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Sample records for controlled pilot study

  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. A Study of the Characteristics of Human-Pilot Control Response to Simulated Aircraft Lateral Motions

    Science.gov (United States)

    Cheatham, Donald C

    1954-01-01

    Report presents the results of studies made in an attempt to provide information on the control operations of the human pilot. These studies included an investigation of the ability of pilots to control simulated unstable yawing oscillations, a study of the basic characteristics of human-pilot control response, and a study to determine whether and to what extent pilot control response can be represented in an analytical form.

  3. Working on asymmetry in Parkinson's disease: randomized, controlled pilot study.

    Science.gov (United States)

    Ricciardi, Lucia; Ricciardi, Diego; Lena, Francesco; Plotnik, Meir; Petracca, Martina; Barricella, Simona; Bentivoglio, Anna Rita; Modugno, Nicola; Bernabei, Roberto; Fasano, Alfonso

    2015-08-01

    Posture, gait and balance problems are very disabling symptoms in Parkinson's disease (PD). An increased stride-to-stri de variability, reduction of automaticity and asymmetry of lower limbs function characterize parkinsonian gait. These features predispose to freezing of gait (FOG), which often leads to falls. The aim of this study was to evaluate how the modulation of asymmetry through physiotherapy might improve gait and reduce FOG, thus preventing falls. Twenty-eight PD patients entered a double-blind pilot feasibility controlled study and were evaluated at baseline and after 3 months of a rehabilitative program (performed twice a week) by means of the motor part of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Gait and Falls Questionnaire, Tinetti balance and gait scale, Short Physical Performance Battery (SPPB), European Quality of Life questionnaire. Patients were randomly assigned to three treatment arms: (1) worst side improvement; (2) best side improvement; (3) standard therapy. All study arms showed a significant improvement of the Tinetti and SPPB scores. BSI led to a greater improvement than ST in terms of UPDRS-III (p = 0.01); Tinetti total score (p = 0.05) and Tinetti gait subscore (p = 0.01). Our study confirms the efficacy of physical therapy in the treatment of PD and, more importantly, suggests that specific intervention tailored on individual feature (e.g., asymmetry of motor condition) might be even more effective than standard rehabilitative programs.

  4. Role of the Controller in an Integrated Pilot-Controller Study for Parallel Approaches

    Science.gov (United States)

    Verma, Savvy; Kozon, Thomas; Ballinger, Debbi; Lozito, Sandra; Subramanian, Shobana

    2011-01-01

    Closely spaced parallel runway operations have been found to increase capacity within the National Airspace System but poor visibility conditions reduce the use of these operations [1]. Previous research examined the concepts and procedures related to parallel runways [2][4][5]. However, there has been no investigation of the procedures associated with the strategic and tactical pairing of aircraft for these operations. This study developed and examined the pilot s and controller s procedures and information requirements for creating aircraft pairs for closely spaced parallel runway operations. The goal was to achieve aircraft pairing with a temporal separation of 15s (+/- 10s error) at a coupling point that was 12 nmi from the runway threshold. In this paper, the role of the controller, as examined in an integrated study of controllers and pilots, is presented. The controllers utilized a pairing scheduler and new pairing interfaces to help create and maintain aircraft pairs, in a high-fidelity, human-in-the loop simulation experiment. Results show that the controllers worked as a team to achieve pairing between aircraft and the level of inter-controller coordination increased when the aircraft in the pair belonged to different sectors. Controller feedback did not reveal over reliance on the automation nor complacency with the pairing automation or pairing procedures.

  5. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Science.gov (United States)

    Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  6. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Directory of Open Access Journals (Sweden)

    Sandra M Eldridge

    Full Text Available We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  7. Pilot age and geographic region of commuter and air taxi crashes: a case-control study.

    Science.gov (United States)

    Rebok, George W; Qiang, Yandong; Baker, Susan P; Li, Guohua

    2011-02-01

    Previous studies of major airline and general aviation crashes have identified a host of risk factors. We examined risk factors related to crashes involving commuter air carrier and air taxi flights. A matched case-control design was applied to assess the association of pilot age, total flight time, and geographic region with commuter air carrier and air taxi crashes (14 CFR Part 135) from 1983-2002 in the United States. A total of 2033 commuter air carrier or air taxi crashes from the National Transportation Safety Board aviation crash database were identified as eligible cases. Controls were randomly selected incidents from the Federal Aviation Administration's (FAA) aviation incident database coded under Part 135 operation. Relative to controls, commuter air carrier and air taxi crashes were less likely to occur in pilots under 30 yr of age (adjusted odds ratio 0.68, 95% confidence interval 0.54-0.88) after adjusting for geographic region and total flight time. With adjustment for pilot age and total flight time, the commuter air carrier and air taxi crashes with pilot error were nearly 13 times as likely to be in Alaska as their matched controls (adjusted odds ratio 12.84, 95% confidence interval 5.24-31.45). These results suggest that pilot age may be associated with risk of crash involvement in Part 135 operations. The excess crash risk in Alaska with or without pilot error underscores the importance of environmental hazards in flight safety.

  8. A pilot study of myoelectrically controlled FES of upper extremity

    NARCIS (Netherlands)

    Thorsen, Rune; Spadone, Rafaella; Ferrarin, Maurizio

    2001-01-01

    Functional electrical stimulation (FES) of upper limbs can be used for the recovery of some hand functions on patients with CNS lesions. This study deals with the control of FES by means of myoelectrical activity detected from voluntarily activated paretic muscles. The specific aim of this paper is

  9. Head and scapular posture in flutists: a pilot controlled study

    OpenAIRE

    Teixeira, Z; Lã, F; Silva, A.

    2011-01-01

    Instrumental practice which requires asymmetrical postures might, in the long term, potentiate musculoskeletal disorders and lead to pain. This, in turn, may have a negative impact on musical performance quality. Thus, the assessment of postural deviations among musicians is of the outmost importance in instrumental pedagogy. This study aims to compare the head and scapular posture of flutists with different levels of expertise and a control group of singers. Results suggest...

  10. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

    Science.gov (United States)

    Williamson, Paula R; Gamble, Carrol; O'Connell Francischetto, Elaine; Metcalfe, Chris; Davidson, Peter; Williams, Hywel; Blazeby, Jane M

    2017-01-01

    Objectives Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or ‘progression’ criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. Design A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. Results There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. Conclusions Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials. PMID:28213598

  11. Gaming and conventional exercises for improvement of arm function after stroke: a randomised controlled pilot study

    NARCIS (Netherlands)

    Kottink, A.I.R.; Prange, G.B.; Krabben, T.; Rietman, J.S.; Buurke, J.H.

    2014-01-01

    Objective: The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach trai

  12. Virtual control room, the REMOT project, networking pilot studies

    NARCIS (Netherlands)

    Andree, H. M. A.; Habets, J.; Koopmans, M.; Kooijman, W.; Kemmerling, G.; Korten, M.; de Laat, C. T. A. M.; Lourens, W.; van der Meer, E. A.; Oomens, A. A. M.; Venema, J.

    1998-01-01

    The Remote Experiment Monitoring and Control (REMOT) project objective is to develop a system architecture to allow remote control of scientific experiments and facilities that require real time operation and multimedia information feedback, using available or deploying communications infrastructure

  13. Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

    Science.gov (United States)

    Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

    2015-01-01

    This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study.

  14. Cardiovascular risk score and cardiovascular events among airline pilots: a case-control study.

    Science.gov (United States)

    Wirawan, I Made Ady; Larsen, Peter D; Aldington, Sarah; Griffiths, Robin F; Ellis, Chris J

    2012-05-01

    A cardiovascular risk prediction score is routinely applied by aviation authorities worldwide. We examined the accuracy of the Framingham-based risk chart used by the New Zealand Civil Aviation Authority in predicting cardiovascular events among airline pilots. A matched case-control design was applied to assess the association of 5-yr cardiovascular risk score and cardiovascular events in Oceania-based airline pilots. Cases were pilots with cardiovascular events as recorded on their medical records. Each case was age and gender matched with four controls that were randomly selected from the pilot population. To collect data before the events, 5-yr retrospective evaluations were conducted. Over a 16-yr study period we identified 15 cases of cardiovascular events, 9 (60%) of which were sudden clinical presentations and only 6 (40%) of which were detected using cardiovascular screening. There were 8 cases (53%) and 16 controls (27%) who had a 5-yr risk of > or = 10-15%. Almost half of the events (7/15) occurred in pilots whose highest 5-yr risk was in the 5-10% range. Cases were 3.91 times more likely to have highest 5-yr risk score of > or =10-15% than controls (OR = 3.91, 95% CI 1.04-16.35). The accuracy of the highest risk scores were moderate (AUC = 0.723, 95% CI 0.583-0.863). The cutoff point of 10% is valid, with a specificity of 0.73, but low sensitivity (0.53). Despite a valid and appropriate cutoff point, the tool had low sensitivity and was unable to predict almost half of the cardiovascular events.

  15. Transcranial direct current stimulation in the recovery of postural control after stroke : a pilot study

    OpenAIRE

    Saeys, Wim; Vereeck, Luc; Lafosse, Christophe; Truijen, Steven; Wuyts, Floris L.; de Heyning, van, P.H.

    2015-01-01

    Abstract: Purpose: This pilot study aimed to evaluate the effectiveness of multiple sessions of transcranial Direct Current Stimulation (tDCS) during 4 weeks on balance and gait parameters after stroke. Method: Thirty-one stroke patients were included in this randomised, double-blind, sham-controlled crossover study. The Tinetti test was used to assess functional balance and gait after stroke. Secondary measures, Rivermead Motor Assessment (RMA) and Trunk Impairment Scale (TIS), were register...

  16. A Pilot Opinion Study of Lateral Control Requirements for Fighter-Type Aircraft

    Science.gov (United States)

    Creer, Brent Y.; Stewart, John D.; Merrick, Robert B.; Drinkwater, Fred J., III

    1959-01-01

    As part of a continuing NASA program of research on airplane handling qualities, a pilot opinion investigation has been made on the lateral control requirements of fighter aircraft flying in their combat speed range. The investigation was carried out using a stationary flight simulator and a moving flight simulator, and the flight simulator results were supplemented by research tests in actual flight. The flight simulator study was based on the presumption that the pilot rates the roll control of an airplane primarily on a single-degree-of-freedom basis; that is, control of angle of roll about the aircraft body axis being of first importance. From the assumption of a single degree of freedom system it follows that there are two fundamental parameters which govern the airplane roll response, namely the roll damping expressed as a time constant and roll control power in terms of roll acceleration. The simulator study resulted in a criterion in terms of these two parameters which defines satisfactory, unsatisfactory, and unacceptable roll performance from a pilot opinion standpoint. The moving simulator results were substantiated by the in-flight investigation. The derived criterion was compared with the roll performance criterion based upon wing tip helix angle and also with other roll performance concepts which currently influence the roll performance design of military fighter aircraft flying in their combat speed range.

  17. Managerial span of control: a pilot study comparing departmental complexity and number of direct reports.

    Science.gov (United States)

    Merrill, Katreena Collette; Pepper, Ginette; Blegen, Mary

    2013-09-01

    Nurse managers play pivotal roles in hospitals. However, restructuring has resulted in nurse managers having wider span of control and reduced visibility. The purpose of this pilot study was to compare two methods of measuring span of control: departmental complexity and number of direct reports. Forty-one nurse managers across nine hospitals completed The Ottawa Hospital Clinical Manager Span of Control Tool (TOH-SOC) and a demographic survey. A moderate positive relationship between number of direct reports and departmental complexity score was identified (r=.49, p=managers' responsibility. Copyright © 2013 Longwoods Publishing.

  18. Isothermal dialysis to control intradialytic hypotension and patient comfort: a pilot study.

    Science.gov (United States)

    Li, Jianjun; Bellury, Lanell; Baird, Marianne; Van Brackle, Lewis N; Aduddell, Kathie

    2014-01-01

    Isothermal hemodialysis to improve intradialytic tolerance in hypotension-prone patients has been effective in outpatient settings. The purpose of this pilot study was to examine thermal control in an acute care setting and describe comfort issues associated with thermal control Although complaints of cold or shivering occurred more frequently with the isothermal hemodialysis group, cold discomfort was managed by nursing interventions and was not a cause of significant discomfort. No statistically significant difference was observed in blood pressure or patient's comfort level between standard and isothermal dialysis. However, isothermal hemodialysis may be an appropriate hemodialysis option for control of intradialytic hypotension in the acute care setting. Further research is recommended.

  19. Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: A randomized controlled pilot study

    NARCIS (Netherlands)

    Dronkers, J.J.; Lamberts, H.; Reutelingsperger, I.M.M.D.; Naber, R.H.; Dronkers-Landman, C.M.; Veldman, A.; Meeteren, N.L.U. van

    2010-01-01

    Objective: Investigation of the feasibility and preliminary effect of a short-term intensive preoperative exercise programme for elderly patients scheduled for elective abdominal oncological surgery. Design: Single-blind randomized controlled pilot study. Setting: Ordinary hospital in the Netherland

  20. Cervical spine degeneration in fighter pilots and controls: a 5-yr follow-up study.

    Science.gov (United States)

    Petrén-Mallmin, M; Linder, J

    2001-05-01

    At 5 yr after MRI of the cervical spine, for evaluation concerning degenerative lesions, follow-up MRI was performed on asymptomatic experienced military high performance aircraft pilots (mean age 47 yr; mean accumulated flying time 3,100 h) and on age-matched controls without military flying experience. Young military high performance aircraft pilots (mean age 28 yr, mean accumulated flying time 915 h) were also re-examined. Compared with baseline MRI 5 yr earlier, there was significant increase in disk protrusions in all groups, in osteophytes in controls, and in foraminal stenoses in experienced pilots, and a significant reduction in disk signal intensity in young pilots. The difference between experienced pilots and controls was markedly reduced compared with that at baseline MRI. Thus, military high performance aircraft pilots seem to be at increased risk of premature development of degenerative lesions of the same type as are seen in an aging population. With increasing age the difference between pilots and controls diminishes.

  1. Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study

    Directory of Open Access Journals (Sweden)

    Zhang Lang

    2007-11-01

    Full Text Available Abstract Background In planning a randomized controlled trial of acupuncture, we conducted a pilot study using validated outcome measures to assess the feasibility of the protocol, and to obtain preliminary data on efficacy and tolerability of 3 different forms of acupuncture treatment as an adjunct for the treatment of chronic pain in patients with Rheumatoid arthritis (RA. Methods The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture (EA, traditional Chinese acupuncture (TCA and sham acupuncture (Sham in patients with RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10. Results From 80 eligible patients, 36 patients with mean age of 58 ± 10 years and disease duration of 9.3 ± 6.4 years were recruited. Twelve patients were randomized to each group. Twelve, 10 and 7 patients from the EA, TCA and Sham group respectively completed the study at 20 weeks (p Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for RA. Trial registration ClinicalTrials.gov NCT00404443

  2. Transcranial direct current stimulation in the recovery of postural control after stroke: a pilot study.

    Science.gov (United States)

    Saeys, Wim; Vereeck, Luc; Lafosse, Christophe; Truijen, Steven; Wuyts, Floris L; Van De Heyning, Paul

    2015-01-01

    This pilot study aimed to evaluate the effectiveness of multiple sessions of transcranial Direct Current Stimulation (tDCS) during 4 weeks on balance and gait parameters after stroke. Thirty-one stroke patients were included in this randomised, double-blind, sham-controlled crossover study. The Tinetti test was used to assess functional balance and gait after stroke. Secondary measures, Rivermead Motor Assessment (RMA) and Trunk Impairment Scale (TIS), were registered to asses both motricity and trunk performance. All tests were administered at baseline, after 4 and 8 weeks. Patients were randomly divided into two groups. Both groups received both sixteen 20-min sessions of tDCS and sixteen 20-min sessions of Sham stimulation. Application method between groups was changed after 4 weeks. A general linear repeated measures model was used to analyse the results of our study. Results revealed an effect on the total score of the Tinetti test (p = 0.049). No significant results were obtained for the RMA (p = 0.166) and the TIS (p = 0.479). This pilot study indicates that 16 tDCS-sessions could have a beneficial effect on balance and gait in stroke patients measured with the Tinetti test. However, further research is needed to elucidate these findings. Implications for Rehabilitation Sixteen sessions of tDCS is beneficial in the recovery of postural control in stroke patients. tDCS has to be applied as soon as possible to enhance beneficial effects.

  3. Diabetes telemonitoring reduces the risk of hypoglycaemia during Ramadan: a pilot randomized controlled study.

    Science.gov (United States)

    Lee, J Y; Lee, S W H; Nasir, N H; How, S; Tan, C S S; Wong, C P

    2015-12-01

    This pilot study evaluated the short-term benefits of a telemonitoring-supplemented focused diabetic education compared with education alone in participants with Type 2 diabetes who were fasting during Ramadan. In this pilot mixed-method study, we identified 37 participants and randomly allocated them to either a telemonitoring group (n = 18) or a group receiving Ramadan-focused pre-education only (usual care; n = 19). The telemonitoring group received goal-setting and personalized feedback. The telemonitoring group was less likely to experience hypoglycaemia than the usual care group (odds ratio: 0.1273; 95% confidence interval: 0.0267-0.6059). No significant differences were noted in glycaemic control at the end of study. Participants viewed telemedicine as a more convenient alternative although technological barriers remain a concern. The results of this study reinforce the need for monitoring as well as educational initiatives for Muslims with diabetes who fast during Ramadan. Telemonitoring offers an attractive option requiring further research. (Clinical Trial Registry No. NCT02189135). © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  4. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

    Directory of Open Access Journals (Sweden)

    Lavinia Fiorentino

    2009-12-01

    Full Text Available Lavinia Fiorentino1, John R McQuaid2, Lianqi Liu3, Loki Natarajan4, Feng He4, Monique Cornejo3, Susan Lawton3, Barbara A Parker6, Georgia R Sadler5, Sonia Ancoli-Israel31Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA, USA; 2Department of Psychiatry, University of California, San Francisco, CA, USA; 3Department of Psychiatry, 4Department of Family and Preventive Medicine, 5Department of Surgery, University of California, San Diego School of Medicine, La Jolla, CA, USA; 6Moores UCSD Cancer Center, La Jolla, CA, USAPurpose: Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I on sleep in breast cancer survivors.Patients and methods: Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions. Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group.Results: Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre–post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep.Conclusions: These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting.Keywords: insomnia, breast cancer, cognitive behavioral therapy

  5. Short cognitive behavioral therapy and cognitive training for adults with ADHD - a randomized controlled pilot study.

    Science.gov (United States)

    Virta, Maarit; Salakari, Anita; Antila, Mervi; Chydenius, Esa; Partinen, Markku; Kaski, Markus; Vataja, Risto; Kalska, Hely; Iivanainen, Matti

    2010-09-07

    In clinical practice, a growing need exists for effective non-pharmacological treatments of adult attention-deficit/hyperactivity disorder (ADHD). Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual cognitive- behavioral therapy (CBT), 9 adults participating in cognitive training (CT), and 10 controls. Self-report questionnaires, independent evaluations, and computerized neurocognitive testing were collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the self- report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing.

  6. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

    DEFF Research Database (Denmark)

    Nejrup, Kirsten; Olivarius, Niels de Fine; Jacobsen, Judith L.

    2008-01-01

    The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18-80 years with pain...... and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed...... acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial...

  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. Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

    2015-11-01

    Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

  9. 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.

  10. Optical People Counting for Demand Controlled Ventilation: A Pilot Study of Counter Performance

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, William J.; Sullivan, Douglas

    2009-12-26

    This pilot scale study evaluated the counting accuracy of two people counting systems that could be used in demand controlled ventilation systems to provide control signals for modulating outdoor air ventilation rates. The evaluations included controlled challenges of the people counting systems using pre-planned movements of occupants through doorways and evaluations of counting accuracies when naive occupants (i.e., occupants unaware of the counting systems) passed through the entrance doors of the building or room. The two people counting systems had high counting accuracy accuracies, with errors typically less than 10percent, for typical non-demanding counting events. However, counting errors were high in some highly challenging situations, such as multiple people passing simultaneously through a door. Counting errors, for at least one system, can be very high if people stand in the field of view of the sensor. Both counting system have limitations and would need to be used only at appropriate sites and where the demanding situations that led to counting errors were rare.

  11. Mirror therapy for distal radial fractures: A pilot randomized controlled study.

    Science.gov (United States)

    Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

    2016-10-12

    To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

  12. Effects of errorless skill learning in people with mild-to-moderate or severe dementia: A randomized controlled pilot study

    NARCIS (Netherlands)

    Kessels, R.P.C.; Olde Hensken, L.M.G.

    2009-01-01

    This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with m

  13. Effects of errorless skill learning in people with mild-to-moderate or severe dementia: a randomized controlled pilot study.

    NARCIS (Netherlands)

    Kessels, R.P.C.; Hensken, L.M.

    2009-01-01

    This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with m

  14. Bisphenol a exposure in Mexico City and risk of prematurity: a pilot nested case control study

    Directory of Open Access Journals (Sweden)

    Mercado-García Adriana

    2010-10-01

    Full Text Available Abstract Background Presence of Bisphenol A (BPA has been documented worldwide in a variety of human biological samples. There is growing evidence that low level BPA exposure may impact placental tissue development and thyroid function in humans. The aim of this present pilot study was to determine urinary concentrations of BPA during the last trimester of pregnancy among a small subset of women in Mexico City, Mexico and relate these concentrations to risk of delivering prematurely. Methods A nested case-control subset of 60 participants in the Early Life Exposure in Mexico to ENvironmental Toxicants (ELEMENT study in Mexico City, Mexico were selected based on delivering less than or equal to 37 weeks of gestation and greater than 37 weeks of gestation. Third trimester archived spot urine samples were analyzed by online solid phase extraction coupled with high performance liquid chromatography isotope dilution tandem mass spectrometry. Results BPA was detected in 80.0% (N = 48 of the urine samples; total concentrations ranged from th week (n = 12, the odds ratio for specific-gravity adjusted BPA was larger and statistically significant (p Conclusions This is the first study to document measurable levels of BPA in the urine of a population of Mexican women. This study also provides preliminary evidence, based on a single spot urine sample collected during the third trimester, that pregnant women who delivered less than or equal to 37 weeks of gestation and prematurely (

  15. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial

    Science.gov (United States)

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-01-01

    Introduction Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. Methods and analysis The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3–8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Ethics and dissemination Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016–15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer

  16. High vs. Low Frequency Stimulation Effects on Fine Motor Control in Chronic Hemiplegia: A Pilot Study

    Science.gov (United States)

    Doucet, Barbara M.; Griffin, Lisa

    2014-01-01

    Introduction The optimal parameters of neuromuscular electrical stimulation (NMES) for recovery of hand function following stroke are not known. This clinical pilot study examined whether higher or lower frequencies are more effective for improving fine motor control of the hand in a chronic post-stroke population. Methods A one-month, 4x/week in-home regimen of either a high frequency (40Hz) or low frequency (20Hz) NMES program was applied to the hemiplegic thenar muscles of 16 persons with chronic stroke. Participants were identified a priori as having a low level of function (LF) or a high level of function (HF). Outcome measures of strength, dexterity, and endurance were measured before and after participation in the regimen. Results LF subjects showed no significant changes with either the high or the low frequency NMES regimen. HF subjects showed significant changes in strength, dexterity and endurance. Within this group, higher frequencies of stimulation yielded strength gains and increased motor activation; lower frequencies impacted dexterity and endurance. Conclusions The results suggest that higher frequencies of stimulation could be more effective in improving strength and motor activation properties and that lower frequencies may impact coordination and endurance changes; results also indicate that persons with a higher functional level of recovery may respond more favorably to NMES regimens, but further study with larger patient groups is warranted. PMID:23893829

  17. Professional kinesiology practice for chronic low back pain: single-blind, randomised controlled pilot study.

    Science.gov (United States)

    Eardley, S; Brien, S; Little, P; Prescott, P; Lewith, G

    2013-01-01

    Chronic low back pain is a highly prevalent condition with no definitive treatment. Professional Kinesiology Practice (PKP) is a little known complementary medicine technique using non-standard muscle testing; no previous effectiveness studies have been performed. This is an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot study with waiting list control (WLC) in private practice UK (2007-2009). 70 participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving 1 treatment weekly for 5 weeks or a WLC. WLC's were re-randomised to real or sham after 6 weeks. The main outcome was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP. With an effect size of 0.7 real treatment was significantly different to sham (mean difference RMDQ score = -2.9, p = 0.04, 95% CI -5.8 to -0.1). Compared to WLC, real and sham groups had significant RMDQ improvements (real -9.0, p < 0.01, 95% CI -12.1 to -5.8; effect size 2.1; sham -6.1, p < 0.01, 95% CI -9.1 to -3.1; effect size 1.4). Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. 3 patients reported minor adverse reactions. Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

  18. Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment

    OpenAIRE

    Allen, Jerilyn K.; Janna Stephens; Dennison Himmelfarb, Cheryl R.; Stewart, Kerry J.; Sara Hauck

    2013-01-01

    Background. The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology. Methods. The study randomized 68 obese adults to receive one of four interventions for six months: (1) intensive counseling intervention, (2) intensi...

  19. A randomized controlled pilot study of the therapeutic effects of yoga in people with Parkinson's disease.

    Science.gov (United States)

    Sharma, Neena K; Robbins, Kristin; Wagner, Kathleen; Colgrove, Yvonne M

    2015-01-01

    Exercise can be beneficial for cardiopulmonary, musculoskeletal or neurological systems, and other factors including mood, and may be beneficial in reducing fall risks, dementia and variables associated with quality of life (QOL). Parkinson's disease (PD) produces progressive motor and cognitive deterioration that may leave those inflicted unable to participate in standard exercise programs. Alternative forms of exercise such as yoga may be successful in improving physical function, QOL and physiological variables for overall well-being. This randomized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD. Thirteen people with stage 1-2 PD were randomized to either a yoga (n = 8) or a control group (n = 5). The yoga group participated in twice-weekly yoga sessions for 12 weeks. Participants were tested at baseline, and at 6 and 12 weeks using the Unified Parkinson's Disease Rating Scale (UPDRS), clinical measures of health-related QOL and physiological measures. Significant improvement in UPDRS scores (P = .006), diastolic blood pressure (P = 0.036) and average forced vital capacity (P = 0.03) was noted in the yoga group over time. Changes between groups were also noted in two SF-36 subscales. Positive trends of improvement were noted in depression scores (P = 0.056), body weight (P = 0.056) and forced expiratory volume (P = 0.059). Yoga participants reported more positive symptom changes including immediate tremor reduction. The results suggest that yoga may improve aspects of QOL and physiological functions in stages 1-2 PD. Future larger studies are needed to confirm and extend our findings of the effects of yoga in PD.

  20. Arterial stiffness in periodontitis patients and controls: A case-control and pilot intervention study

    NARCIS (Netherlands)

    Houcken, W.; Teeuw, W.J.; Bizarro, S.; Rodriguez, E.A.; Mulders, T.A.; van den Born, B.-J.H.; Loos, B.G.

    2016-01-01

    Increased arterial stiffness (AS) is an important indicator for atherosclerotic cardiovascular disease (ACVD). Epidemiologically, periodontitis and ACVD are associated. Therefore, we aimed to investigate AS in periodontitis patients and controls. In addition, we explored the effect of periodontal

  1. Downwards Vertical Attention Bias in Conversion Disorder vs Controls: A Pilot Study.

    Science.gov (United States)

    Gazit, Sivan; Elkana, Odelia; Dawidowicz, Liraz; Yeshayahu, Liel; Biran, Iftah

    2017-07-15

    Conversion disorder (CD) is a largely enigmatic disorder, one that requires a thorough ruling-out process. Prior research suggests that metaphors and conceptualization are rooted in physical experience, and that we interpret our affective world through metaphors. Spatial metaphors (interaction of affect and vertical space) are a prominent example of the grounding of metaphors. This is a relatively unpaved direction of research of CD. The present pilot study sought to explore this view by investigating the "healthy is up, sick is down" spatial metaphors (e.g., "fell ill" and "top shape") in patients with CD, examining the correlation between the processing of bodily-related words, CD, and vertical space. We hypothesized that patients with CD, who experience their bodies as ill, will demonstrate a downwards bias when processing bodily-related words; corresponding to the "healthy is up, sick is down" spatial metaphor. A total of 8 female patients (ages M-38.13 SD-10.44) and 42 female controls (ages M-36.4 SD-14.57) performed a visual attention task. Participants were asked to identify a spatial probe at the top or the bottom of a screen, following either a bodily related (e.g., arm) or non-bodily related (e.g., clock) prime word. As predicted, when processing bodily-related words, patients with CD demonstrated a downwards attention bias. Moreover, the higher the patient's level of somatization, the faster the patient detected lower (vs upper) spatial targets. This study suggests that the changed health paradigm of patients with CD is grounded in sensorimotor perception. Further research could propose new diagnostic and treatment options for CD. Copyright © 2017 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  2. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m[sup 3]) of tertiary oil have been recovered. Microbial activity has increased CO[sub 2] content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  3. Acupucture in the treatment of scoliosis – a single blind controlled pilot study

    Directory of Open Access Journals (Sweden)

    Jahnke Anja

    2008-01-01

    Full Text Available Abstract Background Today, acupuncture therapy is commonly used for pain control throughout the world, although the putative mechanisms are still unclear. A Pub Med search for the key words "Acupuncture" and "Scoliosis" reveals 3 papers only, not containing any results of studies designed for the treatment of scoliosis with the help of acupuncture. Because of this lack of trials especially designed for the treatment of scoliosis this pilot study has been performed. Methods 24 girls undergoing in-patient rehabilitation, 14 – 16 years of age (at average 15,1 years, SD 0,74 with the diagnosis of an Adolescent Idiopathic Scoliosis (AIS have agreed to take part in this controlled single blind crossover study. Average Cobb angle was 33 degrees (SD 9,2 ranging from 16 to 49 degrees. 10 of the girls had a thoracic, one a lumbar, 7 a double major and 6 a thoracolumbar curve pattern. The patients have been scanned with the Formetric® surface topography measurement system before and after lying on the left side [L], before and after sham acupuncture [S] and before and after real acupuncture [R]. Results For the whole group of patients no significant changes have been found during lying, sham acupuncture or real acupuncture. There were no differences between the patient groups with different curve pattern. In the explorative subgroup analysis of Patients with curvatures from 16 to 35 degrees, however significant changes in surface rotation have been found after R intervention as well as a strong differences in lateral deviation while in the L or S intervention no real changes have been achieved. Conclusion One session with real (verum acupuncture seems to have an influence on the deformity of scoliosis patients with no more than 35 degrees. The findings during verum acupuncture clearly are different to sham acupuncture or just lying, while in the whole group of patients also including patients with curvatures of more than 35 degrees no obvious changes

  4. Quantifying cobalt in doping control urine samples--a pilot study.

    Science.gov (United States)

    Krug, Oliver; Kutscher, Daniel; Piper, Thomas; Geyer, Hans; Schänzer, Wilhelm; Thevis, Mario

    2014-01-01

    Since first reports on the impact of metals such as manganese and cobalt on erythropoiesis were published in the late 1920s, cobaltous chloride became a viable though not widespread means for the treatment of anaemic conditions. Today, its use is de facto eliminated from clinical practice; however, its (mis)use in human as well as animal sport as an erythropoiesis-stimulating agent has been discussed frequently. In order to assess possible analytical options and to provide relevant information on the prevalence of cobalt use/misuse among athletes, urinary cobalt concentrations were determined by inductively coupled plasma-mass spectrometry (ICP-MS) from four groups of subjects. The cohorts consisted of (1) a reference population with specimens of 100 non-elite athletes (not being part of the doping control system), (2) a total of 96 doping control samples from endurance sport athletes, (3) elimination study urine samples collected from six individuals having ingested cobaltous chloride (500 µg/day) through dietary supplements, and (4) samples from people supplementing vitamin B12 (cobalamin) at 500 µg/day, accounting for approximately 22 µg of cobalt. The obtained results demonstrated that urinary cobalt concentrations of the reference population as well as the group of elite athletes were within normal ranges (0.1-2.2 ng/mL). A modest but significant difference between these two groups was observed (Wilcoxon rank sum test, p cobalt levels. The elimination study urine specimens yielded cobalt concentrations between 40 and 318 ng/mL during the first 6 h post-administration, and levels remained elevated (>22 ng/mL) up to 33 h. Oral supplementation of 500 µg of cobalamin did not result in urinary cobalt concentrations > 2 ng/mL. Based on these pilot study data it is concluded that measuring the urinary concentration of cobalt can provide information indicating the use of cobaltous chloride by athletes. Additional studies are however

  5. Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study

    OpenAIRE

    Morone, Natalia E.; Greco, Carol M.; Weiner, Debra K.

    2007-01-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were ra...

  6. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study.

    Science.gov (United States)

    Optale, Gabriele; Urgesi, Cosimo; Busato, Valentina; Marin, Silvia; Piron, Lamberto; Priftis, Konstantinos; Gamberini, Luciano; Capodieci, Salvatore; Bordin, Adalberto

    2010-05-01

    Memory decline is a prevalent aspect of aging but may also be the first sign of cognitive pathology. Virtual reality (VR) using immersion and interaction may provide new approaches to the treatment of memory deficits in elderly individuals. The authors implemented a VR training intervention to try to lessen cognitive decline and improve memory functions. The authors randomly assigned 36 elderly residents of a rest care facility (median age 80 years) who were impaired on the Verbal Story Recall Test either to the experimental group (EG) or the control group (CG). The EG underwent 6 months of VR memory training (VRMT) that involved auditory stimulation and VR experiences in path finding. The initial training phase lasted 3 months (3 auditory and 3 VR sessions every 2 weeks), and there was a booster training phase during the following 3 months (1 auditory and 1 VR session per week). The CG underwent equivalent face-to-face training sessions using music therapy. Both groups participated in social and creative and assisted-mobility activities. Neuropsychological and functional evaluations were performed at baseline, after the initial training phase, and after the booster training phase. The EG showed significant improvements in memory tests, especially in long-term recall with an effect size of 0.7 and in several other aspects of cognition. In contrast, the CG showed progressive decline. The authors suggest that VRMT may improve memory function in elderly adults by enhancing focused attention.

  7. Arterial stiffness in periodontitis patients and controls. A case–control and pilot intervention study.

    Science.gov (United States)

    Houcken, W; Teeuw, W J; Bizzarro, S; Alvarez Rodriguez, E; Mulders, T A; van den Born, B-Jh; Loos, B G

    2016-01-01

    Increased arterial stiffness (AS) is an important indicator for atherosclerotic cardiovascular disease (ACVD). Epidemiologically, periodontitis and ACVD are associated. Therefore, we aimed to investigate AS in periodontitis patients and controls. In addition, we explored the effect of periodontal therapy on AS in a sub-group of cases. Pulse-wave velocity (PWV), a non-invasive chair-side function test for AS, was measured in periodontitis patients (n=57; mean age 46.6 years) and compared with a reference group (n=48; mean age 45.5 years). In addition, 45 cases (mean age 46.9 years) were 6 months followed after periodontal treatment, to explore a possible effect on arterial function. Periodontitis patients showed a significantly increased PWV compared with the reference group (8.01±0.20 vs. 7.36±0.22 m s(-1) respectively; P=0.029) and this remained significant after adjustments for ACVD risk factors (P=0.019). After periodontal therapy, no significant reduction in PWV was seen (8.00±1.8 to 7.82±1.6 m s(-1); P=0.13), but systolic blood pressure (SBP) was significantly reduced (119.8±14.6 to 116.9±15.1 mm Hg; P=0.040). It can be concluded that periodontitis is associated with increased AS. This confirms with a new parameter the association of periodontitis with ACVD. Although periodontal treatment did not lower AS significantly, a modest reduction of SBP after 6 months was observed.

  8. Evaluation of vardenafil for the treatment of subjective tinnitus: a controlled pilot study

    Directory of Open Access Journals (Sweden)

    Stöver Timo

    2009-02-01

    Full Text Available Abstract Background Vardenafil (Levitra® represents a potent and highly selective phosphodiesterase type 5 (PDE5 inhibitor, which is established for treatment of various diseases. There are several unpublished reports from patients stating that vardenafil has a considerable therapeutic effect on their concomitant tinnitus. This pilot study was conducted to specifically assess the effect of vardenafil in patients with chronic tinnitus. Methods This trial was based on a prospective, randomized, double-blind, placebo-controlled, parallel group design. Fourty-two consecutive subjects with mon- or binaural chronic tinnitus received 10 mg vardenafil (N = 21 or matching placebo tablets (N = 21 administered orally twice a day over a period of 12 weeks. Clinical examination and data acquisition took place at each visit: at baseline, after 4 weeks, after 12 weeks (end of treatment with study medication, and at non-medicated follow-up after 16 weeks. Assessment of clinical effectiveness was based on a standardized tinnitus questionnaire (TQ, the Short Form 36 health survey (SF-36, audiometric measurements (mode, pitch and loudness of tinnitus; auditory thresholds and biomarkers of oxidative stress in patients' blood (malondialdehyde, protein carbonyl, homocysteine and total antioxidative status. Therapeutic efficacy was evaluated by comparison of subjective and objective parameters with baseline data between both treatment groups (ANCOVA. Results Vardenafil had no superior efficacy over placebo in the treatment of chronic tinnitus during this study. The primary efficacy criterion 'TQ total score' failed to demonstrate significant improvement compared to placebo. Subjective reports of TQ subscales and general quality of life areas (SF-36, objective audiometric examinations as well as investigated biomarkers for oxidative stress did not reveal any significant treatment effects. The safety profile was favorable and consistent with that in other vardenafil

  9. Evaluation of vardenafil for the treatment of subjective tinnitus: a controlled pilot study

    Science.gov (United States)

    Mazurek, Birgit; Haupt, Heidemarie; Szczepek, Agnieszka J; Sandmann, Jörg; Gross, Johann; Klapp, Burghard F; Kiesewetter, Holger; Kalus, Ulrich; Stöver, Timo; Caffier, Philipp P

    2009-01-01

    Background Vardenafil (Levitra®) represents a potent and highly selective phosphodiesterase type 5 (PDE5) inhibitor, which is established for treatment of various diseases. There are several unpublished reports from patients stating that vardenafil has a considerable therapeutic effect on their concomitant tinnitus. This pilot study was conducted to specifically assess the effect of vardenafil in patients with chronic tinnitus. Methods This trial was based on a prospective, randomized, double-blind, placebo-controlled, parallel group design. Fourty-two consecutive subjects with mon- or binaural chronic tinnitus received 10 mg vardenafil (N = 21) or matching placebo tablets (N = 21) administered orally twice a day over a period of 12 weeks. Clinical examination and data acquisition took place at each visit: at baseline, after 4 weeks, after 12 weeks (end of treatment with study medication), and at non-medicated follow-up after 16 weeks. Assessment of clinical effectiveness was based on a standardized tinnitus questionnaire (TQ), the Short Form 36 health survey (SF-36), audiometric measurements (mode, pitch and loudness of tinnitus; auditory thresholds) and biomarkers of oxidative stress in patients' blood (malondialdehyde, protein carbonyl, homocysteine and total antioxidative status). Therapeutic efficacy was evaluated by comparison of subjective and objective parameters with baseline data between both treatment groups (ANCOVA). Results Vardenafil had no superior efficacy over placebo in the treatment of chronic tinnitus during this study. The primary efficacy criterion 'TQ total score' failed to demonstrate significant improvement compared to placebo. Subjective reports of TQ subscales and general quality of life areas (SF-36), objective audiometric examinations as well as investigated biomarkers for oxidative stress did not reveal any significant treatment effects. The safety profile was favorable and consistent with that in other vardenafil studies. Conclusion

  10. A pilot study for control of hyperendemic cystic hydatid disease in China.

    Directory of Open Access Journals (Sweden)

    Wenbao Zhang

    Full Text Available BACKGROUND: Cystic hydatid disease (CHD is a global parasitic zoonosis caused by the dog tapeworm, Echinococcus granulosus. The disease is hyperendemic in western China because of poor economic development; limited community knowledge of CHD; widespread, small-scale household animal production; home killing of livestock; and the feeding of dogs with uncooked offal. METHODOLOGY/PRINCIPAL FINDINGS: A control program focusing on monthly praziquantel (PZQ treatment of all registered dogs and culling unwanted and stray dogs has been designed to control CHD in hyperendemic areas in China. A pilot field control project in two counties (Hutubi and Wensu in Xinjiang, China showed that after 4 years of treatment, the prevalence of dogs with E. granulosus was reduced from 14.7% and 18.6%, respectively, to 0%, and this caused a 90%-100% decrease of CHD in sheep born after commencement of the control program. CONCLUSIONS/SIGNIFICANCE: The strategy aimed at preventing eggs being released from dogs into the environment by treating animals before adult tapeworms are patent can decrease E. granulosus transmission and considerably reduce hyperendemic CHD. Monthly treatment of dogs with PZQ and culling unwanted and stray dogs have been shown to be an efficient, highly cost-effective and practicable measure for implementation in rural communities. As a result, the Chinese Ministry of Health has launched an extensive CHD control program in 117 counties in western China using this control strategy.

  11. Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment

    Directory of Open Access Journals (Sweden)

    Jerilyn K. Allen

    2013-01-01

    Full Text Available Background. The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology. Methods. The study randomized 68 obese adults to receive one of four interventions for six months: (1 intensive counseling intervention, (2 intensive counseling plus smartphone intervention, (3 a less intensive counseling plus smartphone intervention, and (4 smartphone intervention only. The outcome measures of weight, BMI, waist circumference, and self-reported dietary intake and physical activity were assessed at baseline and six months. Results. The sample was 78% female and 49% African American, with an average age of 45 years, and average BMI of 34.3 kg/m2. There were trends for differences in weight loss among the four intervention groups. Participants in the intensive counseling plus self-monitoring smartphone group and less intensive counseling plus self-monitoring smartphone group tended to lose more weight than other groups (5.4 kg and 3.3 kg, resp.. Conclusions. The results of this pilot trial of a weight loss intervention provide preliminary support for using a smartphone application for self-monitoring as an adjunct to behavioral counseling.

  12. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  13. Conducting pilot and feasibility studies.

    Science.gov (United States)

    Cope, Diane G

    2015-03-01

    Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
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  14. Virtual reality in the rehabilitation of the arm after hemiplegic stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Crosbie, J H; Lennon, S; McGoldrick, M C; McNeill, M D J; McDonough, S M

    2012-09-01

    To assess the feasibility of a trial to investigate the effectiveness of virtual reality-mediated therapy compared to conventional physiotherapy in the motor rehabilitation of the arm following stroke, and to provide data for a power analysis to determine numbers for a future main trial. Pilot randomized controlled trial. Clinical research facility. Eighteen people with a first stroke, 10 males and 8 females, 7 right and 2 left side most affected. Mean time since stroke 10.8 months. Participants were randomized to a virtual reality group or a conventional arm therapy group for nine sessions over three weeks. The upper limb Motricity Index and the Action Research Arm Test were completed at baseline, post intervention and six weeks follow-up. Outcome data were obtained from 95% of participants at the end of treatment and at follow-up: one participant withdrew. Compliance was high; only two people reported side-effects from virtual reality exposure. Both groups demonstrated small (7-8 points on upper limb Motricity Index and 4 points on the Action Research Arm Test), but non-significant, changes to their arm impairment and activity levels. A randomized controlled trial of virtual reality-mediated therapy comparable to conventional therapy would be feasible, with some suggested improvements in recruitment and outcome measures. Seventy-eight participants (39 per group) would be required for a main trial.

  15. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  16. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  17. A retrospective pilot study of the use of a new algorithm to improve quality control in bronchodilator studies.

    Science.gov (United States)

    Earle, Charlotte L; Jefferies, Rhys

    2015-01-01

    Reversibility testing is used to identify a positive or negative response to bronchodilators. Results from a reversibility test can not only support a diagnosis of asthma but can alter a patient's treatment plan, so its clinical importance should not be understated. With multiple guidelines published classifying a 'positive response' it becomes unclear on how to categorise certain individuals. This study looks into the discrepancies between the guidelines, and introduces a new algorithm to help clinicians. This retrospective pilot study was completed across four hospitals in South Wales. Data were collected from a total of 117 patients referred for a reversibility study during November 2013 and April 2014. An algorithm was created to improve flow-volume loop (FVL) quality control when assessing airways bronchodilation in symptomatic patients. Each patient result was placed through four major reversibility guidelines [British Thoracic Society (BTS), National Institute for Clinical Excellence (NICE), Association for Respiratory Technology Physiologists (ARTP) and Global Lung Initiative (GLI)] and the new algorithm. When comparing published guidelines, 75% of patients would receive the same bronchodilator response decision, positive or negative, irrespective of the guideline followed. Variability between the numbers of positive responders in each guideline varied by up to 58%, with NICE found to give the least number of positive responses (7%), and BTS giving the greatest (65%). Using the new algorithm, over one third (38%) of patients required a repeat FVL, as baseline and/or post-bronchodilator FVLs did not meet the quality control specification. Further investigation is needed to establish the clinical impact of the new algorithm, and its approach to using the whole of the FVL in bronchodilator analysis; however, quality control during reversibility testing needs to be improved to ensure that bronchodilator responses are correctly identified.

  18. A Pilot Study Investigating the Effects of Advanced Nuclear Power Plant Control Room Technologies: Methods and Qualitative Results

    Energy Technology Data Exchange (ETDEWEB)

    BLanc, Katya Le [Idaho National Lab. (INL), Idaho Falls, ID (United States); Powers, David [Idaho National Lab. (INL), Idaho Falls, ID (United States); Joe, Jeffrey [Idaho National Lab. (INL), Idaho Falls, ID (United States); Spielman, Zachary [Idaho National Lab. (INL), Idaho Falls, ID (United States); Rice, Brandon [Idaho National Lab. (INL), Idaho Falls, ID (United States); Fitzgerald, Kirk [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-08-01

    Control room modernization is an important part of life extension for the existing light water reactor fleet. None of the 99 currently operating commercial nuclear power plants in the U.S. has completed a full-scale control room modernization to date. Nuclear power plant main control rooms for the existing commercial reactor fleet remain significantly analog, with only limited digital modernizations. Upgrades in the U.S. do not achieve the full potential of newer technologies that might otherwise enhance plant and operator performance. The goal of the control room upgrade benefits research is to identify previously overlooked benefits of modernization, identify candidate technologies that may facilitate such benefits, and demonstrate these technologies through human factors research. This report describes a pilot study to test upgrades to the Human Systems Simulation Laboratory at INL.

  19. Microbial Field Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1990-11-01

    This report covers progress made during the first year of the Microbial Field Pilot Study project. Information on reservoir ecology and characterization, facility and treatment design, core experiments, bacterial mobility, and mathematical modeling are addressed. To facilitate an understanding of the ecology of the target reservoir analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. A preliminary design of facilities for the operation of the field pilot test was prepared. In addition, procedures for facilities installation and for injection treatments are described. The Southeast Vassar Vertz Sand Unit (SEVVSU), the site of the proposed field pilot study, is described physically, historically, and geologically. The fields current status is presented and the ongoing reservoir simulation is discussed. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. Two possible mechanisms, relative permeability effects and changes in the capillary number, are discussed and related to four Berea core experiments' results. The experiments were conducted at reservoir temperature using SEVVSU oil, brine, and bacteria. The movement and activity of bacteria in porous media were investigated by monitoring the growth of bacteria in sandpack cores under no flow conditions. The rate of bacteria advancement through the cores was determined. A mathematical model of the MEOR process has been developed. The model is a three phase, seven species, one dimensional model. Finite difference methods are used for solution. Advection terms in balance equations are represented with a third- order upwind differencing scheme to reduce numerical dispersion and oscillations. The model is applied to a batch fermentation example. 52 refs., 26 figs., 21 tabs.

  20. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Buck, Deborah; McColl, Elaine; Powell, Christine J; Shen, Jing; Sloper, John; Steen, Nick; Taylor, Robert; Tiffin, Peter; Vale, Luke; Clarke, Michael P

    2012-10-16

    Childhood intermittent exotropia [X(T)] is a type of strabismus (squint) in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision). Treatment options for X(T) include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T) are limited, and there is no randomised controlled trial (RCT) evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia) pilot study has been designed to test the feasibility of such a trial in the UK. an external pilot patient randomised controlled trial. four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T). Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit.Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T). initial clinical assessment; randomisation (eye muscle surgery or active monitoring); 3-, 6- and 9-month (primary outcome) clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire); qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or loss to follow-up; reasons for agreeing/declining participation; variability of cure rates

  1. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  2. Parent Perception of Two Eye-Gaze Control Technology Systems in Young Children with Cerebral Palsy: Pilot Study.

    Science.gov (United States)

    Karlsson, Petra; Wallen, Margaret

    2017-01-01

    Eye-gaze control technology enables people with significant physical disability to access computers for communication, play, learning and environmental control. This pilot study used a multiple case study design with repeated baseline assessment and parents' evaluations to compare two eye-gaze control technology systems to identify any differences in factors such as ease of use and impact of the systems for their young children. Five children, aged 3 to 5 years, with dyskinetic cerebral palsy, and their families participated. Overall, families were satisfied with both the Tobii PCEye Go and myGaze® eye tracker, found them easy to position and use, and children learned to operate them quickly. This technology provides young children with important opportunities for learning, play, leisure, and developing communication.

  3. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year's report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  4. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year`s report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  5. Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial

    OpenAIRE

    2014-01-01

    Introduction The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. Methods/analysis This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff ne...

  6. Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial.

    Science.gov (United States)

    Rahn, Anne C; Backhus, Imke; Fuest, Franz; Riemann-Lorenz, Karin; Köpke, Sascha; van de Roemer, Adrianus; Mühlhauser, Ingrid; Heesen, Christoph

    2016-09-20

    Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) "average weight" version and (3) "worm prophylaxis" version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42-1.69), p = 0.002). The questionnaire

  7. Electromyogram-controlled assistive exercise for the motor recovery of shoulder in chronic hemiplegia: A pilot study.

    Science.gov (United States)

    Park, Byung Kyu; Kim, Ji-Won; Kwon, Yuri; Heo, Jae-Hoon; Yoon, Joo-Seok; Eom, Gwang-Moon

    2015-01-01

    Correct-active-repetitive exercise is important for the motor recovery in hemiplegics. The present study hypothesizes that the electromyogram (EMG)-controlled assistance of motion would be an effective implementation of the concept for the rehabilitation of the hemiplegic shoulder, even in chronic patients. This study aims to investigate the feasibility of the suggested method. The motor intention is derived from the EMG of the shoulder muscles and the shoulder movement (flexion and abduction) is assisted by an electro-mechanical system only when the motor intention (EMG amplitude) exceeded the threshold. Twelve patients in the chronic stage of stroke participated in this pilot study. The EMG-controlled assistive exercise lasts for two weeks, 20 min per day and 5 days a week. The active range of motion in both abduction and flexion increases significantly after the intervention (p hemiplegia.

  8. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

    2014-02-01

    The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

  9. Interferential light therapy in the treatment of shoulder tendinopathies: a randomized controlled pilot study.

    Science.gov (United States)

    Montes-Molina, Ramón; Martínez-Rodríguez, Maria Elena; Rodríguez, Ana Belén Romojaro; Martínez-Ruiz, Fidel; Prieto-Baquero, Almudena

    2012-12-01

    To test the safety of the diode light therapy and evaluate the advantages of the interferential effect of two light probes versus a conventional light probe in the relief of shoulder pain and disability caused by shoulder tendinopathies. Randomized single-blind pilot study. Clinical electrotherapy unit. A total of 30 patients with shoulder pain from tendinopathies. The patients were randomly assigned into two groups. Group 1 (n = 15) received interferential light therapy generated by two independent and identical cluster probes composed of light emitting and superluminescent diodes. Similarly, two applicators were applied in group 2 (n = 15), but only one was active, as in conventional clinical therapy. Each multi-diode cluster probe was composed of seven light-emitting diodes at 600 nm and 12 superluminescent diodes at 950 nm. Pain was evaluated by visual analogue scale (VAS) at day, at night and during several shoulder movements. Shoulder functional status was measured by means of the University California Los Angeles scale (UCLA). Comparison between both treatments using the Mann-Whitney U-test showed better results for the interferential treatment. There were significant differences in pain reduction during abduction (P < 0.05) and external rotation (P < 0.05), with pain reductions in abduction and external rotation of 1.5 (± 1.3) and 0.5 (± 1.0) respectively. Interferential light therapy was safe and effective regarding the shoulder pain reduction during abduction and external rotation movements. The estimated size sample needed for future two-treatment parallel-design studies will require about 60 patients.

  10. The role of parent-adolescent attachment in the glycemic control of adolescents with Type 1 diabetes: a pilot study.

    Science.gov (United States)

    Rosenberg, Tziporah; Shields, Cleveland G

    2009-09-01

    This pilot study explored the associations between parent and adolescent reports of adolescent attachment and glycemic control in adolescents with Type 1 diabetes. We hypothesized that more secure attachment would correlate with more optimal diabetes control. Thirty-one families completed written self-report questionnaires about adolescent attachment, demographic data, and diabetes control. Adolescents and parents reported on their perceptions of adolescents' attachment to mothers and fathers. Mean HbA1c for the sample was 7.6% (SD = 1.14). Mothers' perceptions of adolescents' attachment were significantly correlated with adolescents' hemoglobin A1c (r = -.42, p = .022), indicating that maternal perceptions of more secure attachment was associated with better glycemic control. Neither fathers' perceptions nor adolescents' reports of attachment was significantly correlated with glycemic control. Attachment appears to be associated with glycemic control in this population though the mechanisms are unclear. Mothers' perceptions of attachment had the strongest associations with control, not adolescent reports. Further research is needed to understand the mechanisms through which parent reports of adolescent attachment are associated with glycemic control.

  11. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study.

    Science.gov (United States)

    Hubert, Dominique; Soubeiran, Lucile; Gourmelon, Fabrice; Grenet, Dominique; Serreau, Raphaël; Perrodeau, Elodie; Zegarra-Parodi, Rafael; Boutron, Isabelle

    2014-01-01

    Pain is a common complication in patients with cystic fibrosis (CF) and is associated with shorter survival. We evaluated the impact of osteopathic manipulative treatment (OMT) on pain in adults with CF. A pilot multicenter randomized controlled trial was conducted with three parallel arms: OMT (group A, 16 patients), sham OMT (sham treatment, group B, 8 patients) and no treatment (group C, 8 patients). Medical investigators and patients were double-blind to treatment for groups A and B, who received OMT or sham OMT monthly for 6 months. Pain was rated as a composite of its intensity and duration over the previous month. The evolution of chest/back pain after 6 months was compared between group A and groups B+C combined (control group). The evolution of cervical pain, headache and quality of life (QOL) were similarly evaluated. There was no statistically significant difference between the treatment and control groups in the decrease of chest/back pain (difference = -2.20 IC95% [-4.81; 0.42], p = 0.098); also, group A did not differ from group B. However, chest/back pain decreased more in groups A (p = 0.002) and B (p = 0.006) than in group C. Cervical pain, headache and QOL scores did not differ between the treatment and control groups. This pilot study demonstrated the feasibility of evaluating the efficacy of OMT to treat the pain of patients with CF. The lack of difference between the group treated with OMT and the control group may be due to the small number of patients included in this trial, which also precludes any definitive conclusion about the greater decrease of pain in patients receiving OMT or sham OMT than in those with no intervention. ClinicalTrials.gov NCT01293019.

  12. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Dominique Hubert

    Full Text Available Pain is a common complication in patients with cystic fibrosis (CF and is associated with shorter survival. We evaluated the impact of osteopathic manipulative treatment (OMT on pain in adults with CF.A pilot multicenter randomized controlled trial was conducted with three parallel arms: OMT (group A, 16 patients, sham OMT (sham treatment, group B, 8 patients and no treatment (group C, 8 patients. Medical investigators and patients were double-blind to treatment for groups A and B, who received OMT or sham OMT monthly for 6 months. Pain was rated as a composite of its intensity and duration over the previous month. The evolution of chest/back pain after 6 months was compared between group A and groups B+C combined (control group. The evolution of cervical pain, headache and quality of life (QOL were similarly evaluated.There was no statistically significant difference between the treatment and control groups in the decrease of chest/back pain (difference = -2.20 IC95% [-4.81; 0.42], p = 0.098; also, group A did not differ from group B. However, chest/back pain decreased more in groups A (p = 0.002 and B (p = 0.006 than in group C. Cervical pain, headache and QOL scores did not differ between the treatment and control groups.This pilot study demonstrated the feasibility of evaluating the efficacy of OMT to treat the pain of patients with CF. The lack of difference between the group treated with OMT and the control group may be due to the small number of patients included in this trial, which also precludes any definitive conclusion about the greater decrease of pain in patients receiving OMT or sham OMT than in those with no intervention.ClinicalTrials.gov NCT01293019.

  13. Scripting, control, and privacy in domestic smart grid technologies: insights from a Danish pilot study

    DEFF Research Database (Denmark)

    Hansen, Meiken; Hauge, Bettina

    2017-01-01

    Smart grid research in Denmark has increasingly turned its focus on aggregator trading flexibility achieved by remotely controlling appliances, studying the technologies involved rather than the control. This paper investigates how different types of control were envisioned and designed for a two......-year smart grid trial in Denmark with 20 private households. Using the notion of script, processes of in- and de-scription were used to gain insights into perceived and enacted control. Based on empirical data from 26 interviews and three workshops, we show how the in-scription process of control can...... a reference for ‘passive consumers’ within a smart grid. This design prompts questions about how the users in smart grid development are envisioned and configured using different ideas about control. With current development and the need for additional energy reductions, consumers who invest in photovoltaic...

