN Document Server

    Viola, L

    2006-01-01

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

  12. Safety and immunogenicity of H1/IC31®, an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Klaus Reither

    Full Text Available Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1 formulated with the adjuvant IC31, was evaluated in HIV-infected adults.HIV-infected adults with CD4+ T cell counts >350/mm3 and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5:1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015. Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.H1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm3. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.Pan African Clinical Trials Registry (PACTR PACTR201105000289276.

  13. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  14. Design principles for CANDU control centres in response to evolving utility business needs

    International Nuclear Information System (INIS)

    Nuclear generation operators are facing a challenging business environment at the beginning of the new millennium. Evolving changes in business context, competitive commercial pressures, and changes in technology have dictated recurring evaluation of operational practices and the adequacy of supporting tools, and the pursuit of opportunities for operational improvement. A key area of utility operations that has been impacted by these changes is the nuclear plant control centre. Changes to workspace layout, equipment provisions, staffing, and work organization are examples of some of the adjustments being introduced to improve operational and safety effectiveness. This paper discusses some of the key factors influencing these changes and identifies additional design principles for CANDU control centres that will enable new control centre designs and retrofits of existing control centres to remain relevant and responsive to utility needs. (author)

  15. The role of function analysis in the ACR control centre design

    International Nuclear Information System (INIS)

    An essential aspect of control centre design is the need to characterize: plant functions and their inter-relationships to support the achievement of operational goals, and roles for humans and automation in sharing and exchanging the execution of functions across all operational phases. Function analysis is a design activity that has been internationally accepted as an approach to satisfy this need. It is recognized as a fundamental and necessary component in the systematic approach to control centre design and is carried out early in the design process. A function analysis can provide a clear basis for: the control centre design for the purposes of design team communication, and customer or regulatory review, the control centre display and control systems, the staffing and layout requirements of the control centre, assessing the completeness of control centre displays and controls prior and supplementary to mock-up walkthroughs or simulator evaluations, and the design of operating procedures and training programs. This paper will explore the role for function analysis in supporting the design of the control centre. The development of the ACR control room will be used as an illustrative context for the discussion. The paper will also discuss the merits of using function analysis in a goal-or function-based approach resulting in a more robust, operationally compatible, and cost-effective design over the life of the plant. Two former papers have previously outlined, the evolution in AECL's application approach and lessons learned in applying function analysis in support of control room design. This paper provides the most recent update to this progression in application refinement. (author)

  16. Retrospective exposure assessment and quality control in an international multi-centre case-control study

    DEFF Research Database (Denmark)

    Tinnerberg, H; Heikkilä, P; Huici-Montagud, A;

    2003-01-01

    to the original CA studies at the time of CA testing, but not for the whole work life. An independent occupational hygienist coordinated harmonization of the assessment criteria and the quality control procedure. The reliability of the exposure assessments was calculated as deviation from the majority......The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high...... was higher among the original assessors (the assessor from the same country as the subject) than the average prevalence assessed by the other four in the quality control round. The original assessors classified more job situations as exposed than the others. Several reasons for this are plausible: real...

  17. A design basis for the development of advanced CANDU control centres

    International Nuclear Information System (INIS)

    The basic design for current CANDU control centres was established in the early 1970's. Plants constructed since then have, for the most part, retained the same basic design. Several factors have led to the need to re-examine CANDU control centre design for plants to be built beyond the year 2000. These factors include the changing roles and responsibilities for the operations staff, an improved understanding of operational issues associated with supervisory control, an improved understanding of human error in operational situations, the opportunity for improved plant performance through the introduction of new technologies, and marketing pressures. This paper describes the proposed design bases for the development of advanced control centres to be implemented in CANDU plants beyond the year 2000. Four areas have been defined covering design goals, design principles, operational bases, and plant functional bases. (author)

  18. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

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

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

    OpenAIRE

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

    2015-01-01

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

  20. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

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

  1. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

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

  2. Doping strategies to control A-centres in silicon: Insights from hybrid density functional theory

    KAUST Repository

    Wang, Hao

    2014-01-01

    Hybrid density functional theory is used to gain insights into the interaction of intrinsic vacancies (V) and oxygen-vacancy pairs (VO, known as A-centres) with the dopants (D) germanium (Ge), tin (Sn), and lead (Pb) in silicon (Si). We determine the structures as well as binding and formation energies of the DVO and DV complexes. The results are discussed in terms of the density of states and in view of the potential of isovalent doping to control A-centres in Si. We argue that doping with Sn is the most efficient isovalent doping strategy to suppress A-centres by the formation of SnVO complexes, as these are charge neutral and strongly bound. © 2014 the Owner Societies.

  3. Always Better Control-Vital Essential Desirable analysis of the drugs used in health centres of Ahmedabad district

    OpenAIRE

    Anand Girish Shah; Bansi K. Davda; Sonal B. Parikh; Bala, D. V.

    2015-01-01

    Background: The basic principle of inventory control is Always Better Control (ABC) based on cost criteria and Vital Essential Desirable (VED) on criticality. Inequity in drug prioritization and expenses directly affects the health of the community. Study design: Based on ABC-VED matrix, inventory analysis was done. Study area: Community health centre (CHC) - Singarva, two primary health centres (PHC) - Kanbha and Sanathal and two urban health centre (UHC) - Amraiwadi and Sabarmati. Study per...

  4. Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial

    OpenAIRE

    Handoll, H. H. G.; Goodchild, L; Brealey, S. D.; Hanchard, N. C. A.; Jefferson, L.; Keding, A; Rangan, A.

    2014-01-01

    Objectives A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods Th...

  5. Raloxifene and body composition and muscle strength in postmenopausal women: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Jacobsen, D.E.; Samson, M.M.; Emmelot-Vonk, M.H.; Verhaar, H.J.

    2010-01-01

    OBJECTIVE: To compare the effects of raloxifene and placebo on body composition and muscle strength. DESIGN: Randomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht, T

  6. An Operational Event Announcer for the LHC Control Centre Using Speech Synthesis

    CERN Document Server

    Page, S

    2011-01-01

    The LHC Island of the CERN Control Centre is a busy working environment with many status displays and running software applications. An audible event announcer was developed in order to provide a simple and efficient method to notify the operations team of events occurring within the many subsystems of the accelerator. The LHC Announcer uses speech synthesis to report messages based upon data received from multiple sources. General accelerator information such as injections, beam energies and beam dumps are derived from data received from the LHC Timing System. Additionally, a software interface is provided that allows other surveillance processes to send messages to the Announcer using the standard control system middleware. Events are divided into categories which the user can enable or disable depending upon their interest. Use of the LHC Announcer is not limited to the Control Centre and is intended to be available to a wide audience, both inside and outside CERN. To accommodate this, it...

  7. Pharmacological treatment of the pathogenetic defects in Type 2 Diabetes. The randomized multi-centre South Danish Diabetes study (SDDS)

    DEFF Research Database (Denmark)

    Gram, Jeppe; Henriksen, Jan Erik; Grodum, Ellen;

    2011-01-01

    AbstractObjective: To determine the effect of treatment with insulin Aspart as compared to NPH insulin, together with metformin/placebo and rosiglitazone/placebo. The hypothesis was that combined correction of major pathogenetic defects in type 2 diabetes would result in optimal glycemic control....... Research Design and Methods: A 2-year investigator driven, randomized, partly placebo controlled, multicenter trial in 371 patients with type 2 diabetes on at least oral antiglycemic treatment. Patients were assigned to one of eight treatment groups in a factorial design with insulin aspart at mealtimes vs...

  8. The CERN Control Centre Setting Standards for the 21st Century

    CERN Document Server

    Manglunki, Django

    2008-01-01

    In 2003, CERN decided to build a unified control centre to replace four of its control rooms: the â€ワMeyrin Control Room” which controlled the PS complex, the â€ワPrevessin Control Room” (PCR) which controlled the SPS and until 2000 LEP, the Technical Control Room (TCR), and the Cryogenics Control Room (QCR). After first contemplating a possible implementation next to the â€ワGlobe of Science and Innovation”, it was decided for budgetary reasons to build the new CERN Control Centre (CCC) on the same location as the PCR. This represented a 50% saving in construction costs as most of the technical infrastructure (computer network, water, electricity, ventilation) was already in place, but added stringent time constraints: civil engineering could not begin before the SPS shutdown in November 2004, yet the room had to be ready for the accelerator operations to resume in March 2006. Although this presented a strict construction schedule, it allowed the project to be completely driven by th...

  9. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

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

  11. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Jennifer

    2012-04-01

    Full Text Available Abstract Background People with Multiple Sclerosis (MS frequently experience balance and mobility impairments, including reduced trunk stability. Pilates-based core stability training, which is aimed at improving control of the body's stabilising muscles, is popular as a form of exercise with people with MS and therapists. A replicated single case series study facilitated by the Therapists in MS Group in the United Kingdom (UK provides preliminary evidence that this approach can improve balance and mobility in ambulant people with MS; further evidence is needed to substantiate these findings to ensure that limited time, energy, finances and resources are used to best effect. This study builds upon the pilot work undertaken in the case series study by implementing a powered randomised controlled study, with the aims of: 1 Establishing the effectiveness of core stability training 2 Comparing core stability training with standardised physiotherapy exercise 3 Exploring underlying mechanisms of change associated with this intervention Methods This is a multi-centre, double blind, block randomised, controlled trial. Eligible participants will be recruited from 4 UK centres. Participants will be randomly allocated to one of three groups: Pilates based core stability training, standardised physiotherapy exercise or contract-relax relaxation sessions (placebo control. All will receive face to face training sessions over a 12 week period; together with a 15 minute daily home programme. All will be assessed by a blinded assessor before training, at the end of the 12 week programme and at 4 week follow-up. The primary outcome measure is the 10 metre timed walk. Secondary outcome measures are the MS walking Scale (MSWS-12, the Functional Reach (forwards and lateral, a 10 point Numerical Rating Scale to determine "Difficulty in carrying a drink when walking", and the Activities-specific Balance Confidence (ABC Scale. In addition, ultrasound imaging of the

  12. Establishing Successful Teamwork in Upset Response - Issues and Control Centre Impacts

    International Nuclear Information System (INIS)

    Effective teamwork among control room and shift staff is essential for plant production and safety in all phases of plant operations. During response to unit upsets and emergencies, effective teamwork among control room and responding shift staff is especially critical for operational, public, and environmental safety, investment protection, and minimization of production loss. In CANDU multi-unit power stations, a common area is used to house the control room resources for all units. With this common control centre arrangement, staff from adjacent units is available to assist in response to upsets or emergencies with any unit. Consequently, the Canadian upset response practice has evolved to draw on the available experience and skills offered by staff from adjacent units. This paper discusses the Canadian experience with achieving effective teamwork during upset response where responding staff from adjacent units are integrated with the unit team members to achieve a co-ordinated and more capable response capability. (authors)

  13. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kang Kyung-Won

    2009-07-01

    Full Text Available Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China, randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group. The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping. The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial

  14. Integrating payload design, planning, and control in the Dutch Utilisation Centre

    Science.gov (United States)

    Grant, T. J.

    1993-03-01

    Spacecraft payload design, experiment planning and scheduling, and payload control are traditionally separate areas of activity. This paper describes the development of a prototype software tool--the Activity Scheduling System (ASS)--which integrates these activity areas. ASS is part of a larger project to build a Dutch Utilisation Centre (DUC), intended eventually to support all space utilization activities in The Netherlands. ASS has been tested on the High Performance Capillary Electrophoresis payload. The paper outlines the integrated preparation and operations concept embodied in ASS. It describes the ASS prototype, including a typical session. The results of testing are summarized. Possible enhancement of ASS, including integration into DUC, is sketched.

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

    NARCIS (Netherlands)

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

    2009-01-01

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

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

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

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

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

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

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

  18. Random Access Game and Medium Access Control Design

    OpenAIRE

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

    2010-01-01

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

  19. Modeling of Random Delays in Networked Control Systems

    Directory of Open Access Journals (Sweden)

    Yuan Ge

    2013-01-01

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

  20. Implementation of EPICS based vacuum control system for variable energy cyclotron centre, Kolkata

    Energy Technology Data Exchange (ETDEWEB)

    Roy, Anindya, E-mail: r-ani@vecc.gov.in; Bhole, R. B.; Nandy, Partha P.; Yadav, R. C.; Pal, Sarbajit; Roy, Amitava [Variable Energy Cyclotron Centre, 1/AF Bidhan Nagar, Kolkata 700064 (India)

    2015-03-15

    The vacuum system of the Room Temperature (K = 130) Cyclotron of Variable Energy Cyclotron Centre is comprised of vacuum systems of main machine and Beam Transport System. The vacuum control system is upgraded to a PLC based Automated system from the initial relay based Manual system. The supervisory control of the vacuum system is implemented in Experimental Physics and Industrial Control System (EPICS). An EPICS embedded ARM based vacuum gauge controller is developed to mitigate the requirement of vendor specific gauge controller for gauges and also for seamless integration of the gauge controllers with the control system. A set of MS-Windows ActiveX components with embedded EPICS Channel Access interface are developed to build operator interfaces with less complex programming and to incorporate typical Windows feature, e.g., user authentication, file handling, better fonts, colors, mouse actions etc. into the operator interfaces. The control parameters, monitoring parameters, and system interlocks of the system are archived in MySQL based EPICS MySQL Archiver developed indigenously. In this paper, we describe the architecture, the implementation details, and the performance of the system.

  1. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

    Directory of Open Access Journals (Sweden)

    SOFIA VON HUMBOLDT

    2013-01-01

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

  2. Investigation of Separate Meter-In Separate Meter-Out Control Strategies for Systems with Over Centre Valves

    DEFF Research Database (Denmark)

    Pedersen, Henrik C.; Andersen, Torben Ole; Hansen, Rico Hjerm;

    2010-01-01

    Traditionally most mobile hydraulic systems are fitted with over centre valves for safety measures. However, it is a well known that over centre valves in combination with flow control valves may lead to oscillatory and unstable system behaviour if not designed correctly. There are several means...... to overcome this problem, but it typically implies higher energy consumption and/or decreased control performance. With the development of robust sensors and new valve types with separate meter-in, separate meter-out control it is, however, possible to overcome these stability problems in a much more......-centre valve included. The paper first presents a general model of the system considered, which is experimentally verified. This is followed by a discussion of different control strategies and their implications. For each of the control strategies controllers are described, taking into account the dynamics...

  3. A randomised controlled trial of a client-centred self-care intervention after stroke

    DEFF Research Database (Denmark)

    Guidetti, Susanne; Ytterberg, Charlotte

    2011-01-01

    PURPOSE: The aim of this randomised controlled pilot study of a client-centred self-care intervention (CCSCI) in individuals with stroke was to study (i) the feasibility of the study design, (ii) effects up to 12 months on activities of daily living (ADL), use of informal care and home help...... services and the caregiver burden. METHOD: An intervention group (IG) received CCSCI and a control group (CG) received ordinary training. Forty individuals with stroke (IG n = 19, CG n = 21) were included. Data were collected at 3, 6 and 12 months using established instruments. RESULTS: After 12 months 24...... people remained in the study (IG = 10, CG = 14). The data collection method was acceptable to most participants. At 12 months there were no differences in ADL, use of services or caregiver's burden. Both groups improved significantly and clinically important improvements were achieved by 80% in the IG...

  4. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial

    OpenAIRE

    Buchweitz, Olaf; Frye, Christian; Moeller, Claus Peter; Nugent, Wolfgang; Krueger, Eckart; Nugent, Andreas; Biel, Peter; Juergens, Sven

    2015-01-01

    Background In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS). Methods A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It w...

  5. Does pulmonary rehabilitation work in clinical practice? A review on selection and dropout in randomized controlled trials on pulmonary rehabilitation

    OpenAIRE

    Bodil Bjoernshave; Jens Korsgaard; Claus Vinther Nielsen

    2010-01-01

    Bodil Bjoernshave1, Jens Korsgaard2, Claus Vinther Nielsen31Medical Department, Horsens Regional Hospital, Denmark; 2Aalborg Hospital Science and Innovation Centre, 3Department of Clinical Social Medicine and Rehabilitation, Institute of Public Health, Aarhus University, DenmarkAim: To analyze randomized controlled trials (RCTs) on pulmonary rehabilitation (PR) to determine whether the patients who complete PR form a representative subset of the chronic obstructive pulmonary disease (COPD) ta...

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

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

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

  7. Multiple input/output random vibration control system

    Science.gov (United States)

    Unruh, James F.

    1988-01-01

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

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

    Science.gov (United States)

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

    2012-07-20

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

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

    CERN Document Server

    Bachelard, Nicolas; Gigan, Sylvain; Sebbah, Patrick

    2012-01-01

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

  10. Randomized algorithms in automatic control and data mining

    CERN Document Server

    Granichin, Oleg; Toledano-Kitai, Dvora

    2015-01-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

  12. Using the centre of percussion to design a steering controller for an autonomous race car

    Science.gov (United States)

    Kritayakirana, Krisada; Gerdes, J. Christian

    2012-01-01

    Understanding how a race car driver controls a vehicle at its friction limits can provide insights into the development of vehicle safety systems. In this paper, a race car driver's behaviour inspires the design of an autonomous racing controller. The resulting controller uses the vehicle's centre of percussion (COP) to design feedforward and feedback steering. At the COP, the effects of rotation and translation from the rear tire force cancel each other out; consequently, the feedforward steering command is robust to the disturbances from the rear tire force. Using the COP also simplifies the equations of motion, as the vehicle's lateral motion is decoupled from the vehicle's yaw motion and highlights the challenge of controlling a vehicle when the rear tires are highly saturated. The resulting dynamics can be controlled with a linear state feedback based on a lane-keeping system with additional yaw damping. Utilising Lyapunov theory, the closed-loop system is shown to remain stable even when the rear tires are highly saturated. The experimental results demonstrate that an autonomous vehicle can operate at its limits while maintaining a minimal lateral error.

  13. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

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

    Directory of Open Access Journals (Sweden)

    Luke Perraton

    2009-11-01

    Full Text Available Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS. The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery were analyzed.Results: Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery.Conclusions: Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.Keywords: hydrotherapy, fibromyalgia syndrome, exercise, effective, components

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

    Directory of Open Access Journals (Sweden)

    Yuanyuan Ju

    2013-01-01

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

  16. The mechanosensory calcium-selective ion channel: key component of a plasmalemmal control centre?

    Science.gov (United States)

    Pickard, B. G.; Ding, J. P.

    1993-01-01

    Mechanosensory calcium-selective ion channels probably serve to detect not only mechanical stress but also electrical, thermal, and diverse chemical stimuli. Because all stimuli result in a common output, most notably a shift in second messenger calcium concentration, the channels are presumed to serve as signal integrators. Further, insofar as second messenger calcium in turn gives rise to mechanical, electrical, and diverse chemical changes, the channels are postulated to initiate regulatory feedbacks. It is proposed that the channels and the feedback loops play a wide range of roles in regulating normal plant function, as well as in mediating disturbance of normal function by environmental stressors and various pathogens. In developing evidence for the physiological performance of the channel, a model for a cluster of regulatory plasmalemmal proteins and cytoskeletal elements grouped around a set of wall-to-membrane and transmembrane linkers has proved useful. An illustration of how the model might operate is presented. It is founded on the demonstration that several xenobiotics interfere both with normal channel behaviour and with gravitropic reception. Accordingly, the first part of the illustration deals with how the channels and the control system within which they putatively operate might initiate gravitropism. Assuming that gravitropism is an asymmetric expression of growth, the activities of the channels and the plasmalemmal control system are extrapolated to account for regulation of both rate and allometry of cell expansion. Finally, it is discussed how light, hormones, redox agents and herbicides could in principle affect growth via the putative plasmalemmal control cluster or centre.