  14. Myoelectrically driven functional electrical stimulation may increase motor recovery of upper limb in poststroke subjects: A randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Rune Thorsen, PhD, MScee

    2013-08-01

    Full Text Available The objective of this randomized controlled pilot study was to assess the feasibility and effectiveness of myoelectrically controlled functional electrical stimulation (MeCFES for rehabilitation of the upper limb in poststroke subjects. Eleven poststroke hemiparetic subjects with residual proximal control of the arm, but impaired volitional opening of the paretic hand, were enrolled and randomized into a treated and a control group. Subjects received 3 to 5 treatment sessions per week until totaling 25 sessions. In the experimental group, myoelectric activity from wrist and finger extensors was used to control stimulation of the same muscles. Patients treated with MeCFES (n = 5 had a significant (p = 0.04 and clinically important improvement in Action Research Arm Test score (median change 9 points, confirmed by an Individually Prioritized Problem Assessment self-evaluation score. This improvement was maintained at follow-up. The control group did not show a significant improvement (p = 0.13. The reduced sample size of participants, together with confounding factors such as spontaneous recovery, calls for larger studies to draw definite conclusions. However, the large and persistent treatment effect seen in our results indicate that MeCFES could play an important role as a clinical tool for stroke rehabilitation.

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

    Directory of Open Access Journals (Sweden)

    Reynolds Debra

    2006-05-01

    Full Text Available Abstract Background To determine whether education and financial incentives increased dentists' delivery of fluoride varnish and sealants to at risk children covered by capitation dental insurance in Washington state (U.S.. Methods In 1999, 53 dental offices in Washington Dental Service's capitation dental plan were invited to participate in the study, and consenting offices were randomized to intervention (n = 9 and control (n = 10 groups. Offices recruited 689 capitation children aged 6–14 and at risk for caries, who were followed for 2 years. Intervention offices received provider education and fee-for-service reimbursement for delivering fluoride varnish and sealants. Insurance records were used to calculate office service rates for fluoride, sealants, and restorations. Parents completed mail surveys after follow-up to measure their children's dental utilization, dental satisfaction, dental fear and oral health status. Regression models estimated differences in service rates between intervention and control offices, and compared survey measures between groups. Results Nineteen offices (34% consented to participate in the study. Fluoride and sealant rates were greater in the intervention offices than the control offices, but the differences were not statistically significant. Restoration rates were lower in the intervention offices than the control offices. Parents in the intervention group reported their children had less dental fear than control group parents. Conclusion Due to low dentist participation the study lacked power to detect an intervention effect on dentists' delivery of caries-control services. The intervention may have reduced children's dental fear.

  16. Pediatric Cardiac Shear Wave Elastography for Quantitative Assessment of Myocardial Stiffness: A Pilot Study in Healthy Controls.

    Science.gov (United States)

    Song, Pengfei; Bi, Xiaojun; Mellema, Daniel C; Manduca, Armando; Urban, Matthew W; Pellikka, Patricia A; Chen, Shigao; Greenleaf, James F

    2016-08-01

    The long-term goal of this study is to assess chemotherapy-induced cardiotoxicity for pediatric cancer patients using cardiac ultrasound shear wave (SW) elastography. This pilot study aimed to systematically investigate the feasibility of using cardiac SW elastography in children and provide myocardial stiffness control data for cancer patients. Twenty healthy volunteers (ages 5-18) were recruited. A novel cardiac SW elastography sequence with pulse-inversion harmonic imaging and time-aligned sequential tracking was developed for this study. Cardiac SW elastography produces and detects transient SWs propagating in the myocardium in late-diastole, which can be used to quantify myocardial stiffness. The parasternal long-axis (L-A) and short-axis (S-A) views of the interventricular septum (IVS) were feasible for pediatric cardiac SW elastography. The L-A and S-A views of the basal and mid IVS provided better success rates than those of the apical IVS. Success rates decreased with increased body mass index (BMI), but did not differ with age or gender. Two-dimensional SW speed measurements were 1.26, 1.22, 1.71 and 1.67 m/s for L-A base, L-A mid, S-A base and S-A mid IVS, respectively. All S-A SW speed values were significantly higher (p pilot study demonstrated, for the first time, the feasibility of using cardiac SW elastography to measure quantitative myocardial stiffness in children, and established control SW speed values for using SW elastography to assess chemo-induced cardiotoxicity for pediatric cancer patients. The results showed that the myocardial anisotropy needs to be accounted for when comparing SW speed from different imaging axes. Copyright © 2016 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

  17. Short cognitive behavioral therapy and cognitive training for adults with ADHD – a randomized controlled pilot study

    Science.gov (United States)

    Virta, Maarit; Salakari, Anita; Antila, Mervi; Chydenius, Esa; Partinen, Markku; Kaski, Markus; Vataja, Risto; Kalska, Hely; Iivanainen, Matti

    2010-01-01

    In clinical practice, a growing need exists for effective non-pharmacological treatments of adult attention-deficit/hyperactivity disorder (ADHD). Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual cognitive- behavioral therapy (CBT), 9 adults participating in cognitive training (CT), and 10 controls. Self-report questionnaires, independent evaluations, and computerized neurocognitive testing were collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the self- report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing. PMID:20856608

  18. Adrenal gland volume measurement in septic shock and control patients: a pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Nougaret, Stephanie; Aufort, S.; Gallix, B. [Hopital Saint Eloi, Department of Abdominal Imaging, CHU Montpellier, Montpellier, Cedex 5 (France); Jung, B.; Chanques, G.; Jaber, S. [Hopital Saint Eloi, Intensive Care Unit, Department of Critical Care and Anesthesiology: DAR B, CHU Montpellier, Montpellier, Cedex 5 (France)

    2010-10-15

    To compare adrenal gland volume in septic shock patients and control patients by using semi-automated volumetry. Adrenal gland volume and its inter-observer variability were measured with tomodensitometry using semi-automated software in 104 septic shock patients and in 40 control patients. The volumes of control and septic shock patients were compared and the relationship between volume and outcome in intensive care was studied. The mean total volume of both adrenal glands was 7.2 {+-} 2.0 cm{sup 3} in control subjects and 13.3 {+-} 4.7 cm{sup 3} for total adrenal gland volume in septic shock patients (p < 0.0001). Measurement reproducibility was excellent with a concordance correlation coefficient value of 0.87. The increasing adrenal gland volume was associated with a higher rate of survival in intensive care. The present study reports that with semi-automated software, adrenal gland volume can be measured easily and reproducibly. Adrenal gland volume was found to be nearly double in sepsis compared with control patients. The absence of increased volume during sepsis would appear to be associated with a higher rate of mortality and may represent a prognosis factor which may help the clinician to guide their strategy. (orig.)

  19. B lymphocyte depletion with the monoclonal antibody rituximab in Graves' disease: a controlled pilot study

    DEFF Research Database (Denmark)

    El Fassi, Daniel; Nielsen, Claus H; Bonnema, Steen Joop

    2007-01-01

    be of benefit in GD. OBJECTIVE/DESIGN: The objective of this prospective, controlled, nonrandomized study was to investigate the effect of RTX in GD. SETTING/PATIENTS: We studied 20 outpatients referred to a university clinic with newly diagnosed (four with relapse) untreated GD. Ten received RTX (+RTX......), whereas 10 did not (-RTX). INTERVENTION: The patients received methimazole (MMI) for a median of 102 d (+RTX) and 110 d (-RTX) before the study. Patients in the +RTX group received 375 mg RTX/m(2) iv on d 1, 8, 15, and 22, and all patients were withdrawn from methimazole (MMI) at d 22. MAIN OUTCOME...

  20. Effects of Passive Hydrotherapy WATSU (WaterShiatsu) in the Third Trimester of Pregnancy: Results of a Controlled Pilot Study.

    Science.gov (United States)

    Schitter, Agnes M; Nedeljkovic, Marko; Baur, Heiner; Fleckenstein, Johannes; Raio, Luigi

    2015-01-01

    Background. WATSU (WaterShiatsu) is a complementary therapeutic treatment method comprising passive stretches and massage techniques administered in 35°C warm water. Pregnant women claim safe methods to reduce pain, stress, and fatigue. Therefore, we conducted a pilot study evaluating the effects of WATSU on pregnancy-related complaints in third trimester pregnant women. Methods. Nine healthy pregnant women at gestational week ≥34 were included in an intervention group (receiving WATSU) and compared to eight women in a passive control group (receiving no treatment). WATSU was performed on days 1 and 4 of the study, accompanied by ultrasound examinations. Outcomes include physiological and psychometric as well as qualitative data. Participants in the control group completed questionnaires only. Results. WATSU was found to significantly lower participants' levels of stress and pain and to improve their mental health-related quality of life and mood. In comparison to the passive control group, participants in the intervention group reported reduction in perceived stress from day 1 to day 8 (P = 0.036, Cohen's f = 0.57). Qualitative data indicate that WATSU was appreciated as enjoyable and deeply relaxing. No negative side effects were reported. Conclusion. Our findings support the notion that WATSU yields therapeutic benefits for pregnant women and warrant further research. This study has been registered at ClinicalTrials.gov: NCT01708018.

  1. Effects of Passive Hydrotherapy WATSU (WaterShiatsu in the Third Trimester of Pregnancy: Results of a Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Agnes M. Schitter

    2015-01-01

    Full Text Available Background. WATSU (WaterShiatsu is a complementary therapeutic treatment method comprising passive stretches and massage techniques administered in 35°C warm water. Pregnant women claim safe methods to reduce pain, stress, and fatigue. Therefore, we conducted a pilot study evaluating the effects of WATSU on pregnancy-related complaints in third trimester pregnant women. Methods. Nine healthy pregnant women at gestational week ≥34 were included in an intervention group (receiving WATSU and compared to eight women in a passive control group (receiving no treatment. WATSU was performed on days 1 and 4 of the study, accompanied by ultrasound examinations. Outcomes include physiological and psychometric as well as qualitative data. Participants in the control group completed questionnaires only. Results. WATSU was found to significantly lower participants’ levels of stress and pain and to improve their mental health-related quality of life and mood. In comparison to the passive control group, participants in the intervention group reported reduction in perceived stress from day 1 to day 8 (P=0.036, Cohen’s f=0.57. Qualitative data indicate that WATSU was appreciated as enjoyable and deeply relaxing. No negative side effects were reported. Conclusion. Our findings support the notion that WATSU yields therapeutic benefits for pregnant women and warrant further research. This study has been registered at ClinicalTrials.gov: NCT01708018.

  2. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Science.gov (United States)

    Ivanov, Iliya V; Mackeben, Manfred; Vollmer, Annika; Martus, Peter; Nguyen, Nhung X; Trauzettel-Klosinski, Susanne

    2016-01-01

    Degenerative retinal diseases, especially retinitis pigmentosa (RP), lead to severe peripheral visual field loss (tunnel vision), which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST). Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses) that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental) and reading (control) training. All subjects who first performed reading training underwent experimental training later (waiting list control group). To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT) during exploratory saccade training, Percent Preferred Walking Speed (PPWS), the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field. In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training condition

  3. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, I.; Muskiet, F.A.J.; Berkelaar, E.; Schut, E.; Penders, R.; Hoenderdos, K.; Jong, de M.C.; Wichers, H.J.

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a

  4. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome : a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, Inge; Muskiet, Frits A. J.; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J.; Jong, Miek C.

    2014-01-01

    Background: The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a

  5. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome : a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, Inge; Muskiet, Frits A. J.; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J.; Jong, Miek C.

    2014-01-01

    Background: The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a Paleolit

  6. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, I.; Muskiet, F.A.J.; Berkelaar, E.; Schut, E.; Penders, R.; Hoenderdos, K.; Jong, de M.C.; Wichers, H.J.

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a Paleolith

  7. Immediate effect of mind sound resonance technique on state anxiety and cognitive functions in patients suffering from generalized anxiety disorder: A self-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Vipin Dhansoia

    2015-01-01

    Conclusion: This pilot study suggests that MSRT may have a potential role in reducing state anxiety and enhancing psychomotor performance in patients suffering from GAD immediately after the practice. These findings need confirmation from studies with a larger sample size and randomized controlled design, which are implicated in the future.

  8. Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study.

    Science.gov (United States)

    Teasdale, Andrew; Jahn, Michael; Bailey, Simon; Feilden, Andrew; Taylor, Graham; Corcoran, Marta L; Malick, Robert; Jenke, Dennis; Stults, Cheryl L M; Nagao, Lee M

    2015-06-01

    The effective management of leachables in pharmaceutical products is a critical aspect of their development. This can be facilitated if extractables information on the materials used in a packaging or delivery system is available to assist companies in selecting materials that will be compatible with the drug product formulation and suitable for the intended use. The Extractables and Leachables Safety Information Exchange (ELSIE) materials working group developed and executed a comprehensive extraction study protocol that included a number of extraction solvents, extraction techniques, and a variety of analytical techniques. This was performed on two test materials, polyethylene (PE) and polyvinyl chloride (PVC), that were selected due to their common use in pharmaceutical packaging. The purpose of the study was to investigate if the protocol could be simplified such that (i) a reduced number or even a single extraction technique could be used and (ii) a reduced number of solvents could be used to obtain information that is useful for material selection regardless of product type. Results indicate that, at least for the PVC, such reductions are feasible. Additionally, the studies indicate that levels of extractable elemental impurities in the two test materials were low and further confirm the importance of using orthogonal analytical detection techniques to gain adequate understanding of extraction profiles.

  9. The effect of a structured intervention on caregivers of patients with dementia and problem behaviors: a randomized controlled pilot study.

    Science.gov (United States)

    Nobili, Alessandro; Riva, Emma; Tettamanti, Mauro; Lucca, Ugo; Liscio, Mariarosaria; Petrucci, Bianca; Porro, Gabriella Salvini

    2004-01-01

    The objective was to assess the effect of a structured intervention on caregiver stress and the institutionalization rate of patients with dementia and problem behaviors. Caregivers contacting the Federazione Alzheimer Italia (AI) to receive help, advice, or information in relation to problem behaviors of outpatients were enrolled. Eligible caregiver-patient dyads were randomized to receive either a structured intervention or the counseling AI usually provides (control group). After basal assessment, families were reassessed at 6 and 12 months. Problem behavior (particularly agitation) was the only variable significantly correlated (P = 0.006) with the baseline caregivers' stress score. Thirty-nine families completed the 12-month follow-up; the mean problem behavior score was significantly lower in the intervention than the control group (p < 0.03); the time needed for care of the patient increased by 0.5 +/- 9.7 hours/day in the control group and decreased by 0.3 +/- 4.1 in the intervention group (p = 0.4, Wilcoxon test). The main determinant of institutionalization seemed to be the level of caregiver stress (p = 0.03). In patients of the intervention group, there was a significant reduction in the frequency of delusions. This pilot study suggests that caregiver stress is relieved by a structured intervention. The number of families lost to follow-up, the relatively short duration of the study, and the ceiling effect due to the severity of the clinical characteristics of patients probably all partly dilute the observed findings.

  10. Neuromodulation of Attentional Control in Major Depression: A Pilot DeepTMS Study

    Directory of Open Access Journals (Sweden)

    Jodie Naim-Feil

    2016-01-01

    Full Text Available While Major Depressive Disorder (MDD is primarily characterized by mood disturbances, impaired attentional control is increasingly identified as a critical feature of depression. Deep transcranial magnetic stimulation (deepTMS, a noninvasive neuromodulatory technique, can modulate neural activity and induce neuroplasticity changes in brain regions recruited by attentional processes. This study examined whether acute and long-term high-frequency repetitive deepTMS to the dorsolateral prefrontal cortex (DLPFC can attenuate attentional deficits associated with MDD. Twenty-one MDD patients and 26 matched control subjects (CS were administered the Beck Depression Inventory and the Sustained Attention to Response Task (SART at baseline. MDD patients were readministered the SART and depressive assessments following a single session (n=21 and after 4 weeks (n=13 of high-frequency (20 Hz repetitive deepTMS applied to the DLPFC. To control for the practice effect, CS (n=26 were readministered the SART a further two times. The MDD group exhibited deficits in sustained attention and cognitive inhibition. Both acute and long-term high-frequency repetitive frontal deepTMS ameliorated sustained attention deficits in the MDD group. Improvement after acute deepTMS was related to attentional recovery after long-term deepTMS. Longer-term improvement in sustained attention was not related to antidepressant effects of deepTMS treatment.

  11. Effects of interactive visual feedback training on post-stroke pusher syndrome: a pilot randomized controlled study.

    Science.gov (United States)

    Yang, Yea-Ru; Chen, Yi-Hua; Chang, Heng-Chih; Chan, Rai-Chi; Wei, Shun-Hwa; Wang, Ray-Yau

    2015-10-01

    We investigated the effects of a computer-generated interactive visual feedback training program on the recovery from pusher syndrome in stroke patients. Assessor-blinded, pilot randomized controlled study. A total of 12 stroke patients with pusher syndrome were randomly assigned to either the experimental group (N = 7, computer-generated interactive visual feedback training) or control group (N = 5, mirror visual feedback training). The scale for contraversive pushing for severity of pusher syndrome, the Berg Balance Scale for balance performance, and the Fugl-Meyer assessment scale for motor control were the outcome measures. Patients were assessed pre- and posttraining. A comparison of pre- and posttraining assessment results revealed that both training programs led to the following significant changes: decreased severity of pusher syndrome scores (decreases of 4.0 ± 1.1 and 1.4 ± 1.0 in the experimental and control groups, respectively); improved balance scores (increases of 14.7 ± 4.3 and 7.2 ± 1.6 in the experimental and control groups, respectively); and higher scores for lower extremity motor control (increases of 8.4 ± 2.2 and 5.6 ± 3.3 in the experimental and control groups, respectively). Furthermore, the computer-generated interactive visual feedback training program produced significantly better outcomes in the improvement of pusher syndrome (p visual feedback training program. Although both training programs were beneficial, the computer-generated interactive visual feedback training program more effectively aided recovery from pusher syndrome compared with mirror visual feedback training. © The Author(s) 2014.

  12. A pilot study of factors associated with glycaemic control in adults with Type 1 diabetes mellitus on insulin pump therapy.

    Science.gov (United States)

    Wen, W; Frampton, R; Wright, K; Fattore, S; Shadbolt, B; Perampalam, S

    2016-02-01

    To identify the knowledge and management factors associated with glycaemic control among adults with Type 1 diabetes mellitus treated with insulin pump therapy. A cross-sectional study of adults with Type 1 diabetes mellitus on insulin pump therapy for at least 12 months (n = 50, 18-70 years old) was undertaken between December 2013 and May 2014. A new questionnaire was developed to evaluate participants' knowledge and management related to insulin pump therapy, and were correlated with insulin pump data, HbA1c and frequency of hypoglycaemia. Participants who changed their insulin pump settings when indicated had significantly better glycaemic control than those who did not (P = 0.04). Multivariate logistic regression analysis found that better overall insulin pump therapy management was a significant predictor of better glycaemic control (odds ratio 4.45, 95% confidence interval 1.61-12.3; P = 0.004) after adjusting for potential confounders including age, gender, duration of diabetes and insulin pump therapy. However, overall insulin pump therapy knowledge was not a significant predictor of glycaemic control (P = 0.058). There was no significant association between frequency of hypoglycaemia and insulin pump therapy knowledge or management. We identified some key knowledge and management factors associated with glycaemic control in adults with Type 1 diabetes mellitus on insulin pump therapy using a newly designed questionnaire. The pilot study assessed the clinical utility of this evaluation tool, which may facilitate provision of targeted education to insulin pump therapy users to achieve optimal glycaemic control. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  13. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Directory of Open Access Journals (Sweden)

    Iliya V Ivanov

    Full Text Available Degenerative retinal diseases, especially retinitis pigmentosa (RP, lead to severe peripheral visual field loss (tunnel vision, which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST.Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental and reading (control training. All subjects who first performed reading training underwent experimental training later (waiting list control group. To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT during exploratory saccade training, Percent Preferred Walking Speed (PPWS, the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field.In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training

  14. Ehlers-Danlos Syndrome, Hypermobility Type: Impact of Somatosensory Orthoses on Postural Control (A Pilot Study

    Directory of Open Access Journals (Sweden)

    Emma G. Dupuy

    2017-06-01

    Full Text Available Elhers-Danlos syndrome (EDS is the clinical manifestation of connective tissue disorders, and comprises several clinical forms with no specific symptoms and selective medical examinations which result in a delay in diagnosis of about 10 years. The EDS hypermobility type (hEDS is characterized by generalized joint hypermobility, variable skin hyperextensibility and impaired proprioception. Since somatosensory processing and multisensory integration are crucial for both perception and action, we put forth the hypothesis that somatosensory deficits in hEDS patients may lead, among other clinical symptoms, to misperception of verticality and postural instability. Therefore, the purpose of this study was twofold: (i to assess the impact of somatosensory deficit on subjective visual vertical (SVV and postural stability; and (ii to quantify the effect of wearing somatosensory orthoses (i.e., compressive garments and insoles on postural stability. Six hEDS patients and six age- and gender-matched controls underwent a SVV (sitting, standing, lying on the right side evaluation and a postural control evaluation on a force platform (Synapsys, with or without visual information (eyes open (EO/eyes closed (EC. These two latter conditions performed either without orthoses, or with compression garments (CG, or insoles, or both. Results showed that patients did not exhibit a substantial perceived tilt of the visual vertical in the direction of the body tilt (Aubert effect as did the control subjects. Interestingly, such differential effects were only apparent when the rod was initially positioned to the left of the vertical axis (opposite the longitudinal body axis. In addition, patients showed greater postural instability (sway area than the controls. The removal of vision exacerbated this instability, especially in the mediolateral (ML direction. The wearing of orthoses improved postural stability, especially in the eyes-closed condition, with a particularly

  15. Modular Ankle Robotics Training in Early Sub-Acute Stroke: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Forrester, Larry W.; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F.

    2014-01-01

    Background Modular lower extremity (LE) robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually-guided and visually-evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. Objective Assess the feasibility and efficacy of daily anklebot training during early sub-acute hospitalization post-stroke. Methods Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (N=18) or passive manual stretching (N=16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an “assist-as-needed” approach during > 200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Results Both groups walked faster at discharge, however the robot group improved more in percent change of temporal symmetry (p=0.032) and also of step length symmetry (p=0.038), with longer nonparetic step lengths in the robot (133%) vs. stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (p≤ 0.001) and mean (p≤ 0.01) angular speeds, and increased movement smoothness (p≤ 0.01). There were no adverse events. Conclusion Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early sub-acute hospitalization is well tolerated and improves ankle motor control and gait patterning. PMID:24515923

  16. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Forrester, Larry W; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F

    2014-09-01

    BACKGROUND. Modular lower extremity robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually guided and visually evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. To assess the feasibility and efficacy of daily anklebot training during early subacute hospitalization poststroke. Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (n = 18) or passive manual stretching (n = 16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an "assist-as-needed" approach during >200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Both groups walked faster at discharge; however, the robot group improved more in percentage change of temporal symmetry (P = .032) and also of step length symmetry (P = .038), with longer nonparetic step lengths in the robot (133%) versus stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (P ≤ .001) and mean (P ≤ .01) angular speeds, and increased movement smoothness (P ≤ .01). There were no adverse events. Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early subacute hospitalization is well tolerated and improves ankle motor control and gait patterning. © The Author(s) 2014.

  17. An observational pilot study on the effect of Gomutra Haritaki, diet control and exercise in the management of Sthaulya (obesity)

    Science.gov (United States)

    Gujarathi, Ritesh A.; Dwivedi, Rambabu; Vyas, Mahesh Kumar

    2014-01-01

    Background: India is currently witnessing rising numbers of people in the middle-class who are obese. A lot of the Indian population has started relying on processed foods that contain a huge percentage of trans-fat, sugars, and other unhealthy and artificial ingredients. Obesity is considered the core of many diseases. Increased weight carries significant health risks for some cancers, diabetes, heart diseases and strokes. Junk food, alcohol and sedentary lifestyle are leading us to silent self destruction, making one in every five Indian men and women either obese or overweight. Aim: To determine the effect of Gomutra Haritaki on Sthaulya. Materials and Methods: An observational pilot study on the effect of Gomutra Haritaki, diet control and exercise in the management of Sthaulya (obesity) was conducted on 21 patients. Enrolled patients were screened on the basis of clinical findings and allocated into two groups. Trial group received Gomutra Haritaki (6 g/day in three divided doses) while control group received placebo capsules in the same dose for 8 weeks. Result: Statistically highly significant relief was found in weight reduction (P < 0.001), and body mass index (BMI) (P < 0.01) in both groups. Control group has shown better results against trial group. Conclusion: These results prove the impact of diet and exercise in the management of Sthaulya. PMID:25558156

  18. A pilot study of a randomized controlled trial of yoga as an intervention for PTSD symptoms in women.

    Science.gov (United States)

    Mitchell, Karen S; Dick, Alexandra M; DiMartino, Dawn M; Smith, Brian N; Niles, Barbara; Koenen, Karestan C; Street, Amy

    2014-04-01

    Posttraumatic stress disorder (PTSD) is a debilitating condition that affects approximately 10% of women in the United States. Although effective psychotherapeutic treatments for PTSD exist, clients with PTSD report additional benefits of complementary and alternative approaches such as yoga. In particular, yoga may downregulate the stress response and positively impact PTSD and comorbid depression and anxiety symptoms. We conducted a pilot study of a randomized controlled trial comparing a 12-session Kripalu-based yoga intervention with an assessment control group. Participants included 38 women with current full or subthreshold PTSD symptoms. During the intervention, yoga participants showed decreases in reexperiencing and hyperarousal symptoms. The assessment control group, however, showed decreases in reexperiencing and anxiety symptoms as well, which may be a result of the positive effect of self-monitoring on PTSD and associated symptoms. Between-groups effect sizes were small to moderate (0.08-0.31). Although more research is needed, yoga may be an effective adjunctive treatment for PTSD. Participants responded positively to the intervention, suggesting that it was tolerable for this sample. Findings underscore the need for future research investigating mechanisms by which yoga may impact mental health symptoms, gender comparisons, and the long-term effects of yoga practice.

  19. Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study.

    NARCIS (Netherlands)

    Pelsser, L.M.; Frankena, K.; Buitelaar, J.K.; Rommelse, N.N.J.

    2010-01-01

    Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we

  20. Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study

    NARCIS (Netherlands)

    Pelsser, L.M.; Frankena, K.; Buitelaar, J.K.; Rommelse, N.N.

    2010-01-01

    Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we

  1. A Play and Joint Attention Intervention for Teachers of Young Children with Autism: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Wong, Connie S.

    2013-01-01

    The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool…

  2. Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study.

    NARCIS (Netherlands)

    Pelsser, L.M.; Frankena, K.; Buitelaar, J.K.; Rommelse, N.N.J.

    2010-01-01

    Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we investigat

  3. Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study

    NARCIS (Netherlands)

    Pelsser, L.M.; Frankena, K.; Buitelaar, J.K.; Rommelse, N.N.

    2010-01-01

    Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we investigat

  4. Short cognitive behavioral therapy and cognitive training for adults with ADHD – a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Maarit Virta

    2010-07-01

    Full Text Available Maarit Virta1,2, Anita Salakari1, Mervi Antila1, Esa Chydenius1, Markku Partinen1, Markus Kaski1, Risto Vataja3, Hely Kalska2, Matti Iivanainen11Rinnekoti Research Centre, Espoo, Finland; 2Department of Psychology, University of Helsinki, Finland; 3Kellokoski Hospital, Kellokoski, FinlandAbstract: In clinical practice, a growing need exists for effective non-pharmacological ­treatments of adult attention-deficit/hyperactivity disorder (ADHD. Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual ­cognitive-behavioral therapy (CBT, 9 adults participating in cognitive training (CT, and 10 controls. Self-report ­questionnaires, independent evaluations, and computerized neurocognitive testing were ­collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT ­participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in ­previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the ­self-report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing.Keywords: CBT, attention-deficit/hyperactivity disorder, cognitive testing, non-­pharmacological treatments

  5. Long-Term Quality Control Program Plan for Cord Blood Banks in Korea: A Pilot Study for Cryopreservation Stability.

    Science.gov (United States)

    Seo, Soo Hyun; Shin, Sue; Roh, Eun Youn; Song, Eun Young; Oh, Sohee; Kim, Byoung Jae; Yoon, Jong Hyun

    2017-03-01

    Maintaining the quality of cryopreserved cord blood is crucial. In this pilot study, we describe the results of the internal quality control program for a cord blood bank thus far. Donated cord blood units unsuitable for transplantation were selected for internal quality control once a month. One unit of cord blood, aliquoted into 21 capillaries, was cryopreserved and thawed annually to analyze the total nucleated cell count, CD34⁺ cell count, cell viability test, and colony-forming units assay. No significant differences in the variables (total nucleated cell count, cell viability, CD34⁺ cell count) were observed between samples cryopreserved for one and two years. Upon comparing the variables before cryopreservation and post thawing with the capillaries of one year of storage, cell viability and CD34⁺ cell counts decreased significantly. The use of cord blood samples in capillaries, which can be easily stored for a long period, was similar to the methods used for testing segments attached to the cord blood unit. The results of this study may be useful for determining the period during which the quality of cryopreserved cord blood units used for transplantation is maintained.

  6. Effects of music therapy on drug therapy of adult psychiatric outpatients: A pilot randomised controlled study

    Directory of Open Access Journals (Sweden)

    Mario Degli Stefani

    2016-10-01

    Full Text Available Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in the treatment of psychiatric outpatients. Method: Participants (n = 27 with ICD-10 diagnoses of F20 (schizophrenia, F25 (schizoaffective disorders, F31 (bipolar affective disorder, F32 (depressive episode and F60 (specific personality disorders were randomised to receive group music therapy plus standard care (48 weekly sessions of two hours or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilisers and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage relative to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilisers did not show any significant change in either group. Conclusions: Group music therapy combined with standard drug care is effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discuss the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centred perspective were also discussed.

  7. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study.

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients' engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed.

  8. Flaxseed supplementation in non-alcoholic fatty liver disease: a pilot randomized, open labeled, controlled study.

    Science.gov (United States)

    Yari, Zahra; Rahimlou, Mehran; Eslamparast, Tannaz; Ebrahimi-Daryani, Naser; Poustchi, Hossein; Hekmatdoost, Azita

    2016-06-01

    A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Participants were assigned to take either a lifestyle modification (LM), or LM +30 g/day brown milled flaxseed for 12 weeks. At the end of the study, body weight, liver enzymes, insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups (p< 0.05); however, this reduction was significantly greater in those who took flaxseed supplementation (p < 0.05). The significant mean differences were reached in hepatic markers between flaxseed and control group, respectively: ALT [-11.12 compared with -3.7 U/L; P< 0.001], AST [-8.29 compared with -4 U/L; p < 0.001], GGT [-15.7 compared with -2.62 U/L; p < 0.001], fibrosis score [-1.26 compared with -0.77 kPa; p = 0.013] and steatosis score [-47 compared with -15.45 dB/m; p = 0.022]. In conclusion, flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management.

  9. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

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

    Science.gov (United States)

    Pahwa, Rajesh; Lyons, Kelly E

    2003-05-01

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

  11. Swedish COBECOS Pilot Study. Costs and Benefits of Control Strategies in selected Swedish fisheries. Final Report

    OpenAIRE

    2013-01-01

    Designing control and enforcement strategies in the fisheries sector to ensure compliance with existing rules is intricate and often hampered by costs. The EU Sixth Framework Programme Project “Costs and benefits of Control Strategies” (COBECOS; https://cobecos.jrc.ec.europa.eu) tackled this impediment to successful fisheries control and enforcement schemes by developing computer based modelling approaches which help to optimise the cost/benefit ratio of envisioned control/enforcement stra...

  12. WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Schrank, Beate; Riches, Simon; Coggins, Tony; Rashid, Tayyab; Tylee, Andre; Slade, Mike

    2014-06-03

    The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18-65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes

  13. A neurocognitive approach for recovering upper extremity movement following subacute stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Sallés, Laia; Martín-Casas, Patricia; Gironès, Xavier; Durà, María José; Lafuente, José Vicente; Perfetti, Carlo

    2017-04-01

    [Purpose] This study aims to describe a protocol based on neurocognitive therapeutic exercises and determine its feasibility and usefulness for upper extremity functionality when compared with a conventional protocol. [Subjects and Methods] Eight subacute stroke patients were randomly assigned to a conventional (control group) or neurocognitive (experimental group) treatment protocol. Both lasted 30 minutes, 3 times a week for 10 weeks and assessments were blinded. Outcome measures included: Motor Evaluation Scale for Upper Extremity in Stroke Patients, Motricity Index, Revised Nottingham Sensory Assessment and Kinesthetic and Visual Imagery Questionnaire. Descriptive measures and nonparametric statistical tests were used for analysis. [Results] The results indicate a more favorable clinical progression in the neurocognitive group regarding upper extremity functional capacity with achievement of the minimal detectable change. The functionality results are related with improvements on muscle strength and sensory discrimination (tactile and kinesthetic). [Conclusion] Despite not showing significant group differences between pre and post-treatment, the neurocognitive approach could be a safe and useful strategy for recovering upper extremity movement following stroke, especially regarding affected hands, with better and longer lasting results. Although this work shows this protocol's feasibility with the panel of scales proposed, larger studies are required to demonstrate its effectiveness.

  14. Cognitive behavioural therapy in multiple sclerosis: a randomized controlled pilot study of acceptance and commitment therapy.

    Science.gov (United States)

    Nordin, Linda; Rorsman, Ia

    2012-01-01

    The aim of this study was to design a trial that could evaluate the effect of acceptance and commitment therapy as a group-intervention for multiple sclerosis patients with psychological distress. Randomized controlled trial with assessment at pretreatment, end of treatment, and at 3-month follow-up. Multiple sclerosis outpatients with elevated symptoms of anxiety and/or depression (n = 21). Patients were randomly assigned to acceptance and commitment therapy or relaxation training. Both treatments consisted of 5 sessions over 15 weeks containing didactic sessions, group discussions, and exercises. Outcome was assessed by self-rated symptoms of anxiety, depression, and a measure of acceptance. At 3-month follow-up, the relaxation training group had a significant decline in anxiety symptoms whereas the acceptance and commitment therapy group showed a maintained improvement in rated acceptance at follow-up. The results reflect the different emphases of the therapies. Acceptance and commitment therapy is aimed at living an active, valued life and increasing acceptance, while relaxation training focuses directly on coping strategies to handle emotional symptoms. The results are preliminary, but supportive of further study of brief group interventions for reducing psychological distress in patients with multiple sclerosis.

  15. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Directory of Open Access Journals (Sweden)

    Andrew J. Butler

    2015-01-01

    Full Text Available Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP, would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14 were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control. SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control. This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.

  16. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Science.gov (United States)

    Butler, Andrew J.; Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.

    2015-01-01

    Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287

  17. A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder.

    Science.gov (United States)

    Van Dijk, Sheri; Jeffrey, Janet; Katz, Mark R

    2013-03-05

    Bipolar disorder (BD) is a chronic and disabling psychiatric disorder characterized by recurrent episodes of mania/hypomania and depression. Dialectical behavior therapy (DBT) techniques have been shown to effectively treat borderline personality disorder, a condition also marked by prominent affective disturbances. The utility of DBT techniques in treating BD has been largely unexplored. The purpose of this research was to conduct a pilot study of a DBT-based psychoeducational group (BDG) in treating euthymic, depressed, or hypomanic Bipolar I or II patients. In this experiment, 26 adults with bipolar I or II were randomized to intervention or wait-list control groups and completed the Beck depression inventory II, mindfulness-based self-efficacy scale, and affective control scale at baseline and 12 weeks. The BDG intervention consisted of 12 weekly 90-min sessions which taught DBT skills, mindfulness techniques, and general BD psychoeducation. Using RM-ANOVA, subjects in BDG demonstrated a trend toward reduced depressive symptoms, and significant improvement in several MSES subscales indicating greater mindful awareness, and less fear toward and more control of emotional states (ACS). These findings were supported with a larger sample of patients who completed the BDG. Furthermore, group attendees had reduced emergency room visits and mental health related admissions in the six months following BDG. The small sample size in RCT affects power to detect between group differences. How well improvements after the12-week BDG were maintained is unknown. There is preliminary evidence that DBT skills reduce depressive symptoms, improve affective control, and improve mindfulness self-efficacy in BD. Its application warrants further evaluation in larger studies. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Cermak, Sharon A.; Stein Duker, Leah I.; Williams, Marian E.; Dawson, Michael E.; Lane, Christianne J.; Polido, José C.

    2015-01-01

    This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n = 22 typical, n = 22 ASD). In an experimental crossover design, each…

  19. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Cermak, Sharon A.; Stein Duker, Leah I.; Williams, Marian E.; Dawson, Michael E.; Lane, Christianne J.; Polido, José C.

    2015-01-01

    This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n = 22 typical, n = 22 ASD). In an experimental crossover design, each…

  20. Confronting Fear Using Exposure and Response Prevention for Anorexia Nervosa: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Steinglass, Joanna E; Albano, Anne Marie; Simpson, H Blair; Wang, Yuanjia; Zou, Jingjing; Attia, Evelyn; Walsh, B. Timothy

    2014-01-01

    Objective Anorexia nervosa (AN) is a severe illness with high rates of relapse. Exposure and Response Prevention for AN (AN-EXRP) is a new approach that specifically addresses maladaptive eating behavior by targeting eating-related fear and anxiety. The aim of this study was to evaluate AN-EXRP as an adjunctive strategy to improve eating behavior during weight restoration, at a pivotal moment when treatment goals shift toward relapse prevention. Method A randomized controlled trial was conducted to compare AN-EXRP with a comparison condition, Cognitive Remediation Therapy (CRT). Hospitalized patients with AN (n=32) who had achieved weight restoration to a BMI > 18.5 kg/m2 received 12 sessions of either AN-EXRP or CRT. Outcome was assessed by change in caloric intake in an objective assessment of eating behavior. Results The average test meal caloric intake of participants who received AN-EXRP increased from 352±263 kcal at baseline to 401±215 kcal post-treatment, while that of participants who received CRT decreased from 501±232 kcal at baseline to 424±221 kcal post-treatment (t(28)=2.5, p=0.02). Improvement in intake was significantly associated with improvement in eating-related anxiety (Spearman’s ρ=0.40, p=0.03). Conclusions These data demonstrate that AN-EXRP, compared to a credible comparison intervention, is associated with better caloric intake in a laboratory meal over time in AN. Additional studies are required to determine whether incorporation of these techniques into a longer treatment program leads to enduring and clinically significant change. PMID:24488838

  1. Paraguayan Education Study: A Pilot Study.

    Science.gov (United States)

    Garcia, Patricia

    A qualitative pilot study, guided by an ecological framework, illustrates the complexities involved in studying the unique linguistic situation in Paraguay between Spanish and the indigenous language of Guarani, and its relationship with education. The pilot study interviewing eight kindergarten children. Seventy five children have been…

  2. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Kreuzer Peter M

    2012-11-01

    Full Text Available Abstract Background Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Methods Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend and in four further two-hour sessions (week 2, 9, 18 and 22. Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ. Results ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010. Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p  Conclusions Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes. The study is registered with clinicaltrials.gov (NCT01540357.

  3. 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

  4. Real-time Assessment of Heart Rate Variability and Loss of Control Eating in Adolescent Girls: A pilot study

    Science.gov (United States)

    Ranzenhofer, Lisa M.; Engel, Scott G.; Crosby, Ross D.; Haigney, Mark; Anderson, Micheline; McCaffery, Jeanne M.; Tanofsky-Kraff, Marian

    2015-01-01

    Objective Studying physiologic underpinnings of loss-of-control (LOC) eating may inform its etiology and contribute to intervention efforts. We therefore examined temporal relationships between autonomic indices (heart rate (HR), heart rate variability (HRV)) and LOC-eating in the natural environment. Method For two days, adolescents (n=17, 14.77±1.55 years, BMI-Z 2.17±0.48) with LOC-eating reported on LOC using an electronic device while HR and HRV were assessed continuously using Holter monitoring. Results Higher HR and lower HRV in the 30-minutes before eating were significantly associated with LOC-eating overall (p’s 0.44). Examined categorically, HR was significantly higher, and HRV significantly lower, prior to high-LOC compared to low-LOC episodes (p’s < 0.001). Discussion This pilot study suggests that LOC-eating may involve physiologic underpinnings. Additional research with larger samples is needed to further investigate this phenomenon. PMID:26401652

  5. Effect of Kinesiology Taping on Breast Cancer-Related Lymphedema: A Randomized Single-Blind Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    A. Smykla

    2013-01-01

    Full Text Available The aim of the study was to assess the efficacy of Kinesiology Taping (KT for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n=20, the Quasi KT group (quasi K-tapes, n=22, or the MCT group (multilayered compression therapy group, n=23. Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P>0.05. The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  6. Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single-blind controlled pilot study.

    Science.gov (United States)

    Smykla, A; Walewicz, K; Trybulski, R; Halski, T; Kucharzewski, M; Kucio, C; Mikusek, W; Klakla, K; Taradaj, J

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  7. An Evaluation of a Smartphone–Assisted Behavioral Weight Control Intervention for Adolescents: Pilot Study

    Science.gov (United States)

    Duncombe, Kristina M; Lott, Mark A; Hunsaker, Sanita L; Duraccio, Kara M; Woolford, Susan J

    2016-01-01

    Background The efficacy of adolescent weight control treatments is modest, and effective treatments are costly and are not widely available. Smartphones may be an effective method for delivering critical components of behavioral weight control treatment including behavioral self-monitoring. Objective To examine the efficacy and acceptability of a smartphone assisted adolescent behavioral weight control intervention. Methods A total of 16 overweight or obese adolescents (mean age=14.29 years, standard deviation=1.12) received 12 weeks of combined treatment that consisted of weekly in-person group behavioral weight control treatment sessions plus smartphone self-monitoring and daily text messaging. Subsequently they received 12 weeks of electronic-only intervention, totaling 24 weeks of intervention. Results On average, participants attained modest but significant reductions in body mass index standard score (zBMI: 0.08 standard deviation units, t (13)=2.22, P=.04, d=0.63) over the in-person plus electronic-only intervention period but did not maintain treatment gains over the electronic-only intervention period. Participants self-monitored on approximately half of combined intervention days but less than 20% of electronic-only intervention days. Conclusions Smartphones likely hold promise as a component of adolescent weight control interventions but they may be less effective in helping adolescents maintain treatment gains after intensive interventions. PMID:27554704

  8. RNA sequencing shows transcriptomic changes in rectosigmoid mucosa in patients with irritable bowel syndrome-diarrhea: a pilot case-control study

    OpenAIRE

    2014-01-01

    Our aim was to conduct a pilot case-control study of RNA expression profile using RNA sequencing of rectosigmoid mucosa of nine females with -diarrhea-predominant irritable bowel syndrome (IBS-D) with accelerated colonic transit and nine female healthy controls. Mucosal total RNA was isolated and purified, and next-generation pair-end sequencing was performed using Illumina TruSeq. Analysis was carried out using a targeted approach toward 12 genes previously associated with IBS and a hypothes...

  9. Mindfulness based cognitive therapy improves frontal control in bipolar disorder: a pilot EEG study

    OpenAIRE

    2012-01-01

    Abstract Background Cognitive processing in Bipolar Disorder is characterized by a number of attentional abnormalities. Mindfulness Based Cognitive Therapy combines mindfulness meditation, a form of attentional training, along with aspects of cognitive therapy, and may improve attentional dysfunction in bipolar disorder patients. Methods 12 euthymic BD patients and 9 control participants underwent record of electroencephalography (EEG, band frequency analysis) during resting states (eyes open...

  10. Multi-Pollutant Emissions Control: Pilot Plant Study of Technologies for Reducing Hg, SO3, NOx and CO2 Emissions

    Energy Technology Data Exchange (ETDEWEB)

    Michael L. Fenger; Richard A. Winschel

    2005-08-31

    A slipstream pilot plant was built and operated to investigate technology to adsorb mercury (Hg) onto the existing particulate (i.e., fly ash) by cooling flue gas to 200-240 F with a Ljungstrom-type air heater or with water spray. The mercury on the fly ash was then captured in an electrostatic precipitator (ESP). An alkaline material, magnesium hydroxide (Mg(OH){sub 2}), is injected into flue gas upstream of the air heater to control sulfur trioxide (SO{sub 3}), which prevents acid condensation and corrosion of the air heater and ductwork. The slipstream was taken from a bituminous coal-fired power plant. During this contract, Plant Design and Construction (Task 1), Start Up and Maintenance (Task 2), Baseline Testing (Task 3), Sorbent Testing (Task 4), Parametric Testing (Task 5), Humidification Tests (Task 6), Long-Term Testing (Task 7), and a Corrosion Study (Task 8) were completed. The Mercury Stability Study (Task 9), ESP Report (Task 11), Air Heater Report (Task 12) and Final Report (Task 14) were completed. These aspects of the project, as well as progress on Public Outreach (Task 15), are discussed in detail in this final report. Over 90% mercury removal was demonstrated by cooling the flue gas to 200-210 F at the ESP inlet; baseline conditions with 290 F flue gas gave about 26% removal. Mercury removal is sensitive to flue gas temperature and carbon content of fly ash. At 200-210 F, both elemental and oxidized mercury were effectively captured at the ESP. Mg(OH){sub 2} injection proved effective for removal of SO{sub 3} and eliminated rapid fouling of the air heater. The pilot ESP performed satisfactorily at low temperature conditions. Mercury volatility and leaching tests did not show any stability problems. No significant corrosion was detected at the air heater or on corrosion coupons at the ESP. The results justify larger-scale testing/demonstration of the technology. These conclusions are presented and discussed in two presentations given in July and

  11. A pilot randomized control study to evaluate endoscopic resection using a ligation device for rectal carcinoid tumors

    Institute of Scientific and Technical Information of China (English)

    Hiroyuki Sakata; Sadahiro Amemori; Kotaro Mannen; Masanobu Mizuguchi; Kazuma Fujimoto; Ryuichi Iwakiri; Akifumi Ootani; Seiji Tsunada; Shinichi Ogata; Hibiki Ootani; Ryo Shimoda; Kanako Yamaguchi; Yasuhisa Sakata

    2006-01-01

    AIM: Rectal carcinoid tumors smaller than 10 mm can be resected with local excision using endoscopy. In order to remove rectal carcinoid tumors completely, we evaluated endoscopic mucosal resection with a ligation device in this pilot control randomized study.METHODS: Fifteen patients were diagnosed with rectal carcinoid tumor (less than 10 mm) in our hospital from 1993 to 2002. There were 9 males and 6 females,with a mean age 61.5 years (range, 34-77 years).The patientshad no complaints of carcinoid syndrome symptoms. Fifteen patients were randomly divided into 2 groups: 7 carcinoid tumors were treated by conventional endoscopic resection, and 8 carcinoid tumors were treated by endoscopic resection using a ligation device.RESULTS: All rectal carcinoid tumors were located at the middle to distal rectum. The size of the tumors varied from 3 mm to 10 mm and background characteristics of the patients were not different in the two groups.The rate of complete removal of carcinoid tumors using a ligation device (100%, 8/8) was significantly higher than that of conventional endoscopic resection (57.1%,4/7). The three patients had tumor involvement of deep margin, for which additional treatment was performed.No complications occurred during or after endoscopic resection using a ligation device. All patients in the both groups were alive during the 3-year observation period.CONCLUSION: Endoscopic resection using a ligation device is a useful and safe method for resection of small rectal carcinoid tumors.

  12. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    Science.gov (United States)

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural pathogens. Collection, preservation and analysis of samples for both organic compounds and microbial characterization add a great degree of complication to the sampling and preservation protocols and a significant increase to the cost for a continental-scale survey. Both these issues must be considered carefully prior to adopting these parameters as part of the soil geochemical survey of North America.

  13. A pilot randomized control study to evaluate endoscopic resection using a ligation device for rectal carcinoid tumors

    Science.gov (United States)

    Sakata, Hiroyuki; Iwakiri, Ryuichi; Ootani, Akifumi; Tsunada, Seiji; Ogata, Shinichi; Ootani, Hibiki; Shimoda, Ryo; Yamaguchi, Kanako; Sakata, Yasuhisa; Amemori, Sadahiro; Mannen, Kotaro; Mizuguchi, Masanobu; Fujimoto, Kazuma

    2006-01-01

    AIM: Rectal carcinoid tumors smaller than 10 mm can be resected with local excision using endoscopy. In order to remove rectal carcinoid tumors completely, we evaluated endoscopic mucosal resection with a ligation device in this pilot control randomized study. METHODS: Fifteen patients were diagnosed with rectal carcinoid tumor (less than 10 mm) in our hospital from 1993 to 2002. There were 9 males and 6 females, with a mean age 61.5 years (range, 34-77 years). The patients had no complaints of carcinoid syndrome symptoms. Fifteen patients were randomly divided into 2 groups: 7 carcinoid tumors were treated by conventional endoscopic resection, and 8 carcinoid tumors were treated by endoscopic resection using a ligation device. RESULTS: All rectal carcinoid tumors were located at the middle to distal rectum. The size of the tumors varied from 3 mm to 10 mm and background characteristics of the patients were not different in the two groups. The rate of complete removal of carcinoid tumors using a ligation device (100%, 8/8) was significantly higher than that of conventional endoscopic resection (57.1%, 4/7). The three patients had tumor involvement of deep margin, for which additional treatment was performed. No complications occurred during or after endoscopic resection using a ligation device. All patients in the both groups were alive during the 3-year observation period. CONCLUSION: Endoscopic resection using a ligation device is a useful and safe method for resection of small rectal carcinoid tumors. PMID:16810752

  14. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study.

    Science.gov (United States)

    Morone, Natalia E; Greco, Carol M; Weiner, Debra K

    2008-02-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P=.008, P=.004) and SF-36 Physical Function (P=.03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.

  15. Pilot Preferences on Displayed Aircraft Control Variables

    Science.gov (United States)

    Trujillo, Anna C.; Gregory, Irene M.

    2013-01-01

    The experiments described here explored how pilots want available maneuver authority information transmitted and how this information affects pilots before and after an aircraft failure. The aircraft dynamic variables relative to flight performance were narrowed to energy management variables. A survey was conducted to determine what these variables should be. Survey results indicated that bank angle, vertical velocity, and airspeed were the preferred variables. Based on this, two displays were designed to inform the pilot of available maneuver envelope expressed as bank angle, vertical velocity, and airspeed. These displays were used in an experiment involving control surface failures. Results indicate the displayed limitations in bank angle, vertical velocity, and airspeed were helpful to the pilots during aircraft surface failures. However, the additional information did lead to a slight increase in workload, a small decrease in perceived aircraft flying qualities, and no effect on aircraft situation awareness.

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

    Directory of Open Access Journals (Sweden)

    Cynthia Arcoverde

    2014-03-01

    Full Text Available Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD patients. Method Elderly (n=20 with mild dementia (NINCDS-ADRDA/CDR1 were randomly assigned to an exercise group (EG on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max and control group (GC 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG. Specifics instruments were also applied to evaluate executive function, memory, attention and concentration, cognitive flexibility, inhibitory control and functional capacity. Results After 16 weeks, the EG showed improvement in cognition CAMCOG whereas the CG declined. Compared to the CG, the EG presented significant improvement on the functional capacity. The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables. Conclusion Walking on treadmill may be recommended as an augmentation treatment for patients with AD.

  17. Pilot control through the TAFCOS automatic flight control system

    Science.gov (United States)

    Wehrend, W. R., Jr.

    1979-01-01

    The set of flight control logic used in a recently completed flight test program to evaluate the total automatic flight control system (TAFCOS) with the controller operating in a fully automatic mode, was used to perform an unmanned simulation on an IBM 360 computer in which the TAFCOS concept was extended to provide a multilevel pilot interface. A pilot TAFCOS interface for direct pilot control by use of a velocity-control-wheel-steering mode was defined as well as a means for calling up conventional autopilot modes. It is concluded that the TAFCOS structure is easily adaptable to the addition of a pilot control through a stick-wheel-throttle control similar to conventional airplane controls. Conventional autopilot modes, such as airspeed-hold, altitude-hold, heading-hold, and flight path angle-hold, can also be included.

  18. Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

    2017-04-01

    Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m(2) and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  19. A randomized controlled pilot study of the therapeutic effects of yoga in people with Parkinson′s disease

    Directory of Open Access Journals (Sweden)

    Neena K Sharma

    2015-01-01

    Full Text Available Background: Exercise can be beneficial for cardiopulmonary, musculoskeletal or neurological systems, and other factors including mood, and may be beneficial in reducing fall risks, dementia and variables associated with quality of life (QOL. Parkinson′s disease (PD produces progressive motor and cognitive deterioration that may leave those inflicted unable to participate in standard exercise programs. Alternative forms of exercise such as yoga may be successful in improving physical function, QOL and physiological variables for overall well-being. Aim: This randomized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD. Methods and Materials: Thirteen people with stage 1-2 PD were randomized to either a yoga (n = 8 or a control group (n = 5. The yoga group participated in twice-weekly yoga sessions for 12 weeks. Participants were tested at baseline, and at 6 and 12 weeks using the Unified Parkinson′s Disease Rating Scale (UPDRS, clinical measures of health-related QOL and physiological measures. Results: Significant improvement in UPDRS scores (P = .006, diastolic blood pressure (P = 0.036 and average forced vital capacity (P = 0.03 was noted in the yoga group over time. Changes between groups were also noted in two SF-36 subscales. Positive trends of improvement were noted in depression scores (P = 0.056, body weight (P = 0.056 and forced expiratory volume (P = 0.059. Yoga participants reported more positive symptom changes including immediate tremor reduction. Conclusions: The results suggest that yoga may improve aspects of QOL and physiological functions in stages 1-2 PD. Future larger studies are needed to confirm and extend our findings of the effects of yoga in PD.

  20. Analytical and Preliminary Simulation Study of a Pilot's Ability to Control the Terminal Phase of a Rendezvous with Simple Optical Devices and a Timer

    Science.gov (United States)

    Lineberry, Edgar C., Jr.; Brissenden, Roy F.; Kurbjun, Max C.

    1961-01-01

    One method of controlling the terminal phase of a space rendezvous between two vehicles is first to correct the flight path of the controlled vehicle so that a constant line of sight is established between the vehicles. This correction is accomplished by thrusting normal to the sight line in a direction to arrest the angular motion of this line. Once this collision course has been established, the second step is to control the closure rate for a safe approach along the line of sight. Adequate control of this maneuver requires range and closure-rate information. A combined analytical and preliminary simulation study was conducted to determine the ability of a human pilot to control the rendezvous by this method using visual sightings made during the initial collision-course control to obtain the range and closure rate. The analytical phase of the study reviewed the geometric relations between the vehicles and formed the basis for techniques to transform the angular sightings into range and closure rate. A preliminary simulation was then made to investigate the accuracy of these techniques. The simulation consisted of an analog computer, an oscilloscope to represent the view a pilot would have-with a stabilized sight, and a timer. Results indicate that pilots, using an optical sight and a timer, can successfully arrest the angular motion of the line of sight between two rendezvous vehicles and obtain relative range and closure rate with sufficient accuracy to perform the final braking maneuver successfully.

  1. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial.

    Science.gov (United States)

    Kim, Joo-Hee; Jung, Hyun Jung; Kim, Tae-Hun; Lee, Seunghoon; Kim, Jung-Eun; Kang, Kyung-Won; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Shin, Mi-Suk; Shin, Kyung-Min; Jung, Hee-Jung; Lee, Seung-Deok; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-09-22

    Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. This pilot multicentre

  2. Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study.

    Science.gov (United States)

    Pelsser, Lidy M; Frankena, Klaas; Buitelaar, Jan K; Rommelse, Nanda N

    2010-09-01

    Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we investigated the effects of an elimination diet on physical and sleep complaints in children with ADHD. A group of 27 children (3.8-8.5 years old), who all met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD, were assigned randomly to either a diet group (15/27) or a control group (12/27). The diet group followed a 5-week elimination diet; the control group adhered to their normal diet. Parents of both groups had to keep an extended diary and had to monitor the behaviour and the physical and sleep complaints of their child conscientiously. The primary endpoint was the clinical response, i.e. a decrease of physical and sleep complaints, at the end of the trial, based on parent ratings on a Physical Complaints Questionnaire. The number of physical and sleep complaints was significantly decreased in the diet group compared to the control group (p < 0.001), with a reduction in the diet group of 77% (p < 0.001, effect size = 2.0) and in the control group of 17% (p = 0.08, effect size = 0.2). Specific complaints that were significantly reduced were in three domains: headaches or bellyaches, unusual thirst or unusual perspiration, and sleep complaints. The reduction of complaints seemed to occur independently of the behavioural changes (p = 0.1). However, the power of this comparison was low. A positive correlation existed between the reduction of physical and behavioural symptoms (p < 0.01). The reduction did not differ between children with or without an atopic constitution (p = 0.7). An elimination diet may be an effective instrument to reduce physical complaints in children with ADHD, but more research is needed to determine the effects of

  3. A natural seaweed derived mineral supplement (Aquamin F for knee osteoarthritis: A randomised, placebo controlled pilot study

    Directory of Open Access Journals (Sweden)

    Kuskowski Michael A

    2009-02-01

    Full Text Available Abstract Background Osteoarthritis (OA is a slowly destructive process that may be influenced by a nutritional mineral balance in the body. Methods This small, double blind, placebo controlled pilot study investigated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin on 6 minute walking distance (6 MWD, range of motion (ROM, and pain and joint mobility measured by the Western Ontario and McMaster Universities (WOMAC Osteoarthritis Index in subjects with moderate to severe OA of the knee during gradual withdrawal of non-steroidal anti-inflammatory drugs (NSAIDs that were being used daily for pain management. Subjects (n = 29 with moderate to severe OA of the knee were randomised to receive either Aquamin (2400 mg/d or Placebo for up to 12 weeks. Results Of the 29 subjects initially randomized, only 22 subjects proceeded to treatment due to 7 subjects not meeting study selection criteria at baseline. Fourteen subjects completed the study and an ITT analysis (n = 22 of the data showed no significant differences in WOMAC scores however, the data did reveal significant improvements in passive and active extension ROM (0.83° ± 1.54 vs. -1.54° ± 2.43; difference, 5.2° ± 2.2, p = 0.028 and 6 MWD (150 ± 48 ft vs. 12.5 ± 31.5 ft; difference, 136 ± 57 ft, p = 0.03 in the Aquamin group compared to the placebo group; respectively, following a 50% reduction in NSAID use. The treatments were well tolerated and the adverse event profiles were not significantly different between the groups. Conclusion This small preliminary study suggests Aquamin may increase range of motion and walking distances in subjects with OA of the knee and may allow partial withdrawal of NSAIDs over 12 weeks of treatment. Additional research is needed to confirm these preliminary observations. Trial registration NCT00755482

  4. Phellodendron and Citrus extracts benefit joint health in osteoarthritis patients: a pilot, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2009-08-01

    Full Text Available Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on joint health in overweight and normal weight adults diagnosed with osteoarthritis. Methods An 8-week placebo-controlled, randomized, double-blind study was conducted with four groups comparing the effects of NP 06-1 to placebo on overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel or matching placebo were given in a dose of two capsules (370 mg each twice daily. The outcome measures were the Lequesne Algofunctional Index (LAI for joint pain and movement as well as biomarkers of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]. Results Eighty (80 subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. The mean total LAI scores at baseline for the four groups ranged from 11.4 to 12.4 (SD 1.2 to 2.4. Treatment for 8 weeks resulted in a statistical improvement in the LAI score in the overweight treatment group compared to placebo (6.3 ± 2.3 vs 11.8 ± 1.5; p Conclusion In this pilot study, NP 06-1 had beneficial effects on symptoms of osteoarthritis of the knee as measured using LAI scores and had anti-inflammatory effects as measured using CRP. Administration of NP 06-1 was also associated with weight loss, which may have been a contributing factor to the other benefits.

  5. Falls prevention advice and visual feedback to those at risk of falling: study protocol for a pilot randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Studies have shown that functional strength and balance exercises can reduce the risk of falling in older people if they are done on a regular basis. However, the repetitive nature of these exercises; combined with the inherent lack of feedback of progress may discourage seniors from exercising in the home, thereby rendering such an intervention ineffective. This study hypothesizes that the use of visual feedback and multimodal games will be more effective in encouraging adherence to home rehabilitation than standard care; thereby promoting independence and improving the quality of life in older adults at risk of falling. Methods A pllel-group pilot randomized controlled trial with 3 groups of participants will be conducted in the home for 12 weeks. Participants will include older adults who have been identified as at risk of falling (n = 48), over the age of 65, living in the community, and suitable for a home exercise intervention. The primary outcome is adherence to exercise. Secondary outcomes include: variability in stride length, stride time and double support time (DST); walking speed; Timed up and go test (TUG); Falls Efficacy Scale International (FES-I); CONFbal scale; Romberg’s test; and quality of life measures (SF-12 and EuroQol EQ-5D). Qualitative assessments on personal experiences with rehabilitation tools will be done before and after the trial. Discussion This study will investigate the use of visual feedback and engaging multimodal activities to address the problem of non-compliance to home exercises for falls rehabilitation. One of the unique qualities of this study is the adaptation of special participatory design methods through which the end users (fallers) will be involved in the design of the proposed rehabilitation tools at various stages of the design process. Trial registration ISRCTN79967470 PMID:23510162

  6. Transdermal diclofenac patches for control of post-extraction pain. Pilot randomized controlled double-blind study.

    Science.gov (United States)

    Krishnan, Sriram; Sharma, Pankaj; Sharma, Rakesh; Kumar, Suman; Verma, Mahesh; Chaudhary, Zainab

    2015-03-01

    The scope of transdermal analgesics have been limited to pain control following local trauma, muscle spasm, minor esthetic surgeries, or sports-related injuries. Its scope of application can be extended in the field of dentistry and minor oral surgical procedures. A total of 40 healthy patients between the age of 18 and 50 years with deeply carious, nontender mandibular molar tooth deemed unsalvageable which was indicated for extraction were taken into study of which subjects were divided into cases and controls. The data were analyzed with chi-square test and Mann-Whitney U test; the chi-square test showed significant association with expected outcome in visual analog scale pain scores, the two groups at 6th and 12th hour. A Mann-Whitney U test was performed to identify strength of association between two groups where there were significant association between all parameters except for pain interference with routine activities and dental health status(0.022, 0.001); the differences between two groups in these parameters were significant (Transdermal route seems to be comparable to oral diclofenac in post-extraction pain relief; further studies are required to confirm the results and safety for its use in various other dental situations.

  7. Quality of Life Enhancement Programme for Individuals with Mood Disorder: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Yun-Ling Chen

    2015-06-01

    Conclusion: The participants who received the 8-week QOLEP demonstrated significant improvement in the level of depression. Studies with a sample size of at least 104 participants are recommended in the future.

  8. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study

    OpenAIRE

    2006-01-01

    Some patients with headache report that they have frequently used physical therapies such as application of cold to relieve their headache. There are only a few reported studies related to cold therapies in patients with migraine. In this study, we investigated the effect of cold application on migraine patients. Twenty-eight migraine patients were included. Cold therapy was administered to them by gel cap. Patients used this cap during their two migraine attacks. Before and after the c...

  9. Mindfulness based cognitive therapy improves frontal control in bipolar disorder: a pilot EEG study

    Directory of Open Access Journals (Sweden)

    Howells Fleur M

    2012-02-01

    Full Text Available Abstract Background Cognitive processing in Bipolar Disorder is characterized by a number of attentional abnormalities. Mindfulness Based Cognitive Therapy combines mindfulness meditation, a form of attentional training, along with aspects of cognitive therapy, and may improve attentional dysfunction in bipolar disorder patients. Methods 12 euthymic BD patients and 9 control participants underwent record of electroencephalography (EEG, band frequency analysis during resting states (eyes open, eyes closed and during the completion of a continuous performance task (A-X version, EEG event-related potential (ERP wave component analysis. The individuals with BD completed an 8-week MBCT intervention and record of EEG was repeated. Results (1 Brain activity, individuals with BD showed significantly decreased theta band power, increased beta band power, and decreased theta/beta ratios during the resting state, eyes closed, for frontal and cingulate cortices. Post MBCT intervention improvement over the right frontal cortex was seen in the individuals with BD, as beta band power decreased. (2 Brain activation, individuals with BD showed a significant P300-like wave form over the frontal cortex during the cue. Post MBCT intervention the P300-like waveform was significantly attenuated over the frontal cortex. Conclusions Individuals with BD show decreased attentional readiness and activation of non-relevant information processing during attentional processes. These data are the first that show, MBCT in BD improved attentional readiness, and attenuated activation of non-relevant information processing during attentional processes.

  10. Control of disability glare by means of electrochromic filtering glasses: A pilot study

    Directory of Open Access Journals (Sweden)

    Rosa Maria Coco-Martín

    2017-01-01

    Full Text Available Purpose: To evaluate the potential clinical usability of a new prototype of ophthalmic blue light filters developed by using electrochromic technology in pseudophakic patients complaining of glare. Methods: A prototype of electrochromic device was developed, with a specific frame that enclosed an electronic driver that allowed personalizing its function for each patient. A prospective, observational case series study was performed to test it. Five patients who had undergone cataract surgery with clear intraocular lenses and complaining of glare were included in the study. Main outcome measures were the results obtained in the satisfaction questionnaire that was delivered to patients. Then, visual acuity, contrast sensitivity, and reading ability data were evaluated with and without the prototype under different lighting conditions and different modes of the prototype after a complete month of use. Lens transmittance was also measured. Results: Visual acuity, contrast sensitivity and reading function did not change significantly with prototype use. The main activity for which the prototype was used was walking. Only one patient found that the dimming level was insufficient. No patients reported variable discomfort when passing tunnels, not sufficiently clear indoors, or put on and remove discomfort. The lenses slightly decreased their transmittance at the end of the study. Conclusion: Glasses based on electrochromic technology may be acceptable for outdoor/indoor use and for distance–near vision. Future studies with larger samples must be conducted to confirm the clinical usability of these glasses.

  11. Identifying Mechanisms that Predict Loss of Control (LOC) Eating Using Ecological Momentary Assessment: A pilot study

    Science.gov (United States)

    2013-08-30

    78 Holter monitoring...the feasibility of attending multiple visits required to conduct studies using EMA and Holter monitoring procedures. Visits will be counted as...negative affect for adolescent girls with LOC eating behavior, and due to the burdensome nature of wearing a Holter monitor, we assessed HRV for two

  12. Treatment of Idiopathic Parkinson's Disease with Traditional Chinese Herbal Medicine: A Randomized Placebo-Controlled Pilot Clinical Study

    Directory of Open Access Journals (Sweden)

    Wan Fung Kum

    2011-01-01

    Full Text Available The objective of this clinical study is to examine the effects of a Chinese herbal medicine formula (Jia Wei Liu Jun Zi Tang: JWLJZT on motor and non-motor symptoms, and on complications of conventional therapy in idiopathic Parkinson's disease (PD, using an add-on design. Fifty-five patients with PD were randomly allocated to receive either Chinese herbal medicine or placebo for 24 weeks. Primary outcome measure was the 39-item Parkinson's Disease Questionnaire (PDQ-39. Secondary outcome measures included the Unified Parkinson's Disease Rating Scale (UPDRS, Short-Form-36 Health Survey (SF-36, Geriatric Depression Scale (GDS, home diaries, and a range of category rating scales. JWLJZT resulted in a significant improvement in the UPDRS IVC when compared with placebo at 12 weeks (P = .039 and 24 weeks (P = .034. In addition, patients in the Chinese herbal medicine group also showed significant improvement in PDQ-39 communication scores at 12 weeks (P = .024 and 24 weeks (P = .047 when compared with the placebo group. There were no significant differences between treatment and control groups for SF-36 variables, GDS score or the mean daily “on-off” time. One case of mild diarrhea was noted in the treatment group. The findings suggest that JWLJZT can relieve some non-motor complications of conventional therapy and improve the communication ability in patients with PD. The results of this pilot study warrant larger multi-center clinical studies to assess long-term efficacy and tolerability of JWLJZT, and to elucidate the mechanisms by which it affects PD function.

  13. Dietary egg whites for phosphorus control in maintenance haemodialysis patients: a pilot study.

    Science.gov (United States)

    Taylor, Lynn M; Kalantar-Zadeh, Kamyar; Markewich, Theodore; Colman, Sara; Benner, Debbie; Sim, John J; Kovesdy, Csaba P

    2011-03-01

    High dietary protein intake is associated with greater survival in maintenance haemodialysis (MHD) patients. High-protein foods may increase dietary phosphorus burden, which is associated with increased mortality in these patients. Hypothesis is: an egg white based diet with low phosphorus to protein ratio (egg whites without phosphorus additives, as principal protein source. Thirteen otherwise stable MHD patients with serum phosphorus >4.0 mg/dl agreed to consume eight ounces (225 g) of pasteurised liquid egg whites one meal per day for six weeks. Recipes were suggested to improve diet variety. Thirteen participating patients included seven women, three African Americans and five diabetics. Twelve patients exhibited drop in serum phosphorus. Mean population fall in serum phosphorus was 0.94 mg/dl, i.e. from 5.58 ± 1.34 (mean ± SD) to 4.63 ± 1.18 (p = 0.003). Serum albumin showed an increase by 0.19 g/dl, i.e. from 4.02 ± 0.29 to 4.21 ± 0.36 g/dl (p = 0.014). Changes in phosphorus pill count were not statistically significant (p = 0.88). The egg white diet was well tolerated, and recipe variety appreciated. Pasteurised liquid egg whites may be an effective diet component lowering serum phosphorus without risking malnutrition. Controlled trials are indicated to examine egg white based dietary interventions in MHD patients at home or during haemodialysis treatment. © 2011 European Dialysis and Transplant Nurses Association/European Renal Care Association.

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

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    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% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  15. The Cognitive Remediation in Bipolar (CRiB) pilot study:Study protocol for a randomised controlled trial

    OpenAIRE

    2016-01-01

    Background: People with bipolar disorder often show difficulties with cognitive functioning, and though these difficulties are identified as important targets for intervention, few treatment options are available. Preliminary evidence suggests that cognitive remediation therapy (a psychological treatment proven beneficial for people diagnosed as having schizophrenia) is helpful for people with bipolar disorders. We are conducting a pilot trial to determine whether individual, computerised, co...

  16. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

    Science.gov (United States)

    Stoller, Oliver; de Bruin, Eling D; Schuster-Amft, Corina; Schindelholz, Matthias; de Bie, Rob A; Hunt, Kenneth J

    2013-09-22

    After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics

  17. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study

    Directory of Open Access Journals (Sweden)

    Serap Ucler

    2006-01-01

    Full Text Available Some patients with headache report that they have frequently used physical therapies such as application of cold to relieve their headache. There are only a few reported studies related to cold therapies in patients with migraine. In this study, we investigated the effect of cold application on migraine patients. Twenty-eight migraine patients were included. Cold therapy was administered to them by gel cap. Patients used this cap during their two migraine attacks. Before and after the cold therapy, headache severity was recorded by using visual analogue scale (VAS. Patients used this cap for 25 min in each application. They recorded their VAS score just after the therapy and 25 min, 1 h, 2 h and 3 h later. Two patients could not use this therapy due to side effects (one due to cold intolerance and one due to vertigo in both applications. Therefore, therapeutic efficacy was evaluated in 26 patients. Twenty-five minutes after treatment of the first attack, VAS score was decreased from 7.89 ± 1.93 to 5.54 ± 2.96 (P < 0.01. Twenty-five minutes after treatment of the second attack, VAS score was decreased from 7.7 ± 1.8 to 5.4 ± 3.55 (P < 0.01. Cold application alone may be effective in some patients suffering from migraine attacks. Its combination with conventional drugs should be investigated in future studies.

  18. Needling versus liquid nitrogen cryotherapy for the treatment of pedal warts a randomized controlled pilot study.

    Science.gov (United States)

    Cunningham, Daniel J; Brimage, Jessica T; Naraghi, Reza N; Bower, Virginia M

    2014-07-01

    We hypothesized that needling of a pedal wart creates local inflammation and a subsequent cell-mediated immune response (CMIR) against human papillomavirus. The primary objective of this study was to investigate whether needling to induce a CMIR against human papillomavirus is an effective treatment for pedal warts compared with liquid nitrogen cryotherapy. A secondary objective was to investigate whether the CMIR induced by needling is effective against satellite pedal warts. Eligible patients with pedal warts were randomly allocated to receive either needling or liquid nitrogen cryotherapy. Only the primary pedal wart was treated during the study. Follow-up was 12 weeks, with outcome assessments made independently under blinded circumstances. Of 37 patients enrolled in the study, 18 were allocated to receive needling and 19 to receive liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% of the needling group (11 of 17) and in 6.2% of the liquid nitrogen cryotherapy group (1 of 16) (P =  .001). No significant relationship was found between needling of the primary pedal wart and regression of satellite pedal warts (P = .615) or complete pedal wart regression (P = .175). There was no significant difference in pain, satisfaction, or cosmesis between the two groups. The regression rate of the primary pedal wart was significantly higher in the needling group compared with the liquid nitrogen cryotherapy group.

  19. Treadmill training improves overground walking economy in Parkinson's disease: a randomized, controlled pilot study.

    Science.gov (United States)

    Fernández-Del-Olmo, Miguel Angel; Sanchez, Jose Andres; Bello, Olalla; Lopez-Alonso, Virginia; Márquez, Gonzalo; Morenilla, Luis; Castro, Xabier; Giraldez, Manolo; Santos-García, Diego

    2014-01-01

    Gait disturbances are one of the principal and most incapacitating symptoms of Parkinson's disease (PD). In addition, walking economy is impaired in PD patients and could contribute to excess fatigue in this population. An important number of studies have shown that treadmill training can improve kinematic parameters in PD patients. However, the effects of treadmill and overground walking on the walking economy remain unknown. The goal of this study was to explore the walking economy changes in response to a treadmill and an overground training program, as well as the differences in the walking economy during treadmill and overground walking. Twenty-two mild PD patients were randomly assigned to a treadmill or overground training group. The training program consisted of 5 weeks (3 sessions/week). We evaluated the energy expenditure of overground walking, before and after each of the training programs. The energy expenditure of treadmill walking (before the program) was also evaluated. The treadmill, but not the overground training program, lead to an improvement in the walking economy (the rate of oxygen consumed per distance during overground walking at a preferred speed) in PD patients. In addition, walking on a treadmill required more energy expenditure compared with overground walking at the same speed. This study provides evidence that in mild PD patients, treadmill training is more beneficial compared with that of walking overground, leading to a greater improvement in the walking economy. This finding is of clinical importance for the therapeutic administration of exercise in PD.

  20. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study.

    Science.gov (United States)

    Ucler, Serap; Coskun, Ozlem; Inan, Levent E; Kanatli, Yonca

    2006-12-01

    Some patients with headache report that they have frequently used physical therapies such as application of cold to relieve their headache. There are only a few reported studies related to cold therapies in patients with migraine. In this study, we investigated the effect of cold application on migraine patients. Twenty-eight migraine patients were included. Cold therapy was administered to them by gel cap. Patients used this cap during their two migraine attacks. Before and after the cold therapy, headache severity was recorded by using visual analogue scale (VAS). Patients used this cap for 25 min in each application. They recorded their VAS score just after the therapy and 25 min, 1 h, 2 h and 3 h later. Two patients could not use this therapy due to side effects (one due to cold intolerance and one due to vertigo) in both applications. Therefore, therapeutic efficacy was evaluated in 26 patients. Twenty-five minutes after treatment of the first attack, VAS score was decreased from 7.89 +/- 1.93 to 5.54 +/- 2.96 (P < 0.01). Twenty-five minutes after treatment of the second attack, VAS score was decreased from 7.7 +/- 1.8 to 5.4 +/- 3.55 (P < 0.01). Cold application alone may be effective in some patients suffering from migraine attacks. Its combination with conventional drugs should be investigated in future studies.

  1. Early enteral nutrition therapy in congenital cardiac repair postoperatively: A randomized, controlled pilot study

    Science.gov (United States)

    Sahu, Manoj Kumar; Singal, Anuradha; Menon, Ramesh; Singh, Sarvesh Pal; Mohan, Alka; Manral, Mala; Singh, Divya; Devagouru, V.; Talwar, Sachin; Choudhary, Shiv Kumar

    2016-01-01

    Background and Objectives: Adequate nutritional supplementation in infants with cardiac malformations after surgical repair is a challenge. Critically ill infants in the early postoperative period are in a catabolic stress. The mismatch between estimated energy requirement (EER) and the intake in the postoperative period is multifactorial, predisposing them to complications such as immune deficiency, more infection, and growth failure. This study aimed to assess the feasibility and efficacy of enriched breast milk feed on postoperative recovery and growth of infants after open heart surgery. Methodology: Fifty infants surgery is feasible and recommended. In addition, enriching the EBM is helpful in achieving the maximum possible calorie intake in the postoperative period. EN therapy might help in providing adequate nutrition, and it decreases ventilation duration, infection rate, LOIS, LOHS, and mortality. PMID:27716696

  2. Robot-assisted reaching exercise promotes arm movement recovery in chronic hemiparetic stroke: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Rymer W Zev

    2006-06-01

    Full Text Available Abstract Background and purpose Providing active assistance to complete desired arm movements is a common technique in upper extremity rehabilitation after stroke. Such active assistance may improve recovery by affecting somatosensory input, motor planning, spasticity or soft tissue properties, but it is labor intensive and has not been validated in controlled trials. The purpose of this study was to investigate the effects of robotically administered active-assistive exercise and compare those with free reaching voluntary exercise in improving arm movement ability after chronic stroke. Methods Nineteen individuals at least one year post-stroke were randomized into one of two groups. One group performed 24 sessions of active-assistive reaching exercise with a simple robotic device, while a second group performed a task-matched amount of unassisted reaching. The main outcome measures were range and speed of supported arm movement, range, straightness and smoothness of unsupported reaching, and the Rancho Los Amigos Functional Test of Upper Extremity Function. Results and discussion There were significant improvements with training for range of motion and velocity of supported reaching, straightness of unsupported reaching, and functional movement ability. These improvements were not significantly different between the two training groups. The group that performed unassisted reaching exercise improved the smoothness of their reaching movements more than the robot-assisted group. Conclusion Improvements with both forms of exercise confirmed that repeated, task-related voluntary activation of the damaged motor system is a key stimulus to motor recovery following chronic stroke. Robotically assisting in reaching successfully improved arm movement ability, although it did not provide any detectable, additional value beyond the movement practice that occurred concurrently with it. The inability to detect any additional value of robot-assisted reaching

  3. Metformin treatment to reduce central adiposity after prenatal growth restraint: a placebo-controlled pilot study in prepubertal children.

    Science.gov (United States)

    Díaz, Marta; Bassols, Judit; López-Bermejo, Abel; de Zegher, Francis; Ibáñez, Lourdes

    2015-11-01

    Children born small-for-gestational-age (SGA) who experience rapid postnatal catch-up in weight are at risk for central adiposity and hyperinsulinemia. To study the effects of prepubertal metformin intervention over 24 months on the body composition and endocrine-metabolic profile of catch-up SGA children. Double-blind, placebo-controlled, pilot study including 23 post-catch-up non-obese prepubertal SGA children [age, 7.7 yr; body mass index standard deviation score (BMI SDS) >50th and 75th for age]. Patients were randomized to receive either placebo or metformin (425 mg/d) for 24 months. Clinical, biochemical [IGF-I, glucose, insulin, lipids, androgens, sex-hormone-binding globulin (SHBG) and high-molecular-weight (HMW)-adiponectin] and imaging [body composition (absorptiometry and MRI; carotid intima-media thickness (ultrasonography)] variables were assessed at baseline, and at 6, 12, and 24 months. After 24 months, metformin-treated children were leaner, had higher SHBG levels, and less total and abdominal fat than placebo-treated children (all p ≤ 0.05). Longitudinal analyses showed that metformin had a significant effect on anthropometric (weight, BMI, and waist) and biochemical variables [glucose, homeostasis model assessment-insulin resistance (HOMA-IR), and triglycerides] (all p ≤ 0.05); and in total and abdominal fat (p = 0.01 and p = 0.02). Prepubertal intervention with metformin reduces central adiposity and improves insulin sensitivity in non-obese catch-up SGA children. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. A pilot study to evaluate the application of a generic protein standard panel for quality control of biomarker detection technologies

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    Valdivia Hernan J

    2011-08-01

    Full Text Available Abstract Background Protein biomarker studies are currently hampered by a lack of measurement standards to demonstrate quality, reliability and comparability across multiple assay platforms. This is especially pertinent for immunoassays where multiple formats for detecting target analytes are commonly used. Findings In this pilot study a generic panel of six non-human protein standards (50 - 10^7 pg/mL of varying abundance was prepared as a quality control (QC material. Simulated "normal" and "diseased" panels of proteins were prepared in pooled human plasma and incorporated into immunoassays using the Meso Scale Discovery® (MSD® platform to illustrate reliable detection of the component proteins. The protein panel was also evaluated as a spike-in material for a model immunoassay involving detection of ovarian cancer biomarkers within individual human plasma samples. Our selected platform could discriminate between two panels of the proteins exhibiting small differences in abundance. Across distinct experiments, all component proteins exhibited reproducible signal outputs in pooled human plasma. When individual donor samples were used, half the proteins produced signals independent of matrix effects. These proteins may serve as a generic indicator of platform reliability. Each of the remaining proteins exhibit differential signals across the distinct samples, indicative of sample matrix effects, with the three proteins following the same trend. This subset of proteins may be useful for characterising the degree of matrix effects associated with the sample which may impact on the reliability of quantifying target diagnostic biomarkers. Conclusions We have demonstrated the potential utility of this panel of standards to act as a generic QC tool for evaluating the reproducibility of the platform for protein biomarker detection independent of serum matrix effects.

  5. A randomised controlled pilot study: the effectiveness of narrative exposure therapy with adult survivors of the Sichuan earthquake

    Directory of Open Access Journals (Sweden)

    Zang Yinyin

    2013-01-01

    Full Text Available Abstract Background Post-Traumatic Stress Disorder (PTSD is a common psychological reaction after large-scale natural disasters. Given the number of people involved and shortage of resources in any major disaster, brief, pragmatic and easily trainable interventions are needed. The aim of this study is to evaluate the efficacy of Narrative Exposure Therapy (NET as a short-term treatment for PTSD using Chinese earthquake survivors. Methods A randomized waiting-list control pilot study was conducted between December 2009 and March 2010, at the site of the Sichuan earthquake in Beichuan County, China. Adult participants with newly diagnosed Post Traumatic Stress Disorder (PTSD were randomly allocated to Narrative Exposure Therapy (NET or a Waiting-List (WL condition. The latter received NET treatment after a two-week waiting period. To compare the effectiveness of NET in traumatised earthquake survivors, both groups were assessed on PTSD symptoms, general mental health, anxiety and depression, social support, coping style and posttraumatic change before and after treatment and two months post treatment. Results Adult participants (n=22 were randomly allocated to receive NET (n=11 or WL (n=11. Twenty two participants (11 in NET group, 11 in WL were included in the analysis of primary outcomes. Compared with WL, NET showed significant reductions in PTSD symptoms, anxiety and depression, general mental stress and increased posttraumatic growth. The WL group later showed similar improvements after treatment. These changes remained stable for a two-month follow-up. Measures of social support and coping showed no stable effects. Conclusions NET is effective in treating post-earthquake traumatic symptoms in adult Chinese earthquake survivors. The findings help advance current knowledge in the management of PTSD after natural disasters and inform future research. Larger sample sizes are needed to extend the present findings. Trial registration Chinese

  6. A randomized controlled pilot study of a brief web-based mindfulness training

    Directory of Open Access Journals (Sweden)

    Glück Tobias M

    2011-11-01

    Full Text Available Abstract Background Mindfulness has been shown to be effective in treating various medical and mental problems. Especially its incorporation in cognitive-behavioural interventions has improved long-term outcomes of those treatments. It has also been shown, that brief mindfulness-based trainings are effective in reducing distress. There have been few web-based interventions incorporating mindfulness techniques in their manual and it remains unclear whether a brief web-based mindfulness intervention is feasible. Methods Out of 50 adults (different distress levels; exclusion criteria: Results 26 participants of the treatment group completed post-measures. Most measures under ITT-analysis revealed no significant improvement for the treatment group, but trends with medium effect sizes for PSQ (d = 0.46 and PANASneg (d = 0.50 and a small, non-significant effect for FMI (d = 0.29. Per-protocol analyses for persons who participated over 50% of the time revealed significant treatment effects for PSQ (d = 0.72 and PANASneg (d = 0.77. Comparing higher distressed participants with lower distressed participants, highly distressed participants seemed to profit more of the training in terms of distress reduction (GSI, d = 0.85. Real change (RCI occurred for PSQ in the treatment condition (OR = 9. Results also suggest that participants continued to benefit from the training at 3MFU. Conclusion This study of a brief web-based mindfulness training indicates that mindfulness can be taught online and may improve distress, perceived stress and negative affect for regular users. Although there were no significant improvements, but trends, for most measures under ITT, feasibility of such a program was demonstrated and also that persons continued to use techniques of the training in daily life. Trial Registration German Clinical Trials Register (DRKS: DRKS00003209

  7. Phellodendron and Citrus extracts benefit cardiovascular health in osteoarthritis patients: a double-blind, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2008-05-01

    Full Text Available Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee. Methods An 8-week, placebo-controlled, randomized, double-blind study was conducted with four groups, comparing the effects of NP 06-1 to placebo in overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel or matching placebo was given in a dose of two capsules (370 mg each twice daily. The outcome measures reported are lipid levels, weight, BMI, blood pressure and fasting glucose. Analyses of variance were used to compare changes of physiological measures over the trial period and between groups. Results Eighty (80 subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. NP 06-1 administration was associated with a general improvement in lipid levels. Both the overweight and normal weight treatment groups had significant reductions in triglycerides and LDL-cholesterol, as well as a significant increase in HDL-cholesterol compared to their respective control groups. Overall there were decreases in blood pressure in both overweight and normal weight treatment groups compared to respective placebo groups. There was also a significant decrease in fasting glucose levels in the overweight treatment group compared to the start of the study and to the overweight placebo group. There was no change in fasting blood sugar for the normal weight groups. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their respective placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks, which was associated with a significant loss in BMI over time. Conclusion In

  8. The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain : a randomised controlled pilot study

    OpenAIRE

    2012-01-01

    Introduction. Cupping has been used since antiquity in the treatment of pain conditions. In this pilot study, we investigated the effect of traditional cupping therapy on chronic nonspecific neck pain (CNP) and mechanical sensory thresholds. Methods. Fifty CNP patients were randomly assigned to treatment (TG, n = 25) or waiting list control group (WL, n = 25). TG received a single cupping treatment. Pain at rest (PR), pain related to movement (PM), quality of life (SF-36), Neck Disability Ind...

  9. Magnetic Anastomosis for Glycemic Insulin Control (MAGIC): A Pilot Study of Minimally Invasive (Endoscopic/Laparoscopic) Side-to-Side Duodeno-Distal Ileal Anastomosis in Pigs

    Science.gov (United States)

    2013-10-08

    17 OCT 2013 2. REPORT TYPE Final 3. DATES COVERED 01 NOv 2012 - 17 Oct 2013 4. TITLE AND SUBTITLE FDG20130001A entitled Magnetic Anastomosis ...for Glycemic Insulin Control (MAGIC): A pilot study of minimally invasive (endoscopic/laparoscopic) side-to-side duodeno-distal ileal anastomosis in...Compression Anastomosis Corrects Insulin Resistance in Diabetic Pigs. PURPOSE: Bariatric surgery corrects insulin resistance independent of weight loss

  10. Efficacy of high intensity exercise on disease activity and cardiovascular risk in active axial spondyloarthritis: a randomized controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Silje Halvorsen Sveaas

    Full Text Available BACKGROUND: Physical therapy is recommended for the management of axial spondyloarthritis (axSpA and flexibility exercises have traditionally been the main focus. Cardiovascular (CV diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases. Therefore, the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA. METHODS: In a single blinded randomized controlled pilot study the exercise group (EG performed 12 weeks of endurance and strength exercise while the control group (CG received treatment as usual. The primary outcome was the Ankylosing Spondylitis (AS Disease Activity Score (ASDAS. Secondary outcomes included patient reported disease activity (Bath AS Disease Activity Index [BASDAI], physical function (Bath AS Functional Index [BASFI], and CV risk factors measured by arterial stiffness (Augmentation Index [Alx] and Pulse Wave Velocity [PWV], cardiorespiratory fitness (VO2 peak and body composition. ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences, and Mann Whitney U-test was used for outcomes with skewed residuals. RESULTS: Twenty-eight patients were included and 24 (EG, n = 10, CG, n = 14 completed the study. A mean treatment effect of -0.7 (95%CI: -1.4, 0.1 was seen in ASDAS score. Treatment effects were also observed in secondary outcomes (mean group difference [95%CI]: BASDAI: -2.0 (-3.6, -0.4, BASFI: -1.4 (-2.6, -0.3, arterial stiffness (estimated median group differences [95% CI]: AIx (%: -5.3 (-11.0, -0.5, and for PVW (m/s: -0.3 (-0.7, 0.0, VO2 peak (ml/kg/min (mean group difference [95%CI]: 3.7 (2.1, 5.2 and trunk fat (%: -1.8 (-3.0, -0.6. No adverse events occurred. CONCLUSION: High intensity exercise improved disease activity and reduced CV risk factors in

  11. Efficacy of high intensity exercise on disease activity and cardiovascular risk in active axial spondyloarthritis: a randomized controlled pilot study.

    Science.gov (United States)

    Sveaas, Silje Halvorsen; Berg, Inger Jorid; Provan, Sella Aarrestad; Semb, Anne Grete; Hagen, Kåre Birger; Vøllestad, Nina; Fongen, Camilla; Olsen, Inge C; Michelsen, Annika; Ueland, Thor; Aukrust, Pål; Kvien, Tore K; Dagfinrud, Hanne

    2014-01-01

    Physical therapy is recommended for the management of axial spondyloarthritis (axSpA) and flexibility exercises have traditionally been the main focus. Cardiovascular (CV) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases. Therefore, the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA. In a single blinded randomized controlled pilot study the exercise group (EG) performed 12 weeks of endurance and strength exercise while the control group (CG) received treatment as usual. The primary outcome was the Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS). Secondary outcomes included patient reported disease activity (Bath AS Disease Activity Index [BASDAI]), physical function (Bath AS Functional Index [BASFI]), and CV risk factors measured by arterial stiffness (Augmentation Index [Alx]) and Pulse Wave Velocity [PWV]), cardiorespiratory fitness (VO2 peak) and body composition. ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences, and Mann Whitney U-test was used for outcomes with skewed residuals. Twenty-eight patients were included and 24 (EG, n = 10, CG, n = 14) completed the study. A mean treatment effect of -0.7 (95%CI: -1.4, 0.1) was seen in ASDAS score. Treatment effects were also observed in secondary outcomes (mean group difference [95%CI]): BASDAI: -2.0 (-3.6, -0.4), BASFI: -1.4 (-2.6, -0.3), arterial stiffness (estimated median group differences [95% CI]): AIx (%): -5.3 (-11.0, -0.5), and for PVW (m/s): -0.3 (-0.7, 0.0), VO2 peak (ml/kg/min) (mean group difference [95%CI]: 3.7 (2.1, 5.2) and trunk fat (%): -1.8 (-3.0, -0.6). No adverse events occurred. High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA. These

  12. Temporal Association of Certain Neuropsychiatric Disorders Following Vaccination of Children and Adolescents: A Pilot Case-Control Study.

    Science.gov (United States)

    Leslie, Douglas L; Kobre, Robert A; Richmand, Brian J; Aktan Guloksuz, Selin; Leckman, James F

    2017-01-01

    Although the association of the measles, mumps, and rubella vaccine with autism spectrum disorder has been convincingly disproven, the onset of certain brain-related autoimmune and inflammatory disorders has been found to be temporally associated with the antecedent administration of various vaccines. This study examines whether antecedent vaccinations are associated with increased incidence of obsessive-compulsive disorder (OCD), anorexia nervosa (AN), anxiety disorder, chronic tic disorder, attention deficit hyperactivity disorder, major depressive disorder, and bipolar disorder in a national sample of privately insured children. Using claims data, we compared the prior year's occurrence of vaccinations in children and adolescents aged 6-15 years with the above neuropsychiatric disorders that were newly diagnosed between January 2002 and December 2007, as well as two control conditions, broken bones and open wounds. Subjects were matched with controls according to age, gender, geographical area, and seasonality. Conditional logistic regression models were used to determine the association of prior vaccinations with each condition. Subjects with newly diagnosed AN were more likely than controls to have had any vaccination in the previous 3 months [hazard ratio (HR) 1.80, 95% confidence interval 1.21-2.68]. Influenza vaccinations during the prior 3, 6, and 12 months were also associated with incident diagnoses of AN, OCD, and an anxiety disorder. Several other associations were also significant with HRs greater than 1.40 (hepatitis A with OCD and AN; hepatitis B with AN; and meningitis with AN and chronic tic disorder). This pilot epidemiologic analysis implies that the onset of some neuropsychiatric disorders may be temporally related to prior vaccinations in a subset of individuals. These findings warrant further investigation, but do not prove a causal role of antecedent infections or vaccinations in the pathoetiology of these conditions. Given the modest

  13. Acute Dietary Nitrate Supplementation and Exercise Performance in COPD: A Double-Blind, Placebo-Controlled, Randomised Controlled Pilot Study.

    Directory of Open Access Journals (Sweden)

    Katrina J Curtis

    Full Text Available Dietary nitrate supplementation can enhance exercise performance in healthy people, but it is not clear if it is beneficial in COPD. We investigated the hypotheses that acute nitrate dosing would improve exercise performance and reduce the oxygen cost of submaximal exercise in people with COPD.We performed a double-blind, placebo-controlled, cross-over single dose study. Subjects were randomised to consume either nitrate-rich beetroot juice (containing 12.9 mmoles nitrate or placebo (nitrate-depleted beetroot juice 3 hours prior to endurance cycle ergometry, performed at 70% of maximal workload assessed by a prior incremental exercise test. After a minimum washout period of 7 days the protocol was repeated with the crossover beverage.21 subjects successfully completed the study (age 68 ± 7 years; BMI 25.2 ± 5.5 kg/m2; FEV1 percentage predicted 50.1 ± 21.6%; peak VO2 18.0 ± 5.9 ml/min/kg. Resting diastolic blood pressure fell significantly with nitrate supplementation compared to placebo (-7 ± 8 mmHg nitrate vs. -1 ± 8 mmHg placebo; p = 0.008. Median endurance time did not differ significantly; nitrate 5.65 (3.90-10.40 minutes vs. placebo 6.40 (4.01-9.67 minutes (p = 0.50. However, isotime oxygen consumption (VO2 was lower following nitrate supplementation (16.6 ± 6.0 ml/min/kg nitrate vs. 17.2 ± 6.0 ml/min/kg placebo; p = 0.043, and consequently nitrate supplementation caused a significant lowering of the amplitude of the VO2-percentage isotime curve.Acute administration of oral nitrate did not enhance endurance exercise performance; however the observation that beetroot juice caused reduced oxygen consumption at isotime suggests that further investigation of this treatment approach is warranted, perhaps targeting a more hypoxic phenotype.ISRCTN Registry ISRCTN66099139.

  14. A primary school active break programme (ACTI-BREAK): study protocol for a pilot cluster randomised controlled trial.

    Science.gov (United States)

    Watson, Amanda; Timperio, Anna; Brown, Helen; Hesketh, Kylie D

    2017-09-19

    Levels of overall physical activity have been shown to decline across childhood. Schools are considered ideal settings to promote physical activity as children spend a large amount of their waking hours at school. Time-efficient physical activity strategies that demonstrate a positive impact on academic-related outcomes are needed to enable physical activity to be prioritised in the school day. The ACTI-BREAK programme requires classroom teachers to integrate active breaks; 5-min bursts of moderate-intensity physical activity into their classroom routine. Active breaks have been shown to be effective in improving academic-related outcomes, a potentially appealing aspect for teachers and schools. The primary aim of this study is to assess the feasibility and potential efficacy of the ACTI-BREAK programme on children's academic achievement. Secondary aims are to explore the impact of ACTI-BREAK on children's on-task behaviour and objectively measured physical activity levels. ACTI-BREAK is a 6-week, classroom-based, physical activity intervention. This pilot trial of the programme will be evaluated using a cluster randomised controlled design. Government primary schools in metropolitan Melbourne, Australia will be invited to participate in the programme in 2017. Randomisation will occur at the school level, with the aim to recruit six schools (three intervention and three control). The ACTI-BREAK programme is theoretically grounded, and was developed with input and guidance from current primary school teachers. Teachers from the intervention schools will receive a 45-min training session and be asked to incorporate ACTI-BREAKS into their classroom routine three times per day for 6 weeks. Intervention support will be provided via assisted delivery. The primary outcomes will be children's academic achievement in mathematics and reading. Children's on-task behaviour and school-day physical activity will be assessed as secondary outcomes. Process evaluation will also be

  15. A randomised controlled trial of intravenous zoledronic acid in malignant pleural disease: a proof of principle pilot study.

    Directory of Open Access Journals (Sweden)

    Amelia O Clive

    Full Text Available Animal studies have shown Zoledronic Acid (ZA may diminish pleural fluid accumulation and tumour bulk in malignant pleural disease (MPD. We performed a pilot study to evaluate its effects in humans.We undertook a single centre, double-blind, placebo-controlled trial in adults with MPD. Patients were randomised (1:1 to receive 2 doses of intravenous ZA or placebo, 3 weeks apart and were followed-up for 6 weeks. The co-primary outcomes were change in Visual Analogue Scale (VAS score measured breathlessness during trial follow-up and change in the initial area under the curve (iAUC on thoracic Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI from randomisation to week 5. Multiple secondary endpoints were also evaluated.Between January 2010 and May 2013, 30 patients were enrolled, 24 randomised and 4 withdrew after randomisation (1 withdrew consent; 3 had a clinical decline. At baseline, the ZA group were more breathless, had more advanced disease on radiology and worse quality of life than the placebo group. There was no significant difference between the groups with regards change in breathlessness (Adjusted mean difference (AMD 4.16 (95%CI -4.7 to 13.0 or change in DCE-MRI iAUC (AMD -15.4 (95%CI -58.1 to 27.3. Two of nine (22% in the ZA arm had a >10% improvement by modified RECIST (vs 0/11 who received placebo. There was no significant difference in quality of life measured by the QLQ-C30 score (global QOL: AMD -4.1 (-13.0 to 4.9, side effects or serious adverse event rates.This is the first human study to evaluate ZA in MPD. The study is limited by small numbers and imbalanced baseline characteristics. Although no convincing treatment effect was identified, potential benefits for specific subgroups of patients cannot be excluded. This study provides important information regarding the feasibility of future trials to evaluate the effects of ZA further.UK Clinical Research Network ID 8877 ISRCTN17030426 www.isrctn.com.

  16. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. Methods/design This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada. Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired. Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Discussion Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been

  17. Functional neuroimaging of emotional processing in women with polycystic ovary syndrome: a case-control pilot study

    Science.gov (United States)

    Marsh, Courtney A.; Berent-Spillson, Alison; Love, Tiffany; Persad, Carol C.; Pop-Busui, Rodica; Zubieta, Jon-Kar; Smith, Yolanda R.

    2013-01-01

    Objective To evaluate emotional processing in women with insulin-resistant polycystic ovary syndrome (IR-PCOS) and its relationship to glucose regulation and the mu-opioid system. Design Case-control pilot. Setting Tertiary referring medical center. Patient(s) Seven women with IR-PCOS and five non-insulin-resistant controls, aged 21–40 years, recruited from the general population. Intervention(s) Sixteen weeks of metformin (1,500 mg/day) in women with IR-PCOS. Main Outcome Measure(s) Assessment of mood, metabolic function, and neuronal activation during an emotional task using functional magnetic resonance imaging (fMRI), and mu-opioid receptor availability using positive emission tomography (PET). Result(s) We found that insulin-resistant PCOS patients [1] had greater limbic activation during an emotion task than controls (n = 5); [2] trended toward decreased positive affect and increased trait anxiety; [3] after metformin treatment, had limbic activation that no longer differed from controls; and [4] had positive correlations between fMRI limbic activation during emotional processing and mu-opioid binding potential. Conclusion(s) Patients with IR-PCOS had greater regional activation during an emotion task than the controls, although this resolved with metformin therapy. Alterations in mu-opioid neurotransmission may underlie limbic system activity and mood disorders in IR-PCOS. Clinical Trial Registration Number NCT00670800. PMID:23557757

  18. Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study.

    LENUS (Irish Health Repository)

    Harmon, Dominic C

    2012-02-03

    PURPOSE: Cognitive deficit after coronary artery bypass surgery (CABG) has a high prevalence and is persistent. Meta-analysis of clinical trials demonstrates a decreased incidence of stroke after CABG when aprotinin is administrated perioperatively. We hypothesized that aprotinin administration would decrease the incidence of cognitive deficit after CABG. METHODS: Thirty-six ASA III-IV patients undergoing elective CABG were included in a prospective, randomized, single-blinded pilot study. Eighteen patients received aprotinin 2 x 10(6) KIU (loading dose), 2 x 10(6) KIU (added to circuit prime) and a continuous infusion of 5 x 10(5) KIU.hr(-1). A battery of cognitive tests was administered to patients and spouses (n = 18) the day before surgery, four days and six weeks postoperatively. RESULTS: Four days postoperatively new cognitive deficit (defined by a change in one or more cognitive domains using the Reliable Change Index method) was present in ten (58%) patients in the aprotinin group compared to 17 (94%) in the placebo group [95% confidence interval (CI) 0.10-0.62, P = 0.005); (P = 0.01)]. Six weeks postoperatively, four (23%) patients in the aprotinin group had cognitive deficit compared to ten (55%) in the placebo group (95% CI 0.80-0.16, P = 0.005); (P = 0.05). CONCLUSION: In this prospective pilot study, the incidence of cognitive deficit after CABG and cardiopulmonary bypass is decreased by the administration of high-dose aprotinin.

  19. Transfer Readiness Pilot Study.

    Science.gov (United States)

    Scott-Skillman, Thelma; And Others

    The California Community Colleges (CCC) has implemented a prototype model for determining student transfer readiness as a primary means of assessing community college transfer effectiveness. This report provides definitions of transfer readiness and guidelines for colleges participating in the CCC transfer readiness study. First, a memorandum from…

  20. Mindfulness training and stress reactivity in substance abuse: results from a randomized, controlled stage I pilot study.

    Science.gov (United States)

    Brewer, Judson A; Sinha, Rajita; Chen, Justin A; Michalsen, Ravenna N; Babuscio, Theresa A; Nich, Charla; Grier, Aleesha; Bergquist, Keri L; Reis, Deidre L; Potenza, Marc N; Carroll, Kathleen M; Rounsaville, Bruce J

    2009-01-01

    Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically validated treatments for SUDs. The goals of this study were to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Thirty-six individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Fourteen individuals completed treatment. There were no differences in treatment satisfaction or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress.

  1. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

    Science.gov (United States)

    Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

    2014-09-06

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  2. Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sackley, Catherine M; Smith, Christina H; Rick, Caroline; Brady, Marian C; Ives, Natalie; Patel, Ramilla; Roberts, Helen; Dowling, Francis; Jowett, Sue; Wheatley, Keith; Patel, Smitaa; Kelly, Debbie; Sands, Gina; Clarke, Carl

    2014-06-07

    Parkinson's disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment. This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson's disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control. The PD COMM pilot is a three arm, assessor-blinded, randomized controlled trial. Randomization will be computer-generated with participants randomized at a ratio of 1:1:1. Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist. The target population are patients with a confirmed diagnosis of idiopathic Parkinson's disease who have problems with their speech or voice. The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60 minutes in length over four weeks, with extra home practice. The standard speech and language therapy intervention group will receive a dose determined by patients' individual needs, but not exceeding eight weeks of treatment. The control group will receive standard care with no speech and language therapy input for at least six months post-randomization. Outcomes will be assessed at baseline (pre-randomization) and post- randomization at three, six, and 12 months. The outcome measures include patient-reported voice measures, quality of life, resource use, and assessor-rated speech recordings. The recruitment aim is at least 60 participants over 21 months from 11 sites, equating to at least 20 participants in each arm of the trial. This trial is ongoing and recruitment commenced in May 2012. This study will

  3. A study of airline pilot morbidity.

    Science.gov (United States)

    Sykes, Adrian J; Larsen, Peter D; Griffiths, Robin F; Aldington, Sarah

    2012-10-01

    It has long been believed that airline pilots are healthier than the general population. There are a number of reasons why this should be the case. However, there is very little evidence to support this belief as fact. This study investigates the health of the pilot population of an Oceanic based airline compared to the health of the general population. Pilots who conducted their medical certificate renewal at the airline's medical unit between 1 November 2009 and 31 October 2010 were included. A medical questionnaire was completed by each pilot at the time of their medical certificate renewal. Data from the questionnaire was entered into a database as well as the pilot's BMI, blood pressure, lipid profile, and blood glucose level. The comparison population was the population who completed the New Zealand Health Survey (NZHS) between 2006-2007. Demographic, lifestyle characteristics, and health status data from the pilots was compared to the NZHS using a Chi-squared test. Included in the study were 595 pilots. With respect to most medical conditions, pilots had a lower prevalence when compared to the general population. Pilots had a higher prevalence of kidney disease (3.3% vs 0.6%) and melanoma skin cancer (19 per 1000 vs 0.4 per 1000). This study suggests that pilots in New Zealand are healthier than the general population with respect to most medical conditions. The two medical conditions that were identified as being overrepresented in pilots may be the result of the occupational environment.

  4. The Meaning-Making intervention (MMi) appears to increase meaning in life in advanced ovarian cancer: a randomized controlled pilot study.

    Science.gov (United States)

    Henry, Melissa; Cohen, S Robin; Lee, Virginia; Sauthier, Philippe; Provencher, Diane; Drouin, Pierre; Gauthier, Philippe; Gotlieb, Walter; Lau, Susie; Drummond, Nancy; Gilbert, Lucy; Stanimir, Gerald; Sturgeon, Jeremy; Chasen, Martin; Mitchell, Julie; Huang, Lina Nuoxin; Ferland, Mira-Klode; Mayo, Nancy

    2010-12-01

    This pilot study aimed to provide supportive evidence for the acceptability and usefulness of the Meaning-Making intervention (MMi) in patients newly diagnosed with Stage III or IV ovarian cancer, and to provide estimates of parameters needed to design a full-scale study. A randomized controlled trial with 24 patients (12 experimental and 12 control) was conducted. Existential well-being (primary outcome), overall quality of life, distress, anxiety, depression and self-efficacy were measured. Compared to the control group, patients in the experimental group had a better sense of meaning in life at one and three months post-intervention. The MMi seems a promising intervention for advanced cancer patients, and a full randomized controlled trial is warranted to further investigate its efficacy.

  5. Early individualised manipulative rehabilitation following lumbar open laser microdiscectomy improves early post-operative functional disability: A randomized, controlled pilot study.

    Science.gov (United States)

    Kim, Byungho J; Ahn, Junghoon; Cho, Heecheol; Kim, Dongyun; Kim, Taeyeong; Yoon, Bumchul

    2016-01-01

    Lumbar open laser microdiscectomy has been shown to be an effective intervention and safe approach for lumbar disc prolapse. However early post-operative physical disability affecting daily activities have been sporadically reported. To evaluate the feasibility of using early individualised manipulative rehabilitation to improve early post-operative functional disability following lumbar discectomy. Randomised controlled pilot trial. Setting at a major metropolitan spine surgery hospital. Twenty-one patients aged 25-69 years who underwent lumbar microdiscectomy were randomised to either the manipulative rehabilitation treatment group or the active control group. Rehabilitation was initiated 2-3 weeks after surgery, twice a week for 4 weeks. Each session was for 30 minutes. Primary outcomes were the Roland-Morris disability questionnaire and the visual analogue pain scale. Outcome measures were assessed at baseline and post-intervention. Early post-operative physical disability was improved with a 55% reduction by early individualised manipulative rehabilitation, compared to that of control care with a 5% increase. Early post-operative residual leg pain decreased with rehabilitation (55%) and control care (9%). This pilot study supports the feasibility of a future definitive randomised control trial and indicates this type of rehabilitation may be an important option for post-operative management after spinal surgery.

  6. Laboratory, semi-pilot and room scale study of nitrite and molybdate mediated control of H(2)S emission from swine manure.

    Science.gov (United States)

    Moreno, Lyman; Predicala, Bernardo; Nemati, Mehdi

    2010-04-01

    The effects of manure age on emission of H(2)S and required level of nitrite or molybdate to control these emissions were investigated in the present work. Molybdate mediated control of H(2)S emission was also studied in semi-pilot scale open systems, and in specifically designed chambers which simulated swine production rooms. With fresh 1-, 3- and 6-month old manures average H(2)S concentration in the headspace gas of the closed systems were 4856+/-460, 3431+/-208, 1037+/-98 ppm and non-detectable, respectively. Moreover, the level of nitrite or molybdate required to control the emission of H(2)S decreased as manure age increased. In the semi-pilot scale open system and chambers, average H(2)S concentration at the surface of agitated fresh manure were 831+/-26 and 88.4+/-5.7 ppm, respectively. Furthermore, 0.1-0.25 mM molybdate was sufficient to control the emission of H(2)S. A cost study for an average size swine operation showed that the cost of treatment with molybdate was less than 1% of the overall production cost for each market hog.

  7. Pilot study to visualise and measure skin tissue oxygenation, erythema, total haemoglobin and melanin content using index maps in healthy controls

    Science.gov (United States)

    Poxon, Ian; Wilkinson, Jack; Herrick, Ariane; Dickinson, Mark; Murray, Andrea

    2014-02-01

    We report on a method for analysing multispectral images of skin in vivo for the measurement and visualisation of skin characteristics. Four different indices were used to characterise skin tissue oxygenation, erythema, total haemoglobin and melanin content. Index values were calculated pixel-wise and combined to create index maps to visualise skin properties. Quantitative measurement of tissue oxygenation saturation was possible by calibrating the oxygenation index using a commercial, calibrated oximeter. Index maps were tested by arterial occlusion of the index finger with multispectral images taken before, during and after occlusion in a pilot study with 10 healthy controls.

  8. A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Betahistine to Counteract Olanzapine-Associated Weight Gain.

    Science.gov (United States)

    Barak, Nir; Beck, Yaffa; Albeck, Joseph H

    2016-06-01

    Patients with schizophrenia experience higher rates of obesity and related morbidity and mortality than the general population does. Given preclinical studies revealing the role of histamine H1 receptor in human eating behavior, and the potential of olanzapine to block with this system, we hypothesized that histamine H1 receptor agonists may be beneficial in reducing antipsychotic-associated weight gain. In the present study, 36 patients with a diagnosis of schizophrenia or schizoaffective disorder and treated with olanzapine were randomized to betahistine (48 mg/d) or matching placebo for 16 weeks. Study outcomes were change in body weight from baseline and effect on antipsychotic efficacy of olanzapine. The patients in the betahistine group had less weight gain (-1.95 kg) compared with placebo group (5.6 + 5.5 kg vs 6.9 + 5.6 kg, respectively). Positive and Negative Syndrome Scale Questionnaire showed improvement within each group and that subjects treated with betahistine enjoyed an improvement (reduction) by a mean of 35.7 points, higher when compared with placebo subjects who had a reduction of 26.6 points (P = 0.233). An almost equal amount of subjects in both groups experienced adverse effects during the course of this study (87.5% of betahistine vs 85.0% of placebo-treated subjects). Overall, there were no clinically marked differences in safety signals between both groups. A larger study addressing the weaknesses of this pilot study is warranted.

  9. No Association between Mycotoxin Exposure and Autism: A Pilot Case-Control Study in School-Aged Children

    Directory of Open Access Journals (Sweden)

    Jennifer Duringer

    2016-07-01

    Full Text Available Evaluation of environmental risk factors in the development of autism spectrum disorder (ASD is needed for a more complete understanding of disease etiology and best approaches for prevention, diagnosis, and treatment. A pilot experiment in 54 children (n = 25 ASD, n = 29 controls; aged 12.4 ± 3.9 years screened for 87 urinary mycotoxins via liquid chromatography-tandem mass spectrometry to assess current exposure. Zearalenone, zearalenone-4-glucoside, 3-acetyldeoxynivalenol, and altenuene were detected in 9/54 (20% samples, most near the limit of detection. No mycotoxin/group of mycotoxins was associated with ASD-diagnosed children. To identify potential correlates of mycotoxin presence in urine, we further compared the nine subjects where a urinary mycotoxin was confirmed to the remaining 45 participants and found no difference based on the presence or absence of mycotoxin for age (t-test; p = 0.322, gender (Fisher’s exact test; p = 0.456, exposure or not to selective serotonin reuptake inhibitors (Fisher’s exact test; p = 0.367, or to other medications (Fisher’s exact test; p = 1.00. While no positive association was found, more sophisticated sample preparation techniques and instrumentation, coupled with selectivity for a smaller group of mycotoxins, could improve sensitivity and detection. Further, broadening sampling to in utero (mothers and newborn-toddler years would cover additional exposure windows.

  10. Does balneotherapy with low radon concentration in water influence the endocrine system? A controlled non-randomized pilot study.

    Science.gov (United States)

    Nagy, Katalin; Berhés, István; Kovács, Tibor; Kávási, Norbert; Somlai, János; Bender, Tamás

    2009-08-01

    Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders. The present study was conducted to ascertain whether baths of relatively low (80 Bq/l) radon concentration have any influence on the functioning of the endocrine system. In the study, a non-randomized pilot study, 27 patients with degenerative musculoskeletal disorders received 30-min radon baths (of 31-32 degrees C temperature and 80 Bq/l average radon concentration) daily, for 15 days. Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol, using thermal water with negligible radon content (6 Bq/l). Serum thyroid stimulating hormone, prolactin, cortisol, adrenocorticotropic hormone, and dehydroepiandrosterone levels were measured before and after a balneotherapy course of 15 sessions. Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups. It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known, only few data have been published in the literature on its effect on endocrine functions. The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system.