  17. Maintaining Control Centre Operational Effectiveness and Teamwork During Transitions in Station Capabilities

    International Nuclear Information System (INIS)

    The one constant in the operation of power generation facilities is the pervasiveness of ongoing change. Ongoing change can be driven by continuing improvement initiatives from commercial and peer competitiveness, safety enhancement, the availability of new capabilities, equipment obsolescence, and regulatory changes. This continuing stream of station changes can result in impacts at all levels of the organization from equipment functionality, location and conventions, to work strategies and practices, and organization responsibilities and priorities. The introduction of these changes must be managed in a way that minimizes challenges and disruption to continuing station operations and ensures the benefits of specific changes are fully realized. An under-appreciated yet critical aspect is the management of transition periods where station operations are conducted between initial change introduction and complete fulfilment. During such periods, the control centre staff become the primary managers of change introduction and mitigation of challenges imposed by conflicts of partial change implementation. This paper discusses the Canadian experience with maintaining control room operational effectiveness and teamwork in CANDU control rooms during the introduction of changes in station capabilities. (authors)

  18. Integrated solution for the complete remote sensing process - Earth Observation Mission Control Centre (EOMC2)

    Science.gov (United States)

    Czapski, Paweł

    2016-07-01

    We are going to show the latest achievements of the Remote Sensing Division of the Institute of Aviation in the area of remote sensing, i.e. the project of the integrated solution for the whole remote sensing process ranging from acquiring to providing the end user with required information. Currently, these tasks are partially performed by several centers in Poland, however there is no leader providing an integrated solution. Motivated by this fact, the Earth Observation Mission Control Centre (EOMC2) was established in the Remote Sensing Division of the Institute of Aviation that will provide such a comprehensive approach. Establishing of EOMC2 can be compared with creating Data Center Aerial and Satellite Data Centre (OPOLIS) in the Institute of Geodesy and Cartography in the mid-70s in Poland. OPOLIS was responsible for broadly defined data processing, it was a breakthrough innovation that initiated the use of aerial image analysis in Poland. Operation center is a part of the project that will be created, which in comparison with the competitors will provide better solutions, i.e.: • Centralization of the acquiring, processing, publishing and archiving of data, • Implementing elements of the INSPIRE directive recommendations on spatial data management, • Providing the end-user with information in the near real-time, • Ability of supplying the system with images of various origin (aerial, satellite, e.g. EUMETCast, Sentinel, Landsat) and diversity of telemetry data, data aggregation and using the same algorithms to images obtained from different sources, • System reconfiguration and batch processing of large data sets at any time, • A wide range of potential applications: precision agriculture, environmental protection, crisis management and national security, aerial, small satellite and sounding rocket missions monitoring.

  19. Structuring communication relationships for interprofessional teamwork (SCRIPT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kenaszchuk Chris

    2007-09-01

    Full Text Available Abstract Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs in general internal medicine (GIM divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS; adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a

  20. CMS Centre at CERN

    CERN Multimedia

    2007-01-01

    A new "CMS Centre" is being established on the CERN Meyrin site by the CMS collaboration. It will be a focal point for communications, where physicists will work together on data quality monitoring, detector calibration, offline analysis of physics events, and CMS computing operations. Construction of the CMS Centre begins in the historic Proton Synchrotron (PS) control room. The historic Proton Synchrotron (PS) control room, Opened by Niels Bohr in 1960, will be reused by CMS to built its control centre. TThe LHC@FNAL Centre, in operation at Fermilab in the US, will work very closely with the CMS Centre, as well as the CERN Control Centre. (Photo Fermilab)The historic Proton Synchrotron (PS) control room is about to start a new life. Opened by Niels Bohr in 1960, the room will be reused by CMS to built its control centre. When finished, it will resemble the CERN Contro...

  1. The effectiveness of family interventions in preventing adolescent illicit drug use: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Smit, E.; Verdurmen, J.E.E.; Engels, R.C.M.E.

    2015-01-01

    In order to quantify the effectiveness of family interventions in preventing and reducing adolescent illicit drug use, we conducted a systematic review and meta-analysis of randomized controlled trials. We searched the Cochrane Database of Systematic Reviews, Educational Research Information Centre

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

    Science.gov (United States)

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

    2014-01-01

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

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

    DEFF Research Database (Denmark)

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

    2009-01-01

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

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

    DEFF Research Database (Denmark)

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

    2009-01-01

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

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

    DEFF Research Database (Denmark)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    McGrath, Patrick; And Others

    1987-01-01

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

  9. Randomized controlled observer-blinded treatment of chronic foot eczema with iontophoresis and bath-PUVA

    NARCIS (Netherlands)

    Tupker, Ron A; Coenraads, Pieter Jan; Zanen, Pieter; Schuttelaar, Marielouise

    2013-01-01

    The aim of this study was to investigate the effect of iontophoresis combined with local psoralen plus ultraviolet A (PUVA) therapy in chronic foot eczema. A randomized, observer-blinded, multi-centre study was conducted in 48 patients with chronic moderate-to-severe foot eczema randomized to one of

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

    OpenAIRE

    Mohammad Shariati; Masuod Yunesian; Iraj Harirchi; Ahmad Khosravi

    2008-01-01

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

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

    CERN Document Server

    Dong, Hongli; Gao, Huijun

    2013-01-01

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

  12. F-actin mechanics control spindle centring in the mouse zygote

    Science.gov (United States)

    Chaigne, Agathe; Campillo, Clément; Voituriez, Raphaël; Gov, Nir S.; Sykes, Cécile; Verlhac, Marie-Hélène; Terret, Marie-Emilie

    2016-01-01

    Mitotic spindle position relies on interactions between astral microtubules nucleated by centrosomes and a rigid cortex. Some cells, such as mouse oocytes, do not possess centrosomes and astral microtubules. These cells rely only on actin and on a soft cortex to position their spindle off-centre and undergo asymmetric divisions. While the first mouse embryonic division also occurs in the absence of centrosomes, it is symmetric and not much is known on how the spindle is positioned at the exact cell centre. Using interdisciplinary approaches, we demonstrate that zygotic spindle positioning follows a three-step process: (1) coarse centring of pronuclei relying on the dynamics of an F-actin/Myosin-Vb meshwork; (2) fine centring of the metaphase plate depending on a high cortical tension; (3) passive maintenance at the cell centre. Altogether, we show that F-actin-dependent mechanics operate the switch between asymmetric to symmetric division required at the oocyte to embryo transition.

  13. Infinitely dimensional control Markov branching chains in random environments

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

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

  14. Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF- iTH): study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Steinmetz, Jacob; Sorensen, Anne Marie; Henriksen, Hanne Hee;

    2016-01-01

    haemorrhage in need of haemostatic resuscitation. METHODS/DESIGN: This is a single-centre, randomized (1:1, active:placebo), placebo-controlled, double-blinded, investigator-initiated phase II trial. The trial population consists of 40 adult patients (>18 years) with traumatic, critical bleeding admitted....../kg fibrinogen concentrate (Riastap®) or placebo 0.9 % saline in equal volume to active treatment, both given as intravenous infusion blinded for the person administering the infusion. The primary end point is the change in thrombelastograph (TEG®) functional fibrinogen maximum amplitude in millimetres at 15 min...... require 19 patients in each group. We have chosen to include 40 patients, 20 evaluable patients in each randomization group in case of attrition, in the present trial. DISCUSSION: Patients considered to be included in the trial will temporarily have a compromised consciousness because of the acute...

  15. Predictors of employment for people with severe mental illness : results of an international six-centre randomised controlled trial

    NARCIS (Netherlands)

    Catty, Jocelyn; Lissouba, Pascale; White, Sarah; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Roessler, Wulf; Tomov, Toma; Van Busschbach, Jooske; Wiersma, Durk; Burns, Tom; Rossler, W.

    2008-01-01

    Background An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. Aims To determine which patients with severe men

  16. Control with a random access protocol and packet dropouts

    Science.gov (United States)

    Wang, Liyuan; Guo, Ge

    2016-08-01

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

  17. The Particle Physicists’ Song : the CERN Choir in full voice in the CERN Control Centre, with writer Danuta Orlowska

    CERN Multimedia

    Maximilien Brice

    2010-01-01

    The song was submitted to CERN Courier by Danuta Orlowska, a clinical psychologist with Guy’s and St Thomas’ NHS Foundation Trust in London. It is written to be sung to the tune of The Hippopotamus Song, by Michael Flanders and Donald Swann, which will be well known to many British readers. On 3 February, members of the CERN choir gathered to give a rendition in the CERN Control Centre – the nerve centre of the LHC, which lies at the heart of the lyrics.

  18. The historic Proton Synchrotron (PS) control room is about to start a new life. Opened by Niels Bohr in 1960, the room will be reused by CMS to built its control centre. When finished, it will resemble the CERN Control Centre for LHC operations, located in Prevessin.

    CERN Multimedia

    Husi C.

    2007-01-01

    The historic Proton Synchrotron (PS) control room is about to start a new life. Opened by Niels Bohr in 1960, the room will be reused by CMS to built its control centre. When finished, it will resemble the CERN Control Centre for LHC operations, located in Prevessin.

  19. A randomized controlled trial of a novel mixed monoamine reuptake inhibitor in adults with ADHD

    Directory of Open Access Journals (Sweden)

    Wesnes Keith

    2008-06-01

    Full Text Available Abstract Background NS2359 is a potent reuptake blocker of noradrenalin, dopamine, and serotonin. The aim of the study was to investigate the efficacy, safety and cognitive function of NS2359 in adults with a DSM IV diagnosis of ADHD. Methods The study was a multi-centre, double-blind, randomized placebo-controlled, parallel group design in outpatient adults (18–55 years testing 0.5 mg NS2359 vs. placebo for 8 weeks. Multiple assessments including computerized neuropsychological evaluation were performed. Results There was no significant difference between NS2359 (n = 63 versus placebo (n = 63 on the primary outcome measure reduction in investigator rated ADHD-RS total score (7.8 versus 6.4; p Conclusion No overall effect of NS2359 was found on overall symptoms of ADHD. There was also a modest signal of improvement in the inattentive adults with ADHD and cognition warranting further exploration using differing doses.

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

    Directory of Open Access Journals (Sweden)

    Ravindra Arya

    2012-01-01

    Full Text Available Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS. Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19–29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm or standard care only (control arm. Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329. Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82–1.44, <0.0001 and habituation (ES 1.05, 95% CI 0.53–1.57, =0.0001. Conclusion. Prenatal music exposure to mother significantly and favourably influences neonatal behaviour.

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

    Science.gov (United States)

    Arya, Ravindra; Chansoria, Maya; Konanki, Ramesh; Tiwari, Dileep K.

    2012-01-01

    Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19–29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm) or standard care only (control arm). Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329). Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82–1.44, P music exposure to mother significantly and favourably influences neonatal behaviour. PMID:22518187

  2. Active subnanometer spectral control of a random laser

    CERN Document Server

    Leonetti, Marco; 10.1063/1.4792759

    2013-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

  4. Shallow Semantic Parsing of Randomized Controlled Trial Reports

    OpenAIRE

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

    2006-01-01

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

  5. Cognitive effects of calligraphy therapy for older people: a randomized controlled trial in Hong Kong

    Directory of Open Access Journals (Sweden)

    Kwok TCY

    2011-10-01

    Full Text Available Timothy CY Kwok1,2, Xue Bai1,3, Henry SR Kao4,5, Jessie CY Li1, Florence KY Ho11Jockey Club Centre for Positive Ageing; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong; 3Department of Social Work and Social Administration; 4Department of Psychology, The University of Hong Kong, Hong Kong; 5Department of Psychology, Fu Jen Catholic University, TaiwanBackground: This pilot study investigated the effects of calligraphy therapy on cognitive function in older Hong Kong Chinese people with mild cognitive impairment.Methods: A single-blind, randomized controlled trial was carried out in a sample of 31 adults aged 65 years or older with mild cognitive impairment. They were randomly assigned to receive either intensive calligraphy training led by a trained research assistant for eight weeks (calligraphy group, n = 14 or no calligraphy treatment (control group, n = 17. Participants' cognitive function was assessed by the Chinese version of the Mini-Mental State Examination (CMMSE before and after calligraphy treatment. Repeated measures analysis of variance and paired samples t-tests were used to analyze the data.Results: A significant interaction effect of time and intervention was detected [F (1, 29 = 9.11, P = 0.005, η2= 0.24]. The calligraphy group was found to have a prominent increase in CMMSE global score, and scores in the cognitive areas of orientation, attention, and calculation after two months (∆M = 2.36, P < 0.01, whereas their counterparts in the control group experienced a decline in CMMSE score (∆M = -0.41, P < 0.05.Conclusion: Calligraphy therapy was effective for enhancing cognitive function in older people with mild cognitive impairment and should be incorporated as part of routine programs in both community and residential care settings.Keywords: calligraphy therapy, Chinese elderly, mild cognitive impairment, cognitive function, randomized controlled trial

  6. Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial

    Science.gov (United States)

    Bradley, Janet; Mony, Prem; Cunningham, Troy; Washington, Maryann; Bhat, Swarnarekha; Rao, Suman; Thomas, Annamma; S, Rajaram; Kar, Arin; N, Swaroop; B M, Ramesh; H L, Mohan; Fischer, Elizabeth; Crockett, Maryanne; Blanchard, James; Moses, Stephen; Avery, Lisa

    2016-01-01

    Background In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth. Methods All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken. Results Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better

  7. The manned space-laboratories control centre - MSCC. Operational functions and its implementation

    Science.gov (United States)

    Brogl, H.; Kehr, J.; Wlaka, M.

    This paper describes the functions of the MSCC during the operations of the Columbus Attached Laboratory and the Free Flying Laboratory as part of the In-Orbit-Infrastructure Ground Segment. For the Attached Laboratory, MSCC payload operations coordination for European experiments within the Attached Laboratory and elsewhere on the Space Station Freedom will be explained. The Free Flying Laboratory will be operated and maintained exclusively from the MSCC during its 30 years lifetime. Several operational scenarios will demonstrate the role of the MSCC during routine - and servicing operations: of main importance are the servicing activities of the Attached Laboratory and the Free Flyer at the Space Station as well as servicing of the Free Flyer by the European Space Plane Hermes. The MSCC will have complex operational-, communications-and management interfaces with the IOI Ground Segment, the Space Station User community and with the international partners. Columbus User Support Centres will be established in many European member states, which have to be coordinated by the MSCC to ensure the proper reception of the scientific data and to provide them with quick access to their experiments in space. For operations planning and execution of experiments in the Attached Laboratory, a close cooperation with the Space Station control authorities in the USA will be established. The paper will show the development of the MSCC being initially used for the upcoming Spacelab Mission D-2 (MSCC Phase-1) and later upgraded to a Columbus dedicated control centre (MSCC Phase-2). For the initial construction phase the establishing of MSCC requirements, the philosophie used for the definition of the 'basic infrastructure' and key features of the installed facilities will be addressed. Resulting from Columbus and D-2 requirements, the sizing of the building with respect to controlrooms, conference rooms, office spare and simulation high-bay areas will be discussed. The defined 'basic

  8. Active control of tensegrity structures under random excitation

    Science.gov (United States)

    Ganesh Raja, M.; Narayanan, S.

    2007-06-01

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

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

    OpenAIRE

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

    2015-01-01

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

  10. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy.

    Science.gov (United States)

    Klopstock, Thomas; Yu-Wai-Man, Patrick; Dimitriadis, Konstantinos; Rouleau, Jacinthe; Heck, Suzette; Bailie, Maura; Atawan, Alaa; Chattopadhyay, Sandip; Schubert, Marion; Garip, Aylin; Kernt, Marcus; Petraki, Diana; Rummey, Christian; Leinonen, Mika; Metz, Günther; Griffiths, Philip G; Meier, Thomas; Chinnery, Patrick F

    2011-09-01

    Major advances in understanding the pathogenesis of inherited metabolic disease caused by mitochondrial DNA mutations have yet to translate into treatments of proven efficacy. Leber's hereditary optic neuropathy is the most common mitochondrial DNA disorder causing irreversible blindness in young adult life. Anecdotal reports support the use of idebenone in Leber's hereditary optic neuropathy, but this has not been evaluated in a randomized controlled trial. We conducted a 24-week multi-centre double-blind, randomized, placebo-controlled trial in 85 patients with Leber's hereditary optic neuropathy due to m.3460G>A, m.11778G>A, and m.14484T>C or mitochondrial DNA mutations. The active drug was idebenone 900 mg/day. The primary end-point was the best recovery in visual acuity. The main secondary end-point was the change in best visual acuity. Other secondary end-points were changes in visual acuity of the best eye at baseline and changes in visual acuity for both eyes in each patient. Colour-contrast sensitivity and retinal nerve fibre layer thickness were measured in subgroups. Idebenone was safe and well tolerated. The primary end-point did not reach statistical significance in the intention to treat population. However, post hoc interaction analysis showed a different response to idebenone in patients with discordant visual acuities at baseline; in these patients, all secondary end-points were significantly different between the idebenone and placebo groups. This first randomized controlled trial in the mitochondrial disorder, Leber's hereditary optic neuropathy, provides evidence that patients with discordant visual acuities are the most likely to benefit from idebenone treatment, which is safe and well tolerated.

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  12. Infection Control in Child Day Care Centres : Development and evaluation of a hand hygiene intervention

    NARCIS (Netherlands)

    T.P. Zomer (Tizza)

    2015-01-01

    markdownabstract__Abstract__ Children attending child day care centres are at increased risk of acquiring gastrointestinal and respiratory infections compared to children cared for at home. Hand hygiene is known to be an effective measure to prevent infections. However, compliance with hand hygiene

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

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

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

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

    Science.gov (United States)

    Timms, M S; Temple, R H

    2002-06-01

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

  15. Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gustafsson Lars

    2008-03-01

    Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria

  16. Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial.

    Science.gov (United States)

    Chen, Keng; Yap, Lee Mei; Marks, Robin; Shumack, Stephen

    2003-11-01

    A dual-centre, randomized, double-blind, vehicle-controlled study was conducted to evaluate the safety and efficacy of short courses of therapy with imiquimod 5% cream in clearing >/=75% of baseline solar keratoses (SK) within a field of treatment. Subjects with 5-15 baseline SK within one treatment area (scalp, forehead and temples, or both cheeks) were randomized to apply imiquimod or vehicle cream to the entire treatment area three times a week for 3 weeks. Subjects were assessed 4 weeks after completing the first course for clearance of lesions. Subjects with cream. Subjects with >/=75% clearance were followed up until study completion without further therapy. All subjects were evaluated at the study endpoint of 14 weeks after initiating therapy for assessment of the primary outcome (>/=75% clearance of baseline solar keratoses). Twenty-one out of 29 (72%) imiquimod-treated subjects cleared >/=75% of baseline lesions compared with 3/10 (30%) subjects using the vehicle cream (Fisher's exact test, P = 0.027). Imiquimod was well tolerated. The present study has a short follow-up endpoint, but suggests that imiquimod is a potential therapeutic alternative in patients with SK. PMID:14616490

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

    Science.gov (United States)

    Brown, Ian; Sheeran, Paschal; Reuber, Markus

    2009-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Daniela Mapelli

    2013-08-01

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

  19. A controllable stitch layout strategy for random needle embroidery

    Institute of Scientific and Technical Information of China (English)

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

    2014-01-01

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

  20. Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

    Directory of Open Access Journals (Sweden)

    van Balkom Anton

    2008-11-01

    Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

  1. Infection Control in Child Day Care Centres: Development and evaluation of a hand hygiene intervention

    OpenAIRE

    Zomer, Tizza

    2015-01-01

    markdownabstract__Abstract__ Children attending child day care centres are at increased risk of acquiring gastrointestinal and respiratory infections compared to children cared for at home. Hand hygiene is known to be an effective measure to prevent infections. However, compliance with hand hygiene guidelines is generally low. In order to develop successful interventions to improve hand hygiene compliance and reduce gastrointestinal and respiratory infections among children attending day care...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-07-01

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

  3. Unified Desktop for Monitoring & Control Applications - The Open Navigator Framework Applied for Control Centre and EGSE Applications

    Science.gov (United States)

    Brauer, U.

    2007-08-01

    The Open Navigator Framework (ONF) was developed to provide a unified and scalable platform for user interface integration. The main objective for the framework was to raise usability of monitoring and control consoles and to provide a reuse of software components in different application areas. ONF is currently applied for the Columbus onboard crew interface, the commanding application for the Columbus Control Centre, the Columbus user facilities specialized user interfaces, the Mission Execution Crew Assistant (MECA) study and EADS Astrium internal R&D projects. ONF provides a well documented and proven middleware for GUI components (Java plugin interface, simplified concept similar to Eclipse). The overall application configuration is performed within a graphical user interface for layout and component selection. The end-user does not have to work in the underlying XML configuration files. ONF was optimized to provide harmonized user interfaces for monitoring and command consoles. It provides many convenience functions designed together with flight controllers and onboard crew: user defined workspaces, incl. support for multi screens efficient communication mechanism between the components integrated web browsing and documentation search &viewing consistent and integrated menus and shortcuts common logging and application configuration (properties) supervision interface for remote plugin GUI access (web based) A large number of operationally proven ONF components have been developed: Command Stack & History: Release of commands and follow up the command acknowledges System Message Panel: Browse, filter and search system messages/events Unified Synoptic System: Generic synoptic display system Situational Awareness : Show overall subsystem status based on monitoring of key parameters System Model Browser: Browse mission database defintions (measurements, commands, events) Flight Procedure Executor: Execute checklist and logical flow interactive procedures Web

  4. Randomized Controlled Trials to Define Viral Load Thresholds for Cytomegalovirus Pre-Emptive Therapy

    Science.gov (United States)

    Griffiths, Paul D.; Rothwell, Emily; Raza, Mohammed; Wilmore, Stephanie; Doyle, Tomas; Harber, Mark; O’Beirne, James; Mackinnon, Stephen; Jones, Gareth; Thorburn, Douglas; Mattes, Frank; Nebbia, Gaia; Atabani, Sowsan; Smith, Colette; Stanton, Anna; Emery, Vincent C.

    2016-01-01

    Background To help decide when to start and when to stop pre-emptive therapy for cytomegalovirus infection, we conducted two open-label randomized controlled trials in renal, liver and bone marrow transplant recipients in a single centre where pre-emptive therapy is indicated if viraemia exceeds 3000 genomes/ml (2520 IU/ml) of whole blood. Methods Patients with two consecutive viraemia episodes each below 3000 genomes/ml were randomized to continue monitoring or to immediate treatment (Part A). A separate group of patients with viral load greater than 3000 genomes/ml was randomized to stop pre-emptive therapy when two consecutive levels less than 200 genomes/ml (168 IU/ml) or less than 3000 genomes/ml were obtained (Part B). For both parts, the primary endpoint was the occurrence of a separate episode of viraemia requiring treatment because it was greater than 3000 genomes/ml. Results In Part A, the primary endpoint was not significantly different between the two arms; 18/32 (56%) in the monitor arm had viraemia greater than 3000 genomes/ml compared to 10/27 (37%) in the immediate treatment arm (p = 0.193). However, the time to developing an episode of viraemia greater than 3000 genomes/ml was significantly delayed among those randomized to immediate treatment (p = 0.022). In Part B, the primary endpoint was not significantly different between the two arms; 19/55 (35%) in the less than 200 genomes/ml arm subsequently had viraemia greater than 3000 genomes/ml compared to 23/51 (45%) among those randomized to stop treatment in the less than 3000 genomes/ml arm (p = 0.322). However, the duration of antiviral treatment was significantly shorter (p = 0.0012) in those randomized to stop treatment when viraemia was less than 3000 genomes/ml. Discussion The results illustrate that patients have continuing risks for CMV infection with limited time available for intervention. We see no need to alter current rules for stopping or starting pre-emptive therapy. PMID:27684379

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

    Science.gov (United States)

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

    2006-01-01

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

  6. Effect of yoga on quality of life of CLBP patients: A randomized control study

    Directory of Open Access Journals (Sweden)

    Tekur Padmini

    2010-01-01

    Full Text Available Context: In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP, 12 to 16 weeks of intervention were found effective in reducing pain and disability. Aim: To study the efficacy of a residential short term intensive yoga program on quality of life in CLBP. Materials and Methods: About 80 patients with CLBP (females 37 registered for a week long treatment at SVYASA Holistic Health Centre in Bengaluru, India. They were randomized into two groups (40 each. The yoga group practiced a specific module for CLBP comprising of asanas (physical postures, pranayama (breathing practices, meditation and lectures on yoga philosophy. The control group practiced physical therapy exercises for back pain. Perceived stress scale (PSS was used to measure baseline stress levels. Outcome measures were WHOQOL Bref for quality of life and straight leg raising test (SLR using a Goniometer. Results: There were significant negative correlations (Pearson′s, P<0.005, r>0.30 between baseline PSS with all four domains and the total score of WHOQOLBref. All the four domains′ WHOQOLBref improved in the yoga group (repeated measures ANOVA P=0.001 with significant groupFNx01time interaction (P<0.05 and differences between groups (P<0.01. SLR increased in both groups (P=0.001 with higher increase in yoga (31.1 % right, 28.4 % left than control (18.7% right, 21.5 % left group with significant groupFNx01time interaction (SLR right leg P=0.044. Conclusion: In CLBP, a negative correlation exists between stress and quality of life. Yoga increases quality of life and spinal flexibility better than physical therapy exercises.

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

    Science.gov (United States)

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

    2008-01-01

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

  8. Escitalopram in obsessive-compulsive disorder: a randomized, placebo-controlled, paroxetine-referenced, fixed-dose, 24-week study

    DEFF Research Database (Denmark)

    Stein, Dan J; Andersen, Elisabeth Anne Wreford; Tonnoir, Brigitte;

    2007-01-01

    OBJECTIVE: A randomized, placebo controlled fixed-dose trial was undertaken to determine the efficacy and tolerability of escitalopram in obsessive-compulsive disorder (OCD), using paroxetine as the active reference. RESEARCH DESIGN AND METHODS: A total of 466 adults with OCD from specialized...... clinical centres, psychiatric hospital departments, psychiatric practices, or general practice were randomized to one of four treatment groups: escitalopram 10 mg/day (n = 116), escitalopram 20 mg/day (n = 116), paroxetine 40 mg/day (n = 119), or placebo (n = 115) for 24 weeks. The primary efficacy...... of adverse events, and on changes in vital signs (blood pressure and pulse). Main outcome measures; RESULTS: Escitalopram 20 mg/day was superior to placebo on the primary and all secondary outcome endpoints, including remission. Escitalopram 10 mg/day and paroxetine 40 mg/day were also effective on...

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

    Directory of Open Access Journals (Sweden)

    Cécile Pino

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

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

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

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

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

    Science.gov (United States)

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

    2014-08-01

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

  12. Identifying and controlling a multiresistant pseudomonas aeruginosa outbreak in a latin-american cancer centre and its associated risk factors

    Directory of Open Access Journals (Sweden)

    Jorge Alberto Cortes

    2009-04-01

    Full Text Available Pseudomonas aeruginosa is an important and frightening microorganism for patients suffering from cancer. Multiresistant P. aeruginosa (MRPA may appear as a consequence of exposure to multiple antibiotics or from a breakdown in infection control practices. This article reports an MRPA outbreak in a cancer treatment centre and the consequent case control study. Mechanical ventilation was identified as being the main risk factor for developing MRPA colonisation or infection; molecular analysis confirmed the outbreak. A multifaceted strategy was adopted, involving reinforcing hand-washing practices, contact isolation, antibiotic restriction and suction devices for mechanically-ventilated patients. MRPA was controlled and the outbreak ended. Such strategy may be effective in controlling MRPS in low-resource environments amongst high risk cancer patients.

  13. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

    Directory of Open Access Journals (Sweden)

    Wong Samuel YS

    2011-11-01

    Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

  14. Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Prinsen Hetty

    2012-06-01

    Full Text Available Abstract Background Postcancer fatigue is a frequently occurring, severe, and invalidating problem, impairing quality of life. Although it is possible to effectively treat postcancer fatigue with cognitive behaviour therapy, the nature of the underlying (neurophysiology of postcancer fatigue remains unclear. Physiological aspects of fatigue include peripheral fatigue, originating in muscle or the neuromuscular junction; central fatigue, originating in nerves, spinal cord, and brain; and physical deconditioning, resulting from a decreased cardiopulmonary function. Studies on physiological aspects of postcancer fatigue mainly concentrate on deconditioning. Peripheral and central fatigue and brain morphology and function have been studied for patients with fatigue in the context of chronic fatigue syndrome and neuromuscular diseases and show several characteristic differences with healthy controls. Methods/design Fifty seven severely fatigued and 21 non-fatigued cancer survivors will be recruited from the Radboud University Nijmegen Medical Centre. Participants should have completed treatment of a malignant, solid tumour minimal one year earlier and should have no evidence of disease recurrence. Severely fatigued patients are randomly assigned to either the intervention condition (cognitive behaviour therapy or the waiting list condition (start cognitive behaviour therapy after 6 months. All participants are assessed at baseline and the severely fatigued patients also after 6 months follow-up (at the end of cognitive behaviour therapy or waiting list. Primary outcome measures are fatigue severity, central and peripheral fatigue, brain morphology and function, and physical condition and activity. Discussion This study will be the first randomized controlled trial that characterizes (neurophysiological factors of fatigue in disease-free cancer survivors and evaluates to which extent these factors can be influenced by cognitive behaviour therapy

  15. 23rd June 2010 - University of Bristol Head of the Aerospace Engineering Department and Professor of Aerospace Dynamics N. Lieven visiting CERN control centre with Beams Department Head P. Collier, visiting the LHC superconducting magnet test hall with R. Veness and CMS control centre with Collaboration Spokesperson G. Tonelli and CMS User J. Goldstein.

    CERN Multimedia

    Jean-Claude Gadmer

    2010-01-01

    23rd June 2010 - University of Bristol Head of the Aerospace Engineering Department and Professor of Aerospace Dynamics N. Lieven visiting CERN control centre with Beams Department Head P. Collier, visiting the LHC superconducting magnet test hall with R. Veness and CMS control centre with Collaboration Spokesperson G. Tonelli and CMS User J. Goldstein.

  16. 中药参松养心胶囊改善冠心病患者异位心律的随机双盲、阳性药对照、多中心临床研究%A random double blind,positive medication control and multi-centre clinical study on the effects of traditional Chinese medicine Shensong Yangxin capsule in improving ectopic cardiac rhythm in coronary heart disease patients

    Institute of Scientific and Technical Information of China (English)

    徐贵成; 霍保民; 吴以岭; 高学东; 王秋风; 尹倚艰; 齐晓琳; 杨立波

    2004-01-01

    OBJECTIVE: To discuss the clinical therapeutic effectiveness and safety of Ginseng-spikenard heart nourishing capsule to ventricular extrasystole in coronary heart disease. METHODS:206 cases of patients accorded with inclusive criteria from outpatient or inpatient department were randomly allocated with randomly double blind double analogue into therapy group with 103 cases and treated with the capsule(4 capsules,3 times a day). 103 cases were allocated into control group and treated with Xinluning(2 tablets,3 times a day). Therapeutic effectiveness and toxic side effects on ventricular extrasystole,main symptoms,and electrocardiogram were assessed after 4 weeks. RESULTS:The effective rate of ventricular extrasystole in the therapy group was 35.0% (36/103) and the total effective rate was 69.0% (71/103), which were markedly higher than those of the control group[18.4% (19/103) and 48.5% (50/103) respectively](Z=3.261,P=0.001). CONCLUSION:The therapeutic effectiveness of the capsule in the treatment of ventricular extrasystole in coronary heart disease was obviously better than that of Xinluning,and the side effects was not found in the routine test of blood,urine,stool and liver,and kidney functions.%目的:探讨参松养心胶囊对冠心病室性期前收缩的临床疗效和安全性. 方法:对符合纳入标准的 206例门诊或住院患者,采用随机双盲双模拟对照,按 1:1随机分为治疗组 103例,给予参松养心胶囊( 4粒, 3次 /d),对照组 103例给予心律宁片( 2片, 3次 /d). 4周后进行室性期前收缩、主要症状、心电图等疗效及毒副作用的评估. 结果:治疗组室性期前收缩显效率 35.0%( 36/103),总有效率 69.0%( 71/103),明显优于对照组显效率 18.4%( 19/103)与总有效率 48.5%( 50/103)( Z=- 3.261, P=0.001). 结论:参松养心胶囊治疗冠心病室性期早搏明显优于心律宁片,未见对血、尿、便常规,肝、肾功能等的不良影响.

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

    Directory of Open Access Journals (Sweden)

    Mohammad Shariati

    2008-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Jorge Luiz de Brito-Gomes

    2015-09-01

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

  19. Enhanced Algebraic Error Control for Random Linear Network Coding

    CERN Document Server

    Yan, Zhiyuan

    2012-01-01

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

  20. Role of the "National Reference Centre for Genetically Modified Organisms (GMO) detection" in the official control of food and feed.

    Science.gov (United States)

    Ciabatti, I; Marchesi, U; Froiio, A; Paternò, A; Ruggeri, M; Amaddeo, D

    2005-08-01

    The National Reference Centre for Genetically Modified Organisms (GMO) detection was established in 2002 within the Istituto Zooprofilattico Sperimentale Lazio e Toscana, with the aim of providing scientific and technical support to the National Health System and to the Ministry of Health within the scope of the regulation of GMO use in food and feed.The recently adopted EU legislation on GMOs (Regulation CE no. 1829/2003 and no. 1830/2003) introduced more rigorous procedures for the authorisation, labelling and analytical control of food and feed consisting, containing or derived from GMOs. The National Reference Centre, besides its institutional tasks as one of the laboratories of the Italian National Health System, collects and analyses data and results of the national official control of GMOs; carries out scientific research aimed at developing, improving, validating and harmonising detection and quantification methods, in cooperation with other scientific institutions, the Community Reference Laboratory and within the European Network of GMOs laboratories (ENGL); collaborates with the Ministry of Health in the definition of control programmes and promotes educational and training initiatives. Objectives defined for 2004-2006, activities in progress and goals already achieved are presented. PMID:16244921

  1. Effects of aerobic exercise training on maternal and neonatal outcome: a randomized controlled trial on pregnant women in Iran

    International Nuclear Information System (INIS)

    Objective: To assess the effect of aerobic exercise training on maternal and neonatal outcome. Methods: The case-control study was conducted between January and July, 2011. It was approved by the Research Ethics Committee of Toyserkan Azad University, and data was collected at prenatal clinics and delivery centres located in Hamedan, Iran. It comprised 80 pregnant women between 20-26 weeks of gestation randomly assigned to two equal and matching groups of cases and controls. The intervention group did exercise continuously on a bicycle ergometre for 15 minutes, three times a week; the intensity being 50-60% of maximal heart rate. The control group did not do any exercise training. All information was obtained from the clinics, delivery centres, and from the reports of delivery room midwives. Results: No statistically significant difference was found between the two groups in gestational weight gain, pregnancy length, mode of delivery, first and second stage of labour, perineal tear, and 1st and 5th min Apgar score. Mean neonatal weight was significantly less in the intervention group than the control group (p<0.001). Conclusion: Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate. (author)

  2. Glycaemic control of diabetic patients in an urban primary health care setting in Sarawak: the Tanah Puteh Health Centre experience.

    Science.gov (United States)

    Wong, J S; Rahimah, N

    2004-08-01

    Achieving glycaemic goals in diabetics has always been a problem, especially in a developing country with inadequate facilities such as in Sarawak in Malaysia. There are no reported studies on the control of diabetes mellitus in a diabetic clinic in the primary health care setting in Sarawak. This paper describes the profile of 1031 patients treated in Klinik Kesihatan Tanah Puteh Health Centre. The mean age was 59 years, the mean BMI 27 kg/m2. There was a female preponderance and mainly type-2 diabetes. Mean HbA1c was 7.4%. Glycaemic control was optimal in 28% (HbA1c 7.5%). Reasonable glycaemic control can be achieved in the primary health care setting in Sarawak. PMID:15727390

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

    OpenAIRE

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

    2015-01-01

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

  4. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079

    Directory of Open Access Journals (Sweden)

    Franck Annette

    2008-07-01

    Full Text Available Abstract Background Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency. Design This is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax® suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus® and PDS® will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 ± 1 months after surgery. Conclusion This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient. Trial registration NCT005725079

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

    Directory of Open Access Journals (Sweden)

    Yulian Jin

    2015-01-01

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

  6. Evaluating cognitive effort in a randomized controlled trial.

    Science.gov (United States)

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

    2016-09-01

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

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

    Science.gov (United States)

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

    2013-05-01

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

  8. Compliance with infection control practices in sputum microscopy centres: a study from Kerala, India.

    Science.gov (United States)

    Aslesh, O P; Ubaid, N P; Nagaraja, S B; Shewade, H D; Padmanabhan, K V; Naik, B R; Satpati, M; Blesson, S; Jayasree, A K

    2015-12-21

    Contexte : Une des stratégies du Programme national révisé de lutte contre la tuberculose (RNTCP) en Inde consiste à lutter contre la tuberculose en augmentant la détection des cas à travers un réseau national de Centres de Diagnostic par Microscopie (DMC). La mise en oeuvre des précautions standard de lutte contre les infections dans ces DMC est très importante pour prévenir la transmission des infections, non seulement vis-à-vis du personnel de laboratoire, mais également vis-à-vis de la population générale. Cependant, en Inde, ceci n'a pas été évalué par une agence externe.Méthode : Une étude transversale a été réalisée pour évaluer les connaissances, la structure et l'adhésion aux pratiques de lutte contre l'infection (ICP) dans les 38 DMC du district de Kannur, état du Kerala, Inde en 2015. Grâce à des observations et à des entretiens, les investigateurs ont recueilli des données dans un format structuré.Résultats : Les connaissances d'ensemble relatives à la lutte contre l'infection ont été jugées satisfaisantes pour 29% des techniciens de laboratoire. Le niveau d'ensemble des centres en matière de lutte contre l'infection a été satisfaisant dans 61% des DMC. L'adhésion aux pratiques de lutte contre l'infection a été satisfaisante dans 45% des DMC. Les connaissances relatives aux pratiques d'ICP ont été meilleures dans les DMC du gouvernement tandis que les installations et l'adhésion aux directives de gestion des déchets biomédicaux ont été meilleures dans les DMC privés.Conclusion : Connaissant le risque très élevé d'infection parmi les techniciens de laboratoire, il y a un besoin urgent de corriger les déficiences des pratiques de lutte contre l'infection.