  11. 90% Compliance Pilot Studies Final Report

    Energy Technology Data Exchange (ETDEWEB)

    None

    2013-06-01

    In early 2010, the U.S. Department of Energy (DOE) announced an opportunity for states to participate in energy code compliance evaluation pilot studies. DOE worked with five Regional Energy Efficiency Organizations (REEOs, formerly referred to as Energy Efficiency Partnerships, or EEPs) to fund pilot studies covering nine states. This report details conclusions stated in individual state reports, as well as conclusions drawn by DOE based on their oversight of the pilot studies, and based on discussions held with the REEOs and representatives from the pilot study states and their contractors.

  12. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS prisons project pilot study: protocol for a randomised controlled trial comparing dihydrocodeine and buprenorphine for opiate detoxification

    Directory of Open Access Journals (Sweden)

    Dalton Richard

    2007-01-01

    Full Text Available Abstract Background In the United Kingdom (UK, there is an extensive market for the class 'A' drug heroin. Many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to cease their drug use. The most commonly used detoxification agents in UK prisons are buprenorphine, dihydrocodeine and methadone. However, national guidelines do not state a detoxification drug of choice. Indeed, there is a paucity of research evaluating the most effective treatment for opiate detoxification in prisons. This study seeks to address the paucity by evaluating routinely used interventions amongst drug using prisoners within UK prisons. Methods/Design The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS Prisons Pilot Study will use randomised controlled trial methodology to compare the open use of buprenorphine and dihydrocodeine for opiate detoxification, given in the context of routine care, within HMP Leeds. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome measure will be abstinence status at five days post detoxification, as determined by a urine test. Secondary outcomes during the detoxification and then at one, three and six months post detoxification will be recorded.

  13. Auricular Point Acupressure to Manage Chronic Low Back Pain in Older Adults: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Chao Hsing Yeh

    2014-01-01

    Full Text Available This prospective, randomized clinical trial (RCT pilot study was designed to (1 assess the feasibility and tolerability of an easily administered, auricular point acupressure (APA intervention and (2 provide an initial assessment of effect size as compared to a sham treatment. Thirty-seven subjects were randomized to receive either the real or sham APA treatment. All participants were treated once a week for 4 weeks. Self-report measures were obtained at baseline, weekly during treatment, at end-of-intervention (EOI, and at a 1-month follow-up. A dropout rate of 26% in the real APA group and 50% in the sham group was observed. The reduction in worst pain from baseline to EOI was 41% for the real and 5% for the sham group with a Cohen’s effect size of 1.22 P<0.00. Disability scores on the Roland Morris Disability Questionnaire (RMDQ decreased in the real group by 29% and were unchanged in the sham group (+3% P<0.00. Given the high dropout rate, results must be interpreted with caution; nevertheless, our results suggest that APA may provide an inexpensive and effective complementary approach for the management of back pain in older adults, and further study is warranted.

  14. Classroom acoustics: Three pilot studies

    Science.gov (United States)

    Smaldino, Joseph J.

    2005-04-01

    This paper summarizes three related pilot projects designed to focus on the possible effects of classroom acoustics on fine auditory discrimination as it relates to language acquisition, especially English as a second language. The first study investigated the influence of improving the signal-to-noise ratio on the differentiation of English phonemes. The results showed better differentiation with better signal-to-noise ratio. The second studied speech perception in noise by young adults for whom English was a second language. The outcome indicated that the second language learners required a better signal-to-noise ratio to perform equally to the native language participants. The last study surveyed the acoustic conditions of preschool and day care classrooms, wherein first and second language learning occurs. The survey suggested an unfavorable acoustic environment for language learning.

  15. Temperatura do ar exalado, um novo biomarcador no controle da asma: um estudo piloto Exhaled breath temperature, a new biomarker in asthma control: a pilot study

    Directory of Open Access Journals (Sweden)

    Raul Emrich Melo

    2010-12-01

    Full Text Available OBJETIVO: Avaliar se a temperatura do ar exalado (TAE, medida por um método não invasivo, é efetiva no monitoramento de pacientes com asma não controlada. MÉTODOS: Estudo piloto com nove pacientes (sete mulheres e dois homens; média de idade: 39 anos com diagnóstico de asma por pelo menos um ano e sem uso de tratamento de manutenção por pelo menos três meses antes do início do estudo. Na primeira visita, os pacientes foram submetidos à espirometria e à medida da TAE. Todos os pacientes foram orientados a iniciar tratamento com budesonida/formoterol (200/6 µg inalatório a cada 12 h por seis semanas. Além disso, os pacientes com asma grave (VEF1 OBJECTIVE: To evaluate whether the exhaled breath temperature (EBT, measured by a noninvasive method, is an effective means of monitoring patients with uncontrolled asthma. METHODS: A pilot study comprising nine patients (seven women and two men; mean age: 39 years diagnosed with asthma at least one year prior to the beginning of the study and not having been under maintenance therapy for the last three months. In the first visit, the patients underwent spirometry and measurement of EBT. The patients were then instructed to use inhaled budesonide/formoterol (200/6 µg every 12 h for six weeks. In addition, the patients with severe asthma (FEV1 < 60% of predicted were instructed to use oral prednisolone (40 mg/day for five days. After six weeks, the patients underwent the same tests. RESULTS: All of the patients reported an improvement in the symptoms of asthma, as confirmed by a statistically significant increase in FEV1 from the first to the second visit (mean, 56.1% vs. 88.7% of predicted; p < 0.05. Five patients used oral prednisolone for the first five days of the treatment period. Six patients used additional doses of inhaled budesonide/formoterol (mean duration, 2.5 weeks. The EBT decreased significantly from the first to the second visit (mean EBT: 35.1ºC vs. 34.1ºC; p < 0

  16. Practicing evidence based medicine at the bedside: a randomized controlled pilot study in undergraduate medical students assessing the practicality of tablets, smartphones, and computers in clinical life.

    Science.gov (United States)

    Friederichs, Hendrik; Marschall, Bernhard; Weissenstein, Anne

    2014-12-05

    Practicing evidence-based medicine is an important aspect of providing good medical care. Accessing external information through literature searches on computer-based systems can effectively achieve integration in clinical care. We conducted a pilot study using smartphones, tablets, and stationary computers as search devices at the bedside. The objective was to determine possible differences between the various devices and assess students' internet use habits. In a randomized controlled pilot study, 120 students were divided in three groups. One control group solved clinical problems on a computer and two intervention groups used mobile devices at the bedside. In a questionnaire, students were asked to report their internet use habits as well as their satisfaction with their respective search tool using a 5-point Likert scale. Of 120 surveys, 94 (78.3%) complete data sets were analyzed. The mobility of the tablet (3.90) and the smartphone (4.39) was seen as a significant advantage over the computer (2.38, p computer (3.22) was rated superior to both tablet computers (2.13) and smartphones (1.68). No significant differences were detected between tablets and smartphones except satisfaction with screen size (tablet 4.10, smartphone 2.00, p computers. However, mobility is regarded as a substantial advantage, and therefore future applications might facilitate quick and simple searches at the bedside.

  17. Effectiveness of an innovative hip energy storage walking orthosis for improving paraplegic walking: A pilot randomized controlled study.

    Science.gov (United States)

    Yang, Mingliang; Li, Jianjun; Guan, Xinyu; Gao, Lianjun; Gao, Feng; Du, Liangjie; Zhao, Hongmei; Yang, Degang; Yu, Yan; Wang, Qimin; Wang, Rencheng; Ji, Linhong

    2017-09-01

    The high energy cost of paraplegic walking using a reciprocating gait orthosis (RGO) is attributed to limited hip motion and excessive upper limb loading for support. To address the limitation, we designed the hip energy storage walking orthosis (HESWO) which uses a spring assembly on the pelvic shell to store energy from the movements of the healthy upper limbs and flexion-extension of the lumbar spine and hip and returns this energy to lift the pelvis and lower limb to assist with the swing and stance components of a stride. Our aim was to evaluate gait and energy cost indices for the HESWO compared to the RGO in patients with paraplegia. The cross-over design was used in the pilot study. Twelve patients with a complete T4-L5 chronic spinal cord injury underwent gait training using the HESWO and RGO. Gait performance (continuous walking distance, as well as the maximum and comfortable walking speeds) and energy expenditure (at a walking speed of 3.3m/min on a treadmill) were measured at the end of the 4-week training session. Compared to the RGO, the HESWO increased continuous walking distance by 24.7% (Penergy expenditure by 13.9% (P<0.05). Our preliminary results provide support for the use of the HESWO as an alternative support for paraplegic walking. Copyright © 2017. Published by Elsevier B.V.

  18. A pilot study testing a natural and a synthetic Molluscicide for controlling invasive apple snails (Pomacea maculata)

    Science.gov (United States)

    Olivier, Heather M.; Jenkins, Jill A.; Berhow, Mark; Carter, Jacoby

    2016-01-01

    Pomacea maculata (formerly P. insularum), an apple snail native to South America, was discovered in Louisiana in 2008. These snails strip vegetation, reproduce at tremendous rates, and have reduced rice production and caused ecosystem changes in Asia. In this pilot study snails were exposed to two molluscicides, a tea (Camellia sinensis) seed derivative (TSD) or niclosamide monohydrate (Pestanal®, 2′,5-dichloro-4′-nitrosalicylanilide, CAS #73360-56-2). Mortality was recorded after exposure to high or low concentrations (0.03 and 0.015 g/L for TSD, 1.3 and 0.13 mg/L for niclosamide). The TSD induced 100 % mortality at both concentrations. Niclosamide caused 100 % and 17 % mortality at high and low concentrations respectively. These molluscicides were also tested on potential biocontrol agents, the red swamp crayfish (Procambarus clarkii) and redear sunfish (Lepomis microlophus). No crayfish mortalities occurred at either concentration for either chemical, but sunfish experienced 100 % mortality with TSD (0.03 g/L), and 21 % mortality with niclosamide (0.13 mg/L).

  19. The effect of Ramadan intermittent fasting on lipid peroxidation in healthy young men while controlling for diet and sleep: A pilot study

    Directory of Open Access Journals (Sweden)

    Ahmed S BaHammam

    2016-01-01

    Conclusion: In this pilot study, under conditions of fixed sleep-wake schedules and caloric intake, Ramadan IF does not alter serum MDA levels in healthy subjects. Larger studies are needed to confirm these findings.

  20. Improving discharge care: the potential of a new organisational intervention to improve discharge after hospitalisation for acute stroke, a controlled before-after pilot study.

    Science.gov (United States)

    Cadilhac, Dominique A; Andrew, Nadine E; Stroil Salama, Enna; Hill, Kelvin; Middleton, Sandy; Horton, Eleanor; Meade, Ian; Kuhle, Sarah; Nelson, Mark R; Grimley, Rohan

    2017-08-04

    Provision of a discharge care plan and prevention therapies is often suboptimal. Our objective was to design and pilot test an interdisciplinary, organisational intervention to improve discharge care using stroke as the case study using a mixed-methods, controlled before-after observational study design. Acute care public hospitals in Queensland, Australia (n=15). The 15 hospitals were ranked against a benchmark based on a composite outcome of three discharge care processes. Clinicians from a 'top-ranked' hospital participated in a focus group to elicit their success factors. Two pilot hospitals then participated in the organisational intervention that was designed with experts and consumers. Hospital clinicians involved in discharge care for stroke and patients admitted with acute stroke or transient ischaemic attack. A four-stage, multifaceted organisational intervention that included data reviews, education and facilitated action planning. Three discharge processes collected in Queensland hospitals within the Australian Stroke Clinical Registry were used to select study hospitals: (1) discharge care plan; (2) antihypertensive medication prescription and (3) antiplatelet medication prescription (ischaemic events only). Primary measure: composite outcome. Secondary measures: individual adherence changes for each discharge process; sensitivity analyses. The performance outcomes were compared 3 months before the intervention (preintervention), 3 months postintervention and at 12 months (sustainability). Data from 1289 episodes of care from the two pilot hospitals were analysed. Improvements from preintervention adherence were: antiplatelet therapy (88%vs96%, p=0.02); antihypertensive prescription (61%vs79%, porganisational intervention. The intervention warrants further application and trialling on a larger scale. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is

  1. Helicopter pilot back pain: a preliminary study.

    Science.gov (United States)

    Shanahan, D F; Reading, T E

    1984-02-01

    Because of the high prevalence of back pain experienced by U.S. Army helicopter pilots, a study was conducted to ascertain the feasibility of reproducing these symptoms in the laboratory. A mock-up of a UH-1H seat and control configuration was mounted to a multi-axis vibration simulator (MAVS). Eleven subjects were tested on the apparatus for two 120-min periods. During one period, the MAVS was programmed to reproduce vibrations recorded from a UH-1H in cruise flight. The subjects received no vibration during the other test period. All subjects reported back pain which they described as identical to the pain they experience during flight, during one or more of their test periods. There was no statistical difference between the vibration and nonvibration test conditions (p greater than 0.05) in terms of time of onset of pain or intensity of pain as measured by a visual analog scale. It appears the vibration at the frequencies and amplitudes tested plays little or no role in the etiology of the back symptoms reported by these pilots. It is proposed that the primary etiological factor for these symptoms is the poor posture pilots are obliged to assume for extended periods while operating helicopters.

  2. A Pilot Study Evaluating the Effectiveness of Platelet-Rich Plasma Therapy for Treating Degenerative Tendinopathies: A Randomized Control Trial with Synchronous Observational Cohort.

    Directory of Open Access Journals (Sweden)

    Marni Wesner

    Full Text Available This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP injection for tendinopathy.Randomized control trial (RCT and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group.The Glen Sather Sport Medicine Clinic, Edmonton, Canada.The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies.Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4 ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program.Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection.For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS, disability (>15 point DASH change, and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed.This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology.Controlled-Trials.com ISRCTN68341698.

  3. Mediation and Moderation Effects of an In-Home Family Intervention : the "In control: No alcohol!" Pilot Study

    NARCIS (Netherlands)

    Vermeulen-Smit, Evelien; Mares, Suzanne H. W.; Verdurmen, Jacqueline E. E.; van der Vorst, Haske; Schulten, Ingrid G. H.; Engels, Rutger C. M. E.; Vollebergh, Wilma A. M.

    2014-01-01

    The aim of this study was to examine the effect of a theory-based in-home family intervention (In control: No alcohol!) on adolescent alcohol cognitions via its putative mediators using a randomized controlled design. In the South Holland region of the Netherlands, a total of 213 children (11-12 yea

  4. Contact Heat Evoked Potentials (CHEPs) in Patients with Mild-Moderate Alzheimer's Disease and Matched Control-A Pilot Study

    DEFF Research Database (Denmark)

    Jensen-Dahm, Christina; Madsen, Caspar Skau; Waldemar, Gunhild

    2016-01-01

    OBJECTIVE: Clinical studies have found that patients with Alzheimer's disease report pain of less intensity and with a lower affective response, which has been thought to be due to altered pain processing. The authors wished to examine the cerebral processing of non-painful and painful stimuli...... using somatosensory evoked potentials and contact heat evoked potentials in patients with Alzheimer's disease and in healthy elderly controls. DESIGN: Case-control study SETTING AND SUBJECTS: Twenty outpatients with mild-moderate Alzheimer's disease and in 17 age- and gender-matched healthy controls...

  5. A pilot study for determining the optimal operation condition for simultaneously controlling the emissions of PCDD/Fs and PAHs from the iron ore sintering process.

    Science.gov (United States)

    Chen, Yu-Cheng; Tsai, Perng-Jy; Mou, Jin-Luh; Kuo, Yu-Chieh; Wang, Shih-Min; Young, Li-Hao; Wang, Ya-Fen

    2012-09-01

    In this study, the cost-benefit analysis technique was developed and incorporated into the Taguchi experimental design to determine the optimal operation combination for the purpose of providing a technique solution for controlling both emissions of PCDD/Fs and PAHs, and increasing both the sinter productivity (SP) and sinter strength (SS) simultaneously. Four operating parameters, including the water content, suction pressure, bed height, and type of hearth layer, were selected and all experimental campaigns were conducted on a pilot-scale sinter pot to simulate various sintering operating conditions of a real-scale sinter plant. The resultant optimal combination could reduce the total carcinogenic emissions arising from both emissions of PCDD/Fs and PAHs by 49.8%, and increase the sinter benefit associated with the increase in both SP and SS by 10.1%, as in comparison with the operation condition currently used in the real plant. The ANOVA results indicate that the suction pressure was the most dominant parameter in determining the optimal operation combination. The above result was theoretically plausible since the higher suction pressure provided more oxygen contents leading to the decrease in both PCDD/F and PAH emissions. But it should be noted that the results obtained from the present study were based on pilot scale experiments, conducting confirmation tests in a real scale plant are still necessary in the future. Copyright © 2012 Elsevier Ltd. All rights reserved.

  6. Liverpool Telecare Pilot: case studies

    Directory of Open Access Journals (Sweden)

    Nigel Barnes

    2006-09-01

    Full Text Available Telecare services use information and communications technology (ICT to support the provision of care to people in their own homes. This paper describes a pilot telecare service employed by Liverpool (UK City Council to support a sample of their frail and elderly social services users. The pilot has been running for over two years and has been deployed for 21 individuals in Liverpool. In this paper we present the pilot system and provide real example cases which help to illustrate the benefits of such a system.

  7. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization.

    Science.gov (United States)

    Thuesen, L L; Loft, A; Egeberg, A N; Smitz, J; Petersen, J H; Andersen, A Nyboe

    2012-10-01

    Is it possible to define an optimal dose of hCG in combination with rFSH from the first day of stimulation in the GnRH agonist protocol applied to IVF? Supplementation with hCG from the first day of stimulation may increase the number of top-quality embryos per patient. Daily doses of hCG up to 150 IU are compatible with good live birth rates. A ceiling level of estradiol (E(2)) was reached with hCG doses above 100 IU/day. A positive dose-response was seen for pre-ovulatory progesterone, but concentrations remained below values for which an impairment of endometrial receptivity has been previously reported. We suggest a large clinical trial to be proceeded with a group given 100 IU hCG daily versus a control group. Prospective multicentre studies have indicated increased live birth rates and increased number of top-quality embryos when low doses of hCG were associated with FSH. We analysed the clinical, embryological and endocrine aspects of adding increasing doses of hCG to rFSH from the first day of stimulation for IVF. A prospective randomized, controlled, open-label dose-response pilot study was conducted between February 2009 and June 2010 at Copenhagen University Hospital, Rigshospitalet, Denmark. Adequate allocation concealment was assured from sequentially numbered, opaque, sealed envelopes prepared from a computer-generated list. Scoring of the embryos was done in an assessor-blinded way. Endocrinologically normal IVF patients aged 25-37 years, BMI 18-30 kg/m(2), regular cycles and FSH D100; n= 16) and Dose 150 (D150; n= 15). Two patients in D150 were withdrawn after randomization because of major (10- to 30-fold) hCG dosing errors, leaving 13 patients in this group. Thus, the results are based on the per protocol population. The mean numbers of top-quality embryos per patient were D0: 0.8 ± 1.2, D50: 0.5 ± 0.7, D100: 1.2 ± 1.7 and D150: 1.5 ± 1.7 (P= 0.04). All pregnancies were singleton gestations, and the live birth rates per started cycle were D0

  8. Topical treatment with fresh human milk versus emollient on atopic eczema spots in young children: a small, randomized, split body, controlled, blinded pilot study.

    Science.gov (United States)

    Berents, Teresa Løvold; Rønnevig, Jørgen; Søyland, Elisabeth; Gaustad, Peter; Nylander, Gro; Løland, Beate Fossum

    2015-05-04

    Public health nurses report on effects of fresh human milk as treatment for conjunctivitis, rhinitis and atopic eczema (AE), the latter being highly prevalent in early childhood. Emollients and topical corticosteroids are first line treatment of AE. As many caregivers have steroid phobia, alternative treatment options for mild AE are of interest. The aim of this small pilot study was to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with AE. This was a split body, controlled, randomized and physician blinded pilot study, of children with AE with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient was applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. The severity and area of the eczema spots was evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation. Of nine patients included, six completed the study. Mean age at inclusion was 18.5 months. The spots examined were localized on the arms, legs or cheeks. The spots were similar in severity, but differed in area. In one patient the eczema ceased after inclusion. In four patients both control and intervention areas increased during the intervention. The relative change in eczema area compared to baseline showed less increase in the intervention spots in two patients, whereas the opposite was observed in three. In four children Staphylococcus aureus was found in their eczema once or more. In three of the 28 human milk samples, Staphylococcus aureus, alfa haemolytic streptococci or coagulase negative staphylococci were detected. Staphylococcus aureus was found once both in human milk and in the eczema spots, no clinical signs of infection were however observed. No secondary infection due to milk application was detected. In this small pilot study, no effect was found on eczema

  9. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

    DEFF Research Database (Denmark)

    Qintar, Mohammed; George, Jason J; Panko, Melanie

    2015-01-01

    consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study......) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1. RESULTS: The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD...

  10. Closed-loop control of ankle plantarflexors and dorsiflexors using an inverted pendulum apparatus: A pilot study

    Directory of Open Access Journals (Sweden)

    Same Michael B.

    2013-01-01

    Full Text Available Considerable demand exists for a device to facilitate hands-free, stable stance in individuals with neurological disorders such as spinal cord injury (SCI and stroke. In this regard, applying functional electrical stimulation (FES to muscles of the lower limbs in closed loop has shown promise. In particular, it has been suggested that a PID control strategy could offer functional benefits to stability by mimicking the neurological control strategy employed in able-bodied stance. In this proof of concept study, we tested this assertion by examining the potential of a PID control strategy with gravity compensation to effectively maintain balance during quiet stance by regulating FES-induced contractions of the ankle plantarflexors and dorsiflexors in able-bodied individuals. A novel Inverted Pendulum Standing Apparatus (IPSA was employed to simulate quiet stance whilst minimizing the voluntary control of able-bodied subjects. Quiet and perturbed standing trials were performed in 3 able-bodied subjects. Performance metrics including those pertaining to stability during quiet stance (root mean square difference, perturbation rejection capabilities (settling time, peak deviation, and ability to transition from an offset initial position (settling time, were examined. For all 3 subjects and for all of the metrics examined, our results showed that the proposed closed-loop controlled FES system improved performance in comparison to voluntary control. These results indicate that the PID plus gravity control strategy used in this study offers meaningful benefits over voluntary control in terms of standing stability. Thus, the controller could potentially be applied to the problem of improving or restoring standing ability in some neurologic patient populations.

  11. Continuous Positive Airway Pressure for Motion Management in Stereotactic Body Radiation Therapy to the Lung: A Controlled Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Goldstein, Jeffrey D. [Department of Radiation Oncology, Chaim Sheba Medical Center, Tel Hashomer, Tel Aviv (Israel); Lawrence, Yaacov R. [Department of Radiation Oncology, Chaim Sheba Medical Center, Tel Hashomer, Tel Aviv (Israel); Sackler School of Medicine, Tel Aviv University, Tel Aviv (Israel); Appel, Sarit; Landau, Efrat; Ben-David, Merav A.; Rabin, Tatiana; Benayun, Maoz; Dubinski, Sergey; Weizman, Noam; Alezra, Dror; Gnessin, Hila; Goldstein, Adam M.; Baidun, Khader [Department of Radiation Oncology, Chaim Sheba Medical Center, Tel Hashomer, Tel Aviv (Israel); Segel, Michael J.; Peled, Nir [Department of Pulmonary Medicine, Chaim Sheba Medical Center, Tel Hashomer, Tel Aviv (Israel); Sackler School of Medicine, Tel Aviv University, Tel Aviv (Israel); Symon, Zvi, E-mail: symonz@sheba.health.gov.il [Department of Radiation Oncology, Chaim Sheba Medical Center, Tel Hashomer, Tel Aviv (Israel); Sackler School of Medicine, Tel Aviv University, Tel Aviv (Israel)

    2015-10-01

    Objective: To determine the effect of continuous positive airway pressure (CPAP) on tumor motion, lung volume, and dose to critical organs in patients receiving stereotactic body radiation therapy (SBRT) for lung tumors. Methods and Materials: After institutional review board approval in December 2013, patients with primary or secondary lung tumors referred for SBRT underwent 4-dimensional computed tomographic simulation twice: with free breathing and with CPAP. Tumor excursion was calculated by subtracting the vector of the greatest dimension of the gross tumor volume (GTV) from the internal target volume (ITV). Volumetric and dosimetric determinations were compared with the Wilcoxon signed-rank test. CPAP was used during treatment if judged beneficial. Results: CPAP was tolerated well in 10 of the 11 patients enrolled. Ten patients with 18 lesions were evaluated. The use of CPAP decreased tumor excursion by 0.5 ± 0.8 cm, 0.4 ± 0.7 cm, and 0.6 ± 0.8 cm in the superior–inferior, right–left, and anterior–posterior planes, respectively (P≤.02). Relative to free breathing, the mean ITV reduction was 27% (95% confidence interval [CI] 16%-39%, P<.001). CPAP significantly augmented lung volume, with a mean absolute increase of 915 ± 432 cm{sup 3} and a relative increase of 32% (95% CI 21%-42%, P=.003), contributing to a 22% relative reduction (95% CI 13%-32%, P=.001) in mean lung dose. The use of CPAP was also associated with a relative reduction in mean heart dose by 29% (95% CI 23%-36%, P=.001). Conclusion: In this pilot study, CPAP significantly reduced lung tumor motion compared with free breathing. The smaller ITV, the planning target volume (PTV), and the increase in total lung volume associated with CPAP contributed to a reduction in lung and heart dose. CPAP was well tolerated, reproducible, and simple to implement in the treatment room and should be evaluated further as a novel strategy for motion management in radiation therapy.

  12. On the synthesis of the pilot optimal control model

    Directory of Open Access Journals (Sweden)

    Adrian TOADER

    2011-09-01

    Full Text Available The study continues some work of the authors, this time performing a synthesis of optimal control model of the human pilot in systems with input delay, by removing the Padé or Hess approximations characterizing the pilot structural central nervous block and their introduction as a pure delay block. On the one hand, the method ensures a better accuracy of synthesis and on the other hand is advantageous with respect to general results to date for time delay systems since: a the optimal control law is given explicitly and b the Riccati equations for the gain matrices do not contain any time advanced or delayed arguments. The approach is stimulated by recent works of M. Basin and his collaborators.

  13. Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET Pilot Study.

    Directory of Open Access Journals (Sweden)

    Peter T Choi

    Full Text Available Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada.After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or = 45 years old, had an expected hospital stay > or = 48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5+/-0.3 (mean+/-SEM subjects per week per centre; 112/494 (22.7% eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5% of 49 subjects in the epidural group crossed over to the IV group; seven (14.3% were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8% of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0% of 101 subjects were successfully followed up until 30 days after their surgery.Of the criteria we defined for the feasibility of a full-scale trial, only the

  14. Motor control exercises of the lumbar-pelvic region improve respiratory function in obese men. A pilot study.

    Science.gov (United States)

    Bezzoli, Emanuela; Andreotti, Dianne; Pianta, Lucia; Mascheroni, Martina; Piccinno, Lorena; Puricelli, Luca; Cimolin, Veronica; Salvadori, Alberto; Codecasa, Franco; Capodaglio, Paolo

    2016-11-10

    Obese subjects have decreased pulmonary function. The hypothesis of our study was that poor coordination of the lumbar-pelvic musculature secondary to obesity may hinder the synergic activation of the respiratory muscles. The aim of the paper was to evaluate whether specific motor control exercises of the lumbar-pelvic musculature were able to improve respiratory function. Twenty obese male patients underwent a rehabilitation program including adapted physical activity and respiratory physiotherapy. Patients were randomly assigned to a Specific Motor Control Exercise Group (SG) and a Control Group (CG). SG followed a protocol according to the SMARTERehab concept aimed at improving posture, intra-abdominal pressure, rib cage mobility, and perception of correct muscle activation. CG performed an exercise training protocol to improve aerobic capacity and muscle strength. After intervention, both groups showed similar changes in body weight, fat, and fat-free mass. Respiratory function indexes improved in SG due to improved proprioception and coordination of the deep lumbar-pelvic muscles. Our study provides preliminary evidence that breathing, postural control, and spinal stability are intertwined. Positive respiratory effects in obese men can be obtained by prescribing specific motor control exercises of the lumbar-pelvic muscles. Implications for rehabilitation Obese subjects present with decreased pulmonary function and postural changes. Poor coordination of the lumbar-pelvic muscles affects posture and the synergic activation of the respiratory muscles. Specific motor control exercises of the lumbar-pelvic musculature can improve respiratory function. Breathing and postural control are intertwined: positive respiratory effects can be obtained by enhancing motor control of the lumbar-pelvic muscles.

  15. Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana: A pilot study

    Directory of Open Access Journals (Sweden)

    Justice Afrifa

    2015-01-01

    Full Text Available Background: Sigma metrics provide a uniquely defined scale with which we can assess the performance of a laboratory. The objective of this study was to assess the internal quality control (QC in the clinical chemistry laboratory of the University of Cape Cost Hospital (UCC using the six sigma metrics application. Materials and Methods: We used commercial control serum [normal (L1 and pathological (L2] for validation of quality control. Metabolites (glucose, urea, and creatinine, lipids [triglycerides (TG, total cholesterol, high-density lipoprotein cholesterol (HDL-C], enzymes [alkaline phosphatase (ALP, alanine aminotransferase (AST], electrolytes (sodium, potassium, chloride and total protein were assessed. Between-day imprecision (CVs, inaccuracy (Bias and sigma values were calculated for each control level. Results: Apart from sodium (2.40%, 3.83%, chloride (2.52% and 2.51% for both L1 and L2 respectively, and glucose (4.82%, cholesterol (4.86% for L2, CVs for all other parameters (both L1 and L2 were >5%. Four parameters (HDL-C, urea, creatinine and potassium achieved sigma levels >1 for both controls. Chloride and sodium achieved sigma levels >1 for L1 but 1 for L2. Glucose and ALP achieved a sigma level >1 for both control levels whereas TG achieved a sigma level >2 for both control levels. Conclusion: Unsatisfactory sigma levels (<3 where achieved for all parameters using both control levels, this shows instability and low consistency of results. There is the need for detailed assessment of the analytical procedures and the strengthening of the laboratory control systems in order to achieve effective six sigma levels for the laboratory.

  16. The effects of yoga on shoulder and spinal actions for women with breast cancer-related lymphoedema of the arm: A randomised controlled pilot study.

    Science.gov (United States)

    Loudon, Annette; Barnett, Tony; Piller, Neil; Immink, Maarten A; Visentin, Denis; Williams, Andrew D

    2016-09-02

    We aimed to evaluate the effect of an 8-week yoga intervention on the shoulder and spinal actions of women with breast cancer-related arm lymphoedema. A randomised controlled pilot trial. The intervention group (n = 12) completed eight weeks of daily yoga sessions while the control group (n = 11) continued with best current care including information on compression sleeves, skin care, risks of temperature variations and recommended safe use of affected arm. Lumbo-pelvic posture, range of motion (ROM) in the shoulder and spine, and strength in shoulder and pectoral major and minor, and serratus anterior were taken at baseline, week 8 and after a 4-week follow-up. Outcome assessors were blinded to allocation. At week eight the intervention group had an improvement in lumbo-pelvic posture, as indicated by a reduction in pelvic obliquity compared to the control group (mean difference = -8.39°, 95 % CI: -15.64 to -1.13°, p = 0.023). A secondary finding was that strength in shoulder abduction significantly increased following the yoga intervention in both the affected (9.5 kg; CI: 0.34 to 18.66, p = 0.042) and non-affected arm (11.58 kg; CI: 0.25 to 22.91; p = 0.045). There were no significant between group changes in any ROM measures as a result of the yoga intervention. This pilot study demonstrates that participation in yoga may provide benefits for posture and strength in women with Breast Cancer Related Lymphoedema. The improvements may be attributed to the focus of yoga on overall postural and functional movement patterns. Further trials with longer intervention that follow this methodology are warranted. The Australian New Zealand Clinical Trials Registry ACTRN12611000202965 .

  17. Social Skills Training for Young Adults with High-Functioning Autism Spectrum Disorders: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Gantman, Alexander; Kapp, Steven K.; Orenski, Kaely; Laugeson, Elizabeth A.

    2012-01-01

    Despite the psychosocial difficulties common among young adults with autism spectrum disorders (ASD), little to no evidence-based social skills interventions exist for this population. Using a randomized controlled trial (RCT) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention…

  18. "Effectiveness of continuous vertebral resonant oscillation using the POLD method in the treatment of lumbar disc hernia". A randomized controlled pilot study.

    Science.gov (United States)

    López-Díaz, Juan Vicente; Arias-Buría, José Luis; Lopez-Gordo, Estrella; Lopez Gordo, Sandra; Oyarzún, Alejandra P Aros

    2015-06-01

    This study analyses the efficacy of manual oscillatory therapy, following the POLD technique, for acute Lumbar Disc Hernia (LDH) and compares it to usual treatment. A randomised, controlled, triple-blind pilot clinical trial. The sample of 30 patients was divided into two homogeneous groups to receive usual treatment (A) or treatment with the POLD technique (B). We analysed range of motion and subjective variables such as the severity (visual analogue pain scale (VAS)) and extension of the pain. With the application of POLD therapy, patients presented significant changes on range of motion (forward flexion with p POLD Method was shown to be an effective manual therapy approach for reducing the severity and irradiation of the pain in LDH patients with sciatica, and more efficient than usual treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Structural differences in gray matter between glider pilots and non-pilots. A voxel based morphometry study.

    Directory of Open Access Journals (Sweden)

    Tosif eAhamed

    2014-11-01

    Full Text Available Glider flying is a unique skill that requires pilots to control an aircraft at high speeds in three dimensions and amidst frequent full body rotations. In the present study we investigated the neural correlates of flying a glider using voxel-based morphometry (VBM. The comparison between gray matter densities of 15 glider pilots and a control group of 15 non-pilots exhibited significant gray matter density increases in left ventral premotor cortex, anterior cingulate cortex and the supplementary eye field. We posit that the identified regions might be associated with cognitive and motor processes related to flying such as joystick control, visuo-vestibular interaction and oculomotor control.

  20. Treatment of functional dyspepsia with sertraline:A double-blind randomized placebo-controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    Victoria PY Tan; Tin K Cheung; Wai M Wong; Roberta Pang; Benjamin CY Wong

    2012-01-01

    .83 ± 6.313 vs 27.19 ± 5.929 respectively,P =0.233; however by week 8,patients in the sertraline group demonstrated a statistically significant difference in their Hong Kong Dyspepsia Index compared to placebo,HKDI 20.53 ± 6.917 vs 23.34 ± 7.199,P =0.02,respectively).There was also no statistically significant difference in overall quality of life measures or the HAD scale related to treatment in either the HTT or PP analysis at week 8.CONCLUSION:This pilot study,the first to examine sertraline,a selective serotonin reuptake inhibitor,for the management of FD,did not find that it was superior to placebo.

  1. Intraperitoneal Vancomycin Plus Either Oral Moxifloxacin or Intraperitoneal Ceftazidime for the Treatment of Peritoneal Dialysis-Related Peritonitis: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Xu, Rong; Yang, Zhikai; Qu, Zhen; Wang, Huan; Tian, Xue; Johnson, David W; Dong, Jie

    2017-07-01

    Intraperitoneal administration of antibiotics is recommended as a first treatment for managing peritoneal dialysis (PD)-related peritonitis. However, the efficacy of oral administration of quinolones has not been well studied. Randomized controlled pilot study. 80 eligible patients with PD-related peritonitis from Peking University First Hospital (40 in each arm). Intraperitoneal vancomycin, 1g, every 5 days plus oral moxifloxacin, 400mg, every day (treatment group) versus intraperitoneal vancomycin, 1g, every 5 days plus intraperitoneal ceftazidime, 1g, every day (control group). The primary end point was complete resolution of peritonitis, and secondary end points were primary or secondary treatment failure. PD effluent white blood cell count. Baseline demographic and clinical characteristics of the 2 groups were comparable. There were 24 and 22 Gram-positive organisms, 6 and 7 Gram-negative organisms, 9 and 10 culture-negative samples, and 1 and 1 fungal sample in the treatment and control groups, respectively. Complete resolution of peritonitis was achieved in 78% and 80% of cases in the treatment and control groups, respectively (OR, 0.86; 95% CI, 0.30-2.52; P=0.8). There were 3 and 1 cases of relapse in the treatment and control groups, respectively. Primary and secondary treatment failure rates were not significantly different (33% vs 20% and 10% vs 13%, respectively). In each group, there was 1 peritonitis-related death and 6 transfers to hemodialysis therapy. During the 3-month follow-up period, 7 and 3 successive episodes of peritonitis occurred in the treatment and control groups, respectively. Only 2 adverse drug reactions (mild nausea and mild rash, respectively) were observed in the 2 groups. Sample size was relatively small and the eligibility ratio was low. Also, the number of peritonitis episodes was low, limiting the power to detect a difference between groups. This pilot study suggests that intraperitoneal vancomycin with oral moxifloxacin is a

  2. Pilot Study of a Web-Delivered Multicomponent Intervention for Rural Teens with Poorly Controlled Type 1 Diabetes

    Directory of Open Access Journals (Sweden)

    Amy Hughes Lansing

    2016-01-01

    Full Text Available Objective. The purpose of this study was to examine the feasibility and effectiveness of a web-delivered multicomponent behavioral and family-based intervention targeting self-regulation and self-monitoring of blood glucose levels (SMBG and glycemic control (HbA1c in teens with type 1 diabetes (T1DM living in rural US. Methods. 15 teens with poorly controlled T1DM participated in a 25-week web-delivered intervention with two phases, active treatment (weekly treatment sessions and working memory training program and maintenance treatment (fading of treatment sessions. Results. Almost all (13 of 15 participants completed at least 14 of 15 treatment sessions and at least 20 of 25 working memory training sessions. SMBG was increased significantly at end of active and maintenance treatment, and HbA1c was decreased at end of active treatment (p’s ≤ 0.05. Executive functioning improved at end of maintenance treatment: performance on working memory and inhibitory control tasks significantly improved (p’s ≤ 0.02 and parents reported fewer problems with executive functioning (p=0.05. Improvement in inhibitory control was correlated with increases in SMBG and decreases in HbA1c. Conclusions. An innovative web-delivered and multicomponent intervention was feasible for teens with poorly controlled T1DM and their families living in rural US and associated with significant improvements in SMBG and HbA1c.

  3. The Effects of Mindfulness-Based Cognitive Therapy on Depressive Symptoms in Elderly Bereaved People with Loss-Related Distress: a Controlled Pilot Study

    DEFF Research Database (Denmark)

    O Connor, Maja; Piet, Jacob; Hougaard, Esben

    2014-01-01

    We examined the effects of mindfulness-based cognitive therapy (MBCT) on symptom severity of depression, complicated grief, posttraumatic stress, and working memory in elderly bereaved people with long-term bereavement-related distress. A non-randomized, controlled pilot design was used in a sample...

  4. The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

    Science.gov (United States)

    Grubbs, Vanessa; Garcia, Faviola; Jue, Bonnie L; Vittinghoff, Eric; Ryder, Mark; Lovett, David; Carrillo, Jacqueline; Offenbacher, Steven; Ganz, Peter; Bibbins-Domingo, Kirsten; Powe, Neil R

    2017-02-01

    Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials. Copyright © 2016. Published by Elsevier Inc.

  5. Airborne Contamination Control through Directed Airflow in the Exam Room: A Pilot Study Using a Membrane Diffuser

    Directory of Open Access Journals (Sweden)

    Debajyoti Pati

    2010-01-01

    Full Text Available Airborne infections have been documented as a major source of hospital acquired infection - one of the major concerns in healthcare delivery. An important factor contributing to airborne infection is cross contamination through air particulate dispersion as affected by the ventilation system design. Clean room technology (with membrane ceiling has been successfully used in technology and pharmaceutical industries to control airborne contamination. This study examined the performance of membrane ceiling technology in controlling air particulate dispersion in a mock-up exam room. It included both performance tests in a mock-up room and a simulation study of six different ventilation system designs using Computational Fluid Dynamics (CFD analysis. Findings suggest that a membrane diffuser directed airflow ventilation strategy occupying approximately 20% to 30% of the ceiling surface and placed over the patient in a contemporary sized exam room provides a less turbulent airflow pattern and less mixing of the air between the patient and others in the room.

  6. [Induced sputum supernatant prostaglandin E2 during oral aspirin challenge of asthmatic patients with and without aspirin hypersensitivity and healthy controls--pilot study].

    Science.gov (United States)

    Ignacak, Maria; Celejewska-Wójcik, Natalia; Wójcik, Krzysztof; Sałapa, Kinga; Konduracka, Ewa; Sanak, Marek; Tyrak, Katarzyna; Sładek, Krzysztof; Musiał, Jacek; Mastalerz, Lucyna

    2016-01-01

    The aim of this pilot study was to evaluate changes in the concentration of prostaglandin E2 (PGE2) in induced sputum supernatant in 3 groups: sub- jects with NSAID-exacerbated respira- tory disease (NERD), aspirin tolerant asthma (ATA) and healthy controls (HC), before and after oral aspirin chal- lenge test. The study was conducted in the years 2014-2015 at the Clinical Department of the Pulmonology Clinic at the University Hospital in Cracow. 43 patients were enrolled in the study (NERD - n = 15, ATA - n = 15 and HC - n = 13). All of them underwent a placebo-controlled oral aspirin challenge. Sputum was induced 24 hours before the challenge and immediately after the test. Induced sputum was processed in order to obtain cystospin slides to depict inflammatory cell patterns and supernatants, in which PGE2 was measured. The concentration of PGE2 was determined using mass spectrometry coupled with gas chromatography (gas chromatography/mass spectrometry - GC/MS). After aspirin challenge, the concentration of PGE2 in induced sputum supernatant decreased in both asthmatics hypersensitive to aspirin (p = 0.01) and those who tolerated aspirin well (p = 0.17). The change in the healthy control group was not statistically significant. These results support the cyclooxygenase theory of PGE2 inhibition by aspirin. However, the mechanism of bronchoconstriction after aspirin administration alone in patients with NSAID-exacerbated respiratory disease remains unclear.

  7. Inflammatory markers in gingival crevicular fluid of periodontitis patients with type 2 diabetes mellitus according to glycemic control: A pilot study.

    Science.gov (United States)

    Longo, Priscila Larcher; Artese, Hilana Paula Carilo; Horliana, Anna Carolina Ratto Tempestini; Gomes, Giovane Hisse; Romito, Giuseppe Alexandre; Dib, Sergio Atala; Mayer, Marcia Pinto Alves

    2015-01-01

    Type 2 diabetes mellitus (T2DM) and periodontitis are inflammatory conditions with a bidirectional association. This pilot study aimed to evaluate whether T2DM and glycemic control interfere in inflammatory markers profiles in gingival crevicular fluid (GCF) in periodontitis patients. Fourteen diabetic periodontitis patients were enrolled in this study, seven with adequate glycemic control (glycated hemoglobin [HbA1c] periodontitis patients without diabetes formed the control group (P). GCF was obtained from diseased sites (probing depth >6 mm) of an entirely hemiarch, pooled and cytokines levels determined using multiplex beads immunoassay. Clinical periodontal parameters were analyzed by Mann-Whitney test and levels of cytokines by Kruskal-Wallis and Dunn's multiple comparison tests with confidence level of 95% (P periodontal pockets presented high levels of inflammatory cytokines, and there were no statistical differences between levels of interleukin-6 (IL-6), IL-8 and tumor necrosis factor-α according to presence of diabetes or percentage of HbA1c among the groups, despite groups with T2DM and periodontitis exhibit higher levels of PD. Within the limitations of this study, inflammatory mediators in GCF are dependent to the local response and do not correlate with the diabetic status.

  8. Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Beeken, Rebecca J; Spanos, Dimitrios; Fovargue, Sally; Hunter, Rachael; Omar, Rumana; Hassiotis, Angela; King, Michael; Wardle, Jane; Croker, Helen

    2013-03-12

    National obesity rates have dramatically risen over the last decade. Being obese significantly reduces life expectancy, increases the risk of a range of diseases, and compromises quality of life. Costs to both the National Health Service and society are high. An increased prevalence of obesity in people with learning disabilities has been demonstrated. The consequences of obesity are particularly relevant to people with learning disabilities who are already confronted by health and social inequalities. In order to provide healthcare for all, and ensure equality of treatment for people with learning disabilities, services must be developed specifically with this population in mind. The aim of this project is to pilot the evaluation of a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities (Shape Up-LD). An individually randomised, controlled pilot trial in 60 overweight and obese (body mass index ≥ 25) adults (age ≥ 18) with mild-moderate learning disabilities and their carers will be carried out, comparing "Shape Up-LD" with usual care. The manualised Shape Up-LD intervention will involve 12 weekly sessions, which include healthy eating messages, advice on physical activity and use of behaviour change techniques to help people manage their weight. Assessments of participants will be conducted at baseline, 12 weeks and 6 months. Service users and their carers and service providers will also give their perspectives on the experience of Shape Up-LD in qualitative interviews at 12 weeks. Feasibility outcomes will include recruitment rates, loss to follow-up, compliance rates, completion rates, collection of information for a cost-effectiveness analysis and an estimation of the treatment effect on weight. The findings from this study will inform our preparation for a definitive randomised controlled trial to test the efficacy of the programme with respect to weight loss and maintenance in this population

  9. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    Science.gov (United States)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  10. Nutritional status, glycemic control and its associated risk factors among a sample of type 2 diabetic individuals, a pilot study

    Directory of Open Access Journals (Sweden)

    Somayyeh Firouzi

    2015-01-01

    Full Text Available Background: The prevalence of type 2 diabetes is increasing in Malaysia, with most patients poorly controlled. Hence, this study aimed to determine nutritional and metabolic status as well as blood pressure of Malaysian patients with type 2 diabetes mellitus and identify associated risk factors for poor glycemic control. Materials and Methods: A total of 104 type 2 diabetic patients were recruited and completed a questionnaire covering socio-demographic status, 3-day diet records, and physical activity. Anthropometry and glycemic control parameters, lipid profile and blood pressure were also measured. Results: Subjects were on average 56.7±9.9 years old with a mean duration of diabetes of 6.5 ± 5.0 years. The mean hemoglobin A1c of the subjects was 7.6% ± 1.4%, with only 20.2% achieving the target goal of <6.5% with no significant differences between genders. The mean body mass index was 26.9 ± 4.7 kg/m 2 , with 86.5% either were overweight or obese. Only 10.6% of the subjects exercised daily. The proportions of macronutrients relative to total energy intake were consistent with the recommendations of most diabetes associations. The adjusted odds of having poor glycemic control were 3.235 (1.043-10.397 (P < 0.05 higher among those who had high density lipoprotein cholesterol levels below the normal range. Those taking one or two types of oral anti-diabetic drugs had 19.9 (2.959-87.391 (P < 0.01 and 14.3 (2.647-77.500 (P < 0.01 higher odds of poor glycemic control respectively compared to those who were being treated by diet alone. Conclusion: Poor glycemic control was prevalent among Malaysian diabetic patients, and this could be associated with low levels of HDL and being treated with oral anti-diabetes agents.

  11. Effect of honey on 50% complement hemolytic activity in infants with protein energy malnutrition: a randomized controlled pilot study.

    Science.gov (United States)

    Abdulrhman, Mamdouh Abdulmaksoud; Nassar, May Fouad; Mostafa, Hisham Waheed; El-Khayat, Zakaria Abdulhalim; Abu El Naga, Marwa Wageh

    2011-05-01

    Protein energy malnutrition (PEM) is associated with a significant impairment of cell-mediated immunity and complement system, which may be responsible for the high incidence of infections among these patients. This study was designed to examine the effect of honey, as a natural substance, on the 50% complement hemolytic activity (CH50) in patients with PEM. Thirty patients with PEM and 20 healthy infants serving as controls participated in this study. The patients were randomized to receive either honey (group 1) or placebo (group 2), in addition to conventional nutritional rehabilitation therapy. Measurements of weight, midarm circumference, skin fold thickness, serum albumin, and CH50 were done for all patients before and after 2 weeks of rehabilitation. Before nutritional rehabilitation, the CH50 was significantly lower in the PEM groups compared with the control. However, after rehabilitation, the CH50 increased significantly in both PEM groups, compared with the pre-interventional state and with the controls. Moreover, the rise of CH50 was significantly more in the honey group compared with the placebo. On the other hand, the improvement in the anthropometric measures and serum albumin did not differ significantly between the honey and placebo groups after rehabilitation. Thus honey supplementation in patients with PEM increased the level of CH50. Whether this would have an effect on the frequency and severity of infections in patients with PEM needs further studies.

  12. Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Mayfield, Karla; Siskind, Dan; Winckel, Karl; Hollingworth, Samantha; Kisely, Steve; Russell, Anthony W

    2015-06-01

    Clozapine causes significant metabolic disturbances including obesity and type 2 diabetes. Recent evidence that reduced glucagon-like-peptide-1 (GLP-1) may contribute to aetiology of clozapine-associated metabolic dysregulation suggests a potential therapeutic role for GLP-1 agonists. This open-label, pilot randomised controlled trial evaluates the effect of exenatide in clozapine-treated obese adults who have schizophrenia, with or without poorly controlled diabetes. Sixty out-patients will be randomised to once weekly extended release exenatide or treatment as usual for 24 weeks. To evaluate the feasibility of larger studies regarding methodology, acceptability, tolerability and estimate efficacy for glycaemic control or weight loss. Secondary outcomes are psychosis severity and metabolic parameters. This is the first trial investigating GLP-1 agonists for glycaemic control and weight loss in clozapine-treated patients with either diabetes or obesity. Clozapine-associated obesity and diabetes with exenatide (CODEX) will provide proof-of-concept empirical evidence addressing whether this novel treatment is practical and worthy of further investigation. A.W.R. has received speaker honoraria and travel grants from AstraZeneca, BoehringerIngelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and has participated on advisory panels for MSD and Novo Nordisk. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  13. Mediation and moderation effects of an in-home family intervention: the "in control: no alcohol!" pilot study.

    Science.gov (United States)

    Vermeulen-Smit, Evelien; Mares, Suzanne H W; Verdurmen, Jacqueline E E; Van der Vorst, Haske; Schulten, Ingrid G H; Engels, Rutger C M E; Vollebergh, Wilma A M

    2014-10-01

    The aim of this study was to examine the effect of a theory-based in-home family intervention (In control: No alcohol!) on adolescent alcohol cognitions via its putative mediators using a randomized controlled design. In the South Holland region of the Netherlands, a total of 213 children (11-12 years) and their mothers were randomly assigned to the prevention program (108 dyads) and the control condition (105 dyads). Mediation effects were analyzed using pretest and two follow-up measurements (5 and 12 months after baseline). A path model was estimated (using Mplus) to examine the effect of the intervention on the putative mediators (frequency- and quality of mother-child communication, rules about alcohol, establishing a nondrinking agreement, and parental monitoring of the child's whereabouts). Outcomes were adolescents' perceived harmfulness of drinking and intention to drink. Multigroup analyses were performed to examine potential differences across gender. The program led to an increase in frequency of alcohol-specific communication, nondrinking agreements, and parental monitoring. Moreover, adolescents in the experimental condition perceived drinking to be more harmful and had less intention to drink compared to adolescents in the control condition. The effect of the program on adolescent alcohol cognitions was significantly mediated through having more frequent conversations about alcohol, yet only among boys. Although results on actual drinking need to be added, findings indicate that this relatively inexpensive, easy-to-administer home intervention is promising.

  14. Ballet and stress. A pilot study.

    Science.gov (United States)

    Tomei, G; Casale, T; Rosati, M V; Melcarne, R; Sinibaldi, F; Capozzella, A; Di Giorgio, V; Giubilati, R; Sacco, C; Tomei, F; Sancini, A

    2015-01-01

    Work-related stress is a complex problem requiring a work environment-based assessment. Artists like dancers represent a category of atypical workers potentially at high risk for work-related stress. Aim of our pilot study is to evaluate organizational stress in a population of professional dancers, using the HSE Indicator Tool for Work Related Stress. We administered the Italian version of the HSE Indicator Tool to 38 ballet dancers, males and females. The questionnaire evaluates 7 key organizational dimensions: demand, control, managers' support, peer support, relationships, role and change. The standards required-ideal conditions are achieved in none of the above-mentioned dimensions. Change is the only dimension for which results fall between the 20th and the 50th percentile, while for other dimensions results fall below the 20th percentile suggesting the need for immediate corrective action. In male dancers an acceptable situation is highlighted for the dimension "change" compared to female dancers. In both sexes there is a high frequency of subjects complaining of verbal abuse, bullying and harassment. Despite the small sample size, our pilot study highlights the presence of heightened levels of organizational stress. Preventive measures targeted towards improving communication between managers and dancers and aimed at team building should be implemented.

  15. BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

    Directory of Open Access Journals (Sweden)

    Singh Betsy B

    2009-06-01

    Full Text Available Abstract Background Delayed onset muscle soreness (DOMS is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein and muscle damage (creatine phosphokinase and myoglobin. Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

  16. BIMOMASS GASIFICATION PILOT PLANT STUDY

    Science.gov (United States)

    The report gives results of a gasification pilot program using two biomass feedstocks: bagasse pellets and wood chips. he object of the program was to determine the properties of biomass product gas and its suitability as a fuel for gas-turbine-based power generation cycles. he f...

  17. EFFECT OF NEBULIZED COLISTIN ON THE VENTILATOR CIRCUIT: A PROSPECTIVE PILOT CASE-CONTROL STUDY FROM A SINGLE CANCER CENTER

    Directory of Open Access Journals (Sweden)

    Iyad M Ghonimat

    2015-04-01

    Full Text Available Nebulized colistin (NC is used for the treatment of pneumonia due to multidrug-resistant Gram-negative bacteria. In this one-year case-control study, our objective was to evaluate the effect of NC on the ventilator circuit (VC components. The case group consisted of 25 mechanically-ventilated patients who received NC, while the control group was 25 mechanically-ventilated patients who did not receive NC. Respiratory therapists inspected the VC every 4 hrs and whenever a ventilator alarm was reported. The VC component was changed if the alarm did not subside after necessary measures were performed. Patients from both groups were treated at the adult ICU in King Hussein Cancer Center (KHCC. In the case group, 22(88% patients required changing at least one of the circuit components (flow sensor, exhalation membrane, or nebulizer kit. The median number of changes (range per patient of the flow sensor, exhalation membrane, and nebulizer kit were: 2(1-3, 2(1-6, and 1(1-2, respectively. Large amounts of white crystals, which resembled the colistin powder, were reported on the replaced VC components. The flow sensor was changed in 2 control patients, but white crystals were absent. Crystals obtained from one case subject were confirmed to be colistin by chromatographic mass spectroscopy. Further studies are needed to evaluate the effect of crystal formation on the efficacy of NC and clinical outcomes.

  18. Effectiveness of polaprezinc for low-dose aspirin-induced small-bowel mucosal injuries as evaluated by capsule endoscopy: a pilot randomized controlled study.

    Science.gov (United States)

    Watari, Ikue; Oka, Shiro; Tanaka, Shinji; Aoyama, Taiki; Imagawa, Hiroki; Shishido, Takayoshi; Yoshida, Shigeto; Chayama, Kazuaki

    2013-07-04

    Treatment of low-dose aspirin (LDA)-induced small-bowel injury has not been established. Polaprezinc, a chelate of zinc and L-carnosine, may be efficacious for such injury. We conducted a pilot randomized controlled study to investigate whether polaprezinc is effective against LDA-induced small-bowel injuries. Consecutive patients under long-term (>3 months) LDA treatment and who agreed to participate in our study underwent initial capsule endoscopy (CE). Patients with LDA-induced small-bowel injury apparent upon initial CE (n = 20) were randomized into a polaprezinc (150 mg/day for 4 weeks) group and a control (no polaprezinc treatment) group. All underwent follow-up CE after 4 weeks. Changes in the number and characteristics of small-bowel mucosal injuries were compared within and between the two groups. The median number of reddened lesions and erosions/ulcers upon follow-up CE in the polaprezinc group significantly decreased (P < 0.05). However, there was no significant difference in the median number of reddened lesions and erosions/ulcers upon follow-up CE in the control group. Co-administration of polaprezinc may be effective against small-bowel mucosal injury associated with long-term LDA therapy.

  19. Comparison of Efficacy and Safety of Ciclosporin to Prednisolone in the Treatment of Erythema Nodosum Leprosum: Two Randomised, Double Blind, Controlled Pilot Studies in Ethiopia.

    Directory of Open Access Journals (Sweden)

    Saba M Lambert

    2016-02-01

    Full Text Available Erythema Nodosum Leprosum (ENL is a serious complication of leprosy. It is normally treated with high dose steroids, but its recurrent nature leads to prolonged steroid usage and associated side effects. There is little evidence on the efficacy of alternative treatments for ENL, especially for patients who have become steroid resistant or have steroid side effects. These two pilot studies compare the efficacy and side effect profile of ciclosporin plus prednisolone against prednisolone alone in the treatment of patients with either new ENL or chronic and recurrent ENL.Thirteen patients with new ENL and twenty patients with chronic ENL were recruited into two double-blinded randomised controlled trials. Patients were randomised to receive ciclosporin and prednisolone or prednisolone treatment only. Patients with acute ENL had a delay of 16 weeks in the occurrence of ENL flare-up episode, with less severe flare-ups and decreased requirements for additional prednisolone. Patients with chronic ENL on ciclosporin had the first episode of ENL flare-up 4 weeks earlier than those on prednisolone, as well as more severe ENL flare-ups requiring 2.5 times more additional prednisolone. Adverse events attributable to prednisolone were more common that those attributable to ciclosporin.This is the first clinical trial on ENL management set in the African context, and also the first trial in leprosy to use patients' assessment of outcomes. Patients on ciclosporin showed promising results in the management of acute ENL in this small pilot study. But ciclosporin, did not appear to have a significant steroid-sparing effects in patients with chronic ENL, which may have been due to the prolonged use of steroids in these patients in combination with a too rapid decrease of steroids in patients given ciclosporin. Further research is needed to determine whether the promising results of ciclosporin in acute ENL can be reproduced on a larger scale.