  9. Continence promotion for older hospital patients following surgery for fractured neck of femur: Pilot of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lynne Parkinson

    2007-01-01

    Full Text Available Lynne Parkinson1,2, Pauline Chiarelli3, Jennifer Byrne1, Richard Gibson1, Suzanne McNeill4, Gillian Lloyd5, Wendy Watts6, Julie Byles11Research Centre for Gender, Health and Ageing, Faculty of Health, The University of Newcastle, NSW, Australia; 2Hunter Ageing Research, Faculty of Health, The University of Newcastle, NSW, Australia; 3Faculty of Health, The University of Newcastle, NSW, Australia; 4NC Trauma Orthopedics, John Hunter Hospital, New Lambton Heights, NSW, Australia; 5Hunter New England Health, Wallsend Community Health Centre, Wallsend, NSW, Australia; 6Royal Newcastle Centre, John Hunter Hospital, New Lambton Heights, NSW, AustraliaAbstract: Evidence suggests that bladder control problems develop or worsen as a result of fractured neck of femur (#NOF and its subsequent management. The primary aim of this study was to reduce the prevalence and severity of post surgery continence problems among patients, aged from 60-years, undergoing surgery for #NOF, using a best practice “case-management model” multifactorial intervention. Eligible consenting patients admitted with #NOF were randomized to intervention or control group. Self-report questionnaires compared pre-surgery, post surgery, and follow-up continence status between groups.This pilot randomized controlled trial, which included 45 eligible patients aged 60 to 93-years, found no evidence that the intervention was effective in reducing prevalence of post-surgery incontinence in this acute setting. Staff surveys highlighted the need for open communication between the research team and hospital staff. Unclear results were attributed to the small sample size.A central outcome was evidence that intervention to improve continence management for older people post-surgery is imperative. Focused assessment and treatment for those most at risk of incontinence after #NOF would be more acceptable to staff and a more efficient use of resources. A simple screening tool would ensure that

  10. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

    Directory of Open Access Journals (Sweden)

    Oedegaard Ketil J

    2010-02-01

    Full Text Available Abstract Background The treatment of depressive phases of bipolar disorder is challenging. The effects of the commonly used antidepressants in bipolar depression are questionable. Electroconvulsive therapy is generally considered to be the most effective treatment even if there are no randomized controlled trials of electroconvulsive therapy in bipolar depression. The safety of electroconvulsive therapy is well documented, but there are some controversies as to the cognitive side effects. The aim of this study is to compare the effects and side effects of electroconvulsive therapy to pharmacological treatment in treatment resistant bipolar depression. Cognitive changes and quality of life during the treatment will be assessed. Methods/Design A prospective, randomised controlled, multi-centre six- week acute treatment trial with seven clinical assessments. Follow up visit at 26 weeks or until remission (max 52 weeks. A neuropsychological test battery designed to be sensitive to changes in cognitive function will be used. Setting: Nine study centres across Norway, all acute psychiatric departments. Sample: n = 132 patients, aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, Montgomery Åsberg Depression Rating Scale Score of at least 25 at baseline. Intervention: Intervention group: 3 sessions per week for up to 6 weeks, total up to 18 sessions. Control group: algorithm-based pharmacological treatment as usual. Discussion This study is the first randomized controlled trial that aims to investigate whether electroconvulsive therapy is better than pharmacological treatment as usual in treatment resistant bipolar depression. Possible long lasting cognitive side effects will be evaluated. The study is investigator initiated, without support from industry. Trial registration NCT00664976

  11. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    OpenAIRE

    Krämer Jürgen; Knauer Christine; Mansmann Ulrich; Witte Steffen; Streitberger Konrad; Scharf Hanns-Peter; Victor Norbert

    2004-01-01

    Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third co...

  12. Radiation protection control report for the research centre Seibersdorf for the year 2001

    International Nuclear Information System (INIS)

    In order to prove that workers and the environment of the Research Centre Seibersdorf are not exposed to undue radiation exposures, an extensive program of evidence monitoring is carried out in and around the Research Centre Seibersdorf. The program ranges from workers' surveillance on external and internal radiation exposure via the monitoring of working places and laboratories with regard to external dose rate, surface contamination and activity concentration in air, the surveillance of releases to immersion monitoring with regard to external dose rate and activity concentrations in the vicinity of the Research Center. The present report comprises a summary of the results of this radiation exposure surveillance of workers and the vicinity of the Research Center in the year 2001. The average radiation exposure of all surveyed persons in the year 2001 was 1.41 mSv including background radiation (1.09 mSv). Subtracting this natural background level, the net annual dose amounts to 0.32 mSv corresponding to 1.6 % of the limit for occupationally exposed persons. In the past year no surpassing of dose limits was observed. The maximum dose of a single worker was 5.46 mSv/a (27 % of the legal limit of 20 mSv/a). Workers which were occupied with open radioactive substances, were surveyed for incorporation. They showed no incorporations above limits, in most surveyed cases no incorporation at all was detected. Releases to the environment were, as in the past years, below limits set by the authorities, generally by orders of magnitude. For the shut-down research reactor for which the release monitoring was continued, the releases in the year 2001 amounted to 0.13 %, for the incineration plant to 0.11 % (alpha-emitters) and 0.0038 % (beta-emitters), for the Safeguard Analytical Laboratory to 3.2 % (alpha-emitters) and 0.67 % (beta-emitters), for the Hot Cell Laboratory to 3.0 % (alpha-emitters) and 0.4 (beta-emitters), and the radiopharmaceutical facility 0.02 % for 131I and

  13. Bowel and Bladder-Control Anxiety: A Preliminary Description of a Viscerally-Centred Phobic Syndrome

    OpenAIRE

    Kamboj, S. K.; Langhoff, C.; Pajak, R.; A. Zhu; A. Chevalier; Watson, S.

    2013-01-01

    Background: People with anxiety disorders occasionally report fears about losing control of basic bodily functions in public. These anxieties often occur in the absence of physical disorder and have previously been recognized as “obsessive” anxieties reflecting a preoccupation with loss of bowel/bladder control. Motivated by our observations of the non-trivial occurrence of such anxieties in our clinical practice we sought to fill a gap in the current understanding of “bowel/bladder-control a...

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

    Science.gov (United States)

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

    2007-10-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2006-09-15

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

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

    NARCIS (Netherlands)

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

    2004-01-01

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

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

    Directory of Open Access Journals (Sweden)

    R. Jadeja

    2015-12-01

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

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

    Institute of Scientific and Technical Information of China (English)

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

    2004-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

  20. Integrating of renewable energy in operation system: the Special Regime Control Centre (CECRE); Integracion de la energia renovable en la operacion del sistema: El Centro de Control de regimen especial (CECRE)

    Energy Technology Data Exchange (ETDEWEB)

    Division, M.

    2007-07-01

    The implementation of Red Electrica de Espana Special Regime Control Centre (CECRE) has demonstrated the Spanish System Operators commitment of integrating the maximum possible wind power generation into the electrical system compatible with secure operation. With this leadership initiative,for the first time in the world, a System Operator Control Centre (CECRE) has succeeded in sending power control instructions to wind power generators over the country through Generation Control Centres (CGC) to which these generators must be connected complying with the Spanish Rules. (Author)

  1. Practices of Radiotherapy Equipment Quality Control in Radiotherapy Centres in Croatia

    OpenAIRE

    Švabić, Manda; Jurković, Slaven; Faj, Dario; Kasabašić, Mladen; Smilović Radojčić, Djeni; Ivković, Ana

    2008-01-01

    From the prescription to the delivery of a radiotherapy treatment, a team of professionals from a number of disciplines is involved. In this way significant potential for errors leading to an accidental exposure becomes apparent. Comprehensive quality assurance/quality control (QA/QC) program to minimize such errors is, therefore, required. One aspect of QA/QC program is quality control of the equipment. In this paper we present experiences in establishing QC procedures in our cen...

  2. LigaSure versus Conventional Suture Ligature for Vaginal Hysterectomy: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mohamed Abd Elzaher, a, b, Ashraf Moawad, a, c and Hanaa Abu-Ria

    2011-07-01

    Full Text Available Introduction: Vaginal hysterectomy is considered to be the method of choice for removal of the uterus. Of particular concern for the vaginal surgeon is the ability to access, visualize, and legate structures while maintaining adequate hemostasis. Surgical hemostasis can be secured by a variety of methods, including mechanical means (sutures or vessel coagulation (diathermy. Electro-surgical vessel sealing (LigaSure is a new hemostatic system based on the combination of pressure and bipolar electrical energy and is able to seal vessels up to 7 mm in diameter. Objective: To assess the safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles during vaginal hysterectomy in comparison with the conventional method of securing the pedicles by suture ligation. Design: Prospective randomized controlled trial. Setting: Obstetrics and Gynecology departments (Al-Kharj University Hospital- KSA, Enjab Hospital - UAE and Gulf Medical College and Research Centre- UAE. Methods: 80 patients undergoing vaginal hysterectomy for benign conditions were randomized to either LigaSure group (n=40 or Suture group (n=40. Main outcome measures: The primary outcome measures were the operative time and blood loss while the secondary outcome measures were the hospital stay and intra- and post-operative complications. Results: Patients in the LigaSure group had a significantly reduced operating time (37.1 ± 8.9 min vs. 63.8 ± 10.9 min; P < 0.001, operative blood loss (125.5 ± 33.2 mL vs. 264.6 ± 70.4 mL; P < 0.001, requirement of surgical sutures(1.2 ± 0.4 units vs. 8.2 ± 0.4 units; p < 0.001, pain status (2.0 ± 0.6 vs. 3.7 ± 0.7; P < 0.001, and hospital stay (30.3 ± 2.5 h vs. 45.7 ±10.5 h; P < 0.001 compared to the control group. The overall complication rate in the study was 10 % (8/80, and did not differ between patients of the LigaSure and control group. Conclusion: The use of LigaSure device can reduce operative time. It allows

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

    Directory of Open Access Journals (Sweden)

    Muhammad Farrukh Yaqub

    2012-01-01

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

  4. Cost-effectiveness of Occupational Therapy in Older People: Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Yamauchi, Keita

    2016-06-01

    A systematic review of the cost-effectiveness of occupational therapy for older people was conducted. MEDLINE, CINAHL, Web of Science, PsycINFO, Cochrane Library, OT seeker and unpublished trials registers were searched. Reference lists of all potentially eligible studies were searched with no language restrictions. We included trial-based full economic evaluations that considered both costs and outcomes in occupational therapy for older people compared with standard care (i.e. other therapy) or no intervention. We reviewed each trial for methodological quality using the Cochrane risk of bias tool and assessed the quality of economic evaluations using a Drummond checklist. In the results of this review, we included five eligible studies (1-5) that were randomized controlled trials with high-quality economic evaluation. Two studies were full economic evaluations of interventions for fall prevention (1 and 2); two studies were full economic evaluations of preventive occupational therapy interventions (3 and 4; one was a comparison of an occupational therapy group with a social work group); one study was a full economic evaluation of occupational therapy for individuals with dementia (5). Two of the studies (one was preventive occupational therapy [3] and the other was occupational therapy for dementia [5]) found a significant effect and confirmed the cost-effectiveness of occupational therapy for older people compared with the control group. These studies found that occupational therapy for older people was clinically effective and cost-effective in comparison with standard care or other therapies. With reference to their clinical implication, these intervention studies (using a client-centred approach) suggested potentially cost-effective means to motivate clients to maintain their own health. However, this review has limitations because of the high heterogeneity of the reviewed studies on full economic evaluations of occupational therapy for older people. Future

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

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

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

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

    Institute of Scientific and Technical Information of China (English)

    Yan Kong; Wanli Dong; Chunfeng Liu

    2007-01-01

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

  7. Randomized controlled study of CBT in bronchial asthma

    Directory of Open Access Journals (Sweden)

    Grover Naveen

    2007-01-01

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

  8. Quality Control of Boar Sperm Processing : Implications from European AI Centres and Two Spermatology Reference Laboratories

    NARCIS (Netherlands)

    Riesenbeck, A; Schulze, M; Rüdiger, K; Henning, H; Waberski, D

    2015-01-01

    In recent years, increased automatization has resulted in a higher efficiency of boar semen processing in AI laboratories. Sophisticated laboratory management and efficient quality control programmes are needed for current tendencies in major pork-producing countries to reduce the sperm number per A

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    Chen, Xinjia

    2015-05-01

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

  11. Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Monica Köhn

    2013-01-01

    Full Text Available An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53±12 years were included. General stress level (measured using Perceived Stress Scale (PSS, burnout (Shirom-Melamed Burnout Questionnaire (SMBQ, anxiety and depression (Hospital Anxiety and Depression Scale (HADS, insomnia severity (Insomnia Severity Index (ISI, pain (visual analogue scale (VAS, and overall health status (Euro Quality of Life VAS (EQ-VAS were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P<0.000, anxiety (P<0.019, and overall health status (P<0.018 compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  13. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    OpenAIRE

    Logan Pip A; Leighton Mat P; Walker Marion F; Armstrong Sarah; Gladman John R F; Sach Tracey H; Smith Shirley; Newell Ossie; Avery Tony; Williams Hywel; Scott James; O’Neil Kathleen; McCluskey Annie; Leach Simon; Barer David

    2012-01-01

    Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings ...

  14. Visceral leishmaniasis on the Indian sub-continent: a multi-centre study of the costs of three interventions for the control of the sandfly vector, Phlebotomus argentipes.

    Science.gov (United States)

    Das, M; Banjara, M; Chowdhury, R; Kumar, V; Rijal, S; Joshi, A; Akhter, S; Das, P; Kroeger, A

    2008-12-01

    The sandflies that transmit the parasites causing human visceral leishmaniasis (VL) can be controlled by several methods, including indoor residual spraying (IRS), the use of long-lasting insecticidal nets (LLIN) and ecological vector management (EVM). The financial costs of each of these three methods of sandfly control have recently been assessed and compared, in a multi-centre study based on the Indian sub-continent. In each of the four study sites (two in Nepal and one each in India and Bangladesh), 24 neighbourhoods were randomly selected in districts with high incidences of VL. The costs of the three interventions were then prospectively assessed in each study neighbourhood, in the local currency, and then converted to U.S. dollars at the prevailing exchange rate in the country concerned. The costs of IRS, which ranged from U.S.$2.4-11.7 (mean = U.S.$5.9) per household-year, were greater than those of LLIN (U.S.$3.5-5.1/household-year, with a mean of U. S.$4.5) but less than those of EVM (U. S.$5.0- 14.0/household-year, with a mean of U.S.$8.7). These results indicate that LLIN and IRS may be the cheaper options for the control of sandflies on the Indian sub-continent, and that EVM should perhaps only be taken up as a complimentary and voluntary method. Various combinations of these interventions (based on country-specific social and economic factors) may, however, be the best and most cost-effective choice.

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

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

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

    NARCIS (Netherlands)

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

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic cort

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

    OpenAIRE

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

    2016-01-01

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

  4. 6th July 2010 - United Kingdom Science and Technology Facilities Council W. Whitehorn signing the guest book with Head of International relations F. Pauss, visiting the Computing Centre with Information Technology Department Head Deputy D. Foster, the LHC superconducting magnet test hall with Technology Department P. Strubin,the Centre Control Centre with Operation Group Leader M. Lamont and the CLIC/CTF3 facility with Project Leader J.-P. Delahaye.

    CERN Multimedia

    Teams : M. Brice, JC Gadmer

    2010-01-01

    6th July 2010 - United Kingdom Science and Technology Facilities Council W. Whitehorn signing the guest book with Head of International relations F. Pauss, visiting the Computing Centre with Information Technology Department Head Deputy D. Foster, the LHC superconducting magnet test hall with Technology Department P. Strubin,the Centre Control Centre with Operation Group Leader M. Lamont and the CLIC/CTF3 facility with Project Leader J.-P. Delahaye.

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

    OpenAIRE

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-04-13

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

  7. Quality control at the Regional Centre of Nuclear Sciences chemical dosimetry laboratory

    Energy Technology Data Exchange (ETDEWEB)

    Souza, Vivianne L.B. de; Melo, Roberto T. de; Silva, Danubia B. da; Pedroza, Eryka H.; Rodrigues, Kelia R.G.; Cunha, Manuela S. da; Figueiredo, Marcela D.C. de [Centro Regional de Ciencias Nucleares (CRCN-NE/CNEN-PE), Recife, PE (Brazil); Oliveira, Aristides, E-mail: vlsouza@cnen.gov.b, E-mail: rtmelo@cnen.gov.b [Hospital de Cancer de Pernambuco, Recife, PE (Brazil)

    2011-07-01

    Standards for accreditation of laboratories as in ISO 9001 in section: 4.11 require inspection, measuring and equipment testing; likewise, IEC 17025: 2005 in section: 5.5.2 requires the equipment to be calibrated or verified before being put into use. In our laboratory, quality control is often accomplished by standards set done by the laboratory scientists themselves; however, at present, Hellma secondary calibration standards (4026 - Holmium oxide - Filters: F0, F2, F3, F4 and filter didymium - F7) have been used in order to verify if errors in the laboratory have been close to the 1-2% margin. Control graphs were made by using the results of synthetically prepared standards and standardized spectral calibration certificates. The set of secondary calibration standards permits to check the accuracy of the spectrophotometers used in research for both the absorbance in the visible spectrum (at 440, 465, 546, 590 and 635 nm wavelengths) and for the wavelengths (270, 280, 300, 320 nm) of the ultraviolet light. Filters (F0, F2, F3, F4 and F7) are stable and do not suffer the influence of temperature (the influence is negligible), the F0 filter was being used as a blank. The purpose is to verify whether the spectrometer needs adjustments, an important procedure to check absorbance stability, baseline flatness, slit width accuracy and stray radiation. The calibration tests are performed annually in our laboratory and recalibration of Hellma secondary standards is recommended every two years. The results show that the Chemical Dosimetry Laboratory in CRCN has a calibrated spectrophotometer and their synthetic standards for Fricke dosimetry could be used as an alternative method for testing the proficiency and competence of calibration laboratories in accordance with the regulations and standards. (author)

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

    OpenAIRE

    Messina, Nena; Calhoun, Stacy; Warda, Umme

    2012-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  10. The effects of steroidal contraceptives on the well-being and sexuality of women: a double-blind, placebo-controlled, two-centre study of combined and progestogen-only methods.

    Science.gov (United States)

    Graham, C A; Ramos, R; Bancroft, J; Maglaya, C; Farley, T M

    1995-12-01

    A placebo-controlled, double-blind study was carried out to assess the direct hormonal effects of combined and progestogen-only oral contraceptives on well-being and sexuality of women in two contrasting cultures. One-hundred-fifty women, who had been sterilised or whose partners had been vasectomised, were recruited from two centres-Manila, Philippines, and Edinburgh, Scotland. After one month pretreatment assessment, women were randomly assigned to one of three treatments (combined oral contraceptive (COC), progestogen-only pill (POP), or placebo; 50 within each treatment group, 25 per centre) and continued on treatment for four months. Assessment was by daily ratings, questionnaires and interviews. The COC adversely affected sexuality in the Edinburgh women, with 12 of the 25 women in this group also reporting the side effect of reduced sexual interest. There were modest negative effects of the combined pill on mood, more noticeable in the Edinburgh women. The POP was associated with no adverse effects on sexuality and some improvement in well-being in both centres. Possible explanations for the apparent lack of adverse effects in the Manila women are discussed. The negative effects reported may be less evident in women using the COC for contraceptive purposes but may lead to discontinuation in some women and warrant further investigation. PMID:8749600

  11. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poh Catherine F

    2011-10-01

    Full Text Available Abstract Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160 and invasive squamous cell carcinoma (N = 240. Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm or white light-guided surgery (control arm. The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1 the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization; or 2 further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS

  12. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    International Nuclear Information System (INIS)

    Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

  13. A controlled multi-centre study of herbal versus synthetic secretolytic drugs for acute bronchitis.

    Science.gov (United States)

    Ernst, E; März, R; Sieder, C

    1997-12-01

    Herbal expectorants and secretolytic drugs hold a sizeable share of the European market. Therefore it is essential to test their clinical effectiveness and safety. The aim of the present study was to compare the herbal medication Bronchipret(®) with various other pharmacotherapeutical options for acute bronchitis. The study was designed as a matched-pair comparison of 7783 patients. Clinical outcomes of bronchitis and adverse reactions were documented. The data were evaluated by comparing the treatment success of the test medication and 3 control groups using ordinal regression. The results suggest that clinical effectiveness of Bronchipret(®) was not less than with synthetic drugs. There was a tendency for better results with Bronchipret(®), particularly in the treatment of adults. Similar results were obtained with respect to adverse reactions. Particularly in the adult sub-group, these were markedly less with herbals as compared to synthetic drugs. These findings imply that a risk/benefit evaluation would favour Bronchipret(®) over synthetic drugs for acute bronchitis. Their interpretation is limited through the fact that this study could not be randomised nor blinded. The results therefore require confirmation through randomised, double-blind trials.

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

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

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

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

    Science.gov (United States)

    Viera, Anthony J; Bangdiwala, Shrikant I

    2007-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Meisel Susanne F

    2012-12-01

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

  17. Oral isoflavone supplementation on endometrial thickness: a meta-analysis of randomized placebo-controlled trials

    Science.gov (United States)

    Liu, Jie; Yuan, Feixiang; Gao, Jian; Shan, Boer; Ren, Yulan; Wang, Huaying; Gao, Ying

    2016-01-01

    Background Isoflavone from soy and other plants modulate hormonal effects in women, and the hormone disorder might result in different caners including endometrial cancer. However, it's effect on the risk of endometrial cancer is still inconclusive. We aimed to assess the effects of isoflavone on endometrial thickness, a risk factor of endometrial cancer in peri- and post-menopausal women. Methods A meta-analysis of randomized controlled trials was conducted to evaluate the effect of oral isoflavone supplementation on endometrial thickness in peri- and post-menopausal women. Electronic searches were performed on the PubMed, Embase, the Cochrane Library, web of science, CINAHL, and WHO ICTRP to August 1st, 2015. Reviews and reference lists of relevant articles were also searched to identify more studies. Summary estimates of standard mean differences (SMD's) and 95%CIs were obtained with random-effects models. Heterogeneity was evaluated with meta-regression and stratified analyses. Results A total of 23 trials were included in the current analysis. The overall results did not show significant change of endometrial thickness after oral isoflavone supplementation (23 studies, 2167subjects; SMD:-0.05; 95%CI:-0.23, 0.13; P=0.60). Stratified analysis suggested that a daily dose of more than 54mg could decrease the endometrial thickness for 0.26mm (10 trials, 984subjects; SMD:-0.26; 95%CI:-0.45, −0.07; P=0.007). Furthermore, isoflavone supplementation significantly decrease the endometrial thickness for 0.23mm in North American studies (7 trials, 726 subjects; SMD:-0.23; 95%CI:-0.44, −0.01; P=0.04), but it suggested an increase for 0.23mm in Asian studies (3 trials, 224 subjects; SMD: 0.23; 95%CI:-0.04, 0.50; P=0.10). Conclusion Oral isoflavone supplementation might have different effects in different populations and at different daily doses. Multiple-centre, larger, and long-term trials are deserved to further evaluate its effect. PMID:26967050

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

    Directory of Open Access Journals (Sweden)

    Dong Yumin

    2014-01-01

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

  19. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kwok T

    2013-09-01

    Full Text Available Timothy Kwok,1,2 Bel Wong,2 Isaac Ip,2 Kenny Chui,2 Daniel Young,2 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region; 2Jockey Club Centre for Positive Ageing, Hong Kong, Special Administrative Region Purpose: Many family caregivers of persons with dementia (PWD are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods: In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results: The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion: A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. Keywords: telephone intervention, psychoeducation, dementia caregivers

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Soo Seog Park

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

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

    OpenAIRE

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

    2014-01-01

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

  5. Target setting in intensive insulin management is associated with metabolic control: the Hvidoere Childhood Diabetes Study Group Centre Differences Study 2005

    DEFF Research Database (Denmark)

    Swift, P.G.F.; Skinner, T.C.; de Beaufort, C.E.;

    2010-01-01

    Objective: To evaluate glycaemic targets set by diabetes teams, their perception by adolescents and parents, and their influence on metabolic control. Methods: Clinical data and questionnaires were completed by adolescents, parents/carers and diabetes teams in 21 international centres. HbA1c was ...

  6. Update on System Coordination Centre

    Energy Technology Data Exchange (ETDEWEB)

    Stangl, W. [Power Pool of Alberta, Calgary, AB (Canada)

    1998-07-01

    The new System Coordination Centre at the Power Pool of Alberta was designed to meet the unique requirements of Alberta`s electric industry under the new regulatory regime. Development of the Centre, key provisions of the energy management system (EMS) are highlighted. The centre will provide an energy management system for the Pool`s system controller function and interface with the Power Pool Administrator`s market functions and the operations of the Transmission Administrator. System controllers are expected to be operating from the new location by the end of 1998. Unique EMS features of the centre include: (1) real-time management of energy market and network operations using diverse SCADA/EMS, (2) inter-control centre protocol used to accommodate the unique participant information requirements, and (3) special custom applications. The Centre is expected to be fully functioning by July 1999. 1 fig.

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

    Directory of Open Access Journals (Sweden)

    Xiaomei Qi

    2012-01-01

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

  8. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

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

    NARCIS (Netherlands)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2008-01-01

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

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

    Science.gov (United States)

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

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

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

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  16. CERN Control Centre Animations

    CERN Multimedia

    2014-01-01

    Individual particles from each beam can stray off their foreseen path and hit the beam pipe or even the inner part of a detector with the risk of damaging them. Therefore, the beam has to be ‘cleaned’ from these stray particles before coming close to the collision regions. At each side of the experiments, there are collimators installed which do this job. These devices consist of jaws that close around the beam and absorb stray particles.

  17. CERN Control Centre Animations

    CERN Multimedia

    2014-01-01

    Two particle beams circulate in the LHC, in opposite directions. Superconducting dipole magnets are used to bend the paths of the particles in order to keep them on their circular track. These magnets are formed of two superconducting coils producing magnetic fields pointing in opposite direction for the two counterrotating beams. Cooled down to the very low temperature of -271.2°C, the superconducting coils allow the high currents to flow without losing any energy to electrical resistance. The current going trough the coils reach 11080 amps in order to generate a magnetic field of 7.8 Teslas. Such high magnetic fields could not be reached with classic resistive electromagnets. Each dipole magnet only deflects the path by 0.3 degrees, so there are 1232 dipole magnets needed to bend the beams around the LHC.

  18. CERN Control Centre Animations

    CERN Multimedia

    2014-01-01

    Particles make 11,245 turns per second in the LHC. Every time a particle has made a turn in the LHC, it passes by a region where it is accelerated by electric fields. These fields are produced inside so-called “Radiofrequency Cavities”. Inside each cavity, the direction of the field oscillates between positive (red) and negative (blue) voltage. The particle bunches is synchronized in order that incoming particles always see an accelerating electric field.

  19. CERN Control Centre Animations

    CERN Multimedia

    2014-01-01

    The journey of the LHC protons begin in a hydrogen bottle. Hydrogen is the simplest element: its atom has a single proton with one electron orbiting around it. The pressure in the bottle forces the hydrogen atoms out, where they are captured in a device, the proton source. Inside, a powerful electrical discharge strips the electrons away from the protons. Under the force of an electric field, the protons whizz off into a cavity where they are accelerated and concentrated.

  20. CERN Control Centre Animations

    CERN Multimedia

    2014-01-01

    The LHC beam is formed of many bunches of particles (up to 2808), each measuring a few centimetres long and a millimetre wide. Their width is smaller than the size of Spain on a 1 Euro coin. However, the bunch size is not constant around the ring. Each bunch, as it circulates around the LHC, gets squeezed and expanded. It gets squeezed as much as possible around the interaction points to increase the probability of a collision. As they approach the collision points, they are squeezed to about 16 micrometers (a human hair is about 50 micrometers thick) to allow for a greater chance of collisions.

  1. CERN Control Centre Animations

    CERN Multimedia

    2014-01-01

    LHC operators need to adjust the machine parameters for optimizing the injection and acceleration of particles in the LHC. They inject low intensity pilot beams into the machine. To monitor their position and their movement after the injection, they can use actuators to move a radiator screen into the beam pipe. When the beams pass through the screen, they make the radiator material emit light that is recorded by a camera.

  2. With the unveiling of its new sign, the CERN Control Centre was officially inaugurated on Thursday 16 March.

    CERN Multimedia

    IT-UDS-AVC Team

    2006-01-01

    To celebrate its startup, CERN Council members visited the sleek centre, a futuristic-looking room filled with a multitude of monitoring screens. Both Iarocci and CERN Director-General Robert Aymar thanked those involved in the CCC's completion.

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

    OpenAIRE

    Jan Zirk-Sadowski; Denes Szucs; Joni Holmes

    2013-01-01

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

  4. Controlling transmission eigenchannels in random media by edge reflection

    CERN Document Server

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2014-01-01

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

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

    NARCIS (Netherlands)

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

    2011-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2006-01-01

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

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

    NARCIS (Netherlands)

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

    2005-01-01

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

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

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

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

  11. Stochastic Control for a Class of Random Evolution Models

    International Nuclear Information System (INIS)

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

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

    OpenAIRE

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

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

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

    OpenAIRE

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

    2009-01-01

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

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

    OpenAIRE

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

    2016-01-01

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

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

    OpenAIRE

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

    2006-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

  20. Chemical and environmental vector control as a contribution to the elimination of visceral leishmaniasis on the Indian subcontinent: cluster randomized controlled trials in Bangladesh, India and Nepal

    Directory of Open Access Journals (Sweden)

    Das Pradeep

    2009-10-01

    Full Text Available Abstract Background Bangladesh, India and Nepal are working towards the elimination of visceral leishmaniasis (VL by 2015. In 2005 the World Health Organization/Training in Tropical Diseases launched an implementation research programme to support integrated vector management for the elimination of VL from Bangladesh, India and Nepal. The programme is conducted in different phases, from proof-of-concept to scaling up intervention. This study was designed in order to evaluate the efficacy of the three different interventions for VL vector management: indoor residual spraying (IRS; long-lasting insecticide treated nets (LLIN; and environmental modification (EVM through plastering of walls with lime or mud. Methods Using a cluster randomized controlled trial we compared three vector control interventions with a control arm in 96 clusters (hamlets or neighbourhoods in each of the 4 study sites: Bangladesh (one, India (one and Nepal (two. In each site four villages with high reported VL incidences were included. In each village six clusters and in each cluster five households were randomly selected for sand fly collection on two consecutive nights. Control and intervention clusters were matched with average pre-intervention vector densities. In each site six clusters were randomly assigned to each of the following interventions: indoor residual spraying (IRS; long-lasting insecticide treated nets (LLIN; environmental management (EVM or control. All the houses (50-100 in each intervention cluster underwent the intervention measures. A reduction of intra-domestic sand fly densities measured in the study households by overnight US Centres for Disease Prevention and Control light trap captures (that is the number of sand flies per trap per night was the main outcome measure. Results IRS, and to a lesser extent EVM and LLINs, significantly reduced sand fly densities for at least 5 months in the study households irrespective of type of walls or whether or

  1. Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Zhang S

    2014-07-01

    Full Text Available Shiyuan Zhang,1 James Paul,2 Manyat Nantha-Aree,2 Norman Buckley,2 Uswa Shahzad,2 Ji Cheng,2 Justin DeBeer,5 Mitchell Winemaker,5 David Wismer,5 Dinshaw Punthakee,5 Victoria Avram,5 Lehana Thabane1–41Department of Clinical Epidemiology and Biostatistics, 2Department of Anesthesia, McMaster University, Hamilton, ON, Canada; 3Biostatistics Unit/Centre for Evaluation of Medicines, St Joseph's Healthcare - Hamilton, Hamilton, ON, Canada; 4Population Health Research Institute, Hamilton Health Science/McMaster University, 5Department of Surgery, Division of Orthopaedics, McMaster University, Hamilton, ON, CanadaBackground: Although seemingly straightforward, the statistical comparison of a continuous variable in a randomized controlled trial that has both a pre- and posttreatment score presents an interesting challenge for trialists. We present here empirical application of four statistical methods (posttreatment scores with analysis of variance, analysis of covariance, change in scores, and percent change in scores, using data from a randomized controlled trial of postoperative pain in patients following total joint arthroplasty (the Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study [MOBILE] trials.Methods: Analysis of covariance (ANCOVA was used to adjust for baseline measures and to provide an unbiased estimate of the mean group difference of the 1-year postoperative knee flexion scores in knee arthroplasty patients. Robustness tests were done by comparing ANCOVA with three comparative methods: the posttreatment scores, change in scores, and percentage change from baseline.Results: All four methods showed similar direction of effect; however, ANCOVA (-3.9; 95% confidence interval [CI]: -9.5, 1.6; P=0.15 and the posttreatment score (-4.3; 95% CI: -9.8, 1.2; P=0.12 method provided the highest precision of estimate compared with the change score (-3.0; 95% CI: -9.9, 3.8; P=0

  2. HIV and childhood disability: a case-controlled study at a paediatric antiretroviral therapy centre in Lilongwe, Malawi.

    Directory of Open Access Journals (Sweden)

    Akash Devendra

    Full Text Available BACKGROUND: As paediatric antiretroviral therapy (ART is rapidly scaled up in Southern Africa, Human Immunodeficiency Virus (HIV infection is becoming a chronic illness. Children growing up with HIV may begin to encounter disabilities. The relationship between HIV, disability and the need for rehabilitation has added an additional element that needs to be addressed by paediatric HIV treatment programmes. STUDY OBJECTIVES: 1 Estimate the prevalence of disabilities in HIV-infected and HIV-uninfected children in Lilongwe, Malawi. 2 Examine types of disability and associated clinical and socio-demographic factors. 3 Identify needs, opportunities and barriers for rehabilitation in Malawi. METHODS: A case-controlled study of 296 HIV-infected children aged 2-9 years attending an ART centre in Lilongwe (cases and their uninfected siblings (controls was conducted. Disability was assessed using the WHO Ten Question Screen (TQS. Socio-demographic and clinical data were collected using a parent-proxy questionnaire and medical records. RESULTS: Of 296 case and control pairs recruited, 33% (98 versus 7% (20 screened positive for a disability (OR 8.4, 4.4-15.7 respectively. Of these 98 HIV-infected cases, 6%, 36%, 33%, 53%, 46% and 6% had a vision, hearing; physical, learning/comprehension, speech or seizure-related disability respectively and 51% had multiple coexisting disabilities. HIV-infected cases with a disability were more likely to be WHO stage III or IV at enrolment (71% vs. 52%, OR 2.7, 1.5-4.2, to have had TB (58% vs. 39%, OR 2.3, 1.4-3.8 and to have below-average school grades (18% vs. 2%, OR 11.1, 2.2-54.6 than those without. Sixty-seven percent of cases with a disability had never attended any rehabilitative service. Twenty-nine percent of caregivers reported facing stigma and discrimination because of the child's disability. CONCLUSION: This study reveals the magnitude of disability among HIV-infected children and the large unmet need for

  3. Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sietske J Tamminga

    Full Text Available OBJECTIVE: One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. METHODS: Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65 or control group (n = 68. The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial, quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. RESULTS: Return-to-work rates were 86% and 83% (p = 0.6 for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14-435 versus 192 days (range 82-465 (p = 0.90 with a hazard ratio of 1.03 (95% CI 0.64-1.6. Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. CONCLUSION: The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which

  4. Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magallón Rosa

    2009-04-01

    Full Text Available Abstract Background Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromyalgia; however, there are no studies on the pharmacological or psychological treatment of catastrophizing. The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia (pregabalin, with duloxetine added where there is a comorbid depression, compared with usual treatment at primary care level. Method/design Design: A multi-centre, randomized controlled trial involving three groups: the control group, consisting of usual treatment at primary care level, and two intervention groups, one consisting of cognitive-behaviour therapy, and the other consisting of the recommended pharmacological treatment for fibromyalgia. Setting: 29 primary care health centres in the city of Zaragoza, Spain. Sample: 180 patients, aged 18–65 years, able to understand and read Spanish, who fulfil criteria for primary fibromyalgia, with no previous psychological treatment, and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study. Intervention: Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al, from the University of New Jersey, for the treatment of somatoform disorders, which has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy. Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia: pregabalin (300–600 mg/day, with duloxetine (60–120 mg/day added where there is a comorbid depression. Measurements: The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class. The diagnosis of psychiatric

  5. Wean Earlier and Automatically with New technology (the WEAN study: a protocol of a multicentre, pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lessard Martin R

    2009-09-01

    Full Text Available Abstract Background Weaning is the process during which mechanical ventilation is withdrawn and the work of breathing is transferred from the ventilator back to the patient. Prolonged weaning is associated with development of ventilator-related complications and longer stays in the Intensive Care Unit (ICU. Computerized or Automated Weaning is a novel weaning strategy that continuously measures and adapts ventilator support (by frequently measuring and averaging three breathing parameters and automatically conducts Spontaneous Breathing Trials to ascertain whether patients can resume autonomous breathing. Automated Weaning holds promise as a strategy to reduce the time spent on the ventilator, decrease ICU length of stay, and improve clinically important outcomes. Methods/Design A pilot weaning randomized controlled trial (RCT is underway in the ICUs of 8 Canadian hospitals. We will randomize 90 critically ill adults requiring invasive ventilation for at least 24 hours and identified at an early stage of the weaning process to either Automated Weaning (SmartCare™ or Protocolized Weaning. The results of a National Weaning Survey informed the design of the Protocolized Weaning arm. Both weaning protocols are operationalized in Pressure Support mode, include opportunities for Spontaneous Breathing Trials, and share a common sedation protocol, oxygen titration parameters, and extubation and reintubation criteria. The primary outcome of the WEAN study is to evaluate compliance with the proposed weaning and sedation protocols. A key secondary outcome of the pilot RCT is to evaluate clinician acceptance of the weaning and sedation protocols. Prior to initiating the WEAN Study, we conducted a run-in phase, involving two patients per centre (randomizing the first participant to either weaning strategy and assigning the second patient to the alternate strategy to ensure that participating centres could implement the weaning and sedation protocols and

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

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

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

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

    OpenAIRE

    Zarei, Soheila; Valizadeh, Leila; BILAN, Nemat

    2013-01-01

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

  8. Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial

    Directory of Open Access Journals (Sweden)

    Derman Richard

    2009-01-01

    Full Text Available Abstract Background The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL reduces the occurrence of severe postpartum haemorrhage by approximately 60–70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. Objective The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. Methods A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour. The simplified package will include uterotonic (oxytocin 10 IU IM injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM, controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome

  9. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  10. WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

    OpenAIRE

    Vernooij-Dassen Myrra; Schornstein Katrin; Leonhart Rainer; Graff Maud; Voigt-Radloff Sebastian; Olde-Rikkert Marcel; Huell Michael

    2009-01-01

    Abstract Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised ...

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

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    NARCIS (Netherlands)

    L. Tavecchio

    2015-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

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

    Science.gov (United States)

    McIntyre, Laura Lee

    2008-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

  19. Putting telemedicine to the test: design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations

    OpenAIRE

    Wallace, P.; Haines, A.; Harrison, R; Barber, J; Thompson, S; Roberts, J.; Jacklin, P.; Lewis, L; Wainwright, P.; , ForTheVirtualOutreachProjectGroup

    2002-01-01

    BACKGROUND: Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in either sc...

  20. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

    OpenAIRE

    Thompson Simon; Barber Julie A; Harrison Robert; Haines Andrew; Wallace Paul; Roberts Jennifer; Jacklin Paul B; Lewis Leo; Wainwright Paul

    2002-01-01

    Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in e...

  1. Oral ingestion of a topical benzydamine hydrochloride-containing gynaecological preparation in association with television advertising in Italy: analysis of cases managed by a National Poison Control Centre

    OpenAIRE

    Settimi, Laura; Davanzo, Franca; Lauria, Laura; Casini, Maria Luisa; Ferrazin, Fernanda

    2012-01-01

    Objective To evaluate the impact of a television advertising campaign on the risk of oral ingestion of a topical non-prescription gynaecological preparation containing benzydamine hydrochloride. Design An interrupted time series design with data routinely collected. Setting A National Poison Control Centre. Participants 215 cases of hazardous exposure to the preparation under study occurred in Italy from January 2005 to December 2010. Primary and secondary outcome measures Mean daily rate of ...

  2. Perioperative medication management: expanding the role of the preadmission clinic pharmacist in a single centre, randomised controlled trial of collaborative prescribing

    OpenAIRE

    Hale, A.R.; Coombes, I D; Stokes, J.; D. McDougall; Whitfield, K; Maycock, E; Nissen, L

    2013-01-01

    Objectives Current evidence to support non-medical prescribing is predominantly qualitative, with little evaluation of accuracy, safety and appropriateness. Our aim was to evaluate a new model of service for the Australia healthcare system, of inpatient medication prescribing by a pharmacist in an elective surgery preadmission clinic (PAC) against usual care, using an endorsed performance framework. Design Single centre, randomised controlled, two-arm trial. Setting Elective surgery PAC in a ...