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

    Science.gov (United States)

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

    2012-01-01

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

  1. Location Independent Professional Project: A Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Hudson, J.A.; Long, J.P.; Miller, M.M.

    1999-02-01

    This pilot study project explored the problem of providing access to the nomadic worker who desires to connect a computer through network access points at a number of different locations within the SNL/NM campus as well as outside the campus. The design and prototype development gathered knowledge that may allow a design to be developed that could be extended to a larger number of SNL/NM network drop boxes. The focus was to provide a capability for a worker to access the SNL IRN from a network drop box (e.g. in a conference room) as easily as when accessing the computer network from the office normally used by the worker. Additional study was done on new methods to authenticate the off campus worker, and protect and control access to data.

  2. Inflammatory markers in gingival crevicular fluid of periodontitis patients with type 2 diabetes mellitus according to glycemic control: A pilot study

    Directory of Open Access Journals (Sweden)

    Priscila Larcher Longo

    2015-01-01

    Full Text Available Background: Type 2 diabetes mellitus (T2DM and periodontitis are inflammatory conditions with a bidirectional association. This pilot study aimed to evaluate whether T2DM and glycemic control interfere in inflammatory markers profiles in gingival crevicular fluid (GCF in periodontitis patients. Materials and Methods: Fourteen diabetic periodontitis patients were enrolled in this study, seven with adequate glycemic control (glycated hemoglobin [HbA1c] 6 mm of an entirely hemiarch, pooled and cytokines levels determined using multiplex beads immunoassay. Clinical periodontal parameters were analyzed by Mann-Whitney test and levels of cytokines by Kruskal-Wallis and Dunn′s multiple comparison tests with confidence level of 95% (P < 0.05. Results: Cytokines profile of GCF obtained from deep periodontal pockets presented high levels of inflammatory cytokines, and there were no statistical differences between levels of interleukin-6 (IL-6, IL-8 and tumor necrosis factor-α according to presence of diabetes or percentage of HbA1c among the groups, despite groups with T2DM and periodontitis exhibit higher levels of PD. Conclusion: Within the limitations of this study, inflammatory mediators in GCF are dependent to the local response and do not correlate with the diabetic status.

  3. A Lead ANRIL Polymorphism Is Associated with Elevated CRP Levels in Periodontitis: A Pilot Case-Control Study.

    Science.gov (United States)

    Teeuw, Wijnand J; Laine, Marja L; Bizzarro, Sergio; Loos, Bruno G

    2015-01-01

    Elevated high sensitive C-reactive protein (hsCRP) is a marker for systemic inflammation and a risk marker for atherosclerotic cardiovascular disease (ACVD), and has also been associated with periodontitis. Inter-individual variation for hsCRP in periodontitis has been shown. ANRIL is the strongest genetic susceptibility locus for both periodontitis and ACVD, and it is speculated that genetic variation in ANRIL may modulate inflammatory processes. Therefore, we explored the possible association between hsCRP plasma levels and a leading ANRIL single nucleotide polymorphism (SNP) in periodontitis patients and controls. 171 healthy subjects with North European descent (115 periodontitis and 56 controls) were included in this case-control study. hsCRP levels were determined and subjects were genotyped for the leading ANRIL SNP rs1333048. In a multivariate analysis, periodontitis, female gender, increasing BMI and homozygosity for the major allele (AA-genotype) of rs1333048 were significantly associated with elevated hsCRP plasma levels (p = 0.012, p = 0.004, p = 0.007 and p = 0.003, respectively). Periodontitis patients with rs1333048 AA-genotype showed higher levels of hsCRP than those carrying the minor C allele (median: 4.5 mg/L vs. 1.6 mg/L, padjusted = 0.007). This study is the first to show that, in addition to gender and BMI, also a leading SNP in ANRIL is explanatory for inter-individual variation in hsCRP levels in periodontitis patients of North European descent.

  4. The effect of a cognitive-motor intervention on voluntary step execution under single and dual task conditions in older adults: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Pichierri G

    2012-07-01

    Full Text Available Giuseppe Pichierri,1 Amos Coppe,1 Silvio Lorenzetti,2 Kurt Murer,1 Eling D de Bruin11Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Switzerland; 2Institute for Biomechanics, Department of Health Sciences and Technology, ETH Zurich, SwitzerlandBackground: This randomized controlled pilot study aimed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention demanding dual task conditions.Methods: Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks (intervention group. The control group received no specific intervention. Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention (Week 12.Results: After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions (U = 9, P = 0.034, r = 0.55 and backward steps under dual task conditions (U = 10, P = 0.045, r = 0.52 in favor of the intervention group, showing altered stepping levels in the intervention group compared to the control group.Conclusion: A cognitive-motor intervention based on strength and balance exercises with additional dance video gaming is able to improve voluntary step execution under both single and dual task conditions in older adults.Keywords: fall prevention, exercise, dance, video game

  5. Atomoxetine treatment for nicotine withdrawal: a pilot double-blind, placebo-controlled, fixed-dose study in adult smokers

    Directory of Open Access Journals (Sweden)

    Silverstone Peter H

    2012-03-01

    Full Text Available Abstract Background Many effective treatments for nicotine addiction inhibit noradrenaline reuptake. Three recent studies have suggested that another noradrenaline reuptake inhibitor, atomoxetine, may reduce smoking behaviors. Methods The present double-blind, placebo-controlled, fixed-dose study was carried out over 21 days during which administration of 40 mg atomoxetine was compared to placebo in 17 individuals. Of these, nine were randomized to atomoxetine and eight to placebo. Baseline and weekly measurements were made using the Cigarette Dependence Scale (CDS, Cigarette Withdrawal Scale (CWS, Questionnaire of Smoking Urges (QSU, reported number of cigarettes smoked, and salivary cotinine levels. Results The study results showed that all those on placebo completed the study. In marked contrast, of the nine individuals who started on atomoxetine, five dropped out due to side effects. In a completer analysis there were statistically significant differences at 14 and 21 days in several measures between the atomoxetine and placebo groups, including CDS, CWS, QSU, number of cigarettes smoked (decreasing to less than two per day in the treatment group who completed the study, and a trend towards lower mean salivary cotinine levels. However, these differences were not seen in a last observation carried forward (LOCF analysis. Conclusions In summary, this is the first study to examine the use of atomoxetine in non-psychiatric adult smokers for a period of more than 7 days, and the findings suggest that atomoxetine might be a useful treatment for nicotine addiction. However, the dose used in the current study was too high to be tolerated by many adults, and a dose-finding study is required to determine the most appropriate dose for future studies of this potential treatment for smoking cessation.

  6. Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study.

    Science.gov (United States)

    Hasan, Alkomiet; Wolff-Menzler, Claus; Pfeiffer, Sebastian; Falkai, Peter; Weidinger, Elif; Jobst, Andrea; Hoell, Imke; Malchow, Berend; Yeganeh-Doost, Peyman; Strube, Wolfgang; Quast, Silke; Müller, Norbert; Wobrock, Thomas

    2015-10-01

    Despite many pharmacological and psychosocial treatment options, schizophrenia remains a debilitating disorder. Thus, new treatment strategies rooted in the pathophysiology of the disorder are needed. Recently, vagus nerve stimulation (VNS) has been proposed as a potential treatment option for various neuropsychiatric disorders including schizophrenia. The objective of this study was to investigate for the first time the feasibility, safety and efficacy of transcutaneous VNS in stable schizophrenia. A bicentric randomized, sham-controlled, double-blind trial was conducted from 2010 to 2012. Twenty schizophrenia patients were randomly assigned to one of two treatment groups. The first group (active tVNS) received daily active stimulation of the left auricle for 26 weeks. The second group (sham tVNS) received daily sham stimulation for 12 weeks followed by 14 weeks of active stimulation. Primary outcome was defined as change in the Positive and Negative Symptom Scale total score between baseline and week 12. Various other secondary measures were assessed to investigate safety and efficacy. The intervention was well tolerated with no relevant adverse effects. We could not observe a statistically significant difference in the improvement of schizophrenia psychopathology during the observation period. Neither psychopathological and neurocognitive measures nor safety measures showed significant differences between study groups. Application of tVNS was well tolerated, but did not improve schizophrenia symptoms in our 26-week trial. While unsatisfactory compliance questions the feasibility of patient-controlled neurostimulation in schizophrenia, the overall pattern of symptom change might warrant further investigations in this population.

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

    Directory of Open Access Journals (Sweden)

    Di Pierro F

    2012-07-01

    Full Text Available Francesco Di Pierro,1 Nicola Villanova,2 Federica Agostini,2 Rebecca Marzocchi,2 Valentina Soverini,2 Giulio Marchesini21Scientific Department, Velleja Research, Milano, 2Diseases of Metabolism, S Orsola Malpighi Hospital, Bologna, ItalyBackground: Suboptimal glycemic control is a common situation in diabetes, regardless of the wide range of drugs available to reach glycemic targets. Basic research in diabetes is endeavoring to identify new actives working as insulin savers, use of which could delay the introduction of injectable insulin or reduce the insulin dose needed. Commonly available as a nutraceutical, berberine is a potential candidate.Methods and results: Because its low oral bioavailability can be overcome by P-glycoprotein inhibitors like herbal polyphenols, we have tested the nutraceutical combination of Berberis aristata extract and Silybum marianum extract (Berberol® in type 2 diabetes in terms of its additive effect when combined with a conventional oral regimen for patients with suboptimal glycemic control. After 90 days of treatment, the nutraceutical association had a positive effect on glycemic and lipid parameters, significantly reducing glycosylated hemoglobin, basal insulin, homeostatic model assessment of insulin resistance, total and low-density lipoprotein cholesterol, and triglycerides. A relevant effect was also observed in terms of liver function by measuring aspartate transaminase and alanine transaminase. The product had a good safety profile, with distinctive gastrointestinal side effects likely due to its acarbose-like action.Conclusion: Although further studies should be carried out to confirm our data, Berberol could be considered a good candidate as an adjunctive treatment option in diabetes, especially in patients with suboptimal glycemic control.Keywords: berberine, silymarin, glycosylated hemoglobin, diabetes

  8. Unmanned Aircraft Systems Human-in-the-Loop Controller and Pilot Acceptability Study: Collision Avoidance, Self-Separation, and Alerting Times (CASSAT)

    Science.gov (United States)

    Comstock, James R., Jr.; Ghatas, Rania W.; Vincent, Michael J.; Consiglio, Maria C.; Munoz, Cesar; Chamberlain, James P.; Volk, Paul; Arthur, Keith E.

    2016-01-01

    The Federal Aviation Administration (FAA) has been mandated by the Congressional funding bill of 2012 to open the National Airspace System (NAS) to Unmanned Aircraft Systems (UAS). With the growing use of unmanned systems, NASA has established a multi-center "UAS Integration in the NAS" Project, in collaboration with the FAA and industry, and is guiding its research efforts to look at and examine crucial safety concerns regarding the integration of UAS into the NAS. Key research efforts are addressing requirements for detect-and-avoid (DAA), self-separation (SS), and collision avoidance (CA) technologies. In one of a series of human-in-the-loop experiments, NASA Langley Research Center set up a study known as Collision Avoidance, Self-Separation, and Alerting Times (CASSAT). The first phase assessed active air traffic controller interactions with DAA systems and the second phase examined reactions to the DAA system and displays by UAS Pilots at a simulated ground control station (GCS). Analyses of the test results from Phase I and Phase II are presented in this paper. Results from the CASSAT study and previous human-in-the-loop experiments will play a crucial role in the FAA's establishment of rules, regulations, and procedures to safely, efficiently, and effectively integrate UAS into the NAS.

  9. Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Su-Min Kim

    2008-09-01

    Full Text Available Objective : This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods : 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain and MSSL(Menstrual Symptom Severity List questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25 and a Normal Saline(N/S treatment group(Control group, n=24. The two groups were injected on the CV4, S36, Sp9 and Sp6 acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results : As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05, and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions : The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

  10. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial.

    Science.gov (United States)

    Blekken, Lene Elisabeth; Nakrem, Sigrid; Gjeilo, Kari Hanne; Norton, Christine; Mørkved, Siv; Vinsnes, Anne Guttormsen

    2015-05-23

    Fecal incontinence has a high prevalence in the nursing home population which cannot be explained by co-morbidity or anatomic and physiological changes of aging alone. Our hypothesis is that fecal incontinence can be prevented, cured, or ameliorated by offering care staff knowledge of best practice. However, it is not clear which educational model is most effective. To assess the effect of two educational programs for care staff, we planned a three armed cluster-randomized controlled trial. There is a lack of research reporting effects of interventions targeting improved continence care processes in older patients. Thus, to improve the quality of the planned trial, we decided to carry out a pilot study to investigate the feasibility of the planned design, the interventions (educational programs) and the outcome measures, and to enable a power calculation. This paper reports the results from the pilot study. Three nursing homes, representing each arm of the planned trial, were recruited. Criteria for assessing success of feasibility were pre-specified. Methods, outcome measures, acceptability, and adherence of the components of the intervention were evaluated by descriptive statistical analyses and qualitative content analysis of one focus group interview (n = 7) and four individual interviews. The main study is feasible with one major and some minor modifications. Due to challenges with recruitment and indications supporting the assumption that a single intervention with one workshop is not sufficient as an implementation strategy, the main study will be reduced to two arms: a multifaceted education intervention and control. The components of the multifaceted intervention seemed to work well together and need only minor modification. Important barriers to consider were sub-optimal use of skill-mix, problems of communicating important assessments and care plans, and isolated nurses with an indistinct nurse identity. Overall, the main study is feasible. The

  11. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Udani Jay K

    2010-08-01

    Full Text Available Abstract Background Arabinogalactan from Larch tree (Larix spp. bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g at the screening visit (V1-Day 0 and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2. They were monitored the following day (V3-Day 31, as well as 21 days (V4-Day 51 and 42 days (V5-Day 72 after vaccination. Responses by the adaptive immune system (antigen specific were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F and salivary IgA levels. Responses by the innate immune system (non-specific were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F at both Day 51 (p = 0.006 and p = 0.002 and at Day 72 (p = 0.008 and p = 0.041. These same subtypes (18C and 23F also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001 and at Day 72 (p = 0.012 and p = 0.003. Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There

  12. Health locus of control and the sense of self-efficacy in patients with systolic heart failure: a pilot study.

    Science.gov (United States)

    Rydlewska, Agnieszka; Krzysztofik, Justyna; Libergal, Julia; Rybak, Agata; Banasiak, Waldemar; Ponikowski, Piotr; Jankowska, Ewa A

    2013-01-01

    Treatment of heart failure (HF) requires the lifelong adherence to medical self-care regimes. The objective of this study was to examine health-control beliefs and the sense of self-efficacy (psychological features particularly important for efficient compliance among patients suffering from chronic diseases) in patients with systolic HF in relation to clinical status and depressive symptoms. Sixty-six consecutive patients with chronic systolic HF, hospitalized in the Centre for Heart Diseases, Military Hospital (94% men, age: 61 ± 11 years, ischemic etiology: 63%, left ventricular ejection fraction: 32% ± 12%), filled in (during their hospital stay): (1) the Multidimensional Health Locus of Control Scale measuring three possible localizations of health control: "internality" (ie, the belief that health status depends only on personal decisions and behaviors); "powerful others externality" ([PHLC subscale] ie, the conviction that health depends on "powerful people" such as doctors, family members, close friends), and "chance externality" (ie, belief that health status is determined by chance, fate, or luck), and (2) the Generalized Self-Efficacy Scale. The results obtained by HF patients were compared to those reported by patients with other chronic diseases and healthy subjects. In patients with HF, internality was similar to values obtained by patients with diabetes, men after myocardial infarction, and women after mastectomy; and was lower than in healthy subjects. Powerful others externality was more pronounced in patients with HF as compared to other groups of patients and healthy people. Only women after mastectomy had higher scores of PHLC. In patients with HF, chance externality was similar to values reported in patients with renal failure, men after myocardial infarction, and women after mastectomy; and was less pronounced than in healthy subjects. The majority (77%) of patients with HF were characterized by a high sense of self-efficacy (>the 7th sten

  13. [Pilot study on compulsory vaccination coverage].

    Science.gov (United States)

    Grandolfo, M E; Lauria, L; Medda, E; Bucciarelli, M; Andreozzi, S; Salinetti, S; Sitzia, G; Bernacchia, R

    1999-01-01

    The disappearance of diphtheria and poliomyelitis is the best evidence of the efficacy of the vaccination strategies adopted in Italy. The active offer of the prophylaxis, reinforced by law, has characterised the operational aspects of the strategy. The active surveillance system is the main tool to take under control the effectiveness of health services responsible for vaccination. This system could be more easily implemented if the health services will be given a specific software aiming to handle and evaluate vaccination registers. The present pilot study, performed in the regions Marche and Sardegna, is an example of active surveillance and it is based on the ARVA software produced by the Istituto Superiore di Sanità. The results show a good level of coverage (> 95%) within the second year of life. Unsatisfactory results were obtained on the timing of vaccinations, as recommended by the vaccination schedule, mostly for the third doses.

  14. Efficacy of moxibustion for pre- or stage I hypertension: study protocol for a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shin Kyung-Min

    2012-10-01

    Full Text Available Abstract Background Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have adverse side effects and poor adherence. The purpose of this study is to evaluate the effects of moxibustion on blood pressure in individuals with pre- or stage I hypertension. Methods/design Forty-five subjects with pre- or stage I hypertension will be randomized into three groups: treatment group A (2 times/week, treatment group B (3 times/week, and the control group (non-treated group. The inclusion criteria will be as follows: (1 aged between 19 and 65 years; (2 prehypertension or stage I hypertension (JNC 7, Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; (3 the participants are volunteers and written consent obtained. The participants in the treatment group A will undergo indirect moxibustion 2 times per week for 4 weeks, and the participants in the treatment group B will undergo indirect moxibustion 3 times per week for 4 weeks. The participants in the control group (non-treated group will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint will be a change in patient blood pressure. The secondary endpoints will be the body mass index, lipid profile, EuroQol and Heart Rate Variability. The data will be analyzed with the Student’s t-test and analysis of variance (ANOVA (p Discussion The results of this study will help to establish the optimal approach for the care of adults with pre- or stage I hypertension. Trial registration Clinical Research Information Service KCT0000469

  15. Health locus of control and the sense of self-efficacy in patients with systolic heart failure: a pilot study

    Directory of Open Access Journals (Sweden)

    Rydlewska A

    2013-04-01

    Full Text Available Agnieszka Rydlewska,1,2 Justyna Krzysztofik,3 Julia Libergal,3 Agata Rybak,3 Waldemar Banasiak,1 Piotr Ponikowski,1,2 Ewa A Jankowska1,21Centre for Heart Diseases, Department of Cardiology, Military Hospital, Wroclaw, Poland; 2Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland; 3Student’s Scientific Organization, Laboratory for Applied Research on Cardiovascular System, Wroclaw Medical University, Wroclaw, PolandBackground: Treatment of heart failure (HF requires the lifelong adherence to medical self-care regimes. The objective of this study was to examine health-control beliefs and the sense of self-efficacy (psychological features particularly important for efficient compliance among patients suffering from chronic diseases in patients with systolic HF in relation to clinical status and depressive symptoms.Subjects and methods: Sixty-six consecutive patients with chronic systolic HF, hospitalized in the Centre for Heart Diseases, Military Hospital (94% men, age: 61 ± 11 years, ischemic etiology: 63%, left ventricular ejection fraction: 32% ± 12%, filled in (during their hospital stay: (1 the Multidimensional Health Locus of Control Scale measuring three possible localizations of health control: “internality” (ie, the belief that health status depends only on personal decisions and behaviors; “powerful others externality” ([PHLC subscale] ie, the conviction that health depends on “powerful people” such as doctors, family members, close friends, and “chance externality” (ie, belief that health status is determined by chance, fate, or luck, and (2 the Generalized Self-Efficacy Scale. The results obtained by HF patients were compared to those reported by patients with other chronic diseases and healthy subjects.Results: In patients with HF, internality was similar to values obtained by patients with diabetes, men after myocardial infarction, and women after mastectomy; and was lower than in healthy

  16. The effects of long-term noninvasive ventilation in hypercapnic COPD patients: a randomized controlled pilot study

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    De Backer L

    2011-11-01

    Full Text Available L De Backer¹, W Vos², B Dieriks¹, D Daems¹, S Verhulst¹, S Vinchurkar², K Ides¹, J De Backer², P Germonpre¹, W De Backer¹1Antwerp University Hospital, Department of Respiratory Medicine, 2FluidDa, Antwerp, BelgiumIntroduction: Noninvasive ventilation (NIV is a well-established treatment for acute-on-chronic respiratory failure in hypercapnic COPD patients. Less is known about the effects of a long-term treatment with NIV in hypercapnic COPD patients and about the factors that may predict response in terms of improved oxygenation and lowered CO2 retention.Methods: In this study, we randomized 15 patients to a routine pharmacological treatment (n = 5, age 66 [standard deviation ± 6] years, FEV1 30.5 [±5.1] %pred, PaO2 65 [±6] mmHg, PaCO2 52.4 [±6.0] mmHg or to a routine treatment and NIV (using the Synchrony BiPAP device [Respironics, Inc, Murrsville, PA] (n = 10, age 65 [±7] years, FEV1 29.5 [±9.0] %pred, PaO2 59 [±13] mmHg, PaCO2 55.4 [±7.7] mmHg for 6 months. We looked at arterial blood gasses, lung function parameters and performed a low-dose computed tomography of the thorax, which was later used for segmentation (providing lobe and airway volumes, iVlobe and iVaw and post-processing with computer methods (providing airway resistance, iRaw giving overall a functional image of the separate airways and lobes.Results: In both groups there was a nonsignificant change in FEV1 (NIV group 29.5 [9.0] to 38.5 [14.6] %pred, control group 30.5 [5.1] to 36.8 [8.7] mmHg. PaCO2 dropped significantly only in the NIV group (NIV: 55.4 [7.7] → 44.5 [4.70], P = 0.0076; control: 52.4 [6.0] → 47.6 [8.2], NS. Patients actively treated with NIV developed a more inhomogeneous redistribution of mass flow than control patients. Subsequent analysis indicated that in NIV-treated patients that improve their blood gases, mass flow was also redistributed towards areas with higher vessel density and less emphysema, indicating that flow was

  17. Ran domized controlled clinical tria l on the efficacy of team play football on schizophrenic patients: a pilot study

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    Giancarlo Vinci

    2015-10-01

    Full Text Available The physical activity is an important aspect of good health for everyone; it is even more important for psychiatric patients who usually live an unhealthy lifestyle. The aim of this study was to investigate the effects of football practice on the self-reported health quality of life (SRHQL and Wellbeing in schizophrenic subjects. A randomized controlled clinical trial was conducted to assess the effectiveness of the Psychosocial Rehabilitation Program performed by Daily Center Mazzacurati, Department of Mental Health Roma/D , for psychotic subjects that included weekly football activities for a period of 9 months. The results show that the model proved effective in the experimental group (SG as regards the psychopathological dimensions, which are significantly improved (Median(IQR: 31(16 versus 53(18; p=0.001; in particular the negative symptomatology has been reduced, and this result is hardly achieved with the drug therapy (17(7 versus 25(15; p=0.003. This study increases the awareness of following this ap proach and improving the extension and the confirmation of the results achieved.

  18. Effects of combined exercise on physical fitness and neurotransmitters in children with ADHD: a pilot randomized controlled study

    Science.gov (United States)

    Lee, Sun-Kyoung; Lee, Chung-Moo; Park, Jong-Hwan

    2015-01-01

    [Purpose] The purpose of the present study was to determine the effect of a jump rope and ball combined exercise program on the physical fitness the neurotransmitter (epinephrine, serotonin) levels of children with attention-deficit hyperactivity disorder. [Subjects and Methods] The subjects were 12 boys attending elementary school, whose grade levels ranged from 1–4. The block randomization method was used to distribute the participants between the combined exercise group (n = 6) and control group (n = 6). The program consisted of a 60-min exercise (10-min warm-up, 40-min main exercise, and 10-min cool down) performed three times a week, for a total of 12 weeks. [Results] The exercise group showed a significant improvement in cardiorespiratory endurance, muscle strength, muscle endurance and flexibility after 12 weeks. A significant increase in the epinephrine level was observed in the exercise group. [Conclusion] The 12-week combined exercise program in the current study (jump rope and ball exercises) had a positive effect on overall fitness level, and neurotransmission in children with attention-deficit hyperactivity disorder. PMID:26504324

  19. A randomized controlled pilot study of home-based step training in older people using videogame technology.

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    Daniel Schoene

    Full Text Available BACKGROUND: Stepping impairments are associated with physical and cognitive decline in older adults and increased fall risk. Exercise interventions can reduce fall risk, but adherence is often low. A new exergame involving step training may provide an enjoyable exercise alternative for preventing falls in older people. PURPOSE: To assess the feasibility and safety of unsupervised, home-based step pad training and determine the effectiveness of this intervention on stepping performance and associated fall risk in older people. DESIGN: Single-blinded two-arm randomized controlled trial comparing step pad training with control (no-intervention. SETTING/PARTICIPANTS: Thirty-seven older adults residing in independent-living units of a retirement village in Sydney, Australia. INTERVENTION: Intervention group (IG participants were provided with a computerized step pad system connected to their TVs and played a step game as often as they liked (with a recommended dose of 2-3 sessions per week for 15-20 minutes each for eight weeks. In addition, IG participants were asked to complete a choice stepping reaction time (CSRT task once each week. MAIN OUTCOME MEASURES: CSRT, the Physiological Profile Assessment (PPA, neuropsychological and functional mobility measures were assessed at baseline and eight week follow-up. RESULTS: Thirty-two participants completed the study (86.5%. IG participants played a median 2.75 sessions/week and no adverse events were reported. Compared to the control group, the IG significantly improved their CSRT (F31,1 = 18.203, p<.001, PPA composite scores (F31,1 = 12.706, p = 0.001, as well as the postural sway (F31,1 = 4.226, p = 0.049 and contrast sensitivity (F31,1 = 4.415, p = 0.044 PPA sub-component scores. In addition, the IG improved significantly in their dual-task ability as assessed by a timed up and go test/verbal fluency task (F31,1 = 4.226, p = 0.049. CONCLUSIONS: Step pad training can

  20. Facilitated patient experience feedback can improve nursing care: a pilot study for a phase III cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Control and Feedback Plus = 8.28 ± 7.2 (p = 0.02)). Conclusions This study provides preliminary evidence that facilitated patient feedback can improve patients’ experiences such that a full trial is justified. These findings suggest that merely informing nurses of patient survey results in writing does not stimulate improvements, even if results are disaggregated by ward, but the addition of ward meetings had an important and significant impact. PMID:23826970

  1. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study

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    Irish AK

    2017-01-01

    Full Text Available Amanda K Irish,1 Constance M Erickson,1 Terry L Wahls,2,3 Linda G Snetselaar,4 Warren G Darling1 1Motor Control Laboratories, Department of Health and Human Physiology, College of Liberal Arts and Sciences, The University of Iowa, 2Veterans Affairs Medical Center, 3Department of Internal Medicine, Carver College of Medicine, 4Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA, USA Background/objective: A Paleolithic diet may improve fatigue and quality of life in progressive multiple sclerosis (MS patients, but past research has evaluated the effects of this dietary intervention in combination with other treatments such as exercise. Thus, the purpose of this pilot study was to evaluate a modified Paleolithic dietary intervention (MPDI in the treatment of fatigue and other symptoms in relapsing-remitting MS (RRMS.Methods: We measured the effects of a MPDI in 17 individuals with RRMS. Of 34 subjects randomly assigned to control (maintain usual diet and intervention (MPDI groups, nine subjects (one man completed the control group and eight subjects (one man completed the MPDI.Results: Significant improvements were seen in Fatigue Severity Scale score and also in Multiple Sclerosis Quality of Life-54 and time to complete (dominant hand 9-Hole Peg Test from baseline in MPDI subjects compared to controls. Increased vitamin K serum levels were also observed in MPDI subjects postprotocol compared to controls.Conclusion: A Paleolithic diet may be useful in the treatment and management of MS, by reducing perceived fatigue, increasing mental and physical quality of life, increasing exercise capacity, and improving hand and leg function. By increasing vitamin K serum levels, the MPDI may also reduce inflammation. Keywords: diet therapy, nutrition therapy, gluten-free, quality of life, fatigue, complementary medicine, alternative medicine

  2. Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study.

    Science.gov (United States)

    Plaugher, Gregory; Long, Cynthia R; Alcantara, Joel; Silveus, Alyssa D; Wood, Herbert; Lotun, Kapildeo; Menke, J Michael; Meeker, William C; Rowe, Stephen H

    2002-05-01

    To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group. Randomized controlled-comparison trial with 3 parallel groups. Private practice outpatient chiropractic clinic. Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room. Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool. Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0

  3. Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Schneider, Kristin L; Panza, Emily; Handschin, Barbara; Ma, Yunsheng; Busch, Andrew M; Waring, Molly E; Appelhans, Bradley M; Whited, Matthew C; Keeney, Jacey; Kern, Daniel; Blendea, Mihaela; Ockene, Ira; Pagoto, Sherry L

    2016-03-01

    Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study.

  4. Hypertension Prevalence, Awareness and Blood Pressure Control in Matao, Brazil: A Pilot Study in Partnership With the Brazilian Family Health Strategy Program.

    Science.gov (United States)

    Minelli, Cesar; Borin, Lucileni Aparecida; Trovo, Mayra de Cassia; Dos Reis, Geraldo Cassio

    2016-07-01

    Around 30% of Brazilian population is hypertensive. Brazilian's Family Health Strategy (FHS) is a community-based approach to provide primary health care and control chronic disease as hypertension. The aims of this pilot study were to study hypertension prevalence and awareness and to analyze the feasibility of FHS program with community healthy agents (CHA) to collect data about hypertensive subjects in Matao, Brazil. A cross-sectional study was conducted in subjects equal or older than 40 years old in a neighborhood belonging to FHS program. CHA were trained to collect data and to assess blood pressure (BP) with an automated device. Hypertension diagnosis was defined if systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg or subject had previous use of hypertensive drug. Chi-square test and univariate logistic regression analysis were applied with significance level of 5% and a confidence interval of 95%. In 625 subjects, hypertension prevalence was 68.8% and women (71.9%) were more hypertensive than men (63.2%) (P = 0.02). Prevalence of hypertension increased with age group, from 46.3% (40 - 49 years) to 82.5% (70 - 79 years) (P < 0.001). The overall prevalence of pre-hypertension was 40.1%: stage 1, 25.7% and stage 2, 17.0%. Hypertension awareness was 81.8% and 79.8% reported use of anti-hypertensive drugs. BP was not controlled in 61.8% and 67.7% of them was using anti-hypertensive drugs. CHA reported no difficulties to collect data and BP assessment with the automated device. We observed a high hypertension prevalence rate, awareness, and subjects with uncontrolled hypertension even with use of anti-hypertensive drugs. CHA from FHS program are a feasible option to BP control in future studies involving larger populations.

  5. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

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    Francesca Lombardi

    Full Text Available Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13 versus the 23-valent polysaccharide vaccine (PPSV23 in HIV-infected adults.We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50 received two doses of PCV13 eight weeks apart, and group 2 (n = 50 received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100 were also enrolled as baseline controls.Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group.In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated.ClinicalTrials.gov NCT02123433.

  6. Participants’ perspectives on mindfulness-based cognitive therapy for inflammatory bowel disease: a qualitative study nested within a pilot randomised controlled trial

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    Schoultz, Mariyana; Macaden, Leah; Hubbard, Gill

    2016-01-01

    Background Mindfulness-based interventions have shown to improve depression and anxiety symptoms as well as quality of life in patients with inflammatory bowel disease (IBD). However, little is known about the experiences of this group of patients participating in mindfulness interventions. This paper sets out to explore the perspectives of patients with IBD recruited to a pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) about the intervention. Methods In ...

  7. Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study

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    Stephanie J. Sohl

    2016-01-01

    Full Text Available Lifestyle change is recommended as treatment for adults at risk for metabolic syndrome (MetS, although adoption of new behavioral patterns is limited. In addition, most existing lifestyle interventions do not address psychological stress or quality of life, both of which impact the burden of MetS. Yoga, a form of physical activity that incorporates psychological components (e.g., maintaining attention, relaxation, is a promising intervention for improving the burden of MetS. This randomized controlled trial assessed the feasibility and preliminary efficacy of a 12-week yoga program coupled with an evidence-based health education program (HED compared to HED alone. A secondary, exploratory aim examined perceived stress, quality of life, and related psychological outcomes (mindfulness, perceived health competence, and mood. Sixty-seven adults at risk for MetS enrolled (mean age [SD]: 58 [10] years; 50% male; 79% non-Hispanic White. Preliminary results revealed significantly larger improvements in two quality of life domains (role-physical and general health perceptions in the HED plus yoga group versus HED alone (ps<0.05. This is the first study that implemented lifestyle education along with yoga to evaluate the potential unique effects of yoga on participants at risk for MetS. A larger clinical trial is warranted to further investigate these promising patient-reported outcomes.

  8. A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

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    Ka-Kit Tsang

    2017-01-01

    Full Text Available Nanocrystalline silver (nAg and Manuka honey (MH dressing have increasing popularity for treating diabetic foot ulcer (DFU. This study was an open-label randomized controlled trial with three parallel groups’ design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45% than the MH group (86.21% and the conventional group (75.17%. In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate.

  9. Impact of biofeedback on self-efficacy and stress reduction in obesity: a randomized controlled pilot study.

    Science.gov (United States)

    Teufel, Martin; Stephan, Kerstin; Kowalski, Axel; Käsberger, Saskia; Enck, Paul; Zipfel, Stephan; Giel, Katrin E

    2013-09-01

    Biofeedback application is an evidence-based technique to induce relaxation. A primary mechanism of action is the improvement of self-efficacy, which is needed to facilitate the translation of health behavioral intentions into action. Obesity is often associated with low self-efficacy and dysfunctional eating patterns, including comfort eating as an inexpedient relaxation technique. This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity. In the present experiment, 31 women, mean body mass index 35.5 kg/m², were randomized to a food-specific biofeedback paradigm, a non-specific relaxation biofeedback paradigm, or a waiting list control. Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific landscape stimulus. Self-efficacy, stress, ability to relax, eating behavior, and electrodermal activity were assessed before, directly after, and 3 months after the intervention. The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress. The non-specific relaxation biofeedback showed effects on the ability to relax. Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli. Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment.

  10. A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

    Science.gov (United States)

    Kwong, Enid Wai-Yung; To, Tony Shing-Shun; Wong, Thomas Kwok-Shing

    2017-01-01

    Nanocrystalline silver (nAg) and Manuka honey (MH) dressing have increasing popularity for treating diabetic foot ulcer (DFU). This study was an open-label randomized controlled trial with three parallel groups' design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group) diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45%) than the MH group (86.21%) and the conventional group (75.17%). In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate. PMID:28239398

  11. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.

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    Antje R Weseler

    Full Text Available BACKGROUND: Cardiovascular diseases are expanding to a major social-economic burden in the Western World and undermine man's deep desire for healthy ageing. Epidemiological studies suggest that flavanol-rich foods (e.g. grapes, wine, chocolate sustain cardiovascular health. For an evidenced-based application, however, sound clinical data on their efficacy are strongly demanded. METHODS: In a double-blind, randomized, placebo-controlled intervention study we supplemented 28 male smokers with 200 mg per day of monomeric and oligomeric flavanols (MOF from grape seeds. At baseline, after 4 and 8 weeks we measured macro- and microvascular function and a cluster of systemic biomarkers for major pathological processes occurring in the vasculature: disturbances in lipid metabolism and cellular redox balance, and activation of inflammatory cells and platelets. RESULTS: In the MOF group serum total cholesterol and LDL decreased significantly (P ≤ 0.05 by 5% (n = 11 and 7% (n = 9, respectively in volunteers with elevated baseline levels. Additionally, after 8 weeks the ratio of glutathione to glutathione disulphide in erythrocytes rose from baseline by 22% (n = 15, P<0.05 in MOF supplemented subjects. We also observed that MOF supplementation exerts anti-inflammatory effects in blood towards ex vivo added bacterial endotoxin and significantly reduces expression of inflammatory genes in leukocytes. Conversely, alterations in macro- and microvascular function, platelet aggregation, plasma levels of nitric oxide surrogates, endothelin-1, C-reactive protein, fibrinogen, prostaglandin F2alpha, plasma antioxidant capacity and gene expression levels of antioxidant defense enzymes did not reach statistical significance after 8 weeks MOF supplementation. However, integrating all measured effects into a global, so-called vascular health index revealed a significant improvement of overall vascular health by MOF compared to placebo (P ≤ 0.05. CONCLUSION: Our

  12. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    Science.gov (United States)

    2013-01-01

    -test and ANCOVA (P <0.05). Discussion The results of this study will allow evaluation of contralateral acupuncture from two aspects. First, if the contralateral acupuncture shows the effects similar to ipsilateral acupuncture, this will establish clinical basis for contralateral acupuncture. Second, if the effects of contralateral acupuncture are not comparable to the effects of ipsilateral acupuncture, but are shown to be similar to the effects of the sham acupuncture, we can establish the basis for using the same acupoints of the unaffected side as a control in acupuncture clinical studies. Trial registration This trial has been registered with the ‘Clinical Research Information Service (CRIS)’, Republic of Korea: KCT0000628. PMID:23768129

  13. Seven-year retrospective analysis of the myopic control effect of orthokeratology in children: a pilot study

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    Alan Kwok-Hei Mok

    2011-02-01

    Full Text Available Alan Kwok-Hei Mok1,2, Cindy Sin-Ting Chung11Eye’ni, Hong Kong, People’s Republic of China; 2Department of Anatomy, LiKaShing Faculty of Medicine, The University of Hong Kong, Hong Kong, People’s Republic of ChinaObjectives: To investigate retrospectively the difference in myopia progression, over about 7 years, between two groups of Hong Kong Chinese myopic children who wore overnight orthokeratology lenses or single-vision spectacles.Methods: A total of 238 records of children wearing overnight orthokeratology lenses or single-vision spectacles from Eye’ni optical shop (Hong Kong between January 1999 and December 2009 were reviewed. Refractive and central corneal curvature data with 6-year or a longer follow-up period of 70 patients were retrieved: 34 children (15 boys and 19 girls, aged 9.2 ± 1.8 years wore orthokeratology lenses and 36 (20 boys and 16 girls, aged 10.2 ± 2.0 years wore spectacles. Myopic progression was determined as the change of myopia from the baseline to the final visit.Results: No statistically significant differences (P > 0.05 in age, central flat corneal curvatures, baseline refractive error, or follow-up period were observed between the two groups. Average myopic progression of the overnight orthokeratology contact lens cohort (-0.37 ± 0.49 D was significantly less (P < 0.001 than of the single-vision spectacle group (-2.06 ± 0.81 D over about 7 years.Conclusion: Our preliminary 7-year data support the claim that overnight orthokeratology contact lenses may be a feasible clinical method for myopic progression control. Prospective and randomized investigations are warranted to overcome the limitations of this retrospective study.Keywords: myopia, contact lens, orthokeratology, myopia progression

  14. The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain: a randomised controlled pilot study.

    Science.gov (United States)

    Lauche, Romy; Cramer, Holger; Hohmann, Claudia; Choi, Kyung-Eun; Rampp, Thomas; Saha, Felix Joyonto; Musial, Frauke; Langhorst, Jost; Dobos, Gustav

    2012-01-01

    Introduction. Cupping has been used since antiquity in the treatment of pain conditions. In this pilot study, we investigated the effect of traditional cupping therapy on chronic nonspecific neck pain (CNP) and mechanical sensory thresholds. Methods. Fifty CNP patients were randomly assigned to treatment (TG, n = 25) or waiting list control group (WL, n = 25). TG received a single cupping treatment. Pain at rest (PR), pain related to movement (PM), quality of life (SF-36), Neck Disability Index (NDI), mechanical detection (MDT), vibration detection (MDT), and pressure pain thresholds (PPT) were measured before and three days after a single cupping treatment. Patients also kept a pain and medication diary (PaDi, MeDi) during the study. Results. Baseline characteristics were similar in the two groups. After cupping TG reported significantly less pain (PR: -17.9 mm VAS, 95%CI -29.2 to -6.6; PM: -19.7, 95%CI -32.2 to -7.2; PaDi: -1.5 points on NRS, 95%CI -2.5 to -0.4; all P cupping might be an effective treatment for improving pain, quality of life, and hyperalgesia in CNP.

  15. A double-blind, placebo-controlled pilot study to estimate the efficacy and tolerability of a nonsteroidal cream for the treatment of cradle cap (seborrheic dermatitis).

    Science.gov (United States)

    David, Elmer; Tanuos, Hanan; Sullivan, Timothy; Yan, Albert; Kircik, Leon H

    2013-04-01

    This study was a multicenter, double-blind, placebo-controlled, parallel-group pilot study of efficacy and tolerability of a nonsteroidal cream (Promiseb® Topical Cream; Promius Pharma, LLC, Bridgewater, NJ) for treatment of cradle cap when applied topically twice daily for up to 14 days in 42 pediatric subjects. Both treatments were similarly effective in reducing disease severity, as measured by success with Investigator's Global Assessment scores at day 7 or end of treatment, with 96% of subjects achieving success in the nonsteroidal cream group and 92% of subjects achieving success in the placebo cream group. Both treatments resulted in significant reductions from baseline in terms of erythema, crusting, scaling, and oiliness (P<.05), with no significant difference between treatments. There was a significant difference (P=.03) between treatment groups for percent reduction in scaling at the end of treatment, with a 90% reduction in the nonsteroidal cream group compared with a 58% reduction in the placebo cream group. All subjects in both groups had an overall safety score of excellent, and there were no adverse events related to treatment for either group.

  16. Cognitive behavioural therapy and mindfulness for stress and burnout: a waiting list controlled pilot study comparing treatments for parents of children with chronic conditions.

    Science.gov (United States)

    Anclair, Malin; Lappalainen, Raimo; Muotka, Joona; Hiltunen, Arto J

    2017-08-29

    Parents of children with chronic conditions often experience a crisis with serious mental health problems for themselves as a consequence. The healthcare focus is on the children; however, the parents often worry about their children's health and future but are seldom offered any counselling or guidance. The aim of this study was to investigate the effectiveness of two group-based behavioural interventions on stress and burnout among parents of children with chronic conditions. After a waiting list control period (n = 28), parents were offered either a cognitive behavioural (CBT, n = 10) or a mindfulness program (MF, n = 9). Both interventions decreased significantly stress and burnout. The within-group effect sizes were large in both interventions (CBT, g = 1.28-1.64; MF, g = 1.25-2.20). Hence, the results of this pilot study show that treating a group using either CBT or mindfulness can be an efficient intervention for reducing stress levels and burnout in parents of children with chronic conditions. © 2017 Nordic College of Caring Science.

  17. The effect of aircraft control forces on pilot performance during instrument landings in a flight simulator.

    Science.gov (United States)

    Hewson, D J; McNair, P J; Marshall, R N

    2001-07-01

    Pilots may have difficulty controlling aircraft at both high and low force levels due to larger variability in force production at these force levels. The aim of this study was to measure the force variability and landing performance of pilots during an instrument landing in a flight simulator. There were 12 pilots who were tested while performing 5 instrument landings in a flight simulator, each of which required different control force inputs. Pilots can produce the least force when pushing the control column to the right, therefore the force levels for the landings were set relative to each pilot's maximum aileron-right force. The force levels for the landings were 90%, 60%, and 30% of maximal aileron-right force, normal force, and 25% of normal force. Variables recorded included electromyographic activity (EMG), aircraft control forces, aircraft attitude, perceived exertion and deviation from glide slope and heading. Multivariate analysis of variance was used to test for differences between landings. Pilots were least accurate in landing performance during the landing at 90% of maximal force (p < 0.05). There was also a trend toward decreased landing performance during the landing at 25% of normal force. Pilots were more variable in force production during the landings at 60% and 90% of maximal force (p < 0.05). Pilots are less accurate at performing instrument landings when control forces are high due to the increased variability of force production. The increase in variability at high force levels is most likely associated with motor unit recruitment, rather than rate coding. Aircraft designers need to consider the reduction in pilot performance at high force levels, as well as pilot strength limits when specifying new standards.

  18. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

  19. Effects of mobile augmented reality learning compared to textbook learning on medical students: randomized controlled pilot study.

    Science.gov (United States)

    Albrecht, Urs-Vito; Folta-Schoofs, Kristian; Behrends, Marianne; von Jan, Ute

    2013-08-20

    ARble, fatigue (z=2.214, P=.03) and numbness (z=2.07, P=.04) decreased with statistical significance when comparing pre- and post-tests. Vigor rose slightly, while irritability did not increase significantly. Changes in the control group were insignificant. Regarding hedonic quality (identification, stimulation, attractiveness), there were significant differences between mARble (mean 1.179, CI -0.440 to 0.440) and the book chapter (mean -0.982, CI -0.959 to 0.959); the pragmatic quality mean only differed slightly. The mARble group performed considerably better regarding learning efficiency; there are hints for activating components of the mAR concept that may serve to fascinate the participants and possibly boost interest in the topic for the remainder of the class. While the small sample size reduces our study's conclusiveness, its design seems appropriate for determining the effects of interactive eLearning material with respect to emotions, learning efficiency, and hedonic and pragmatic qualities using a larger group. German Clinical Trial Register (DRKS), DRKS-ID: DRKS00004685; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004685.

  20. Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study.

    Science.gov (United States)

    Taniguchi, Norimasa; Nakamura, Takeshi; Sawada, Takahisa; Matsubara, Kinya; Furukawa, Keizo; Hadase, Mitsuyoshi; Nakahara, Yoshifumi; Nakamura, Takashi; Matsubara, Hiroaki

    2010-11-01

    Erythropoietin (EPO) enhances re-endothelialization and anti-apoptotic action. Larger clinical studies to examine the effects of high-dose EPO are in progress in patients with acute myocardial infarction (AMI). The aim of this multi-center pilot study was to investigate the effect of `low-dose EPO' (6,000 IU during percutaneous coronary intervention (PCI), 24 h and 48 h) in 35 patients with a first ST-elevated AMI undergoing PCI who was randomly assigned to EPO or placebo (saline) treatment. Neointimal volume, cardiac function and infarct size were examined in the acute phase and 6 months later (ClinicalTrials.gov identifier: NCT00423020). No significant regression in in-stent neointimal volume was observed, whereas left ventricular (LV) ejection fraction was significantly improved (49.2% to 55.7%, P=0.003) and LV end-systolic volume was decreased in the EPO group (47.7 ml to 39.0 ml, P=0.036). LV end-diastolic volume tended to be reduced from 90.2% to 84.5% (P=0.159), whereas in the control group it was inversely increased (91.7% to 93.7%, P=0.385). Infarction sizes were significantly reduced by 38.5% (P=0.003) but not in the control group (23.7%, P=0.051). Hemoglobin, peak creatine kinase values, and CD34(+)/CD133(+)/CD45(dim) endothelial progenitors showed no significant changes. No adverse events were observed during study periods. This is a first study demonstrating that short-term `low-dose' EPO to PCI-treated AMI patients did not prevent neointimal hyperplasia but rather improved cardiac function and infarct size without any clinical adverse effects.

  1. The ENIQ pilot study: current status

    Energy Technology Data Exchange (ETDEWEB)

    Lemaitre, P.; Eriksen, B.; Crutzen, S. [European Commission, DG Joint Research Centre, Petten (Netherlands); Hansch, M. [Preussische Elektrizitaets-AG (Preussenelektra), Hannover (Germany); Whittle, J. [AEA Technology, Warrington (United Kingdom)

    1998-11-01

    A pilot study is currently being carried out by ENIQ (European Network for Inspection Qualification) in order to explore the issues involved in inspection qualification applied along the general principles of the European methodology. The components selected for the pilot study are austenitic pipe to pipe and pipe to elbows welds typical of those in BWR recirculation loops. A range of defect parameters has been defined. A suitable inspection procedure designed to find the designated defects will be applied to geometrically representative test pieces. The procedure/equipment will be qualified through open trials and technical justification. The personnel qualification will be done in a blind way. Once all features of the inspection system will have been qualified an in-service inspection will be simulated in order to test the feasibility of the qualification approach followed. In this paper the current status of this pilot study is discussed. (orig.)

  2. Does wearing unstable shoes reduce low back pain and disability in nurses? A randomized controlled pilot study.

    Science.gov (United States)

    Vieira, Edgar R; Brunt, Denis

    2016-02-01

    To evaluate if wearing unstable shoes reduces low back pain and disability in nurses. A randomized controlled trial. Hospitals and homecare. A total of 20 matched female registered nurses with low back pain. The mean (standard deviation) age was 31 years (5) for the control and 34 years (6) for the intervention group; height was 161 cm (5) and 165 cm (7), respectively. The intervention group received unstable shoes at Week 2 to wear for at least 36 h/week for a month. The Oswestry Low Back Pain Disability Questionnaire and a visual analogue pain scale. The mean (standard deviation) pain level was 6 (1) at baseline vs. 6 (2) at Week 6 for the control group, and 5 (1) vs. 1 (1) for the intervention group. The mean (standard deviation) disability level was 31% (9) at baseline vs. 28% (7) at Week 6 for the control, and 27% (12) vs. 13% (5) for the intervention group. There were no significant changes over time on pain or disability levels for the control group. The intervention group reported lower levels of pain on Weeks 4 (mean difference ⩾-1.4, p ⩽ 0.009) and 6 (mean difference ⩾-3.1, p back pain and disability in nurses and might be helpful as part of the back pain rehabilitation process. © The Author(s) 2015.

  3. Cognitive Inhibitory Control and Arithmetic Word Problem Solving in Children with Attention Deficit/ Hyperactivity Disorder: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Sigem Sabagh-Sabbagh

    2010-02-01

    Full Text Available A sample of 30 subjects, 10 with Attention Deficit and Hyperactivity Disorder(ADHD and 20 non-ADHD children, statistically controlled byage, gender, academic grades and normal full scale intelligence quotient,was selected. To measure cognitive inhibitory control, a math problem solving ability test containing four problems for each level with verbal and numerical irrelevant content was administered. ADHD children exhibited significantly inferior performance in choosing correct answers (p = 0.011 with a large effect size (d = 1.00 and a significantly superior number of irrelevant answers (p = 0.004 with a very large effect size. In conclusion ADHD children showed a cognitive inhibitory control disorder, measured by math problem solving ability.

  4. Educational intervention to reduce falls and fear of falling in patients after fragility fracture: results of a controlled pilot study.

    Science.gov (United States)

    Rucker, Diana; Rowe, Brian H; Johnson, Jeffrey A; Steiner, Ivan P; Russell, Anthony S; Hanley, David A; Maksymowych, Walter P; Holroyd, Brian R; Harley, Charles H; Morrish, Donald W; Wirzba, Brian J; Majumdar, Sumit R

    2006-04-01

    Falls and fear of falling are a major health problem. We sought to determine the effectiveness of an educational intervention in reducing fear of falling and preventing recurrent falls in community-dwelling patients after a fragility fracture. One hundred two community-dwelling patients aged 50 years or older who fell and sustained a wrist fracture and were treated at Emergency Departments in Edmonton, Alberta, Canada (2001-2002) were allocated to either standardized educational leaflets and post-discharge telephone counseling regarding fall prevention strategies ("intervention") or attention-controls ("controls"). Main outcomes were fear of falling and recurrent falls 3 months after fracture. Mean age was 67 years and most patients were female (80%). The majority of falls (76%) leading to fracture occurred outdoors. Three months post-fracture, almost half of patients (48%) reported increased fear of falling and 11 of 102 (11%) reported falling again. The intervention did not reduce the fear of falling (43% had increased fear vs. 53% of controls, adjusted P value=0.55) or decrease recurrent falls (17% fell vs. 5% of controls, adjusted P value=0.059) within 3 months of fracture. An educational intervention undertaken in the Emergency Department was no more effective than usual care in reducing fear of falling or recurrent falls in community-dwelling patients. Future strategies must address a number of dimensions beyond simple education.

  5. A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

    2016-01-01

    We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

  6. A comparative evaluation of different supraglottic ventilatory devices during general anesthesia with controlled ventilation: A pilot study

    Directory of Open Access Journals (Sweden)

    Ahmed A. Abd El Aziz

    2014-10-01

    Conclusions: We concluded that the I-gel, PLMA and SLIPA are effective ventilatory devices during controlled ventilation, without major complications. I-gel offers advantage over PLMA and SLIPA in being less manipulation needed during placement, less air leak, less postoperative sore throat and less in blood stained to the device after its removal in comparison with PLMA and SLIPA.

  7. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Patrick Meybohm

    Full Text Available BACKGROUND: Remote ischemic preconditioning (RIPC has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD in patients undergoing complex cardiac surgery. METHODS: We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5-7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion or if the combined Z score was 1.96 or greater (Z score criterion. RESULTS: According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5-7 days after surgery (p = 0.753. The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30 compared to the RIPC group (1.14±4.02; p = 0.228. Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19-1.94 µg/L vs. 0.48 (0.07-1.84 µg/L] and 24 hours after surgery [0.36 (0.14-1.89 µg/L vs. 0.26 (0.07-0.90 µg/L]. CONCLUSIONS: We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00877305.

  8. The mechanical effect of kinesiology tape on rounded shoulder posture in seated male workers: a single-blinded randomized controlled pilot study.

    Science.gov (United States)

    Han, Jin-Tae; Lee, Jung-Hoon; Yoon, Chul-Han

    2015-02-01

    Single-blinded randomized controlled pilot study. To examine the changes in pectoralis minor length (PML), the supine measurement of rounded shoulder posture (RSP), and the total scapular distance (TSD) in seated male workers with RSP, after rounded-shoulder-taping (RST) using kinesiology tape with (experimental taping) and without stretch (placebo taping). RSP, a postural impairment, is a known cause of upper quarter pain. Fourteen men with RSP, who worked for at least 7 h/d in a seated position, were selected for RST, with the shoulders randomly assigned to two kinesiology taping methods: (1) with 35-40% stretch of its original length; and (2) without stretch. The PML, supine measurements of RSP, and TSD, before and after kinesiology taping, with and without stretch, were assessed. Kinesiology taping with stretch significantly increased the PML and significantly decreased the supine measurement of RSP and TSD; kinesiology taping without stretch did not increase the PML significantly and did not decrease the supine measurement of RSP and TSD. RST using kinesiology tape with stretch produces immediate mechanical correction of RSP in seated male workers.

  9. Designing an iPad App to Monitor and Improve Classroom Behavior for Children with ADHD: iSelfControl Feasibility and Pilot Studies.

    Science.gov (United States)

    Schuck, Sabrina; Emmerson, Natasha; Ziv, Hadar; Collins, Penelope; Arastoo, Sara; Warschauer, Mark; Crinella, Francis; Lakes, Kimberley

    2016-01-01

    Children with Attention Deficit/Hyperactivity Disorder (ADHD) receive approximately 80% of instruction in the general education classroom, where individualized behavioral management strategies may be difficult for teachers to consistently deliver. Mobile device apps provide promising platforms to manage behavior. This pilot study evaluated the utility of a web-based application (iSelfControl) designed to support classroom behavior management. iSelfControl prompted students every 'Center' (30-minutes) to self-evaluate using a universal token-economy classroom management system focused on compliance, productivity, and positive relationships. Simultaneously, the teacher evaluated each student on a separate iPad. Using Multi Level Modeling, we examined 13 days of data gathered from implementation with 5th grade students (N = 12) at a school for children with ADHD and related executive function difficulties. First, an unconditional growth model evaluated the overall amount of change in aggregated scores over time as well as the degree of systematic variation in scores within and across teacher-student dyads. Second, separate intercepts and slopes were estimated for teacher and student to estimate degree of congruency between trajectories. Finally, differences between teacher and student scores were tested at each time-point in separate models to examine unique 'Center' effects. 51% of the total variance in scores was attributed to differences between dyads. Trajectories of student and teacher scores remained relatively stable across seven time-points each day and did not statistically differ from each other. On any given day, students tended to evaluate their behaviors more positively (entered higher scores for themselves) compared to corresponding teacher scores. In summary, iSelfControl provides a platform for self and teacher evaluation that is an important adjunct to conventional classroom management strategies. The application captured teacher/student discrepancies

  10. Designing an iPad App to Monitor and Improve Classroom Behavior for Children with ADHD: iSelfControl Feasibility and Pilot Studies

    Science.gov (United States)

    Emmerson, Natasha; Ziv, Hadar; Collins, Penelope; Arastoo, Sara; Warschauer, Mark; Crinella, Francis; Lakes, Kimberley

    2016-01-01

    Children with Attention Deficit/Hyperactivity Disorder (ADHD) receive approximately 80% of instruction in the general education classroom, where individualized behavioral management strategies may be difficult for teachers to consistently deliver. Mobile device apps provide promising platforms to manage behavior. This pilot study evaluated the utility of a web-based application (iSelfControl) designed to support classroom behavior management. iSelfControl prompted students every ‘Center’ (30-minutes) to self-evaluate using a universal token-economy classroom management system focused on compliance, productivity, and positive relationships. Simultaneously, the teacher evaluated each student on a separate iPad. Using Multi Level Modeling, we examined 13 days of data gathered from implementation with 5th grade students (N = 12) at a school for children with ADHD and related executive function difficulties. First, an unconditional growth model evaluated the overall amount of change in aggregated scores over time as well as the degree of systematic variation in scores within and across teacher-student dyads. Second, separate intercepts and slopes were estimated for teacher and student to estimate degree of congruency between trajectories. Finally, differences between teacher and student scores were tested at each time-point in separate models to examine unique ‘Center’ effects. 51% of the total variance in scores was attributed to differences between dyads. Trajectories of student and teacher scores remained relatively stable across seven time-points each day and did not statistically differ from each other. On any given day, students tended to evaluate their behaviors more positively (entered higher scores for themselves) compared to corresponding teacher scores. In summary, iSelfControl provides a platform for self and teacher evaluation that is an important adjunct to conventional classroom management strategies. The application captured teacher

  11. The atrial fibrillation ablation pilot study

    DEFF Research Database (Denmark)

    Arbelo, Elena; Brugada, Josep; Hindricks, Gerhard

    2014-01-01

    AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse...... tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib...