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

    OpenAIRE

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

    2010-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2016-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

  12. Group versus Internet-based cognitive-behavioral therapy for procrastination: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Alexander Rozental

    2014-04-01

    Full Text Available Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday lives. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive-behavioral therapy is often deemed a treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the proposed study is therefore to test the efficacy of cognitive-behavioral therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into blocks of thirty will be used, comparing an eight-week Internet-based cognitive-behavioral therapy intervention, and an eight-week group cognitive-behavioral therapy based intervention. It is believed that the proposed study will result in two important findings. First, different treatment interventions in cognitive-behavioral therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both an Internet-based cognitive-behavioral therapy intervention and a group intervention are presumed suitable for administering treatment for procrastination, which is considered important as the availability of adequate care is limited, particularly among students. The proposed study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well

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

    OpenAIRE

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

    2015-01-01

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

  14. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  15. Cultural tailoring for the promotion of Hepatitis B screening in Turkish Dutch: a protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mackenbach Johan

    2010-11-01

    Full Text Available Abstract Background Chronic hepatitis B virus infection (HBV is an important health problem in the Turkish community in the Netherlands, and promotion of screening for HBV in this risk group is necessary. An individually tailored intervention and a culturally tailored intervention have been developed to promote screening in first generation 16-40 year old Turkish immigrants. This paper describes the design of the randomized controlled trial, which will be used to evaluate the effectiveness of the two tailored internet interventions as compared to generic online information on HBV, and to assess the added value of tailoring on socio-cultural factors. Methods/Design A cluster randomized controlled trial design, in which we invite all Rotterdam registered inhabitants born in Turkey, aged 16-40 (n = 10,000, to visit the intervention website is used. A cluster includes all persons living at one house address. The clusters are randomly assigned to either group A, B or C. On the website, persons eligible for testing will be selected through a series of exclusion questions and will then continue in the randomly assigned intervention group. Group A will receive generic information on HBV. Group B will receive individually tailored information related to social-cognitive determinants of screening. Group C will receive culturally tailored information which, next to social-cognitive factors, addresses cultural factors related to screening. Subsequently, participants may obtain a laboratory form, with which they can be tested free of charge at local health centres. The main outcome of the study is the percentage of eligible persons tested for HBV through to participation in one of the three groups. Measurements of the outcome behaviour and its determinants will be at baseline and five weeks post-intervention. Discussion This trial will provide information on the effectiveness of a culturally tailored internet intervention promoting HBV-screening in first

  16. How a structured vibrational environment controls the performance of a photosystem II reaction centre-based photocell

    CERN Document Server

    Stones, Richard; van Grondelle, Rienk; Olaya-Castro, Alexandra

    2016-01-01

    Photosynthetic reaction centres are pigment-protein complexes that can transform photo-induced electronic excitations into stable charge separated states with near-unit quantum efficiency. Here we consider a theoretical photovoltaic device that places a single photosystem II reaction centre between electrodes to investigate how the mean photo-current and its fluctuations depend on the vibrational environment that assists energy and electron transfer. Our results indicate that selective coupling to well resolved vibrational modes does not necessarily offer an advantage in terms of power output but does lead to photo-currents with suppressed noise levels. The exciton manifold and the structured vibrations assisting electron transfer can also support the emergence of a phenomenon akin to dynamical channel blockade, whereby excitonic traps can impose competing routes for population transfer under steady state operation. Our results help characterizing the device-like functionality of these complexes for their pot...

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

    Institute of Scientific and Technical Information of China (English)

    JIANG Nan; CHEN Shi-Jian

    2011-01-01

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

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

    DEFF Research Database (Denmark)

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

    2000-01-01

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

  19. Target setting in intensive insulin management is associated with metabolic control: the Hvidoere Childhood Diabetes Study Group Centre Differences Study 2005

    DEFF Research Database (Denmark)

    Swift, P.G.F.; Skinner, T.C.; de Beaufort, C.E.;

    2010-01-01

    Objective: To evaluate glycaemic targets set by diabetes teams, their perception by adolescents and parents, and their influence on metabolic control. Methods: Clinical data and questionnaires were completed by adolescents, parents/carers and diabetes teams in 21 international centres. HbA1c...... was measured centrally. Results: A total of 2062 adolescents completed questionnaires (age 14.4 +/- 2.3 yr; diabetes duration 6.1 +/- 3.5 yr). Mean HbA 1c = 8.2 +/- 1.4% with significant differences between centres (F = 12.3; p ... (r = 0.20) and adolescent (r = 0.21) reports of their perceived ideal HbA1c and their actual HbA1c result (p A1c they would be happy with and their actual HbA1c result. There were significant...

  20. Wavelet Transform Analysis of the Power Spectrum of Centre of Pressure Signals to Detect the Critical Point Interval of Postural Control

    Science.gov (United States)

    Singh, Neeraj Kumar; Snoussi, Hichem; Hewson, David; Duchêne, Jacques

    The aim of this study was to develop a method to detecting the critical point interval (CPI) when sensory feedback is used as part of a closed-loop postural control strategy. Postural balance was evaluated using centre of pressure (COP) displacements from a force plate for 17 control and 10 elderly subjects under eyes open, eyes closed, and vibration conditions. A modified local-maximum-modulus wavelet transform analysis using the power spectrum of COP signals was used to calculate CPI. Lower CPI values indicate increased closed-loop postural control with a quicker response to sensory input. Such a strategy requires greater energy expenditure due to the repeated muscular interventions to remain stable. The CPI for elderly occurred significantly quicker than for controls, indicating tighter control of posture. Similar results were observed for eyes closed and vibration conditions. The CPI parameter can be used to detect differences in postural control due to ageing.

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

    Directory of Open Access Journals (Sweden)

    Jing-Yu Tan

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

  2. KWARTA (Quality Assurance in the Radiotherapy centres of the Antwerp province): Quality control of the contract therapy machine and treatment planning system

    Energy Technology Data Exchange (ETDEWEB)

    De Ost, B.; Schaeken, B.; Vanregemorter, J. [Algemeen Ziekenhuis Middelheim, Antwerp (Belgium); Bellekens, L. [Sint-Vincentius Ziekenhuis, Antwerp (Belgium); Cardoen, R.; Pieters, D. [Medisch Instituut Sint Augustinus, Wilrijk (Belgium); Goossens, H. [Sint-Elisabeth Ziekenhuis, Turnhout (Belgium); Haest, K.; Mertens, N. [Sint Norbertus Ziekenhuis, Duffel (Belgium)

    1995-12-01

    During the first year of the provincial QA project, joint procedures were set up for the routine quality control of linear accelerators, Cobalt treatment machines and simulators. A set of standard forms was produced for use in all centres, respecting the differences in each individual machine. Since forms are now in use in all centres, the second year of the project mainly focused on the QA/QC of the contract therapy machine and treatment planning system. QC measurements for the contract therapy machines were performed in air or in a phantom. Since the output was checked with the same ionisation chamber (0.33 cc flat chamber calibrated for 50 kV) and the same type of electrometer in all centres, the results could be compared mutually and with the reference values. The major parameter groups, tested for the treatment planning system were: isodose distribution (visual control of all square fields in the database of the system), PDD data (analysing of 10 x 10 cm{sup 2}, 20 x 20 cm{sup 2}, 30 x 30 cm{sup 2} and 40 x 40 cm{sup 2} open or wedged fields), output factors, wedge and tray factors, inverse square law, geometrical testing of the digitizer - screen - printer and geometrical and densitometrical testing of the CT images - screen - printer. Between 496 and 1243 parameters were investigated in the different centres (depending on the presence of the electron data). Irregularities (0 % to 4 % of the total investigated parameters) were reported to the respective physicist.

  3. Phage display of the serpin alpha-1 proteinase inhibitor randomized at consecutive residues in the reactive centre loop and biopanned with or without thrombin.

    Directory of Open Access Journals (Sweden)

    Benjamin M Scott

    Full Text Available In spite of the power of phage display technology to identify variant proteins with novel properties in large libraries, it has only been previously applied to one member of the serpin superfamily. Here we describe phage display of human alpha-1 proteinase inhibitor (API in a T7 bacteriophage system. API M358R fused to the C-terminus of T7 capsid protein 10B was directly shown to form denaturation-resistant complexes with thrombin by electrophoresis and immunoblotting following exposure of intact phages to thrombin. We therefore developed a biopanning protocol in which thrombin-reactive phages were selected using biotinylated anti-thrombin antibodies and streptavidin-coated magnetic beads. A library consisting of displayed API randomized at residues 357 and 358 (P2-P1 yielded predominantly Pro-Arg at these positions after five rounds of thrombin selection; in contrast the same degree of mock selection yielded only non-functional variants. A more diverse library of API M358R randomized at residues 352-356 (P7-P3 was also probed, yielding numerous variants fitting a loose consensus of DLTVS as judged by sequencing of the inserts of plaque-purified phages. The thrombin-selected sequences were transferred en masse into bacterial expression plasmids, and lysates from individual colonies were screening for API-thrombin complexing. The most active candidates from this sixth round of screening contained DITMA and AAFVS at P7-P3 and inhibited thrombin 2.1-fold more rapidly than API M358R with no change in reaction stoichiometry. Deep sequencing using the Ion Torrent platform confirmed that over 800 sequences were significantly enriched in the thrombin-panned versus naïve phage display library, including some detected using the combined phage display/bacterial lysate screening approach. Our results show that API joins Plasminogen Activator Inhibitor-1 (PAI-1 as a serpin amenable to phage display and suggest the utility of this approach for the selection

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

    CERN Document Server

    Tempo, Roberto; Dabbene, Fabrizio

    2013-01-01

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

  5. Does pulmonary rehabilitation work in clinical practice? A review on selection and dropout in randomized controlled trials on pulmonary rehabilitation

    Directory of Open Access Journals (Sweden)

    Bodil Bjoernshave

    2010-04-01

    Full Text Available Bodil Bjoernshave1, Jens Korsgaard2, Claus Vinther Nielsen31Medical Department, Horsens Regional Hospital, Denmark; 2Aalborg Hospital Science and Innovation Centre, 3Department of Clinical Social Medicine and Rehabilitation, Institute of Public Health, Aarhus University, DenmarkAim: To analyze randomized controlled trials (RCTs on pulmonary rehabilitation (PR to determine whether the patients who complete PR form a representative subset of the chronic obstructive pulmonary disease (COPD target population and to discuss what impact this may have for the generalizability and implementation of PR in practice.Material and methods: A review of 26 RCTs included in a Cochrane Review 2007. We analyzed the selection at three different levels: 1 sampling; 2 inclusion and exclusion; 3 and dropout. Results: Of 26 studies only 3 (12% described the sampling as the number of patients contacted. In these studies 28% completed PR. In all we found, that 75% of the patients suitable for PR programs were omitted due to sampling exclusion and dropout. Most of the study populations are not representative of the target population.Conclusion: The RCTs selected for the Cochrane review gave sparse information about the sampling procedure. The demand for high internal validity in studies on PR reduced their external validity. The patients completing PR programs in RCTs were not drawn from a representative subset of the target population. The ability to draw conclusions relevant to clinical practice from the results of the RCTs on PR is impaired.Keywords: COPD, rehabilitation, selection, dropout, external validity

  6. Effects of fucoidan from Fucus vesiculosus in reducing symptoms of osteoarthritis: a randomized placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Myers SP

    2016-05-01

    Full Text Available Stephen P Myers,1 Ann M Mulder,1 Don G Baker,1 Shelley R Robinson,1 Margaret I Rolfe,2 Lyndon Brooks,1 J Helen Fitton,3 1NatMed-Research Unit, Southern Cross University, 2University Centre for Rural Health, Sydney School of Public Health, The University of Sydney, Lismore, NSW, 3Marinova Pty Ltd, Cambridge, TAS, Australia Purpose: Preliminary investigation of a fucoidan with demonstrated reduction in the symptoms of osteoarthritis (OA of the hip and knee. Patients and methods: A double-blind randomized controlled trial was carried out to determine the safety and efficacy of a 300 mg dose of a Fucus vesiculosus extract (85% fucoidan over a 12-week period in a population (n=122 with mild-to-moderate OA of the hip and knee as measured by the validated instrument "Comprehensive Osteoarthritis Test." Safety was measured by assessing cholesterol, liver function, renal function, and hematopoietic function, and closely monitoring adverse events. Result: Ninety-six participants completed the study. The reduction in symptoms of OA was not significantly different from the placebo response. There were no changes in the blood measurements that were of any clinical significance during the course of the study. Conclusion: The F. vesiculosus fucoidan extract was safe and well tolerated. At a dose of 300 mg, the extract showed no difference in reduction of OA symptoms from the placebo. Keywords: joint pain, clinical trial, seaweed, polysaccharide 

  7. Comparative Immunogenicity of HIV-1 gp140 Vaccine Delivered by Parenteral, and Mucosal Routes in Female Volunteers; MUCOVAC2, A Randomized Two Centre Study.

    Directory of Open Access Journals (Sweden)

    Catherine A Cosgrove

    Full Text Available Defining optimal routes for induction of mucosal immunity represents an important research priority for the HIV-1 vaccine field. In particular, it remains unclear whether mucosal routes of immunization can improve mucosal immune responses.In this randomized two center phase I clinical trial we evaluated the systemic and mucosal immune response to a candidate HIV-1 Clade C CN54gp140 envelope glycoprotein vaccine administered by intramuscular (IM, intranasal (IN and intravaginal (IVAG routes of administration in HIV negative female volunteers. IM immunizations were co-administered with Glucopyranosyl Lipid Adjuvant (GLA, IN immunizations with 0.5% chitosan and IVAG immunizations were administered in an aqueous gel.Three IM immunizations of CN54 gp140 at either 20 or 100 μg elicited significantly greater systemic and mucosal antibodies than either IN or IVAG immunizations. Following additional intramuscular boosting we observed an anamnestic antibody response in nasally primed subjects. Modest neutralizing responses were detected against closely matched tier 1 clade C virus in the IM groups. Interestingly, the strongest CD4 T-cell responses were detected after IN and not IM immunization.These data show that parenteral immunization elicits systemic and mucosal antibodies in women. Interestingly IN immunization was an effective prime for IM boost, while IVAG administration had no detectable impact on systemic or mucosal responses despite IM priming.EudraCT 2010-019103-27 and the UK Clinical Research Network (UKCRN Number 11679.

  8. Duodenum preserving pancreatectomy in chronic pancreatitis: Design of a randomized controlled trial comparing two surgical techniques [ISRCTN50638764

    Directory of Open Access Journals (Sweden)

    Reidel Margot A

    2006-05-01

    Full Text Available Abstract Background Chronic pancreatitis is an inflammatory disease which is characterized by an irreversible conversion of pancreatic parenchyma to fibrous tissue. Beside obstructive jaundice and pseudocyst formation, about half of the patients need surgical intervention due to untreatable chronic pain during the course of the disease. In most of the patients with chronic pancreatitis, the head of the pancreas is the trigger of the chronic inflammatory process. Therefore, resection of pancreatic head tissue must be the central part of any surgical intervention. However, it is unclear to which extent the surgical procedure must be radical in order to obtain a favourable outcome for the patients. Design A single centre randomized controlled, superiority trial to compare two techniques of duodenum preserving pancreatic head resection. Sample size: 65 patients will be included and randomized intraoperatively. Eligibility criteria: All patients with chronic pancreatitis and indication for surgical resection and signed informed consent. Cumulative primary endpoint (hierarchical model: duration of surgical procedure, quality of life after one year, duration of intensive care unit stay, duration of hospital stay. Reference treatment: Resection of the pancreatic head with dissection of the pancreas from the portal vein and transsection of the gland (Beger procedure. Intervention: Partial Resection of the pancreatic head without transsection of the organ and visualization of the portal vein (Berne procedure. Duration: September 2003-October 2007. Organisation/responsibility The trial is conducted in compliance with the protocol and in accordance with the moral, ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and the Good Clinical Practice guideline (GCP. The Center for Clinical Studies of the Department of Surgery Heidelberg is responsible for planning, conducting and final

  9. The centre of the action

    CERN Document Server

    2008-01-01

    The CERN Control Centre (CCC) has all the ingredients of an action movie control room: hundreds of screens, technicians buzzing in and out, huge floor-to-ceiling windows revealing the looming vista of a mountain range, flashing lights, microphones… This is the place where not just the LHC, but the whole of CERN’s accelerator complex and technical support is based - truly the centre of the action at CERN.

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

    Science.gov (United States)

    Turinici, Gabriel; Rabitz, Herschel

    2004-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Yan Jie

    2009-08-01

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

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  13. Randomized controlled trial of antibiotic prophylaxis regimens for transrectai ultrasound-guided prostate biopsy

    Institute of Scientific and Technical Information of China (English)

    CHAN Eddie Shu-yin; LO Ka-lun; NG Chi-fai; HOU See-ming; YIP Sidney Kam-hung

    2012-01-01

    Background A prior study showed significant antibioti resistance to quinotone in our poputation.In this study we aimed to evaluate and compare the efficacy of a single versus a combined prophylactic antibiotic regimen before transrectal ultrasound-guided prostate biopsy(TRUGPB).Methods A prospective randomized study was conducted at a university hospital.Patients undergoing TRUGPB were randomized into an amoicillin-clavulanate alone(1mg;one dose before and two doses after biopsy)or an amoxicllin-clavulanate+ciprofloxacin group(250mg;one dose before and two doses after biopsy).Patients were surveyed for infection symptoms by phine on days 3 and 30 after TRUGPB.We defined an infective complication as the iccurrence of symptoms including fever,chills or rigor within 30 days after prostate biopsy,requiring medical treatment or hospitalization,aided by a tertiory-wide etectronic medical record system.Results Between November 2007 and July 2009,367 patients were randomized to either amoxicillin-clavulanate alone or amoxicillin-caavulanate+ciprofloxacin group.The infection rates after TRUGPB were 3.9%in the former group(7 out of 179 patoents)versus 0.53%(1 out of 188 patients)in the latter.Sixty-three percent(5/8)of patients with infective complications needed hospitalization.There was no intensive care unit admission or mortality during the study period.Conclusions Combining prophylactic antibiotics with amoxicllin-clavulanate+soprofloxacin significantly reduced the in cidence of infective complications after TRUGPB.We recommended a combination regimen,especially in centre with high incidence of post-TRUGPB infection.

  14. Medication errors: pharmacovigilance centres in detection and prevention

    OpenAIRE

    Bencheikh, Rachida Soulaymani; Benabdallah, Ghita

    2009-01-01

    Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. A...

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

    Science.gov (United States)

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

    2014-01-01

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

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

    NARCIS (Netherlands)

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

    2007-01-01

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

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

    OpenAIRE

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

    2001-01-01

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

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

    OpenAIRE

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

    2009-01-01

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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    DEFF Research Database (Denmark)

    Sandbæk, Annelli

    1999-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

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

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

    NARCIS (Netherlands)

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

    2014-01-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception

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

    Science.gov (United States)

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

    2011-01-01

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

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

    Science.gov (United States)

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

    2000-01-01

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

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

    Science.gov (United States)

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2016-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2001-01-01

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

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

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    2008-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

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

    OpenAIRE

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Institute of Scientific and Technical Information of China (English)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2001-01-01

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

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

    Science.gov (United States)

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

    2008-01-01

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

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2008-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

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

    Science.gov (United States)

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Vincent Cheung

    2015-01-01

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

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

    Science.gov (United States)

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

    2003-12-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    NARCIS (Netherlands)

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

    2003-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2005-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

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

    Science.gov (United States)

    Amir, Nader; Taylor, Charles T.

    2012-01-01

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

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

    NARCIS (Netherlands)

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

    2012-01-01

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

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

    DEFF Research Database (Denmark)

    Laugesen, Søren; Elliott, Stephen J.

    1993-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    NARCIS (Netherlands)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2014-01-01

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

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

    NARCIS (Netherlands)

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

    1990-01-01

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

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

    NARCIS (Netherlands)

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

    2016-01-01

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

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

    Science.gov (United States)

    Chaney, Bradford

    2016-01-01

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

  8. 77 FR 26789 - Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and...

    Science.gov (United States)

    2012-05-07

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

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

    LENUS (Irish Health Repository)

    McDonnell, John G

    2008-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2010-01-01

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

  15. Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Jeong-Su

    2012-01-01

    Full Text Available Abstract Background Gyejibongnyeong-hwan (GJBNH is one of the most popular Korean medicine formulas for menstrual pain of dysmenorrhea. The concept of blood stagnation in Korean medicine is considered the main factor of causing abdominal pain, or cramps, during menstrual periods. To treat the symptoms, GJBNH is used to fluidify the stagnated blood and induce the blood flow to be smooth, reducing pain as the result. The purpose of this trial is to identify the efficacy of GJBNH in dysmenorrhea caused by blood stagnation. Methods This study is a multi-centre, randomised, double-blind, controlled trial with two parallel arms: the group taking GJBNH and the group taking placebo. 100 patients (women from age 18 to 35 will be enrolled to the trial. Through randomization 50 patients will be in experiment arm, and the other 50 patients will be in control arm. At the second visit (baseline, all participants who were already screened that they fulfil both the inclusion and the exclusion criteria will be randomised into two groups. Each group will take the intervention three times per day during two menstrual cycles. After the treatment for two cycles, each patient will be followed up during their 3rd, 4th and 5th menstrual cycles. From the screening (Visit 1 through the second follow-up (Visit 6 the entire process will take 25 weeks. Discussion This trial will provide evidence for the effectiveness of GJBNH in treating periodical pain due to dysmenorrhea that is caused by blood stagnation. The primary outcome between the two groups will be measured by changes in the Visual Analogue Score (VAS of pain. The secondary outcome will be measured by the Blood Stagnation Scale, the Short-form McGill questionnaire and the COX menstrual symptom scale. Analysis of covariance (ANCOVA and repeated measured ANOVA will be used to analyze the data analysis. Trial registration Current Controlled Trials: ISRCTN30426947

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

    OpenAIRE

    Hammer, Rodney L.

    2010-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

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

    OpenAIRE

    McIntyre, Laura Lee

    2008-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2016-10-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    Institute of Scientific and Technical Information of China (English)

    Chen Shi-Jian; Hong Yi-Guang

    2011-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

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

    OpenAIRE

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

    2016-01-01

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

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

    Science.gov (United States)

    Wang, Chunjin; Wang, Zhenzhong; Xu, Qiao

    2015-12-01

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

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

    Science.gov (United States)

    Wang, Chunjin; Wang, Zhenzhong; Xu, Qiao

    2015-12-01

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

  10. 27 May 2010 - UCLA Chancellor G. Block signing the guest book with Coordinator for External Relations F. Pauss and visiting CMS control centre at building 354 with Collaboration Former Deputy Spokesperson B. Cousins and Deputy Spokesperson J. Incandela.

    CERN Multimedia

    Maximilien Brice

    2010-01-01

    27 May 2010 - UCLA Chancellor G. Block signing the guest book with Coordinator for External Relations F. Pauss and visiting CMS control centre at building 354 with Collaboration Former Deputy Spokesperson B. Cousins and Deputy Spokesperson J. Incandela.

  11. 15th March 2011 - Singapore National Research Foundation Permanent Secretary(National Research and Development)T. M. Kian signing the guest book with Head of International Relations F. Pauss and visiting CMS control centre with Collaboration Spokesperson G. Tonelli.

    CERN Multimedia

    Maximilien Brice

    2011-01-01

    15th March 2011 - Singapore National Research Foundation Permanent Secretary(National Research and Development)T. M. Kian signing the guest book with Head of International Relations F. Pauss and visiting CMS control centre with Collaboration Spokesperson G. Tonelli.

  12. Proposal for the award of a contract for the design, supply, installation and commissioning of a Heating, Ventilation and Air-Conditioning (HVAC) system for the computer room of the CERN Control Centre

    CERN Document Server

    2012-01-01

    Proposal for the award of a contract for the design, supply, installation and commissioning of a Heating, Ventilation and Air-Conditioning (HVAC) system for the computer room of the CERN Control Centre

  13. 1 April 2011 - Indian Saha Institute of Nuclear Physics Director M. K. Sanyal in CERN Control Centre with Head of Operation M. Lamont and Adviser R. Voss; signing the guest book with CERN Director-General R. Heuer.

    CERN Multimedia

    Maximilien Brice

    2011-01-01

    1 April 2011 - Indian Saha Institute of Nuclear Physics Director M. K. Sanyal in CERN Control Centre with Head of Operation M. Lamont and Adviser R. Voss; signing the guest book with CERN Director-General R. Heuer.

  14. 7 March 2013 -Stanford University Professor N. McKeown FREng, Electrical Engineering and Computer Science and B. Leslie, Creative Labs visiting CERN Control Centre and the LHC tunnel with Director for Accelerators and Technology S. Myers.

    CERN Multimedia

    Anna Pantelia

    2013-01-01

    7 March 2013 -Stanford University Professor N. McKeown FREng, Electrical Engineering and Computer Science and B. Leslie, Creative Labs visiting CERN Control Centre and the LHC tunnel with Director for Accelerators and Technology S. Myers.

  15. Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

    Science.gov (United States)

    Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

    2016-10-01

    The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (Pyoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits. PMID:26791478

  16. The Aube centre; Le Centre de l`Aube

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    This educational booklet is devoted to a general presentation of the Aube radioactive wastes storage centre. After a short presentation of the Andra, the French national agency for the management of radioactive wastes, it gives some general information about radioactive wastes (origin, classification), containers (quality assurance and different types), wastes transportation (planning, safety), and about the Aube centre itself: description, treatment and conditioning of drums (compacting and injection), storage facilities, geological situation of the site, and environmental controls. (J.S.)

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

    Directory of Open Access Journals (Sweden)

    Zhou Jincao

    2013-01-01

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

  18. Duration of luteal support (DOLS with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gazvani Rafet

    2012-07-01

    Full Text Available Abstract Background Luteal support with progesterone is necessary for successful implantation of the embryo following egg collection and embryo transfer in an in-vitro fertilization (IVF cycle. Progesterone has been used for as little as 2 weeks and for as long as 12 weeks of gestation. The optimal length of treatment is unresolved at present and it remains unclear how long to treat women receiving luteal supplementation. Design The trial is a prospective, randomized, double-blind, placebo-controlled trial to investigate the effect of the duration of luteal support with progesterone in IVF cycles. Following 2 weeks standard treatment and a positive biochemical pregnancy test, this randomized control trial will allocate women to a supplementary 8 weeks treatment with vaginal progesterone or 8 weeks placebo. Further studies would be required to investigate whether additional supplementation with progesterone is beneficial in early pregnancy. Discussion Currently at the Hewitt Centre, approximately 32.5% of women have a positive biochemical pregnancy test 2 weeks after embryo transfer. It is this population that is eligible for trial entry and randomization. Once the patient has confirmed a positive urinary pregnancy test they will be invited to join the trial. Once the consent form has been completed by the patient a trial prescription sheet will be sent to pharmacy with a stated collection time. The patient can then be randomized and the drugs dispensed according to pharmacy protocol. A blood sample will then be drawn for measurement of baseline hormone levels (progesterone, estradiol, free beta-human chorionic gonadotrophin, pregnancy-associated plasma protein-A, Activin A, Inhibin A and Inhibin B. The primary outcome measure is the proportion of all randomized women that continue successfully to a viable pregnancy (at least one fetus with fetal heart rate >100 beats/minute on transabdominal/transvaginal ultrasound at 10 weeks post embryo

  19. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N;

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  20. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial

    Science.gov (United States)

    Arjyal, Amit; Basnyat, Buddha; Nhan, Ho Thi; Koirala, Samir; Giri, Abhishek; Joshi, Niva; Shakya, Mila; Pathak, Kamal Raj; Mahat, Saruna Pathak; Prajapati, Shanti Pradhan; Adhikari, Nabin; Thapa, Rajkumar; Merson, Laura; Gajurel, Damodar; Lamsal, Kamal; Lamsal, Dinesh; Yadav, Bharat Kumar; Shah, Ganesh; Shrestha, Poojan; Dongol, Sabina; Karkey, Abhilasha; Thompson, Corinne N; Thieu, Nga Tran Vu; Thanh, Duy Pham; Baker, Stephen; Thwaites, Guy E; Wolbers, Marcel; Dolecek, Christiane

    2016-01-01

    Summary Background Because treatment with third-generation cephalosporins is associated with slow clinical improvement and high relapse burden for enteric fever, whereas the fluoroquinolone gatifloxacin is associated with rapid fever clearance and low relapse burden, we postulated that gatifloxacin would be superior to the cephalosporin ceftriaxone in treating enteric fever. Methods We did an open-label, randomised, controlled, superiority trial at two hospitals in the Kathmandu valley, Nepal. Eligible participants were children (aged 2–13 years) and adult (aged 14–45 years) with criteria for suspected enteric fever (body temperature ≥38·0°C for ≥4 days without a focus of infection). We randomly assigned eligible patients (1:1) without stratification to 7 days of either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day for patients aged 2–13 years, or 2 g per day for patients aged ≥14 years). The randomisation list was computer-generated using blocks of four and six. The primary outcome was a composite of treatment failure, defined as the occurrence of at least one of the following: fever clearance time of more than 7 days after treatment initiation; the need for rescue treatment on day 8; microbiological failure (ie, blood cultures positive for Salmonella enterica serotype Typhi, or Paratyphi A, B, or C) on day 8; or relapse or disease-related complications within 28 days of treatment initiation. We did the analyses in the modified intention-to-treat population, and subpopulations with either confirmed blood-culture positivity, or blood-culture negativity. The trial was powered to detect an increase of 20% in the risk of failure. This trial was registered at ClinicalTrials.gov, number NCT01421693, and is now closed. Findings Between Sept 18, 2011, and July 14, 2014, we screened 725 patients for eligibility. On July 14, 2014, the trial was stopped early by the data safety and monitoring board because S Typhi

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

    Institute of Scientific and Technical Information of China (English)

    Qin Xiangjun; Zhang Xun'an; Sheldon Cherry

    2008-01-01

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

  2. The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Faggiano Fabrizio

    2011-05-01

    Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN

  3. Investigating the effects of 6 months extended duration, in-centre nocturnal versus conventional haemodialysis treatment: a non-randomised, controlled feasibility study

    Science.gov (United States)

    Graham-Brown, Matthew P M; Preston, Robert; Pickering, Warren; McCann, Gerry P

    2016-01-01

    Introduction In-centre nocturnal haemodialysis (INHD) is an underutilised dialysis regimen that can potentially provide patients with better clinical outcomes due to extended treatment times. We have established an INHD programme within our clinical network, fulfilling a previously unmet patient need. This feasibility study aims to gather sufficient data on numerous outcome measures to inform the design of a multicentre randomised controlled trial that will establish the potential benefits of INHD and increase the availability of this service nationally and internationally. Methods and analysis This will be a non-randomised controlled study. Prevalent patients on haemodialysis (HD) will electively change from a conventional in-centre HD regimen of 4 hours thrice weekly to a regimen of extended treatment times (5–8 hours) delivered in-centre overnight thrice weekly. After recruitment of the INHD cohort, a group of patients matched for age, gender and dialysis vintage will be selected from patients remaining on a conventional daytime dialysis programme. Outcome measures will include left ventricular mass as measured by MRI, physical performance measured by the short physical performance battery and physical activity measured by accelerometry. Additionally we will measure quality of life using validated questionnaires, nutritional status by bioimpedance spectroscopy and food diaries, and blood sampling for markers of cardiovascular disease, systemic inflammation. Suitable statistical tests shall be used to analyse the data. We will use omnibus tests to observe changes over the duration of the intervention and between groups. We will also look for associations between outcome measures that may warrant further investigation. These data will be used to inform the power calculation for future studies. Ethics and dissemination A favourable opinion was granted by Northampton Research Ethics Committee (15/EM/0268). It is anticipated that results of this study will be

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

    Science.gov (United States)

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

    2011-01-01

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

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

    Institute of Scientific and Technical Information of China (English)

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

    2005-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Bindu John

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Francesco Cerritelli

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

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

    Science.gov (United States)

    Johnson, A E

    1998-08-01

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

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

    Science.gov (United States)

    Ranade, Manjiri; Chary, Dingari Laxmana

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

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

  12. The utility of Aspirin in dukes C and high risk dukes B colorectal cancer - The ASCOLT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ali Raghib

    2011-12-01

    Full Text Available Abstract Background High quality evidence indicates that aspirin is effective in reducing colorectal polyps; and numerous epidemiological studies point towards an ability to prevent colorectal cancer. However the role of Aspirin as an adjuvant agent in patients with established cancers remains to be defined. Recently a nested case-control study within the Nurses Health cohort suggested that the initiation of Aspirin after the diagnosis of colon cancer reduced overall colorectal cancer specific mortality. Although this data is supportive of Aspirin's biological activity in this disease and possible role in adjuvant therapy, it needs to be confirmed in a randomized prospective trial. Methods/Design We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT can improve survival in this patient population over placebo control. The primary endpoint of this study is Disease Free Survival and the secondary Endpoint is 5 yr Overall Survival. This study will randomize eligible patients with Dukes C or high risk Dukes B colorectal cancer, after completion of surgery and standard adjuvant chemotherapy (+/- radiation therapy for rectal cancer patients to 200 mg Aspirin or Placebo for 3 years. Stratification factors include study centre, rectal or colon cancer stage, and type of adjuvant chemotherapy (exposed/not exposed to oxaliplatin. After randomization, patient will be followed up with 3 monthly assessments whilst on study drug and for a total of 5 years. Patients with active peptic ulcer disease, bleeding diathesis or on treatment with aspirin or anti-platelet agents will be excluded from the study. Discussion This study aims to evaluate Aspirin's role as an adjuvant treatment in colorectal cancer. If indeed found to be beneficial, because aspirin is cheap, accessible and easy to administer, it will positively impact the lives of many individuals in Asia

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    Science.gov (United States)

    Zhu, Xiaoyuan; Zhang, Hui; Fang, Zongde

    2015-12-01

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

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

    Science.gov (United States)

    Jha, Abhishek; Bhashyam, Mamtha

    2016-01-01

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

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

    Science.gov (United States)

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

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

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

    DEFF Research Database (Denmark)

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

    2006-01-01

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

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

    Science.gov (United States)

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

    2015-07-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

    Goetschy, A; Stone, A D

    2013-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Jennifer L. McGinley

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Robert L. Woolfolk

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Jiao Yan

    2009-02-01

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

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

    Science.gov (United States)

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

    2016-08-30

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    DEFF Research Database (Denmark)

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

    2002-01-01

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

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

    Science.gov (United States)

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

    2016-07-06

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

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

    OpenAIRE

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

    2008-01-01

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

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

    OpenAIRE

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

    2000-01-01

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

  11. Individual Cognitive Stimulation Therapy for dementia (iCST: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Orrell Martin

    2012-09-01

    Full Text Available Abstract Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

  12. A systematic review of randomized controlled trials on exercise parameters in the treatment of patellofemoral pain: what works?

    Directory of Open Access Journals (Sweden)

    Kumar S

    2011-10-01

    Full Text Available Daniel Harvie, Timothy O'Leary, Saravana Kumar International Centre for Allied Health Evidence (iCAHE, City East Campus, University of South Australia, Adelaide, Australia Purpose: There is research evidence which supports the effectiveness of exercise in reducing pain and increasing function in patients with patellofemoral pain syndrome. However, what is unclear are the parameters underpinning this intervention. This has led to uncertainty when operationalizing exercises for patients with patellofemoral pain syndrome in clinical practice. The aim of this review was to evaluate the parameters of exercise programs reported in primary research, to provide clinicians with evidence-based recommendations for exercise prescription for patellofemoral pain. Methods: A systematic review of randomized controlled trials was undertaken. Only trials that identified exercise to be effective in treating patellofemoral pain were included. Appropriate databases and reference lists were searched using established keywords. Data relating to common exercise parameters such as the type of exercise, length, and frequency of intervention, intensity, repetitions, sets, and specific technique were extracted, along with details of co-interventions that may have been used. Results: A total of ten randomized controlled trials were included in this review and from these trials 14 interventions arms were evaluated. All 14 interventions focused on active exercises, all but two of which also included a passive stretching component. The current body of evidence demonstrates positive results with exercise interventions such as knee extension, squats, stationary cycling, static quadriceps, active straight leg raise, leg press, and step-up and down exercises for patients with patellofemoral pain syndrome. A progressive regime of daily exercises of two to four sets of ten or more repetitions over an intervention period of 6 weeks or more, combined with exercises to address

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

    Lexchin, Joel

    2002-01-01

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

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

    OpenAIRE

    2014-01-01

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

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

    OpenAIRE

    Marie Pirotta; Roberta Chow; Ian Relf

    2008-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

    Dermen, Kurt H.; Thomas, Sherilyn N.

    2011-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

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

    2012-01-01

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

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

    OpenAIRE

    Kim, Sang-Dol

    2015-01-01

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

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

    OpenAIRE

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

    2004-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

    GÜRSOY, Tuğba; Ovalı, Fahri; Karatekin, Güner

    2015-01-01

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

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

    OpenAIRE

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

    2016-01-01

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

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

    OpenAIRE

    UCHIDA, Shinya; Kawashima, Ryuta

    2008-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Gordon Adam L

    2012-06-01

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

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

    OpenAIRE

    Paul Ratanasiripong; Nop Ratanasiripong; Duangrat Kathalae

    2012-01-01

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

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

    Science.gov (United States)

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

    2011-02-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

    Lolita Rapolienė; Artūras Razbadauskas; Antanas Jurgelėnas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were i...

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

    OpenAIRE

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

    2016-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

    Anup Malani

    2004-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Zahra Abedian

    2015-07-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2009-01-01

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

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

    OpenAIRE

    Badiee, Zohreh; Vakiliamini, Mazyar; Mohammadizadeh, Majid

    2013-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    R Rahmani

    2012-11-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Stephen K Field

    2009-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

    Ardigo, Sheila; Herrmann, François; Moret, Véronique; Derame, Laurence; Giannelli, Sandra Véronique; Gold, Gabriel; Pautex, Sophie Marie

    2016-01-01

    Background: Chronic pain is a common and serious health problem in older patients. Treatment often includes non pharmacological approaches despite a relatively modest evidence base in this population. Hypnosis has been used in younger adults with positive results. The main objective of this study was to measure the feasibility and efficacy of hypnosis (including self hypnosis) in the management of chronic pain in older hospitalized patients. Methods: A single center randomized controlled tria...

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

    OpenAIRE

    Mahbobeh Faramarzi; Hajar Pasha; Seddigheh Esmailzadeh; Farzan Kheirkhah; Shima Heidary; Zohreh Afshar

    2013-01-01

    Background: Infertility has been described as creating a form of stress leading to a variety of psychological problems. Both psychotherapy and pharmacotherapy are effective treatments for infertility stress. The aim of this study was to evaluate the effectiveness of cognitive behavioral therapy along with fluoxetine for improvement infertility stress in infertile women. Materials and Methods: In a randomized controlled clinical trial, 89 infertile women with mild to moderate depression (Beck ...

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

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  20. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge;

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  1. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no P

  2. Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy: a meta-analysis of 16 randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Bing Pang

    2016-01-01

    Conclusion: HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities. Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy. However, the methodological quality of the randomized controlled trials was generally low. Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.

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

    NARCIS (Netherlands)

    Hak, AE; Bak, AAA; Lindemans, J; Planellas, J; Bennink, HJTC; Hofman, A; Grobbee, DE; Witteman, JCM

    2001-01-01

    Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine

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

    Science.gov (United States)

    O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

    2015-01-01

    A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

  5. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Science.gov (United States)

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Meta-Analyses of Randomized Controlled Clinical Trials (RCTs... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled clinical trials (RCTs) to evaluate safety risks associated with the use of human drugs or biological...

  6. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    Science.gov (United States)

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  7. Effects of vacuum-compression therapy on healing of diabetic foot ulcers: randomized controlled trial.

    Science.gov (United States)

    Akbari, Asghar; Moodi, Hesam; Ghiasi, Fatemeh; Sagheb, Hamidreza Mahmoudzadeh; Rashidi, Homayra

    2007-01-01

    A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.

  8. Stability and Stabilization of Networked Control System with Forward and Backward Random Time Delays

    Directory of Open Access Journals (Sweden)

    Ye-Guo Sun

    2012-01-01

    Full Text Available This paper deals with the problem of stabilization for a class of networked control systems (NCSs with random time delay via the state feedback control. Both sensor-to-controller and controller-to-actuator delays are modeled as Markov processes, and the resulting closed-loop system is modeled as a Markovian jump linear system (MJLS. Based on Lyapunov stability theorem combined with Razumikhin-based technique, a new delay-dependent stochastic stability criterion in terms of bilinear matrix inequalities (BMIs for the system is derived. A state feedback controller that makes the closed-loop system stochastically stable is designed, which can be solved by the proposed algorithm. Simulations are included to demonstrate the theoretical result.