  12. Postoperative Neurocognitive Dysfunction in Patients Undergoing Cardiac Surgery after Remote Ischemic Preconditioning: A Double-Blind Randomized Controlled Pilot Study

    Science.gov (United States)

    Meybohm, Patrick; Renner, Jochen; Broch, Ole; Caliebe, Dorothee; Albrecht, Martin; Cremer, Jochen; Haake, Nils; Scholz, Jens; Zacharowski, Kai; Bein, Berthold

    2013-01-01

    Background Remote ischemic preconditioning (RIPC) has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD) in patients undergoing complex cardiac surgery. Methods We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5–7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion) or if the combined Z score was 1.96 or greater (Z score criterion). Results According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5–7 days after surgery (p = 0.753). The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30) compared to the RIPC group (1.14±4.02; p = 0.228). Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19–1.94) µg/L vs. 0.48 (0.07–1.84) µg/L] and 24 hours after surgery [0.36 (0.14–1.89) µg/L vs. 0.26 (0.07–0.90) µg/L]. Conclusions We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. Trial Registration ClinicalTrials.gov NCT00877305 PMID:23741380

  13. Single-Lever Power Control for General Aviation Aircraft Promises Improved Efficiency and Simplified Pilot Controls

    Science.gov (United States)

    Musgrave, Jeffrey L.

    1997-01-01

    General aviation research is leading to major advances in internal combustion engine control systems for single-engine, single-pilot aircraft. These advances promise to increase engine performance and fuel efficiency while substantially reducing pilot workload and increasing flight safety. One such advance is a single-lever power control (SLPC) system, a welcome departure from older, less user-friendly, multilever engine control systems. The benefits of using single-lever power controls for general aviation aircraft are improved flight safety through advanced engine diagnostics, simplified powerplant operations, increased time between overhauls, and cost-effective technology (extends fuel burn and reduces overhaul costs). The single-lever concept has proven to be so effective in preliminary studies that general aviation manufacturers are making plans to retrofit current aircraft with the technology and are incorporating it in designs for future aircraft.

  14. Improving Hand Function in Stroke Survivors: A Pilot Study of Contralaterally Controlled Functional Electrical Stimulation in Chronic Hemiplegia

    Science.gov (United States)

    Knutson, Jayme S.; Harley, Mary Y.; Hisel, Terri Z.; Chae, John

    2014-01-01

    Objective To assess the feasibility of a new stroke rehabilitation therapy for the hemiparetic hand. Design Case series. Pre- and post-intervention assessment with 1 and 3 month follow-ups. Setting Clinical research laboratory of a large public hospital. Participants Three subjects with chronic (> 6 mo post-CVA) upper extremity hemiplegia. Intervention Subjects used an electrical stimulator to cause the paretic hand extensor muscles to contract and thereby open the hand. The subjects controlled the intensity of the stimulation, and thus the degree of hand opening, by volitionally opening the unimpaired contralateral hand, which was detected by an instrumented glove. For 6 weeks the subjects used the stimulator to perform active repetitive hand opening exercises 2 hours daily at home and functional tasks 1½ hours twice a week in the laboratory. Outcome Measures Maximum voluntary finger extension, maximum voluntary isometric finger extension moment, finger movement control, and Box and Block score at pre- and post-treatment, and at 1 month and 3 months post-treatment. Results Maximum voluntary finger extension increased from baseline to end-of-treatment and from end-of-treatment to 1 month follow-up in two subjects. Maximum voluntary isometric finger extension moment, finger movement control, and Box and Block score increased from baseline to end-of-treatment and from end-of-treatment to 1 month follow-up in all 3 subjects. The improvements generally declined at 3 months. Conclusions The results suggest a positive effect on motor impairment, meriting further investigation of the intervention. PMID:17398254

  15. The Relationship between P-Selectin Polymorphisms and Thrombosis in Antiphospholipid Syndrome: A Pilot Case-Control Study

    Directory of Open Access Journals (Sweden)

    Nilüfer Alpay

    2014-12-01

    Full Text Available OBJECTIVE: The selectins are cell adhesion molecules that mediate the interactions among leukocytes, activated platelets, and endothelial cells. We aimed to investigate whether P-selectin polymorphisms are associated with thrombosis in patients with antiphospholipid syndrome (APS. METHODS: The diagnosis and classification of APS were based on the report of an international workshop. Genomic DNA was extracted from citrated blood samples of all subjects. Three single nucleotide polymorphisms associated with the P-selectin coding region (S290N, c.1087G>A; N562D, c.1902G>A; T715P, c.2363A>C were assessed. RESULTS: There were 26 APS (65% patients with thrombosis. The number of patients without thrombosis was 14 (35%. The frequency of the N562D-DN genotype was significantly higher in patients with APS than in healthy controls (p=0.003. The frequency of this genotype was significantly higher in patients with APS with thrombosis compared with patients with no thrombosis (p=0.03. The N562D-NN genotype was found at a higher frequency in patients with APS than in healthy controls (p=0.004. CONCLUSION: Our results suggest that the N562D polymorphism of the DN genotype of P-selectin is associated with an increased risk of thrombosis in patients with APS.

  16. The Relationship between P-Selectin Polymorphisms and Thrombosis in Antiphospholipid Syndrome: A Pilot Case-Control Study.

    Science.gov (United States)

    Alpay, Nilüfer; Hançer, Veysel Sabri; Erer, Burak; İnanç, Murat; Diz-Küçükkaya, Reyhan

    2014-12-05

    The selectins are cell adhesion molecules that mediate the interactions among leukocytes, activated platelets, and endothelial cells. We aimed to investigate whether P-selectin polymorphisms are associated with thrombosis in patients with antiphospholipid syndrome (APS). The diagnosis and classification of APS were based on the report of an international workshop. Genomic DNA was extracted from citrated blood samples of all subjects. Three single nucleotide polymorphisms associated with the P-selectin coding region (S290N, c.1087G>A; N562D, c.1902G>A; T715P, c.2363A>C) were assessed. There were 26 APS (65%) patients with thrombosis. The number of patients without thrombosis was 14 (35%). The frequency of the N562D-DN genotype was significantly higher in patients with APS than in healthy controls (p=0.003). The frequency of this genotype was significantly higher in patients with APS with thrombosis compared with patients with no thrombosis (p=0.03). The N562D-NN genotype was found at a higher frequency in patients with APS than in healthy controls (p=0.004). Our results suggest that the N562D polymorphism of the DN genotype of P-selectin is associated with an increased risk of thrombosis in patients with APS.

  17. Development and Validation of Project Management Constructs of Security Door Access Control Systems: A Pilot Study in Macau

    Directory of Open Access Journals (Sweden)

    Chan Brenda Wing Han

    2016-06-01

    Full Text Available A Security Door Access Control System (SDACS project involves a number of teams from different organizations with diverse project goals. One of the main challenges of such projects is the lack of a standard approach or common understanding to achieve a common goal among project parties. This research examines various management concerns for SDACS projects, highlights the expected common understanding for project participants, develops the project management constructs, and emphasizes on the resulting value of the project to all participants. A two-stage process of scale development and validation was conducted. First, six generic constructs were identified based on the Security Access Control System Framework. Next, a multi-item scale for each construct was developed with reference to the Result-Oriented Management Framework. Expert judges were invited to conduct manual sorting of the items iteratively until reliability and validity was reached. In the next stage, further refinement and validation were carried out with a synthesized survey instrument and a series of statistical testing followed. The finalized SDACS project management constructs and the related findings help reinforce the importance of a standardized management practice for SDACS projects. The value of this research not only benefits SDACS project managers but everyone who works on the project.

  18. Upper airway dimensions in patients with craniocervical junction malformations with and without sleep apnea. A pilot case-control study

    Directory of Open Access Journals (Sweden)

    Ramon Barbalho Guerreiro

    2015-04-01

    Full Text Available Objective Patients with craniocervical junction malformations (CCJM tend to suffer more frequently from sleep respiratory disturbances, which are more frequent and severe in patients with basilar invagination. Here we evaluate if patients with CCJM and sleep respiratory disorders (SRD present smaller airway dimensions than patients without SRD. Method Patients with CCCM with and without sleep respiratory disturbances were evaluated clinically by Bindal's score, modified Mallampati classification, full-night polysomnography and upper airway cone beam tomography. Results Eleven patients had sleep respiratory disorders (SRD, and nine patients performed control group without SRD. CCJM patients with SRD were predominantly female, older, had higher BMI, were more likely to have Mallampati grades 3 and 4 and had statistically significant smaller anteroposterior diameter of the upper airway than patients without SRD. Conclusion Patients with CCJM and sleep respiratory disturbances have higher BMI, higher Mallampati score and smaller anterior posterior diameter of the upper airway.

  19. Acupuncture decreases competitive anxiety prior to a competition in young athletes: a randomized controlled trial pilot study.

    Science.gov (United States)

    Zarei, Sahar; Shayestehfar, Monir; Memari, Amir-Hossein; SeifBarghi, Tohid; Sobhani, Vahid

    2017-03-01

    Background Although a certain level of competitive anxiety may increase performance, many athletes with anxiety experience uncontrolled negative feelings and cognition that in turn can have overwhelming effects on their performance. Methods We aimed to assess the effect of acupuncture on competitive anxiety of the adolescent football players prior to the competition using psychological and physiological markers. A total of 30 athletes were randomly and equally allocated to either acupuncture or sham control group. Results The results of t-test on posttest scores showed that acupuncture had a significant effect on cognitive anxiety (p=0.001) and somatic anxiety (p0.05). Furthermore, the results showed that acupuncture significantly decreased the skin conductance in acupuncture group compared to sham group (p=0.006) (p<0.001). Conclusions In conclusion, the results suggested that acupuncture has the capacity to decrease cognitive and somatic anxiety prior to competition in adolescent athletes while this was accompanied by significant physiological changes.

  20. Comparison of embedded and added motor imagery training in patients after stroke: study protocol of a randomised controlled pilot trial using a mixed methods approach

    Directory of Open Access Journals (Sweden)

    Andrews Brian

    2009-10-01

    Full Text Available Abstract Background Two different approaches have been adopted when applying motor imagery (MI to stroke patients. MI can be conducted either added to conventional physiotherapy or integrated within therapy sessions. The proposed study aims to compare the efficacy of embedded MI to an added MI intervention. Evidence from pilot studies reported in the literature suggests that both approaches can improve performance of a complex motor skill involving whole body movements, however, it remains to be demonstrated, which is the more effective one. Methods/Design A single blinded, randomised controlled trial (RCT with a pre-post intervention design will be carried out. The study design includes two experimental groups and a control group (CG. Both experimental groups (EG1, EG2 will receive physical practice of a clinical relevant motor task ('Going down, laying on the floor, and getting up again' over a two week intervention period: EG1 with embedded MI training, EG2 with MI training added after physiotherapy. The CG will receive standard physiotherapy intervention and an additional control intervention not related to MI. The primary study outcome is the time difference to perform the task from pre to post-intervention. Secondary outcomes include level of help needed, stages of motor task completion, degree of motor impairment, balance ability, fear of falling measure, motivation score, and motor imagery ability score. Four data collection points are proposed: twice during baseline phase, once following the intervention period, and once after a two week follow up. A nested qualitative part should add an important insight into patients' experience and attitudes towards MI. Semi-structured interviews of six to ten patients, who participate in the RCT, will be conducted to investigate patients' previous experience with MI and their expectations towards the MI intervention in the study. Patients will be interviewed prior and after the intervention period

  1. Physiotherapy and a Homeopathic Complex for Chronic Low Back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study

    OpenAIRE

    Pellow, Janice

    2016-01-01

    Abstract:Context: Osteoarthritis (OA) is a common cause of chronic low back pain (CLBP) and can be managed with the use of drug therapy and physiotherapy. Homeopathic remedies may assist in the management of OA; however, research that supports their effectiveness is limited. Objectives: The study aimed to investigate the efficacy of a homeopathic complex in combination with physiotherapy in the treatment of CLBP due to OA. Design: The study was a six-week, randomized, double-blind, placebo-co...

  2. Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training:A randomized controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    Sachin Wankhede; Vishwaraman Mohan; Prasad Thakurdesai

    2016-01-01

    Purpose: To evaluate the efficacy and safety of the glycoside fraction of fenugreek (Trigonella foenum-graecum) seeds (Fenu-FG) on physiologi-cal parameters related to muscle anabolism, androgenic hormones, and body fat in healthy male subjects during an 8-week resistance training program using a prospective, randomized, double-blind, placebo controlled design. Methods: Sixty healthy male subjects were randomized to ingest capsules of Fenu-FG (1 capsule of 300 mg, twice per day) or the matching placebo at a 1:1 ratio. The subjects participated in a supervised 4-day per week resistance-training program for 8 weeks. The outcome measurements were recorded at recruitment (baseline) and at the end of the treatment (8 weeks). The efficacy outcome included serum testosterone (total and free) levels, muscle strength and repetitions to failure, metabolic markers for anabolic activity (serum creatinine and blood urea nitrogen), and % body fat. The standard safety measurements such as adverse events monitoring, vital signs, hematology, biochemistry, and urinalysis were performed. Results: Fenu-FG supplementation demonstrated significant anabolic and androgenic activity as compared with the placebo. Fenu-FG treated subjects showed significant improvements in body fat without a reduction in muscle strength or repetitions to failure. The Fenu-FG supplemen-tation was found to be safe and well-tolerated. Conclusion: Fenu-FG supplementation showed beneficial effects in male subjects during resistance training without any clinical side effects.

  3. Multivariate proteomic analysis of the cerebrospinal fluid of patients with peripheral neuropathic pain and healthy controls – a hypothesis-generating pilot study

    Directory of Open Access Journals (Sweden)

    Bäckryd E

    2015-07-01

    -generating pilot study have to be confirmed in larger, hypothesis-driven studies with age-matched controls, but the present study illustrates the fruitfulness of combining proteomics with multivariate data analysis in hypothesis-generating pain biomarker studies in humans. Keywords: cerebrospinal fluid, multivariate data analysis, neuropathic pain, proteomics

  4. Microbial field pilot study. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m{sup 3}) of tertiary oil have been recovered. Microbial activity has increased CO{sub 2} content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  5. A pilot study testing a natural and a synthetic molluscicide for controlling invasive apple snails (Pomacea maculata)

    Science.gov (United States)

    Pomacea maculata (formerly P. insularum), an apple snail native to South America, was discovered in Louisiana in 2008. These snails strip vegetation, reproduce at tremendous rates, and have reduced rice production and caused ecosystem changes in Asia. In this study snails were exposed to two mollusc...

  6. Improving the Mental Health, Healthy Lifestyle Choices, and Physical Health of Hispanic Adolescents: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Melnyk, Bernadette M.; Jacobson, Diana; Kelly, Stephanie; O'Haver, Judith; Small, Leigh; Mays, Mary Z.

    2009-01-01

    Background: Obesity and mental health disorders are 2 major public health problems in American adolescents, with prevalence even higher in Hispanic teens. Despite the rapidly increasing incidence and adverse health outcomes associated with overweight and mental health problems, very few intervention studies have been conducted with adolescents to…

  7. Effects of Mobile Augmented Reality Learning Compared to Textbook Learning on Medical Students: Randomized Controlled Pilot Study

    Science.gov (United States)

    2013-01-01

    Background By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. Objective To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). Methods A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the “Profile of Mood States” questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Results Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a

  8. Training symmetry of weight distribution after stroke: a randomized controlled pilot study comparing task-related reach, Bobath and feedback training approaches.

    Science.gov (United States)

    Mudie, M H; Winzeler-Mercay, U; Radwan, S; Lee, L

    2002-09-01

    To determine (1) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and (2) whether improvements could be generalized to weight distribution in standing. Inpatient rehabilitation unit. Forty asymmetrical acute stroke subjects were randomly allocated to one of four groups in this pilot study. Changes in weight distribution were compared between the 10 subjects of each of three treatment groups (task-specific reach, Bobath, or Balance Performance Monitor [BPM] feedback training) and a no specific treatment control group. One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was randomly allocated. Measurements were performed using the BPM daily before treatment sessions, two weeks after cessation of treatment and 12 weeks post study. Weight distribution was calculated in terms of mean balance (percentage of total body weight) or the mean of 300 balance points over a 30-s data run. In the short term, the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke (p = 0.004). Training with the BPM and no training were also significant (p = 0.038 and p = 0.035 respectively) and task-specific reach training failed to reach significance (p = 0.26). At 12 weeks post study 83% of the BPM training group, 38% of the task-specific reach group, 29% of the Bobath group and 0% of the untrained group were found to be distributing their weight to both sides. Some generalization of symmetry training in sitting to standing was noted in the BPM training group which appeared to persist long term. Results should be treated with caution due to the small group sizes. However, these preliminary findings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position.

  9. Pilot study of feasibility of a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy.

    Science.gov (United States)

    Riley, Judith; Hunt, Anna; McDouall, Alice; Waqanivavalagi, Steve; Braithwaite, Irene; Weatherall, Mark; Stanley, Thorsten; Beasley, Richard; Mitchell, Edwin A; Dalziel, Stuart R

    2016-10-14

    To undertake a randomised controlled trial (RCT) of paracetamol versus ibuprofen use during infancy to determine if paracetamol is associated with an increased risk of developing asthma, the preferred method of recruitment needs to be determined. We assessed three different recruitment domains to determine the likely enrolment rates of newborn infants into a three-year or six-year RCT of paracetamol versus ibuprofen and the development of asthma symptoms. The proposed RCT would require 1,806 participants. A questionnaire was administered to a convenience sample of Auckland and Wellington based parents/guardians within three different recruitment domains: antenatal classes, postnatal wards and six-week well-child visits at primary healthcare centres. Over a twelve-week period 19/586 (3.2%), 196/861 (22.8%), and 0/110 (0%) questionnaires were completed by parents/guardians of newborn infants in antenatal, postnatal and primary healthcare domains. In the postnatal recruitment domain, the likelihood of newborn infants being enrolled in the proposed RCT was rated 'very likely', 'likely' and 'neutral' by 15 (8%, CI 4-12%), 65 (33%, CI 26-40%) and 64 (33%, CI 25-39%) of respondents for a RCT of three years duration; and by 5 (3%, CI 1-5%), 37 (19%, CI 14-25%) and 59 (30%, CI 24-36%) of respondents respectively for a RCT of six years duration. Postnatal wards are expected to be the most successful recruitment domain for the proposed RCT, likely a reflection of the face-to-face direct recruitment by researchers. It appears feasible to recruit into the proposed RCT using three large New Zealand tertiary hospitals.

  10. A randomized controlled pilot study of outcomes of strict allowance of fluid therapy in hyponatremic heart failure (SALT-HF).

    Science.gov (United States)

    Albert, Nancy M; Nutter, Benjamin; Forney, Jennifer; Slifcak, Ellen; Tang, W H Wilson

    2013-01-01

    Currently, fluid restriction recommendations in heart failure (HF) are based on expert opinion. After implementing a 1,000-mL/d fluid restriction for 60 days after discharge, outcomes were examined. In a randomized controlled design, hyponatremic patients (serum sodium ≤137 mg/dL) received usual care (UC; n = 26) or 1,000 mL/d fluid restriction (n = 20) at discharge. Quality of life (QoL), thirst, difficulty following fluid recommendations, adherence to fluid restriction, HF emergency care, HF rehospitalization, and all-cause death were examined. Mean age was 62.8 ± 12.8 years; 46% were white. There were no differences by group in baseline demographics, comorbidities, and QoL, except that more UC patients had New York Heart Association (NYHA) functional class III/IV status (P = .019). Median [interquartile range] QoL scores were better in the 1,000 mL/d group for symptom burden (83.3 [68.8-91.7] vs 50 [29.2-79.2]; P = .018), total symptoms (77.1 [58.1-91.7] vs 54.2 [30.2-73.9]; P = .022), overall QoL summary (72.6 [52.2-86.3] vs 51.0 [37.7-68.5]; P = .038), and clinical QoL summary (75.5 [57.8-92.9] vs 59.1 [35.7-77.3]; P = .039). There were no group differences in thirst, difficulty adhering to fluid recommendations, adherence to fluid restriction, or health care consumption. The 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge. Future research in a larger more heterogeneous sample is needed. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Efficacy of High Intensity Exercise on Disease Activity and Cardiovascular Risk in Active Axial Spondyloarthritis: A Randomized Controlled Pilot Study

    OpenAIRE

    Silje Halvorsen Sveaas; Inger Jorid Berg; Sella Aarrestad Provan; Anne Grete Semb; Kåre Birger Hagen; Nina Vøllestad; Camilla Fongen; Inge C Olsen; Annika Michelsen; Thor Ueland; Pål Aukrust; Kvien, Tore K; Hanne Dagfinrud

    2014-01-01

    BACKGROUND: Physical therapy is recommended for the management of axial spondyloarthritis (axSpA) and flexibility exercises have traditionally been the main focus. Cardiovascular (CV) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases. Therefore, the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patien...

  12. Interleukin-1 Blockade in Acute Decompensated Heart Failure: A Randomized, Double-Blinded, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Van Tassell, Benjamin W; Abouzaki, Nayef A; Oddi Erdle, Claudia; Carbone, Salvatore; Trankle, Cory R; Melchior, Ryan D; Turlington, Jeremy S; Thurber, Clinton J; Christopher, Sanah; Dixon, Dave L; Fronk, Daniel T; Thomas, Christopher S; Rose, Scott W; Buckley, Leo F; Dinarello, Charles A; Biondi-Zoccai, Giuseppe; Abbate, Antonio

    2016-06-01

    Heart failure is an inflammatory disease. Patients with acute decompensated heart failure (ADHF) exhibit significant inflammatory activity on admission. We hypothesized that Interleukin-1 blockade, with anakinra (Kineret, Swedish Orphan Biovitrum), would quench the acute inflammatory response in patients with ADHF. We randomized 30 patients with ADHF, reduced left ventricular ejection fraction (Interleukin-1 blockade with anakinra reduces the systemic inflammatory response in patients with ADHF. Further studies are warranted to determine whether this anti-inflammatory effect translates into improved clinical outcomes.

  13. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial

    OpenAIRE

    Kim, Joo-Hee; Jung, Hyun Jung; Kim, Tae-Hun; Lee, Seunghoon; Kim, Jung-Eun; Kang, Kyung-Won; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Shin, Mi-Suk; Shin, Kyung-Min; Jung, Hee-Jung; Lee, Seung-Deok; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-01-01

    Background Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised c...

  14. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study

    Directory of Open Access Journals (Sweden)

    Franciska Gyulai

    2015-01-01

    Full Text Available Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee.

  15. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study.

    Science.gov (United States)

    Gyulai, Franciska; Rába, Katalin; Baranyai, Ildikó; Berkes, Enikő; Bender, Tamás

    2015-01-01

    Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee.

  16. Eye Movement Desensitization and Reprocessing (EMDR Versus Treatment as Usual for Non-Specific Chronic Back Pain Patients with Psychological Trauma: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Andreas Gerhardt

    2016-12-01

    Full Text Available Objective: Eye-Movement-Desensitization and Reprocessing (EMDR – an evidence-based approach to eliminate emotional distress from traumatic experiences – was recently suggested for the treatment of chronic pain. Aim of this study was to estimate preliminary efficacy of a pain-focused EMDR intervention for the treatment of non-specific chronic back pain.Design: Randomized controlled pilot study.Methods: Forty non-specific chronic back pain patients reporting previous experiences of psychological trauma were consecutively recruited from outpatient tertiary-care pain centers. After baseline assessment, patients were randomized to intervention or control group (1:1. The intervention group received ten sessions standardized pain-focused EMDR in addition to treatment-as-usual. The control group received treatment-as-usual alone.The primary outcome was preliminary efficacy, measured by pain intensity, disability, and treatment satisfaction from the patients' perspective. Clinical relevance of changes was determined according to established recommendations. Assessments were conducted at the baseline, post-treatment, and at a 6-month follow-up. Intention-to-treat-analysis with last-observation-carried-forward method was used. Registered with ClinicalTrials.gov (NCT01850875.Results: Estimated effect sizes (between-group, pooled standard deviation for pain intensity and disability were d=0.79 (CI95%: 0.13, 1.42 and d=0.39 (CI95%: -0.24, 1.01 post-treatment, and d=0.50 (CI95%: 0.14, 1.12 and d=0.14 (CI95%: -0.48, 0.76 at 6-month follow-up. Evaluation on individual patient basis showed that about 50% of the patients in the intervention group improved clinically relevant and also rated their situation as clinically satisfactory improved, compared to zero patients in the control group.Conclusions: There is preliminary evidence that pain-focused EMDR might be useful for non-specific chronic back pain patients with previous experiences of psychological trauma

  17. The effects of aquatic trunk exercise on gait and muscle activity in stroke patients: a randomized controlled pilot study.

    Science.gov (United States)

    Park, Byoung-Sun; Noh, Ji-Woong; Kim, Mee-Young; Lee, Lim-Kyu; Yang, Seung-Min; Lee, Won-Deok; Shin, Yong-Sub; Kim, Ju-Hyun; Lee, Jeong-Uk; Kwak, Taek-Yong; Lee, Tae-Hyun; Kim, Ju-Young; Park, Jaehong; Kim, Junghwan

    2015-11-01

    [Purpose] The purpose of this study was to investigate the relationship between muscle activity and gait function following aquatic trunk exercise in hemiplegic stroke patients. [Subjects and Methods] This study's participants included thirteen hemiplegic patients (ten males and three females). The aquatic therapy consisted of administering concentrative aquatic therapy for four weeks in a therapeutic pool. Gait parameters were measured using a gait analysis system adjusted to each subject's comfortable walking speed. Electromyographic signals were measured for the rectus abdominis, external abdominal oblique, transversus abdominis/internal-abdominal oblique, and erector spine of each patients. [Results] The pre- and post-training performances of the transversus abdominis/internal-abdominal oblique were compared statistically. There was no statistical difference between the patients' pre- and post-training values of maximal voluntary isometric contraction of the rectus abdominis, but the external abdominal oblique values tended to improve. Furthermore, gait factors improved significantly in terms of walking speeds, walking cycles, affected-side stance phases, affected-stride lengths, and stance-phase symmetry indices, respectively. [Conclusion] These results suggest that the trunk exercise during aquatic therapy may in part contribute to clinically relevant improvements in muscle activities and gait parameters.

  18. Focused and Radial Shock Wave Therapy in the Treatment of Tennis Elbow: A Pilot Randomised Controlled Study

    Directory of Open Access Journals (Sweden)

    Król Piotr

    2015-09-01

    Full Text Available The purpose of this article was to evaluate and compare the efficacy of radial and focused shock wave therapies applied to treat tennis elbow. Patients with tennis elbow were randomized into two comparative groups: focused shock wave therapy (FSWT; n=25 and radial shock wave therapy (RSWT; n=25. Subjects in the FSWT and RSWT groups were applied with a focused shock wave (3 sessions, 2000 shocks, 4 Hz, 0.2 mJ/mm2 and a radial shock wave (3 sessions, 2000 + 2000 shocks, 8 Hz, 2.5 bar, respectively. The primary study endpoints were pain relief and functional improvement (muscle strength one week after therapy. The secondary endpoint consisted of the results of the follow-up observation (3, 6 and 12 weeks after the study. Successive measurements showed that the amount of pain patients felt decreased in both groups. At the same time grip strength as well as strength of wrist extensors and flexors of the affected extremity improved significantly. Both focused and radial shock wave therapies can comparably and gradually reduce pain in subjects with tennis elbow. This process is accompanied by steadily improved strength of the affected extremity.

  19. Focused and Radial Shock Wave Therapy in the Treatment of Tennis Elbow: A Pilot Randomised Controlled Study.

    Science.gov (United States)

    Król, Piotr; Franek, Andrzej; Durmała, Jacek; Błaszczak, Edward; Ficek, Krzysztof; Król, Barbara; Detko, Ewa; Wnuk, Bartosz; Białek, Lidia; Taradaj, Jakub

    2015-09-29

    The purpose of this article was to evaluate and compare the efficacy of radial and focused shock wave therapies applied to treat tennis elbow. Patients with tennis elbow were randomized into two comparative groups: focused shock wave therapy (FSWT; n=25) and radial shock wave therapy (RSWT; n=25). Subjects in the FSWT and RSWT groups were applied with a focused shock wave (3 sessions, 2000 shocks, 4 Hz, 0.2 mJ/mm(2)) and a radial shock wave (3 sessions, 2000 + 2000 shocks, 8 Hz, 2.5 bar), respectively. The primary study endpoints were pain relief and functional improvement (muscle strength) one week after therapy. The secondary endpoint consisted of the results of the follow-up observation (3, 6 and 12 weeks after the study). Successive measurements showed that the amount of pain patients felt decreased in both groups. At the same time grip strength as well as strength of wrist extensors and flexors of the affected extremity improved significantly. Both focused and radial shock wave therapies can comparably and gradually reduce pain in subjects with tennis elbow. This process is accompanied by steadily improved strength of the affected extremity.

  20. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

  1. Temperature Control of a Pilot Anaerobic Digestion Reactor

    Directory of Open Access Journals (Sweden)

    Finn Haugen

    2013-07-01

    Full Text Available Results of analysis and design and implementation of a temperature controlsystem for a practical pilot anaerobic digestion (AD bioreactor fed with dairywaste are presented. A dynamic model of the reactor temperature is used asthe basis for theoretical results, including simulations. Controller functionsinclude on-off control, proportional plus integral (PI control, andfeedforward control. Various PI controller tuning methods are compared. Theneed for adaptivity of PI settings is investigated. Results for asimulated full-scale reactor are given.

  2. Pilot plant study for ethanol production

    Energy Technology Data Exchange (ETDEWEB)

    Kim, J.S. [Korea Inst. of Science and Technology, Seoul (Korea, Republic of)

    1996-02-01

    Most of domestic alcohol fermentation factory adopt batch process of which productivity is lower than continuous fermentation process. They have made great effort to increase productivity by means of partial unit process automatization and process improvement with their accumulated experience but there is technical limitation in productivity of batch fermentation process. To produce and supply fuel alcohol, economic aspects must be considered first of all. Therefore, development of continuous fermentation process, of which productivity is high, is prerequisite to produce and use fuel alcohol but only a few foreign company possess continuous fermentation technic and use it in practical industrial scale fermentation. We constructed pilot plant (5 Stage CSTR 1 kl 99.5 v/v% ethanol/Day scale) to study some aspects stated below and our ultimate aims are production of industrial scale fuel alcohol and construction of the plant by ourselves. Some study concerned with energy saving separation and contamination control technic were entrusted to KAIST, A-ju university and KIST respectively. (author) 67 refs., 100 figs., 58 tabs.

  3. RNA sequencing shows transcriptomic changes in rectosigmoid mucosa in patients with irritable bowel syndrome-diarrhea: a pilot case-control study.

    Science.gov (United States)

    Camilleri, Michael; Carlson, Paula; Acosta, Andres; Busciglio, Irene; Nair, Asha A; Gibbons, Simon J; Farrugia, Gianrico; Klee, Eric W

    2014-06-15

    Our aim was to conduct a pilot case-control study of RNA expression profile using RNA sequencing of rectosigmoid mucosa of nine females with -diarrhea-predominant irritable bowel syndrome (IBS-D) with accelerated colonic transit and nine female healthy controls. Mucosal total RNA was isolated and purified, and next-generation pair-end sequencing was performed using Illumina TruSeq. Analysis was carried out using a targeted approach toward 12 genes previously associated with IBS and a hypothesis-generating approach. Of the 12 targeted genes tested, patients with IBS-D had decreased mRNA expression of TNFSF15 (fold change controls to IBS-D: 1.53, P = 0.01). Overall, up- and downregulated mRNA expressions of 21 genes (P = 10(-5) to 10(-8); P values with false detection rates are shown) were potentially relevant to IBS-D including the following: neurotransmitters [P2RY4 (P = 0.001), vasoactive intestinal peptide (VIP, P = 0.02)]; cytokines [CCL20 (P = 0.019)]; immune function [C4BPA complement cascade (P = 0.0187)]; interferon-related [IFIT3 (P = 0.016)]; mucosal repair and cell adhesion [trefoil protein (TFF1, P = 0.012)], retinol binding protein [RBP2 (P = 0.017)]; fibronectin (FN1, P = 0.009); and ion channel functions [guanylate cyclase (GUCA2B, P = 0.017), PDZ domain-containing protein 3 (PDZD3, P = 0.029)]. Ten genes associated with functions related to pathobiology of IBS-D were validated by RT-PCR. There was significant correlation in fold changes of the selected genes (Rs = 0.73, P = 0.013). Up- or downregulation of P2RY4, GUC2AB, RBP2, FNI, and C4BPA genes were confirmed on RT-PCR, which also revealed upregulation of farnesoid X receptor (FXR) and apical sodium-coupled bile acid transporter (IBAT/ASBT). RNA-Seq and RT-PCR analysis of rectosigmoid mucosa in IBS-D show transcriptome changes that provide the rationale for validation studies to explore the role of mucosal factors in the pathobiology of IBS-D.

  4. Predicting Loss-of-Control Boundaries Toward a Piloting Aid

    Science.gov (United States)

    Barlow, Jonathan; Stepanyan, Vahram; Krishnakumar, Kalmanje

    2012-01-01

    This work presents an approach to predicting loss-of-control with the goal of providing the pilot a decision aid focused on maintaining the pilot's control action within predicted loss-of-control boundaries. The predictive architecture combines quantitative loss-of-control boundaries, a data-based predictive control boundary estimation algorithm and an adaptive prediction method to estimate Markov model parameters in real-time. The data-based loss-of-control boundary estimation algorithm estimates the boundary of a safe set of control inputs that will keep the aircraft within the loss-of-control boundaries for a specified time horizon. The adaptive prediction model generates estimates of the system Markov Parameters, which are used by the data-based loss-of-control boundary estimation algorithm. The combined algorithm is applied to a nonlinear generic transport aircraft to illustrate the features of the architecture.

  5. Feasibility of the “Bring Your Own Device” Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool

    Science.gov (United States)

    Pugliese, Laura; Woodriff, Molly; Crowley, Olga; Sohn, Jeremy; Bradley, Scott

    2016-01-01

    Background Rising rates of smartphone ownership highlight opportunities for improved mobile application usage in clinical trials. While current methods call for device provisioning, the "bring your own device” (BYOD) model permits participants to use personal phones allowing for improved patient engagement and lowered operational costs. However, more evidence is needed to demonstrate the BYOD model’s feasibility in research settings. Objective To assess if CentrosHealth, a mobile application designed to support trial compliance, produces different outcomes in medication adherence and application engagement when distributed through study-provisioned devices compared to the BYOD model. Methods 87 participants were randomly selected to use the mobile application or no intervention for a 28-day pilot study at a 2:1 randomization ratio (2 intervention: 1 control) and asked to consume a twice-daily probiotic supplement. The application users were further randomized into two groups: receiving the application on a personal "BYOD” or study-provided smartphone. In-depth interviews were performed in a randomly-selected subset of the intervention group (five BYOD and five study-provided smartphone users). Results The BYOD subgroup showed significantly greater engagement than study-provided phone users, as shown by higher application use frequency and duration over the study period. The BYOD subgroup also demonstrated a significant effect of engagement on medication adherence for number of application sessions (unstandardized regression coefficient beta=0.0006, p=0.02) and time spent therein (beta=0.00001, p=0.03). Study-provided phone users showed higher initial adherence rates, but greater decline (5.7%) than BYOD users (0.9%) over the study period. In-depth interviews revealed that participants preferred the BYOD model over using study-provided devices.  Conclusions Results indicate that the BYOD model is feasible in health research settings and improves participant

  6. A randomized, controlled pilot study of MDMA (± 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD).

    Science.gov (United States)

    Oehen, Peter; Traber, Rafael; Widmer, Verena; Schnyder, Ulrich

    2013-01-01

    Psychiatrists and psychotherapists in the US (1970s to 1985) and Switzerland (1988-1993) used MDMA legally as a prescription drug, to enhance the effectiveness of psychotherapy. Early reports suggest that it is useful in treating trauma-related disorders. Recently, the first completed pilot study of MDMA-assisted psychotherapy for PTSD yielded encouraging results. Designed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD; our randomized, double-blind, active-placebo controlled trial enrolled 12 patients for treatment with either low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose). MDMA was administered during three experimental sessions, interspersed with weekly non-drug-based psychotherapy sessions. Outcome measures used were the Clinician-Administered PTSD Scale (CAPS) and the Posttraumatic Diagnostic Scale (PDS). Patients were assessed at baseline, three weeks after the second and third MDMA session (end of treatment), and at the 2-month and 1-year follow-ups. We found that MDMA-assisted psychotherapy can be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in CAPS scores (p = 0.066), although there was clinically and statistically significant self-reported (PDS) improvement (p = 0.014). CAPS scores improved further at the 1-year follow-up. In addition, three MDMA sessions were more effective than two (p = 0.016).

  7. Cytogenetics of jaw cysts - a pilot study.

    Science.gov (United States)

    Manor, Esther; Brennan, Peter A; Bodner, Lipa

    2012-07-01

    The pathogenesis of cysts that arise in the jaws is still not certain, and the underlying mechanisms of epithelial proliferation are not fully understood. Cysts of the jaw may involve a reactive, inflammatory, or neoplastic process. Cytogenetics, the study of the number and structure of chromosomes, has provided valuable information about the diagnosis, prognosis, and targeted treatment in many cancers, including oral squamous cell carcinoma. Cytogenetics can also provide information about the possible aetiology or neoplastic potential of a lesion, though to our knowledge no studies of this technique have been used for cysts in the jaws. In this pilot study we used cytogenetics in a series of 10 cysts (3 radicular, 4 dentigerous, 2 of the nasopalatine duct, and 1 dermoid). In all cases we found normal karyotypes. Further work and larger numbers are needed for a definitive study, but we can hypothesise from this pilot study that these cysts do not have cytogenetic aberrations and so have no neoplastic potential.

  8. A Study of the Effects of Latent Iron Deficiency on Measures of Cognition: A Pilot Randomised Controlled Trial of Iron Supplementation in Young Women

    Directory of Open Access Journals (Sweden)

    Alecia J. Leonard

    2014-06-01

    Full Text Available Rates of iron deficiency are high amongst healthy young women. Cognitive impairment occurs secondary to iron deficiency in infants and children, but evaluation of the impact on cognition among young women is inconsistent. The aim was to determine the suitability of the IntegNeuro test battery for assessing cognitive function in iron-deficient and iron-sufficient young women. A pilot double-blinded, placebo-controlled intervention trial was conducted in iron-deficient (serum ferritin ≤ 20 μg/L and haemoglobin > 120 g/L and iron-sufficient young women (18–35 years. Cognitive function and haematological markers of iron status were measured at baseline and follow-up. Iron-deficient participants (n = 24 were randomised to receive placebo, 60 mg or 80 mg elemental iron daily supplements for 16 weeks. A control group of iron-sufficient participants (n = 8 was allocated to placebo. Change scores for Impulsivity and Attention were significantly greater in plasma ferritin improvers than in non-improvers (p = 0.004, p = 0.026. IntegNeuro was easy to administer and acceptable to young women. Based on the differences in Memory and Attention scores between iron-deficient participants on iron treatment and those on placebo, it was decided that between 26 and 84 participants would be required in each iron treatment group for an adequately powered extension of this pilot RCT.

  9. Linking the global positioning system (GPS to a personal digital assistant (PDA to support tuberculosis control in South Africa: a pilot study

    Directory of Open Access Journals (Sweden)

    McIntyre James A

    2006-08-01

    Full Text Available Abstract Background Tuberculosis (TB is the leading clinical manifestation of HIV infection and caseloads continue to increase in high HIV prevalence settings. TB treatment is prolonged and treatment interruption has serious individual and public health consequences. We assessed the feasibility of using a handheld computing device programmed with customised software and linked to a GPS receiver, to assist TB control programmes to trace patients who interrupt treatment in areas without useful street maps. In this proof of concept study, we compared the time taken to re-find a home comparing given residential addresses with a customised personalised digital assistant linked to a global positioning system (PDA/GPS device. Additionally, we assessed the feasibility of using aerial photographs to locate homes. Results The study took place in two communities in Greater Johannesburg, South Africa: Wheillers Farm, a relatively sparsely populated informal settlement, and a portion of Alexandra, an urban township with densely populated informal settlements. Ten participants in each community were asked to locate their homes on aerial photographs. Nine from Wheillers Farm and six from Alexandra were able to identify their homes. The total time taken by a research assistant, unfamiliar with the area, to locate 10 homes in each community using the given addresses was compared with the total time taken by a community volunteer with half an hour of training to locate the same homes using the device. Time taken to locate the ten households was reduced by 20% and 50% in each community respectively using the PDA/GPS device. Conclusion In this pilot study we show that it is feasible to use a simple PDA/GPS device to locate the homes of patients. We found that in densely populated informal settlements, GPS technology is more accurate than aerial photos in identifying homes and more efficient than addresses provided by participants. Research assessing issues of

  10. Efficacy of Deep Dry Needling on Latent Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain: A Randomized, Controlled Clinical Trial Pilot Study

    Science.gov (United States)

    Pacheco-da-Costa, Soraya; Hita-Herranz, Edgar

    2017-01-01

    Background: Nonspecific shoulder pain has a high prevalence in older adults and causes functional alterations. Furthermore, there are difficulties in establishing a clinical diagnosis, effective treatments are lacking, and little evidence has been found regarding the use of invasive physical therapy techniques in this age group. Purpose: To determine the efficacy of a single physical therapy intervention with deep dry needling (DDN) on latent and active myofascial trigger points (MTrPs) in older adults with nonspecific shoulder pain. Methods: This pilot study is a single-blind, randomized, controlled clinical trial that included 20 participants, aged 65 years and older, who were diagnosed with nonspecific shoulder pain. The study was approved by the Clinical Research Ethics Committee of the area. Participants were recruited at their homes or at a care center and were randomly assigned into either an experimental group (n = 10), which received a session of DDN on 1 active and 1 latent MTrP of the infraspinatus muscle, or a control group (n = 10), which received a session of DDN on only 1 active MTrP. A blind examiner assessed the pain intensity, pain pressure threshold on the anterior deltoid, and extensor carpi radialis brevis muscles and grip strength before, immediately after, and 1 week after the intervention. Results: Statistically significant differences (P < .05) in the pressure pain thresholds (PPTs) of the extensor carpi radialis brevis were found in the experimental group in both posttreatment assessments. Moreover, the effect size values (d Cohen) varied from small for grip strength (0.017-0.36) to moderate for the pain intensity (0.46-0.78) and PPT in the anterior deltoid (0.49-0.66) and to large for the PPT in the extensor carpi radialis brevis (1.06-1.58). Conclusions: A single physical therapy intervention with DDN on 1 latent MTrP, in conjunction with 1 active MTrP, in the infraspinatus muscle may increase the PPT of the extensor carpi radialis

  11. Efficacy of Deep Dry Needling on Latent Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain: A Randomized, Controlled Clinical Trial Pilot Study.

    Science.gov (United States)

    Calvo-Lobo, César; Pacheco-da-Costa, Soraya; Hita-Herranz, Edgar

    Nonspecific shoulder pain has a high prevalence in older adults and causes functional alterations. Furthermore, there are difficulties in establishing a clinical diagnosis, effective treatments are lacking, and little evidence has been found regarding the use of invasive physical therapy techniques in this age group. To determine the efficacy of a single physical therapy intervention with deep dry needling (DDN) on latent and active myofascial trigger points (MTrPs) in older adults with nonspecific shoulder pain. This pilot study is a single-blind, randomized, controlled clinical trial that included 20 participants, aged 65 years and older, who were diagnosed with nonspecific shoulder pain. The study was approved by the Clinical Research Ethics Committee of the area. Participants were recruited at their homes or at a care center and were randomly assigned into either an experimental group (n = 10), which received a session of DDN on 1 active and 1 latent MTrP of the infraspinatus muscle, or a control group (n = 10), which received a session of DDN on only 1 active MTrP. A blind examiner assessed the pain intensity, pain pressure threshold on the anterior deltoid, and extensor carpi radialis brevis muscles and grip strength before, immediately after, and 1 week after the intervention. Statistically significant differences (P < .05) in the pressure pain thresholds (PPTs) of the extensor carpi radialis brevis were found in the experimental group in both posttreatment assessments. Moreover, the effect size values (d Cohen) varied from small for grip strength (0.017-0.36) to moderate for the pain intensity (0.46-0.78) and PPT in the anterior deltoid (0.49-0.66) and to large for the PPT in the extensor carpi radialis brevis (1.06-1.58). A single physical therapy intervention with DDN on 1 latent MTrP, in conjunction with 1 active MTrP, in the infraspinatus muscle may increase the PPT of the extensor carpi radialis brevis muscle area immediately following and 1 week after

  12. Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

    Directory of Open Access Journals (Sweden)

    Ayansina Dolapo

    2011-03-01

    Full Text Available Abstract Background Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. Methods Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS Boards for 6 months. Eligible patients are all women who are: (1 aged between 18 and 65 years; (2 in paid employment or self-employed; (3 living or working in Lothian or Tayside, Scotland, UK; (4 diagnosed with an invasive breast cancer tumour; (5 treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B, fatigue (FACIT-Fatigue and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. Discussion To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and

  13. A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

    Directory of Open Access Journals (Sweden)

    Tourangeau Ann

    2008-12-01

    Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This

  14. A web delivered intervention for depression combining Behavioural Activation with physical activity promotion: study protocol for a pilot randomised controlled trial

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    Jeffrey David Lambert

    2015-10-01

    Full Text Available Background: Physical activity (PA yields moderate effect sizes for treating depression (Cooney et al., 2013. PA may also help reduce depressive relapse, providing additional psychological benefits such as positive self-regard and a sense of competence (Babyak et al., 2000. Behavioural Activation (BA is an evidence-based psychological therapy for depression, which aims to get people more engaged with activities that provide positive reinforcement for non-depressed behaviours (Hopko, Lejuez, LePage, Hopko, & McNeil, 2003. The structured nature of BA is consistent with the use of good behaviour change techniques (specific goal-setting, self-regulation offering a potential platform for promoting PA alongside depression treatment. BA may also be useful for gradually increasing PA in people who are more sedentary than the general population. Aims: This pilot randomised controlled trial aims to assess the feasibility, acceptability, and fidelity of a web-delivered intervention combining BA and PA (eBAcPAc to enhance mental and physical health, and assess the trial methods. Method: A community sample of 120 people exhibiting symptoms of depression and who are participating in less than 150 minutes of moderate to vigorous physical activity per week will be randomized to receive eBAcPAc or be put on a wait list control group. eBAcPAc is informed by previous work (Farrand et al., 2014; Pentecost et al., 2015 and further developed using the Centre for eHealth Research and Disease management Roadmap (CeHReS (van Gemert-Pijnen et al., 2011 in order to be applied in an web-based setting. A platform hosted by the University of Glasgow which has been used to deliver a wide range of successful web-delivered interventions for mental health, will be used to deliver eBAcPAc. Feasibility measures will include data on recruitment, attrition and acceptability. Pre-post outcome measures will include the PHQ-9, and self-reported and accelerometer measured PA. Process and

  15. Feeling safe in the plane: neural mechanisms underlying superior action control in airplane pilot trainees – a combined EEG/MRS study

    Science.gov (United States)

    Dharmadhikari, Shalmali; Chmielewski, Witold; Glaubitz, Benjamin; Schmidt-Wilcke, Tobias; Edden, Richard; Dydak, Ulrike; Beste, Christian

    2015-01-01

    In day-to-day life, we need to apply strategies to cascade different actions for efficient unfolding of behaviour. While deficits in action cascading are examined extensively, almost nothing is known about the neuronal mechanisms mediating superior performance above the normal level. To examine this question, we investigate action control in airplane pilot trainees. We use a stop-change paradigm that is able to estimate the efficiency of action cascading on the basis of mathematical constraints. Behavioural and EEG data is analyzed along these constraints and integrated with neurochemical data obtained using Magnetic Resonance Spectroscopy (MRS) from the striatal gamma-aminobutyric acid (GABA) -ergic system. We show that high performance in action cascading, as exemplified in airplane pilot trainees, can be driven by intensified attentional processes, circumventing response selection processes. The results indicate that the efficiency of action cascading and hence the speed of responding as well as attentional gating functions are modulated by striatal GABA and Glutamate + Glutamine concentrations. In superior performance in action cascading similar increases in the concentrations of GABA and Glutamate + Glutamine lead to stronger neurophysiological and behavioural effects as compared to subjects with normal performance in action cascading. PMID:24753040

  16. Breakthrough Listen on MWA Pilot Study

    Science.gov (United States)

    Croft, S.; Siemion, A.; Kaplan, D. L.; Tremblay, S.

    2016-07-01

    We propose a pilot study, using the Voltage Capture System, for Breakthrough Listen on the MWA. Breakthrough Listen (BL) is a major new project that aims to dramatically improve the coverage of parameter space in the search for intelligent life beyond Earth. BL has already deployed hardware and software to the Green Bank Telescope, and will bring a similar program with the Parkes Telescope online in the second half of 2016. The low frequency sky is however currently very poorly explored. The superb capabilities of the MWA (large field of view, low frequency of operation, and location in a very radio quiet site) provide a unique opportunity for a pilot study to obtain voltage data for a SETI (Search For Extraterrestrial Intelligence) study of the Galactic Plane. We propose commensal observations, piggybacking on the proposed pulsar search of Tremblay et al. Using existing VCS software, combined with the pipeline developed for Breakthrough Listen at GBT and Parkes, we will perform a blind search for candidate signals from extraterrestrial intelligence. Although the chances of a detection are not large, particularly for a pilot study such as that proposed here, the Breakthrough Listen team plan to perform extensive testing and analysis on the data obtained which should be useful for other users of the MWA VCS. We will make the secondary SETI data products and associated documentation available as a resource to the community via the Breakthrough Listen online archive.

  17. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study.

    Science.gov (United States)

    Boers, Inge; Muskiet, Frits Aj; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J; Jong, Miek C

    2014-10-11

    The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a Paleolithic-type diet and may provide new insights in the pathophysiological mechanisms underlying the metabolic syndrome. In addition, more information on feasibility and designing an innovative dietary research program on the basis of a Palaeolithic-type diet was obtained. Thirty-four subjects, with at least two characteristics of the metabolic syndrome, were randomized to a two weeks Palaeolithic-type diet (n = 18) or an isoenergetic healthy reference diet, based on the guidelines of the Dutch Health Council (n = 14). Thirty-two subjects completed the study. Measures were taken to keep bodyweight stable. As primary outcomes oral glucose tolerance and characteristics of the metabolic syndrome (abdominal circumference, blood pressure, glucose, lipids) were measured. Secondary outcomes were intestinal permeability, inflammation and salivary cortisol. Data were collected at baseline and after the intervention. Subjects were 53.5 (SD9.7) year old men (n = 9) and women (n = 25) with mean BMI of 31.8 (SD5.7) kg/m2. The Palaeolithic-type diet resulted in lower systolic blood pressure (-9.1 mmHg; P = 0.015), diastolic blood pressure (-5.2 mmHg; P = 0.038), total cholesterol (-0.52 mmol/l; P = 0.037), triglycerides (-0.89 mmol/l; P = 0.001) and higher HDL-cholesterol (+0.15 mmol/l; P = 0.013), compared to reference. The number of characteristics of the metabolic syndrome decreased with 1.07 (P = 0.010) upon the Palaeolithic-type diet, compared to reference. Despite efforts to keep bodyweight stable, it decreased in the Palaeolithic group compared to reference (-1.32 kg; P = 0.012). However, favourable effects remained after post-hoc adjustments for this

  18. High versus moderate energy use of bipolar fractional radiofrequency in the treatment of acne scars: a split-face double-blinded randomized control trial pilot study.

    Science.gov (United States)

    Phothong, Weeranut; Wanitphakdeedecha, Rungsima; Sathaworawong, Angkana; Manuskiatti, Woraphong

    2016-02-01

    Bipolar fractional radiofrequency (FRF) device was firstly FDA-approved for treating atrophic acne scar in 2008 through the process of dermal coagulation and minimal epidermal ablation. The average energy at 60 mJ/pin was widely used to treat atrophic acne scars. However, the higher energy was delivered, the deeper ablation and coagulation were found. At present, the new generation of a device with bipolar FRF technology with electrode-pin tip was developed to maximize ability to deliver energy up to 100 mJ/pin. The objective of the study was to explore and compare the efficacy of utilizing high energy (100 mJ/pin) and moderate energy (60 mJ/pin) of bipolar fractional radiofrequency in treatment of atrophic acne scar in Asians. This is a split-face, double-blinded, randomized control trial, pilot study by using parallel group design technique. Thirty healthy subjects with Fitzpatrick skin phototype III-IV diagnosed as atrophic acne scares were enrolled. All subjects received four monthly sessions of bipolar FRF treatment. Left and right facial sides of individual patients were randomly assigned for different energy (high energy at 100 mJ/pin versus moderate energy at 60 mJ/pin). Acne scars improvement was blinded graded by dermatologist using global acne scarring score (GASS) which was subjectively evaluated at baseline, 1-, 3-, and 6-month follow-up. Objective scar analysis was also done using UVA-light video camera to measure scar volume, skin smoothness, and wrinkle at baseline, 3-, and 6-month follow-up after the last treatment. Side effects including pain, erythema, swelling, and crusting were also recorded. Thirty subjects completed the study with full 4-treatment course. The mean GASS of high energy side and moderate energy side was significantly reduced at 1-, 3-, and 6-month follow-up visits. At 1 month follow-visit, high energy side demonstrated significant improvement compared with moderate energy side (p = 0.03). Postinflammatory hyperpigmentation

  19. Protocol for a pilot randomised controlled trial of metformin in pre-diabetes after kidney transplantation: the Transplantation and Diabetes (Transdiab) study.

    Science.gov (United States)

    Alnasrallah, Basil; Pilmore, Helen; Manley, Paul

    2017-08-23

    Post-transplant diabetes mellitus (PTDM) is a common complication of kidney transplantation and is associated with significant morbidity and mortality. In the general population, metformin has been used for diabetes prevention in high-risk individuals. Improving insulin sensitivity is one of many proven favourable effects of metformin. Despite the high incidence of PTDM in kidney transplant recipients, there is a lack of evidence for the role of metformin in the prevention of diabetes in this setting. METHODS AND ANALYSIS: Transplantation and Diabetes (Transdiab) is a single-centre, unblinded, pilot randomised controlled trial assessing the feasibility, tolerability and efficacy of metformin after renal transplantation in patients with impaired glucose tolerance (IGT). Participants will undergo an oral glucose tolerance test in the 4-12 weeks post-transplantation; those with IGT will be randomised to standard care or standard care and metformin 500 mg twice daily, and followed up for 12 months. The primary outcomes of the study will be the feasibility of recruitment, the tolerability of metformin assessed using the Gastrointestinal Symptom Rating Scale at 3 and 12 months, and the efficacy of metformin assessed by morning glucose and glycated haemoglobin at 3, 6, 9 and 12 months. Despite the significant morbidity and mortality of PTDM, there are currently no randomised clinical trials assessing pharmacological interventions for its prevention after kidney transplantation. The Transdiab trial will thus provide important data on the feasibility, safety, tolerability and efficacy of metformin after renal transplantation in patients with IGT; this will facilitate undertaking larger multicentre trials of interventions to reduce the incidence or severity of diabetes after kidney transplantation. This study has been approved by the Northern B Health and Disability Ethics Committee of the Ministry of Health in New Zealand. On study completion, results are expected to be

  20. Hazing in the Military: A Pilot Study

    Science.gov (United States)

    2013-05-14

    different. It is important not to assume they are the same in policy or treatment. A policy covering hazing may enable workplace bullying to go unnoticed...while an education program to reduce workplace bullying will not likely transfer to decrease hazing. HAZING IN THE MILITARY: A PILOT STUDY 3...however, it is also found in the adult workplace . Bullying behaviors, like hazing, may be psychological or physical in nature, vary in severity, and

  1. The Effect of Traditional Cupping on Pain and Mechanical Thresholds in Patients with Chronic Nonspecific Neck Pain: A Randomised Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Romy Lauche

    2012-01-01

    Full Text Available Introduction. Cupping has been used since antiquity in the treatment of pain conditions. In this pilot study, we investigated the effect of traditional cupping therapy on chronic nonspecific neck pain (CNP and mechanical sensory thresholds. Methods. Fifty CNP patients were randomly assigned to treatment (TG, n=25 or waiting list control group (WL, n=25. TG received a single cupping treatment. Pain at rest (PR, pain related to movement (PM, quality of life (SF-36, Neck Disability Index (NDI, mechanical detection (MDT, vibration detection (MDT, and pressure pain thresholds (PPT were measured before and three days after a single cupping treatment. Patients also kept a pain and medication diary (PaDi, MeDi during the study. Results. Baseline characteristics were similar in the two groups. After cupping TG reported significantly less pain (PR: −17.9 mm VAS, 95%CI −29.2 to −6.6; PM: −19.7, 95%CI −32.2 to −7.2; PaDi: −1.5 points on NRS, 95%CI −2.5 to −0.4; all P<0.05 and higher quality of life than WL (SF-36, Physical Functioning: 7.5, 95%CI 1.4 to 13.5; Bodily Pain: 14.9, 95%CI 4.4 to 25.4; Physical Component Score: 5.0, 95%CI 1.4 to 8.5; all P<0.05. No significant effect was found for NDI, MDT, or VDT, but TG showed significantly higher PPT at pain-areas than WL (in lg(kPa; pain-maximum: 0.088, 95%CI 0.029 to 0.148, pain-adjacent: 0.118, 95%CI 0.038 to 0.199; both P<0.01. Conclusion. A single application of traditional cupping might be an effective treatment for improving pain, quality of life, and hyperalgesia in CNP.