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

    Science.gov (United States)

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

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

    International Nuclear Information System (INIS)

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

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

    Institute of Scientific and Technical Information of China (English)

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

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepres-sants in the treatment of bipolar disorder. DATA SOURCES:A literature search of randomized, double-blind, control ed trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Control ed Trials databases. The keywords“bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed mania and depression, rapid cycling and bipolar disorder”, AND “antidepressant agent, antidepressive agents second-generation, antidepressive agents tricyclic, monoamine oxidase inhibitor, noradrenaline uptake in-hibitor, serotonin uptake inhibitor, and tricyclic antidepressant agent” were used. The studies that were listed in the reference list of the published papers but were not retrieved in the above-mentioned databases were supplemented. STUDY SELECTION: Studies selected were double-blind randomized control ed trials assessing the efficacy and safety of antidepressants in patients with bipolar disorder. Al participants were aged 18 years or older, and were diagnosed as having primary bipolar disorder. Antidepressants or antidepressants combined with mood stabilizers were used in experimental interventions. Placebos, mood stabilizers, antipsychotics and other antide pressants were used in the control interventions. Studies that were quasi-randomized studies, or used antidepressants in combination with antipsy-chotics in the experimental group were excluded. Al analyses were conducted using Review Man-ager 5.1 provided by the Cochrane Col aboration. MAIN OUTCOME MEASURES:The primary outcome was the response and switching to mania. The secondary outcomes included remission, discontinuation rate, and suicidality. RESULTS: Among 5 001 treatment studies published, 14 double-blind randomized control ed trials involving 1 244 patients were included in the meta

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

    OpenAIRE

    Eman Mohammed Kamal Aboseif; Sameh Mohammed Osman

    2015-01-01

    Objective: To evaluate the clinical efficacy of remifentanil infusion in comparison with sodium nitroprusside regarding controlled hypotension during rhinoplasty. Background: Controlled hypotension is a well-known technique used in many operations to reduce blood loss and need for blood transfusion and to provide satisfactory bloodless surgical field. Many pharmacological agents are used to perform controlled hypotension intraoperatively. Patients and methods: A total of 130 adult conse...

  13. Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Seitsalo Seppo

    2007-12-01

    Full Text Available Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS. As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28, treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28, treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs to assess activity-related symptoms. We also estimated the direct healthcare costs. Results Both groups showed marked improvement during the follow-up. The mean improvement in the Kujala score was 12.9 (95% confidence interval (CI 8.2–17.6 in the arthroscopy group and 11.4 (95% CI 6.9–15.8 in the control group. However, there was no difference between the groups in mean improvement in the Kujala score (group difference 1.1 (95% CI -7.4 - 5.2 or in any of the VAS scores. Total direct healthcare costs in the arthroscopy group were estimated to exceed on average those of the control group by €901 per patient (p Conclusion In this controlled trial involving patients with chronic PFPS, the outcome when arthroscopy was used in addition to a home exercise program was no better than when the home exercise program was used alone. Trial registration Current Controlled Trials ISRCTN 41800323

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

    Directory of Open Access Journals (Sweden)

    Cheng-Hua Ni

    2013-01-01

    Full Text Available The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil and control (water vapor conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromatherapy showed a greater reduction in preoperative anxiety than those in the control groups. Aromatherapy may be a useful part of a holistic approach to reducing preoperative anxiety before ambulatory surgery.

  15. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    Science.gov (United States)

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  16. Congruence Couple Therapy for Pathological Gambling: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Bonnie K; Awosoga, Olu

    2015-09-01

    A multi-site pilot randomized controlled trial of Congruence Couple Therapy (CCT) for problem gambling was conducted in Ontario and Alberta, Canada from 2009 to 2011. The purpose was to assess the feasibility of a full trial and to identify methodological modifications to enhance future trials. The sample (N = 30; 15 couples) consisted of 66% male gamblers and 34% female. Mean age of sample was 49.1 years. Baseline mean DSM-IV gambling score was 8.7/10. Retention of the treatment couples was 89% at 2-month follow-up. Retention of control couples was 78%. A randomized controlled design compared the status of couples in treatment condition to control condition. Treatment couples received 12-week CCT while control couples received three brief check-ins over 12 weeks. No significant difference was found between treatment and control group at baseline on all measures. At (1) week 12 post-treatment, and (2) week 20 follow-up, significant treatment effects were found for gambling symptoms (p = 0.008; p = 0.041), mental distress (p = 0.001; p = 0.035), and family systems function (p = 0.023; p = 0.054) between treatment and control group. Within group changes for treatment couples over time were significant for mental distress (p = 0.000), dyadic adjustment (p = 0.002), and family systems function (p = 0.000). On similar measures, control group showed non-significant improvement. Future methodological changes, advantages and disadvantages of multi-site partnerships with community treatment agencies are discussed. Of interest is that control participants showed unintended improvement. CCT as a treatment was favourably accepted by counselors, problem gamblers and their spouses. Positive outcome trends ranging from small to large effect size on key measures indicate that a full-scaled trial will require approximately 140 couples and is an investment worth pursuing.

  17. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program

    Science.gov (United States)

    2016-01-01

    Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. PMID:27689502

  18. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  19. Factors controlling the redox potential of ZnCe6 in an engineered bacterioferritin photochemical 'reaction centre'.

    Directory of Open Access Journals (Sweden)

    Abdullah Mahboob

    Full Text Available Photosystem II (PSII of photosynthesis has the unique ability to photochemically oxidize water. Recently an engineered bacterioferritin photochemical 'reaction centre' (BFR-RC using a zinc chlorin pigment (ZnCe6 in place of its native heme has been shown to photo-oxidize bound manganese ions through a tyrosine residue, thus mimicking two of the key reactions on the electron donor side of PSII. To understand the mechanism of tyrosine oxidation in BFR-RCs, and explore the possibility of water oxidation in such a system we have built an atomic-level model of the BFR-RC using ONIOM methodology. We studied the influence of axial ligands and carboxyl groups on the oxidation potential of ZnCe6 using DFT theory, and finally calculated the shift of the redox potential of ZnCe6 in the BFR-RC protein using the multi-conformational molecular mechanics-Poisson-Boltzmann approach. According to our calculations, the redox potential for the first oxidation of ZnCe6 in the BRF-RC protein is only 0.57 V, too low to oxidize tyrosine. We suggest that the observed tyrosine oxidation in BRF-RC could be driven by the ZnCe6 di-cation. In order to increase the efficiency of tyrosine oxidation, and ultimately oxidize water, the first potential of ZnCe6 would have to attain a value in excess of 0.8 V. We discuss the possibilities for modifying the BFR-RC to achieve this goal.

  20. Factors controlling the redox potential of ZnCe6 in an engineered bacterioferritin photochemical 'reaction centre'.

    Science.gov (United States)

    Mahboob, Abdullah; Vassiliev, Serguei; Poddutoori, Prashanth K; van der Est, Art; Bruce, Doug

    2013-01-01

    Photosystem II (PSII) of photosynthesis has the unique ability to photochemically oxidize water. Recently an engineered bacterioferritin photochemical 'reaction centre' (BFR-RC) using a zinc chlorin pigment (ZnCe6) in place of its native heme has been shown to photo-oxidize bound manganese ions through a tyrosine residue, thus mimicking two of the key reactions on the electron donor side of PSII. To understand the mechanism of tyrosine oxidation in BFR-RCs, and explore the possibility of water oxidation in such a system we have built an atomic-level model of the BFR-RC using ONIOM methodology. We studied the influence of axial ligands and carboxyl groups on the oxidation potential of ZnCe6 using DFT theory, and finally calculated the shift of the redox potential of ZnCe6 in the BFR-RC protein using the multi-conformational molecular mechanics-Poisson-Boltzmann approach. According to our calculations, the redox potential for the first oxidation of ZnCe6 in the BRF-RC protein is only 0.57 V, too low to oxidize tyrosine. We suggest that the observed tyrosine oxidation in BRF-RC could be driven by the ZnCe6 di-cation. In order to increase the efficiency of tyrosine oxidation, and ultimately oxidize water, the first potential of ZnCe6 would have to attain a value in excess of 0.8 V. We discuss the possibilities for modifying the BFR-RC to achieve this goal. PMID:23935866

  1. Activities of Radiation Protection Centre in 2000

    CERN Document Server

    Radiat. Prot. Cent. Vilnius

    2001-01-01

    Description of the activities of Radiation Protection Centre in 2000 is presented. Radiation Protection Centre is responsible for radiation protection issues. Currently there are six departments at Radiation Protection Centre: two in Vilnius - Department of Radiation Protection Supervision and Control and Department of Programs and Expertise, and four in the districts. Brief information on subject controlled by each departments is provided focusing on main achievements and events.

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

    Directory of Open Access Journals (Sweden)

    Ahmed N. U.

    2005-01-01

    Full Text Available We consider a dynamic model that simulates the interaction of TCP sources with active queue management system (AQM. We propose a modified version of an earlier dynamic model called RED. This is governed by a system of stochastic differential equations driven by a doubly stochastic point process with intensity as the control. The feedback control law proposed observes the router (queue status and controls the intensity by sending congestion signals (warnings to the sources for adjustment of their transmission rates. The (feedback control laws used are of polynomial type (including linear with adjustable coefficients. They are optimized by use of genetic algorithm (GA and random recursive search (RRS technique. The numerical results demonstrate that the proposed model and the method can improve the system performance significantly.

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

    DEFF Research Database (Denmark)

    Karstoft, Kristian; Winding, Kamilla; Knudsen, Sine H.;

    Formål: To evaluate the feasibility of free-living walking training in type 2 diabetes patients, and to investigate the effects of interval-walking training (IWT) versus continuous-walking training (CWT) upon self reported health, physical fitness, body composition and glycemic control. Metoder...... alternated 3-min repetitions at low and high intensity. Before and after the 4-month intervention, the following variables were measured: Self-reported health, Physical fitness (VO2max), body composition, and glycemic control (fasting glucose, HbA1c, oral glucose tolerance test, continuous glucose monitoring......: Subjects with type 2 diabetes were randomized to a control (n = 8), CWT (n = 12), or IWT group (n = 12). Training groups were prescribed five sessions per week (60 min/session) and were controlled with an accelerometer and a heart-rate monitor. CWT performed all training at moderate intensity, whereas IWT...

  4. Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies

    Directory of Open Access Journals (Sweden)

    Shobana Balasingam

    2016-08-01

    Conclusions: Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events.

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

    OpenAIRE

    Meisel Susanne F; Beeken Rebecca J; van Jaarsveld Cornelia HM; Wardle Jane

    2012-01-01

    Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice i...

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

    Directory of Open Access Journals (Sweden)

    Kim Yong-Suk

    2011-03-01

    Full Text Available Abstract Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010

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

    Directory of Open Access Journals (Sweden)

    Tae-Hun Kim

    Full Text Available OBJECTIVE: We conducted systematic review to evaluate current evidence of herbal medicines (HMs for Parkinson's disease (PD. METHODS: Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs, quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. RESULTS: From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. CONCLUSION: Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future.

  8. Single- versus two- layer intestinal anastomosis: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Taji Yoshinori

    2006-01-01

    Full Text Available Abstract Background To compare single- with two- layer intestinal anastomosis after intestinal resection: a meta-analysis of randomized controlled trials. Methods Randomized controlled trials comparing single- with two-layer intestinal anastomosis were identified using a systematic search of Medline, Embase and the Cochrane Library Databases covering articles published from 1966 to 2004. Outcome of primary interest was postoperative leak. A risk ratio for trial outcomes and weighted pooled estimates for data were calculated. A fixed-effect model weighted using Mantel-Haenszel methods and a random-effect model using DerSimonian-Laird methods were employed. Results Six trials were analyzed, comprising 670 participants (single-layer group, n = 299; two-layer group, n = 371. Data on leaks were available from all included studies. Combined risk ratio using DerSimonian-Laird methods was 0.91 (95% CI = 0.49 to 1.69, and indicated no significant difference. Inter-study heterogeneity was significant (χ2 = 10.5, d.f. = 5, p = 0.06. Conclusion No evidence was found that two-layer intestinal anastomosis leads to fewer post-operative leaks than single layer. Considering duration of the anastomosis procedure and medical expenses, single-layer intestinal anastomosis appears to represent the optimal choice for most surgical situations.

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

    Science.gov (United States)

    Fassoulaki, Argyro; Vassi, Emilia; Korkolis, Dimitrios; Zotou, Marianna

    2016-02-01

    Wound infusion with local anesthetics has been used for postoperative pain relief with variable results. This randomized, controlled, double-blind clinical trial examines the effect of ropivacaine infusion on pain after laparoscopic cholecystectomy. A total of 110 patients were randomly assigned to 2 groups. After induction of anesthesia a 75-mm catheter was inserted subcutaneously and connected to an elastomeric pump containing either 0.75% ropivacaine (ropivacaine group) or normal saline (control group) for 24 hours postoperatively. Before skin closure, each hole was infiltrated with 2 mL of 0.75% ropivacaine or normal saline according to randomization. Pain at rest, pain during cough, and analgesic consumption were recorded in the postanesthesia care unit and at 2, 4, 8, 24, and 48 hours postoperatively. Analgesic requirements and pain scores were recorded 1 and 3 months after surgery. The ropivacaine group reported less pain during cough (P=0.044) in the postanesthesia care unit (P=0.017) and 4 hours postoperatively (P=0.038). Ropivacaine wound infusion had no effect on late and chronic pain. PMID:26679680

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

    Science.gov (United States)

    Fröber, Kerstin; Dreisbach, Gesine

    2014-06-01

    Growing evidence suggests that positive affect and reward have differential effects on cognitive control. So far, however, these effects have never been studied together. Here, the authors present one behavioral study investigating the influences of positive affect and reward (contingent and noncontingent) on proactive control. A modified version of the AX-continuous performance task, which has repeatedly been shown to be sensitive to reward and affect manipulations, was used. In a first phase, two experimental groups received either neutral or positive affective pictures before every trial. In a second phase, the two halves of a given affect group additionally received, respectively, performance-contingent or random rewards. The results replicated the typical affect effect, in terms of reduced proactive control under positive as compared to neutral affect. Also, the typical reward effects associated with increased proactive control were replicated. Most interestingly, performance-contingent reward counteracted the positive affect effect, whereas random reward mirrored that effect. In sum, this study provides first evidence that performance-contingent reward, on the one hand, and positive affect and performance-noncontingent reward, on the other hand, have oppositional effects on cognitive control: Only performance-contingent reward showed a motivational effect in terms of a strategy shift toward increased proactive control, whereas positive affect alone and performance-noncontingent reward reduced proactive control. Moreover, the integrative design of this study revealed the vulnerability of positive affect effects to motivational manipulations. The results are discussed with respect to current neuroscientific theories of the effects of dopamine on affect, reward, and cognitive control. PMID:24659000

  11. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA.

    Science.gov (United States)

    Hong, Z; Moessler, H; Bornstein, N; Brainin, M; Heiss, W-D

    2009-10-01

    Cerebrolysin has exhibited neuroprotective as well as neurotrophic properties in various animal models of cerebral ischaemia and has shown clinical efficacy and good safety in several small controlled clinical studies in ischaemic stroke. Therefore, a large double-blind placebo-controlled randomized clinical trial was launched in Asia to prove the validity of this treatment strategy. In the more than 50 participating centres patients with acute ischemic hemispheric stroke are randomized within 12 hours of symptoms onset to treatment (30 ml Cerebrolysin diluted in physiologic saline) or placebo (saline) given as intravenous infusion once daily added to standard care for 10 days. The patients are followed with regular visits for 90 days. Efficacy is evaluated on day 90 by three outcome scales - modified Rankin Scale, Barthel Index and NIH Stroke Scale - combined to single global directional test. Additionally, adverse events are documented to prove safety. In this study a total of 1060 patients will be included and analysis of data will be completed in 2010. If positive, this trial will add an effective strategy to the treatment of acute ischaemic stroke.

  12. Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol

    Directory of Open Access Journals (Sweden)

    Leatherdale Scott T

    2011-09-01

    Full Text Available Abstract Background Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered - do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. Methods/Design A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months. Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000. Eligible subjects interested in free NRT will be determined at baseline (N = 1,000 and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco at 6-month follow-up as compared to subjects who do not

  13. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Shawn D Aaron

    Full Text Available BACKGROUND: Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF. METHODS: We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18 or placebo (N = 17 for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1 and quality of life. RESULTS: Over the 24 week treatment period, 4 of 18 (22% patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31% placebo treated patients, P = 0.70. FEV(1 declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34. Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. CONCLUSION: We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00528190.

  14. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van de Ven Geertje

    2012-01-01

    Full Text Available Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an

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

    Directory of Open Access Journals (Sweden)

    Ian Relf

    2008-01-01

    Full Text Available Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

  16. Protocol for Shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Christoffer H; Andersen, Lars L; Mortensen, Ole S;

    2011-01-01

    ABSTRACT: BACKGROUND: Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Such musculoskeletal pain - which is often associated with restricted range of motion and loss of muscle strength - is one of the most common conditions...... training of the painful area. Our study investigates the effect of the latter approach. METHODS/DESIGN: A randomized controlled trial of 10 weeks duration is currently being conducted. Employed office workers with severe neck-shoulder pain are randomized to 3 × 20 min shoulder function training...... including jobs characterized by intensive computer work. The first 100 positive replies entered the study. Among these inclusion criteria were pain intensity in the neck/shoulder of at least 3 on a 0-9 scale. Exclusion criteria were cardiovascular disease, trauma, hypertension, or serious chronic disease...

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

    Science.gov (United States)

    Jain, Shamini; McMahon, George F; Hasen, Patricia; Kozub, Madelyn P; Porter, Valencia; King, Rauni; Guarneri, Erminia M

    2012-09-01

    Post-traumatic stress disorder (PTSD) remains a significant problem in returning military and warrants swift and effective treatment. We conducted a randomized controlled trial to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery [HT+GI]) reduced PTSD symptoms as compared to treatment as usual (TAU) returning combat-exposed active duty military with significant PTSD symptoms. Active duty military (n = 123) were randomized to 6 sessions (within 3 weeks) of HT+GI vs. TAU. The primary outcome was PTSD symptoms; secondary outcomes were depression, quality of life, and hostility. Repeated measures analysis of covariance with intent-to-treat analyses revealed statistically and clinically significant reduction in PTSD symptoms (p biofield therapy approaches for mitigating PTSD in military populations is warranted.

  18. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Krebs, Teri S; Johansen, Pål-Ørjan

    2012-07-01

    Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

  19. A randomized controlled study of exposure therapy as aftercare for alcohol use disorder

    DEFF Research Database (Denmark)

    Mellentin, Angelina Isabella; Nielsen, Bent; Nielsen, Anette Søgaard;

    2016-01-01

    Background It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses...... on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphone or in group sessions increases the effect of Cognitive Behavioural Treatment in groups of alcohol dependent...... as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized into one of the three following aftercare groups after concluding primary treatment: (1) CET as a smartphone application; (2...

  20. Personal view: randomized controlled trials in epilepsy specialist nursing: the seduction of content by form.

    Science.gov (United States)

    Brown, Stephen

    2002-04-01

    Research into the effectiveness of epilepsy specialist nursing needs to take into account a number of factors, which have not been adequately addressed in previous studies. Nursing outcome measures are different to medical ones and it is inappropriate to confuse these. Specialist nurses affect the whole culture of a service, and their impact on service quality may go beyond that of their individual patient contacts. Thus randomized studies within a service that already has specialist nurses may not give valid results. Some service users will benefit more from direct contact with a specialist nurse than others, and people who give informed consent to take part in randomized controlled trials might not be representative of those who would benefit most from specialist nurse access. The stampede for level one evidence risks failing to address the issues properly by overvaluing research process (form) against its appropriateness (content), yet there remain great opportunities for good quality research in this area.