  2. The Effect of Traditional Cupping on Pain and Mechanical Thresholds in Patients with Chronic Nonspecific Neck Pain: A Randomised Controlled Pilot Study

    Science.gov (United States)

    Lauche, Romy; Cramer, Holger; Hohmann, Claudia; Choi, Kyung-Eun; Rampp, Thomas; Saha, Felix Joyonto; Musial, Frauke; Langhorst, Jost; Dobos, Gustav

    2012-01-01

    Introduction. Cupping has been used since antiquity in the treatment of pain conditions. In this pilot study, we investigated the effect of traditional cupping therapy on chronic nonspecific neck pain (CNP) and mechanical sensory thresholds. Methods. Fifty CNP patients were randomly assigned to treatment (TG, n = 25) or waiting list control group (WL, n = 25). TG received a single cupping treatment. Pain at rest (PR), pain related to movement (PM), quality of life (SF-36), Neck Disability Index (NDI), mechanical detection (MDT), vibration detection (MDT), and pressure pain thresholds (PPT) were measured before and three days after a single cupping treatment. Patients also kept a pain and medication diary (PaDi, MeDi) during the study. Results. Baseline characteristics were similar in the two groups. After cupping TG reported significantly less pain (PR: −17.9 mm VAS, 95%CI −29.2 to −6.6; PM: −19.7, 95%CI −32.2 to −7.2; PaDi: −1.5 points on NRS, 95%CI −2.5 to −0.4; all P < 0.05) and higher quality of life than WL (SF-36, Physical Functioning: 7.5, 95%CI 1.4 to 13.5; Bodily Pain: 14.9, 95%CI 4.4 to 25.4; Physical Component Score: 5.0, 95%CI 1.4 to 8.5; all P < 0.05). No significant effect was found for NDI, MDT, or VDT, but TG showed significantly higher PPT at pain-areas than WL (in lg(kPa); pain-maximum: 0.088, 95%CI 0.029 to 0.148, pain-adjacent: 0.118, 95%CI 0.038 to 0.199; both P < 0.01). Conclusion. A single application of traditional cupping might be an effective treatment for improving pain, quality of life, and hyperalgesia in CNP. PMID:22203873

  3. Effect of dietary heat-killed Lactobacillus brevis SBC8803 (SBL88™) on sleep: a non-randomised, double blind, placebo-controlled, and crossover pilot study.

    Science.gov (United States)

    Nakakita, Y; Tsuchimoto, N; Takata, Y; Nakamura, T

    2016-09-01

    We previously reported that dietary heat-killed Lactobacillus brevis SBC8803 affects sleep rhythms in mice. The present study evaluated the effect of consumption of heat-killed SBC8803 on sleep architecture in humans. A non-randomised, placebo-controlled, double blind, and crossover pilot study was conducted using volunteers who scored at a slightly high level (i.e. ≥6) on the Athens Insomnia Scale (AIS). Male subjects (n=17; age 41-69 y) consumed placebo or SBC8803 capsules (25 mg/day of heat-killed SBC8803) for 10 days. Electroencephalograms (EEG) were recorded using a mobile, one-channel system, providing objective data on sleep. Subjects' sleep journals and administration of the AIS provided subjective data on sleep. Three subjects were excluded from the statistical analysis. Analysis of the remaining 14 volunteers revealed no significant differences between placebo and SBC8803 consumption in either the AIS or the sleep EEG. The sleep journals revealed an improvement in 'waking' for the SBC8803 consumption periods (P=0.047), and there was a marginally significant effect on 'drowsiness during the following day' (P=0.067). Effects on the EEG delta power value (μV(2)/min) were revealed by a stratified analysis based on age, AIS, and the Beck Depression Inventory (BDI). Specifically, effects were found among subjects in their 40s who consumed the SBC8803 capsules (P=0.049) and among subjects with a BDI score less than the all-subjects average (13.3) (P=0.045). A marginally significant effect was found among subjects with an AIS score less than the all-subjects average (11.6) (P=0.065). The delta power value of 5 subjects with both BDI and AIS scores less than the average increased significantly (P=0.017). While the number of subjects was limited, a beneficial effect on sleep due to consumption of heat-killed L. brevis SBC8803 was found in subjects with slightly challenged sleep.

  4. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization

    DEFF Research Database (Denmark)

    Loft, A; Egeberg, Anne Noes; Smitz, J;

    2012-01-01

    Is it possible to define an optimal dose of hCG in combination with rFSH from the first day of stimulation in the GnRH agonist protocol applied to IVF? SUMMARY ANSWER: Supplementation with hCG from the first day of stimulation may increase the number of top-quality embryos per patient. Daily doses...... of hCG up to 150 IU are compatible with good live birth rates. A ceiling level of estradiol (E(2)) was reached with hCG doses above 100 IU/day. A positive dose-response was seen for pre-ovulatory progesterone, but concentrations remained below values for which an impairment of endometrial receptivity...... has been previously reported. We suggest a large clinical trial to be proceeded with a group given 100 IU hCG daily versus a control group. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Prospective multicentre studies have indicated increased live birth rates and increased number of top-quality embryos when...

  5. Reprint of "Assessing the impact of a joint human-porcine intervention package for Taenia solium control: Results of a pilot study from northern Lao PDR".

    Science.gov (United States)

    Okello, Anna L; Thomas, Lian; Inthavong, Phouth; Ash, Amanda; Khamlome, Boualam; Keokamphet, Chattouphone; Newberry, Kim; Gauci, Charles G; Gabriël, Sarah; Dorny, Pierre; Thompson, Rc Andrew; Lightowlers, Marshall W; Allen, John

    2017-01-01

    Following confirmation that a remote village of approximately 300 inhabitants in northern Lao PDR was hyperendemic for the Neglected Tropical Disease Taenia solium, a pilot human-porcine therapeutic control intervention was implemented between October 2013 and November 2014. Mass drug administration with a three day albendazole 400mg protocol was offered to all eligible humans in October 2013 and March 2014. At these times, and again in October 2014, eligible village pigs received the anti-cysticercosis TSOL18 vaccination and an oral dose of oxfendazole anthelmintic at 30mg/kg, both repeated one month later. Community and individual human taeniasis prevalences were estimated via copro-antigen ELISA of volunteered human faecal samples prior to October 2013, and again in January 2015, in order to examine the short term impact of the intervention.

  6. Assessing the impact of a joint human-porcine intervention package for Taenia solium control: Results of a pilot study from northern Lao PDR.

    Science.gov (United States)

    Okello, Anna L; Thomas, Lian; Inthavong, Phouth; Ash, Amanda; Khamlome, Boualam; Keokamphet, Chattouphone; Newberry, Kim; Gauci, Charles G; Gabriël, Sarah; Dorny, Pierre; Thompson, Rc Andrew; Lightowlers, Marshall W; Allen, John

    2016-07-01

    Following confirmation that a remote village of approximately 300 inhabitants in northern Lao PDR was hyperendemic for the Neglected Tropical Disease Taenia solium, a pilot human-porcine therapeutic control intervention was implemented between October 2013 and November 2014. Mass drug administration with a three day albendazole 400mg protocol was offered to all eligible humans in October 2013 and March 2014. At these times, and again in October 2014, eligible village pigs received the anti-cysticercosis TSOL18 vaccination and an oral dose of oxfendazole anthelmintic at 30mg/kg, both repeated one month later. Community and individual human taeniasis prevalences were estimated via copro-antigen ELISA of volunteered human faecal samples prior to October 2013, and again in January 2015, in order to examine the short term impact of the intervention.

  7. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy.

    Directory of Open Access Journals (Sweden)

    Tih-Shih Lee

    Full Text Available Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15 and waitlist control arms (n = 16. Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon's randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001. Specifically, there were significant improvements in immediate memory (p = 0.038, visuospatial/constructional (p = 0.014, attention (p = 0.039, and delayed memory (p<0.001 scores. Our BCI-based system shows promise in improving memory and attention in healthy

  8. A randomized, double blind, placebo and active comparator controlled pilot study of UP446, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin

    Directory of Open Access Journals (Sweden)

    Sampalis John S

    2012-04-01

    Full Text Available Abstract Background Current use of prescribed or over the counter non-steroidal anti-inflammatory drugs (NSAIDs for pain and osteoarthritis (OA have untoward gastrointestinal and cardiovascular related side effects, as a result the need for a safe and effective alternative has become unequivocally crucial. Method A randomized, double blind, placebo and active controlled pilot study of a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of botanical origin, UP446 was conducted. Sixty subjects (age 40-75 with symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15; Group A0 (Placebo, CMC capsule, Group A1 (UP446 250 mg/day, Group A2 (UP446 500 mg/day and Group A3 (Celecoxib, 200 mg/day. MOS-SF-36 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC data were collected at baseline and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte sedimentation rate, C-reactive protein, plasma thrombin time (PTT, fructosamine, Hematology, clinical chemistry and fecal occult blood were monitored for safety. Results Statistically significant decrease in WOMAC pain score were observed for Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days. Statistically significant decrease in WOMAC stiffness score were observed for Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3. The mean change in WOMAC functional impairment scores were statistically significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p = 0.006, at 60 days (p = 0.016 and p = 0.002 and at 90 days (p = 0.018 and p = 0.002, these changes were not significant for Group A0 and Group A3. Based on MOS -SF-36 questionnaires, statistically significant improvements in physical function, endurance and mental health scores were observed for all active treatment groups compared to placebo. No significant changes suggestive of toxicity in routine hematologies

  9. USGS Tampa Bay Pilot Study

    Science.gov (United States)

    Yates, K.K.; Cronin, T. M.; Crane, M.; Hansen, M.; Nayeghandi, A.; Swarzenski, P.; Edgar, T.; Brooks, G.R.; Suthard, B.; Hine, A.; Locker, S.; Willard, D.A.; Hastings, D.; Flower, B.; Hollander, D.; Larson, R.A.; Smith, K.

    2007-01-01

    Many of the nation's estuaries have been environmentally stressed since the turn of the 20th century and will continue to be impacted in the future. Tampa Bay, one the Gulf of Mexico's largest estuaries, exemplifies the threats that our estuaries face (EPA Report 2001, Tampa Bay Estuary Program-Comprehensive Conservation and Management Plan (TBEP-CCMP)). More than 2 million people live in the Tampa Bay watershed, and the population constitutes to grow. Demand for freshwater resources, conversion of undeveloped areas to resident and industrial uses, increases in storm-water runoff, and increased air pollution from urban and industrial sources are some of the known human activities that impact Tampa Bay. Beginning on 2001, additional anthropogenic modifications began in Tampa Bat including construction of an underwater gas pipeline and a desalinization plant, expansion of existing ports, and increased freshwater withdrawal from three major tributaries to the bay. In January of 2001, the Tampa Bay Estuary Program (TBEP) and its partners identifies a critical need for participation from the U.S. Geological Survey (USGS) in providing multidisciplinary expertise and a regional-scale, integrated science approach to address complex scientific research issue and critical scientific information gaps that are necessary for continued restoration and preservation of Tampa Bay. Tampa Bay stakeholders identified several critical science gaps for which USGS expertise was needed (Yates et al. 2001). These critical science gaps fall under four topical categories (or system components): 1) water and sediment quality, 2) hydrodynamics, 3) geology and geomorphology, and 4) ecosystem structure and function. Scientists and resource managers participating in Tampa Bay studies recognize that it is no longer sufficient to simply examine each of these estuarine system components individually, Rather, the interrelation among system components must be understood to develop conceptual and

  10. Effects of a tailored interactive multimedia computer program on determinants of colorectal cancer screening: a randomized controlled pilot study in physician offices.

    Science.gov (United States)

    Jerant, Anthony; Kravitz, Richard L; Rooney, Mairin; Amerson, Scott; Kreuter, Matthew; Franks, Peter

    2007-04-01

    Screening reduces colorectal cancer (CRC) mortality and is cost-effective, yet uptake is suboptimal. We developed and evaluated a personally tailored interactive multimedia computer program (IMCP) to encourage CRC screening. Randomized controlled pilot trial evaluating the effects of the personally tailored CRC screening IMCP as compared with a non-tailored IMCP ("electronic leaflet") control. The IMCP was tailored to patient preference, self-efficacy, barriers, and readiness and deployed in busy primary care offices before scheduled doctor visits. Main outcomes were: CRC screening knowledge, self-efficacy, benefits and barriers, and stage of readiness. We enrolled 54 subjects; software glitches occurred in 5, leaving 49 subjects for analysis. In adjusted analyses, compared with control, the experimental group had a significant increase in CRC screening self-efficacy (p=0.049), a significantly greater likelihood of moving to a more advanced stage of readiness for screening (p=0.034), a trend toward fewer perceived barriers to screening (p=0.149), and no difference in perceived benefits or knowledge of screening. Our personally tailored IMCP was significantly more effective than control in bolstering CRC screening readiness and self-efficacy. If further streamlined, personally tailored IMCPs might be usefully deployed in busy primary care offices to improve uptake of CRC screening.

  11. Postural control and shoulder steadiness in F-16 pilots

    DEFF Research Database (Denmark)

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S

    2014-01-01

    to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. RESULTS: At follow......-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within...... the previous 3 mo and 25 pilots without such pain. DISCUSSION: Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity, and there may be a ceiling effect in the ability to improve these parameters. For individuals with highly developed...

  12. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

    Energy Technology Data Exchange (ETDEWEB)

    Rollmann, Denise C. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Novotny, Paul J. [Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota (United States); Petersen, Ivy A.; Garces, Yolanda I.; Bauer, Heather J.; Yan, Elizabeth S. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Wahner-Roedler, Dietlind; Vincent, Ann [Department of General Internal Medicine, Mayo Clinic, Rochester, Minnesota (United States); Sloan, Jeff A. [Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota (United States); Issa Laack, Nadia N., E-mail: laack.nadia@mayo.edu [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States)

    2015-07-01

    Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.

  13. A randomized controlled pilot study of VO2 max testing: a potential model for measuring relative in vivo efficacy of different red blood cell products.

    Science.gov (United States)

    Bennett-Guerrero, Elliott; Lockhart, Evelyn L; Bandarenko, Nicholas; Campbell, Mary L; Natoli, Michael J; Jamnik, Veronika K; Carter, Timothy R; Moon, Richard E

    2017-03-01

    Randomized trials, for example, RECESS, comparing "young" (median, 7-day) versus "middle-aged" (median, 28-day) red blood cells (RBCs), showed no difference in outcome. These data are important; however, they do not inform us about the safety and effectiveness of the oldest RBCs, which some patients receive. It may not be feasible to conduct a clinical trial randomizing patients to receive the oldest blood. Therefore, we propose strenuous exercise (VO2 max testing) as a model to study the relative efficacy to increase oxygen delivery to tissue of different RBC products, for example, extremes of storage duration. In this pilot study, eight healthy subjects had 2 units of leukoreduced RBCs collected by apheresis in AS-3 using standard methods. Subjects were randomized to receive both (2) units of their autologous RBCs at either 7 or 42 days after blood collection. VO2 max testing on a cycle ergometer was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). This design avoids confounding effects on intravascular volume from the 2-unit blood transfusion. The primary outcome was the difference in VO2 max between Friday and Monday (delta VO2 max). VO2 max increased more in the 7-day RBC arm (8.7 ± 6.9% vs. 1.9 ± 6.5%, p = 0.202 for comparison between arms). Exercise duration (seconds) increased in the 7-day RBC arm (8.4 ± 1.7%) but actually decreased in the 42-day arm (-2.6 ± 3.6%, p = 0.002). This pilot study suggests that VO2 max testing has potential as a rigorous and quantitative in vivo functional assay of RBC function. Our preliminary results suggest that 42-day RBCs are inferior to 7-day RBCs at delivering oxygen to tissues. © 2016 AABB.

  14. Piloted simulator investigation of helicopter control systems effects on handling qualities during instrument flight

    Science.gov (United States)

    Forrest, R. D.; Chen, R. T. N.; Gerdes, R. M.; Alderete, T. S.; Gee, D. R.

    1979-01-01

    An exploratory piloted simulation was conducted to investigate the effects of the characteristics of helicopter flight control systems on instrument flight handling qualities. This joint FAA/NASA study was motivated by the need to improve instrument flight capability. A near-term objective is to assist in updating the airworthiness criteria for helicopter instrument flight. The experiment consisted of variations of single-rotor helicopter types and levels of stability and control augmentation systems (SCAS). These configurations were evaluated during an omnirange approach task under visual and instrument flight conditions. The levels of SCAS design included a simple rate damping system, collective decoupling plus rate damping, and an attitude command system with collective decoupling. A limited evaluation of stick force versus airspeed stability was accomplished. Some problems were experienced with control system mechanization which had a detrimental effect on longitudinal stability. Pilot ratings, pilot commentary, and performance data related to the task are presented.

  15. A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia.

    Science.gov (United States)

    Koffel, Erin; Kuhn, Eric; Petsoulis, Napoleon; Erbes, Christopher R; Anders, Samantha; Hoffman, Julia E; Ruzek, Josef I; Polusny, Melissa A

    2016-06-27

    There has been growing interest in utilizing mobile phone applications (apps) to enhance traditional psychotherapy. Previous research has suggested that apps may facilitate patients' completion of cognitive behavioral therapy for insomnia (CBT-I) tasks and potentially increase adherence. This randomized clinical trial pilot study (n = 18) sought to examine the feasibility, acceptability, and potential impact on adherence and sleep outcomes related to CBT-I Coach use. All participants were engaged in CBT-I, with one group receiving the app as a supplement and one non-app group. We found that patients consistently used the app as intended, particularly the sleep diary and reminder functions. They reported that it was highly acceptable to use. Importantly, the app did not compromise or undermine benefits of cognitive behavioral therapy for insomnia and patients in both groups had significantly improved sleep outcomes following treatment. © The Author(s) 2016.

  16. An interdisciplinary knowledge translation intervention in long-term care: Study protocol for the vitamin D and osteoporosis study (ViDOS pilot cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kennedy Courtney C

    2012-05-01

    Full Text Available Abstract Background Knowledge translation (KT research in long-term care (LTC is still in its early stages. This protocol describes the evaluation of a multifaceted, interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes. Methods and design The Vitamin D and Osteoporosis Study (ViDOS is underway in 40 LTC homes (n = 19 intervention, n = 21 control across Ontario, Canada. The primary objectives of this study are to assess the feasibility of delivering the KT intervention, and clinically, to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily. Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician. The target audience within each LTC home is the Professional Advisory Committee (PAC, an interdisciplinary team who meets quarterly. The key elements of the intervention are three interactive educational sessions led by an expert opinion leader, action planning using a quality improvement cycle, audit and feedback reports, nominated internal champions, and reminders/point-of-care tools. Control homes do not receive any intervention, however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy. Primary outcomes are feasibility measures (recruitment, retention, attendance at educational sessions, action plan items identified and initiated, internal champions identified, performance reports provided and reviewed, and vitamin D (≥800 IU/daily prescribing at 6 and 12 months. Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications, and falls and fractures. Qualitative methods will examine the experience of the LTC team with the KT intervention. Homes are centrally randomized to intervention and control groups in blocks of variable size using

  17. A pilot study to control Lutzomyia umbratilis (Diptera: Psychodidae, the major vector of Leishmania brazileiensis guyanensis, in a peri-urban rainforest of Manaus, Amazonas State, Brazil

    Directory of Open Access Journals (Sweden)

    P. D. Ready

    1985-03-01

    Full Text Available In the second half of 1980, 112 (or ca. 16% of the inhabitants of the new settlement of São José, city of Manaus, contracted cutaneous leishmaniasis whilst clearing their properties of terra firme rainforest. With the aid of SUCAM, the authors carried out a pilot study to investigate the feasibility of reducing populations of Lutzomyia umbratilis, the local silvatic vector of Leishmania braziliensis guyanensis, by spraying insecticide on its favoured diurnal resting sites, the bases of the larger forest trees. Most manvector contact is at these resting sites and, therefore, it was encouraging to record a marked reduction of the tree-base populations of L. umbratilis for 21 days following just one application of D.D.T. emulsion in an area 200m square. Most of the treated trunks were not occupied by L. umbratilis for at least eleven months. Suggestions for extending the pilot study are made, and the need for collaboration with a clinical team is emphasized. Leishmania b. guyanensis is the aetiological agent of [quot ]pain bois[quot ], which is hyperendemic from French Guiana to central Amazônia. In the absence of proven vaccines or methods of vector control, some simple methods for limiting transmission of Le. b. guyanensis to man are listed.No segundo semestre de 1980, 112 (ou aproximadamente 16% dos habitantes do recém estabelecido bairro de São José, cidade de Manaus, contraíram leishmaniose, durante o desmatamento que realizavam em seus lotes localizados na floresta tipo "terra firme". Com a ajuda da SUCAM, os AA. realizaram um estudo piloto para investigar a viabilidade de redução das populações de Lutzomyia umbratilis, o vetor silvático de Leishmania braziliensis guyanensis, borrifando inseticidas na base das árvores grandes da floresta que são os lugares preferidos de repouso diurno destes insetos. A maioria do contato homem-vetor ocorre nestes lugares de repouso diurno (o vetor sendo mais ativo à noite nas copas das

  18. Pilot-in-the-Loop Analysis of Propulsive-Only Flight Control Systems

    Science.gov (United States)

    Chou, Hwei-Lan; Biezad, Daniel J.

    1996-01-01

    Longitudinal control system architectures are presented which directly couple flight stick motions to throttle commands for a multi-engine aircraft. This coupling enables positive attitude control with complete failure of the flight control system. The architectures chosen vary from simple feedback gains to classical lead-lag compensators with and without prefilters. Each architecture is reviewed for its appropriateness for piloted flight. The control systems are then analyzed with pilot-in-the-loop metrics related to bandwidth required for landing. Results indicate that current and proposed bandwidth requirements should be modified for throttles only flight control. Pilot ratings consistently showed better ratings than predicted by analysis. Recommendations are made for more robust design and implementation. The use of Quantitative Feedback Theory for compensator design is discussed. Although simple and effective augmented control can be achieved in a wide variety of failed configurations, a few configuration characteristics are dominant for pilot-in-the-loop control. These characteristics will be tested in a simulator study involving failed flight controls for a multi-engine aircraft.

  19. Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Seungwon Shin

    2016-01-01

    Full Text Available This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

  20. Practical Implications of Metacognitively Oriented Psychotherapy in Psychosis : Findings From a Pilot Study

    NARCIS (Netherlands)

    de Jong, Steven; van Donkersgoed, Rozanne J. M.; Aleman, Andre; van der Gaag, Mark; Wunderink, Lex; Arends, Johan; Lysaker, Paul H.; Pijnenborg, Marieke

    2016-01-01

    In preparation for a multicenter randomized controlled trial, a pilot study was conducted investigating the feasibility and acceptance of a shortened version (12 vs. 40 sessions) of an individual metacognitive psychotherapy (Metacognitive Reflection and Insight Therapy [MERIT]). Twelve participants

  1. The Effect of Shared Information on Pilot/Controller And Controller/Controller Interactions

    Science.gov (United States)

    Hansman, R. John

    1999-01-01

    In order to respond to the increasing demand on limited airspace system resources, a number of applications of information technology have been proposed, or are under investigation, to improve the efficiency, capacity and reliability of ATM (Asynchronous Transfer Mode) operations. Much of the attention in advanced ATM technology has focused on advanced automation systems or decision aiding systems to improve the performance of individual Pilots or Controllers. However, the most significant overall potential for information technology appears to he in increasing the shared information between human agents such as Pilots, Controllers or between interacting Controllers or traffic flow managers. Examples of proposed shared information systems in the US include; Controller Pilot Databank Communication (CPDLC), Traffic Management Advisor (TMA); Automatic Dependent Surveillance (ADS); Collaborative Decision Making (CDM) and NAS Level Common Information Exchange. Air Traffic Management is fundamentally a human centered process consisting of the negotiation, execution and monitoring of contracts between human agents for the allocation of limited airspace, runway and airport surface resources. The decision processes within ATM tend to be Semistructured. Many of the routine elements in ATM decision making on the part of the Controllers or Pilots are well Structured and can be represented by well defined rules or procedures. However in disrupted conditions, the ATM decision processes are often Unstructured and cannot be reduced to a set of discrete rules. As a consequence, the ability to automate ATM processes will be limited and ATM will continue to be a human centric process where the responsibility and the authority for the negotiation will continue to rest with human Controllers and Pilots. The use of information technology to support the human decision process will therefore be an important aspect of ATM modernization. The premise of many of the proposed shared

  2. Chiropractic manipulation in Adolescent Idiopathic Scoliosis: a pilot study

    Directory of Open Access Journals (Sweden)

    Stoline Michael R

    2006-08-01

    Full Text Available Abstract Background Adolescent idiopathic scoliosis (AIS remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. Methods Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment, two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. Conclusion Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. Trial registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

  3. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: Rationale and study design of a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Klarenbach Scott

    2006-02-01

    Full Text Available Abstract Background Nocturnal hemodialysis (NHD is an alternative to conventional three times per week hemodialysis (CvHD and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV mass, as measured by cardiac magnetic resonance imaging (cMR. Methodology/design All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP to a goal of Discussion To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

  4. Human biomonitoring pilot study DEMOCOPHES in Germany

    DEFF Research Database (Denmark)

    Schwedler, Gerda; Seiwert, Margarete; Fiddicke, Ulrike

    2017-01-01

    on a European Scale) and DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human Biomonitoring on a European Scale) were formed, comprising 35 partners from 27 European countries. In COPHES a research scheme and guidelines were developed to exemplarily measure in a pilot study mercury in hair......Human biomonitoring (HBM) is an effective tool to assess human exposure to environmental pollutants, but comparable HBM data in Europe are lacking. In order to expedite harmonization of HBM studies on a European scale, the twin projects COPHES (Consortium to Perform Human Biomonitoring......, cadmium, cotinine and several phthalate metabolites in urine of 6–11 year old children and their mothers in an urban and a rural region. Seventeen European countries simultaneously conducted this cross-sectional DEMOCOPHES feasibility study. The German study population was taken in the city of Bochum...

  5. The Bipolar Depression Electrical Treatment Trial (BETTER: Design, Rationale, and Objectives of a Randomized, Sham-Controlled Trial and Data from the Pilot Study Phase

    Directory of Open Access Journals (Sweden)

    Bernardo de Sampaio Pereira Junior

    2015-01-01

    Full Text Available Background. Bipolar depression (BD is a prevalent condition, with poor therapeutic options and a high degree of refractoriness. This justifies the development of novel treatment strategies, such as transcranial direct current stimulation (tDCS that showed promising results in unipolar depression. Methods. We describe a randomized, sham-controlled, double-blinded trial using tDCS for refractory, acutely symptomatic BD (the bipolar depression electrical treatment trial, BETTER. Sixty patients will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is change (over time and across groups in the scores of the Hamilton Depression Rating Scale (17 items. Biological markers such as blood neurotrophins and interleukins, genetic polymorphisms, heart rate variability, and motor cortical excitability will be assessed. Twelve anodal-left/cathodal-right 2 mA tDCS sessions over the dorsolateral prefrontal cortex will be performed in 6 weeks. Results. In the pilot phase, five patients received active tDCS and were double-blindly assessed, two presenting clinical response. TDCS was well-tolerated, with no changes in cognitive scores. Conclusion. This upcoming clinical trial will address the efficacy of tDCS for BD on different degrees of refractoriness. The evaluation of biological markers will also help in understanding the pathophysiology of BD and the mechanisms of action of tDCS.

  6. Effects of Different Heave Motion Components on Pilot Pitch Control Behavior

    Science.gov (United States)

    Zaal, Petrus M. T.; Zavala, Melinda A.

    2016-01-01

    The study described in this paper had two objectives. The first objective was to investigate if a different weighting of heave motion components decomposed at the center of gravity, allowing for a higher fidelity of individual components, would result in pilot manual pitch control behavior and performance closer to that observed with full aircraft motion. The second objective was to investigate if decomposing the heave components at the aircraft's instantaneous center of rotation rather than at the center of gravity could result in additional improvements in heave motion fidelity. Twenty-one general aviation pilots performed a pitch attitude control task in an experiment conducted on the Vertical Motion Simulator at NASA Ames under different hexapod motion conditions. The large motion capability of the Vertical Motion Simulator also allowed for a full aircraft motion condition, which served as a baseline. The controlled dynamics were of a transport category aircraft trimmed close to the stall point. When the ratio of center of gravity pitch heave to center of gravity heave increased in the hexapod motion conditions, pilot manual control behavior and performance became increasingly more similar to what is observed with full aircraft motion. Pilot visual and motion gains significantly increased, while the visual lead time constant decreased. The pilot visual and motion time delays remained approximately constant and decreased, respectively. The neuromuscular damping and frequency both decreased, with their values more similar to what is observed with real aircraft motion when there was an equal weighting of the heave of the center of gravity and heave due to rotations about the center of gravity. In terms of open- loop performance, the disturbance and target crossover frequency increased and decreased, respectively, and their corresponding phase margins remained constant and increased, respectively. The decomposition point of the heave components only had limited

  7. A remotely piloted aircraft system in major incident management: concept and pilot, feasibility study.

    Science.gov (United States)

    Abrahamsen, Håkon B

    2015-06-10

    Major incidents are complex, dynamic and bewildering task environments characterised by simultaneous, rapidly changing events, uncertainty and ill-structured problems. Efficient management, communication, decision-making and allocation of scarce medical resources at the chaotic scene of a major incident is challenging and often relies on sparse information and data. Communication and information sharing is primarily voice-to-voice through phone or radio on specified radio frequencies. Visual cues are abundant and difficult to communicate between teams and team members that are not co-located. The aim was to assess the concept and feasibility of using a remotely piloted aircraft (RPA) system to support remote sensing in simulated major incident exercises. We carried out an experimental, pilot feasibility study. A custom-made, remotely controlled, multirotor unmanned aerial vehicle with vertical take-off and landing was equipped with digital colour- and thermal imaging cameras, a laser beam, a mechanical gripper arm and an avalanche transceiver. We collected data in five simulated exercises: 1) mass casualty traffic accident, 2) mountain rescue, 3) avalanche with buried victims, 4) fisherman through thin ice and 5) search for casualties in the dark. The unmanned aerial vehicle was remotely controlled, with high precision, in close proximity to air space obstacles at very low levels without compromising work on the ground. Payload capacity and tolerance to wind and turbulence were limited. Aerial video, shot from different altitudes, and remote aerial avalanche beacon search were streamed wirelessly in real time to a monitor at a ground base. Electromagnetic interference disturbed signal reception in the ground monitor. A small remotely piloted aircraft can be used as an effective tool carrier, although limited by its payload capacity, wind speed and flight endurance. Remote sensing using already existing remotely piloted aircraft technology in pre

  8. Flight simulation using a Brain-Computer Interface: A pilot, pilot study.

    Science.gov (United States)

    Kryger, Michael; Wester, Brock; Pohlmeyer, Eric A; Rich, Matthew; John, Brendan; Beaty, James; McLoughlin, Michael; Boninger, Michael; Tyler-Kabara, Elizabeth C

    2017-01-01

    As Brain-Computer Interface (BCI) systems advance for uses such as robotic arm control it is postulated that the control paradigms could apply to other scenarios, such as control of video games, wheelchair movement or even flight. The purpose of this pilot study was to determine whether our BCI system, which involves decoding the signals of two 96-microelectrode arrays implanted into the motor cortex of a subject, could also be used to control an aircraft in a flight simulator environment. The study involved six sessions in which various parameters were modified in order to achieve the best flight control, including plane type, view, control paradigm, gains, and limits. Successful flight was determined qualitatively by evaluating the subject's ability to perform requested maneuvers, maintain flight paths, and avoid control losses such as dives, spins and crashes. By the end of the study, it was found that the subject could successfully control an aircraft. The subject could use both the jet and propeller plane with different views, adopting an intuitive control paradigm. From the subject's perspective, this was one of the most exciting and entertaining experiments she had performed in two years of research. In conclusion, this study provides a proof-of-concept that traditional motor cortex signals combined with a decoding paradigm can be used to control systems besides a robotic arm for which the decoder was developed. Aside from possible functional benefits, it also shows the potential for a new recreational activity for individuals with disabilities who are able to master BCI control. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pushpa-Rajah, Angela; Bradshaw, Lucy; Dorling, Jon; Gyte, Gill; Mitchell, Eleanor J; Thornton, Jim; Duley, Lelia

    2014-06-30

    Preterm birth is the most important single determinant of adverse outcome in the United Kingdom; one in every 70 babies (1.4%) is born before 32 weeks (very preterm), yet these births account for over half of infant deaths.Deferring cord clamping allows blood flow between baby and placenta to continue for a short time. This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation. Optimal timing for clamping the cord remains uncertain, however. The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome, but larger studies reporting substantive outcomes and with long-term follow-up are needed. Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes. This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK. Women are eligible for the trial if they are expected to have a live birth before 32 weeks gestation. Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome, triplet or higher order multiple pregnancy, and known major congenital malformation. The interventions will be cord clamping within 20 seconds compared with cord clamping after at least two minutes. For births with cord clamping after at least two minutes, initial neonatal care is at the bedside. For the pilot trial, outcomes include measures of recruitment, compliance with the intervention, retention of participants and data quality for the clinical outcomes.Information about the trial is available to women during their antenatal care. Women considered likely to have a very preterm birth are approached for informed consent. Randomisation is close to the time of birth. Follow-up for the women is for one year, and for the children to two years of age (corrected for gestation

  10. The incidence of venous thromboembolism in commercial airline pilots: a cohort study of 2630 pilots.

    Science.gov (United States)

    Kuipers, S; Venemans-Jellema, A; Cannegieter, S C; van Haften, M; Middeldorp, S; Büller, H R; Rosendaal, F R

    2014-08-01

    Airline pilots may be at increased risk of venous thromboembolism (VTE) because air travel has recently been established as a risk factor for VTE. The aim of this study was to assess the risk of VTE in a cohort of Dutch airline pilots. Airline pilots who had been active members of the Dutch aviation society (VNV) were questioned for the occurrence of VTE, presence of risk factors for VTE and number of flight hours per year and rank. Incidence rates among pilots were compared with those of the general Dutch population and with a population of frequently flying employees of multinational organizations. A total of 2630 male pilots were followed-up for a total of 20420 person-years (py). Six venous thromboses were reported, yielding an incidence rate of 0.3 per 1000 py. The standardized morbidity ratio, comparing these pilots with the general Dutch population adjusted for age, was 0.8. Compared with the international employee cohort, the standardized morbidity ratio was 0.7 when all employees were included and 0.6 when only the frequently travelling employees were included. The incidence rate did not increase with number of flight hours per year and did not clearly vary by rank. We conclude that the risk of VTE is not increased amongst airline pilots. © 2014 International Society on Thrombosis and Haemostasis.

  11. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    OBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.

  12. Simulated control in Aspen Dynamics for the production of limonene epoxide at pilot scale

    OpenAIRE

    Yeison Agudelo Arenas; Rolando Barrera Zapata

    2016-01-01

    In this contribution is reported the study and analysis of the control system (simulated) for the process of obtaining limonene epoxide. The modelling of the process at pilot scale was implemented in the software Aspen Plus from literature reports. Aspen Dynamics was used for the study of the process control. The model allows observing the behavior of the variables of interest in the process such as outflows from the distillation tower, heat duty, operating temperaturas and purity of the fina...

  13. Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Mailhot, Tanya; Cossette, Sylvie; Bourbonnais, Anne; Côté, José; Denault, André; Côté, Marie-Claude; Lamarche, Yoan; Guertin, Marie-Claude

    2014-07-30

    Despite the use of evidence-based preventive measures, delirium affects about 40% of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers. There is some evidence that family involvement as a core component of delirium management may be beneficial since familiarity helps patients stay in contact with reality, however, this merits further investigation. There is also currently a gap in the scientific literature regarding objective indicators that could enhance early detection and monitoring of delirium. Therefore, this randomized pilot trial examines the acceptability, feasibility, and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery delirium in their relatives. It also explores the validity of a new and innovative measure that has potential as an indicator for delirium. In this two-group randomized pilot study (n = 30), the control group will receive usual care and the intervention group will receive the experimental intervention aimed at reducing delirium severity. The intervention nurse's objective will be to foster the family caregiver's self-efficacy in behaving in a supportive manner during delirium episodes. Data will be collected from standard delirium assessment scales and a novel measure of delirium, i.e., cerebral oximetry obtained using near infrared spectroscopy, as well as medical records and participants' responses to questionnaires. New strategies for early detection, monitoring, and management of delirium are needed in order to improve outcomes for both patients and families. The present article exposes feasibility issues based on the first few months of the empirical phase of the study that may be useful to the scientific community interested in improving the care of patients with delirium. Another potentially important contribution is in the exploration of cerebral oximetry, a promising measure as an objective

  14. The Pilot Staffing Conundrum: A Delphi Study

    Science.gov (United States)

    2009-06-01

    Project, AFIT/ GMO /LAL/98J-2. School of Logistics and Acquisition Management, Air Force Institute of Technology (AU), Wright Patterson AFB, OH, June...Kafer, John H. Relationship of Airline Pilot Demand and Air Force Pilot Retention. Graduate Research Project, AFIT/ GMO /LAL/98J-11. School of Logistics

  15. Core stability exercise is as effective as task-oriented motor training in improving motor proficiency in children with developmental coordination disorder: a randomized controlled pilot study.

    Science.gov (United States)

    Au, Mei K; Chan, Wai M; Lee, Lin; Chen, Tracy Mk; Chau, Rosanna Mw; Pang, Marco Yc

    2014-10-01

    To compare the effectiveness of a core stability program with a task-oriented motor training program in improving motor proficiency in children with developmental coordination disorder (DCD). Randomized controlled pilot trial. Outpatient unit in a hospital. Twenty-two children diagnosed with DCD aged 6-9 years were randomly allocated to the core stability program or the task-oriented motor program. Both groups underwent their respective face-to-face training session once per week for eight consecutive weeks. They were also instructed to carry out home exercises on a daily basis during the intervention period. Short Form of the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition) and Sensory Organization Test at pre- and post-intervention. Intention-to-treat analysis revealed no significant between-group difference in the change of motor proficiency standard score (P=0.717), and composite equilibrium score derived from the Sensory Organization Test (P=0.100). Further analysis showed significant improvement in motor proficiency in both the core stability (mean change (SD)=6.3(5.4); p=0.008) and task-oriented training groups (mean change(SD)=5.1(4.0); P=0.007). The composite equilibrium score was significantly increased in the task-oriented training group (mean change (SD)=6.0(5.5); P=0.009), but not in the core stability group (mean change(SD) =0.0(9.6); P=0.812). In the task-oriented training group, compliance with the home program was positively correlated with change in motor proficiency (ρ=0.680, P=0.030) and composite equilibrium score (ρ=0.638, P=0.047). The core stability exercise program is as effective as task-oriented training in improving motor proficiency among children with DCD. © The Author(s) 2014.

  16. Fatty acids and sleep in UK children: subjective and pilot objective sleep results from the DOLAB study--a randomized controlled trial.

    Science.gov (United States)

    Montgomery, Paul; Burton, Jennifer R; Sewell, Richard P; Spreckelsen, Thees F; Richardson, Alexandra J

    2014-08-01

    Sleep problems in children are associated with poor health, behavioural and cognitive problems, as are deficiencies of long-chain omega-3 fatty acids such as docosahexaenoic acid. Theory and some evidence support a role for these fatty acids in sleep regulation, but this issue has received little formal investigation. We examined associations between blood fatty acid concentrations (from fingerstick blood samples) and subjective sleep (using an age-standardized parent questionnaire) in a large epidemiological sample of healthy children aged 7-9 years (n = 395) from mainstream UK schools. In a randomized controlled trial, we then explored whether 16-week supplementation (600 mg day(-1) ) with algal docosahexaenoic acid versus placebo might improve sleep in a subset of those children (n = 362) who were underperforming in reading. In a randomly selected subsample (n = 43), sleep was also assessed objectively via actigraphy. In 40% of the epidemiological sample, Child Sleep Habits Questionnaire scores indicated clinical-level sleep problems. Furthermore, poorer total sleep disturbance scores were associated weakly but significantly with lower blood docosahexaenoic acid (std coeff. -0.105*) and a lower docosahexaenoic acid : arachidonic acid ratio (std coeff. -0.119**). The treatment trial showed no significant effects on subjective sleep measures. However, in the small actigraphy subsample, docosahexaenoic acid supplementation led on average to seven fewer wake episodes and 58 min more sleep per night. Cautiously, we conclude that higher blood levels of docosahexaenoic acid may relate to better child sleep, as rated by parents. Exploratory pilot objective evidence from actigraphy suggests that docosahexaenoic acid supplementation may improve children's sleep, but further investigations are needed.

  17. Tai Chi for older nurses: a workplace wellness pilot study.

    Science.gov (United States)

    Palumbo, Mary Val; Wu, Ge; Shaner-McRae, Hollie; Rambur, Betty; McIntosh, Barbara

    2012-02-01

    The purpose of this pilot study was to assess the feasibility of a Tai Chi workplace wellness program as a cost effective way of improving physical and mental health, reducing work related stress, and improving work productivity among older nurses in a hospital setting Design A randomized control trial of two groups (control and Tai Chi group). A randomized control trial of two groups (control and Tai Chi group). Northeastern academic medical center. A convenience sample of eleven female nurses (mean age 54.4 years). The Tai Chi group (n = 6) was asked to attend Tai Chi classes once a week offered at their worksite and to practice on their own for 10 minutes each day at least 4 days per week for 15 weeks. Controls (n = 5) received no intervention. SF-36 Health Survey, Nursing Stress Scale (NSS), Perceived Stress Scale (PSS), Sit-and-Reach test, Functional Reach test, the Work Limitations Questionnaire, workplace injury and unscheduled time off. The two study groups were compared descriptively and changes across time in the intervention versus control were compared. The Tai Chi group took no unscheduled time-off hours, whereas, the control group was absent 49 hours during the study period. There was also a 3% increase in work productivity and significant improvement in functional reach (p=0.03) compared to the control group. Other outcomes were not statistically significant. This pilot study demonstrates the feasibility of Tai Chi with older female workers as a cost effective wellness option in the workplace; thus encouraging replication with a larger sample. Methodological implications were also addressed. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Pilot Evaluation of Adaptive Control in Motion-Based Flight Simulator

    Science.gov (United States)

    Kaneshige, John T.; Campbell, Stefan Forrest

    2009-01-01

    The objective of this work is to assess the strengths, weaknesses, and robustness characteristics of several MRAC (Model-Reference Adaptive Control) based adaptive control technologies garnering interest from the community as a whole. To facilitate this, a control study using piloted and unpiloted simulations to evaluate sensitivities and handling qualities was conducted. The adaptive control technologies under consideration were ALR (Adaptive Loop Recovery), BLS (Bounded Linear Stability), Hybrid Adaptive Control, L1, OCM (Optimal Control Modification), PMRAC (Predictor-based MRAC), and traditional MRAC

  19. Comparison of Human Pilot (Remote Control Systems in Multirotor Unmanned Aerial Vehicle Navigation

    Directory of Open Access Journals (Sweden)

    Zainal Rasyid Mahayuddin

    2017-02-01

    Full Text Available This paper concerns about the human pilot or remote control system in UAV navigation. Demands for Unmanned Aerial Vehicle (UAV are increasing tremendously in aviation industry and research area. UAV is a flying machine that can fly with no pilot onboard and can be controlled by ground-based operators. In this paper, a comparison was made between different proposed remote control systems and devices to navigate multirotor UAV, like hand-controllers, gestures and body postures techniques, and vision-based techniques. The overall reviews discussed in this paper have been studied in various research sources related to UAV and its navigation system. Every method has its pros and cons depends on the situation. At the end of the study, those methods will be analyzed and the best method will be chosen in term of accuracy and efficiency.

  20. 75 FR 80827 - Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for...

    Science.gov (United States)

    2010-12-23

    ...; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice To Extend Expiration Date...) Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs... ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs.'' Previous extensions...

  1. 'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Porteous, Terry; Wyke, Sally; Smith, Sarah; Bond, Christine; Francis, Jill; Lee, Amanda J; Lowrie, Richard; Scotland, Graham; Sheikh, Aziz; Thomas, Mike; Smith, Lorraine

    2013-07-15

    Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome

  2. Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen Inoculum From Unrelated Donors: A Randomized, Open-Label, Controlled Pilot Study

    OpenAIRE

    Youngster, Ilan; Sauk, Jenny; Pindar, Christina; Wilson, Robin G; Kaplan, Jess L.; Smith, Mark B.; Alm, Eric J; Gevers, Dirk; Russell, George H.; Hohmann, Elizabeth L.

    2014-01-01

    Fecal microbiota transplant is increasingly used to treat recurrent or relapsing Clostridium difficile infection. In this randomized controlled study, using a frozen inoculum from unrelated donors was safe and effective, whether administered by nasogastric tube or by colonoscopy.

  3. Application of a pilot control banding tool for risk level assessment and control of nanoparticle exposures

    Energy Technology Data Exchange (ETDEWEB)

    Paik, S Y; Zalk, D M; Swuste, P

    2008-03-03

    Control Banding (CB) strategies offer simplified solutions for controlling worker exposures to constituents that are found in the workplace in the absence of firm toxicological and exposure data. These strategies may be particularly useful in nanotechnology applications, considering the overwhelming level of uncertainty over what nanomaterials and nanotechnologies present as potential work-related health risks, what about these materials might lead to adverse toxicological activity, how risk related to these might be assessed, and how to manage these issues in the absence of this information. This study introduces a pilot CB tool or 'CB Nanotool' that was developed specifically for characterizing the health aspects of working with engineered nanoparticles and determining the level of risk and associated controls for five ongoing nanotechnology-related operations being conducted at two Department of Energy (DOE) research laboratories. Based on the application of the CB Nanotool, four of the five operations evaluated in this study were found to have implemented controls consistent with what was recommended by the CB Nanotool, with one operation even exceeding the required controls for that activity. The one remaining operation was determined to require an upgrade in controls. By developing this dynamic CB Nanotool within the realm of the scientific information available, this application of CB appears to be a useful approach for assessing the risk of nanomaterial operations, providing recommendations for appropriate engineering controls, and facilitating the allocation of resources to the activities that most need them.

  4. Functional respiratory imaging after neostigmine- or sugammadex-enhanced recovery from neuromuscular blockade in the anesthetised rat: a randomised controlled pilot study

    Directory of Open Access Journals (Sweden)

    Tom Schepens

    Full Text Available Abstract Objectives Reductions in diaphragm activity are associated with the postoperative development of atelectasis. Neostigmine reversal is also associated with increased atelectasis. We assessed the effects of neostigmine, sugammadex, and spontaneous reversal on regional lung ventilation and airway flow. Methods Six Sprague-Dawley rats were paralysed with rocuronium and mechanically ventilated until recovery of the train-of-four ratio to 0.5. We administered neostigmine (0.06 mg.kg-1, sugammadex (15 mg.kg-1, or saline (n = 2 per group. Computed tomography scans were obtained during the breathing cycle. Three-dimensional models of lung lobes were generated using functional respiratory imaging technology, and lobar volumes were calculated during the breathing cycle. The diaphragmatic surface was segmented for the end-expiratory and end-inspiratory scans. The total change in volume was reported by the lung volume change from the end-expiratory scan to the end-inspiratory scan. Chest wall movement was defined as the lung volume change minus the volume change that resulted from diaphragm excursion. Results The two rats that received neostigmine exhibited a smaller relative contribution of diaphragm movement to the total change in lung volume compared with the two rats that received sugammadex or saline (chest wall contribution (%: 26.69 and 25.55 for neostigmine; -2.77 and 15.98 for sugammadex; 18.82 and 10.30 for saline. Conclusion This pilot study in rats demonstrated an increased relative contribution of chest wall expansion after neostigmine compared with sugammadex or saline. This smaller relative contribution of diaphragm movement may be explained by a neostigmine-induced decrease in phrenic nerve activity or by remaining occupied acetylcholine receptors after neostigmine.

  5. [Functional respiratory imaging after neostigmine- or sugammadex-enhanced recovery from neuromuscular blockade in the anesthetised rat: a randomised controlled pilot study].

    Science.gov (United States)

    Schepens, Tom; Cammu, Guy; Maes, Sabine; Desmedt, Benny; Vos, Wim; Deseure, Kristof

    Reductions in diaphragm activity are associated with the postoperative development of atelectasis. Neostigmine reversal is also associated with increased atelectasis. We assessed the effects of neostigmine, sugammadex, and spontaneous reversal on regional lung ventilation and airway flow. Six Sprague-Dawley rats were paralysed with rocuronium and mechanically ventilated until recovery of the train-of-four ratio to 0.5. We administered neostigmine (0.06mg.kg(-1)), sugammadex (15mg.kg(-1)), or saline (n=2 per group). Computed tomography scans were obtained during the breathing cycle. Three-dimensional models of lung lobes were generated using functional respiratory imaging technology, and lobar volumes were calculated during the breathing cycle. The diaphragmatic surface was segmented for the end-expiratory and end-inspiratory scans. The total change in volume was reported by the lung volume change from the end-expiratory scan to the end-inspiratory scan. Chest wall movement was defined as the lung volume change minus the volume change that resulted from diaphragm excursion. The two rats that received neostigmine exhibited a smaller relative contribution of diaphragm movement to the total change in lung volume compared with the two rats that received sugammadex or saline (chest wall contribution (%): 26.69 and 25.55 for neostigmine; -2.77 and 15.98 for sugammadex; 18.82 and 10.30 for saline). This pilot study in rats demonstrated an increased relative contribution of chest wall expansion after neostigmine compared with sugammadex or saline. This smaller relative contribution of diaphragm movement may be explained by a neostigmine-induced decrease in phrenic nerve activity or by remaining occupied acetylcholine receptors after neostigmine. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  6. Study of occupational stress among railway engine pilots

    Directory of Open Access Journals (Sweden)

    Devesh Kumar

    2011-01-01

    Full Text Available Background: Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Materials and Methods: Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Results: Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. Conclusions: These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening.

  7. Study of occupational stress among railway engine pilots

    Science.gov (United States)

    Kumar, Devesh; Singh, Jai Vir; Kharwar, Poonam S.

    2011-01-01

    Background: Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Materials and Methods: Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI) test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Results: Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. Conclusions: These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening. PMID:21808497

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

    OpenAIRE

    Cristina Cavaiuolo; Anna Casani; Gaetano Di Manso; Luigi Orfeo

    2015-01-01

    Objective: The aim of this pilot study was to determine the effect of music by Mozart on heel prick procedural pain in premature infants.Background: Painful procedures are routinely performed in the setting of neonatal intensive care unit (NICU). Pain may exert short- and long-term deleterious effects on premature babies. Many non-pharmacological interventions have been proven efficacious for blunting neonatal pain.Study design: Randomized, controlled trial.Methods: The study was carried out ...

  9. Simulation of Controller Pilot Data Link Communications over VHF Digital Link Mode 3

    Science.gov (United States)

    Bretmersky, Steven C.; Murawski, Robert; Nguyen, Thanh C.; Raghavan, Rajesh S.

    2004-01-01

    The Federal Aviation Administration (FAA) has established an operational plan for the future Air Traffic Management (ATM) system, in which the Controller Pilot Data Link Communications (CPDLC) is envisioned to evolve into digital messaging that will take on an ever increasing role in controller to pilot communications, significantly changing the way the National Airspace System (NAS) is operating. According to FAA, CPDLC represents the first phase of the transition from the current analog voice system to an International Civil Aviation Organization (ICAO) compliant system in which digital communication becomes the alternate and perhaps primary method of routine communication. The CPDLC application is an Air Traffic Service (ATS) application in which pilots and controllers exchange messages via an addressed data link. CPDLC includes a set of clearance, information, and request message elements that correspond to existing phraseology employed by current Air Traffic Control (ATC) procedures. These message elements encompass altitude assignments, crossing constraints, lateral deviations, route changes and clearances, speed assignments, radio frequency assignments, and various requests for information. The pilot is provided with the capability to respond to messages, to request clearances and information, to report information, and to declare/rescind an emergency. A 'free text' capability is also provided to exchange information not conforming to defined formats. This paper presents simulated results of the aeronautical telecommunication application Controller Pilot Data Link Communications over VHF Digital Link Mode 3 (VDL Mode 3). The objective of this simulation study was to determine the impact of CPDLC traffic loads, in terms of timely message delivery and capacity of the VDL Mode 3 subnetwork. The traffic model is based on and is used for generating air/ground messages with different priorities. Communication is modeled for the en route domain of the Cleveland

  10. Preliminary Hydrogeologic Characterization Results from the Wallula Basalt Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    B.P. McGrail; E. C. Sullivan; F. A. Spane; D. H. Bacon; G. Hund; P. D. Thorne; C. J. Thompson; S. P. Reidel; F. S. Colwell

    2009-12-01

    The DOE's Big Sky Regional Carbon Sequestration Partnership has completed drilling the first continental flood basalt sequestration pilot borehole to a total depth (TD) of 4,110 feet on the Boise White Paper Mill property at Wallula, Washington. Site suitability was assessed prior to drilling by the 2007-2008 acquisition, processing and analysis of a four-mile, five-line three component seismic swath, which was processed as a single data-dense line. Analysis of the seismic survey data indicated a composite basalt formation thickness of {approx}8,000 feet and absence of major geologic structures (i.e., faults) along the line imaged by the seismic swath. Drilling of Wallula pilot borehole was initiated on January 13, 2009 and reached TD on April 6, 2009. Based on characterization results obtained during drilling, three basalt breccia zones were identified between the depth interval of 2,716 and 2,910 feet, as being suitable injection reservoir for a subsequent CO2 injection pilot study. The targeted injection reservoir lies stratigraphically below the massive Umtanum Member of the Grande Ronde Basalt, whose flow-interior section possesses regionally recognized low-permeability characteristics. The identified composite injection zone reservoir provides a unique and attractive opportunity to scientifically study the reservoir behavior of three inter-connected reservoir intervals below primary and secondary caprock confining zones. Drill cuttings, wireline geophysical logs, and 31one-inch diameter rotary sidewall cores provided geologic data for characterization of rock properties. XRF analyses of selected rock samples provided geochemical characterizations of the rocks and stratigraphic control for the basalt flows encountered by the Wallula pilot borehole. Based on the geochemical results, the pilot borehole was terminated in the Wapshilla Ridge 1 flow of the Grande Ronde Basalt Formation. Detailed hydrologic test characterizations of 12 basalt interflow

  11. Psycho-education programme for temporomandibular disorders: a pilot study

    Directory of Open Access Journals (Sweden)

    El Maaytah Mohammed

    2007-03-01

    Full Text Available Abstract Background Temporomandibular disorders (TMDs are by far the most predominant condition affecting the temporomandibular joint (TMJ, however many patients have mild self-limiting symptoms and should not be referred for specialist care. The aim of this pilot study was to develop a simple, cost-effective management programme for TMDs using CD-ROM. 41 patients (age 18–70 participated in this study, patients were divided into three groups: the 1st group were involved in an attention placebo CD-ROM (contain anatomical information about the temporomandibular system, the 2nd group received information on CD-ROM designed to increase their control and self efficacy, while the 3rd group received the same programme of the 2nd group added to it an introduction to self-relaxing techniques followed by audio tape of progressive muscle relaxation exercises. Each of the groups was asked to complete a number of questionnaires on the day of initial consultation and six weeks afterwards. Results The two experimental groups (2nd & 3rd were equally effective in reducing pain, disability and distress, and both were more effective than the attention placebo group (1st, however the experimental groups appeared to have improved at follow-up relative to the placebo-group in terms of disability, pain and depressed mood. Conclusion This pilot study demonstrates the feasibility and acceptability of the design. A full, randomized, controlled trial is required to confirm the efficacy of the interventions developed here.

  12. Control of a Buoyancy-Based Pilot Underwater Lifting Body

    Directory of Open Access Journals (Sweden)

    Finn Haugen

    2010-04-01

    Full Text Available This paper is about position control of a specific small-scale pilot underwater lifting body where the lifting force stems from buoyancy adjusted with an air pocket in the lifting body. A mathematical model is developed to get a basis for a simulator which is used for testing and for designing the control system, including tuning controller parameters. A number of different position controller solutions were tried both on a simulator and on the physical system. Successful control on both the simulator and the physical system was obtained with cascade control based on feedback from measured position and height of the air pocket in the lifting body. The primary and the secondary controllers of the cascade control system were tuned using Skogestad's model-based PID tuning rules. Feedforward from estimated load force was implemented in combination with the cascade control system, giving a substantial improvement of the position control system, both with varying position reference and varying disturbance (load mass.

  13. Postural control and shoulder steadiness in F-16 pilots

    DEFF Research Database (Denmark)

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S

    2014-01-01

    to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. RESULTS: At follow......-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within...... physiological capacity, a battery of tests with more stringent demands should be considered, e.g., increased number of repetitions, prolonged duration of the tests, or testing with eyes closed....

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

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

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

  15. Endoscopic procedure with a modified Reiki intervention: a pilot study.

    Science.gov (United States)

    Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

    2010-01-01

    This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

  16. A Movement Monitor Based on Magneto-Inertial Sensors for Non-Ambulant Patients with Duchenne Muscular Dystrophy: A Pilot Study in Controlled Environment.

    Directory of Open Access Journals (Sweden)

    Anne-Gaëlle Le Moing

    Full Text Available Measurement of muscle strength and activity of upper limbs of non-ambulant patients with neuromuscular diseases is a major challenge. ActiMyo® is an innovative device that uses magneto-inertial sensors to record angular velocities and linear accelerations that can be used over long periods of time in the home environment. The device was designed to insure long-term stability and good signal to noise ratio, even for very weak movements. In order to determine relevant and pertinent clinical variables with potential for use as outcome measures in clinical trials or to guide therapy decisions, we performed a pilot study in non-ambulant neuromuscular patients. We report here data from seven Duchenne Muscular Dystrophy (DMD patients (mean age 18.5 ± 5.5 years collected in a clinical setting. Patients were assessed while wearing the device during performance of validated tasks (MoviPlate, Box and Block test and Minnesota test and tasks mimicking daily living. The ActiMyo® sensors were placed on the wrists during all the tests. Software designed for use with the device computed several variables to qualify and quantify muscular activity in the non-ambulant subjects. Four variables representative of upper limb activity were studied: the rotation rate, the ratio of the vertical component in the overall acceleration, the hand elevation rate, and an estimate of the power of the upper limb. The correlations between clinical data and physical activity and the ActiMyo® movement parameters were analyzed. The mean of the rotation rate and mean of the elevation rate appeared promising since these variables had the best reliability scores and correlations with task scores. Parameters could be computed even in a patient with a Brooke functional score of 6. The variables chosen are good candidates as potential outcome measures in non-ambulant patients with Duchenne Muscular Dystrophy and use of the ActiMyo® is currently being explored in home environment

  17. The DOE Water Cycle Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Miller, N.L.; King, A.W.; Miller, M.A.; Springer, E.P.; Wesely, M.L.; Bashford, K.E.; Conrad, M.E.; Costigan, K.; Foster, P.N.; Gibbs, H.K.; Jin, J.; Klazura, J.; Lesht, B.M.; Machavaram, M.V.; Pan, F.; Song, J.; Troyan, D.; Washington-Allen, R.A.

    2003-09-20

    A Department of Energy (DOE) multi-laboratory Water Cycle Pilot Study (WCPS) investigated components of the local water budget at the Walnut River Watershed in Kansas to study the relative importance of various processes and to determine the feasibility of observational water budget closure. An extensive database of local meteorological time series and land surface characteristics was compiled. Numerical simulations of water budget components were generated and, to the extent possible, validated for three nested domains within the Southern Great Plains; the DOE Atmospheric Radiation Measurement/Cloud Atmospheric Radiation Testbed (ARM/CART), the Walnut River Watershed (WRW), and the Whitewater Watershed (WW), Kansas A 2-month Intensive Observation Period (IOP) was conducted to gather detailed observations relevant to specific details of the water budget, including fine-scale precipitation, streamflow, and soil moisture measurements not made routinely by other programs. Event and season al water isotope (delta 18O, delta D) sampling in rainwater, streams, soils, lakes, and wells provided a means of tracing sources and sinks within and external to the WW, WRW, and the ARM/CART domains. The WCPS measured changes in leaf area index for several vegetation types, deep groundwater variations at two wells, and meteorological variables at a number of sites in the WRW. Additional activities of the WCPS include code development toward a regional climate model with water isotope processes, soil moisture transect measurements, and water level measurements in ground water wells.

  18. Climatotherapy in Japan: a pilot study

    Science.gov (United States)

    Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela

    2017-08-01

    Twenty-nine urban inhabitants participated in a half-day climatotherapy programme at the moderate mountain area and lowland area in the northwest part of the main island of Japan. The current study was aimed to investigate physically and mentally the objective and subjective influence of our short programme, which was a prospective pilot study of single intervention. Blood pressure was significantly descended during terrain cure at the uphill mountain path and returned after fresh-air rest cure, while there was no significant change throughout the programme at lowland flat path. Heart rate was significantly ascended and descended at both area, and more clearly changed at the mountain path. Profile of Mood Status brief form Japanese version administered before and after our half-day programme. Age adjusted T score of negative subscales, `tension-anxiety', `depression', `anger-hostility', `fatigue' and `confusion' were significantly lower after climatotherapy at both sites. Whereas, there was no significant change concerning `vigour' score. This short-version climatotherapy programme has been designed for people without enough time for long stay at health resort. It turned out our half-day climatotherapy programme contribute to mood status improvement. In addition, repeated practice of our short-version programme including endurance exercise with cool body shell using uphill path can be expected that blood pressure will go toward the normal range and heart rate will decrease both in usual time and during exercise. Therefore, health benefits can be expected of this climatotherapy programme.

  19. ShopTrip Pilot Study : The Preference-Conscious Choice Modelled and Observed

    DEFF Research Database (Denmark)

    Barratt, Daniel; Selsøe-Sørensen, Henrik; Qvistgaard, Francoise

    The goal of the current pilot study was to construct and test a new kind of setup for observing the consumer’s purchasing behaviour, with a particular focus on fairness and misleadingness issues as opposed to marketing and sales. The setup described represents a compromise between ecological...... validity and experimental control in at least two ways: the way the consumer’s behaviour is monitored and the way the consumer’s behaviour is brought about. The first part of the pilot study involved a simulation of an ‘e-shopping environment’ which had the advantage of creating a relatively realistic...... of the pilot study, the participants were presented with actual products and instructed to assume the role of ‘health detectives’ in order to enhance the degree of preference consciousness even further. In the third and final part of the pilot study, the participants were asked to fill out a questionnaire...

  20. Controle químico da microflora oral em pacientes fissurados labiopalatais durante o tratamento ortodôntico-cirúrgico: estudo piloto Oral microflora chemical control in cleft lip and palate patients during orthodontic-surgical treatment pilot study

    Directory of Open Access Journals (Sweden)

    Alcion Alves Silva

    2004-06-01

    hygiene. Alternative techniques, like chemical agents, was proposed like auxiliary procedures. This study design was exploratoy, microbiological (pilot, double-blind, for test the present chemical agents: triclosan 0,03% (Plax-Colgate-Palmolive and digluconate clorexidin 0,12% (Duplak-Herpro/Dentispy. The sample was composed for 30 volunteers separeted at 3 groups: Group I (control, Group II (test-digluconate clorexidin 0,12, Group III (test-triclosan 0,03%. All groups recived buccal hygiene orientation preceding the first material colect. After 7 days of chemical agent use, a secon colect was proceeded and the agent use was stopped. A tird colect was procedeed after 7 days of agent suspension. A semiquantitative technique purposed for PILONETTO and PILONETTO (1998 was adopted to evaluate bacterial colonies growth. Results showed more significant reduction of buccal microflora at Group II when compared with Group III.

  1. Computerized control of circulation. Optimal storage climate with minimal energy consumption. Pilot study; Computergestuurde Circulatieregelingen. Optimaal bewaarklimaat met minimaal energieverbruik. Praktijkonderzoek

    Energy Technology Data Exchange (ETDEWEB)

    Wildschut, J. [Praktijkonderzoek Plant en Omgeving PPO, Bloembollen, Boomkwekerij en Fruit, Lisse (Netherlands); Janssen, H.H.J.; Gielen, T.G.; Sapounas, A. [WUR Glastuinbouw, Wageningen (Netherlands)

    2011-04-15

    The objective of this study is to develop computerized controls for circulation that are based on sensors, allowing for significant conservation in the electricity use of circulation [Dutch] Doelstelling van dit project is het ontwikkelen van op sensoren gebaseerde computergestuurde regelingen voor de circulatie, waardoor bij een optimaal bewaarklimaat voor alle bolgewassen zeer fors op het elektraverbruik voor circulatie bespaard kan worden.

  2. Vestibulo-Ocular Response and Balance Control in Children and Young Adults with Mild-to-Moderate Intellectual and Developmental Disability: A Pilot Study

    Science.gov (United States)

    Zur, Oz; Ronen, Ayelet; Melzer, Itshak; Carmeli, Eli

    2013-01-01

    The vestibulo-ocular response (VOR) may not be fully developed in children with an intellectual and developmental disability (IDD). This study aimed to identify the presence of VOR deficit in children and young adults with unspecified mild-to-moderate intellectual and developmental disability and its effect on balance control. Twenty-one children…

  3. Supplementation with Eicosapentaenoic Omega-3 Fatty Acid Does Not Influence Serum Brain-Derived Neurotrophic Factor in Diabetes Mellitus Patients with Major Depression : A Randomized Controlled Pilot Study

    NARCIS (Netherlands)

    Bot, Mariska; Pouwer, Francois; Assies, Johanna; Jansen, Eugene H. J. M.; Beekman, Aartjan T. F.; de Jonge, Peter

    2011-01-01

    Background: Low brain-derived neurotrophic factor (BDNF) levels are observed in both depressed and diabetes patients. Animal research has shown that omega-3 polyunsaturated fatty acids increase BDNF levels. In this exploratory randomized double-blind placebo-controlled study in diabetes patients wit

  4. Honey and a mixture of honey, beeswax, and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis: a randomized controlled pilot study.

    Science.gov (United States)

    Abdulrhman, Mamdouh; Elbarbary, Nancy Samir; Ahmed Amin, Dina; Saeid Ebrahim, Rania

    2012-04-01

    In spite of being one of the most investigated subjects among supportive care in cancer, no therapy has been found effective in treatment of chemotherapy-induced oral mucositis. Based on the observations that honey bees products have anti-inflammatory and wound healing effects, the present study tried to evaluate the effect of topical application of honey and a mixture of honey, olive oil-propolis extract, and beeswax (HOPE) in treatment of oral mucositis. This was a randomized controlled clinical trial conducted on 90 patients with acute lymphoblastic leukemia and oral mucositis grades 2 and 3. The mean age of enrolled patients was 6.9 years. The patients were assigned into 3 equal treatment groups: Honey, HOPE, and control groups. Topical treatment for each patient consists of honey, HOPE, and benzocaine gel for honey, HOPE, and control groups, respectively. Recovery time in grade 2 mucositis was significantly reduced in the honey group as compared with either HOPE or controls (P < .05). In grade 3 mucositis, recovery time did not differ significantly between honey and HOPE (P = 0.61) but compared with controls, healing was faster with either honey or HOPE (P < .01). Generally, in both grades of mucositis, honey produced faster healing than either HOPE or controls (P < .05). Based on our results that showed that honey produced faster healing in patients with grade 2/3 chemotherapy-induced mucositis, we recommend using honey and possibly other bee products and olive oil in future therapeutic trials targeting chemotherapy-induced mucositis.

  5. Hearing loss in civilian airline and helicopter pilots compared to air traffic control personnel.

    Science.gov (United States)

    Wagstaff, Anthony S; Arva, Per

    2009-10-01

    In order to investigate possible hearing loss as a consequence of aviation noise, a comparative analysis of audiometric data from Norwegian Air Traffic Control (ATC) personnel, airline (fixed-wing) pilots, and helicopter pilots was performed. The results may be of use in giving advice regarding preventive measures. Male ATC, airline, and helicopter pilots were selected randomly from the Civil Aviation Authority (CAA) medical files. There were 182 subjects included in the study: 50, 81, and 51 subjects for ATC, helicopter, and airline pilots, respectively. Two audiograms with a 2-3-yr interval were analyzed for each individual. Age correction was performed using data from ISO 7129. Threshold changes per year for the frequencies 3, 4, and 6 kHz were examined in particular after age correction. For all three groups, mean hearing threshold levels were above (worse than) ISO 7129 predictions for most frequencies. As expected, hearing thresholds increased with age in the group as a whole. Looking at the 3-, 4-, and 6-kHz frequencies in particular, all groups had small but highly significant increases in hearing thresholds at 4 kHz between the first and second audiogram. The mean hearing thresholds for this group of aviation personnel are higher than International Standard ISO-7129 would predict according to age. Highly significant changes in hearing threshold after age correction, indicating possible noise-induced hearing loss, were found in all groups at 4 kHz. The fact that helicopter pilots had similar hearing loss to their other aviation colleagues indicates that current hearing protection for these pilots is effective in counteracting the increased noise levels in helicopters.

  6. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken W.

    2015-01-01

    support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two......-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...

  7. Homeopathic Secretin in autism: a clinical pilot study.

    Science.gov (United States)

    Robinson, T W

    2001-04-01

    Autism is a condition characterised by impairments of social communication, social interaction and social imagination. The exact aetiology of autism is unknown but some autistic features have been explained by the 'opioid excess theory' in which excess brain peptide levels have a morphine-like activity. Reduction of peptide levels by administration of the duodenal enzyme Secretin has been found to improve social and language skills in autistic patients. Homeopathic Secretin has been said to produce similar effects. A pilot study was undertaken to study these effects by administration of Secretin to a group of autistic patients. Weekly assessment for 12 weeks was performed by the patients' care workers. Statistical analysis of the mean pre-treatment results compared with the mean treatment results suggested a worsening in the autistic symptoms during treatment. Discussion with the care workers revealed changes and some improvements that were not recordable on the scoring system. Further research into Secretin treatment of autism using a more detailed and customized scoring system would be justified. Following this pilot study a randomised controlled trial of Secretin vs placebo would be appropriate.

  8. LAM Pilot Study with Imatinib Mesylate (LAMP-1)

    Science.gov (United States)

    2015-10-01

    AD______________ AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate ( LAMP -1) PRINCIPAL INVESTIGATOR: Charlie...AND SUBTITLE LAM Pilot Study with Imatinib Mesylate ( LAMP -1) 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-14-1-0132 5c. PROGRAM ELEMENT...AVAILABILITY STATEMENT Approved for Public Release; Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT The LAMP -1 study is

  9. Genetic influences of resting state fMRI activity in language-related brain regions in healthy controls and schizophrenia patients: a pilot study.

    Science.gov (United States)

    Jamadar, Sharna; Powers, Natalie R; Meda, Shashwath A; Calhoun, Vince D; Gelernter, Joel; Gruen, Jeffrey R; Pearlson, Godfrey D

    2013-03-01

    Individuals with schizophrenia show a broad range of language impairments, similar to those observed in reading disability (RD). Genetic linkage and association studies of RD have identified a number of candidate RD-genes that are associated with neuronal migration. Some individuals with schizophrenia also show evidence of impaired cortical neuronal migration. We have previously linked RD-related genes with gray matter distributions in healthy controls and schizophrenia. The aim of the current study was to extend these structural findings and to examine links between putative RD-genes and functional connectivity of language-related regions in healthy controls (n = 27) and schizophrenia (n = 28). Parallel independent component analysis (parallel-ICA) was used to examine the relationship between language-related regions extracted from resting-state fMRI and 16 single nucleotide polymorphisms (SNPs) spanning 5 RD-related genes. Parallel-ICA identified four significant fMRI-SNP relationships. A Left Broca-Superior/Inferior Parietal network was related to two KIAA0319 SNPs in controls but not in schizophrenia. For both diagnostic groups, a Broca-Medial Parietal network was related to two DCDC2 SNPs, while a Left Wernicke-Fronto-Occipital network was related to two KIAA0319 SNPs. A Bilateral Wernicke-Fronto-Parietal network was related to one KIAA0319 SNP only in controls. Thus, RD-genes influence functional connectivity in language-related regions, but no RD-gene uniquely affected network function in schizophrenia as compared to controls. This is in contrast with our previous study where RD-genes affected gray matter distribution in some structural networks in schizophrenia but not in controls. Thus these RD-genes may exert a more important influence on structure rather than function of language-related networks in schizophrenia.

  10. Stress and cancer in dogs: Comparison between a population of dogs diagnosed with vancer and a control population - A pilot study

    Directory of Open Access Journals (Sweden)

    Simona Cannas

    2016-10-01

    Full Text Available It is widely accepted that psychological stress and mental illness can compromise the function of the immune system. Clinical and epidemiological studies on humans recognized that specific psychosocial factors, such as stress, chronic depression and lack of social support are risk factors for the development and progression of cancer. Unfortunately, most of the animals studies on this subject are based on laboratory tests performed on mice. This retrospective cohort study aims to analyze the relation between stress and tumor in pet dogs, by evaluating and comparing the stress level in two groups of 69 dogs each, balanced for sex and age: the oncologic group consists of dogs diagnosed with cancer and the control group consists of healthy dogs. Our results show that, before the cancer diagnosis, more dogs in the oncologic group faced changes in their household and routine as opposed to the control group (p<0.05. More dogs of the oncologic group than the control group also showed signs of stress and anxiety, before the cancer diagnosis (p<0.05. As reported by their owners, these included attention seeking, hiding without a specific reason, following the owner around the house, hyper-vigilance, fear of fireworks and gunshots, biting, aggression towards other dogs, licking and chewing excessively parts of their body. Our results are aligned with the evidence from human research, indicating that dogs with cancer are significantly more likely to have shown signs of stress compared to the control dogs during their life.

  11. Impact of nutrition messages on children's food choice: pilot study.

    Science.gov (United States)

    Bannon, Katie; Schwartz, Marlene B

    2006-03-01

    This pilot study tested the influence of nutrition message framing on snack choice among kindergarteners. Three classrooms were randomly assigned to watch one of the following 60s videos: (a) a gain-framed nutrition message (i.e. the positive benefits of eating apples) (n=14); (b) a loss-framed message (i.e. the negative consequences of not eating apples) (n=18); or (c) a control scene (children playing a game) (n=18). Following this, the children were offered a choice between animal crackers and an apple for their snack. Among the children who saw one of the nutrition message videos, 56% chose apples rather than animal crackers; in the control condition only 33% chose apples. This difference was statistically significant (chi2=7.56, p<0.01). These results suggest that videos containing nutritional messages may have a positive influence on children's short-term food choices.

  12. Reducing TV watching during adult obesity treatment: two pilot randomized controlled trials.

    Science.gov (United States)

    Raynor, Hollie A; Steeves, Elizabeth Anderson; Bassett, David R; Thompson, Dixie L; Gorin, Amy A; Bond, Dale S

    2013-12-01

    The more time adults spend being sedentary, the greater the risk of obesity. The effect of reducing television (TV) watching, a prominent sedentary behavior, on weight loss has not been tested in an adult standard behavioral obesity intervention, and the mechanisms by which reducing TV watching influences energy balance behaviors are not well understood. Two, 8-week, pilot, randomized controlled trials were conducted examining the effect of a reduced TV watching prescription on energy balance behaviors and weight loss within an adult standard behavioral obesity intervention. In the first study, participants (n=24) were randomized into one of two conditions: (a) reduce energy intake and increase moderate to vigorous physical activity (MVPA) (INCREASE PA); or (b) reduce energy intake and decrease TV watching (DECREASE TV). As findings from the first pilot study did not show an increase in MVPA in the DECREASE TV group, the second study was designed to examine the effect of adding a reduced TV prescription to a standard intervention to optimize outcomes. In Pilot Study 2, participants (n=28) were randomized to INCREASE PA or to INCREASE PA+DECREASE TV. Outcomes included objectively measured TV watching and MVPA, self-reported light physical activity (LPA-Pilot Study 2 only), self-reported dietary intake while watching TV, and weight. Conditions with TV watching prescriptions significantly reduced TV watching. Both studies showed medium to large effect sizes for conditions with TV watching prescriptions to show greater reductions in dietary intake while watching TV. Pilot Study 1 found a trend for an increase in MVPA in INCREASE PA and Pilot Study 2 found significant increases in MVPA in both conditions. Pilot Study 2 found a significant increase in LPA in the INCREASE PA+DECREASE TV. Results indicate adding a TV watching prescription to a standard obesity intervention did not enhance increases in MVPA, but may assist with reducing dietary intake while TV watching and

  13. Antimicrobial Susceptibility Pattern in Diabetic Foot Ulcer: A Pilot Study

    African Journals Online (AJOL)

    Antimicrobial Susceptibility Pattern in Diabetic Foot Ulcer: A Pilot Study. ... of microbes that cause infections are helpful to determine proper antibiotic therapy. ... including extended spectrum beta lactamase producing strains of Proteus ...

  14. 1999 ANNUAL REPORT NATO/CCMS PILOT STUDY

    Science.gov (United States)

    This annual report present the proceedings of the second annual NATO/CCMS pilot study meeting in Belfast, UK in March 1999. Guest speakers focused on efforts in the research arena of clean products, clean processes, and pollution prevention tools.

  15. Supervisory control of a pilot-scale cooling loop

    Energy Technology Data Exchange (ETDEWEB)

    Kris Villez; Venkat Venkatasubramanian; Humberto Garcia

    2011-08-01

    We combine a previously developed strategy for Fault Detection and Identification (FDI) with a supervisory controller in closed loop. The combined method is applied to a model of a pilot-scale cooling loop of a nuclear plant, which includes Kalman filters and a model-based predictive controller as part of normal operation. The system has two valves available for flow control meaning that some redundancy is available. The FDI method is based on likelihood ratios for different fault scenarios which in turn are derived from the application of the Kalman filter. A previously introduced extension of the FDI method is used here to enable detection and identification of non-linear faults like stuck valve problems and proper accounting of the time of fault introduction. The supervisory control system is designed so to take different kinds of actions depending on the status of the fault diagnosis task and on the type of identified fault once diagnosis is complete. Some faults, like sensor bias and drift, are parametric in nature and can be adjusted without need for reconfiguration of the regulatory control system. Other faults, like a stuck valve problem, require reconfiguration of the regulatory control system. The whole strategy is demonstrated for several scenarios.

  16. The effect of an eyes-closed dance-specific training program on dynamic balance in elite pre-professional ballet dancers: a randomized controlled pilot study.

    Science.gov (United States)

    Hutt, Kimberley; Redding, Emma

    2014-03-01

    Visual conditions for a dancer vary greatly between theatrical performance environments and dance studios, and this variability may be detrimental to their dynamic balance performance, particularly under stage lighting. In order to maintain balance control, dancers reportedly rely heavily on visual input, yet those who rely more on proprioceptive strategies for balancing have been found to be more stable. The purpose of this study was to assess the capability of an eyes-closed, dance-specific training program to nurture in dancers proprioceptive mechanisms that may facilitate their dynamic balance control. Eighteen elite pre-professional ballet dancers were randomly assigned to either a control (eyes open) or experimental (eyes closed) group for the intervention. The balance abilities of all subjects were tested using five dance-specific variations of the Star Excursion Balance Test before and after a 4 week balance intervention. Reach distance and time to complete the tests were recorded separately as indirect measurements of dynamic balance. The intervention consisted of dance-specific, eyes-closed exercises integrated into the dancers' daily ballet class and designed progressively to challenge the dancers' balance. During the intervention period, the control group undertook the same exercise program with their eyes open. Results revealed significant improvements in time to complete the three "timed" balance tests, and distances reached significantly improved in one of the two "reach" balance tests. No significant improvements were observed in the control group for any variation of the tests. These results indicate that dancers can be trained to adopt proprioceptive strategies to maintain dynamic balance, which consequently improves their balance performance. Such findings could encourage use of eyes-closed training in daily dance classes due to its potential to improve dancers' balance control.

  17. PILOT STUDY: CCQM-P32 pilot study. Anion calibration solutions

    Science.gov (United States)

    Weber, Michael; Wüthrich, Jürg

    2003-01-01

    In the CCQM-P32 pilot study two gravimetrically prepared anion calibration solutions of chloride and phosphate each of about 1 g/kg mass fraction were investigated. The comparison was an activity of the Inorganic Analysis Working Group of CCQM in 2002 and was piloted by the Swiss Federal Laboratories for Materials Testing and Research (EMPA). The following institutes participated in this study (in alphabetical order): BAM (Germany), CENAM (Mexico), EMPA (Switzerland), GUM (Poland), KRISS (South Korea), LNE (France), NIST (United States of America), NMIJ (Japan), NRCCRM (China), PTB (Germany), SMU (Slovakia). For the chloride calibration solution 11 participants provided 16 results by the following analytical techniques: coulometry (7), titrimetry (5) and ion chromatography (4). The phosphate amount content was determined by 9 NMIs and 11 results were reported. Phosphate ion chromatography was the most applied technique (4), followed by titrimetry (2), ICP-OES (2), gravimetry (1) and ion-exchange coulometry (1). All results were found within a range of +/-0.5% with respect to the gravimetric value. The variability (RSD) of the results is 0.13% for chloride and 0.26% for phosphate. The reported results of all participants are also graphically displayed in this report. Main text. To reach the main text of this paper, click on Final Report. The final report has been peer-reviewed and approved for publication by the CCQM Working Group on Inorganic Analysis, according to the provisions of the Mutual Recognition Arrangement (MRA).

  18. Effect of lyophilized lactobacilli and 0.03 mg estriol (Gynoflor®) on vaginitis and vaginosis with disrupted vaginal microflora: a multicenter, randomized, single-blind, active-controlled pilot study.

    Science.gov (United States)

    Donders, G G G; Van Bulck, B; Van de Walle, P; Kaiser, R R; Pohlig, G; Gonser, S; Graf, F

    2010-01-01

    To evaluate the efficacy of lyophilized lactobacilli in combination with 0.03 mg estriol when compared to metronidazole in the treatment of bacterial vaginal infections. Multicenter, randomized, single-blind, active-controlled pilot study in 3 independent gynecological practices in Belgium. Forty-six, 18- to 50-year-old premenopausal women with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis, aerobic vaginitis) were included, provided that fresh phase-contrast microscopy of the vaginal fluid showed lactobacillary flora grade 2B or 3. Patients were given a blinded box with either 12 vaginal tablets of Gynoflor® (study medication) or 6 vaginal suppositories containing 500 mg metronidazole (control medication). Eight efficacy variables were studied to assess the status of the vaginal flora at entry, 3-7 days (control 1), 4-6 (control 2) weeks and 4 months after the end of therapy. At control 1, the combined variables equally improved in the lactobacilli group as in the metronidazole group. At control 2, the lactobacillus preparation showed slightly inferior results when compared to metronidazole. At 4 months, this analysis could not be performed due to low numbers, but analysis of recurrence rate and extra medication needed was not different between both groups. Lyophilized lactobacilli in combination with low-dose estriol are equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month. Further studies are required to evaluate the long-term efficacy of lactobacilli when applied repeatedly. Copyright © 2010 S. Karger AG, Basel.

  19. Remote monitoring of inhaled bronchodilator use and weekly feedback about asthma management: an open-group, short-term pilot study of the impact on asthma control.

    Directory of Open Access Journals (Sweden)

    David Van Sickle

    Full Text Available OBJECTIVE: Adequate symptom control is a problem for many people with asthma. We asked whether weekly email reports on monitored use of inhaled, short-acting bronchodilators might improve scores on composite asthma-control measures. METHODS: Through an investigational electronic medication sensor attached to each participant's inhaler, we monitored 4 months' use of inhaled, short-acting bronchodilators. Participants completed surveys, including the Asthma Control Test(TM (ACT, to assess asthma control at entry and monthly thereafter. After the first month, participants received weekly email reports for 3 months. The reports summarized inhaled bronchodilator use during the preceding week and provided suggestions derived from National Asthma Education and Prevention Program (NAEPP guidelines. Paired t-tests and random-effects mixed models were implemented to assess changes in primary asthma endpoints. RESULTS: Thirty individuals participated in the 4-month study; 29 provided complete asthma control information. Mean age was 36.8 years (range: 19-74 years; 52% of respondents were female. Mean ACT scores were 17.6 (Standard Deviation [SD]  = 3.35 at entry and 18.4 (SD = 3.60 at completion of the first month. No significant difference appeared between ACT values at entry and completion of the first month (p = 0.66; however, after participants began receiving email reports and online information about their inhaler use, mean ACT scores increased 1.40 points (95% CI: 0.61, 2.18 for each subsequent study month. Significant decreases occurred in 2-week histories of daytime symptoms (β = -1.35, 95% CI: -2.65, -0.04 and nighttime symptoms (β = -0.84, 95% CI: -1.25, -0.44; no significant change in activity limitation (β = -0.21, 95% CI: -0.69, 0.26 was observed. Participants reported increased awareness and understanding of asthma patterns, level of control, bronchodilator use (timing, location and triggers, and improved

  20. Remote monitoring of inhaled bronchodilator use and weekly feedback about asthma management: an open-group, short-term pilot study of the impact on asthma control.

    Science.gov (United States)

    Van Sickle, David; Magzamen, Sheryl; Truelove, Shaun; Morrison, Teresa

    2013-01-01

    Adequate symptom control is a problem for many people with asthma. We asked whether weekly email reports on monitored use of inhaled, short-acting bronchodilators might improve scores on composite asthma-control measures. Through an investigational electronic medication sensor attached to each participant's inhaler, we monitored 4 months' use of inhaled, short-acting bronchodilators. Participants completed surveys, including the Asthma Control Test(TM) (ACT), to assess asthma control at entry and monthly thereafter. After the first month, participants received weekly email reports for 3 months. The reports summarized inhaled bronchodilator use during the preceding week and provided suggestions derived from National Asthma Education and Prevention Program (NAEPP) guidelines. Paired t-tests and random-effects mixed models were implemented to assess changes in primary asthma endpoints. Thirty individuals participated in the 4-month study; 29 provided complete asthma control information. Mean age was 36.8 years (range: 19-74 years); 52% of respondents were female. Mean ACT scores were 17.6 (Standard Deviation [SD]  = 3.35) at entry and 18.4 (SD = 3.60) at completion of the first month. No significant difference appeared between ACT values at entry and completion of the first month (p = 0.66); however, after participants began receiving email reports and online information about their inhaler use, mean ACT scores increased 1.40 points (95% CI: 0.61, 2.18) for each subsequent study month. Significant decreases occurred in 2-week histories of daytime symptoms (β = -1.35, 95% CI: -2.65, -0.04) and nighttime symptoms (β = -0.84, 95% CI: -1.25, -0.44); no significant change in activity limitation (β = -0.21, 95% CI: -0.69, 0.26) was observed. Participants reported increased awareness and understanding of asthma patterns, level of control, bronchodilator use (timing, location) and triggers, and improved preventive practices. Weekly email reports and

  1. Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

    Science.gov (United States)

    Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

    2016-01-01

    Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95

  2. Portable pilot plant for evaluating marine biofouling growth and control in heat exchangers-condensers.

    Science.gov (United States)

    Casanueva, J F; Sánchez, J; García-Morales, J L; Casanueva-Robles, T; López, J A; Portela, J R; Nebot, E; Sales, D

    2003-01-01

    Biofouling frequently involves a serious impediment to achieving optimum operating conditions in heat exchangers-condensers. The economic coat and energy losses associated with this phenomenon are significant and the environmental impact of biocides must satisfy stringent regulations. A portable pilot plant has been designed in order to carry out in-situ experimental study as biofilm is formed under thermal and hydrodynamically controlled conditions. The pilot plant has an automatic monitoring, control and data acquisition system, which automatically processes data from indirect measure of fouling in terms of increased fluid frictional and heat transfer resistances. A particular method is used and proposed for direct measuring and biofilm characterization. Once we know the actual film thickness, we can calculate the effective thermal conductivity of the layer by using the appropriate heat transfer equations.

  3. A 16-Week Open-Label, Multicenter Pilot Study Assessing Insulin Pump Therapy in Patients with Type 2 Diabetes Suboptimally Controlled with Multiple Daily Injections

    Science.gov (United States)

    Frias, Juan P; Bode, Bruce W; Bailey, Timothy S; Kipnes, Mark S; Brunelle, Rocco; Edelman, Steven V

    2011-01-01

    Background We assessed the efficacy, safety, and patient-reported outcomes (PROs) of insulin pump therapy in patients with type 2 diabetes mellitus (T2DM) who were suboptimally controlled with a multiple daily injection (MDI) regimen. Methods In this subanalysis of a 16-week multicenter study, 21 insulin-pump-naïve patients [age 57 ± 13 years, hemoglobin A1c (A1C) 8.4 ± 1.0%, body weight 98 ± 20 kg, total daily insulin dose 99 ± 65 U, mean ± standard deviation] treated at baseline with MDI therapy with or without oral antidiabetic agents discontinued all diabetes medications except metformin and initiated insulin pump therapy. Insulin was titrated to achieve the best possible glycemic control with the simplest possible dosing regimen. Outcome measures included A1C, fasting and postprandial glucose, body weight, incidence of hypoglycemia, and PROs. Results Glycemic control improved significantly after 16 weeks: A1C 7.3 ± 1.0% (−1.1 ± 1.2%, p insulin doses were 66 ± 36, 56 ± 40, and 122 ± 72 U (1.2 U/kg), respectively, and 90% of patients were treated with two or fewer daily basal rates. Body weight increased by 2.8 ± 2.6 kg (p Insulin pump therapy using a relatively simple dosing regimen safely improved glucose control and PROs in patients with T2DM who were unable to achieve glycemic targets with MDI therapy. Controlled trials are needed to further assess the clinical benefits and cost-effectiveness of insulin pumps in this patient population. PMID:21880230

  4. The Effect of Sweet Bee Venom Pharmacopuncture(SBVP on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study

    Directory of Open Access Journals (Sweden)

    Hwa-Seung Yoo

    2008-03-01

    Full Text Available Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS(0, no pain at all, 10, worst pain imaginable were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day for group A and Normal Saline Placebo(1ml/day for group B was injected into the abdomen acupoint, Zhong Wan(CV 12. The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS before and after each treatment for “Pain right now” and “Average pain in last 24 hours”. Statistical Analysis : regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample ttest nd Wilcoxon signed rank test with level of significance at 5%. Results : fferences in NRS of “Pain right now” for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group(2.48°±1.52 vs 0.97°±1.88, p<0.05. Differences in average pain score before and after treatment in SBVP group were also significant(5.13°±1.77 vs 2.65°±0.67, p<0.05 compared with control group. The two groups showed no significant differences for long term effects in “Average pain in last 24 hours.” Conclusion : Although further study will be needed on

  5. Chinese Herbal Medicine (Zi Shen Qing for Mild-to-Moderate Systematic Lupus Erythematosus: A Pilot Prospective, Single-Blinded, Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Linda L. D. Zhong

    2013-01-01

    Full Text Available Objective. The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula Zi Shen Qing (ZSQ in the treatment of systematic lupus erythematosus (SLE in Chinese patients. Methods. A randomized controlled trial was conducted over 12 weeks in 84 Chinese patients who reported total scores of SLE Disease Activity Index-2000 (SLEDAI-2000 was from 5 to 14. The primary outcome was the changes of the SLEDAI-2000. The secondary outcomes included score changes of Chinese Medicine Syndromes (CMS, the changes of steroid dosage, the incidence of disease flare-up and biologic markers. Results. ZSQ significantly reduced SLEDAI-2000, the total scores of CMS in the treatment group compared with the controlled group (P<0.05. Superiority of ZSQ over controlled group was also observed with greater improvement in the withdrawal dosage of corticosteroids and the incidence of disease flare-up (P<0.05. There were no serious adverse events, and safety indices of whole blood counts, renal and liver functions were normal, both before and after the treatment. Conclusion. ZSQ is safe and effective for decreasing SLE disease activity and withdrawal dosage of corticosteroids in the mild to moderate SLE patients with “Deficiency of Qi and Yin” Pattern.

  6. Differences in EEG delta frequency characteristics and patterns in slow-wave sleep between dementia patients and controls: a pilot study.

    Science.gov (United States)

    Bonanni, Enrica; Di Coscio, Elisa; Maestri, Michelangelo; Carnicelli, Luca; Tsekou, Hara; Economou, Nicholas Tiberio; Paparrigopoulos, Thomas; Bonakis, Anastasios; Papageorgiou, Sokratis G; Vassilopoulos, Dimitris; Soldatos, Constantin R; Murri, Luigi; Ktonas, Periklis Y

    2012-02-01

    To evaluate the modifications of EEG activity during slow-wave sleep in patients with dementia compared with healthy elderly subjects, using spectral analysis and period-amplitude analysis. Five patients with dementia and 5 elderly control subjects underwent night polysomnographic recordings. For each of the first three nonrapid eye movement-rapid eye movement sleep cycles, a well-defined slow-wave sleep portion was chosen. The delta frequency band (0.4-3.6 Hz) in these portions was analyzed with both spectral analysis and period-amplitude analysis. Spectral analysis showed an increase in the delta band power in the dementia group, with a decrease across the night observed only in the control group. For the dementia group, period-amplitude analysis showed a decrease in well-defined delta waves of frequency lower than 1.6 Hz and an increase in such waves of frequency higher than 2 Hz, in incidence and amplitude. Our study showed (1) a loss of the dynamics of delta band power across the night sleep, in dementia, and (2) a different distribution of delta waves during slow-wave sleep in dementia compared with control subjects. This kind of computer-based analysis can highlight the presence of a pathologic delta activity during slow-wave sleep in dementia and may support the hypothesis of a dynamic interaction between sleep alteration and cognitive decline.

  7. A novel approach to search for identity by descent in small samples of patients and controls from the same mendelian breeding unit: a pilot study on myopia.

    Science.gov (United States)

    Heath, S; Robledo, R; Beggs, W; Feola, G; Parodo, C; Rinaldi, A; Contu, L; Dana, D; Stambolian, D; Siniscalco, M

    2001-01-01

    Autosomal dominant high myopia, a genetic disorder already mapped to region 18p11.31, is common in Carloforte (Sardinia, Italy), an isolated village of 8,000 inhabitants descending from a founder group of 300 in the early 1700s. Fifteen myopic propositi and 36 normal controls were selected for not having ancestors in common at least up to the grandparental generation, although still descendants of the original founders. All subjects were genotyped for 14 markers located on autosome 18 at a resolution of about 10 cM. Allelic distributions were found to be similar at all tested loci in propositi and controls, except for the candidate marker D18S63 known to segregate in close linkage association with high myopia. In particular, the frequency of allele 85 among the propositi was almost double that of the controls (Fisher's exact test, p = 0.037). The association is more striking when the frequency of the genotype 85/85 in the two groups is compared (Fisher's exact test, p = 0.005). This conclusion was further evaluated through a bootstrap analysis by computing the overall probability of the observed data under the null hypothesis (i.e. no difference between the two groups in frequency distributions for the chromosome 18 markers). Again, marker D18S63 was found to have a sample probability lower than 0.004, which is significant at the 0.05 level after correcting for simultaneous testing of multiple loci. The study demonstrates the efficiency of our novel strategy to detect identity by descent (IBD) in small numbers of patients and controls when they are both part of well-defined Mendelian breeding units (MBUs). The iterative application of our strategy in separate MBUs is expected to become the method of choice to evaluate the ever-growing number of reported associations between candidate genes and multifactorial traits and diseases.

  8. Vitamins C and E treatment combined with exercise modulates oxidative stress markers in blood of patients with fibromyalgia: a controlled clinical pilot study.

    Science.gov (United States)

    Nazıroğlu, Mustafa; Akkuş, Selami; Soyupek, Feray; Yalman, Kadir; Çelik, Ömer; Eriş, Sevilay; Uslusoy, Gökçen Ay

    2010-11-01

    We aimed to investigate effects of vitamins C and E (VCE) supplementation with exercise (EX) on antioxidant vitamin and lipid peroxidation (LP) levels in blood of patients with fibromyalgia (FM). A controlled study was performed on blood samples from 32 female FM patients and 30 age-matched controls. The patients were divided into three groups namely EX (n = 10), VCE (n = 11), and EX plus VCE (n = 11) after taking basal blood samples. After 12 weeks of EX and VCE supplementation, blood samples were taken once more from the patients. LP levels in plasma and erythrocytes were higher in the patients at baseline than those in controls, whereas LP levels were lower in the VCE and EX groups at the end of 12 weeks than those at baseline. Plasma concentrations of vitamins A and E and reduced glutathione were lower in the patients than those in controls and their concentrations were increased by VCE and EX. Glutathione peroxidase activity in erythrocytes was increased by VCE supplementation, with or without EX. Concentrations of β-carotene in the groups did not change with treatment. Despite the measured effects on anti-oxidative mechanisms, FM symptoms were not improved by the treatments. In conclusion, VCE with EX may protect against FM-induced oxidative stress by up-regulation of an antioxidant redox system in the plasma and erythrocytes of patients with FM. Such protective effects of VCE in the patients seemed to be greater in combination with EX than EX alone.

  9. Ecological study of sleep disruption in PTSD: a pilot study.

    Science.gov (United States)

    Germain, Anne; Hall, Martica; Katherine Shear, M; Nofzinger, Eric A; Buysse, Daniel J

    2006-07-01

    Laboratory-based sleep studies have yielded inconsistent results regarding the presence and nature of objective sleep anomalies in posttraumatic stress disorder (PTSD). This pilot study aimed at assessing sleep in adult crime victims with PTSD by using in-home polysomnography. Compared to healthy archival subjects, PTSD subjects showed longer sleep latency, reduced total sleep time, and increased duration of nocturnal awakening. Quantitative electroencephalography (EEG) measures of delta and beta activity also differed in PTSD and healthy subjects. These preliminary findings suggest that ambulatory methods can capture objective signs of sleep disruption, and corroborate subjective complaints of disrupted sleep in PTSD.

  10. Influence of UAS Pilot Communication and Execution Delay on Controller's Acceptability Ratings of UAS-ATC Interactions

    Science.gov (United States)

    Vu, Kim-Phuong L.; Morales, Gregory; Chiappe, Dan; Strybel, Thomas Z.; Battiste, Vernol; Shively, Jay; Buker, Timothy J

    2013-01-01

    Successful integration of UAS in the NAS will require that UAS interactions with the air traffic management system be similar to interactions between manned aircraft and air traffic management. For example, UAS response times to air traffic controller (ATCo) clearances should be equivalent to those that are currently found to be acceptable with manned aircraft. Prior studies have examined communication delays with manned aircraft. Unfortunately, there is no analogous body of research for UAS. The goal of the present study was to determine how UAS pilot communication and execution delays affect ATCos' acceptability ratings of UAS pilot responses when the UAS is operating in the NAS. Eight radar-certified controllers managed traffic in a modified ZLA sector with one UAS flying in it. In separate scenarios, the UAS pilot verbal communication and execution delays were either short (1.5 s) or long (5 s) and either constant or variable. The ATCo acceptability of UAS pilot communication and execution delays were measured subjectively via post trial ratings. UAS verbal pilot communication delay, were rated as acceptable 92% of the time when the delay was short. This acceptability level decreased to 64% when the delay was long. UAS pilot execution delay had less of an influence on ATCo acceptability ratings in the present stimulation. Implications of these findings for UAS in the NAS integration are discussed.

  11. Regular Yoga Practice Improves Antioxidant Status, Immune Function, and Stress Hormone Releases in Young Healthy People: A Randomized, Double-Blind, Controlled Pilot Study.

    Science.gov (United States)

    Lim, Sung-Ah; Cheong, Kwang-Jo

    2015-09-01

    The aim of the present study is to highlight the beneficial effects of yoga practice on bio-parameters, such as oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in healthy young people. This study was conducted on healthy volunteers recruited from among university students, who were divided into two groups: a control (no yoga intervention, n=13) group and a yoga (n=12) group. Yoga practice was with an instructor for 90 minutes once a week spread over 12 weeks, with recommendations to practice daily at home for 40 minutes with the help of a DVD. The yoga program consisted of yoga body poses (asanas), exercises involving awareness, voluntary regulation of breath (pranayama), and meditational practices. Whole blood samples were collected when the volunteers had fasted for 8 hours at 0 and 12 weeks. The oxidative stress/antioxidant components, immune-related cytokines, and stress hormones were evaluated in serum or plasma. Serum levels of nitric oxide, F2-isoprostane, and lipid peroxide were significantly decreased by yoga practice (pyoga practice compared with the control group (pYoga practice also significantly increased immune-related cytokines, such as interleukin-12, and interferon-γ, in serum (pYoga practice significantly reduced the plasma levels of adrenalin (pyoga practice remarkably attenuated oxidative stress and improved antioxidant levels of the body. Moreover, yoga beneficially affected stress hormone releases as well as partially improved immune function.

  12. A pilot study on the impact of a low fructose diet and allopurinol on clinic blood pressure among overweight and prehypertensive subjects: a randomized placebo controlled trial.

    Science.gov (United States)

    Madero, Magdalena; Rodríguez Castellanos, Francisco E; Jalal, Diana; Villalobos-Martín, Maria; Salazar, Jonathan; Vazquez-Rangel, Armando; Johnson, Richard J; Sanchez-Lozada, L Gabriela

    2015-11-01

    Fructose and sodium intake have been associated with hypertension and metabolic syndrome. Although various mechanisms are involved, fructose causes hypertension partly through rising intracellular and serum uric acid. To date, there are no studies in adults that have evaluated the impact of low fructose diets and allopurinol on prehypertensive and overweight subjects. The objective of this study was to compare the effect of low fructose diet and allopurinol or placebo on blood pressure (BP) and metabolic syndrome components The study was a controlled clinical trial and consisted of two phases; in the first phase of intervention (4 weeks), patients were randomized to either low fructose diet (34 patients) or control diet (38 patients). In the second phase of intervention (weeks 4-8), the same groups continued with the same diet prescriptions but were further randomized to receive placebo or allopurinol (300 mg/d). Clinic and 24-hour ambulatory BP, anthropometric measures, and laboratory data were determined at baseline, weeks 4 and 8. Seventy-two patients were included in the trial. At the end of the dietary phase, both diet groups significantly reduced their BP, but there were no between-group differences. Compared to placebo, at the end of follow-up, subjects in the allopurinol group had a lower clinic systolic blood pressure and this was significant within- and between-group comparisons. The percentage of dippers was higher in the allopurinol group, and weight was reduced significantly despite the absence of caloric restriction Allopurinol was associated with a significant reduction in clinic BP, an increase in the percentage of dippers, and significant weight loss. Larger studies with longer follow-up are needed to confirm our findings. Copyright © 2015 American Society of Hypertension. All rights reserved.

  13. A randomized controlled pilot study comparing aqueous cream with a beeswax and herbal oil cream in the provision of relief from postburn pruritus.

    Science.gov (United States)

    Lewis, Peter A; Wright, Kay; Webster, Anne; Steer, Matthew; Rudd, Michael; Doubrovsky, Anna; Gardner, Glenn

    2012-01-01

    Postburn itch is reported to affect up to 87% of the burn population. Although treatments for postburn itch are multimodal, they remain consistently ineffective. However, recent anecdotal evidence from several outpatients at a tertiary referral hospital suggests that a cream combining beeswax and several herbal oils may be effective in the minimization of postburn itch. The aim of this study was to test the efficacy of beeswax and herbal oil cream against the standard treatment of aqueous cream in the provision of relief from the symptoms of postburn itch. A randomized controlled trial compared two groups using a visual analog scale, frequency of cream application, itch recurrence after cream application, use of antipruritic medications, and sleep disturbance to determine the effect of itch severity and duration. Fifty-two participants were enrolled in the study (84% male) with a mean age of 35 years (SD = 16) and mean burn TBSA of 7.2% (SD = 7.7). Study results found that the beeswax and herbal oil cream reduce itch after application more frequently than aqueous cream (P = .001). In addition, when managed with beeswax and herbal oil cream, participants found that their itch recurred later (P ≤ .001) and their use of antipruritic medications was lower (P = .023). Findings of this study suggest beeswax and herbal oil cream to be more effective in the minimization of postburn itch than aqueous cream. Given this, a larger study examining the efficacy of beeswax and herbal oil cream appears warranted.

  14. Clinical evaluation of XaraColl®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

    Directory of Open Access Journals (Sweden)

    Cusack SL

    2012-06-01

    Full Text Available Susan L Cusack,1 Mark Jaros,2 Michael Kuss,3 Harold S Minkowitz,4 Peter Winkle,5 Lisa Hemsen61Cusack Pharmaceutical Consulting, Burlington, NJ, 2Summit Analytical, Denver, CO, USA; 3Premier Research Group, Austin, TX, USA; 4Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 5Advanced Clinical Research Institute, Anaheim, CA, USA; 6Innocoll Technologies, Athlone, IrelandBackground: XaraColl®, a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches.Methods: We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively. Enrolled patients (50 in study 1 and 53 in study 2 were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI, total use of opioid analgesia (TOpA, and an integrated endpoint (I-SPI-TOpA. Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively.Results: Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively. Over the same time intervals in the pooled analysis, treated patients experienced

  15. Evaluation of a novel technique in airway clearance therapy – Specific Cough Technique (SCT) in cystic fibrosis: A pilot study of a series of N-of-1 randomised controlled trials

    Science.gov (United States)

    Gursli, Sandra; Sandvik, Leiv; Bakkeheim, Egil; Skrede, Bjørn; Stuge, Britt

    2017-01-01

    Objectives: The aim of this pilot study was to evaluate the efficacy, safety and participants’ perception of a novel technique in airway clearance therapy – specific cough technique in cystic fibrosis. Methods: We conducted randomised controlled individual trials (N-of-1 randomised controlled trials) in six adults. Each trial included 8 weeks of treatment with two interventions each week, one with specific cough technique and one with forced expiration technique. The efficacy was investigated by a blinded assessor measuring wet weight of sputum (g) after each session. Perceived usefulness and preference was self-reported at the end of study. Additional measurements included oxygen saturation and heart rate before and after each session and lung function (week 2). Results: Three of six participants produced significantly higher mean sputum weight when using specific cough technique, differences being 21%, 38% and 23%, respectively. In three of the six participants, mean sputum weight was lower after forced expiration technique than after specific cough technique in each of the eight treatment pairs. Participant-reported outcomes were completed in all participants. Specific cough technique was reported to be easier to use in daily treatments and more normalising in everyday life. Conclusion: Specific cough technique was well tolerated and accepted by the participants with cystic fibrosis. Specific cough technique was non-inferior to forced expiration technique in terms of sputum production, thus specific cough technique appears to represent a promising alternative for clearing sputum in airway clearance therapy. PMID:28540046

  16. Osseointegrated implants placed at supracrestal level may harbour higher counts of A. gerencseriae and S. constellatus – a randomized, controlled pilot study

    Directory of Open Access Journals (Sweden)

    Mariana Ribeiro de Moraes Rego

    2015-10-01

    Full Text Available Purpose: This study aimed at evaluating the bacterial colonization in dental implants inserted in the crestal or supracrestal position and correlated it to radiographic bone measurements. Methods: Thirty-five implants with regular platform in nine patients (mean age 62.4±11.2 years were inserted either at the bone crest level (control group or at a suprecrestal level (test group. Radiographic examination was performed at baseline (implant installation and after 6 months. Clinical and microbiological data were collected after 6 months. Digital radiography was used to assess bone remodeling (marginal bone loss and optical alveolar density. Bacterial profile was analyzed by checkerboard DNA–DNA hybridization, including a panel of 40 bacterial species. Results: After 6 months, there were significantly higher counts of Actinomyces gerencseriae (p=0.009 and Streptococcus constellatus (p=0.05 in the test group. No significant differences between test and control groups were observed for marginal bone loss (p=0.725 and optical alveolar density (p=0.975. Probing depth was similar in both groups. Conclusion: Significantly higher counts of A. gerencseriae and S. constellatus were found in implants placed at the supracrestal level compared to the ones placed at the bone level. No relation was found between the installation level of dental implants and peri-implant bone remodeling.

  17. The Benefit of a Mechanical Needle Stimulation Pad in Patients with Chronic Neck and Lower Back Pain: Two Randomized Controlled Pilot Studies

    Directory of Open Access Journals (Sweden)

    Claudia Hohmann

    2012-01-01

    Full Text Available Objectives. The objective was to investigate whether a treatment with a needle stimulation pad (NSP changes perceived pain and/or sensory thresholds in patients with chronic neck (NP and lower back pain (BP. Methods. 40 patients with chronic NP and 42 patients with chronic BP were equally randomized to either treatment or waiting list control group. The treatment group self-administered a NSP over a period of 14 days. Pain ratings were recorded on numerical rating scales (NRSs. Mechanical detection thresholds (MDTs and pressure pain thresholds (PPTs were determined at the site of maximal pain and in the adjacent region, vibration detection thresholds (VDT were measured at close spinal processes. The Northwick Park Neck Pain Questionnaire (NPQ and the Oswestry Disability Index (ODI were utilized for the NP and BP study, respectively. Results. NRS ratings were significantly reduced for the treatment groups compared to the control groups (NP: P=.021 and BP: P<.001, accompanied by a significant increase of PPT at pain maximum (NP: P=.032 and BP: P=.013. There was no effect on VDT and MDT. The NPQ showed also a significant improvement, but not the ODI. Conclusions. The mechanical NSP seems to be an effective treatment method for chronic NP and BP.

  18. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

    Directory of Open Access Journals (Sweden)

    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  19. Effect of a single dose of lidocaine and ketamine on intraoperative opioids requirements in patients undergoing elective gynecological laparotomies under general anesthesia. A randomized, placebo controlled pilot study

    Directory of Open Access Journals (Sweden)

    Jusset Teresa García-Navia

    2016-01-01

    Full Text Available Background and goal of study: there is evidence that perioperative intravenous ketamine and lidocaine reduce postoperative pain, postoperative opioids consumption, shortens hospital stay and accelerates intestinal function recovery. However, it has not been studied the beneficial effects in the intraoperative period. The aim of this study was to evaluate the effect of a single dose of lidocaine and ketamine on intraoperative opioids requirements in patients undergoing elective gynecological laparotomies under general anesthesia. Materials and methods: we performed a single-centre, prospective, randomized, double-blinded, placebo-controlled study. We included 33 patients (11 in the ketamine group, 11 in the lidocaine group and 11 in the placebo group. Postoperative analgesia was accomplished by patient-controlled morphine. Patients were randomly assigned to receive either a 1.5 mg/kg of 2% lidocaine, 0.5 mg/kg of 5% ketamine or 0.9% saline bolus. The primary outcome was the opioids consumption during surgery. The secondary outcomes included: emergence time, pain scores, opioids consumption within 24 h after surgery and side effects. Results: decreased intraoperative opioids requirements were noted in the experimental groups (ketamine: 402.3 } 106.3 and lidocaine: 397.7 } 107.5, compared with saline: 561.4 } 97.1; p = 0.001. We found a positive correlation between intraoperative opioids consumption and emergence time (r = 0.864, p < 0.001. There was no significant difference between the groups in VAS pain scores at rest within the first 24 postoperative hours. Total morphine consumption within 24 h after surgery did not differ significantly among the groups (placebo: 27.54 } 11.75; ketamine: 30.95 } 7.88; lidocaine 34.77 } 10.25; p = 0.26. Postoperative nausea and vomiting were more common in placebo group (it was observed in 3 subjects in ketamine group, in 5 subjects in lidocaine group and in 9 subjects in placebo group; p = 0

  20. The effect of an expressive writing intervention (EWI) on stress in infertile couples undergoing assisted reproductive technlogy (ART) treatment: A randomized controlled pilot study

    DEFF Research Database (Denmark)

    Matthiesen, Signe Maria Schneevoigt; Klonoff-Cohen, Hillary; Zachariae, Robert

    2012-01-01

    Objectives. Infertile couples undergoing fertility treatments may experience stress and could benefit from psychological intervention. Expressive Writing Intervention (EWI) has shown promising results on various psychological outcomes, yet only one study has applied the method to infertility......-related stress. Our aim was to assess feasibility and effectiveness of EWI for patients in treatment with Assisted Reproductive Technology (ART). Design and participants. Patients enrolling in their first ART treatment at the fertility clinic, Aarhus University Hospital, Denmark were offered to participate....... A total of 82 participants (45 women, 37 men), mean age: 33.17, were randomized to home-based EWI or neutral writing control group and completed an infertility-related stress questionnaire at treatment enrollment, 3 weeks later (at the time of down regulation), and 6 weeks after the intervention...

  1. Comparative alveolar ridge preservation using allogenous tooth graft versus free-dried bone allograft: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2017-01-01

    Full Text Available Background: For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA in alveolar ridge preservation. Materials and Methods: Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases. Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL,