Effectivity of artrihpi irrigation for diabetic ulcer healing: A randomized controlled trial

NASA Astrophysics Data System (ADS)

Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

2018-02-01

The healing process of diabetic ulcer is often impeded by inflammation, infection, and decreased immune state. High pressure irrigation (10-15 psi) may be used to control the infection level. This research was designed to identify the effectiveness of artrihpi irrigation device towards diabetic ulcers in public hospitals in the Central Java. This research is a randomized control trial with cross over design. Sixty four subjects were selected using block randomization technique, and were divided into control and intervention group. The intervention was given in 6 days along with wound healing evaluation in every 3 days. The results demonstrated that there was a significant difference decrease scoring healing after treatment, even though the difference scoring healing between both groups was not statistically significant. However, it means difference was found that in the intervention artrihpi the wound healing was better than the spuit. These results illustrates the artrihpi may be solution of using high pressure irrigation to help healing process diabetic ulcers.

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

PubMed Central

Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

2014-01-01

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock: Study protocol for a randomized cross-over design.

PubMed

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-02-01

Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia

PubMed Central

2013-01-01

Background Lavender essential oil shows evidence of sedative properties in neurophysiological and animal studies but clinical trials of its effectiveness as a treatment of agitation in people with dementia have shown mixed results. Study methods have varied widely, however, making comparisons hazardous. To help remedy previous methodological shortcomings, we delivered high grade lavender oil in specified amounts to nursing home residents whose agitated behaviours were recorded objectively. Methods 64 nursing home residents with frequent physically agitated behaviours were entered into a randomized, single-blind cross-over trial of dermally-applied, neurophysiologically active, high purity 30% lavender oil versus an inactive control oil. A blinded observer counted the presence or absence of target behaviours and rated participants’ predominant affect during each minute for 30 minutes prior to exposure and for 60 minutes afterwards. Results Lavender oil did not prove superior to the control oil in reducing the frequency of physically agitated behaviours or in improving participants’ affect. Conclusions Studies of essential oils are constrained by their variable formulations and uncertain pharmacokinetics and so optimal dosing and delivery regimens remain speculative. Notwithstanding this, topically delivered, high strength, pure lavender oil had no discernible effect on affect and behaviour in a well-defined clinical sample. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN 12609000569202) PMID:24219098

Laser backscattered from partially convex targets of large sizes in random media for E-wave polarization.

PubMed

El-Ocla, Hosam

2006-08-01

The characteristics of a radar cross section (RCS) of partially convex targets with large sizes up to five wavelengths in free space and random media are studied. The nature of the incident wave is an important factor in remote sensing and radar detection applications. I investigate the effects of beam wave incidence on the performance of RCS, drawing on the method I used in a previous study on plane-wave incidence. A beam wave can be considered a plane wave if the target size is smaller than the beam width. Therefore, to have a beam wave with a limited spot on the target, the target size should be larger than the beam width (assuming E-wave incidence wave polarization. The effects of the target configuration, random medium parameters, and the beam width on the laser RCS and the enhancement in the radar cross section are numerically analyzed, resulting in the possibility of having some sort of control over radar detection using beam wave incidence.

Effects of rose hip intake on risk markers of type 2 diabetes and cardiovascular disease: a randomized, double-blind, cross-over investigation in obese persons

PubMed Central

Andersson, U; Berger, K; Högberg, A; Landin-Olsson, M; Holm, C

2012-01-01

BACKGROUND/OBJECTIVES: In studies performed in mice, rose hip powder has been shown to both prevent and reverse high-fat diet-induced obesity and glucose intolerance as well as reduce plasma levels of cholesterol. The aim of this study was to investigate whether daily intake of rose hip powder over 6 weeks exerts beneficial metabolic effects in obese individuals. SUBJECTS/METHODS: A total of 31 obese individuals with normal or impaired glucose tolerance were enrolled in a randomized, double-blind, cross-over study in which metabolic effects of daily intake of a rose hip powder drink over 6 weeks was compared with a control drink. Body weight, glucose tolerance, blood pressure, blood lipids and markers of inflammation were assessed in the subjects. RESULTS: In comparison with the control drink, 6 weeks of daily consumption of the rose hip drink resulted in a significant reduction of systolic blood pressure (−3.4% P=0.021), total plasma cholesterol (−4.9% P=0.0018), low-density lipoprotein (LDL) cholesterol (−6.0% P=0.012) and LDL/HDL ratio (−6.5% P=0.041). The Reynolds risk assessment score for cardiovascular disease was decreased in the rose hip group compared with the control group (−17% P=0.007). Body weight, diastolic blood pressure, glucose tolerance, and plasma levels of high-density lipoprotein (HDL) cholesterol, triglycerides, incretins and markers of inflammation did not differ between the two groups. CONCLUSIONS: Daily consumption of 40 g of rose hip powder for 6 weeks can significantly reduce cardiovascular risk in obese people through lowering of systolic blood pressure and plasma cholesterol levels. PMID:22166897

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

Chorionic gonadotropin in weight control. A double-blind crossover study.

PubMed

Young, R L; Fuchs, R J; Woltjen, M J

1976-11-29

Two hundred two patients participated in a double-blind random cross-over study of the effectiveness of human chorionic gonadotropin (HCG) vs placebo in a wieght reduction program. Serial measurements were made of weight, skin-fold thickness, dropout rates, reasons for dropping out, and patient subjective response. There was no statistically significant difference between those receiving HCG vs placebo during any phase of this study (P greater than .1).

Random access actuation of nanowire grid metamaterial

NASA Astrophysics Data System (ADS)

Cencillo-Abad, Pablo; Ou, Jun-Yu; Plum, Eric; Valente, João; Zheludev, Nikolay I.

2016-12-01

While metamaterials offer engineered static optical properties, future artificial media with dynamic random-access control over shape and position of meta-molecules will provide arbitrary control of light propagation. The simplest example of such a reconfigurable metamaterial is a nanowire grid metasurface with subwavelength wire spacing. Recently we demonstrated computationally that such a metadevice with individually controlled wire positions could be used as dynamic diffraction grating, beam steering module and tunable focusing element. Here we report on the nanomembrane realization of such a nanowire grid metasurface constructed from individually addressable plasmonic chevron nanowires with a 230 nm × 100 nm cross-section, which consist of gold and silicon nitride. The active structure of the metadevice consists of 15 nanowires each 18 μm long and is fabricated by a combination of electron beam lithography and ion beam milling. It is packaged as a microchip device where the nanowires can be individually actuated by control currents via differential thermal expansion.

Effects of Silexan on the Serotonin-1A Receptor and Microstructure of the Human Brain: A Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study with Molecular and Structural Neuroimaging

PubMed Central

Baldinger, Pia; Höflich, Anna S.; Mitterhauser, Markus; Hahn, Andreas; Rami-Mark, Christina; Spies, Marie; Wadsak, Wolfgang; Lanzenberger, Rupert

2015-01-01

Background: Recently, Silexan, a patented active substance comprised of an essential oil produced from Lavandula angustifolia flowers, has been authorized in Germany as a medicinal product for the treatment of states of restlessness related to anxious mood. Its efficacy has been shown in several forms of anxiety disorders. Findings from preclinical and clinical studies attribute a major role to the serotonin-1A receptor in the pathogenesis and treatment of anxiety. Methods: To elucidate the effect of Silexan on serotonin-1A receptor binding, 17 healthy men underwent 2 positron emission tomography measurements using the radioligand [carbonyl-11C]WAY-100635 following the daily intake of 160mg Silexan or placebo for a minimum of 8 weeks (randomized, double-blind, cross-over design). Additionally, structural magnetic resonance imaging and voxel-based morphometry analysis was performed to determine potential effects on gray matter microstructure. Results: Serotonin-1A receptor binding potential was shown to be significantly reduced following the intake of Silexan compared with placebo in 2 large clusters encompassing the temporal gyrus, the fusiform gyrus and the hippocampus on one hand as well as the insula and anterior cingulate cortex on the other hand. No effects of Silexan on gray matter volume could be detected in this investigation. Conclusion: This positron emission tomography study proposes an involvement of the serotonin-1A receptor in the anxiolytic effects of Silexan. The study was registered in the International Standard Randomized Controlled Trial Number Register as ISRCTN30885829 (http://www.controlled-trials.com/isrctn/). PMID:25522403

Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study)

PubMed Central

Pedret, Anna; Catalán, Úrsula; Fernández-Castillejo, Sara; Farràs, Marta; Valls, Rosa-M; Rubió, Laura; Canela, Núria; Aragonés, Gerard; Romeu, Marta; Castañer, Olga; de la Torre, Rafael; Covas, Maria-Isabel; Fitó, Montse; Motilva, Maria-José; Solà, Rosa

2015-01-01

The effects of olive oil phenolic compounds (PCs) on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO) and two functional VOOs, enriched with their own PCs (FVOO) or complemented with thyme PCs (FVOOT), in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain) from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200mg/dL; 19 men and 14 women; aged 35 to 80 years) were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect. Trial Registration International Standard Randomized Controlled Trials ISRCTN77500181. PMID:26061039

Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study).

PubMed

Pedret, Anna; Catalán, Úrsula; Fernández-Castillejo, Sara; Farràs, Marta; Valls, Rosa-M; Rubió, Laura; Canela, Núria; Aragonés, Gerard; Romeu, Marta; Castañer, Olga; de la Torre, Rafael; Covas, Maria-Isabel; Fitó, Montse; Motilva, Maria-José; Solà, Rosa

2015-01-01

The effects of olive oil phenolic compounds (PCs) on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO) and two functional VOOs, enriched with their own PCs (FVOO) or complemented with thyme PCs (FVOOT), in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain) from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years) were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect. International Standard Randomized Controlled Trials ISRCTN77500181.

A Randomized Controlled Trial of Atorvastatin in Patients With Bronchiectasis Infected With Pseudomonas Aeruginosa: A Proof of Concept Study.

PubMed

Bedi, Pallavi; Chalmers, James D; Graham, Catriona; Clarke, Andrea; Donaldson, Samantha; Doherty, Catherine; Govan, John R W; Davidson, Donald J; Rossi, Adriano G; Hill, Adam T

2017-08-01

There are no randomized controlled trials of statin therapy in patients with severe bronchiectasis who are chronically infected with Pseudomonas aeruginosa. Thirty-two patients chronically infected with P aeruginosa were recruited in this double-blind cross-over randomized controlled trial. Sixteen patients were recruited in each arm, were given atorvastatin 80 mg or placebo for 3 months followed by a washout period for 6 weeks, and then crossed over and administered the alternative therapy for 3 months. Twenty-seven patients completed the study. Atorvastatin did not significantly improve the primary end point of cough as measured by the Leicester Cough Questionnaire (mean difference, 1.92; 95% CI for difference, -0.57-4.41; P = .12). However, atorvastatin treatment resulted in an improved St. Georges Respiratory Questionnaire (-5.62 points; P = .016) and reduced serum levels of CXCL8 (P = .04), tumor necrosis factor (P = .01), and intercellular adhesion molecule 1 (P = .04). There was a trend toward improvement in serum C-reactive protein and serum neutrophil counts (P = .07 and P = .06, respectively). We demonstrated in vitro that atorvastatin 10 μM reduced formyl-methionyl-leucyl phenylalanine-induced upregulation of CD11b expression and changes in calcium flux, reflecting an ability to decrease neutrophil activation. We demonstrated that atorvastatin reduced systemic inflammation and improved quality of life in patients with bronchiectasis who were infected with P aeruginosa. These effects may be due to an ability of atorvastatin to modulate neutrophil activation. ClinicalTrials.gov; No.: NCT01299194; URL: www.clinicaltrials.gov. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

PubMed

Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

2017-01-01

Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm ( n  = 200) or the control arm ( n  = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant ( p  < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r  = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

Cross-Age Peer Tutoring and Fluency-Based Instruction to Achieve Fluency with Mathematics Computation Skills: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Greene, Irene; Mc Tiernan, Aoife; Holloway, Jennifer

2018-01-01

The current study employed a randomized controlled trial to evaluate the use of peer tutoring and fluency-based instruction to increase mathematics fluency with addition and subtraction computation skills. Forty-one elementary school students between the ages of eight and 12 years participated in the 8-week study using cross-age peer tutoring, Say…

Knot probabilities in random diagrams

NASA Astrophysics Data System (ADS)

Cantarella, Jason; Chapman, Harrison; Mastin, Matt

2016-10-01

We consider a natural model of random knotting—choose a knot diagram at random from the finite set of diagrams with n crossings. We tabulate diagrams with 10 and fewer crossings and classify the diagrams by knot type, allowing us to compute exact probabilities for knots in this model. As expected, most diagrams with 10 and fewer crossings are unknots (about 78% of the roughly 1.6 billion 10 crossing diagrams). For these crossing numbers, the unknot fraction is mostly explained by the prevalence of ‘tree-like’ diagrams which are unknots for any assignment of over/under information at crossings. The data shows a roughly linear relationship between the log of knot type probability and the log of the frequency rank of the knot type, analogous to Zipf’s law for word frequency. The complete tabulation and all knot frequencies are included as supplementary data.

Dark chocolate and vascular function in patients with peripheral artery disease: a randomized, controlled cross-over trial.

PubMed

Hammer, Alexandra; Koppensteiner, Renate; Steiner, Sabine; Niessner, Alexander; Goliasch, Georg; Gschwandtner, Michael; Hoke, Matthias

2015-01-01

Flavonoid-rich dark chocolate has positive effects on vascular function in healthy subjects and in patients at risk of atherosclerosis. The impact of dark chocolate on endothelial and microvascular function in patients with symptomatic peripheral artery disease (PAD) has not been investigated so far. In an investigator blinded, randomized, controlled, cross-over trial we assessed the effect of flavonoid-rich dark chocolate and cocoa-free control chocolate on flow-mediated dilatation (FMD) of the brachial artery and on microvascular function (assessed by Laser Doppler fluxmetry) in 21 patients with symptomatic (Fontaine stage II) PAD. Measurements were done in each patient on 2 single days, with an interval of 7 days, at baseline and at 2 hours after ingestion of 50 g dark chocolate or 50 g white chocolate, respectively. FMD remained unchanged after intake of dark chocolate (baseline and 2 hours after ingestion, %: 5.1 [IQR 4.4 to 7.3] and 5.5 [IQR 3.9 to 10.4]; p = 0.57, and after intake of white chocolate (baseline and 2 hours after ingestion, %: 6.4 [IQR 4.5 to 11.4] and 4.4 [IQR 2.6 to 8.7]; p = 0.14. Similarly, microcirculatory parameters were not significantly altered after intake of any chocolate compared with the respective baseline values. In conclusion, a single consumption of 50 g dark chocolate has no effect on endothelial and microvascular function in patients with symptomatic PAD.

Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study.

PubMed

Holm, Bente; Husted, Henrik; Kehlet, Henrik; Bandholm, Thomas

2012-08-01

To investigate the acute effect of knee joint icing on knee extension strength and knee pain in patients shortly after total knee arthroplasty. A prospective, single-blinded, randomized, cross-over study. A fast-track orthopaedic arthroplasty unit at a university hospital. Twenty patients (mean age 66 years; 10 women) scheduled for primary unilateral total knee arthroplasty. The patients were treated on two days (day 7 and day 10) postoperatively. On one day they received 30 minutes of knee icing (active treatment) and on the other day they received 30 minutes of elbow icing (control treatment). The order of treatments was randomized. Maximal knee extension strength (primary outcome), knee pain at rest and knee pain during the maximal knee extensions were measured 2-5 minutes before and 2-5 minutes after both treatments by an assessor blinded for active or control treatment. The change in knee extension strength associated with knee icing was not significantly different from that of elbow icing (knee icing change (mean (1 SD)) -0.01 (0.07) Nm/kg, elbow icing change -0.02 (0.07) Nm/kg, P = 0.493). Likewise, the changes in knee pain at rest (P = 0.475), or knee pain during the knee extension strength measurements (P = 0.422) were not different between treatments. In contrast to observations in experimental knee effusion models and inflamed knee joints, knee joint icing for 30 minutes shortly after total knee arthroplasty had no acute effect on knee extension strength or knee pain.

Cross over of recurrence networks to random graphs and random geometric graphs

NASA Astrophysics Data System (ADS)

Jacob, Rinku; Harikrishnan, K. P.; Misra, R.; Ambika, G.

2017-02-01

Recurrence networks are complex networks constructed from the time series of chaotic dynamical systems where the connection between two nodes is limited by the recurrence threshold. This condition makes the topology of every recurrence network unique with the degree distribution determined by the probability density variations of the representative attractor from which it is constructed. Here we numerically investigate the properties of recurrence networks from standard low-dimensional chaotic attractors using some basic network measures and show how the recurrence networks are different from random and scale-free networks. In particular, we show that all recurrence networks can cross over to random geometric graphs by adding sufficient amount of noise to the time series and into the classical random graphs by increasing the range of interaction to the system size. We also highlight the effectiveness of a combined plot of characteristic path length and clustering coefficient in capturing the small changes in the network characteristics.

Substitution of red meat with legumes in the therapeutic lifestyle change diet based on dietary advice improves cardiometabolic risk factors in overweight type 2 diabetes patients: a cross-over randomized clinical trial.

PubMed

Hosseinpour-Niazi, S; Mirmiran, P; Hedayati, M; Azizi, F

2015-05-01

The objective of this study was to determine the effects of substitution of red meat with legumes in the Therapeutic Lifestyle Change (TLC) diet on cardiometabolic risk factors in type 2 diabetes patients based on dietary education. This study was a randomized, controlled, cross-over trial. Thirty-one participants (24 women and 7 men; age: 58.1 ± 6.0 years) with type 2 diabetes were randomly assigned to consume a control diet (legume-free TLC diet) and legume-based TLC diet for 8 weeks. Legume-based TLC diet was the same as the control diet, but the legume-based TLC group was advised to replace two servings of red meat with legumes, 3 days per week. After the interventional period, a washout period was conducted for 4 weeks. The groups were then advised to follow the alternate treatment for 8 weeks. Cardiometabolic risk factors were measured. Compared with the legume-free TLC diet, the legume-based TLC diet significantly decreased fasting blood glucose (P=0.04), fasting insulin (P=0.04), triglyceride concentrations (P=0.04) and low-density lipoprotein cholesterol (P=0.02). Total cholesterol concentrations decreased after consumption of both TLC diet and legume TLC diet; however, the data did not differ significantly between the two diets. body mass index (BMI), waist circumference, systolic and diastolic blood pressures did not change significantly after consumption of either the legume-free TLC diet or the legume-based TLC diet. Dietary advice given for substitution of red meat with legume intakes within a TLC diet-improved lipid profiles and glycemic control among diabetes patients, which were independent from BMI change. This trial was registered in the Iranian Registry of Clinical Trials (http://www.irct.ir) as IRCT201202251640N7.

Cue-induced smoking urges deplete cigarette smokers' self-control resources.

PubMed

Hagger, Martin S; Leaver, Eamonn; Esser, Kerstin; Leung, Chung-Ming; Te Pas, Nina; Keatley, David A; Chan, Derwin K-C; Chatzisarantis, Nikos L D

2013-12-01

Exposure to smoking-related cues leads to increased urge to smoke in regular cigarette smokers and resisting these urges requires considerable self-control. Adopting a resource depletion model, two studies tested the hypothesis that resisting smoking urges depletes self-control resources. Adopting a within-participants randomized cross-over design, participants (study 1, N = 19; study 2, N = 32) were exposed to smoking-related (study 1: smoking images; study 2: cigarette cue-exposure task) and neutral (study 1: neutral images; study 2: drinking-straw task) cues with presentation order randomized. After each cue set, participants completed self-control tasks (study 1: handgrip task; study 2: handgrip and Stroop tasks), performance on which constituted dependent measures of self-control. Self-control task performance was significantly impaired when exposed to smoking-related cues compared to neutral cues. No significant presentation-order effects, or interaction effects between stimulus and presentation order, were found. Findings corroborate our hypothesis that resisting smoking urges depletes cigarette smokers' self-control resources and suggests that self-control capacity is governed by a limited resource.

Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol.

PubMed

Sandilands, Euan A; Cameron, Sharon; Paterson, Frances; Donaldson, Sam; Briody, Lesley; Crowe, Jane; Donnelly, Julie; Thompson, Adrian; Johnston, Neil R; Mackenzie, Ivor; Uren, Neal; Goddard, Jane; Webb, David J; Megson, Ian L; Bateman, Nicholas; Eddleston, Michael

2012-02-03

Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease. We designed a 4-part study. We have set up randomised controlled cross-over studies to assess the effect of intravenous (50 mg/kg/hr for 2 hrs before contrast exposure, then 20 mg/kg/hr for 5 hrs) or oral acetylcysteine (1200 mg twice daily for 2 days, starting the day before contrast exposure) on renal function in normal and diseased kidneys, and normal kidneys exposed to contrast. We have also set up a parallel-group randomized controlled trial to assess the effect of intravenous or oral acetylcysteine on patients with chronic kidney disease stage III undergoing elective coronary angiography. The primary outcome is change in renal blood flow; secondary outcomes include change in glomerular filtration rate, tubular function, urinary proteins, and oxidative balance. Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials. Clinical Trials.gov: NCT00558142; EudraCT: 2006-003509-18.

Study protocol for improving asthma outcomes through cross-cultural communication training for physicians: a randomized trial of physician training.

PubMed

Patel, Minal R; Thomas, Lara J; Hafeez, Kausar; Shankin, Matthew; Wilkin, Margaret; Brown, Randall W

2014-06-16

Massive resources are expended every year on cross-cultural communication training for physicians. Such training is a focus of continuing medical education nationwide and is part of the curriculum of virtually every medical school in America. There is a pressing need for evidence regarding the effects on patients of cross-cultural communication training for physicians. There is a need to understand the added benefit of such training compared to more general communication. We know of no rigorous study that has assessed whether cross-cultural communication training for physicians results in better health outcomes for their patients. The current study aims to answer this question by enhancing the Physician Asthma Care Education (PACE) program to cross cultural communication (PACE Plus), and comparing the effect of the enhanced program to PACE on the health outcomes of African American and Latino/Hispanic children with asthma. A three-arm randomized control trial is used to compare PACE Plus, PACE, and usual care. Both PACE and PACE Plus are delivered in two, two-hour sessions over a period of two weeks to 5-10 primary care physicians who treat African American and Latino/Hispanic children with asthma. One hundred twelve physicians and 1060 of their pediatric patients were recruited who self-identify as African American or Latino/Hispanic and experience persistent asthma. Physicians were randomized into receiving either the PACE Plus or PACE intervention or into the control group. The comparative effectiveness of PACE and PACE Plus on clinician's therapeutic and communication practices with the family/patient, children's urgent care use for asthma, asthma control, and quality of life, and parent/caretaker satisfaction with physician performance will be assessed. Data are collected via telephone survey and medical record review at baseline, 9 months following the intervention, and 21 months following the intervention. This study aims to reduce disparities in asthma outcomes among African American and Latino/Hispanic children through cross-cultural communication training of their physicians and assessing the added value of this training compared to general communication. The results of this study will provide important information about the value of cross-cultural training in helping to address persistent racial disparities in outcomes. ClinicalTrials.gov: NCT01251523 December 1, 2010.

Video-game based therapy performed by children with cerebral palsy: a cross-over randomized controlled trial and a cross-sectional quantitative measure of physical activity.

PubMed

Zoccolillo, L; Morelli, D; Cincotti, F; Muzzioli, L; Gobbetti, T; Paolucci, S; Iosa, M

2015-12-01

Previous studies reported controversial results about the efficacy of video-game based therapy (VGT) in improving neurorehabilitation outcomes in children with cerebral palsy (CP). Primary aim was to investigate the effectiveness of VGT with respect to conventional therapy (CT) in improving upper limb motor outcomes in a group of children with CP. Secondary aim was to quantify if VGT leads children to perform a higher number of movements. A cross-over randomized controlled trial (RCT) for investigating the primary aim and a cross-sectional study for investigating the secondary aim of this study. Outpatients. clinical diagnosis of CP, age between 4 and 14 years, level of GMFC between I and IV. QI<35, severe comorbidities, incapacity to stand even with an external support. Twenty-two children with CP (6.89±1.91-year old) were enrolled in a cross-over RCT with 16 sessions of VGT (using Xbox with Kinect device) and then 16 of CT or vice versa. Upper limb functioning was assessed using the Quality of Upper Extremities Skills Test (QUEST) and hand abilities using Abilhand-kids score. According to the secondary aim of this study a secondary cross-sectional study has been performed. Eight children with CP (6.50±1.60-year old) were enrolled into a trial in which five wireless triaxial accelerometers were positioned on their forearms, legs and trunk for quantifying the physical activity during VGT vs. CT. QUEST scores significantly improved only after VGT (P=0.003), and not after CT (P=0.056). The reverse occurred for Abilhand-kids scores (P=0.165 vs. P=0.013, respectively). Quantity of performed movements was three times higher in VGT than in CT (+198%, P=0.027). VGT resulted effective in improving the motor functions of upper limb extremities in children with CP, conceivably for the increased quantity of limb movements, but failed in improving the manual abilities for performing activities of daily living which benefited more from CT. VGT performed using the X-Box with Kinect device could enhance the number of upper limb movements in children with CP during rehabilitation and in turn improving upper limb motor skills, but CT remained superior for improving performances in manual activities of daily living.

Clomiphene citrate before and after withdrawal bleeding for induction of ovulation in women with polycystic ovary syndrome: Randomized cross-over trial.

PubMed

Elbohoty, Ahmed E H; Amer, Mohamed; Abdelmoaz, Mohamed

2016-08-01

To compare the ovarian response to early versus late clomiphene citrate (CC) in women with polycystic ovary syndrome (PCOS). This cross-over randomized controlled clinical trial included 90 infertile amenorrheic women with PCOS. After inducing withdrawal bleeding, patients were randomly divided into two equal groups to receive ovulation induction with CC 100 mg/day for 5 days. Group I started treatment the next day after finishing medroxyprogesterone acetate course for a menstrual cycle, and after a washout period of another menstrual cycle, the treatment was shifted to start on day 2 of withdrawal bleeding. Group II received a reversed protocol: late then early treatment. Women were followed up on transvaginal ultrasonography to monitor follicular growth, endometrial thickness and evidence of ovulation. Human chorionic gonadotropin 10 000 IU was given i.m. to trigger ovulation when at least one mature follicle measured ≥18 mm at day 14. In all cases, early induction protocol resulted in significantly higher proportion of ovulating patients, thicker endometrium and higher number of follicles 14-17 mm in diameter, ≥ 18 mm in diameter and total number of follicles (P < 0.001 for all comparisons). In women with PCOS, early initiation of CC before withdrawal bleeding or during the last days of the luteal phase can achieve a better ovulatory response. © 2016 Japan Society of Obstetrics and Gynecology.

High-cocoa polyphenol-rich chocolate improves HDL cholesterol in Type 2 diabetes patients.

PubMed

Mellor, D D; Sathyapalan, T; Kilpatrick, E S; Beckett, S; Atkin, S L

2010-11-01

To examine the effects of chocolate on lipid profiles, weight and glycaemic control in individuals with Type 2 diabetes. Twelve individuals with Type 2 diabetes on stable medication were enrolled in a randomized, placebo-controlled double-blind crossover study. Subjects were randomized to 45 g chocolate with or without a high polyphenol content for 8 weeks and then crossed over after a 4-week washout period. Changes in weight, glycaemic control, lipid profile and high-sensitivity C-reactive protein were measured at the beginning and at the end of each intervention. HDL cholesterol increased significantly with high polyphenol chocolate (1.16 ± 0.08 vs. 1.26 ± 0.08 mmol/l, P = 0.05) with a decrease in the total cholesterol: HDL ratio (4.4 ± 0.4 vs. 4.1 ± 0.4 mmol/l, P = 0.04). No changes were seen with the low polyphenol chocolate in any parameters. Over the course of 16 weeks of daily chocolate consumption neither weight nor glycaemic control altered from baseline. High polyphenol chocolate is effective in improving the atherosclerotic cholesterol profile in patients with diabetes by increasing HDL cholesterol and improving the cholesterol:HDL ratio without affecting weight, inflammatory markers, insulin resistance or glycaemic control.

Evaluation of a needle social marketing strategy to control HIV among injecting drug users in China.

PubMed

Wu, Zunyou; Luo, Wei; Sullivan, Sheena G; Rou, Keming; Lin, Peng; Liu, Wei; Ming, Zhongqiang

2007-12-01

To evaluate the effectiveness of a needle social marketing strategy to reduce needle sharing and hepatitis C Virus (HCV)/HIV transmission among injecting drug users (IDU) in China. Two-armed, prospective, community-randomized prevention trial. Four counties/townships in Guangxi and Guangdong provinces; one randomized to intervention the other to control in each province. Injecting drug users: 823 (443 intervention, 382 control) at baseline and 852 (415 intervention, 407 control) at the second cross-sectional survey 12 months later. A needle social marketing programme, including promotion of safe injection norms and increased access to clean needles over a 12 month period. Cross sectional surveys at baseline and follow-up compared changes in drug using behaviours and HIV and HCV rates in the intervention and control communities. Needle sharing behaviours were similar in the two groups at baseline (68.4 vs. 67.8%), and dropped significantly to 35.3% in the intervention community and remained relatively stable in the control community (62.3%; P < 0.001). In a subset of cohort of new injectors, the incidence of HCV was significant lower in intervention than in control in both provinces (P < 0.001, P = 0.014) and overall (P < 0.001) but HIV was only significantly lower in intervention in Guangdong (P = 0.011). Needle social marketing can reduce risky injecting behaviour and HIV/HCV transmission among injecting drug users in China and should be expanded.

Synbiotic Lactobacillus acidophilus NCFM and cellobiose does not affect human gut bacterial diversity but increases abundance of lactobacilli, bifidobacteria and branched-chain fatty acids: a randomized, double-blinded cross-over trial.

PubMed

van Zanten, Gabriella C; Krych, Lukasz; Röytiö, Henna; Forssten, Sofia; Lahtinen, Sampo J; Abu Al-Soud, Waleed; Sørensen, Søren; Svensson, Birte; Jespersen, Lene; Jakobsen, Mogens

2014-10-01

Probiotics, prebiotics, and combinations thereof, that is synbiotics, have been reported to modulate gut microbiota of humans. In this study, effects of a novel synbiotic on the composition and metabolic activity of human gut microbiota were investigated. Healthy volunteers (n = 18) were enrolled in a double-blinded, randomized, and placebo-controlled cross-over study and received synbiotic [Lactobacillus acidophilus NCFM (10(9) CFU) and cellobiose (5 g)] or placebo daily for 3 weeks. Fecal samples were collected and lactobacilli numbers were quantified by qPCR. Furthermore, 454 tag-encoded amplicon pyrosequencing was used to monitor the effect of synbiotic on the composition of the microbiota. The synbiotic increased levels of Lactobacillus spp. and relative abundances of the genera Bifidobacterium, Collinsella, and Eubacterium while the genus Dialister was decreased (P < 0.05). No other effects were found on microbiota composition. Remarkably, however, the synbiotic increased concentrations of branched-chain fatty acids, measured by gas chromatography, while short-chain fatty acids were not affected. © 2014 Federation of European Microbiological Societies. Published by John Wiley & Sons Ltd. All rights reserved.

Electrocardiographic effects of hawthorn (Crataegus oxyacantha) in healthy volunteers: A randomized controlled trial.

PubMed

Trexler, Stephanie E; Nguyen, Elaine; Gromek, Samantha M; Balunas, Marcy J; Baker, William L

2018-04-19

The objective of this study was to evaluate the electrocardiographic effects of hawthorn in healthy adult volunteers. It was double-blind cross-over trial randomized 20 healthy adult volunteers to receive either a single oral 160-mg dose of hawthorn or matching placebo. Triplicate 12-lead electrocardiograms were taken before treatment and at 1-, 2-, 4-, and 6-hr post-dose. Following at least a 7-day washout period, participants were crossed over to the opposing treatment arm and had the measurements repeated. The primary endpoint was the change in corrected (Fridericia) QT intervals (QT c I) at 4 and 6 hr. Maximum post-dose QT c I and changes in PR and QRS intervals were measured. No significant differences in 4- or 6-hr QT c I were seen between hawthorn and placebo. Maximum post-dose QT c I in the hawthorn and placebo groups were similar (346 ± 35 vs 346 ± 40 ms; p = .979). No significant adverse events were seen. In conclusion, a single dose of oral hawthorn had no effect on electrocardiographic parameters in healthy volunteers. Copyright © 2018 John Wiley & Sons, Ltd.

Run charts revisited: a simulation study of run chart rules for detection of non-random variation in health care processes.

PubMed

Anhøj, Jacob; Olesen, Anne Vingaard

2014-01-01

A run chart is a line graph of a measure plotted over time with the median as a horizontal line. The main purpose of the run chart is to identify process improvement or degradation, which may be detected by statistical tests for non-random patterns in the data sequence. We studied the sensitivity to shifts and linear drifts in simulated processes using the shift, crossings and trend rules for detecting non-random variation in run charts. The shift and crossings rules are effective in detecting shifts and drifts in process centre over time while keeping the false signal rate constant around 5% and independent of the number of data points in the chart. The trend rule is virtually useless for detection of linear drift over time, the purpose it was intended for.

Effects of synbiotic food consumption on metabolic status of diabetic patients: a double-blind randomized cross-over controlled clinical trial.

PubMed

Asemi, Zatollah; Khorrami-Rad, Ashraf; Alizadeh, Sabihe-Alsadat; Shakeri, Hossein; Esmaillzadeh, Ahmad

2014-04-01

We are aware of no study indicating the effects of synbiotic food consumption on metabolic profiles, inflammation and oxidative stress among diabetic patients. The aim of the current study was to investigate the effects of synbiotic food consumption on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic patients. This randomized double-blinded cross-over controlled clinical trial was performed among 62 diabetic patients aged 35-70 y. After a 2-wk run-in period, subjects were randomly assigned to consume either a synbiotic (n = 62) or control food (n = 62) for 6 weeks. A 3-week washout period was applied following which subjects were crossed over to the alternate treatment arm for an additional 6 weeks. The synbiotic food consisted of a probiotic viable and heat-resistant Lactobacillus sporogenes (1 × 10(7) CFU), 0.04 g inulin (HPX) as prebiotic with 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food (the same substance without probiotic bacteria and prebiotic inulin) was packed in identical 9-gram packages. Patients were asked to consume the synbiotic and control foods three times a day. Fasting blood samples were taken at baseline and after a 6-wk intervention to measure metabolic profiles, hs-CRP and biomarkers of oxidative stress. Consumption of a synbiotic food, compared to the control, resulted in a significant decrease in serum insulin levels (changes from baseline: -1.75 ± 0.60 vs. +0.95 ± 1.09 μIU/mL, P = 0.03). Although we failed to find a significant effect of synbiotic food consumption on total- and LDL-cholesterol levels and HOMA-IR, the effects on FPG (22.3 vs. 4.2 mg/dL, P = 0.09), serum triglycerides (45.9 vs. 20.6 mg/dL, P = 0.08) and HDL-cholesterol levels (3.1 vs. -2 mg/dL, P = 0.06) tended to be significant. A significant reduction in serum hs-CRP levels (-1057.86 ± 283.74 vs. 95.40 ± 385.38 ng/mL, P = 0.01) was found following the consumption of synbiotic food compared with the control group. Supplementation with the synbiotic food led to a significant increase in plasma total GSH (319.98 vs. 19.73 μmol/L, P < 0.001) and serum uric acid levels (+0.7 vs. -0.1 mg/dL, P = 0.04) compared to the control food. No significant effect of the synbiotic food was observed on plasma TAC levels. In conclusion, consumption of a synbiotic food for 6 weeks among diabetic patients had significant effects on serum insulin, hs-CRP, uric acid and plasma total GSH levels. www.irct.ir: IRCT201201195623N1. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Linkage disequilibrium in HLA cannot be explained by selective recombination.

PubMed

Termijtelen, A; D'Amaro, J; van Rood, J J; Schreuder, G M

1995-11-01

Some combinations of HLA-A, -B and -DR antigens occur more frequently than would be expected from their gene frequencies in the population. This phenomenon, referred to as Linkage Disequilibrium (LD) has been the origin of many speculations. One hypothesis to explain LD is that some haplotypes are protected from recombination. A second hypothesis is that these HLA antigens preferentially recombine after cross-over to create an LD haplotype. We tested these 2 hypotheses: from a pool of over 10,000 families typed in our department, we analyzed 126 families in which HLA-A:B or B:DR recombinant offspring was documented. To overcome a possible bias in our material, we used the non-recombined haplotypes from the same 126 families as a control group. Our results show that the number of cross-overs through LD haplotypes is not significantly lower then would be expected if recombination occurred randomly. Also the number of LD haplotypes created upon recombination was not significantly increased.

C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

PubMed

Plazier, Mark; Ost, Jan; Stassijns, Gaëtane; De Ridder, Dirk; Vanneste, Sven

2015-01-01

Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. Copyright © 2015 Elsevier Inc. All rights reserved.

Mosquito larval source management for controlling malaria

PubMed Central

Tusting, Lucy S; Thwing, Julie; Sinclair, David; Fillinger, Ulrike; Gimnig, John; Bonner, Kimberly E; Bottomley, Christian; Lindsay, Steven W

2015-01-01

Background Malaria is an important cause of illness and death in people living in many parts of the world, especially sub-Saharan Africa. Long-lasting insecticide treated bed nets (LLINs) and indoor residual spraying (IRS) reduce malaria transmission by targeting the adult mosquito vector and are key components of malaria control programmes. However, mosquito numbers may also be reduced by larval source management (LSM), which targets mosquito larvae as they mature in aquatic habitats. This is conducted by permanently or temporarily reducing the availability of larval habitats (habitat modification and habitat manipulation), or by adding substances to standing water that either kill or inhibit the development of larvae (larviciding). Objectives To evaluate the effectiveness of mosquito LSM for preventing malaria. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CABS Abstracts; and LILACS up to 24 October 2012. We handsearched the Tropical Diseases Bulletin from 1900 to 2010, the archives of the World Health Organization (up to 11 February 2011), and the literature database of the Armed Forces Pest Management Board (up to 2 March 2011). We also contacted colleagues in the field for relevant articles. Selection criteria We included cluster randomized controlled trials (cluster-RCTs), controlled before-and-after trials with at least one year of baseline data, and randomized cross-over trials that compared LSM with no LSM for malaria control. We excluded trials that evaluated biological control of anopheline mosquitoes with larvivorous fish. Data collection and analysis At least two authors assessed each trial for eligibility. We extracted data and at least two authors independently determined the risk of bias in the included studies. We resolved all disagreements through discussion with a third author. We analyzed the data using Review Manager 5 software. Main results We included 13 studies; four cluster-RCTs, eight controlled before-and-after trials, and one randomized cross-over trial. The included studies evaluated habitat modification (one study), habitat modification with larviciding (two studies), habitat manipulation (one study), habitat manipulation plus larviciding (two studies), or larviciding alone (seven studies) in a wide variety of habitats and countries. Malaria incidence In two cluster-RCTs undertaken in Sri Lanka, larviciding of abandoned mines, streams, irrigation ditches, and rice paddies reduced malaria incidence by around three-quarters compared to the control (RR 0.26, 95% CI 0.22 to 0.31, 20,124 participants, two trials, moderate quality evidence). In three controlled before-and-after trials in urban and rural India and rural Kenya, results were inconsistent (98,233 participants, three trials, very low quality evidence). In one trial in urban India, the removal of domestic water containers together with weekly larviciding of canals and stagnant pools reduced malaria incidence by three quarters. In one trial in rural India and one trial in rural Kenya, malaria incidence was higher at baseline in intervention areas than in controls. However dam construction in India, and larviciding of streams and swamps in Kenya, reduced malaria incidence to levels similar to the control areas. In one additional randomized cross-over trial in the flood plains of the Gambia River, where larval habitats were extensive and ill-defined, larviciding by ground teams did not result in a statistically significant reduction in malaria incidence (2039 participants, one trial). Parasite prevalence In one cluster-RCT from Sri Lanka, larviciding reduced parasite prevalence by almost 90% (RR 0.11, 95% CI 0.05 to 0.22, 2963 participants, one trial, moderate quality evidence). In five controlled before-and-after trials in Greece, India, the Philippines, and Tanzania, LSM resulted in an average reduction in parasite prevalence of around two-thirds (RR 0.32, 95% CI 0.19 to 0.55, 8041 participants, five trials, moderate quality evidence). The interventions in these five trials included dam construction to reduce larval habitats, flushing of streams, removal of domestic water containers, and larviciding. In the randomized cross-over trial in the flood plains of the Gambia River, larviciding by ground teams did not significantly reduce parasite prevalence (2039 participants, one trial). Authors’ conclusions In Africa and Asia, LSM is another policy option, alongside LLINs and IRS, for reducing malaria morbidity in both urban and rural areas where a sufficient proportion of larval habitats can be targeted. Further research is needed to evaluate whether LSM is appropriate or feasible in parts of rural Africa where larval habitats are more extensive. PMID:23986463

Short-term effect of strontium- and zinc-containing toothpastes and mouthrinses on volatile sulphur compounds in morning breath: a randomized, double-blind, cross-over clinical study.

PubMed

Soares, Léo G; Jonski, Grazyna; Tinoco, Eduardo M B; Young, Alix

2015-04-01

Zinc (Zn) reduces the formation of volatile sulphur compounds (VSCs) associated with oral malodour. Although strontium (Sr) is included in some products for reducing dental hypersensitivity, it may also have anti-halitosis properties. This randomized, double-blind, cross-over clinical study compared the anti-VSC effect of brushing with commercial toothpastes and rinses containing Zn and Sr. The volunteers (n = 30) either brushed/rinsed with/without tongue brushing using Zn-containing toothpaste/rinse, Sr-containing toothpaste/rinse, or placebo (control). Volatile sulphur compounds [hydrogen sulphide (H2 S) and methyl mercaptan (CH3 SH)] were measured, in morning breath, using gas chromatography. The anti-VSC effects of the test toothpastes and test rinses were significantly better than the anti-VSC effects of the respective controls. Toothbrushing with test toothpastes gave median reductions, compared with the control, of 70% for H2 S and 55-57% for CH3 SH. Rinsing with the Sr- and Zn-containing solutions had the same anti-VSC effect as toothbrushing and tooth- and tongue brushing with the Sr- and Zn-containing toothpastes. Zinc-containing rinse resulted in a significantly higher median salivary level of Zn compared with brushing with Zn-containing toothpaste, although this effect did not correlate with the anti-VSC effect. It can be concluded that the Sr- and Zn-containing toothpastes and the Zn- and Sr-containing rinses, when used in the evening, are equally effective in reducing morning-breath VSCs the following day. © 2015 Eur J Oral Sci.

Specific and cross over effects of massage for muscle soreness: randomized controlled trial.

PubMed

Jay, Kenneth; Sundstrup, Emil; Søndergaard, Stine D; Behm, David; Brandt, Mikkel; Særvoll, Charlotte A; Jakobsen, Markus D; Andersen, Lars L

2014-02-01

Muscle soreness can negatively interfere with the activities of daily living as well as sports performance. In the working environment, a common problem is muscle tenderness, soreness and pain, especially for workers frequently exposed to unilateral high repetitive movements tasks. The aim of the study is therefore to investigate the acute effect of massage applied using a simple device Thera-band roller Massager on laboratory induced hamstring muscle soreness, and the potential cross over effect to the non-massaged limb. 22 healthy untrained men (Mean age 34 +/- 7 years; mean height 181.7 +/- 6.9 cm; mean weight 80.6 +/- 6.4 kg; BMI: 24.5 +/- 1.3) with no prior history of knee, low back or neck injury or other adverse health issues were recruited. Participants visited the researchers on two separate occasions, separated by 48 hours, each time providing a soreness rating (modified visual analog scale 0-10), and being tested for pressure pain threshold (PPT) and active range of motion (ROM) of the hamstring muscles. During the first visit, delayed onset muscular soreness of the hamstring muscles was induced by 10 x 10 repetitions of the stiff-legged dead-lift. On the second visit participants received either 1) 10 minutes of roller massage on one leg, while the contralateral leg served as a cross over control, or 2) Resting for 10 minutes with no massage at all. Measurement of soreness, PPT and ROM were taken immediately before and at 0, 10, 30 and 60 min. after treatment. There was a significant group by time interaction for soreness (p < 0.0001) and PPT (p = 0.0007), with the massage group experiencing reduced soreness and increasing PPT compared with the control group. There was no group by time interaction for ROM (p = 0.18). At 10 min. post massage there was a significant reduction in soreness of the non-massaged limb in the cross over control group compared to controls but this effect was lost 30 minutes post massage. Massage with a roller device reduces muscle soreness and is accompanied by a higher PPT of the affected muscle. 2c; outcomes research.

Carnitine for fatigue in multiple sclerosis.

PubMed

Tejani, Aaron M; Wasdell, Michael; Spiwak, Rae; Rowell, Greg; Nathwani, Shabita

2012-05-16

Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients. To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose. A literature search was performed using Cochrane MS Group Trials Register (09 September 2011), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2011, issue 3", MEDLINE (PubMed) (1966-09 September 2011), EMBASE (1974-09 September 2011), and www.clinicaltrials.gov for ongoing trials retrieval. Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied. Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults affected by multiple sclerosis with a clinical diagnosis of fatigue associated with multiple sclerosis were included. Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer, however this was not necessary.The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up. The search identified one ongoing randomized, placebo-controlled, cross-over trial (expected completion 2013) and one completed randomized, active-comparator, cross-over trial. In the completed study, adult patients with relapsing-remitting and secondary progressive MS were exposed to both acetyl L-carnitine 2 grams daily and amantadine 200 mg daily The effects of carnitine on fatigue are unclear. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55) and no patients experienced a serious adverse event in either treatment group. Mortality and quality of life were not reported. There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators. Results of the ongoing trial are eagerly anticipated in order to provide clarity.

Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial.

PubMed

Niazi, Maria; Hashempur, Mohammad Hashem; Taghizadeh, Mohsen; Heydari, Mojtaba; Shariat, Abdolhamid

2017-10-01

To evaluate the effect of topical formulation of Rosa damascena Mill. (R. damascena) oil on migraine headache, applying syndrome diffrentiation model. Forty patients with migraine headache were randomly assigned to 2 groups of this double-blind, placebo-controlled cross-over trial. The patients were treated for the first 2 consecutive migraine headache attacks by topical R. damascena oil or placebo. Then, after one week of washout period, cross-over was done. Pain intensity of the patients' migraine headache was recorded at the beginnig and ten-sequence time schadule of attacks up to 24h. In addition, photophobia, phonophobia, and nausea and/or vomitting (N/V) of the patients were recorded as secondary outcomes. Finally, gathered data were analysed in a syndrome differentiation manner to assess the effect of R. damascena oil on Hot- and Cold-type migraine headache. Mean pain intensity of the patients' migraine headache in the different time-points after R. damascena oil or placebo use, was not significantly different. Additionally, regarding mean scores of N/V, photophobia, and phonophobia severity of the patients, no significant differences between the two groups were observed. Finally, applying syndrome differentiation model, the mean score of migraine headache pain intensity turned out to be significantly lower in patients with "hot" type migraine syndrome at in 30, 45, 60, 90, and 120min after R. damascena oil application compared to "cold" types (P values: 0.001, 0.001, <0.001, <0.001, and 0.02; respectively). It seems that syndrome differentiation can help in selection of patients who may benefit from the topical R. damascena oil in short-term relief of pain intensity in migraine headache. Further studies of longer follow-up and larger study population, however, are necessitated for more scientifically rigorous judgment on efficacy of R. damascena oil for patients with migraine headache. Copyright © 2017 Elsevier Ltd. All rights reserved.

Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

PubMed

Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

2015-10-28

The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (P<0·01; n 21) and significant reductions in stool ammonia concentration (P<0·05; n 21) after consumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (P<0·01; n 21). Our data indicate that consumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota.

The effects of Sahaja Yoga meditation on mental health: a systematic review.

PubMed

Hendriks, Tom

2018-05-30

Objectives To determine the efficacy of Sahaja Yoga (SY) meditation on mental health among clinical and healthy populations. Methods All publications on SY were eligible. Databases were searched up to November 2017, namely PubMed, MEDLINE (NLM), PsychINFO, and Scopus. An internet search (Google Scholar) was also conducted. The quality of the randomized controlled trails was assessed using the Cochrane Risk Assessment for Bias. The quality of cross-sectional studies, a non-randomized controlled trial and a cohort study was assessed with the Newcastle-Ottawa Quality Assessment Scale. Results We included a total of eleven studies; four randomized controlled trials, one non-randomized controlled trial, five cross-sectional studies, and one prospective cohort study. The studies included a total of 910 participants. Significant findings were reported in relation to the following outcomes: anxiety, depression, stress, subjective well-being, and psychological well-being. Two randomized studies were rated as high quality studies, two randomized studies as low quality studies. The quality of the non-randomized trial, the cross-sectional studies and the cohort study was high. Effect sizes could not be calculated in five studies due to unclear or incomplete reporting. Conclusions After reviewing the articles and taking the quality of the studies into account, it appears that SY may reduce depression and possibly anxiety. In addition, the practice of SY is also associated with increased subjective wellbeing and psychological well-beng. However, due to the limited number of publications, definite conclusions on the effects of SY cannot be made and more high quality randomized studies are needed to justify any firm conclusions on the beneficial effects of SY on mental health.

Comparison of the inhibitory effects of cilostazol, acetylsalicylic acid and ticlopidine on platelet functions ex vivo. Randomized, double-blind cross-over study.

PubMed

Ikeda, Y; Kikuchi, M; Murakami, H; Satoh, K; Murata, M; Watanabe, K; Ando, Y

1987-05-01

A randomized double-blind cross-over study was conducted to determine the inhibitory effects of acetylsalicylic acid (ASA), ticlopidine (TP) and cilostazol (OPC-13013; in the following briefly called CS), a new antithrombotic agent on platelet functions ex vivo. Nine patients with cerebral thrombosis were enrolled in this study. Patients were given each of the three drugs for one week in a complete cross-over design according to a randomization schedule, followed by a wash-out period with a placebo for one week. It was found that CS and TP significantly inhibited platelet aggregation induced by ADP. Collagen- and arachidonic acid-induced platelet aggregation was all inhibited by CS, TP and ASA. Duncan's multiple range test to compare the anti-platelet effects of the three drugs revealed that: CS greater than ASA and TP greater than ASA in inhibiting ADP-induced platelet aggregation and CS greater than TP and ASA greater than TP in inhibiting arachidonic acid-induced platelet aggregation. These results may suggest that CS is superior to ASA and TP in inhibiting platelet aggregation ex vivo.

Heart rate variability during acute psychosocial stress: A randomized cross-over trial of verbal and non-verbal laboratory stressors.

PubMed

Brugnera, Agostino; Zarbo, Cristina; Tarvainen, Mika P; Marchettini, Paolo; Adorni, Roberta; Compare, Angelo

2018-05-01

Acute psychosocial stress is typically investigated in laboratory settings using protocols with distinctive characteristics. For example, some tasks involve the action of speaking, which seems to alter Heart Rate Variability (HRV) through acute changes in respiration patterns. However, it is still unknown which task induces the strongest subjective and autonomic stress response. The present cross-over randomized trial sought to investigate the differences in perceived stress and in linear and non-linear analyses of HRV between three different verbal (Speech and Stroop) and non-verbal (Montreal Imaging Stress Task; MIST) stress tasks, in a sample of 60 healthy adults (51.7% females; mean age = 25.6 ± 3.83 years). Analyses were run controlling for respiration rates. Participants reported similar levels of perceived stress across the three tasks. However, MIST induced a stronger cardiovascular response than Speech and Stroop tasks, even after controlling for respiration rates. Finally, women reported higher levels of perceived stress and lower HRV both at rest and in response to acute psychosocial stressors, compared to men. Taken together, our results suggest the presence of gender-related differences during psychophysiological experiments on stress. They also suggest that verbal activity masked the vagal withdrawal through altered respiration patterns imposed by speaking. Therefore, our findings support the use of highly-standardized math task, such as MIST, as a valid and reliable alternative to verbal protocols during laboratory studies on stress. Copyright © 2018 Elsevier B.V. All rights reserved.

Feasibility of a Latin Dance Program for Older Latinos With Mild Cognitive Impairment.

PubMed

Aguiñaga, Susan; Marquez, David X

2017-12-01

This study investigates the feasibility of a Latin dance program in older Latinos with mild cognitive impairment (MCI) via a feasibility mixed methods randomized controlled design. Spanish-speaking older Latinos (N = 21, 75.4 [6.3] years old, 16 females/5 males, 22.4 [2.8] Mini-Mental State Examination [MMSE] score) were randomized into a 16-week dance intervention (BAILAMOS) or wait-list control; the control group crossed over at week 17 and received the dance intervention. Feasibility was determined by assessing reach, retention, attendance, dance logs, and postintervention focus groups. Reach was 91.3% of people who were screened and eligible. Program retention was 95.2%. The dropout rate was 42.8% (n = 9), and attendance for all participants was 55.76%. The focus group data revealed 4 themes: enthusiasm for dance, positive aspects of BAILAMOS, unfavorable aspects of BAILAMOS, and physical well-being after BAILAMOS. In conclusion, older Latinos with MCI find Latin dance as an enjoyable and safe mode of physical activity.

The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

2013-12-01

Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

Does the nature of the definitive impression material influence the outcome of (mandibular) complete dentures?

PubMed

McCord, J Fraser; McNally, Lisa M; Smith, Philip W; Grey, Nicholas J A

2005-09-01

The effects of impression materials on the outcome of complete dentures are poorly understood. This double-blind cross-over randomized controlled trial investigated eleven adult edentulous patients. Each received a maxillary denture and three mandibular dentures (which differed only in the three materials used to record the definitive impressions). The three mandibular dentures were given in a random order. Patients' opinions of each denture were recorded using a Linear Analogue Scale. There was a statistically-significant difference between the outcome of the dentures constructed when zinc-oxide eugenol was used, this material being least favoured (p < 0.001). It would therefore appear that care should be exercised when selecting impression materials when constructing mandibular complete dentures.

Impact of different concentrations of an octenidine dihydrochloride mouthwash on salivary bacterial counts: a randomized, placebo-controlled cross-over trial.

PubMed

Lorenz, Katrin; Jockel-Schneider, Yvonne; Petersen, Nicole; Stölzel, Peggy; Petzold, Markus; Vogel, Ulrich; Hoffmann, Thomas; Schlagenhauf, Ulrich; Noack, Barbara

2018-03-02

This bi-centric, placebo-controlled, randomized, evaluator-blinded, incomplete cross-over clinical phase II trial was initialized to identify the most appropriate concentration of octenidine dihydrochloride (OCT) in mouth rinses. Rinses of 0.10, 0.15, and 0.20% OCT were compared to a saline placebo rinse regarding the reduction of salivary bacterial counts (SBCs) in 90 gingivitis patients over 4 days. Changes in plaque (PI) and gingival index (GI), taste perception, and safety issues were evaluated. At baseline, the first OCT (0.10, 0.15, 0.20%) rinse resulted in a decrease of SBC (reduction by 3.63-5.44 log 10 colony forming units [CFU]) compared to placebo (p < 0.001). Differences between OCT concentrations were not verified. After 4 days, the last OCT rinse again resulted in a significant SBC decrease (3.69-4.22 log 10 CFU) compared to placebo (p < 0.001). Overall, SBC reduction between baseline and day 4 was significantly higher in OCT 0.15 and 0.20% groups compared to OCT 0.10% and placebo. Mean GI/PIs were significantly lower in OCT groups than in the placebo group (p < 0.001). Differences in GI/PI between OCT groups were not verified. Adverse effects increased with increasing OCT concentrations. Considering antibacterial efficacy, frequency of adverse events, and user acceptance, 0.10% OCT was identified as the preferred concentration to be used in future clinical trials. Due to its low toxicity and pronounced antibacterial properties, octenidine dihydrochloride (OCT) is a promising candidate for the use in antiseptic mouth rinses. OCT concentrations of 0.10% are recommended for future clinical trials evaluating the plaque-reducing properties of OCT mouth rinses. ( www.clinicaltrials.gov , NCT022138552).

A randomized cross-over controlled study on cognitive rehabilitation of instrumental activities of daily living in Alzheimer disease.

PubMed

Thivierge, Stéphanie; Jean, Léonie; Simard, Martine

2014-11-01

The goal of the study was to investigate the effectiveness of a memory rehabilitation program to re-learn instrumental activities of daily living (IADLs) in patients with Alzheimer disease (AD). This was a 6-month block-randomized cross-over controlled study. All evaluation and training sessions were performed at each patient's home. Twenty participants with mild to moderate AD. The trained IADL was chosen by the patient and his/her caregiver in order to target the patient's needs and interests. Participants were trained twice a week for 4 weeks with the errorless learning (ELL) and spaced retrieval (SR) cognitive techniques. After training, there were several follow-ups over a period of at least 3 months. Performance on the trained IADL was assessed by a Direct Measure of Training (DMT), an observational instrument adapted from a well-validated scale. General cognitive function, everyday memory functioning, quality of life, neuropsychiatric symptoms and ADL/IADL of patients, as well as the caregiver's burden were assessed as secondary outcomes. A statistical significant difference was found between the trained and untrained groups on the DMT immediately following the intervention. Improvements were maintained for a 3-month period. The training did not have effects on any other measures. The present study showed that it is possible for AD patients to relearn significant IADLs with the ELL and SR techniques and to maintain these gains during at least 3 months. The findings of this study emphasize the importance to design robust but individualized intervention tailored on patients' particular needs. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Marked antioxidant effect of orange juice intake and its phytomicronutrients in a preliminary randomized cross-over trial on mild hypercholesterolemic men.

PubMed

Constans, Joël; Bennetau-Pelissero, Catherine; Martin, Jean-François; Rock, Edmond; Mazur, Andrzej; Bedel, Aurélie; Morand, Christine; Bérard, Annie M

2015-12-01

Blond orange juice is the most consumed fruit juice in the world. It is a source of hesperidin, a bioavailable flavonoid reported to exhibit potential vascular protective actions. However, the specific impact on vascular function of Citrus phytomicronutrients, is unknown. For the first time, we investigated the effects of blond orange juice compared with a control beverage mimicking the composition of orange juice (including Vitamin C but no phytomicronutrients), on antioxidant markers, cardiovascular risk factors and endothelial function. Twenty five male volunteers with two cardiovascular risk factors (age over 50 years and LDL-cholesterol between 130 and 190 mg/L) were enrolled in a randomized cross-over study. They received 3 times daily 200 mL of either blond orange juice or control beverage for 4 weeks, spaced by a 5-week wash-out. Endothelial function (flow mediated dilatation and plasma markers), oxidative status, lipid profile and inflammatory markers were assessed. Daily intakes of orange juice significantly led to a marked antioxidant effect which was correlated to hesperetin plasma levels and related with a decrease in reactive oxygen species. A tendency towards reduction of endothelial dysfunction and modest increase in plasma apoA-I concentration were also observed. This allows further experiments demonstrating the specific effect of phytomicronutrients from orange juice. These findings suggest that daily intake of nutritionally relevant dose of blond orange juice may contribute for a significant antioxidant effect through the phytochemicals contained in. Orange juice may be associated to other healthy foods to achieve a significant effect on the vascular function. This study is recorded in ClinicalTrials.com as NCT00539916. Copyright © 2014. Published by Elsevier Ltd.

Micromechanical analysis of composites with fibers distributed randomly over the transverse cross-section

NASA Astrophysics Data System (ADS)

Weng, Jingmeng; Wen, Weidong; Cui, Haitao; Chen, Bo

2018-06-01

A new method to generate the random distribution of fibers in the transverse cross-section of fiber reinforced composites with high fiber volume fraction is presented in this paper. Based on the microscopy observation of the transverse cross-sections of unidirectional composite laminates, hexagon arrangement is set as the initial arrangement status, and the initial velocity of each fiber is arbitrary at an arbitrary direction, the micro-scale representative volume element (RVE) is established by simulating perfectly elastic collision. Combined with the proposed periodic boundary conditions which are suitable for multi-axial loading, the effective elastic properties of composite materials can be predicted. The predicted properties show reasonable agreement with experimental results. By comparing the stress field of RVE with fibers distributed randomly and RVE with fibers distributed periodically, the predicted elastic modulus of RVE with fibers distributed randomly is greater than RVE with fibers distributed periodically.

Effective cross-over to granisetron after failure to ondansetron, a randomized double blind study in patients failing ondansetron plus dexamethasone during the first 24 hours following highly emetogenic chemotherapy

PubMed Central

de Wit, R; de Boer, A C; vd Linden, G H M; Stoter, G; Sparreboom, A; Verweij, J

2001-01-01

In view of the similarity in chemical structure of the available 5HT3-receptor antagonists it is assumed, whilst these agents all act at the same receptor, that failure to one agent would predict subsequent failure to all 5HT3-receptor antagonists. We conducted a randomized double blind trial of granisetron 3 mg plus dexamethasone 10 mg versus continued treatment with ondansetron 8 mg plus dexamethasone 10 mg in patients with protection failure on ondansetron 8 mg plus dexamethasone 10 mg during the first 24 hours following highly emetogenic chemotherapy. Of 40 eligible patients, 21 received ondansetron + dexamethasone and 19 received granisetron + dexamethasone. We found a significant benefit from crossing-over to granisetron after failure on ondansetron. Of the 19 patients who crossed over to granisetron, 9 patients obtained complete protection, whereas this was observed in 1 of the 21 patients continuing ondansetron, P = 0.005. These results indicate that there is no complete cross-resistance between 5HT3-receptor antagonists, and that patients who have acute protection failure on one 5HT3-receptor antagonist should be offered cross-over to another 5HT3-receptor antagonist. © 2001 Cancer Research Campaign  http://www.bjcancer.com PMID:11710819

Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol

PubMed Central

2012-01-01

Background Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease. Methods/Design We designed a 4-part study. We have set up randomised controlled cross-over studies to assess the effect of intravenous (50 mg/kg/hr for 2 hrs before contrast exposure, then 20 mg/kg/hr for 5 hrs) or oral acetylcysteine (1200 mg twice daily for 2 days, starting the day before contrast exposure) on renal function in normal and diseased kidneys, and normal kidneys exposed to contrast. We have also set up a parallel-group randomized controlled trial to assess the effect of intravenous or oral acetylcysteine on patients with chronic kidney disease stage III undergoing elective coronary angiography. The primary outcome is change in renal blood flow; secondary outcomes include change in glomerular filtration rate, tubular function, urinary proteins, and oxidative balance. Discussion Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials. Trial registration Clinical Trials.gov: NCT00558142; EudraCT: 2006-003509-18. PMID:22305183

Healthy and happy in Europe? On the association between happiness and life expectancy over time.

PubMed

Bjørnskov, Christian

2008-04-01

This paper revisits the standard finding in individual-level studies that happiness leads to longevity. It does so in a cross-country time-series analysis in which the use of a random effects estimator controls for most relevant time-invariant factors. The findings suggest that happiness is negatively associated with longevity at the national level, and suggests a potential indirect transmission channel, as national happiness is negatively associated with public health expenditures. The paper concludes by discussing the implications of the results for public policy and future research.

Dilemma of Timing of Administration of Non-Steroidal Anti-inflammatory Agents in Relation to Food in the Prevention of Drug Induced Gastritis: Debusting the Myth.

PubMed

Udaykumar, Padmaja; Udaykumar, K; Scandashree, K; Anurag, K

2016-01-01

We aimed to identify the signals that indicate the possible benefits of administering Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) at the initiation of meal, compared to immediately after food. This was a randomized, controlled, pilot study in 160 patients who received only NSAIDs for various pain conditions. Patients were randomized to Group I (control group) -NSAID After Food (AF), Group II-NSAID Before Food (BF), Group III-NSAID BF for 2 days and then crossed over to AF for next two days (CO-1) and Group IV-NSAID AF for 2 days and then crossed over to BF for next two days (C0-2 group). Group III & Group IV were given a washout period of 48 hours after the initial two days of treatment. All were followed up for the next 2 drug free days. Patients were observed for the development of gastritis (epigastric distress, epigastric pain, nausea, fullness of stomach, repeated reflux) throughout the study. Symptoms of gastritis were seen in 6.45% (2/31) and 36.11% (13/36) patients in group I and II, respectively. There was no statistically significant difference in the development of gastritis in AF group. However, statistically significant difference (P<0.05) was found between BF group and AF intake of NSAIDs [CO-1 (AF), CO-2 (A.F), AF (control group)] in terms of development of gastritis. Administering NSAIDs at the initiation of meal is better tolerated as indicated by the lower incidence of gastritis. If proved in larger population, routine concurrent administration of medication for prevention of gastritis can be avoided.

Area-specific modulation of neural activation comparing escitalopram and citalopram revealed by pharmaco-fMRI: a randomized cross-over study.

PubMed

Windischberger, Christian; Lanzenberger, Rupert; Holik, Alexander; Spindelegger, Christoph; Stein, Patrycja; Moser, Ulrike; Gerstl, Florian; Fink, Martin; Moser, Ewald; Kasper, Siegfried

2010-01-15

Area-specific and stimulation-dependent changes of human brain activation by selective serotonin reuptake inhibitors (SSRI) are an important issue for improved understanding of treatment mechanisms, given the frequent prescription of these drugs in depression and anxiety disorders. The aim of this neuroimaging study was to investigate differences in BOLD-signal caused by administration of the SSRIs escitalopram and citalopram using pharmacological functional magnetic resonance imaging (pharmaco-fMRI). Eighteen healthy subjects participated in a placebo-controlled, randomized, double-blind study in cross-over repeated measures design. Each volunteer performed facial emotional discrimination and a sensorimotor control paradigm during three scanning sessions. Citalopram (20 mg/d), escitalopram (10 mg/d) and placebo were administered for 10 days each with a drug-free period of at least 21 days. Significant pharmacological effects on BOLD-signal were found in the amygdala, medial frontal gyrus, parahippocampal, fusiform and middle temporal gyri. Post-hoc t-tests revealed decreased BOLD-signal in the right amygdala and left parahippocampal gyrus in both pharmacological conditions, compared to placebo. Escitalopram, compared to citalopram, induced a decrease of BOLD-signal in the medial frontal gyrus and an increase in the right fusiform and left parahippocampal gyri. Drug effects were concentrated in brain regions with dense serotonergic projections. Both escitalopram and citalopram attenuated BOLD-signal in the amygdala and parahippocampal cortex to emotionally significant stimuli compared to control stimuli. We believe that reduced reactivity in the medial frontal gyrus found for escitalopram compared to citalopram administration might explain the response differences between study drugs as demonstrated in previous clinical trials.

Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study.

PubMed

Lainé, Fabrice; Laviolle, Bruno; Bardou-Jacquet, Edouard; Fatih, Nadia; Jezequel, Caroline; Collet, Nicolas; Ropert, Martine; Morcet, Jeff; Hamon, Catherine; Reymann, Jean-Michel; Loréal, Olivier

2017-10-01

Hepcidin, secreted by hepatocytes, controls iron metabolism by limiting iron egress in plasma. Hepcidin is upregulated during inflammation through the activation of the signal transducer and activator of transcription 3 (STAT3) transduction pathway, which decreases iron bioavailability and may explain the anemia of chronic inflammatory disease. In vitro, it has been shown that curcumin can decrease hepcidin synthesis by decreasing STAT3 activity. We conducted a proof-of-concept study to assess the effect of curcuma on hepcidin synthesis in human. This was a placebo-controlled, randomized, double-blind, cross-over, two-period study performed in 18 healthy male volunteers. Subjects received a single oral dose of 6 g curcuma containing 2% of curcumin or placebo. Serum hepcidin and iron parameters were assessed repeatedly until 48 h after dosing. When compared with a placebo curcuma decreased hepcidin levels significantly at 6 h (-19%, P = 0.004), 8 h (-17%, P = 0.009), and 12 h (-17%, P = 0.007) and tended to decrease hepcidin at 24 h (-15%, P = 0.076). Curcuma also significantly increased serum ferritin levels at 6 and 8 h (+7% for both times, P = 0.018, 0.030, respectively) and had no effects on serum iron, transferrin, and transferrin saturation. This pilot study showed that curcuma decreases serum hepcidin levels in human and supports the idea that curcuma could be useful in treating hepcidin overproduction during inflammatory processes. Confirmatory studies in patients with chronic inflammation are now required to determine the optimal dose and therapeutic scheme of curcuma. © 2017 Société Française de Pharmacologie et de Thérapeutique.

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management.

PubMed

Janice Jimenez-Torres, G; Weinstein, Benjamin L; Walker, Cory R; Christopher Fowler, J; Ashford, Philippa; Borckardt, Jeffrey J; Madan, Alok

2017-03-01

Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience. Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial. Eighty-four participants will be randomized (1:1) into a single-blind, 2×12 (group×time) controlled trial. A battery-powered direct and constant current stimulator (Soterix Medical Inc. 2014) delivers anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the right DLPFC. Active tDCS is applied by supplying a 2mA current for 20min/session over 10 sessions. Participants complete self-report and performance-based assessments on a weekly basis just prior to brain stimulation. Self-report assessments are collected via Chronic Pain Tracker version 3.6, an iPad interfaced application. The performance-based pain tolerance task is completed through the cold presser task. Interventions with cross-symptomatic therapeutic potential are absolutely essential in the context of CP, in which psychiatric comorbidity is the norm. Modalities that can be used in tandem with evidence-based, non-opioid therapies have the potential to have a synergistic effect, resulting in increased effectiveness of what have been modestly effective treatments to date. Copyright © 2017 Elsevier Inc. All rights reserved.

Using cross-correlations of random wavefields for surface waves tomography and structural health monitoring.

NASA Astrophysics Data System (ADS)

Sabra, K.

2006-12-01

The random nature of noise and scattered fields tends to suggest limited utility. Indeed, seismic or acoustic fields from random sources or scatterers are often considered to be incoherent, but there is some coherence between two sensors that receive signals from the same individual source or scatterer. An estimate of the Green's function (or impulse response) between two points can be obtained from the cross-correlation of random wavefields recorded at these two points. Recent theoretical and experimental studies in ultrasonics, underwater acoustics, structural monitoring and seismology have investigated this technique in various environments and frequency ranges. These results provide a means for passive imaging using only the random wavefields, without the use of active sources. The coherent wavefronts emerge from a correlation process that accumulates contributions over time from random sources whose propagation paths pass through both receivers. Results will be presented from experiments using ambient noise cross-correlations for the following applications: 1) passive surface waves tomography from ocean microseisms and 2) structural health monitoring of marine and airborne structures embedded in turbulent flow.

Virtual Reality-Based Training to Improve Obstacle-Crossing Performance and Dynamic Balance in Patients With Parkinson's Disease.

PubMed

Liao, Ying-Yi; Yang, Yea-Ru; Cheng, Shih-Jung; Wu, Yih-Ru; Fuh, Jong-Ling; Wang, Ray-Yau

2015-08-01

Obstacle crossing is a balance-challenging task and can cause falls in people with Parkinson's disease (PD). However, programs for people with PD that effectively target obstacle crossing and dynamic balance have not been established. To examine the effects of virtual reality-based exercise on obstacle crossing performance and dynamic balance in participants with PD. Thirty-six participants with a diagnosis of PD (Hoehn and Yahr score ranging 1 to 3) were randomly assigned to one of three groups. In the exercise groups, participants received virtual reality-based Wii Fit exercise (VRWii group) or traditional exercise (TE group) for 45 minutes, followed by 15 minutes of treadmill training in each session for a total of 12 sessions over 6 weeks. Participants in the control group received no structured exercise program. Primary outcomes included obstacle crossing performance (crossing velocity, stride length, and vertical toe obstacle clearance) and dynamic balance (maximal excursion, movement velocity, and directional control measured by the limits-of-stability test). Secondary outcomes included sensory organization test (SOT), Parkinson's Disease Questionnaire (PDQ39), fall efficacy scale (FES-I), and timed up and go test (TUG). All outcomes were assessed at baseline, after training, and at 1-month follow-up. The VRWii group showed greater improvement in obstacle crossing velocity, crossing stride length, dynamic balance, SOT, TUG, FES-I, and PDQ39 than the control group. VRWii training also resulted in greater improvement in movement velocity of limits-of-stability test than TE training. VRWii training significantly improved obstacle crossing performance and dynamic balance, supporting implementation of VRWii training in participants with PD. © The Author(s) 2014.

Peer tutoring in reading: the effects of role and organization on two dimensions of self-esteem.

PubMed

Miller, David; Topping, Keith; Thurston, Allen

2010-09-01

Paired reading (PR) is an application of peer tutoring. It has been extensively researched, and its efficacy across a range of outcomes has been established. Benefits include improvements in key reading skills, and also in affective aspects of learning. Several studies have shown gains in self-esteem, although measurement methods have varied, and the model of self-esteem has rarely been clearly articulated. To investigate the changes in self-esteem of children participating in a randomized trial of PR over a 15-week treatment period. To investigate the relative contribution of self-worth and self-competence to any gains in self-esteem. To investigate whether the pattern of change differs in children who take on different roles in the PR process. The participants comprised a subset of a large-scale randomized trial of peer learning (The Fife Peer Learning Project). Four schools were randomly selected from schools allocated to the same-age PR condition, and four schools from those allocated to the cross-age PR condition. The same-age group consisted of 87 primary 6 children (10-11 years old). The cross-age group consisted of 81 primary 6 children. The controls, from schools randomly selected from a neighbouring authority, consisted of 92 primary 6 children. A pre-post design employing self-report measures of self-esteem. Rosenberg's Self-Esteem Scale was used, with scores analysed for worth and competence. The treatment period was 15 weeks, with the participants following a prescribed PR process. Significant pre-post gains were noted in self-esteem, driven predominantly by improved beliefs about competence, in both same-age and cross-age conditions, but not for controls. Gains were also seen in self-worth in the cross-age condition. Further analyses of the influence of organizational condition (same-age or cross-age) and role played (tutor vs. tutee) showed significant differences between same-age tutors and cross-age tutors in relation to self-worth. Effect sizes were generally small or moderate. The findings provide further support for the belief that PR can enhance self-esteem. Importantly, the use of a two-dimensional model provides extra information about self-perceptions in PR contexts: first, the central role of self-competence; and second, the gains in self-worth which are associated with tutoring younger children (but not same-age peers). This new information has educational significance for schools considering the potential of peer tutoring and the benefits of different organizational conditions.

Effects of transcranial random noise stimulation (tRNS) on affect, pain and attention in multiple sclerosis.

PubMed

Palm, Ulrich; Chalah, Moussa A; Padberg, Frank; Al-Ani, Tarik; Abdellaoui, Mohamed; Sorel, Marc; Dimitri, Dalia; Créange, Alain; Lefaucheur, Jean-Pascal; Ayache, Samar S

2016-01-01

Pain and cognitive impairment are frequent symptoms in patients with multiple sclerosis (MS). Neglecting experimental pain and paying attention to demanding tasks is reported to decrease the pain intensity. Little is known about the interaction between chronic neuropathic pain and attention disorders in MS. Recently, transcranial direct current stimulation (tDCS) was used to modulate various cognitive and motor symptoms in MS. We aimed to study the effects of transcranial random noise stimulation (tRNS), a form of transcranial electric stimulation, over the left dorsolateral prefrontal cortex (DLPFC) on attention and neuropathic pain in MS patients. 16 MS patients were included in a randomized, sham-controlled, cross-over study. Each patient randomly received two tRNS blocks, separated by three weeks of washout interval. Each block consisted of three consecutive daily sessions of either active or sham tRNS. The patients were evaluated for pain, attention and mood and further underwent an electrophysiological evaluation. Compared to sham, tRNS showed a trend to decrease the N2-P2 amplitudes of pain related evoked potentials and improve pain ratings. Attention performance and mood scales did not change after stimulations. This study suggests the role of tRNS in pain modulation, which could have been more evident with longer stimulation protocols.

Dense genetic linkage maps of three Populus species (Populus deltoides, P. nigra and P. trichocarpa) based on AFLP and microsatellite markers.

PubMed

Cervera, M T; Storme, V; Ivens, B; Gusmão, J; Liu, B H; Hostyn, V; Van Slycken, J; Van Montagu, M; Boerjan, W

2001-06-01

Populus deltoides, P. nigra, and P. trichocarpa are the most important species for poplar breeding programs worldwide. In addition, Populus has become a model for fundamental research on trees. Linkage maps were constructed for these three species by analyzing progeny of two controlled crosses sharing the same female parent, Populus deltoides cv. S9-2 x P. nigra cv. Ghoy and P. deltoides cv. S9-2 x P. trichocarpa cv. V24. The two-way pseudotestcross mapping strategy was used to construct the maps. Amplified fragment length polymorphism (AFLP) markers that segregated 1:1 were used to form the four parental maps. Microsatellites and sequence-tagged sites were used to align homoeologous groups between the maps and to merge linkage groups within the individual maps. Linkage analysis and alignment of the homoeologous groups resulted in 566 markers distributed over 19 groups for P. deltoides covering 86% of the genome, 339 markers distributed over 19 groups for P. trichocarpa covering 73%, and 369 markers distributed over 28 groups for P. nigra covering 61%. Several tests for randomness showed that the AFLP markers were randomly distributed over the genome.

Dense genetic linkage maps of three Populus species (Populus deltoides, P. nigra and P. trichocarpa) based on AFLP and microsatellite markers.

PubMed Central

Cervera, M T; Storme, V; Ivens, B; Gusmão, J; Liu, B H; Hostyn, V; Van Slycken, J; Van Montagu, M; Boerjan, W

2001-01-01

Populus deltoides, P. nigra, and P. trichocarpa are the most important species for poplar breeding programs worldwide. In addition, Populus has become a model for fundamental research on trees. Linkage maps were constructed for these three species by analyzing progeny of two controlled crosses sharing the same female parent, Populus deltoides cv. S9-2 x P. nigra cv. Ghoy and P. deltoides cv. S9-2 x P. trichocarpa cv. V24. The two-way pseudotestcross mapping strategy was used to construct the maps. Amplified fragment length polymorphism (AFLP) markers that segregated 1:1 were used to form the four parental maps. Microsatellites and sequence-tagged sites were used to align homoeologous groups between the maps and to merge linkage groups within the individual maps. Linkage analysis and alignment of the homoeologous groups resulted in 566 markers distributed over 19 groups for P. deltoides covering 86% of the genome, 339 markers distributed over 19 groups for P. trichocarpa covering 73%, and 369 markers distributed over 28 groups for P. nigra covering 61%. Several tests for randomness showed that the AFLP markers were randomly distributed over the genome. PMID:11404342

The level crossing rates and associated statistical properties of a random frequency response function

NASA Astrophysics Data System (ADS)

Langley, Robin S.

2018-03-01

This work is concerned with the statistical properties of the frequency response function of the energy of a random system. Earlier studies have considered the statistical distribution of the function at a single frequency, or alternatively the statistics of a band-average of the function. In contrast the present analysis considers the statistical fluctuations over a frequency band, and results are obtained for the mean rate at which the function crosses a specified level (or equivalently, the average number of times the level is crossed within the band). Results are also obtained for the probability of crossing a specified level at least once, the mean rate of occurrence of peaks, and the mean trough-to-peak height. The analysis is based on the assumption that the natural frequencies and mode shapes of the system have statistical properties that are governed by the Gaussian Orthogonal Ensemble (GOE), and the validity of this assumption is demonstrated by comparison with numerical simulations for a random plate. The work has application to the assessment of the performance of dynamic systems that are sensitive to random imperfections.

Flexible chain molecules in the marginal and concentrated regimes: universal static scaling laws and cross-over predictions.

PubMed

Laso, Manuel; Karayiannis, Nikos Ch

2008-05-07

We present predictions for the static scaling exponents and for the cross-over polymer volumetric fractions in the marginal and concentrated solution regimes. Corrections for finite chain length are made. Predictions are based on an analysis of correlated fluctuations in density and chain length, in a semigrand ensemble in which mers and solvent sites exchange identities. Cross-over volumetric fractions are found to be chain length independent to first order, although reciprocal-N corrections are also estimated. Predicted scaling exponents and cross-over regimes are compared with available data from extensive off-lattice Monte Carlo simulations [Karayiannis and Laso, Phys. Rev. Lett. 100, 050602 (2008)] on freely jointed, hard-sphere chains of average lengths from N=12-500 and at packing densities from dilute ones up to the maximally random jammed state.

Salivary mutans streptococci and lactobacilli modulations in young children on consumption of probiotic ice-cream containing Bifidobacterium lactis Bb12 and Lactobacillus acidophilus La5.

PubMed

Singh, Richa Polka; Damle, Satyawan Gangaram; Chawla, Amrita

2011-11-01

To compare the levels of mutans streptococci and lactobacilli in saliva of school children, before and after consumption of probiotic and control ice-cream. A double-blind, cross-over, placebo-controlled trial was carried out in forty, 12-14 year-old children, with no clinically detectable caries. The selected children were randomized equally into two groups I and II. Following an initial run-in period of 1 week, children in group I and II were given ice-creams 'A' and 'B', respectively, for 10 days. Being a cross-over study, the ice-creams were interchanged in the two groups after a 2-week wash-out period. Saliva samples at baseline and follow-up were assessed using Dentocult SM and Dentocult LB kits. On statistical evaluation, it was seen that probiotic ice-cream brought about a statistically significant reduction (p-value = 0.003) in salivary mutans streptococci levels with no significant effect on lactobacilli levels. In conclusion, probiotic ice-cream containing Bifidobacterium lactis Bb-12 ATCC27536 and Lactobacillus acidophilus La-5 can reduce the levels of certain caries-associated micro-organisms in saliva.

Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica.

PubMed

Gonzalez, Paula; Hildesheim, Allan; Herrero, Rolando; Katki, Hormuzd; Wacholder, Sholom; Porras, Carolina; Safaeian, Mahboobeh; Jimenez, Silvia; Darragh, Teresa M; Cortes, Bernal; Befano, Brian; Schiffman, Mark; Carvajal, Loreto; Palefsky, Joel; Schiller, John; Ocampo, Rebeca; Schussler, John; Lowy, Douglas; Guillen, Diego; Stoler, Mark H; Quint, Wim; Morales, Jorge; Avila, Carlos; Rodriguez, Ana Cecilia; Kreimer, Aimée R

2015-04-27

The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routine vaccination was enrolled, and will be followed by cervical cancer screening over 6 years. To form the UCG, 5000 women were selected from a local census, of whom 2836 women (61% of eligible women) agreed to participate. Over 90% of participants complied with an interview, blood and cervical specimen collection. Evaluation of comparability between the original (Hepatitis-A arm of CVT) and new (UCG) control groups showed that women's characteristics, as well as their predicted future risk for cervical HPV acquisition, were similar, thus validating use of the UCG. LTFU is poised to comprehensively address many important questions related to long-term effects of prophylactic HPV vaccines. Copyright © 2015 Elsevier Ltd. All rights reserved.

A randomized controlled comparison of stretching procedures for posterior shoulder tightness.

PubMed

McClure, Philip; Balaicuis, Jenna; Heiland, David; Broersma, Mary Ellen; Thorndike, Cheryl K; Wood, April

2007-03-01

Randomized controlled trial, To compare changes in shoulder internal rotation range of motion (ROM), for 2 stretching exercises, the "cross-body stretch" and the "sleeper stretch," in individuals with posterior shoulder tightness. Recently, some authors have expressed the belief that the sleeper stretch is better than the cross-body stretch to address glenohumeral posterior tightness because the scapula is stabilized. Fifty-four asymptomatic subjects (20 males, 34 females) participated in the study. The control group (n=24) consisted of subjects with a between-shoulder difference in internal rotation ROM of less than 10 degrees, whereas those subjects with more than a 10 degrees difference were randomly assigned to 1 of 2 intervention groups, the sleeper stretch group (n=15) or the cross-body stretch group (n=15). Shoulder internal rotation ROM, with the arm abducted to 90 degrees and scapula motion prevented, was measured before and after a 4-week intervention period. Subjects in the control group were asked not to engage in any new stretching activities, while subjects in the 2 stretching groups were asked to perform stretching exercises on the more limited side only, once daily for 5 repetitions, holding each stretch for 30 seconds. The improvements in internal rotation ROM for the subjects in the cross-body stretch group (mean +/- SD, 20.0 degrees +/- 12.9 degrees) were significantly greater than for the subjects in the control group (5.9 degrees +/- 9.4 degrees, P = .009). The gains in the sleeper stretch group (12.4 degrees +/- 10.4 degrees) were not significant compared to those of the control group (P = .586) and those of the cross-body stretch group (P = .148). The cross-body stretch in individuals with limited shoulder internal rotation ROM appears to be more effective than no stretching in controls without internal rotation asymmetry to improve shoulder internal rotation ROM. While the improvement in internal rotation from the cross-body stretch was greater than for the sleeper stretch and of a magnitude that could be clinically significant, the small sample size likely precluded statistical significance between groups.

How do children learn to cross the street? The process of pedestrian safety training

PubMed Central

Schwebel, David C.; Shen, Jiabin; McClure, Leslie A.

2016-01-01

Objective Pedestrian injuries are a leading cause of child death, and may be reduced by training children to cross streets more safely. Such training is most effective when children receive repeated practice at the complex cognitive-perceptual task of judging moving traffic and selecting safe crossing gaps, but there is limited data on how much practice is required for children to reach adult levels of functioning. Using existing data, we examined how children’s pedestrian skill changed over the course of six pedestrian safety training sessions, each comprised of 45 crossings within a virtual pedestrian environment. Methods As part of a randomized controlled trial on pedestrian safety training, 59 children ages 7-8 crossed the street within a semi-immersive virtual pedestrian environment 270 times over a 3-week period (6 sessions of 45 crossings each). Feedback was provided after each crossing, and traffic speed and density was advanced as children’s skill improved. Post-intervention pedestrian behavior was assessed a week later in the virtual environment and compared to adult behavior with identical traffic patterns. Results Over the course of training, children entered traffic gaps more quickly and chose tighter gaps to cross within; their crossing efficiency appeared to increase. By the end of training, some aspects of children’s pedestrian behavior was comparable to adult behavior but other aspects were not, indicating the training was worthwhile but insufficient for most children to achieve adult levels of functioning. Conclusions Repeated practice in a simulated pedestrian environment helps children learn aspects of safe and efficient pedestrian behavior. Six twice-weekly training sessions of 45 crossings each were insufficient for children to reach adult pedestrian functioning, however, and future research should continue to study the trajectory and quantity of child pedestrian safety training needed for children to become competent pedestrians. PMID:26760077

A randomized controlled clinical study of the effect of daily intake of Ascophyllum nodosum alga on calculus, plaque, and gingivitis.

PubMed

van Dijken, Jan W V; Koistinen, S; Ramberg, Per

2015-07-01

The aim of this study is to evaluate, in a randomized controlled cross-over study, the effect of daily intake of the alga Ascophyllum nodosum on supragingival calculus, plaque formation, and gingival health over a 6-month period. Sixty-one adults with moderate to heavy calculus formation since their last yearly recall visit participated. In a randomized order over two 6-month periods, they swallowed two capsules daily, comprising a total of 500 mg dried marine alga powder (Ascophyllum nodosum, ProDen PlaqueOff®) or two negative control tablets. During the study, the participants maintained their regular oral habits. Their teeth were professionally cleaned at the start of each period and after the 6-month registrations. A wash out period of 1 month separated the two 6-month periods. Supragingival calculus (Volpe Manhold), gingivitis (Löe and Silness), gingival bleeding (Ainamo and Bay), and plaque (Quigley-Hein) were registered at screening and at the end of the two periods. Differences in oral health between the test and control periods were analyzed using a paired t test and Wilcoxon signed rank test. Fifty-five participants completed the study. After the alga intake, the mean calculus reduction was 52% compared to the control (p < 0.0001). Fifty-two participants showed less calculus formation in the alga group than in the control group. Plaque (p = 0.008) and gingival bleeding (p = 0.02) were also significantly less in the alga group. However, no significant difference was found between the groups for gingivitis (p = 0.13). The alga intake significantly reduced the formation of supragingival calculus and plaque and occurrence of gingival bleeding. The alga has a systemic effect on oral health. Daily intake of the alga Ascophyllum nodosum as an adjunct to customary oral hygiene showed a major reduction of supragingival calculus formation and reduced plaque formation. In addition, the calculus in the alga group was characterized by a more porous and less solid structure and was easier to remove than the calculus in the control group.

Transdermal granisetron versus palonosetron for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: a multicenter, randomized, open-label, cross-over, active-controlled, and phase IV study.

PubMed

Seol, Young Mi; Kim, Hyo Jeong; Choi, Young Jin; Lee, Eun Mi; Kim, Yang Soo; Oh, Sung Yong; Koh, Su Jin; Baek, Jin Ho; Lee, Won Sik; Joo, Young Don; Lee, Hyun Gi; Yun, Eun Young; Chung, Joo Seop

2016-02-01

Palonosetron is the second-generation 5-hydroxytryptamine 3 receptor antagonist (5-HT3RA) that has shown better efficacy than the first-generation 5-HT3RA for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC). Granisetron transdermal delivery system (GTDS), a novel transdermal formulation, was developed to deliver granisetron continuously over 7 days. This study compared the efficacy and tolerability of the GTDS to palonosetron for the control of CINV following MEC. A total of 196 patients were randomized to GP or PG group. In this multicenter, randomized, open-label, cross-over, active-controlled, Phase IV study, GP group was assigned to receive transdermal granisetron (one GTDS patch, 7 days) in the first chemotherapy cycle, palonosetron (iv 0.25 mg/day, 1 days) in the second chemotherapy cycle before receiving MEC, and PG group was assigned to receive palonosetron in the first cycle and GTDS in the second cycle. Primary endpoint was the percentage of chemotherapy cycles achieving complete response (CR; defined as no emetic episodes and no rescue medication use) during the acute phase (0-24 h in post-chemotherapy; non-inferiority comparison with palonosetron). Total 333 cycles (165 in GTDS and 168 in palonosetron) were included in the per protocol analysis. The GTDS cycles showed non-inferiority to palonosetron cycles during the acute phase: CR was achieved by 124 (75.2 %) patients in the GTDS cycles and 134 (79.8 %) patients in the palonosetron cycles (treatment difference, -4.6 %; 95 % confidence interval, -13.6-4.4). There was no significant difference in CR rate during acute phase after the end of the first and second chemotherapy cycle between GP and PG group (p = 0.405, p = 0.074). Patients' satisfaction, assessed using Functional Living Index-Emesis (FLI-E), GTDS cycle were higher than those of palonosetron cycle in GP group (FLI-E score; median 1549.5 in GTDS cycle, median 1670.0 in palonosetron cycle). Both treatments were well tolerated and safe. Transdermal granisetron is a good alternative therapeutic option to palonosetron for preventing CINV after MEC.

Sensitivity Analysis for Multivalued Treatment Effects: An Example of a Cross-Country Study of Teacher Participation and Job Satisfaction

ERIC Educational Resources Information Center

Chang, Chi

2015-01-01

It is known that interventions are hard to assign randomly to subjects in social psychological studies, because randomized control is difficult to implement strictly and precisely. Thus, in nonexperimental studies and observational studies, controlling the impact of covariates on the dependent variables and addressing the robustness of the…

Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

PubMed

Spertus, John A; Maron, David J; Cohen, David J; Kolm, Paul; Hartigan, Pam; Weintraub, William S; Berman, Daniel S; Teo, Koon K; Shaw, Leslee J; Sedlis, Steven P; Knudtson, Merril; Aslan, Mihaela; Dada, Marcin; Boden, William E; Mancini, G B John

2013-07-01

In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown. We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]). Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.

The effect of using an audience response system on learning, motivation and information retention in the orthodontic teaching of undergraduate dental students: a cross-over trial.

PubMed

Dhaliwal, Harmeet Kaur; Allen, Mark; Kang, Jing; Bates, Claire; Hodge, Trevor

2015-06-01

New methods of teaching and learning are constantly being sought in the adult learning environment. Audience Response Systems (ARS) have been used in many different learning environments, especially in the field of medical education. The objective of this investigation was to ascertain the effect of ARS use in undergraduate teaching in a UK dental school. A cross-over clustered randomized educational trial. Leeds Dental Institute. Year 4 undergraduate dental students in orthodontics. Students at Leeds Dental Institute were taught two different topics within the curriculum to test the use of ARS in a cross-over trial. A questionnaire was delivered to the test (ARS) and control (non-ARS) groups. The response rate to the questionnaires was 89·5% (test group) and 82·9% (control group). The ARS enabled students to perform better as shown by knowledge retention (P = 0·013). Students found the seminar more interesting (P = 0·013), easier to concentrate (P = 0·025) and easier to participate in (P = 0·020) when ARS was used. When ARS was used, students were more able to answer questions (P<0·0001), were more likely to prepare for the seminar (P<0·0001) and significantly preferred using ARS (P<0·0001). ARS was found to significantly improve student concentration and participation in small group seminar teaching and significantly improved knowledge retention. ARS may be useful in facilitating orthodontic teaching in the future.

Effects of expiratory ribcage compression before endotracheal suctioning on arterial blood gases in patients receiving mechanical ventilation.

PubMed

Kohan, Mahmoud; Rezaei-Adaryani, Morteza; Najaf-Yarandi, Akram; Hoseini, Fatemeh; Mohammad-Taheri, Nahid

2014-09-01

To investigate the effects of expiratory ribcage compression (ERCC) before endotracheal suctioning on the arterial blood gases (ABG) in patients receiving mechanical ventilation. Endotracheal suctioning is one of the most frequently used methods for airway clearance in patients receiving mechanical ventilation. Chest physiotherapy techniques such as ERCC before endotracheal suctioning can be used as a means to facilitate mobilizing and removing airway secretions and improving alveolar ventilation. A prospective, randomized, controlled cross-over design. A randomized controlled cross-over trial with a convenience sample of 70 mechanically ventilated patients was conducted from 2006 to 2007. The patients received endotracheal suctioning with (experiment-period) or without (control-period) an antecedent 5-min expiratory ribcage. All the patients experienced both periods with at least a 3-h washed-out interval between the two periods. ABG were measured 5 min before and 25 min after endotracheal suctioning. The statistical tests showed that the levels of partial pressure of oxygen (PaO2 )/fraction of inspired oxygen (FiO2 ), partial pressure of carbon dioxide (PaCO2 ) and arterial oxygen saturation (SaO2 ) in the experimental period at 25 min after the intervention were significantly different from the control period. The tests also revealed that the levels of these variables at 25 min after suctioning were also significantly different from baseline values. However, these differences were clinically significant only for PaO2 /FiO2 . By improving the levels of PaO2 /FiO2 , ERCC can reduce the patients' need for oxygen and hence it can at least reduce the side effects of oxygen therapy. Improving PaO2 /FiO2 levels means less need for oxygen therapy. Hence, by applying ERCC we can at least minimize the side effects of oxygen therapy. © 2014 British Association of Critical Care Nurses.

Estimation of Complex Generalized Linear Mixed Models for Measurement and Growth

ERIC Educational Resources Information Center

Jeon, Minjeong

2012-01-01

Maximum likelihood (ML) estimation of generalized linear mixed models (GLMMs) is technically challenging because of the intractable likelihoods that involve high dimensional integrations over random effects. The problem is magnified when the random effects have a crossed design and thus the data cannot be reduced to small independent clusters. A…

A Multicenter Approach Evaluating the Impact of Vitamin E-Blended Polyethylene in Cementless Total Hip Replacement

PubMed Central

Jäger, Marcus; van Wasen, Andrea; Warwas, Sebastian; Landgraeber, Stefan; Haversath, Marcel; Group, VITAS

2014-01-01

Since polyethylene is one of the most frequently used biomaterials as a liner in total hip arthroplasty, strong efforts have been made to improve design and material properties over the last 50 years. Antioxidants seems to be a promising alternative to further increase durability and reduce polyethylene wear in long term. As of yet, only in vitro results are available. While they are promising, there is yet no clinical evidence that the new material shows these advantages in vivo. To answer the question if vitamin-E enhanced ultra-high molecular weight polyethylene (UHMWPE) is able to improve long-term survivorship of cementless total hip arthroplasty we initiated a randomized long-term multicenter trial. Designed as a superiority study, the oxidation index assessed in retrieval analyses of explanted liners was chosen as primary parameter. Radiographic results (wear rate, osteolysis, radiolucency) and functional outcome (Harris Hip Scores, University of California-Los Angeles, Hip Disability and Osteoarthritis Outcome Score, Visual Analogue Scale) will serve as secondary parameters. Patients with the indication for a cementless total hip arthroplasty will be asked to participate in the study and will be randomized to either receive a standard hip replacement with a highly cross-linked UHMWPE-X liner or a highly cross-linked vitamin-E supplemented UHMWPE-XE liner. The follow-up will be 15 years, with evaluation after 5, 10 and 15 years. The controlled randomized study has been designed to determine if Vitamin-E supplemented highly cross-linked polyethylene liners are superior to standard XLPE liners in cementless total hip arthroplasty. While several studies have been started to evaluate the influence of vitamin-E, most of them evaluate wear rates and functional results. The approach used for this multicenter study, to analyze the oxidation status of retrieved implants, should make it possible to directly evaluate the ageing process and development of the implant material itself over a time period of 15 years. PMID:25002933

Reciprocal longitudinal relations between weight/shape concern and comorbid pathology among women at very high risk for eating disorder onset.

PubMed

Fitzsimmons-Craft, Ellen E; Eichen, Dawn M; Kass, Andrea E; Trockel, Mickey; Crosby, Ross D; Taylor, C Barr; Wilfley, Denise E

2017-12-28

Understanding how known eating disorder (ED) risk factors change in relating to one another over time may inform efficient intervention targets. We examined short-term (i.e., 1 month) reciprocal longitudinal relations between weight/shape concern and comorbid symptoms (i.e., depressed mood, anxiety) and behaviors (i.e., binge drinking) over the course of 24 months using cross-lagged panel models. Participants were 185 women aged 18-25 years at very high risk for ED onset, randomized to an online ED preventive intervention or waitlist control. We also tested whether relations differed based on intervention receipt. Weight/shape concern in 1 month significantly predicted depressed mood the following month; depressed mood in 1 month also predicted weight/shape concern the following month, but the effect size was smaller. Likewise, weight/shape concern in 1 month significantly predicted anxiety the following month, but the reverse was not true. Results showed no temporal relations between weight/shape concern and binge drinking in either direction. Relations between weight/shape concern, and comorbid symptoms and behaviors did not differ based on intervention receipt. Results support focusing intervention on reducing weight/shape concern over reducing comorbid constructs for efficient short-term change. Level I, evidence obtained from a properly designed randomized controlled trial.

A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder.

PubMed

El-Hage, G; Eden, J A; Manga, R Zoa

2007-08-01

To assess the safety and efficacy of 10 mg topical testosterone therapy daily (2 cm Andro-Feme cream) as a treatment for low sexual desire in postmenopausal hysterectomized women who were already on transdermal estrogen. A double-blind, randomized, placebo-controlled, cross-over study (each period being of 3 months' duration) was performed in the research center of a tertiary referral women's hospital. Thirty-six menopausal healthy women were recruited who had undergone a hysterectomy, who were not depressed, were in a stable relationship and who fulfilled diagnostic criteria for low sexual desire, as measured by the Brief Index of Sexual Function for Women (BISF-W). The primary outcome measure was improvement in the sexuality score as measured by a validated tool (BISF-W); secondary measures were sub-scores of the BISF-W, effect on mood and energy, lipids and testosterone levels. Testosterone cream significantly improved sexual desire, frequency of sex, receptivity and initiation as measured by the BISF-W score. It did not change mood, energy, lipids, blood pressure or weight over the study period. Testosterone cream significantly improved sexual scores in menopausal women with low sexual desire. It was effective, easy to use and had no side-effects over the 3-month period of active treatment. It offers a novel and acceptable method of administering testosterone to menopausal women.

Fish oil-supplementation increases appetite in healthy adults. A randomized controlled cross-over trial.

PubMed

Damsbo-Svendsen, Signe; Rønsholdt, Mia Dybkjær; Lauritzen, Lotte

2013-07-01

Marine n-3 fatty acids are hypothesized to have beneficial effects on obesity and cancer cachexia possibly via an effect on appetite. The aim of this study was to investigate, if fish oil-supplementation affects appetite in healthy individuals. In a randomized cross-over study, 20 normal-weight subjects (50% females) were given ten 0.5-mL capsules/day of fish oil or soybean oil for 3 weeks separated by 1-week wash-out. In the end of each period, appetite was assessed by 10-cm visual analog scales immediately before and after a standardized breakfast. Results were analyzed in accordance with the paired design considering oil sequence and gender. All subjects completed both periods with a compliance of 96% and oil sequence did not affect the results. There was no difference between the two supplements in any pre-breakfast appetite scores, but the post-prandial sensation of being full was 1.21 cm (0.20; 2.22) lower after the fish oil-period. Furthermore, there was a supplement × gender-interaction on "desire to eat more" due to a score increase of 1.09 cm (0.28; 1.90) in women only. These results suggest that marine n-3 fatty acid may increase appetite. This finding would be potentially beneficial for patients with compromised nutritional status. Copyright © 2013 Elsevier Ltd. All rights reserved.

The effects of alprazolam on tinnitus: a cross-over randomized clinical trial.

PubMed

Jalali, Mir Mohammad; Kousha, Abdorrahim; Naghavi, Sayed Ebrahim; Soleimani, Robabeh; Banan, Rozbeh

2009-11-01

Tinnitus remains a phenomenon with an unknown pathophysiology and for which few therapeutic measures are available. To date there has been insufficient evidence to support the use of alprazolam in the treatment of tinnitus. We sought to evaluate the efficacy of alprazolam for relief of tinnitus. Thirty-six tinnitus sufferers participated in this cross-over, randomized, triple-blind, placebo-controlled trial. Inclusion criteria included patients between ages 21 and 65, with a complaint of non-pulsatile tinnitus of more than 1 year duration. Patients with depressive or anxiety disorders were excluded, as were those using hearing aids. Participants received alprazolam 1.5 mg daily versus placebo in each period. Primary outcome variables included the Tinnitus Handicap Inventory (THI), a Visual Analog Scale (VAS), and tinnitus loudness. Thirty patients completed the study. The average age of patients was 47.58+/-7.65 years. Alprazolam in comparison with placebo did not result in statistically significantly greater relief in THI score and tinnitus loudness. There was a significant improvement in VAS score in the alprazolam group compared with the placebo group (p<0.001). These results suggest that although alprazolam did not improve the THI score or sensation level of loudness significantly, it has a desirable effect on VAS. Further work is needed to determine the beneficial effects of alprazolam in distressed or depressed patients.

Using acupressure and Montessori-based activities to decrease agitation for residents with dementia: a cross-over trial.

PubMed

Lin, Li-Chan; Yang, Man-Hua; Kao, Chieh-Chun; Wu, Shiao-Chi; Tang, Sai-Hung; Lin, Jaung-Geng

2009-06-01

To explore the effectiveness of acupressure and Montessori-based activities in decreasing the agitated behaviors of residents with dementia. A double-blinded, randomized (two treatments and one control; three time periods) cross-over design was used. Six special care units for residents with dementia in long-term care facilities in Taiwan were the sites for the study. One hundred thirty-three institutionalized residents with dementia. Subjects were randomized into three treatment sequences: acupressure-presence-Montessori methods, Montessori methods-acupressure-presence and presence-Montessori methods-acupressure. All treatments were done once a day, 6 days per week, for a 4-week period. The Cohen-Mansfield Agitation Inventory, Ease-of-Care, and the Apparent Affect Rating Scale. After receiving the intervention, the acupressure and Montessori-based-activities groups saw a significant decrease in agitated behaviors, aggressive behaviors, and physically nonaggressive behaviors than the presence group. Additionally, the ease-of-care ratings for the acupressure and Montessori-based-activities groups were significantly better than for the presence group. In terms of apparent affect, positive affect in the Montessori-based-activities group was significantly better than in the presence group. This study confirms that a blending of traditional Chinese medicine and a Western activities program would be useful in elderly care and that in-service training for formal caregivers in the use of these interventions would be beneficial for patients

The effects of anticholinergic drugs on attention span and short-term memory skills in children.

PubMed

Giramonti, Karla M; Kogan, Barry A; Halpern, Leslie F

2008-01-01

Studies have shown cognitive problems in adults treated with anticholinergics. It is unclear if children are also susceptible to anticholinergic adverse effects. This study evaluates the effects of long-acting oxybutynin and tolterodine on short-term memory and attention in children with urgency and urge incontinence. Children with urgency or urge incontinence were recruited to take part in a prospective, randomized double-blinded placebo controlled trial using long-acting oxybutynin or tolterodine. Patients underwent a baseline test of their memory/recall ability and attention span using a standardized developmental/neuropsychological assessment tool. They were then randomized to either medication or placebo with retesting in 2 weeks, at which time they were crossed. They were retested after the second 2 weeks. Fourteen children (9 boys and 5 girls), ranging in age from 5 to 11 (M = 7.7) participated in the study. Attention and memory scores increased over time in all children, however, the analyses showed no significant negative effects of anticholinergic medications on attention or memory. Indeed, though not statistically significant, trends were for improvement in test scores in both areas. Our results in a double blinded cross-over trial suggest that long-acting oxybutynin and tolterodine do not have a deleterious effect on children's attention and memory. Other cognitive functions may be affected. (c) 2007 Wiley-Liss, Inc

Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial.

PubMed

Souday, Vincent; Koning, Nick J; Perez, Bruno; Grelon, Fabien; Mercat, Alain; Boer, Christa; Seegers, Valérie; Radermacher, Peter; Asfar, Pierre

2016-01-01

To test the hypothesis whether enriched air nitrox (EAN) breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression. Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2) in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes). Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler. Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P < 0.001). Three decompression incidents, all presenting as cutaneous itching, occurred in the air versus zero in the EAN group (P = 0.217). Weak correlations were observed between bubble scores and age or body mass index, respectively. EAN breathing markedly reduces venous gas bubble emboli after decompression in volunteers selected for susceptibility for intravascular bubble formation. When using similar diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing. ISRCTN 31681480.

Impact of referral source and study applicants' preference for randomly assigned service on research enrollment, service engagement, and evaluative outcomes.

PubMed

Macias, Cathaleene; Barreira, Paul; Hargreaves, William; Bickman, Leonard; Fisher, William; Aronson, Elliot

2005-04-01

The inability to blind research participants to their experimental conditions is the Achilles' heel of mental health services research. When one experimental condition receives more disappointed participants, or more satisfied participants, research findings can be biased in spite of random assignment. The authors explored the potential for research participants' preference for one experimental program over another to compromise the generalizability and validity of randomized controlled service evaluations as well as cross-study comparisons. Three Cox regression analyses measured the impact of applicants' service assignment preference on research project enrollment, engagement in assigned services, and a service-related outcome, competitive employment. A stated service preference, referral by an agency with a low level of continuity in outpatient care, and willingness to switch from current services were significant positive predictors of research enrollment. Match to service assignment preference was a significant positive predictor of service engagement, and mismatch to assignment preference was a significant negative predictor of both service engagement and employment outcome. Referral source type and service assignment preference should be routinely measured and statistically controlled for in all studies of mental health service effectiveness to provide a sound empirical base for evidence-based practice.

Quantifying economic fluctuations by adapting methods of statistical physics

NASA Astrophysics Data System (ADS)

Plerou, Vasiliki

2001-09-01

The first focus of this thesis is the investigation of cross-correlations between the price fluctuations of different stocks using the conceptual framework of random matrix theory (RMT), developed in physics to describe the statistical properties of energy-level spectra of complex nuclei. RMT makes predictions for the statistical properties of matrices that are universal, i.e., do not depend on the interactions between the elements comprising the system. In physical systems, deviations from the predictions of RMT provide clues regarding the mechanisms controlling the dynamics of a given system so this framework is of potential value if applied to economic systems. This thesis compares the statistics of cross-correlation matrix C-whose elements Cij are the correlation coefficients of price fluctuations of stock i and j-against the ``null hypothesis'' of a random matrix having the same symmetry properties. It is shown that comparison of the eigenvalue statistics of C with RMT results can be used to distinguish random and non-random parts of C. The non-random part of C which deviates from RMT results, provides information regarding genuine cross-correlations between stocks. The interpretations and potential practical utility of these deviations are also investigated. The second focus is the characterization of the dynamics of stock price fluctuations. The statistical properties of the changes G Δt in price over a time interval Δ t are quantified and the statistical relation between G Δt and the trading activity-measured by the number of transactions NΔ t in the interval Δt is investigated. The statistical properties of the volatility, i.e., the time dependent standard deviation of price fluctuations, is related to two microscopic quantities: NΔt and the variance W2Dt of the price changes for all transactions in the interval Δ t. In addition, the statistical relationship between G Δt and the number of shares QΔt traded in Δ t is investigated.

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

PubMed

Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios

2016-02-16

The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

PubMed Central

2016-01-01

Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Conclusions Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV). PMID:26883052

Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial.

PubMed

Hilderley, Alicia J; Fehlings, Darcy; Lee, Gloria W; Wright, F Virginia

2016-01-01

Enhancement of functional ambulation is a key goal of rehabilitation for children with cerebral palsy (CP) who experience gross motor impairment. Physiotherapy (PT) approaches often involve overground and treadmill-based gait training to promote motor learning, typically as free walking or with body-weight support. Robotic-assisted gait training (RAGT), using a device such as the Lokomat ® Pro, may permit longer training duration, faster and more variable gait speeds, and support walking pattern guidance more than overground/treadmill training to further capitalize on motor learning principles. Single group pre-/post-test studies have demonstrated an association between RAGT and moderate to large improvements in gross motor skills, gait velocity and endurance. A single published randomized controlled trial (RCT) comparing RAGT to a PT-only intervention showed no difference in gait kinematics. However, gross motor function and walking endurance were not evaluated and conclusions were limited by a large PT group drop-out rate. In this two-group cross-over RCT, children are randomly allocated to the RAGT or PT arm (each with twice weekly sessions for eight weeks), with cross-over to the other intervention arm following a six-week break. Both interventions are grounded in motor learning principles with incorporation of individualized mobility-based goals. Sessions are fully operationalized through manualized, menu-based protocols and post-session documentation to enhance internal and external validity. Assessments occur pre/post each intervention arm (four time points total) by an independent assessor. The co-primary outcomes are gross motor functional ability (Gross Motor Function Measure (GMFM-66) and 6-minute walk test), with secondary outcome measures assessing: (a) individualized goals; (b) gait variables and daily walking amounts; and (c) functional abilities, participation and quality of life. Investigators and statisticians are blinded to study group allocation in the analyses, and assessors are blinded to treatment group. The primary analysis will be the pre- to post-test differences (change scores) of the GMFM-66 and 6MWT between RAGT and PT groups. This study is the first RCT comparing RAGT to an active gait-related PT intervention in paediatric CP that addresses gait-related gross motor, participation and individualized outcomes, and as such, is expected to provide comprehensive information as to the potential role of RAGT in clinical practice. Trial registration ClinicalTrials.gov NCT02196298.

The impact of a multidisciplinary self-care management program on quality of life, self-care, adherence to anti-hypertensive therapy, glycemic control, and renal function in diabetic kidney disease: A Cross-over Study Protocol.

PubMed

Helou, Nancy; Talhouedec, Dominique; Shaha, Maya; Zanchi, Anne

2016-07-19

Diabetic kidney disease, a global health issue, remains associated with high morbidity and mortality. Previous research has shown that multidisciplinary management of chronic disease can improve patient outcomes. The effect of multidisciplinary self-care management on quality of life and renal function of patients with diabetic kidney disease has not yet been well established. The aim of this study is to evaluate the impact of a multidisciplinary self-care management program on quality of life, self-care behavior, adherence to anti-hypertensive treatment, glycemic control, and renal function of adults with diabetic kidney disease. A uniform balanced cross-over design is used, with the objective to recruit 40 adult participants with diabetic kidney disease, from public and private out-patient settings in French speaking Switzerland. Participants are randomized in equal number into four study arms. Each participant receives usual care alternating with the multidisciplinary self- care management program. Each treatment period lasts three months and is repeated twice at different time intervals over 12 months depending on the cross-over arm. The multidisciplinary self-care management program is led by an advanced practice nurse and adds nursing and dietary consultations and follow-ups, to the habitual management provided by the general practitioner, the nephrologist and the diabetologist. Data is collected every three months for 12 months. Quality of life is measured using the Audit of Diabetes-Dependent Quality of Life scale, patient self-care behavior is assessed using the Revised Summary of Diabetes Self-Care Activities, and adherence to anti-hypertensive therapy is evaluated using the Medication Events Monitoring System. Blood glucose control is measured by the glycated hemoglobin levels and renal function by serum creatinine, estimated glomerular filtration rate and urinary albumin/creatinine ratio. Data will be analyzed using STATA version 14. The cross-over design will elucidate the responses of individual participant to each treatment, and will allow us to better evaluate the use of such a design in clinical settings and behavioral studies. This study also explores the impact of a theory-based nursing practice and its implementation into a multidisciplinary context. ClinicalTrials.gov identifier: NCT01967901 , registered on the 18th of October 2013.

Effects of a cross-training exercise program in persons with osteoarthritis of the knee a randomized controlled trial.

PubMed

Péloquin, L; Bravo, G; Gauthier, P; Lacombe, G; Billiard, J S

1999-06-01

This study was designed to evaluate, by means of a randomized controlled trial, the effects of a physical activity program incorporating aerobic, strength, and stretching exercises in individuals with osteoarthritis of the knee. We randomly assigned 137 volunteers ages >/=50 to an experimental group or a control group. The experimental group participated in three 1-hour sessions of supervised exercises per week over a 3-month period. The control participants were instructed to continue their usual daily activities, and they attended 1-hour education sessions twice a month. The effectiveness of the program was evaluated using repeated measurements of parameters related to self-reported health status, physical capacity, and joint tenderness.After 3 months, significantly greater improvements were observed in the experimental group than the control group in terms of: arthritis pain (p = 0.02), ability to walk and bend (p = 0.03), aerobic capacity (p < 0.0001), hamstring and low back flexibility (p = 0.003), quadriceps and hamstring strength (p <0.01), and the perception of changes relating to osteoarthritis of the knee and general condition (p < 0.0001). However, no significant differences were observed between the groups in isokinetic strength of the quadriceps (all p's >== 0.05), joint tenderness (p = 0.18), and health perception (p = 0.7). The overall results suggest that this program is effective for older persons with osteoarthritis of the knee and that it could contribute to maintaining their independence and improving their quality of life.

Comparison of forcing functions in magnetohydrodynamics

NASA Astrophysics Data System (ADS)

McKay, Mairi E.; Linkmann, Moritz; Clark, Daniel; Chalupa, Adam A.; Berera, Arjun

2017-11-01

Results are presented of direct numerical simulations of incompressible, homogeneous magnetohydrodynamic turbulence without a mean magnetic field, subject to different mechanical forcing functions commonly used in the literature. Specifically, the forces are negative damping (which uses the large-scale velocity field as a forcing function), a nonhelical random force, and a nonhelical static sinusoidal force (analogous to helical ABC forcing). The time evolution of the three ideal invariants (energy, magnetic helicity, and cross helicity), the time-averaged energy spectra, the energy ratios, and the dissipation ratios are examined. All three forcing functions produce qualitatively similar steady states with regard to the time evolution of the energy and magnetic helicity. However, differences in the cross-helicity evolution are observed, particularly in the case of the static sinusoidal method of energy injection. Indeed, an ensemble of sinusoidally forced simulations with identical parameters shows significant variations in the cross helicity over long time periods, casting some doubt on the validity of the principle of ergodicity in systems in which the injection of helicity cannot be controlled. Cross helicity can unexpectedly enter the system through the forcing function and must be carefully monitored.

Supervised Home Training of Dialogue Skills in Chronic Aphasia: A Randomized Parallel Group Study

ERIC Educational Resources Information Center

Nobis-Bosch, Ruth; Springer, Luise; Radermacher, Irmgard; Huber, Walter

2011-01-01

Purpose: The aim of this study was to prove the efficacy of supervised self-training for individuals with aphasia. Linguistic and communicative performance in structured dialogues represented the main study parameters. Method: In a cross-over design for randomized matched pairs, 18 individuals with chronic aphasia were examined during 12 weeks of…

Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study).

PubMed

Lind, Marcus; Polonsky, William; Hirsch, Irl B; Heise, Tim; Bolinder, Jan; Dahlqvist, Sofia; Pehrsson, Nils-Gunnar; Moström, Peter

2016-05-01

The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI). Individuals with type 1 diabetes and inadequate glycemic control (HbA1c ≥ 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase. A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016. It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability. © 2016 Diabetes Technology Society.

A double blind, placebo controlled, phase II randomised cross-over trial investigating the use of duloxetine for the treatment of chemotherapy-induced peripheral neuropathy.

PubMed

Battaglini, Eva; Park, Susanna B; Barnes, Elizabeth H; Goldstein, David

2018-04-20

Chemotherapy-induced peripheral neuropathy (CIPN) is a significant side effect of cancer treatment, potentially leading to early cessation of chemotherapy, enduring symptoms and long-lasting disability. Evidence from preclinical and clinical studies suggests that duloxetine, a serotonin-noradrenaline reuptake inhibitor, may be effective in the symptomatic treatment of CIPN. This double blind, placebo controlled, phase II randomised cross-over trial aims to determine whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment. Participants who have received neurotoxic chemotherapy and experience daily symptoms as a consequence of peripheral neuropathy will be randomly allocated to control or experimental group with a 1:1 allocation, stratified by chemotherapy type. The primary endpoint will be patient-reported CIPN symptoms, as assessed via the FACT/GOG-Ntx. As a secondary objective, the trial will investigate whether duloxetine improves neurophysiological parameters and functional status in patients who have received neurotoxic chemotherapy treatment. This trial will investigate the effectiveness of duloxetine in reducing neuropathic symptoms following chemotherapy treatment, and aims to provide insight into the mechanisms underlying the symptomatic relief that duloxetine may provide. These results will be informative in advancing clinical knowledge regarding the treatment of CIPN. Copyright © 2018 Elsevier Inc. All rights reserved.

Job strain and resting heart rate: a cross-sectional study in a Swedish random working sample.

PubMed

Eriksson, Peter; Schiöler, Linus; Söderberg, Mia; Rosengren, Annika; Torén, Kjell

2016-03-05

Numerous studies have reported an association between stressing work conditions and cardiovascular disease. However, more evidence is needed, and the etiological mechanisms are unknown. Elevated resting heart rate has emerged as a possible risk factor for cardiovascular disease, but little is known about the relation to work-related stress. This study therefore investigated the association between job strain, job control, and job demands and resting heart rate. We conducted a cross-sectional survey of randomly selected men and women in Västra Götalandsregionen, Sweden (West county of Sweden) (n = 1552). Information about job strain, job demands, job control, heart rate and covariates was collected during the period 2001-2004 as part of the INTERGENE/ADONIX research project. Six different linear regression models were used with adjustments for gender, age, BMI, smoking, education, and physical activity in the fully adjusted model. Job strain was operationalized as the log-transformed ratio of job demands over job control in the statistical analyses. No associations were seen between resting heart rate and job demands. Job strain was associated with elevated resting heart rate in the unadjusted model (linear regression coefficient 1.26, 95 % CI 0.14 to 2.38), but not in any of the extended models. Low job control was associated with elevated resting heart rate after adjustments for gender, age, BMI, and smoking (linear regression coefficient -0.18, 95 % CI -0.30 to -0.02). However, there were no significant associations in the fully adjusted model. Low job control and job strain, but not job demands, were associated with elevated resting heart rate. However, the observed associations were modest and may be explained by confounding effects.

OROS-methylphenidate efficacy on specific executive functioning deficits in adults with ADHD: a randomized, placebo-controlled cross-over study.

PubMed

Bron, Tannetje I; Bijlenga, Denise; Boonstra, A Marije; Breuk, Minda; Pardoen, Willem F H; Beekman, Aartjan T F; Kooij, J J Sandra

2014-04-01

Attention-deficit/hyperactivity disorder (ADHD) is linked to impaired executive functioning (EF). This is the first study to objectively investigate the effects of a long-acting methylphenidate on neurocognitive test performance of adults with ADHD. Twenty-two adults with ADHD participated in a 6-weeks study examining the effect of osmotic-release oral system methylphenidate (OROS-mph) on continuous performance tests (CPTs; objective measures), and on the self-reported ADHD rating scale (subjective measure) using a randomized, double-blind, placebo-controlled cross-over design. OROS-mph significantly improved reaction time variability (RTV), commission errors (CE) and d-prime (DP) as compared to baseline (Cohen's d>.50), but did not affect hit reaction time (HRT) or omission errors (OE). Compared to placebo, OROS-mph only significantly influenced RTV on one of two CPTs (p<.050). Linear regression analyses showed predictive ability of more beneficial OROS-mph effects in ADHD patients with higher EF severity (RTV: β=.670, t=2.097, p=.042; omission errors (OE): β=-.098, t=-4.759, p<.001), and with more severe ADHD symptoms (RTV: F=6.363, p=.019; HRT: F=3.914, p=.061). Side effects rates were substantially but non-significantly greater for OROS-mph compared to placebo (77% vs. 46%, p=.063). OROS-mph effects indicated RTV as the most sensitive parameter for measuring both neuropsychological and behavioral deficits in adults with ADHD. These findings suggest RTV as an endophenotypic parameter for ADHD symptomatology, and propose CPTs as an objective method for monitoring methylphenidate titration. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

Effects of Oral L-Carnitine Administration in Narcolepsy Patients: A Randomized, Double-Blind, Cross-Over and Placebo-Controlled Trial

PubMed Central

Miyagawa, Taku; Kawamura, Hiromi; Obuchi, Mariko; Ikesaki, Asuka; Ozaki, Akiko; Tokunaga, Katsushi; Inoue, Yuichi; Honda, Makoto

2013-01-01

Narcolepsy is a sleep disorder characterized by excessive daytime sleepiness, cataplexy, and rapid eye movement (REM) sleep abnormalities. A genome-wide association study (GWAS) identified a novel narcolepsy-related single nucleotide polymorphism (SNP), which is located adjacent to the carnitine palmitoyltransferase 1B (CPT1B) gene encoding an enzyme involved in β-oxidation of long-chain fatty acids. The mRNA expression levels of CPT1B were associated with this SNP. In addition, we recently reported that acylcarnitine levels were abnormally low in narcolepsy patients. To assess the efficacy of oral l-carnitine for the treatment of narcolepsy, we performed a clinical trial administering l-carnitine (510 mg/day) to patients with the disease. The study design was a randomized, double-blind, cross-over and placebo-controlled trial. Thirty narcolepsy patients were enrolled in our study. Two patients were withdrawn and 28 patients were included in the statistical analysis (15 males and 13 females, all with HLA-DQB1*06:02). l-carnitine treatment significantly improved the total time for dozing off during the daytime, calculated from the sleep logs, compared with that of placebo-treated periods. l-carnitine efficiently increased serum acylcarnitine levels, and reduced serum triglycerides concentration. Differences in the Japanese version of the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) vitality and mental health subscales did not reach statistical significance between l-carnitine and placebo. This study suggests that oral l-carnitine can be effective in reducing excessive daytime sleepiness in narcolepsy patients. Trial Registration University hospital Medical Information Network (UMIN) UMIN000003760 PMID:23349733

Combined N-of-1 trials to investigate mexiletine in non-dystrophic myotonia using a Bayesian approach; study rationale and protocol.

PubMed

Stunnenberg, Bas C; Woertman, Willem; Raaphorst, Joost; Statland, Jeffrey M; Griggs, Robert C; Timmermans, Janneke; Saris, Christiaan G; Schouwenberg, Bas J; Groenewoud, Hans M; Stegeman, Dick F; van Engelen, Baziel G M; Drost, Gea; van der Wilt, Gert Jan

2015-03-25

To obtain evidence for the clinical and cost-effectiveness of treatments for patients with rare diseases is a challenge. Non-dystrophic myotonia (NDM) is a group of inherited, rare muscle diseases characterized by muscle stiffness. The reimbursement of mexiletine, the expert opinion drug for NDM, has been discontinued in some countries due to a lack of independent randomized controlled trials (RCTs). It remains unclear however, which concessions can be accepted towards the level 1 evidence needed for coverage decisions, in rare diseases. Considering the large number of rare diseases with a lack of treatment evidence, more experience with innovative trial designs is needed. Both NDM and mexiletine are well suited for an N-of-1 trial design. A Bayesian approach allows for the combination of N-of-1 trials, which enables the assessment of outcomes on the patient and group level simultaneously. We will combine 30 individual, double-blind, randomized, placebo-controlled N-of-1 trials of mexiletine (600 mg daily) vs. placebo in genetically confirmed NDM patients using hierarchical Bayesian modeling. Our results will be compared and combined with the main results of an international cross-over RCT (mexiletine vs. placebo in NDM) published in 2012 that will be used as an informative prior. Similar criteria of eligibility, treatment regimen, end-points and measurement instruments are employed as used in the international cross-over RCT. The treatment of patients with NDM with mexiletine offers a unique opportunity to compare outcomes and efficiency of novel N-of-1 trial-based designs and conventional approaches in producing evidence of clinical and cost-effectiveness of treatments for patients with rare diseases. ClinicalTrials.gov Identifier: NCT02045667.

Stochastic resonance training reduces musculoskeletal symptoms in metal manufacturing workers: a controlled preventive intervention study.

PubMed

Burger, Christian; Schade, Volker; Lindner, Christina; Radlinger, Lorenz; Elfering, Achim

2012-01-01

This study examined the effects of stochastic resonance whole-body vibration training on work-related musculoskeletal symptoms and accidents. Participants were white and blue-collar employees of a Swiss metal manufacturer (N=38), and participation was voluntary. The study was designed as a switching-replications longitudinal trial with randomized group allocation. The randomized controlled cross-over design consisted of two groups each given four weeks of exercise and no intervention during a second four-week period. Outcome was measured on a daily basis with questionnaires. Three components constituted musculoskeletal symptoms: musculoskeletal pain, related function limitations and musculoskeletal well-being. Accidents were assessed by ratings for balance and daily near-accidents. For statistical analysis, a mixed model was calculated. At the end of the training period musculoskeletal pain and related function limitation were significantly reduced, whereas musculoskeletal well-being had significantly increased. For function limitation and musculoskeletal well-being, change over time was linear. There was no effect on balance or near-accidents. Stochastic resonance whole-body vibration was found to be effective in the prevention of work-related musculoskeletal symptoms. It is well suited for the use in a work environment since it requires very little effort in terms of infrastructure, time and investment from participants.

A randomized, controlled trial of bright light therapy for agitated behaviors in dementia patients residing in long-term care.

PubMed

Lyketsos, C G; Lindell Veiel, L; Baker, A; Steele, C

1999-07-01

Agitated behaviors are common in dementia patients residing in chronic care settings. Their occurrence may be associated with lack of adequate exposure to sunlight and with circadian rhythm disturbances. Prior research has suggested that bright light therapy (BLT) may reduce agitated behaviors in dementia patients. The aim of this study was to test the efficacy of BLT in a randomized, controlled, crossover clinical trial. Fifteen patients with dementia and agitated behaviors residing in a chronic care facility were randomized in a crossover design to morning BLT for 1 hour per day or to a control condition with dim light exposure. Patients were treated in either condition for 4 weeks, followed by 1 week on no treatment, prior to being crossed over to the other condition. Eight out of 15 patients completed the entire study. The rest completed at least 2 weeks of study. Patients randomized to the BLT condition exhibited a statistically significant improvement in nocturnal sleep from a mean of 6.4 hours/night to 8.1 hours/night 4 weeks later (p<0.05). The sleep of patients in the control condition did not improve significantly. There were no other significant differences between baseline and follow-up, nor between BLT and control treated patients on the other outcome measures, which included the Behavioral Pathology in Alzheimer Disease scale (Behave-AD) and the Cornell Scale for Depression in Dementia. Patients with dementia in chronic care who exhibit agitated behaviors sleep more hours at night when administered morning BLT. However, BLT does not lead to improvements in agitated behaviors in institutionalized patients with dementia with non-disturbed sleep-wake cycles. Copyright 1999 John Wiley & Sons, Ltd.

Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial.

PubMed

Trimarco, Valentina; Izzo, Raffaele; Stabile, Eugenio; Rozza, Francesco; Santoro, Mario; Manzi, Maria Virginia; Serino, Federica; Schiattarella, Gabriele Giacomo; Esposito, Giovanni; Trimarco, Bruno

2015-06-01

Nutraceuticals (NUT) are forms of compounds with biological activity commonly used to improve health in dosage largely exceeding those obtainable in food. We compared, in a double blind randomized cross-over trial, the effects of two NUT combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins. At study start patients were given dietary counseling and received placebo for 2 weeks. After this run-in period, patients were randomized: (1) Combination A [Policosanol, Red yeast rice (Monakolin K 3 mg), Berberine 500 mg, Astaxantine, Folic Acid and Coenzyme Q10] for 4 weeks followed by 4 weeks of Combination B [Red yeast rice (Monakolin K 3.3 mg), Berberine 531.25 mg and leaf extract of Morus alba]; (2) Combination B for 4 weeks followed by 4 weeks of Combination A. Combination B reduced LDL cholesterol below 130 mg/dl in 56.5 % of the patients, and Cambination A only in 21.7 % of them (p ≤ 0.027). Both treatments reduced plasma levels of triglycerides, total and LDL cholesterol and increased HDL cholesterol (all p < 0.03). Total and LDL cholesterol reduction was more pronounced in patients taking Combination B (p < 0.005). Combination B reduced also glycated hemoglobin, fasting glucose and insulin plasma levels as well as HOMA index (p < 0.005). An increased content of Berberin and Monacolin K and the addition of Morus alba extract improves the effect on plasma cholesterol and on glucose metabolism of the NUT Combination. These effects may allow the speculation of a more marked improvement in cardiovascular prognosis.


Intrathecal analgesia by bupivacaine is not enhanced by coadministration of morphine in patients with severe cancer-related pain: a randomized double-blind cross-over study.

PubMed

Reif, Ingalill; Wincent, Anders; Stiller, Carl-Olav

2017-06-01

The objective of this randomized double blind cross-over trial was to determine if patients with severe cancer-related pain and inadequate response to systemic opioids prefer intrathecal (IT) pain relief with a combination of bupivacaine and morphine or bupivacaine only. Adult patients with cancer-related pain (n = 23) scheduled for IT analgesia at the Pain Center at the Karo-linska University Hospital Solna, Stockholm, Sweden, were included. The optimal individual flow rate of IT bupivacaine (2 mg/mL) in addition to bolus doses was titrated and maintained for 4 days. Morphine (1 mg/mL) was added to bupivacaine either on day 2 or 4 according to a randomization protocol. Expression of pain relief preference for morphine instead of control (bupivacaine only) was the primary outcome. Secondary outcomes were difference in pain intensity, pain relief, total use of bupivacaine per 24 hours and number of requested bolus doses. Eight patients dropped out during the 4-day study period for reasons not related to the trial. IT bupivacaine significantly decreased median (interquartile range) pain intensity from 5 (3 - 7) at baseline (before catheter insertion) to 1 (0 - 1) (p = 0.0001; Wilcoxon test). Only 1 patient of 15 with 4-day data expressed any preference for morphine. The addition of IT morphine did not result in any significant change of pain intensity, pain relief score, total use of bupivacaine per 24 hours, or number of requested bolus doses. These results suggest that patients with cancer-related pain treated with high doses of systemic opioids, may start IT treatment with an optimal dose of IT bupivacaine without morphine.
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Acute electromyographic responses of deep thoracic paraspinal muscles to spinal manual therapy interventions. An experimental, randomized cross-over study.

PubMed

Fryer, Gary; Bird, Michael; Robbins, Barry; Johnson, Jane C

2017-07-01

This single group, randomized, cross-over study explored whether manual therapy alters motor tone of deep thoracic back muscles by examining resting electromyographic activity (EMG) after 2 types of manual therapy and a sham control intervention. Twenty-two participants with thoracic spinal pain (15 females, 7 males, mean age 28.1 ± 6.4 years) had dual fine-wire, intramuscular electrodes inserted into deep transversospinalis muscles at a thoracic level where tissues appeared abnormal to palpation (AbP) and at 2 sites above and below normal and non-tender to palpation (NT). A surface electrode was on the contralateral paraspinal mass at the level of AbP. EMG signals were recorded for resting prone, two 3-s free neck extension efforts, two 3-s resisted maximal voluntary isometric contractions (MVIC), and resting prone before the intervention. Randomized spinal manipulation, counterstrain, or sham manipulation was delivered and EMG re-measured. Participants returned 1 and 2 weeks later for the remaining 2 treatments. Reductions in resting EMG followed counterstrain in AbP (median decrease 3.3%, P = 0.01) and NT sites (median decrease 1.0%, P = 0.05) and for the surface electrode site (median decrease 2.0%, P = 0.009). Reduction in EMG following counterstrain during free neck extension was found for the surface electrode site (median decrease 2.7%, P < 0.01). Spinal manipulation produced no change in EMG, whereas counterstrain technique produced small significant reductions in paraspinal muscle activity during prone resting and free neck extension conditions. The clinical relevance of these changes is unclear. Copyright © 2017 Elsevier Ltd. All rights reserved.

Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study.

PubMed

Ohtsuki, Mamitaro; Kubo, Hiroshi; Morishima, Hitomi; Goto, Ryosuke; Zheng, Richuan; Nakagawa, Hidemi

2018-06-15

Previous global studies of guselkumab have demonstrated clinical benefits in patients with psoriasis. The aim of this 52-week, phase 3 study was to evaluate efficacy and safety of guselkumab in Japanese patients with moderate to severe plaque-type psoriasis. Patients randomly received guselkumab 50 mg or 100 mg at weeks 0, 4 and every 8 weeks, or placebo with cross-over to guselkumab 50 mg or 100 mg at week 16. Co-primary end-points were the proportion of patients achieving Investigator's Global Assessment (IGA) cleared/minimal (0/1) and 90% or more improvement in Psoriasis Area and Severity Index (PASI-90) at week 16. Overall, 192 patients were randomized to placebo, guselkumab 50 mg or 100 mg. At week 16, patients in the placebo group were crossed over to guselkumab 50 mg or 100 mg. At week 16, a significantly (P < 0.001) higher proportion of patients receiving guselkumab 50 mg and 100 mg versus placebo achieved IGA 0/1 (92.3% and 88.9% vs 7.8%) and PASI-90 (70.8% and 69.8% vs 0%). Patients in guselkumab 50 mg and 100 mg groups achieved significant improvement versus placebo in PASI-75 (89.2% and 84.1% vs 6.3%, P < 0.001) at week 16; improvement was maintained through week 52. Incidences of treatment-emergent adverse events were comparable among the groups through week 16; the most commonly reported was nasopharyngitis. No new safety concerns were observed until week 52. In conclusion, guselkumab treatment demonstrated superior efficacy over placebo and was well tolerated in Japanese patients with moderate to severe plaque-type psoriasis. © 2018 Janssen Pharmaceutical K.K. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

Generation of Stationary Non-Gaussian Time Histories with a Specified Cross-spectral Density

DOE PAGES

Smallwood, David O.

1997-01-01

The paper reviews several methods for the generation of stationary realizations of sampled time histories with non-Gaussian distributions and introduces a new method which can be used to control the cross-spectral density matrix and the probability density functions (pdfs) of the multiple input problem. Discussed first are two methods for the specialized case of matching the auto (power) spectrum, the skewness, and kurtosis using generalized shot noise and using polynomial functions. It is then shown that the skewness and kurtosis can also be controlled by the phase of a complex frequency domain description of the random process. The general casemore » of matching a target probability density function using a zero memory nonlinear (ZMNL) function is then covered. Next methods for generating vectors of random variables with a specified covariance matrix for a class of spherically invariant random vectors (SIRV) are discussed. Finally the general case of matching the cross-spectral density matrix of a vector of inputs with non-Gaussian marginal distributions is presented.« less

Circular Data Images for Directional Data

NASA Technical Reports Server (NTRS)

Morpet, William J.

2004-01-01

Directional data includes vectors, points on a unit sphere, axis orientation, angular direction, and circular or periodic data. The theoretical statistics for circular data (random points on a unit circle) or spherical data (random points on a unit sphere) are a recent development. An overview of existing graphical methods for the display of directional data is given. Cross-over occurs when periodic data are measured on a scale for the measurement of linear variables. For example, if angle is represented by a linear color gradient changing uniformly from dark blue at -180 degrees to bright red at +180 degrees, the color image will be discontinuous at +180 degrees and -180 degrees, which are the same location. The resultant color would depend on the direction of approach to the cross-over point. A new graphical method for imaging directional data is described, which affords high resolution without color discontinuity from "cross-over". It is called the circular data image. The circular data image uses a circular color scale in which colors repeat periodically. Some examples of the circular data image include direction of earth winds on a global scale, rocket motor internal flow, earth global magnetic field direction, and rocket motor nozzle vector direction vs. time.

A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): rationale and design.

PubMed

Tsang, Tracey W; Kohn, Michael R; Hermens, Daniel F; Clarke, Simon D; Clark, C Richard; Efron, Daryl; Cranswick, Noel; Lamb, Chris; Williams, Leanne M

2011-03-13

The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant) is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD). The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study. Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment), Session 2 (six weeks, atomoxetine or placebo), and Session 3 (13 weeks, cross-over after one-week washout period). The standardized touch-screen battery, "IntegNeuro™", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo. The methodology for the ACTION study has been detailed. The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD with and without comorbid anxiety. First enrollment was in March 2008. The outcomes of this study will be a significant step towards a 'personalized medicine' (and therefore a more efficient) approach to ADHD treatment. Australian and New Zealand Clinical Trials Registry ANZCTRN12607000535471.

Effect of serving size and addition of sugar on the glycemic response elicited by oatmeal: A randomized, cross-over study.

PubMed

Wolever, Thomas M S; van Klinken, B Jan-Willem; Spruill, Susan E; Jenkins, Alexandra L; Chu, YiFang; Harkness, Laura

2016-12-01

We aimed to determine the impact of serving size and addition of sucrose on the glycemic response elicited by oatmeal. We studied 38 healthy subjects (mean ± SD age 40 ± 12 yr, BMI 26.4 ± 3.6 kg/m 2 ) on 8 separate days using a randomized, cross-over design. Capillary blood-glucose responses over 2hr after consuming 30, 40 and 60 g Classic Quaker Quick Oats (18, 24 and 36 g available-carbohydrate [avCHO], respectively) and 30 g Oats plus 9 g sucrose (27 g avCHO) were compared with those after avCHO-matched servings of Cream of Rice cereal (Control) (22, 29, 44 and 33 g cereal, respectively). Blood-glucose incremental area under the curve (iAUC), peak-rise, rate-of-decline, time-to-peak and time-to-baseline were calculated. As serving size increased, iAUC, peak-rise, rate-of-decline and time-to-baseline increased significantly for both cereals, but the rate of increase was significantly greater for Control than for Oats. Time-to-peak increased significantly with serving size only for Oats. Compared to avCHO-matched servings of Control, mean (95%CI) iAUC, peak-rise and rate-of-decline, respectively were 22 (16, 27)%, 22 (19, 26)% and 23 (18, 27)% lower after consuming Oats without sucrose and 26 (18, 34)%, 14 (9, 20)% and 16 (9, 24)% lower after consuming Oats plus sucrose. Oatmeal elicited a significantly lower glycemic response than avCHO-matched servings of Cream of Rice, even when sucrose was added to the oatmeal. Measures of glycemic response tended to increase with increased serving size; although the pattern of change varied between cereal types. These results suggest that oatmeal may be a good choice for minimizing postprandial glycemia. ClinicalTrials.gov (NCT02506972). Copyright © 2016 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial.

PubMed

Pedersen-Bjergaard, Ulrik; Kristensen, Peter L; Beck-Nielsen, Henning; Nørgaard, Kirsten; Perrild, Hans; Christiansen, Jens S; Jensen, Tonny; Parving, Hans-Henrik; Thorsteinsson, Birger; Tarnow, Lise

2017-01-01

The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4mmol/mol) lower HbA1c. Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p<0.0001)). Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Adult Male Circumcision: Effects on Sexual Function and Sexual Satisfaction in Kisumu, Kenya

PubMed Central

Krieger, John N.; Mehta, Supriya D.; Bailey, Robert C.; Agot, Kawango; Ndinya-Achola, Jeckoniah O.; Parker, Corette; Moses, Stephen

2010-01-01

Introduction Male circumcision is being promoted for HIV prevention in high-risk heterosexual populations. However, there is a concern that circumcision may impair sexual function. Aim To assess adult male circumcision’s effect on men’s sexual function and pleasure. Methods Participants in a controlled trial of circumcision to reduce HIV incidence in Kisumu, Kenya were uncircumcised, HIV negative, sexually active men, aged 18–24 years, with a hemoglobin ≥9.0 mmol/L. Exclusion criteria included foreskin covering less than half the glans, a condition that might unduly increase surgical risks, or a medical indication for circumcision. Participants were randomized 1:1 to either immediate circumcision or delayed circumcision after 2 years (control group). Detailed evaluations occurred at 1, 3, 6, 12, 18, and 24 months. Main Outcome Measures (i) Sexual function between circumcised and uncircumcised men; and (ii) sexual satisfaction and pleasure over time following circumcision. Results Between February 2002 and September 2005, 2,784 participants were randomized, including the 100 excluded from this analysis because they crossed over, were not circumcised within 30 days of randomization, did not complete baseline interviews, or were outside the age range. For the circumcision and control groups, respectively, rates of any reported sexual dysfunction decreased from 23.6% and 25.9% at baseline to 6.2% and 5.8% at month 24. Changes over time were not associated with circumcision status. Compared to before they were circumcised, 64.0% of circumcised men reported their penis was “much more sensitive,” and 54.5% rated their ease of reaching orgasm as “much more” at month 24. Conclusions Adult male circumcision was not associated with sexual dysfunction. Circumcised men reported increased penile sensitivity and enhanced ease of reaching orgasm. These data indicate that integration of male circumcision into programs to reduce HIV risk is unlikely to adversely effect male sexual function. PMID:18761593

Genetic improvement in mastitis resistance: comparison of selection criteria from cross-sectional and random regression sire models for somatic cell score.

PubMed

Odegård, J; Klemetsdal, G; Heringstad, B

2005-04-01

Several selection criteria for reducing incidence of mastitis were developed from a random regression sire model for test-day somatic cell score (SCS). For comparison, sire transmitting abilities were also predicted based on a cross-sectional model for lactation mean SCS. Only first-crop daughters were used in genetic evaluation of SCS, and the different selection criteria were compared based on their correlation with incidence of clinical mastitis in second-crop daughters (measured as mean daughter deviations). Selection criteria were predicted based on both complete and reduced first-crop daughter groups (261 or 65 daughters per sire, respectively). For complete daughter groups, predicted transmitting abilities at around 30 d in milk showed the best predictive ability for incidence of clinical mastitis, closely followed by average predicted transmitting abilities over the entire lactation. Both of these criteria were derived from the random regression model. These selection criteria improved accuracy of selection by approximately 2% relative to a cross-sectional model. However, for reduced daughter groups, the cross-sectional model yielded increased predictive ability compared with the selection criteria based on the random regression model. This result may be explained by the cross-sectional model being more robust, i.e., less sensitive to precision of (co)variance components estimates and effects of data structure.

Development of a cross-over randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods.

PubMed

Dibari, Filippo; Bahwere, Paluku; Huerga, Helena; Irena, Abel Hailu; Owino, Victor; Collins, Steve; Seal, Andrew

2013-01-01

To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg · m(-2), 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries. Copyright © 2013 Elsevier Inc. All rights reserved.

Assessment of Noise and Associated Health Impacts at Selected Secondary Schools in Ibadan, Nigeria

PubMed Central

Ana, Godson R. E. E.; Shendell, Derek G.; Brown, G. E.; Sridhar, M. K. C.

2009-01-01

Background. Most schools in Ibadan, Nigeria, are located near major roads (mobile line sources). We conducted an initial assessment of noise levels and adverse noise-related health and learning effects. Methods. For this descriptive, cross-sectional study, four schools were selected randomly from eight participating in overall project. We administered 200 questionnaires, 50 per school, assessing health and learning-related outcomes. Noise levels (A-weighted decibels, dBA) were measured with calibrated sound level meters. Traffic density was assessed for school with the highest measured dBA. Observational checklists assessed noise control parameters and building physical attributes. Results. Short-term, cross-sectional school-day noise levels ranged 68.3–84.7 dBA. Over 60% of respondents reported that vehicular traffic was major source of noise, and over 70% complained being disturbed by noise. Three schools reported tiredness, and one school lack of concentration, as the most prevalent noise-related health problems. Conclusion. Secondary school occupants in Ibadan, Nigeria were potentially affected by exposure to noise from mobile line sources. PMID:20041025

Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial.

PubMed

Chinwong, Surarong; Chinwong, Dujrudee; Mangklabruks, Ampica

2017-01-01

This open-label, randomized, controlled, crossover trial assessed the effect of daily virgin coconut oil (VCO) consumption on plasma lipoproteins levels and adverse events. The study population was 35 healthy Thai volunteers, aged 18-25. At entry, participants were randomly allocated to receive either (i) 15 mL VCO or (ii) 15 mL 2% carboxymethylcellulose (CMC) solution (as control), twice daily, for 8 weeks. After 8 weeks, participants had an 8-week washout period and then crossed over to take the alternative regimen for 8 weeks. Plasma lipoproteins levels were measured in participants at baseline, week-8, week-16, and week-24 follow-up visits. Results . Of 32 volunteers with complete follow-up (16 males and 16 females), daily VCO intake significantly increased high-density lipoprotein cholesterol by 5.72 mg/dL ( p = 0.001) compared to the control regimen. However, there was no difference in the change in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels between the two regimens. Mild diarrhea was reported by some volunteers when taking VCO, but no serious adverse events were reported. Conclusion . Daily consumption of 30 mL VCO in young healthy adults significantly increased high-density lipoprotein cholesterol. No major safety issues of taking VCO daily for 8 weeks were reported.

Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial

PubMed Central

2017-01-01

This open-label, randomized, controlled, crossover trial assessed the effect of daily virgin coconut oil (VCO) consumption on plasma lipoproteins levels and adverse events. The study population was 35 healthy Thai volunteers, aged 18–25. At entry, participants were randomly allocated to receive either (i) 15 mL VCO or (ii) 15 mL 2% carboxymethylcellulose (CMC) solution (as control), twice daily, for 8 weeks. After 8 weeks, participants had an 8-week washout period and then crossed over to take the alternative regimen for 8 weeks. Plasma lipoproteins levels were measured in participants at baseline, week-8, week-16, and week-24 follow-up visits. Results. Of 32 volunteers with complete follow-up (16 males and 16 females), daily VCO intake significantly increased high-density lipoprotein cholesterol by 5.72 mg/dL (p = 0.001) compared to the control regimen. However, there was no difference in the change in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels between the two regimens. Mild diarrhea was reported by some volunteers when taking VCO, but no serious adverse events were reported. Conclusion. Daily consumption of 30 mL VCO in young healthy adults significantly increased high-density lipoprotein cholesterol. No major safety issues of taking VCO daily for 8 weeks were reported. PMID:29387131

No effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates.

PubMed

Biesiekierski, Jessica R; Peters, Simone L; Newnham, Evan D; Rosella, Ourania; Muir, Jane G; Gibson, Peter R

2013-08-01

Patients with non-celiac gluten sensitivity (NCGS) do not have celiac disease but their symptoms improve when they are placed on gluten-free diets. We investigated the specific effects of gluten after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates (fermentable, oligo-, di-, monosaccharides, and polyols [FODMAPs]) in subjects believed to have NCGS. We performed a double-blind cross-over trial of 37 subjects (aged 24-61 y, 6 men) with NCGS and irritable bowel syndrome (based on Rome III criteria), but not celiac disease. Participants were randomly assigned to groups given a 2-week diet of reduced FODMAPs, and were then placed on high-gluten (16 g gluten/d), low-gluten (2 g gluten/d and 14 g whey protein/d), or control (16 g whey protein/d) diets for 1 week, followed by a washout period of at least 2 weeks. We assessed serum and fecal markers of intestinal inflammation/injury and immune activation, and indices of fatigue. Twenty-two participants then crossed over to groups given gluten (16 g/d), whey (16 g/d), or control (no additional protein) diets for 3 days. Symptoms were evaluated by visual analogue scales. In all participants, gastrointestinal symptoms consistently and significantly improved during reduced FODMAP intake, but significantly worsened to a similar degree when their diets included gluten or whey protein. Gluten-specific effects were observed in only 8% of participants. There were no diet-specific changes in any biomarker. During the 3-day rechallenge, participants' symptoms increased by similar levels among groups. Gluten-specific gastrointestinal effects were not reproduced. An order effect was observed. In a placebo-controlled, cross-over rechallenge study, we found no evidence of specific or dose-dependent effects of gluten in patients with NCGS placed diets low in FODMAPs. Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

Material Hardship and Internal Locus of Control Over the Prevention of Child Obesity in Low-Income Hispanic Pregnant Women.

PubMed

Gross, Rachel S; Mendelsohn, Alan L; Gross, Michelle B; Scheinmann, Roberta; Messito, Mary Jo

2016-07-01

To determine the relations between household material hardships and having a low internal locus of control over the prevention of child obesity in low-income Hispanic pregnant women. We performed a cross-sectional analysis of baseline data collected during a third trimester prenatal visit from women participating in the Starting Early Study, a randomized controlled trial to test the efficacy of a primary care-based family-centered early child obesity prevention intervention. Using multiple logistic regression analyses, we determined whether 4 domains of material hardship (food insecurity, difficulty paying bills, housing disrepair, neighborhood stress), considered individually and also cumulatively, were associated with having a low internal locus of control over the prevention of child obesity. The sample included 559 low-income Hispanic pregnant women, with 60% having experienced at least 1 hardship. Food insecurity was independently associated with a low internal locus of control over the prevention of child obesity (adjusted odds ratio, 2.38; 95% confidence interval, 1.50-3.77), controlling for other hardships and confounders. Experiencing a greater number of material hardships was associated in a dose-dependent relationship with an increased odds of having a low internal locus of control. Prenatal material hardships, in particular food insecurity, were associated with having a lower prenatal internal locus of control over the prevention of child obesity. Longitudinal follow-up of this cohort is needed to determine how relations between material hardships and having a low internal locus of control will ultimately affect infant feeding practices and child weight trajectories. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Psychotherapy Augmentation through Preconscious Priming

PubMed Central

Borgeat, François; O’Connor, Kieron; Amado, Danielle; St-Pierre-Delorme, Marie-Ève

2013-01-01

Objective: To test the hypothesis that repeated preconscious (masked) priming of personalized positive cognitions could augment cognitive change and facilitate achievement of patients’ goals following a therapy. Methods: Twenty social phobic patients (13 women) completed a 36-weeks study beginning by 12 weeks of group behavioral therapy. After the therapy, they received 6 weeks of preconscious priming and 6 weeks of a control procedure in a randomized cross-over design. The Priming condition involved listening twice daily with a passive attitude to a recording of individualized formulations of appropriate cognitions and attitudes masked by music. The Control condition involved listening to an indistinguishable recording where the formulations had been replaced by random numbers. Changes in social cognitions were measured by the Social Interaction Self Statements Test (SISST). Results: Patients improved following therapy. The Priming procedure was associated with increased positive cognitions and decreased negative cognitions on the SISST while the Control procedure was not. The Priming procedure induced more cognitive change when applied immediately after the group therapy. Conclusion: An effect of priming was observed on social phobia related cognitions in the expected direction. This self administered addition to a therapy could be seen as an augmentation strategy. PMID:23508724

An evaluation of the cognitive and mood effects of an energy shot over a 6h period in volunteers: a randomized, double-blind, placebo controlled, cross-over study.

PubMed

Wesnes, Keith A; Barrett, Marilyn L; Udani, Jay K

2013-08-01

Energy drinks are widely available mostly containing glucose, and several have been demonstrated to improve alertness and cognitive function; these effects generally being identified 30-60min after administration. The present study assessed whether an energy shot without carbohydrates would affect major aspects of cognitive function and also mood in volunteers over a 6h time period. This randomized, double-blind, placebo-controlled,crossover study compared the acute effects of the energy shot with a matching placebo in 94 healthy volunteers. Cognitive function was assessed with a widely used set of automated tests of attention and memory. Mood was assessed with the Bond-Lader, Beck Anxiety Index, Beck Depression Index, Chalder Fatigue Scales (CFS), and the POMS. The volunteers were requested to limit their sleep to between 3 and 6h the night before each testing day. Compared to the placebo, the energy shot significantly improved 6 validated composite cognitive function measures from the CDR System as well as self-rated alertness; the benefits on 4 of the cognitive measures still remaining at 6h. The overall effect sizes of the performance improvements were in the small to medium range and thus notable in this field. In conclusion, an energy shot can significantly improve important aspects of cognitive function for up to 6h compared to placebo in partially sleep-deprived healthy volunteers. Copyright © 2013 Elsevier Ltd. All rights reserved.

Combined caffeine and bright light reduces dangerous driving in sleep-deprived healthy volunteers: a pilot cross-over randomised controlled trial.

PubMed

Hartley, S L; Barbot, F; Machou, M; Lejaille, M; Moreau, B; Vaugier, I; Lofaso, F; Quera-Salva, M A

2013-06-01

To explore the effects of caffeine and bright light therapy on simulated nighttime driving in sleep-deprived healthy volunteers. Twelve male healthy volunteers aged 20 to 50 years participated in a randomized cross-over study of simulated nighttime driving at a sleep laboratory, followed by recovery sleep with polysomnography at home. The volunteers received variable combinations of caffeine 200mg (C+), caffeine placebo (C-), bright light 10,000 lux (L+), and bright light placebo<50 lux (L-), in four sessions (C+L+, C+L-, C-L+, C-L-), in random order with a wash-out period of 7 days. Treatments were given at 1 a.m. and testing was performed at 1:30 a.m., 3 a.m., 4 a.m., and 6 a.m. Lane drifting was the primary outcome measure. Other measures were reaction times, self-rated fatigue, sleepiness and recovery sleep. Without treatment, lane drifting increased throughout the night, and objective and subjective vigilance declined. Paired comparisons showed that lane drifting was significantly worse at 6 a.m. and at 4 a.m. than at 1:30 a.m. There was a global treatment effect on lane drifting. Lane drifting at 6 a.m. was significantly decreased with C+L+ compared to C-L-. Bright light therapy combined with caffeine administered at 1 a.m. decreased lane drifting by healthy volunteers during simulated nighttime driving. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Effects of Soy Flour Fortified Bread Consumption on Cardiovascular Risk Factors According to APOE Genotypes in Overweight and Obese Adult Women: A Cross-over Randomized Controlled Clinical Trial

PubMed Central

Sharifi-Zahabi, Elham; Maracy, Mohammad R

2015-01-01

Recent studies suggest that inclusion of soy product in the diet may have favorable effects on relief of cardiovascular diseases (CVDs) and risk factors. These effects might be associated with the presence of specific polymorphism in gene. The aim of this study was to examine the effects of consumption of soy flour fortified bread on cardiovascular risk factors in overweight and obese women according to APOE genotype. In a randomized cross-over clinical trial 30 overweight and obese women received a mild weight loss diet and assigned to a regular diet and a soy bread diet, each for 6 weeks and a washout period for 20 days. Subjects in the soy bread diet were asked to replace 120 grams of their daily usual bread intake with equal amount of soy bread. No significant effects of soy bread on serum lipid, systolic blood pressure and anthropometric indices were observed compared to the regular diet (p > 0.05). For diastolic blood pressure (DBP), comparison of mean differences between two groups showed a marginally significant effect of soy bread (p = 0.06). Compared to regular diet, soy bread had a significant effect on DBP in E2 genotype group (ε2/ε2) (p = 0.03). Having ε2 allele may influences responses of CVD risk factor to soy bread consumption. However more nutrigenetic studies are required. PMID:26566517

Immediate acid-suppressing effects of ranitidine hydrochloride and rabeprazole sodium following initial administration and reintroduction: A randomized, cross-over study using wireless pH monitoring capsules.

PubMed

Ono, Shouko; Kato, Mototsugu; Ono, Yuji; Imai, Aki; Yoshida, Takeshi; Shimizu, Yuichi; Asaka, Masahiro

2009-04-01

Histamine 2 receptor antagonists and proton-pump inhibitors, drugs that are widely used for the treatment of acid-related diseases, have different clinical characteristics. The objective of this study was to compare the acid-suppressing effects of ranitidine hydrochloride and those of rabeprazole sodium at the first administration and re-administration after withdrawal. The study was designed as an open-label, randomized, two-way cross-over trial. Seven Helicobacter pylori-negative healthy volunteers were enrolled in this study. Ranitidine hydrochloride (300 mg/day) or rabeprazole sodium (20 mg/day) was administered from days 1 to 7 and from days 11 to 13. The percentage of time with gastric pH < 4 and the median gastric pH were evaluated for 15 consecutive days by a Bravo capsule fixed to the stomach. On day 1, there was no significant difference between the acid-suppressing effects of the two drugs (ranitidine vs rabeprazole: not significant). Although rabeprazole sodium maintained a potent and stable effect from days 2 to 7 (ranitidine vs rabeprazole: P < 0.05), the effect of ranitidine hydrochloride was attenuated after day 4. In addition, the effect of ranitidine hydrochloride at re-administration was attenuated (days 11, 12, and 13 vs pre-administration: not significant). In view of our observations, we expect symptoms associated with gastric acidity to be more adequately controlled with rabeprazole sodium in the short term when compared to ranitidine hydrochloride.

Effects of Acute Exercise on Resting EEG in Children with Attention-Deficit/Hyperactivity Disorder.

PubMed

Huang, Chung-Ju; Huang, Ching-Wen; Hung, Chiao-Ling; Tsai, Yu-Jung; Chang, Yu-Kai; Wu, Chien-Ting; Hung, Tsung-Min

2018-06-05

This two stage study examined the effects of acute exercise on resting electroencephalographic (EEG) patterns of children with attention-deficit hyperactivity disorder (ADHD). The first stage compared the neural oscillatory patterns of children with and without ADHD. Resting EEGs were recorded under an open-eyes condition from 24 boys with ADHD and 28 matched controls. The second stage of the study employed a randomized cross-over trial design. The 24 boys with ADHD engaged in a 30-min intervention that consisted of either running on a treadmill or watching a video on alternative days, with resting EEGs recorded before and after treatment. The first stage found that children with ADHD exhibited significantly higher theta/beta ratios over the midline electrodes sites than controls. The second stage further indicated that children with ADHD displayed smaller theta/beta ratios following the exercise condition compared with the video-watching condition. This finding suggests that acute exercise normalizes arousal and alertness of children with ADHD, as reflected in resting EEG readings.

Male recombination in Brazilian populations of Drosophila ananassae.

PubMed

Goñi, Beatriz; Matsuda, Muneo; Tobari, Yoshiko N

2016-07-01

With few exceptions, spontaneous crossing over does not normally occur in male Drosophila. Drosophila ananassae males show considerable amounts of crossing over. In wild males of D. ananassae from Asian (2008) and Brazilian populations (1986 and 2007) variable frequencies of meiotic crossing over, estimated from chiasmata counts, suggested the existence of factors controlling male crossing over in these populations. To corroborate for such prediction, we present data on spontaneous recombination in F1 males of D. ananassae heterozygous for chromosomes of the same Brazilian populations (1986) and marker chromosomes using three testers stocks. Mean recombination value was low, although high variability existed between individual frequencies. Recombination frequencies between lines in each tester stock were not significantly different, excepting when the 3ple-px and 3ple-cy testers were compared (p < 0.05). These two testers differ in respect to the regional distribution of crossovers. The occurrence of recombination in chromosomes 2 and 3 in F1 males tested with e(65) se; bri ru was not related, suggesting they are under independent genetic control. Our data are consistent with proposed genetic factors controlling male crossing over in the tester stocks and to the presence of enhancers and suppressors of male crossing over segregating in the Brazilian populations (1986).

Impact of Referral Source and Study Applicants’ Preference for Randomly Assigned Service on Research Enrollment, Service Engagement, and Evaluative Outcomes

PubMed Central

Macias, Cathaleene; Barreira, Paul; Hargreaves, William; Bickman, Leonard; Fisher, William; Aronson, Elliot

2009-01-01

Objective The inability to blind research participants to their experimental conditions is the Achilles’ heel of mental health services research. When one experimental condition receives more disappointed participants, or more satisfied participants, research findings can be biased in spite of random assignment. The authors explored the potential for research participants’ preference for one experimental program over another to compromise the generalizability and validity of randomized controlled service evaluations as well as cross-study comparisons. Method Three Cox regression analyses measured the impact of applicants’ service assignment preference on research project enrollment, engagement in assigned services, and a service-related outcome, competitive employment. Results A stated service preference, referral by an agency with a low level of continuity in outpatient care, and willingness to switch from current services were significant positive predictors of research enrollment. Match to service assignment preference was a significant positive predictor of service engagement, and mismatch to assignment preference was a significant negative predictor of both service engagement and employment outcome. Conclusions Referral source type and service assignment preference should be routinely measured and statistically controlled for in all studies of mental health service effectiveness to provide a sound empirical base for evidence-based practice. PMID:15800153

A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial

PubMed Central

Melzer, Itshak; Elbar, Ori; Tsedek, Irit; Oddsson, Lars IE

2008-01-01

Background Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136). Methods/Design The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65–88) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training). Voluntary step reaction times and postural stability using stabiliogram diffusion analysis will be tested before and after the 12 weeks of training. Discussion This study will determine whether a water-based balance training program that includes perturbation exercises, in a group setting, can improve speed of voluntary stepping responses and improve balance control. Results will help guide the development of more cost-effective interventions that can prevent the occurrence of falls in the elderly. PMID:18706103

Estrogen and cognitive functioning in men with mild cognitive impairment.

PubMed

Sherwin, Barbara B

2002-01-01

Although men do not experience an abrupt cessation of gonadal hormone production at midlife as do women, levels of testosterone (T) decrease gradually with aging. Because estradiol (E2) arises mainly from the conversion of T in men, the availability of E2 also decreases with increasing age. In randomized clinical trials, E2 replacement therapy has been shown to maintain aspects of cognition in postmenopausal women, specifically with regard to verbal memory. The present prospective, randomized, cross-over trial is being undertaken in order to determine whether E2 will enhance verbal memory in men with Mild Cognitive Impairment (MCI). Men with MCI will randomly receive E2 or placebo for the first 3 mo of treatment and will then be crossed-over to the other treatment for an additional 3 mo. A battery of neuropsychological tests will be administered at pretreatment and, again, following each 3-mo treatment phase. It is hypothesized that elderly men with MCI will perform better on tests of explicit memory when they are being treated with E2 compared to their performance under placebo conditions.

Fatal accidents at railway level crossings in Great Britain 1946-2009.

PubMed

Evans, Andrew W

2011-09-01

This paper investigates fatal accidents and fatalities at level crossings in Great Britain over the 64-year period 1946-2009. The numbers of fatal accidents and fatalities per year fell by about 65% in the first half of that period, but since then have remained more or less constant at about 11 fatal accidents and 12 fatalities per year. At the same time other types of railway fatalities have fallen, so level crossings represent a growing proportion of the total. Nevertheless, Britain's level crossing safety performance remains good by international standards. The paper classifies level crossings into three types: railway-controlled, automatic, and passive. The safety performance of the three types of crossings has been very different. Railway-controlled crossings are the best-performing crossing type, with falling fatal accident rates. Automatic crossings have higher accident rates per crossing than railway controlled or passive crossings, and the accident rates have not decreased. Passive crossings are by far the most numerous, but many have low usage by road users. Their fatal accident rate has remained remarkably constant over the whole period at about 0.9 fatal accidents per 1000 crossings per year. A principal reason why fatal accidents and fatalities have not fallen in the second half of the period as they did in the first half is the increase in the number of automatic crossings, replacing the safer railway controlled crossings on some public roads. However, it does not follow that this replacement was a mistake, because automatic crossings have advantages over controlled crossings in reducing delays to road users and in not needing staff. Based on the trends for each type of crossing and for pedestrian and non-pedestrian accidents separately, in 2009 a mean of about 5% of fatal accidents were at railway controlled crossings, 52% were at automatic crossings, and 43% were at passive crossings. Fatalities had similar proportions. About 60% of fatalities were to pedestrians. A simple comparison of automatic railway level crossings and signalised road intersections found that in 2005 the numbers of fatalities per 1000 crossings or intersections were similar. Copyright © 2011 Elsevier Ltd. All rights reserved.

Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients With Chronic Noncancer Pain

PubMed Central

Viscusi, Eugene R.; Barrett, Andrew C.; Paterson, Craig; Forbes, William P.

2016-01-01

Background and Objectives In patients with chronic noncancer pain, subcutaneous methylnaltrexone for opioid-induced constipation (OIC) was examined in a randomized controlled trial (RCT) followed by an open-label extension (OLE). This study examined the reproducibility of RCT findings by analyzing data from placebo-treated patients who crossed over to methylnaltrexone. Methods Adults with less than 3 weekly rescue-free bowel movements (RFBMs), taking 50 mg or more of an oral morphine equivalent per day, were randomized to receive methylnaltrexone 12 mg or placebo for 4 weeks, followed by open-label methylnaltrexone 12 mg as needed for 8 weeks. Results A total of 134 placebo-treated patients (median morphine equivalent dose, 150 mg/d; mean of 1.1 RFBM per week) crossed over to methylnaltrexone in OLE. During the RCT, 9.7% of placebo-treated patients experienced an RFBM within 4 hours of first dose and 9.0% of all placebo injections resulted in an RFBM within 4 hours compared with 45.9% and 34.5%, respectively, with methylnaltrexone treatment in the OLE. When expressed as percentage of patients experiencing 3 or more RFBMs per week and a 1-RFBM increase over baseline, weekly values ranged from 35% to 40% during placebo treatment; at week 5 of OLE methylnaltrexone, this percentage increased to more than 70% and remained relatively stable throughout the OLE. The most common adverse events during methylnaltrexone treatment were abdominal pain (9.7% vs 1.5% for placebo) and nausea (5.2% vs 6.7%). Conclusions Findings during placebo treatment further establish the profile of OIC and support that little or no gastrointestinal tolerance develops across time. Findings under open-label conditions established the reproducibility and durability of methylnaltrexone for OIC. PMID:26650429

Behavior Treatment of Deviant Sex-Role Behaviors in a Male Child.

ERIC Educational Resources Information Center

Rekers, George A.; And Others

This study demonstrated reinforcement control over pronounced feminine behaviors in a male child who had been psychologically evaluated as manifesting "childhood cross-gender identity." Reinforcement control over cross-gender behavior was demonstrated by identifying some behavioral treatment conditions under which feminine behaviors could be…

Random network peristalsis in Physarum polycephalum organizes fluid flows across an individual

PubMed Central

Alim, Karen; Amselem, Gabriel; Peaudecerf, François; Brenner, Michael P.; Pringle, Anne

2013-01-01

Individuals can function as integrated organisms only when information and resources are shared across a body. Signals and substrates are commonly moved using fluids, often channeled through a network of tubes. Peristalsis is one mechanism for fluid transport and is caused by a wave of cross-sectional contractions along a tube. We extend the concept of peristalsis from the canonical case of one tube to a random network. Transport is maximized within the network when the wavelength of the peristaltic wave is of the order of the size of the network. The slime mold Physarum polycephalum grows as a random network of tubes, and our experiments confirm peristalsis is used by the slime mold to drive internal cytoplasmic flows. Comparisons of theoretically generated contraction patterns with the patterns exhibited by individuals of P. polycephalum demonstrate that individuals maximize internal flows by adapting patterns of contraction to size, thus optimizing transport throughout an organism. This control of fluid flow may be the key to coordinating growth and behavior, including the dynamic changes in network architecture seen over time in an individual. PMID:23898203

Random network peristalsis in Physarum polycephalum organizes fluid flows across an individual.

PubMed

Alim, Karen; Amselem, Gabriel; Peaudecerf, François; Brenner, Michael P; Pringle, Anne

2013-08-13

Individuals can function as integrated organisms only when information and resources are shared across a body. Signals and substrates are commonly moved using fluids, often channeled through a network of tubes. Peristalsis is one mechanism for fluid transport and is caused by a wave of cross-sectional contractions along a tube. We extend the concept of peristalsis from the canonical case of one tube to a random network. Transport is maximized within the network when the wavelength of the peristaltic wave is of the order of the size of the network. The slime mold Physarum polycephalum grows as a random network of tubes, and our experiments confirm peristalsis is used by the slime mold to drive internal cytoplasmic flows. Comparisons of theoretically generated contraction patterns with the patterns exhibited by individuals of P. polycephalum demonstrate that individuals maximize internal flows by adapting patterns of contraction to size, thus optimizing transport throughout an organism. This control of fluid flow may be the key to coordinating growth and behavior, including the dynamic changes in network architecture seen over time in an individual.

Use of multispectral satellite remote sensing to assess mixing of suspended sediment downstream of large river confluences

NASA Astrophysics Data System (ADS)

Umar, M.; Rhoads, Bruce L.; Greenberg, Jonathan A.

2018-01-01

Although past work has noted that contrasts in turbidity often are detectable on remotely sensed images of rivers downstream from confluences, no systematic methodology has been developed for assessing mixing over distance of confluent flows with differing surficial suspended sediment concentrations (SSSC). In contrast to field measurements of mixing below confluences, satellite remote-sensing can provide detailed information on spatial distributions of SSSC over long distances. This paper presents a methodology that uses remote-sensing data to estimate spatial patterns of SSSC downstream of confluences along large rivers and to determine changes in the amount of mixing over distance from confluences. The method develops a calibrated Random Forest (RF) model by relating training SSSC data from river gaging stations to derived spectral indices for the pixels corresponding to gaging-station locations. The calibrated model is then used to predict SSSC values for every river pixel in a remotely sensed image, which provides the basis for mapping of spatial variability in SSSCs along the river. The pixel data are used to estimate average surficial values of SSSC at cross sections spaced uniformly along the river. Based on the cross-section data, a mixing metric is computed for each cross section. The spatial pattern of change in this metric over distance can be used to define rates and length scales of surficial mixing of suspended sediment downstream of a confluence. This type of information is useful for exploring the potential influence of various controlling factors on mixing downstream of confluences, for evaluating how mixing in a river system varies over time and space, and for determining how these variations influence water quality and ecological conditions along the river.

Aceneuramic Acid Extended Release Administration Maintains Upper Limb Muscle Strength in a 48-week Study of Subjects with GNE Myopathy: Results from a Phase 2, Randomized, Controlled Study.

PubMed

Argov, Zohar; Caraco, Yoseph; Lau, Heather; Pestronk, Alan; Shieh, Perry B; Skrinar, Alison; Koutsoukos, Tony; Ahmed, Ruhi; Martinisi, Julia; Kakkis, Emil

2016-03-03

GNE Myopathy (GNEM) is a progressive adult-onset myopathy likely caused by deficiency of sialic acid (SA) biosynthesis. Evaluate the safety and efficacy of SA (delivered by aceneuramic acid extended-release [Ace-ER]) as treatment for GNEM. A Phase 2, randomized, double-blind, placebo-controlled study evaluating Ace-ER 3 g/day or 6 g/day versus placebo was conducted in GNEM subjects (n = 47). After the first 24 weeks, placebo subjects crossed over to 3 g/day or 6 g/day for 24 additional weeks (dose pre-assigned during initial randomization). Assessments included serum SA, muscle strength by dynamometry, functional assessments, clinician- and patient-reported outcomes, and safety. Dose-dependent increases in serum SA levels were observed. Supplementation with Ace-ER resulted in maintenance of muscle strength in an upper extremity composite (UEC) score at 6 g/day compared with placebo at Week 24 (LS mean difference +2.33 kg, p = 0.040), and larger in a pre-specified subgroup able to walk ≥200 m at Screening (+3.10 kg, p = 0.040). After cross-over, a combined 6 g/day group showed significantly better UEC strength than a combined 3 g/day group (+3.46 kg, p = 0.0031). A similar dose-dependent response was demonstrated within the lower extremity composite score, but was not significant (+1.06 kg, p = 0.61). The GNEM-Functional Activity Scale demonstrated a trend improvement in UE function and mobility in a combined 6 g/day group compared with a combined 3 g/day group. Patients receiving Ace-ER tablets had predominantly mild-to-moderate AEs and no serious adverse events. This is the first clinical study to provide evidence that supplementation with SA delivered by Ace-ER may stabilize muscle strength in individuals with GNEM and initiating treatment earlier in the disease course may lead to better outcomes.

Aceneuramic Acid Extended Release Administration Maintains Upper Limb Muscle Strength in a 48-week Study of Subjects with GNE Myopathy: Results from a Phase 2, Randomized, Controlled Study

PubMed Central

Argov, Zohar; Caraco, Yoseph; Lau, Heather; Pestronk, Alan; Shieh, Perry B.; Skrinar, Alison; Koutsoukos, Tony; Ahmed, Ruhi; Martinisi, Julia; Kakkis, Emil

2016-01-01

Background: GNE Myopathy (GNEM) is a progressive adult-onset myopathy likely caused by deficiency of sialic acid (SA) biosynthesis. Objective: Evaluate the safety and efficacy of SA (delivered by aceneuramic acid extended-release [Ace-ER]) as treatment for GNEM. Methods: A Phase 2, randomized, double-blind, placebo-controlled study evaluating Ace-ER 3 g/day or 6 g/day versus placebo was conducted in GNEM subjects (n = 47). After the first 24 weeks, placebo subjects crossed over to 3 g/day or 6 g/day for 24 additional weeks (dose pre-assigned during initial randomization). Assessments included serum SA, muscle strength by dynamometry, functional assessments, clinician- and patient-reported outcomes, and safety. Results: Dose-dependent increases in serum SA levels were observed. Supplementation with Ace-ER resulted in maintenance of muscle strength in an upper extremity composite (UEC) score at 6 g/day compared with placebo at Week 24 (LS mean difference +2.33 kg, p = 0.040), and larger in a pre-specified subgroup able to walk ≥200 m at Screening (+3.10 kg, p = 0.040). After cross-over, a combined 6 g/day group showed significantly better UEC strength than a combined 3 g/day group (+3.46 kg, p = 0.0031). A similar dose-dependent response was demonstrated within the lower extremity composite score, but was not significant (+1.06 kg, p = 0.61). The GNEM-Functional Activity Scale demonstrated a trend improvement in UE function and mobility in a combined 6 g/day group compared with a combined 3 g/day group. Patients receiving Ace-ER tablets had predominantly mild-to-moderate AEs and no serious adverse events. Conclusions: This is the first clinical study to provide evidence that supplementation with SA delivered by Ace-ER may stabilize muscle strength in individuals with GNEM and initiating treatment earlier in the disease course may lead to better outcomes. PMID:27854209

Postprandial serum endotoxin in healthy humans is modulated by dietary fat in a randomized, controlled, cross-over study.

PubMed

Lyte, Joshua M; Gabler, Nicholas K; Hollis, James H

2016-11-05

High-fat diets may contribute to metabolic disease via postprandial changes in serum endotoxin and inflammation. It is unclear how dietary fat composition may alter these parameters. We hypothesized that a meal rich in n-3 (ω3) fatty acids would reduce endotoxemia and associated inflammation but a saturated or n-6 (ω6) fatty acid-rich meal would increase postprandial serum endotoxin concentrations and systemic inflammation in healthy adults. Healthy adults (n = 20; mean age 25 ± 3.2 S.D. years) were enrolled in this single-blind, randomized, cross-over study. Participants were randomized to treatment and reported to the laboratory, after an overnight fast, on four occasions separated by at least one week. Participants were blinded to treatment meal and consumed one of four isoenergetic meals that provided: 1) 20 % fat (control; olive oil) or 35 % fat provided from 2) n-3 (ω3) (DHA = 500 mg; fish oil); 3) n-6 (ω6) (7.4 g; grapeseed oil) or 4) saturated fat (16 g; coconut oil). Baseline and postprandial blood samples were collected. Primary outcome was defined as the effect of treatment meal on postprandial endotoxemia. Serum was analyzed for metabolites, inflammatory markers, and endotoxin. Data from all 20 participants were analyzed using repeated-measures ANCOVA. Participant serum endotoxin concentration was increased during the postprandial period after the consumption of the saturated fat meal but decreased after the n-3 meal (p < 0.05). The n-6 meal did not effect a different outcome in participant postprandial serum endotoxin concentration from that of the control meal (p > 0.05). There was no treatment meal effect on participant postprandial serum biomarkers of inflammation. Postprandial serum triacylglycerols were significantly elevated following the n-6 meal compared to the n-3 meal. Non-esterified fatty acids were significantly increased after consumption of the saturated fat meal compared to other treatment meals. Meal fatty acid composition modulates postprandial serum endotoxin concentration in healthy adults. However, postprandial endotoxin was not associated with systemic inflammation in vivo. This study was retrospectively registered at clinicaltrials.gov as NCT02521779 on July 28, 2015.

Effects of guar gum ingestion on postprandial blood pressure in older adults.

PubMed

Jang, A L; Hwang, S K; Kim, D U

2015-03-01

The aim of this study was to investigate the effects of guar gum on postprandial blood pressure in older people. A randomized, double-blind, placebo-controlled, cross-over design. Community senior centers in B city, South Korea. Twenty-two older female adults aged 67 to 88 with postprandial hypotension. The participants were randomly assigned to guar gum (semi-fluid food with 9 gram) or placebo intervention during the first treatment phase. After a washout period of 1 week, the two interventions were switched to the other in the second treatment phase. Blood pressure was measured during both phases before having a meal and every 15 minutes during 120 minutes after a meal with automated sphygmomanometer. Change in systolic blood pressure (SBP) over time was significantly different between guar gum and placebo groups (F=4.07, p=0.001). Compared with placebo group, guar gum group had significantly low prevalence of postprandial hypotension (PPH) (guar gum group=18.2% vs. placebo group=72.7%; χ² =13.20, p<0.001). It also had significant difference in change of diastolic blood pressure (DBP) over time between guar gum and placebo groups (F=2.49, p=0.027). This findings show that guar gum could be effective on postprandial drops in blood pressure in older female adults.

Effects of 7.5% CO2 challenge in generalized anxiety disorder.

PubMed

Seddon, Kate; Morris, Kelly; Bailey, Jayne; Potokar, John; Rich, Ann; Wilson, Sue; Bettica, Paolo; Nutt, David J

2011-01-01

We have previously developed a putative model of generalized anxiety disorder in healthy volunteers using a 20-minute 7.5% carbon dioxide (CO(2)) inhalation challenge. The aim of this study was to validate the 7.5% CO(2) paradigm by assessing its effects in patients with generalized anxiety disorder in a test-retest design. Twelve medication-free generalized anxiety disorder patients attended our lab for two study days. On each study day placebo (compressed air) and 7.5% CO(2) mixture were randomly administered over 20 min, at least 30 min apart, in a single blind, randomized, placebo-controlled cross-over design. Subjective ratings, cardiovascular measures and cortisol levels were collected throughout. CO(2) challenge significantly increased ratings for anxiety and other subjective symptoms associated with generalized anxiety disorder, compared with air. It also significantly increased systolic blood pressure on day 2, indicating increased autonomic arousal. There was no change between the two test days in mean anxiety rating scores, and there also appeared to be a correlation for individual scores on a number of the subjective measures. In conclusion, 20 min of 7.5% CO(2) gas inhalation increases anxiety responses in patients with generalized anxiety disorder, and this is reliable over time.

A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

PubMed

Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A

2016-08-01

Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

Economic evaluation of a randomized controlled trial of pharmacist-supervized patient self-testing of warfarin therapy.

PubMed

Gallagher, J; Mc Carthy, S; Woods, N; Ryan, F; O' Shea, S; Byrne, S

2015-02-01

The increase in numbers of patients requiring oral anti-coagulation testing in outpatient clinics has focused attention on alternative flexible systems of anti-coagulation management. One option is pharmacist led patient self-testing (PST) of international normalised ratio (INR) levels. PST has demonstrated improvements in anti-coagulation control, but its cost-effectiveness is inconclusive. This study reports the first cost-effectiveness evaluation of a randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on oral anti-coagulation therapy. We conducted an economic evaluation alongside a randomised controlled trial investigating a pharmacist led PST method. The primary outcome was to determine the cost effectiveness of PST in comparison with usual care (management in a hospital based anti-coagulation clinic). Long term anti-coagulation patients were recruited to a 6 month cross over study between PST and routine care in an anti-coagulation clinic. Economic evaluation was from the healthcare payer perspective. On a per patient basis over a 6 month period, PST resulted in an incremental cost of €59.08 in comparison with routine care. Patients achieved a significantly higher time in therapeutic range (TTR) during the PST arm in comparison with routine care, (72 ± 19.7% vs. 59 ± 13.5%). Overall cost of managing a patient through pharmacist supervised PST for a 6 month period is €226.45. Additional analysis of strategies from a societal perspective indicated that PST was the dominant strategy. Pharmacist led patient self-testing is a viable method of management. It provides significant increases in anti-coagulation control for a minimal increase in cost. © 2014 John Wiley & Sons Ltd.

Simvastatin Treatment Does Not Affect Serum Vitamin D Concentrations in Patients with Dyslipidemia: A Randomized Double-blind Placebo-controlled Cross-over Trial.

PubMed

Mazidi, Mohsen; Rokni, Haleh; Sahebkar, Amir Hossein; Mohammadi, Akram; Ghayour-Mobarhan, Majid; Ferns, Gordon A

2016-01-01

Hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) are antihyperlipidemic drugs with an established efficacy in stabilizing atherosclerotic plaques and preventing atherogenesis and reducing cardiovascular events. The purpose of this study was to determine the effect of simvastatin on serum Vitamin D status in dyslipidemic patients as Vitamin D status has an impact on monocyte/macrophage function and may also contribute to cardiovascular risk. Selected individuals (n = 102) were treated with simvastatin (40 mg/day), or matching placebo in a randomized, double-blind, placebo-controlled, crossover trial. Each treatment period (with simvastatin or placebo) lasted for 30 days and was separated by a 2-week washout phase. Serum Vitamin D concentration was assessed pre- and post-treatment. Seventy-seven completed the trial, noncompliance with the study protocol and drug intolerance or relocation were the causes for drop-out. No significant carry-over effect was observed for the assessed parameters. There was a reduction in the serum levels of low-density lipoprotein cholesterol (P < 0.001), total cholesterol (P < 0.001), and triglycerides (P < 0.05). Nevertheless, simvastatin therapy did not significantly affect serum level of high-density lipoprotein cholesterol and Vitamin D level (P > 0.05). Short-term treatment with simvastatin (40 mg/day) does not have a significant affect on serum levels of Vitamin D.

Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

PubMed

Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

2017-09-01

To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial.

PubMed

Austin, Matthew S; Urbani, Brian T; Fleischman, Andrew N; Fernando, Navin D; Purtill, James J; Hozack, William J; Parvizi, Javad; Rothman, Richard H

2017-04-19

The value of formal physical therapy after total hip arthroplasty is unknown. With substantial changes that have occurred in surgical and anesthesia techniques, self-directed therapy may be efficacious in restoring function to patients undergoing total hip arthroplasty. We conducted a single-center, randomized trial of 120 patients undergoing primary, unilateral total hip arthroplasty who were eligible for direct home discharge. The experimental group followed a self-directed home exercise program for 10 weeks. The control group received the standard protocol for physical therapy that included in-home visits with a physical therapist for the first 2 weeks followed by formal outpatient physical therapy for 8 weeks. Functional outcomes were measured using validated instruments including the Harris hip score (HHS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) preoperatively, at 1 month postoperatively, and at 6 to 12 months postoperatively. Of 120 randomized patients, 108 were included in the final analysis. Ten patients (19%) were randomized to unsupervised home exercise and 20 patients (37%) were randomized to formal outpatient therapy crossed over between groups. There was no significant difference in any of the measured functional outcomes between patients receiving formal therapy (n = 54) and those participating in unsupervised home exercise (n = 54) at any time point (HHS, p = 0.82; WOMAC, p = 0.80; and SF-36 physical health, p = 0.90). This randomized trial suggests that unsupervised home exercise is both safe and efficacious for a majority of patients undergoing total hip arthroplasty, and formal physical therapy may not be required. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

The effect of a cinnamon-, chromium- and magnesium-formulated honey on glycaemic control, weight loss and lipid parameters in type 2 diabetes: an open-label cross-over randomised controlled trial.

PubMed

Whitfield, Patricia; Parry-Strong, Amber; Walsh, Emily; Weatherall, Mark; Krebs, Jeremy D

2016-04-01

This randomised controlled trial assessed the acute and long-term effects of daily supplementation of kanuka honey, formulated with cinnamon, chromium and magnesium on glucose metabolism, weight and lipid parameters in individuals with type 2 diabetes. Twelve individuals with type 2 diabetes received 53.5 g of a formulated honey and a control (non-formulated) kanuka honey in a random order for 40 days, using cross-over design. Fasting glucose, insulin, HbA1c, lipids and anthropometric measures were measured at baseline and end of treatment. A meal tolerance test was performed at baseline to assess acute metabolic response. There was no statistically significant difference in acute glucose metabolism between treatment groups, as measured by the Matsuda index and AUC for glucose and insulin. After the 40-day intervention with honey, fasting glucose did not differ significantly between the two treatments (95 % CI -2.6 to 0.07). There was no statistically significant change in HbA1c or fasting insulin. There was a statistically significant reduction in total cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23), LDL cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23) and weight by -2.2 kg (95 % CI -4.2 to -0.1). There was a trend towards increased HDL and reduced systolic blood pressure in the intervention treatment. The addition of cinnamon, chromium and magnesium supplementation to kanuka honey was not associated with a significant improvement in glucose metabolism or glycaemic control in individuals with type 2 diabetes. Use of the formulated honey was associated with a reduction in weight and improvements in lipid parameters, and should be investigated further.

L-theanine and caffeine improve task switching but not intersensory attention or subjective alertness.

PubMed

Einöther, Suzanne J L; Martens, Vanessa E G; Rycroft, Jane A; De Bruin, Eveline A

2010-04-01

Tea ingredients L-theanine and caffeine have repeatedly been shown to deliver unique cognitive benefits when consumed in combination. The current randomized, placebo-controlled, double-blind, cross-over study compared a combination of L-theanine (97 mg) and caffeine (40 mg) to a placebo on two attention tasks and a self-report questionnaire before, and 10 and 60 min after consumption. The combination of L-theanine and caffeine significantly improved attention on a switch task as compared to the placebo, while subjective alertness and intersensory attention were not improved significantly. The results support previous evidence that L-theanine and caffeine in combination can improve attention. Copyright 2010 Elsevier Ltd. All rights reserved.

Effects of a 6-month multimodal training intervention on retention of functional fitness in older adults: a randomized-controlled cross-over design.

PubMed

Gudlaugsson, Janus; Gudnason, Vilmundur; Aspelund, Thor; Siggeirsdottir, Kristin; Olafsdottir, Anna S; Jonsson, Palmi V; Arngrimsson, Sigurbjorn A; Harris, Tamara B; Johannsson, Erlingur

2012-09-10

Older adults have the highest rates of disability, functional dependence and use of healthcare resources. Training interventions for older individuals are of special interest where regular physical activity (PA) has many health benefits. The main purpose of this study was to assess the immediate and long-term effects of a 6-month multimodal training intervention (MTI) on functional fitness in old adults. For this study, 117 participants, 71 to 90 years old, were randomized in immediate intervention group and a control group (delayed intervention group). The intervention consisted of daily endurance and twice-a-week strength training. The method was based on a randomized-controlled cross-over design. Short Physical Performance Battery (SPPB), 8 foot up-and-go test, strength performance, six min walking test (6 MW), physical activity, BMI and quality of life were obtained at baseline, after a 6-month intervention- and control phase, again after 6-month crossover- and delayed intervention phase, and after anadditional 6-month follow-up. After 6 months of MTI, the intervention group improved in physical performance compared with the control group via Short Physical Performance Battery (SPPB) score (mean diff = 0.6, 95 % CI: 0.1, 1.0) and 8-foot up-and-go test (mean diff = -1.0 s, 95 % CI: -1.5, -0.6), and in endurance performance via 6-minute walking test (6 MW) (mean diff = 44.2 meters, 95 % CI: 17.1, 71.2). In strength performance via knee extension the intervention group improved while control group declined (mean diff = 55.0 Newton, 95 % CI: 28.4, 81.7), and also in PA (mean diff = 125.9 cpm, 95 % CI: 96.0, 155.8). Long-term effects of MTI on the particpants was assesed by estimating the mean difference in the variables measured between time-point 1 and 4: SPPB (1.1 points, 95 % CI: 0.8, 1.4); 8-foot up-and-go (-0.9 s, 95 % CI: -1.2, -0.6); 6 MW (18.7 m, 95 % CI: 6.5, 31.0); knee extension (4.2 Newton, 95 % CI: -10.0, 18.3); hand grip (6.7 Newton, 95 % CI: -4.4, 17.8); PA (-4.0 cpm, 95 % CI: -33.9, 26.0); BMI (-0.6 kg/m2, 95 % CI: -0.9, -0.3) and Icelandic quality of life (0.3 points, 95 % CI: -0.7, 1.4). Our results suggest that regular MTI can improve and prevent decline in functional fitness in older individuals, influence their lifestyle and positively affect their ability to stay independent, thus reducing the need for institutional care. This study was approved by the National Bioethics Committee in Iceland, VSNb20080300114/03-1.

Treatment of asthma patients with herbal medicine TJ-96: a randomized controlled trial.

PubMed

Urata, Y; Yoshida, S; Irie, Y; Tanigawa, T; Amayasu, H; Nakabayashi, M; Akahori, K

2002-06-01

Alternative medicine use has increased at a remarkable pace all over the world in recent years. Although herbal medicine for the treatment of asthma is becoming the focus of public attention, randomized studies had not been performed, even in Eastern countries including Japan. This study was designed to investigate whether one of the Japanese government approved herbal complexes Saiboku-to (TJ-96) is effective for the treatment of atopic asthma, and to investigate whether this protective activity is associated with a reduction in eosinophilic inflammation. A double-blind, randomized, crossover design was used. Subjects received 2.5 g of TJ-96 or placebo orally 3 times daily for 4 weeks and then, after a washout period of at least 4 weeks, crossed over to receive the alternative treatment. We assessed the effects of pretreatment with TJ-96 on bronchoconstriction precipitated by inhalation of methacholine. Furthermore, eosinophil counts and measurement of eosinophilic cationic protein (ECP) were performed. After 4 weeks of treatment with TJ-96, values of PC20 -methacholine significantly improved in the treatment with TJ-96. Also, patients' symptoms, blood eosinophils, serum ECP, sputum eosinophils, and sputum ECP were significantly decreased. Our results suggest that TJ-96 has an antiinflammatory effect on bronchial eosinophilic infiltration. This study raises further interesting therapeutic possibilities and argues for further trials of new approaches to the treatment of asthma.

Characterization of addressability by simultaneous randomized benchmarking.

PubMed

Gambetta, Jay M; Córcoles, A D; Merkel, S T; Johnson, B R; Smolin, John A; Chow, Jerry M; Ryan, Colm A; Rigetti, Chad; Poletto, S; Ohki, Thomas A; Ketchen, Mark B; Steffen, M

2012-12-14

The control and handling of errors arising from cross talk and unwanted interactions in multiqubit systems is an important issue in quantum information processing architectures. We introduce a benchmarking protocol that provides information about the amount of addressability present in the system and implement it on coupled superconducting qubits. The protocol consists of randomized benchmarking experiments run both individually and simultaneously on pairs of qubits. A relevant figure of merit for the addressability is then related to the differences in the measured average gate fidelities in the two experiments. We present results from two similar samples with differing cross talk and unwanted qubit-qubit interactions. The results agree with predictions based on simple models of the classical cross talk and Stark shifts.

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Active control of the forced and transient response of a finite beam. M.S. Thesis

NASA Technical Reports Server (NTRS)

Post, John T.

1990-01-01

Structural vibrations from a point force are modelled on a finite beam. This research explores the theoretical limit on controlling beam vibrations utilizing another point source as an active controller. Three different types of excitation are considered, harmonic, random, and transient. For harmonic excitation, control over the entire beam length is possible only when the excitation frequency is near a resonant frequency of the beam. Control over a subregion may be obtained even between resonant frequencies at the cost of increasing the vibration outside of the control region. For random excitation, integrating the expected value of the displacement squared over the required interval, is shown to yield the identical cost function as obtained by integrating the cost function for harmonic excitation over all excitation frequencies. As a result, it is always possible to reduce the cost function for random excitation whether controlling the entire beam or just a subregion, without ever increasing the vibration outside the region in which control is desired. The last type of excitation considered is a single, transient pulse. The form of the controller is specified as either one or two delayed pulses, thus constraining the controller to be casual. The best possible control is examined while varying the region of control and the controller location. It is found that control is always possible using either one or two control pulses.

Influence of Caffeine Ingestion on Perceived Mood States, Concentration, and Arousal Levels during a 75-Min University Lecture

ERIC Educational Resources Information Center

Peeling, Peter; Dawson, Brian

2007-01-01

This investigation aimed to assess the effect of a caffeine supplement on perceived mood state, concentration, and arousal during a 75-min university lecture. Methods. This randomized, blind, cross-over design investigation ran over a course of 2 consecutive weeks. During "week" 1, 10 third-year Human Movement and Exercise Science…

Morphological hippocampal markers for automated detection of Alzheimer's disease and mild cognitive impairment converters in magnetic resonance images.

PubMed

Ferrarini, Luca; Frisoni, Giovanni B; Pievani, Michela; Reiber, Johan H C; Ganzola, Rossana; Milles, Julien

2009-01-01

In this study, we investigated the use of hippocampal shape-based markers for automatic detection of Alzheimer's disease (AD) and mild cognitive impairment converters (MCI-c). Three-dimensional T1-weighted magnetic resonance images of 50 AD subjects, 50 age-matched controls, 15 MCI-c, and 15 MCI-non-converters (MCI-nc) were taken. Manual delineations of both hippocampi were obtained from normalized images. Fully automatic shape modeling was used to generate comparable meshes for both structures. Repeated permutation tests, run over a randomly sub-sampled training set (25 controls and 25 ADs), highlighted shape-based markers, mostly located in the CA1 sector, which consistently discriminated ADs and controls. Support vector machines (SVMs) were trained, using markers from either one or both hippocampi, to automatically classify control and AD subjects. Leave-1-out cross-validations over the remaining 25 ADs and 25 controls resulted in an optimal accuracy of 90% (sensitivity 92%), for markers in the left hippocampus. The same morphological markers were used to train SVMs for MCI-c versus MCI-nc classification: markers in the right hippocampus reached an accuracy (and sensitivity) of 80%. Due to the pattern recognition framework, our results statistically represent the expected performances of clinical set-ups, and compare favorably to analyses based on hippocampal volumes.

The effect of sitting and calf activity on leg fluid and snoring.

PubMed

Singh, Bhajan; Yadollahi, Azadeh; Lyons, Owen; Alshaer, Hisham; Bradley, T Douglas

2017-06-01

Prolonged sitting may promote leg fluid retention that redistributes to the neck during sleep and contributes to snoring. This could be attenuated by calf activity while sitting. In 16 healthy non-obese subjects we measured leg fluid volume (LFV) below the knees using bioelectrical impedance while sitting for 4h, snoring using a portable BresoDx™ device, and Mallampati grade. Using a double cross-over study design, subjects were randomized to one of two arms and crossed-over one week later: control arm - no calf exercise while sitting; intervention arm - calf contraction against a pedal resistance while sitting. The effects of sitting±calf activity on LFV and snoring were compared. We found that LFV increased by 216±101.0ml (p<0.0001) after sitting. Calf activity while sitting attenuated LFV by 53.8ml (p<0.0001) and, in all five subjects with severe upper airway narrowing (Mallampati grade IV), reduced snoring duration (from 357±132.9 to 116.2±72.1s/h, p=0.02) suggesting reduced overnight rostral fluid shift to the neck. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of a multivitamin/multimineral supplement on young males with physical overtraining: a placebo-controlled, randomized, double-blinded cross-over trial.

PubMed

Li, Xin; Huang, Wen Xu; Lu, Ju Ming; Yang, Guang; Ma, Fang Ling; Lan, Ya Ting; Meng, Jun Hua; Dou, Jing Tao

2013-07-01

To investigate the effects of vitamin-mineral supplement on young males with physical overtraining. Two hundred and forty male Chinese field artillery personnel who undertook large scale and endurance military training and were on ordinary Chinese diet were randomized to receive a multivitamin/multimineral supplement or a placebo for 1 week. After a 1-week wash-out period, a cross-over with 1 week course of a placebo or multivitamin/multimineral supplement was conducted. Blood and urine samples were analyzed for adrenal, gonadal and thyroid hormones. In addition, cellular immune parameters (CD3+, CD3+CD4+, CD3+CD8+, CD4/CD8, CD3-CD56+, CD3-CD19+) were examined and psychological tests were performed before and after the training program and nutrition intervention. After a large scale and endurance military training, the participants showed significantly increased thyroid function, decreased adrenal cortex, testosterone and immunological function, and significantly increased somatization, anger and tension. Compared to placebo, multivitamin/ multimineral intervention showed significant effects on functional recovery of the pituitary - adrenal axis, pituitary-gonadal axis, pituitary- thyroid axis and immune system as well as psychological parameters. High-intensity military operations have significant impacts on the psychology, physical ability and neuroendocrine-immune system in young males. Appropriate supplementation of multivitamin/multimineral can facilitate the recovery of the psychology, physical ability and neuroendocrine-immune system in young males who take ordinary Chinese diet. Copyright © 2013 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

Glycemic Response to Black Beans and Chickpeas as Part of a Rice Meal: A Randomized Cross-Over Trial.

PubMed

Winham, Donna M; Hutchins, Andrea M; Thompson, Sharon V

2017-10-04

Legumes, such as black beans ( Phaseolus vulgaris L.) and chickpeas ( Cicer arietinum L.), have a low glycemic index, and may reduce the glycemic load of meals in which they are included. Although the low glycemic response of beans consumed alone has been documented, few studies have examined the glycemic response to traditional food combinations such as black beans and rice or chickpeas and rice. This randomized cross-over study examined the glycemic and insulinemic impact of 50 grams of available carbohydrate from three test meals: plain white rice (control), black beans with rice, and chickpeas with rice among healthy adult women ( n = 12, 18-65 years). Treatments were consumed on different mornings, a minimum of 7 days apart. Blood samples were collected at time 0 (fasting), and at 30, 60, 90, and 120 min postprandial, and were subsequently analyzed for glucose and insulin concentrations. Glucose response based on the incremental area under the curve showed a significant difference by treatment ( p = 0.027). Changes in blood glucose concentrations were significantly different for the black bean meal and the chickpea meal in comparison to rice alone at 60 min ( p = 0.026 and p = 0.024), 90 min ( p = 0.001 and p = 0.012) and 120 min post prandial ( p = 0.024; black bean meal). Findings indicate that combinations of black beans and chickpeas with white rice improve glycemic response, providing evidence that has promising implications for dietary guidance to reduce postprandial glucose and related health risks through traditional food patterns.

Use of remote sensing to identify spatial risk factors for malaria in a region of declining transmission: a cross-sectional and longitudinal community survey.

PubMed

Moss, William J; Hamapumbu, Harry; Kobayashi, Tamaki; Shields, Timothy; Kamanga, Aniset; Clennon, Julie; Mharakurwa, Sungano; Thuma, Philip E; Glass, Gregory

2011-06-10

The burden of malaria has decreased dramatically within the past several years in parts of sub-Saharan Africa. Further malaria control will require targeted control strategies based on evidence of risk. The objective of this study was to identify environmental risk factors for malaria transmission using remote sensing technologies to guide malaria control interventions in a region of declining burden of malaria. Satellite images were used to construct a sampling frame for the random selection of households enrolled in prospective longitudinal and cross-sectional surveys of malaria parasitaemia in Southern Province, Zambia. A digital elevation model (DEM) was derived from the Shuttle Radar Topography Mission version 3 DEM and used for landscape characterization, including landforms, elevation, aspect, slope, topographic wetness, topographic position index and hydrological models of stream networks. A total of 768 individuals from 128 randomly selected households were enrolled over 21 months, from the end of the rainy season in April 2007 through December 2008. Of the 768 individuals tested, 117 (15.2%) were positive by malaria rapid diagnostic test (RDT). Individuals residing within 3.75 km of a third order stream were at increased risk of malaria. Households at elevations above the baseline elevation for the region were at decreasing risk of having RDT-positive residents. Households where new infections occurred were overlaid on a risk map of RDT positive households and incident infections were more likely to be located in high-risk areas derived from prevalence data. Based on the spatial risk map, targeting households in the top 80th percentile of malaria risk would require malaria control interventions directed to only 24% of the households. Remote sensing technologies can be used to target malaria control interventions in a region of declining malaria transmission in southern Zambia, enabling a more efficient use of resources for malaria elimination.

Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system.

PubMed

Ryan, F; Byrne, S; O'Shea, S

2009-08-01

Increased frequency of prothrombin time testing, facilitated by patient self-testing (PST) of the International Normalized Ratio (INR) can improve the clinical outcomes of oral anticoagulation therapy (OAT). However, oversight of this type of management is often difficult and time-consuming for healthcare professionals. This study reports the first randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on OAT. A prospective, randomized controlled cross-over study was performed to test the hypothesis that supervised PST using an internet-based, direct-to-patient expert system could provide improved anticoagulation control as compared with that provided by an anticoagulation management service (AMS). During the 6 months of supervised PST, patients measured their INR at home using a portable meter and entered this result, along with other information, onto the internet web page. Patients received instant feedback from the system as to what dose to take and when the next test was due. During the routine care arm, patients attended the AMS at least every 4-6 weeks and were dosed by the anticoagulation pharmacist or physician. The primary outcome variable was the difference in the time in therapeutic range (TTR) between both arms. One hundred and sixty-two patients were enrolled (male 61.6%, mean age 58.7 years), and 132 patients (81.5%) completed both arms. TTR was significantly higher during PST management than during AMS management (median TTR 74% vs 58.6%; z=5.67, P < 0.001). The use of an internet-based, direct-to-patient expert system for the management of PST improves the control of OAT as compared with AMS management.

Magnetic versus manual catheter navigation for mapping and ablation of right ventricular outflow tract ventricular arrhythmias: a randomized controlled study.

PubMed

Zhang, Fengxiang; Yang, Bing; Chen, Hongwu; Ju, Weizhu; Kojodjojo, Pipin; Cao, Kejiang; Chen, Minglong

2013-08-01

No randomized controlled study has prospectively compared the performance and clinical outcomes of remote magnetic control (RMC) vs manual catheter control (MCC) during ablation of right ventricular outflow tract (RVOT) ventricular premature complexes (VPC) or ventricular tachycardia (VT). The purpose of this study was to prospectively evaluate the efficacy and safety of using either RMC vs MCC for mapping and ablation of RVOT VPC/VT. Thirty consecutive patients with idiopathic RVOT VPC/VT were referred for catheter ablation and randomized into either the RMC or MCC group. A noncontact mapping system was deployed in the RVOT to identify origins of VPC/VT. Conventional activation and pace-mapping was performed to guide ablation. If ablation performed using 1 mode of catheter control was acutely unsuccessful, the patient crossed over to the other group. The primary endpoints were patients' and physicians' fluoroscopic exposure and times. Mean procedural times were similar between RMC and MCC groups. The fluoroscopic exposure and times for both patients and physicians were much lower in the RMC group than in the MCC group. Ablation was acutely successful in 14 of 15 patients in the MCC group and 10 of 15 in the RMC group. Following crossover, acute success was achieved in all patients. No major complications occurred in either group. During 22 months of follow-up, RVOT VPC recurred in 2 RMC patients. RMC navigation significantly reduces patients' and physicians' fluoroscopic times by 50.5% and 68.6%, respectively, when used in conjunction with a noncontact mapping system to guide ablation of RVOT VPC/VT. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Sailing for Rehabilitation of Patients with Severe Mental Disorders: Results of a Cross Over Randomized Controlled Trial

PubMed Central

Carta, Mauro G; Maggiani, Federica; Pilutzu, Laura; Moro, Maria F; Mura, Gioia; Cadoni, Federica; Sancassiani, Federica; Vellante, Marcello; Machado, Sergio; Preti, Antonio

2014-01-01

This study set out to evaluate the effectiveness of a sailing and learning-to-sail rehabilitation protocol in a sample of patients diagnosed with severe mental disorders. The study was a randomized, crossover, waiting-list controlled trial, following recruitment in the Departments of Mental Health of South Sardinia. Participants were outpatients diagnosed with severe mental disorders, recruited through announcements to the directors of the Departments of Mental Health of South Sardinia. Out of the 40 patients enrolled in the study, those exposed to rehabilitation with sailing during a series of guided and supervised sea expeditions near the beach of Cagliari (Sardinia), where the aim to explore the marine environment while sailing was emphasized, showed a statistically significant improvement of their clinical status (measured by BPRS) and, as well, of their general functioning (measured by HoNOS Scale) against the control group. The improvement was maintained at follow-up for some months only: after 12 months, the patients returned to their baseline values on the measures of psychopathology and showed a worsening trend of their quality of life. Sailing can represent a substitute of important experiences that the patients with severe mental disorders miss because of their illness. PMID:25191520

Observing random walks of atoms in buffer gas through resonant light absorption

NASA Astrophysics Data System (ADS)

Aoki, Kenichiro; Mitsui, Takahisa

2016-07-01

Using resonant light absorption, random-walk motions of rubidium atoms in nitrogen buffer gas are observed directly. The transmitted light intensity through atomic vapor is measured, and its spectrum is obtained, down to orders of magnitude below the shot-noise level to detect fluctuations caused by atomic motions. To understand the measured spectra, the spectrum for atoms performing random walks in a Gaussian light beam is computed, and its analytical form is obtained. The spectrum has 1 /f2 (f is frequency) behavior at higher frequencies, crossing over to a different, but well-defined, behavior at lower frequencies. The properties of this theoretical spectrum agree excellently with the measured spectrum. This understanding also enables us to obtain the diffusion constant, the photon cross section of atoms in buffer gas, and the atomic number density from a single spectral measurement. We further discuss other possible applications of our experimental method and analysis.

Does the ingestion of a 24 hour low glycaemic index Asian mixed meal diet improve glycaemic response and promote fat oxidation? A controlled, randomized cross-over study.

PubMed

Camps, Stefan Gerardus; Kaur, Bhupinder; Quek, Rina Yu Chin; Henry, Christiani Jeyakumar

2017-07-12

The health benefits of consuming a low glycaemic index (GI) diet to reduce the risk of type 2 Diabetes are well recognized. In recent years the GI values of various foods have been determined. Their efficacy in constructing and consuming a low GI diet over 24 h in modulating glycaemic response has not been fully documented. The translation of using single-point GI values of foods to develop a 24 h mixed meal diet can provide valuable information to consumers, researchers and dietitians to optimize food choice for glycaemic control. By using GI values of foods to develop mixed meals, our study is the first to determine how both blood glucose and substrate oxidation may be modulated over 24 h. The study included 11 Asian men with a BMI between 17-24 kg/m 2 who followed both a 1-day low GI and 1-day high GI diet in a randomized, controlled cross-over design. Test meals included breakfast, lunch, snack and dinner. Glycaemic response was measured continuously for over 24 h and postprandial substrate oxidation for 10 h inside a whole body calorimeter. The low GI diet resulted in lower 24 h glucose iAUC (860 ± 440 vs 1329 ± 614 mmol/L.min; p = 0.014) with lower postprandial glucose iAUC after breakfast (p < 0.001), lunch (p = 0.009), snack (p = 0.012) and dinner (p = 0.003). Moreover, 24 h mean amplitude of glycaemic excursion was lower during the low GI vs high GI diet (1.44 ± 0.63 vs 2.33 ± 0.82 mmol/L; p < 0.001). Simultaneously, decrease in 10 h fat oxidation was less during the low vs high GI diet (-0.033 ± 0.021 vs -0.050 ± 0.017 g/min; p < 0.001), specifically after breakfast (p < 0.001) and lunch (p < 0.001). Our study corroborates that using low GI local foods to construct a 24 h low GI diet, is able to reduce glycaemic response and variability as recorded by continuous glucose monitoring. Our observations also confirm that a low GI diet promotes fat oxidation over carbohydrate oxidation when compared to a high GI diet. These observations provide public health support for the encouragement of healthier nutrition choices by consuming low GI foods. NCT 02631083 (Clinicaltrials.gov).

The impact of insecticide-treated material to reduce flies among pork outlets in Kampala, Uganda.

PubMed

Heilmann, Martin; Roesel, Kristina; Grace, Delia; Bauer, Burkhard; Clausen, Peter-Henning

2017-06-01

Synanthropic flies have adapted to the mass of decaying organic matter near human settlements. As such, they feed and breed on food, faeces and other organic material and are known vectors for various diseases. Many of these diseases are associated with food, and foodborne diseases are of growing concern in developing countries where human population and food consumption increase. This pilot study aims at investigating the impact of a novel application of insecticide-treated material (ZeroFly®) to reduce flies among pork outlets in Kampala, Uganda. A cross-sectional survey randomly selected 60 of 179 pork outlets in Kampala. A controlled longitudinal trial followed in which 23 out of the 60 pork outlets were recruited for an intervention with insecticide-treated material. The pork outlets were randomly allocated to a group of 18 netted pork outlets (intervention) and five non-netted pork outlets (control). Monitoring took place over 15 weeks including 2 weeks as the baseline survey. The units were monitored for fly abundance using non-attractant sticky traps, which were placed within the pork outlet once per week for 48 consecutive hours. Medians of fly numbers before and after the intervention indicated a decrease of fly numbers of 48% (p = 0.002). Fly bioassays showed that the insecticidal activity of the netting remained active over the entire intervention period and led to a total paralysis of flies within at least 6 h after exposure. Insecticide-treated material provides a practical and sustainable solution in controlling flies and is therefore recommended as a complementary strategy for an integrated vector control and hygiene management.

A Randomized, Head-to-Head Study of Virtual Reality Exposure Therapy for Posttraumatic Stress Disorder.

PubMed

McLay, Robert N; Baird, Alicia; Webb-Murphy, Jennifer; Deal, William; Tran, Lily; Anson, Heather; Klam, Warren; Johnston, Scott

2017-04-01

Virtual reality exposure therapy (VRET) is one of the few interventions supported by randomized controlled trials for the treatment of combat-related posttraumatic stress disorder (PTSD) in active duty service members. A comparative effectiveness study was conducted to determine if virtual reality technology itself improved outcomes, or if similar results could be achieved with a control exposure therapy (CET) condition. Service members with combat-related PTSD were randomly selected to receive nine weeks of VRET or CET. Assessors, but not therapists, were blinded. PTSD symptom improvement was assessed one week and 3 months after the conclusion of treatment using the clinician-administered PTSD scale (CAPS). A small crossover component was included. Results demonstrated that PTSD symptoms improved with both treatments, but there were no statistically significant differences between groups. Dropout rates were higher in VRET. Of those who received VRET, 13/42 (31%) showed >30% improvement on the CAPS, versus 16/43 (37%) who received CET. Three months after treatment, >30% improvement was seen in 10/33 (30%) of VRET participants and 12/33 (36%) in CET. Participants who crossed over (n = 11) showed no statistically significant improvements in a second round of treatment, regardless of condition. This study supported the utility of exposure therapy for PTSD, but did not support additional benefit by the inclusion of virtual reality.

Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

PubMed

Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

2017-01-01

We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

Experimental analysis of the flow near the boundary of random porous media

NASA Astrophysics Data System (ADS)

Wu, Zhenxing; Mirbod, Parisa

2018-04-01

The aim of this work is to experimentally examine flow over and near random porous media. Different porous materials were chosen to achieve porosity ranging from 0.95 to 0.99. In this study, we report the detailed velocity measurements of the flow over and near random porous material inside a rectangular duct using a planar particle image velocimetry (PIV) technique. By controlling the flow rate, two different Reynolds numbers were achieved. We determined the slip velocity at the interface between the porous media and free flow. Values of the slip velocity normalized either by the maximum flow velocity or by the shear rate at the interface and the screening distance K1/2 were found to depend on porosity. It was also shown that the depth of penetration inside the porous material was larger than the screening length using Brinkman's prediction. Moreover, we examined a model for the laminar coupled flow over and inside porous media and analyzed the permeability of a random porous medium. This study provided detailed analysis of flow over and at the interface of various specific random porous media using the PIV technique. This analysis has the potential to serve as a first step toward using random porous media as a new passive technique to control the flow over smooth surfaces.

A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.

PubMed

Schiffenbauer, Adam; Garg, Megha; Castro, Christine; Pokrovnichka, Angelina; Joe, Galen; Shrader, Joseph; Cabalar, Imelda Victoria; Faghihi-Kashani, Sara; Harris-Love, Michael O; Plotz, Paul H; Miller, Frederick W; Gourley, Mark

2018-06-01

To investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM). A randomized, double-blind, placebo-controlled trial including subjects with active DM or PM. Participants had stable doses of immunosuppressive medication and prednisone (≤0.5mg/kg/day), and exhibited clinical signs of muscle weakness for at least 4 weeks prior to study entry. Participants received infusions of either placebo or infliximab 5mg/kg at 0, 2, 6, and 14 weeks in blinded manner. The primary outcome was a ≥15% manual muscle strength (MMT) improvement at week 16 compared to week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMACS) criteria. At week 16, responders in each arm had the option of either continuing the same treatment or changing to the non-responder treatment for that study arm. Non-responders in the 5mg/kg infliximab arm were increased to infliximab 7.5mg/kg for weeks 22, 30, and 38. Non-responders in the placebo arm at week 16 received infliximab 5mg/kg at weeks 16, 18, 22, 30, and 38. Outcomes were reassessed at week 40. Twelve subjects completed the study to week 16. Six of the 12 subjects received infliximab treatment at the dose of 5mg/kg with only one subject meeting the responder criteria at that dose. Of the remaining five subjects on infliximab, three crossed over to the infliximab 7.5mg/kg dose. One of those three subjects responded. All six patients in the placebo arm crossed over to the 5mg/kg dosing regimen after week 16, and two of those responded to infliximab. Infliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients. Published by Elsevier Inc.

Effects of Pycnogenol on endothelial function in patients with stable coronary artery disease: a double-blind, randomized, placebo-controlled, cross-over study.

PubMed

Enseleit, Frank; Sudano, Isabella; Périat, Daniel; Winnik, Stephan; Wolfrum, Mathias; Flammer, Andreas J; Fröhlich, Georg M; Kaiser, Priska; Hirt, Astrid; Haile, Sarah R; Krasniqi, Nazmi; Matter, Christian M; Uhlenhut, Klaus; Högger, Petra; Neidhart, Michel; Lüscher, Thomas F; Ruschitzka, Frank; Noll, Georg

2012-07-01

Extracts from pine tree bark containing a variety of flavonoids have been used in traditional medicine. Pycnogenol is a proprietary bark extract of the French maritime pine tree (Pinus pinaster ssp. atlantica) that exerts antioxidative, anti-inflammatory, and anti-platelet effects. However, the effects of Pycnogenol on endothelial dysfunction, a precursor of atherosclerosis and cardiovascular events, remain still elusive. Twenty-three patients with coronary artery disease (CAD) completed this randomized, double-blind, placebo-controlled cross-over study. Patients received Pycnogenol (200 mg/day) for 8 weeks followed by placebo or vice versa on top of standard cardiovascular therapy. Between the two treatment periods, a 2-week washout period was scheduled. At baseline and after each treatment period, endothelial function, non-invasively assessed by flow-mediated dilatation (FMD) of the brachial artery using high-resolution ultrasound, biomarkers of oxidative stress and inflammation, platelet adhesion, and 24 h blood pressure monitoring were evaluated. In CAD patients, Pycnogenol treatment was associated with an improvement of FMD from 5.3 ± 2.6 to 7.0 ± 3.1 (P < 0.0001), while no change was observed with placebo (5.4 ± 2.4 to 4.7 ± 2.0; P = 0.051). This difference between study groups was significant [estimated treatment effect 2.75; 95% confidence interval (CI): 1.75, 3.75, P < 0.0001]. 15-F(2t)-Isoprostane, an index of oxidative stress, significantly decreased from 0.71 ± 0.09 to 0.66 ± 0.13 after Pycnogenol treatment, while no change was observed in the placebo group (mean difference 0.06 pg/mL with an associated 95% CI (0.01, 0.11), P = 0.012]. Inflammation markers, platelet adhesion, and blood pressure did not change after treatment with Pycnogenol or placebo. This study provides the first evidence that the antioxidant Pycnogenol improves endothelial function in patients with CAD by reducing oxidative stress.

Cardiovascular Effects of Energy Drinks in Familial Long QT Syndrome: A Randomized Cross-Over Study.

PubMed

Gray, Belinda; Ingles, Jodie; Medi, Caroline; Driscoll, Timothy; Semsarian, Christopher

2017-03-15

Caffeinated energy drinks may trigger serious cardiac effects. The aim of this study was to determine the cardiovascular effects of caffeinated energy drink consumption in patients with familial long QT syndrome (LQTS). From 2014-2016, 24 LQTS patients aged 16-50 years were recruited to a randomized, double-blind, cross-over study of energy drink (ED) versus control (CD) with participants acting as their own controls (one week washout). The primary study outcome was an increase in corrected QT interval (QTc) by >20ms. Secondary outcomes were changes in systolic and diastolic blood pressure. In 24 patients with LQTS (no dropout), mean age was 29±9 years, 13/24 (54%) were female, and 8/24 (33%) were probands. Intention to treat analysis revealed no significant change in QTc with ED compared with CD (12±28ms vs 16±27ms, 3% vs 4%, p=0.71). The systolic and diastolic blood pressure significantly increased with ED compared to CD (peak change 7±16mmHg vs 1±16mmHg, 6% vs 0.8%, p=0.046 and 8±10 vs 2±9mmHg, 11% vs 3% p=0.01 respectively). These changes correlated with significant increases in serum caffeine (14.6±11.3 vs 0.5±0.1μmol/L, p<0.001) and serum taurine (737±199 vs -59±22μmol/L, p<0.001). There were three patients with dangerous QTc prolongation of ≥50ms following energy drink consumption. Caffeinated energy drinks have significant haemodynamic effects in patients with LQTS, especifically an acute increase in blood pressure. Since dangerous QTc prolongation was seen in some LQTS patients, we recommend caution in young patients with LQTS consuming energy drinks. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effects of smartphone use with and without blue light at night in healthy adults: A randomized, double-blind, cross-over, placebo-controlled comparison.

PubMed

Heo, Jung-Yoon; Kim, Kiwon; Fava, Maurizio; Mischoulon, David; Papakostas, George I; Kim, Min-Ji; Kim, Dong Jun; Chang, Kyung-Ah Judy; Oh, Yunhye; Yu, Bum-Hee; Jeon, Hong Jin

2017-04-01

Smartphones deliver light to users through Light Emitting Diode (LED) displays. Blue light is the most potent wavelength for sleep and mood. This study investigated the immediate effects of smartphone blue light LED on humans at night. We investigated changes in serum melatonin levels, cortisol levels, body temperature, and psychiatric measures with a randomized, double-blind, cross-over, placebo-controlled design of two 3-day admissions. Each subject played smartphone games with either conventional LED or suppressed blue light from 7:30 to 10:00PM (150 min). Then, they were readmitted and conducted the same procedure with the other type of smartphone. Serum melatonin levels were measured in 60-min intervals before, during and after use of the smartphones. Serum cortisol levels and body temperature were monitored every 120 min. The Profile of Mood States (POMS), Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), and auditory and visual Continuous Performance Tests (CPTs) were administered. Among the 22 participants who were each admitted twice, use of blue light smartphones was associated with significantly decreased sleepiness (Cohen's d = 0.49, Z = 43.50, p = 0.04) and confusion-bewilderment (Cohen's d = 0.53, Z = 39.00, p = 0.02), and increased commission error (Cohen's d = -0.59, t = -2.64, p = 0.02). Also, users of blue light smartphones experienced a longer time to reach dim light melatonin onset 50% (2.94 vs. 2.70 h) and had increases in body temperature, serum melatonin levels, and cortisol levels, although these changes were not statistically significant. Use of blue light LED smartphones at night may negatively influence sleep and commission errors, while it may not be enough to lead to significant changes in serum melatonin and cortisol levels. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized, single-blind cross-over design evaluating the effectiveness of an individually defined, targeted physical therapy approach in treatment of children with cerebral palsy.

PubMed

Franki, Inge; Van den Broeck, Christine; De Cat, Josse; Tijhuis, Wieke; Molenaers, Guy; Vanderstraeten, Guy; Desloovere, Kaat

2014-10-01

A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program. A randomized, single-blind cross-over design. Ten ambulant children with bilateral spastic cerebral palsy, age four to nine years. Participants were randomly assigned into a ten-week individually defined, targeted or a general program, followed by a cross-over. Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis. General outcome parameters were Gross Motor Function Measure-88 scores, time and distance parameters, gait profile score and movement analysis profiles. Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function. No significant changes were observed regarding gross motor function. Only after individualized therapy, step- and stride-length increased significantly (p = 0.022; p = 0.017). Change in step-length was higher after the individualized program (p = 0.045). Within-group effects were found for the pelvis in transversal plane after the individualized program (p = 0.047) and in coronal plane after the general program (p = 0.047). Between-program differences were found for changes in the knee in sagittal plane, in the advantage of the individual program (p = 0.047). A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program, respectively. Functional goal attainment was higher after the individual therapy program compared with the general program (48 to 43.5). The results indicate slightly favorable effects towards the individualized program. To detect clinically significant changes, future studies require a minimal sample size of 72 to 90 participants. © The Author(s) 2014.

High job control enhances vagal recovery in media work.

PubMed

Lindholm, Harri; Sinisalo, Juha; Ahlberg, Jari; Jahkola, Antti; Partinen, Markku; Hublin, Christer; Savolainen, Aslak

2009-12-01

Job strain has been linked to increased risk of cardiovascular diseases. In modern media work, time pressures, rapidly changing situations, computer work and irregular working hours are common. Heart rate variability (HRV) has been widely used to monitor sympathovagal balance. Autonomic imbalance may play an additive role in the development of cardiovascular diseases. To study the effects of work demands and job control on the autonomic nervous system recovery among the media personnel. From the cross-sectional postal survey of the employees in Finnish Broadcasting Company (n = 874), three age cohorts (n = 132) were randomly selected for an analysis of HRV in 24 h electrocardiography recordings. In the middle-aged group, those who experienced high job control had significantly better vagal recovery than those with low or moderate control (P < 0.01). Among young and ageing employees, job control did not associate with autonomic recovery. High job control over work rather than low demands seemed to enhance autonomic recovery in middle-aged media workers. This was independent of poor health habits such as smoking, physical inactivity or alcohol consumption.

Effects of an 8-Week Outdoor Brisk Walking Program on Fatigue in Hi-Tech Industry Employees: A Randomized Control Trial.

PubMed

Wu, Li-Ling; Wang, Kuo-Ming; Liao, Po-I; Kao, Yu-Hsiu; Huang, Yi-Ching

2015-10-01

Over 73% of hi-tech industry employees in Taiwan lack regular exercise. They are exposed to a highly variable and stressful work environment for extended periods of time, and may subsequently experience depression, detrimental to workers' physiological and mental health. In this cross-sectional survey, the authors explored the effect of an 8-week brisk walking program on the fatigue of employees in the hi-tech industry. The participants, from a hi-tech company in northern Taiwan, were randomly assigned to an experimental group (EG; 41 subjects, Mage = 33.34 ± 6.40) or control group (CG; 45 subjects, Mage = 29.40 ± 3.60). Following the 8-week brisk walking program, the EG showed significantly lower scores for subjective fatigue, working motivation, attention, and overall fatigue. The authors confirmed that the 8-week outdoor brisk walking program significantly improved the level of fatigue among employees of the hi-tech industry. The finding serves as an important reference for health authorities in Taiwan and provides awareness of workplace health promotion in the hi-tech industry. © 2015 The Author(s).

Spine deviations and orthodontic treatment of asymmetric malocclusions in children

PubMed Central

2012-01-01

Background The aim of this randomized clinical trial was to assess the effect of early orthodontic treatment for unilateral posterior cross bite in the late deciduous and early mixed dentition using orthopedic parameters. Methods Early orthodontic treatment was performed by initial maxillary expansion and subsequent activator therapy (Münster treatment concept). The patient sample was initially comprised of 80 patients with unilateral posterior cross bite (mean age 7.3 years, SD 2.1 years). After randomization, 77 children attended the initial examination appointment (therapy = 37, control = 40); 31 children in the therapy group and 35 children in the control group were monitored at the follow-up examination (T2). The mean interval between T1 and T2 was 1.1 years (SD 0.2 years). Rasterstereography was used for back shape analysis at T1 and T2. Using the profile, the kyphotic and lordotic angle, the surface rotation, the lateral deviation, pelvic tilt and pelvic torsion, statistical differences at T1 and T2 between the therapy and control groups were calculated (t-test). Our working hypothesis was, that early orthodontic treatment can induce negative therapeutic changes in body posture through thoracic and lumbar position changes in preadolescents with uniltaral cross bite. Results No clinically relevant differences between the control and the therapy groups at T1 and T2 were found for the parameters of kyphotic and lordotic angle, the surface rotation, lateral deviation, pelvic tilt, and pelvic torsion. Conclusions Our working hypothesis was tested to be not correct (within the limitations of this study). This randomized clinical trial demonstrates that in a juvenile population with unilateral posterior cross bite the selected early orthodontic treatment protocol does not affect negatively the postural parameters. Trial registration DRKS00003497 on DRKS PMID:22906114

Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

PubMed

Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R; Ramstad, Erica; Magnusson, Frederik Løgstrup; Krogh, Helle B; Groth, Camilla; Gillies, Donna; Zwi, Morris; Skoog, Maria; Gluud, Christian; Simonsen, Erik

2017-01-01

To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found.

Effects of Pelvic and Core Strength Training on High School Cross-Country Race Times.

PubMed

Clark, Anne W; Goedeke, Maggie K; Cunningham, Saengchoy R; Rockwell, Derek E; Lehecka, Bryan J; Manske, Robert C; Smith, Barbara S

2017-08-01

Clark, AW, Goedeke, MK, Cunningham, SR, Rockwell, DE, Lehecka, BJ, Manske, RC, and Smith, BS. Effects of pelvic and core strength training on high school cross-country race times. J Strength Cond Res 31(8): 2289-2295, 2017-There is only limited research examining the effect of pelvic and core strength training on running performance. Pelvic and core muscle fatigue is believed to contribute to excess motion along frontal and transverse planes which decreases efficiency in normal sagittal plane running motions. The purpose of this study was to determine whether adding a 6-week pelvic and core strengthening program resulted in decreased race times in high school cross-country runners. Thirty-five high school cross-country runners (14-19 years old) from 2 high schools were randomly assigned to a strengthening group (experimental) or a nonstrengthening group (control). All participants completed 4 standardized isometric strength tests for hip abductors, adductors, extensors, and core musculature in a test-retest design. The experimental group performed a 6-week pelvic and core strengthening program along with their normal training. Participants in the control group performed their normal training without additional pelvic and core strengthening. Baseline, 3-week, and 6-week race times were collected using a repeated measures design. No significant interaction between experimental and control groups regarding decreasing race times and increasing pelvic and core musculature strength occurred over the 6-week study period. Both groups increased strength and decreased overall race times. Clinically significant findings reveal a 6-week pelvic and core stability strengthening program 3 times a week in addition to coach led team training may help decrease race times.

The effect of chronic progressive-dose sodium bicarbonate ingestion on CrossFit-like performance: A double-blind, randomized cross-over trial.

PubMed

Durkalec-Michalski, Krzysztof; Zawieja, Emilia E; Podgórski, Tomasz; Łoniewski, Igor; Zawieja, Bogna E; Warzybok, Marta; Jeszka, Jan

2018-01-01

Sodium bicarbonate (SB) has been proposed as an ergogenic aid, as it improves high-intensity and resistance exercise performance. However, no studies have yet investigated SB application in CrossFit. This study examined the effects of chronic, progressive-dose SB ingestion on CrossFit-like performance and aerobic capacity. In a randomized, double-blind, cross-over trial, 21 CrossFit-trained participants were randomly allocated to 2 groups and underwent 2 trials separated by a 14-day washout period. Participants ingested either up to 150 mg∙kg-1 of SB in a progressive-dose regimen or placebo for 10 days. Before and after each trial, Fight Gone Bad (FGB) and incremental cycling (ICT) tests were performed. In order to examine biochemical responses, blood samples were obtained prior to and 3 min after completing each exercise test. No gastrointestinal (GI) side effects were reported during the entire protocol. The overall FGB performance improved under SB by ~6.1% (p<0.001) and it was ~3.1% higher compared to post placebo (PLApost) (p = 0.040). The number of repetitions completed in each round also improved under SB (mean from baseline: +5.8% to +6.4%). Moreover, in ICT, the time to ventilatory threshold (VT) (~8:25 min SBpost vs. ~8:00 min PLApost, p = 0.020), workload at VT (~218 W SBpost vs. ~208 W PLApost, p = 0.037) and heart rate at VT (~165 bpm SBpost vs. ~161 bpm PLApost, p = 0.030) showed higher SBpost than PLApost. Furthermore, the maximum carbon dioxide production increased under SB by ~4.8% (from ~3604 mL∙min-1 to ~3776 mL∙min-1, p = 0.049). Pyruvate concentration and creatine kinase activity before ICT showed higher SBpost than PLApost (~0.32 mmol∙L-1 vs. ~0.26 mmol∙L-1, p = 0.001; ~275 U∙L-1 vs. ~250 U∙L-1, p = 0.010, respectively). However, the small sample size limits the wide-application of our results. Progressive-dose SB ingestion regimen eliminated GI side effects and improved CrossFit-like performance, as well as delayed ventilatory threshold occurrence.

Comparison of Effects of Teaching English to Thai Undergraduate Teacher-Students through Cross-Curricular Thematic Instruction Program Based on Multiple Intelligence Theory and Conventional Instruction

ERIC Educational Resources Information Center

Rattanavich, Saowalak

2013-01-01

This study is aimed at comparing the effects of teaching English to Thai undergraduate teacher-students through cross-curricular thematic instruction program based on multiple intelligence theory and through conventional instruction. Two experimental groups, which utilized Randomized True Control Group-Pretest-posttest Time Series Design and…

A randomized, double-blind, placebo-controlled, cross-over study to assess the efficacy of tadalafil (Cialis[reg]) in the treatment of erectile dysfunction following three-dimensional conformal external-beam radiotherapy for prostatic carcinoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Incrocci, Luca; Slagter, Cleo; Slob, A. Koos

2006-10-01

Purpose: Erectile dysfunction after three-dimensional conformal external-beam radiotherapy (3DCRT) for prostatic carcinoma is reported in as many as 64% of those patients. The purpose of this study was to determine the efficacy of the oral drug tadalafil (Cialis (registered) ) in patients with erectile dysfunction after radiotherapy for prostatic carcinoma. Methods and Materials: Patients (N = 358) who completed radiotherapy at least 12 months before the study were approached by mail. All patients had been treated by 3DCRT; 60 patients were included and entered a double-blind, placebo-controlled, cross-over study lasting 12 weeks. They received 20 mg of tadalafil or placebomore » for 6 weeks. Drug or placebo was taken on demand at patient's discretion, with no restrictions regarding the consumption of alcohol or food, at least once a week and no more than once daily. At 6 weeks patients crossed over to the alternative treatment. Data were collected using the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF) questionnaires. Side effects were also recorded. Results: Mean age at study entry was 69 years. All patients completed the study. For almost all questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with tadalafil, but not with placebo. Sixty-seven percent of the patients reported an improvement of erectile function with tadalafil (placebo: 20%), and 48% reported successful intercourse with tadalafil (placebo: 9%) (p < 0.0001). Side effects were mild or moderate. Conclusions: Tadalafil is an effective treatment for erectile dysfunction after 3DCRT for prostatic carcinoma with successful intercourse reported in almost 50% of the patients, and it is well tolerated.« less

Pulmonary rehabilitation after total laryngectomy: a randomized cross-over clinical trial comparing two different heat and moisture exchangers (HMEs).

PubMed

Herranz, Jesús; Espiño, María Alvarez; Morado, Carolina Ogen

2013-09-01

Post-laryngectomy heat and moisture exchanger (HME) use is known to have a beneficial effect on tracheal climate, pulmonary symptoms and related aspects. This study aims to investigate differences in clinical effects between the first and second generation Provox HMEs. The second generation (Provox XtraHME) has better humidification properties than the first generation (Provox HME), and has been shown to further improve tracheal climate. Forty-five laryngectomized patients, who were already using an HME, participated in a prospective, randomized cross-over clinical study in which each HME was used for 6 weeks. Results showed that for most parameters studied, the second generation HME performed equally well or better than the first generation HME. The improvement in tracheal climate translated into patients reporting significantly less tracheal dryness with the second generation than with the first generation (p = 0.039). Using an HME with better humidification properties is related to a reduction in tracheal dryness in our study population.

A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine.

PubMed

Bayer, Otmar; Brémová, Tatiana; Strupp, Michael; Hüfner, Katharina

2018-02-01

Vestibular paroxysmia (VP) is characterized by short, often oligosymptomatic attacks of vertigo which occur spontaneously or are sometimes provoked by turning the head. Despite the description of the disease almost 40 years ago (first termed "disabling positional vertigo"), no controlled treatment trial has been published to date. The Vestparoxy trial was designed as a randomized, placebo-controlled, double-blind cross-over trial to examine the therapeutic effect of oxcarbazepine (OXA) in patients with definite or probable VP. Patients were recruited from August 2005 to December 2011 in the outpatient Dizziness Unit of the Department of Neurology of the Munich University Hospital, and randomized to receive OXA (first week: 300 mg once per day, second week: 300 mg b.i.d., third week: 300 mg t.i.d. until the end of the third month), followed by placebo or vice versa with a 1-month wash-out period in between. The primary endpoint was the number of days with one or more attacks. Secondary endpoints were the number of attacks during the observed days, and the median (for each day) duration of attacks. All these endpoints were assessed using standardized diaries collected at the end of each treatment phase. Forty-three patients were randomized, 18 patients provided usable data (2525 patient days) for at least one treatment phase and were included in the main (intention-to-treat) analysis. The most common reasons for discontinuation documented were adverse events. The risk of experiencing a day with at least one attack was 0.41 under OXA, and 0.62 under placebo treatment, yielding a relative risk of 0.67 (95% CI 0.47-0.95, p = 0.025). The number of attacks during the observed days ratio was 0.53 (95% CI 0.42-0.68, p < 0.001) under OXA compared to placebo. Median attack duration was 4 s (Q25: 2 s, Q75: 120 s) under OXA, and 3 s (Q25: 2 s, Q75: 60 s) under placebo treatment. When days with no attacks, i.e., duration = 0, were included in the analysis, these figures changed to 0 (Q25: 0, Q75: 3 s), and 2 (Q25: 0, Q75: 6 s). No serious adverse events or new safety findings were identified during the trial. The Vestparoxy trial showed a significant reduction of VP attacks under OXA compared to placebo treatment, confirming the known and revealing no new side effects.

Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design

PubMed Central

Kim, Myoung Kwon; Shin, Young Jun

2017-01-01

Background The objective of this study was to investigate the immediate effect on gait function when ankle balance taping is applied to amateur soccer players with lateral ankle sprain. Material/Methods A cross-over randomized design was used. Twenty-two soccer players with an ankle sprain underwent 3 interventions in a random order. Subjects were randomly assigned to ankle balance taping, placebo taping, and no taping groups. The assessment was performed using the GAITRite portable walkway system, which records the location and timing of each footfall during ambulation. Results Significant differences were found in the velocity, step length, stride length, and H-H base support among the 3 different taping methods (p<0.05). The ankle balance taping group showed significantly greater velocity, step length, and stride length in comparison to the placebo and no taping group. The ankle balance taping group showed a statistically significant decrease (p<0.05) in the H-H base support compared to the placebo and no taping groups, and the placebo group showed significantly greater velocity in comparison to the no taping group (p<0.05). Conclusions We conclude that ankle balance taping that uses kinesiology tape instantly increased the walking ability of amateur soccer players with lateral ankle sprain. Therefore, ankle balance taping is a useful alternative to prevent and treat ankle sprain of soccer players. PMID:29158472

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

PubMed

Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

2016-02-01

The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

A High Fiber Cookie Made with Resistant Starch Type 4 Reduces Post-Prandial Glucose and Insulin Responses in Healthy Adults.

PubMed

Stewart, Maria L; Zimmer, J Paul

2017-03-05

Distarch phosphate is a resistant starch type 4 (RS4) containing phosphodiester cross-links within and between starch molecules. This study examined the glycemic effects of VERSAFIBE 1490™ resistant starch, a distarch phosphate derived from potato, containing 90% total dietary fiber (TDF, AOAC 991.43 method). In this double-blind, randomized, placebo-controlled, cross-over study, 28 healthy adults consumed a cookie containing 24 g fiber from distarch phosphate (fiber cookie) or a control cookie containing 0.5 g fiber that was matched for fat, protein, and total carbohydrate content. Intravenous blood glucose, intravenous blood insulin, and capillary glucose were measured for two hours after cookie consumption. The fiber cookie reduced the post-prandial blood glucose incremental area under the curve from 0 to 120 minutes (iAUC 0-120min ) by 44% ( p = 0.004) and reduced the maximum glucose concentration (C max0-120min ) by 8% ( p = 0.001) versus the control cookie. Consumption of the fiber cookie resulted in a significant 46% reduction of the post-prandial serum insulin iAUC 0-120min ( p < 0.001) and a 23% reduction in Cmax 0-120min ( p = 0.007) versus the control cookie. This study shows that distarch phosphate RS4 can be incorporated into a cookie and significantly reduce post-prandial glucose and insulin responses in healthy adults.

Revisiting sample size: are big trials the answer?

PubMed

Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

2012-07-18

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.

Associations between the dimensions of perceived togetherness, loneliness, and depressive symptoms among older Finnish people.

PubMed

Pynnönen, Katja; Rantanen, Taina; Kokko, Katja; Tiikkainen, Pirjo; Kallinen, Mauri; Törmäkangas, Timo

2017-07-06

We studied the associations between perceived togetherness, depressive symptoms, and loneliness over a six-month period among 222 people aged 75-79 who reported loneliness or depressive mood at baseline. The present cross-lagged models utilized baseline and six-month follow-up data of a randomized controlled trial that examined the effects of a social intervention on loneliness and depression (ISRCTN78426775). Dimensions of perceived togetherness, i.e. attachment, social integration, guidance, alliance, nurturance, and reassurance of worth, were measured with the Social Provisions Scale, depressive symptoms with a short form of the Geriatric Depression Scale, and loneliness with a single item. After controlling for baseline loneliness and depressive symptoms, baseline higher attachment in all participants and baseline higher opportunity for nurturance in the social intervention group predicted lower depressive mood at follow-up. No cross-lagged associations between the dimensions of perceived togetherness at baseline and loneliness at follow-up were observed. In addition, depressive symptoms and loneliness at baseline tended to negatively predict the dimensions of perceived togetherness at follow-up. Depressive symptoms and loneliness appear to be precursor for perceived togetherness, rather than dimensions of perceived togetherness to be antecedents of loneliness and depressiveness among older people.

Scattering from randomly oriented circular discs with application to vegetation

NASA Technical Reports Server (NTRS)

Karam, M. A.; Fung, A. K.

1984-01-01

A vegetation layer is modeled by a collection of randomly oriented circular discs over a half space. The backscattering coefficient from such a half space is computed using the radiative transfer theory. It is shown that significantly different results are obtained from this theory as compared with some earlier investigations using the same modeling approach but with restricted disc orientations. In particular, the backscattered cross polarized returns cannot have a fast increasing angular trend which is inconsistent with measurements. By setting the appropriate angle of orientation to zero the theory reduces to previously published results. Comparisons are shown with measurements taken from milo, corn and wheat and good agreements are obtained for both polarized and cross polarized returns.

Scattering from randomly oriented circular discs with application to vegetation

NASA Technical Reports Server (NTRS)

Karam, M. A.; Fung, A. K.

1983-01-01

A vegetation layer is modeled by a collection of randomly oriented circular discs over a half space. The backscattering coefficient from such a half space is computed using the radiative transfer theory. It is shown that significantly different results are obtained from this theory as compared with some earlier investigations using the same modeling approach but with restricted disc orientations. In particular, the backscattered cross-polarized returns cannot have a fast increasing angular trend which is inconsistent with measurements. By setting the appropriate angle of orientation to zero the theory reduces to previously published results. Comparisons are shown with measurements taken from milo, corn and wheat and good agreements are obtained for both polarized and cross-polarized returns.

Mobile Application vs Paper Pictorial Blood Assessment Chart to Track Menses in Young Women: A Randomized Cross-over Design.

PubMed

Jacobson, Amanda E; Vesely, Sara K; Haamid, Fareeda; Christian-Rancy, Myra; O'Brien, Sarah H

2018-04-01

Heavy menstrual bleeding is a common symptom reported by approximately 30% of women. The Pictorial Blood Assessment Chart (PBAC) score is often used to quantify severity of menstrual bleeding. However, the traditional PBAC paper diary might be subject to recall bias and compliance issues, especially in adolescents. We developed a mobile application (app) version of the PBAC score and evaluated patient satisfaction and compliance with app reporting vs paper reporting. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: This study was a randomized cross-over study of 25 postmenarchal female adolescents and young women ages 13-21 years. Participants agreed to track bleeding in 2 consecutive menstrual cycles and were randomized to use the PBAC paper diary or mobile app format first. At the end of each cycle, a satisfaction survey and system usability scale (app only) was used to assess the acceptability of the format used. Twenty-five participants had a median age of 15 years. Cross-over analysis showed that satisfaction level was significantly higher for the app (P < .001). Twenty of 25 (80%) participants preferred the app over the paper diary. For the app, 20 of 25 participants (80%) had high compliance for reporting bleeding, with a mean of 2 app entries per day. Participants' PBAC scores did not vary significantly between the paper diary (median, 95) and mobile app (median, 114). All paper diaries met definition for high compliance. There was no significant period or carryover effect. This study showed that a PBAC app compared with the paper diary was the preferred method of recording menstrual bleeding in adolescents and showed feasibility as a research data collection tool. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Estimation of treatment efficacy with complier average causal effects (CACE) in a randomized stepped wedge trial.

PubMed

Gruber, Joshua S; Arnold, Benjamin F; Reygadas, Fermin; Hubbard, Alan E; Colford, John M

2014-05-01

Complier average causal effects (CACE) estimate the impact of an intervention among treatment compliers in randomized trials. Methods used to estimate CACE have been outlined for parallel-arm trials (e.g., using an instrumental variables (IV) estimator) but not for other randomized study designs. Here, we propose a method for estimating CACE in randomized stepped wedge trials, where experimental units cross over from control conditions to intervention conditions in a randomized sequence. We illustrate the approach with a cluster-randomized drinking water trial conducted in rural Mexico from 2009 to 2011. Additionally, we evaluated the plausibility of assumptions required to estimate CACE using the IV approach, which are testable in stepped wedge trials but not in parallel-arm trials. We observed small increases in the magnitude of CACE risk differences compared with intention-to-treat estimates for drinking water contamination (risk difference (RD) = -22% (95% confidence interval (CI): -33, -11) vs. RD = -19% (95% CI: -26, -12)) and diarrhea (RD = -0.8% (95% CI: -2.1, 0.4) vs. RD = -0.1% (95% CI: -1.1, 0.9)). Assumptions required for IV analysis were probably violated. Stepped wedge trials allow investigators to estimate CACE with an approach that avoids the stronger assumptions required for CACE estimation in parallel-arm trials. Inclusion of CACE estimates in stepped wedge trials with imperfect compliance could enhance reporting and interpretation of the results of such trials.

Low-Energy Truly Random Number Generation with Superparamagnetic Tunnel Junctions for Unconventional Computing

NASA Astrophysics Data System (ADS)

Vodenicarevic, D.; Locatelli, N.; Mizrahi, A.; Friedman, J. S.; Vincent, A. F.; Romera, M.; Fukushima, A.; Yakushiji, K.; Kubota, H.; Yuasa, S.; Tiwari, S.; Grollier, J.; Querlioz, D.

2017-11-01

Low-energy random number generation is critical for many emerging computing schemes proposed to complement or replace von Neumann architectures. However, current random number generators are always associated with an energy cost that is prohibitive for these computing schemes. We introduce random number bit generation based on specific nanodevices: superparamagnetic tunnel junctions. We experimentally demonstrate high-quality random bit generation that represents an orders-of-magnitude improvement in energy efficiency over current solutions. We show that the random generation speed improves with nanodevice scaling, and we investigate the impact of temperature, magnetic field, and cross talk. Finally, we show how alternative computing schemes can be implemented using superparamagentic tunnel junctions as random number generators. These results open the way for fabricating efficient hardware computing devices leveraging stochasticity, and they highlight an alternative use for emerging nanodevices.

Viscous Fingering in Multiport Hele Shaw Cell for Controlled Shaping of Fluids.

PubMed

Islam, Tanveer Ul; Gandhi, Prasanna S

2017-11-30

The pursuit of mimicking complex multiscale systems has been a tireless effort with many successes but a daunting task ahead. A new perspective to engineer complex cross-linked meshes and branched/tree-like structures at different scales is presented here. Control over Saffman-Taylor instability which otherwise randomly rearranges viscous fluid in a 'lifted Hele-Shaw cell' is proposed for the same. The proposed control employs multiple-ports or source-holes in this cell, to spontaneously shape a stretched fluid film into a network of well defined webs/meshes and ordered multiscale tree-like patterns. Use of multiple ports enables exercising strong control to fabricate such structures, in a robust and repeated fashion, which otherwise are completely non-characteristic to viscous fingering process. The proposed technique is capable of fabricating spontaneously families of wide variety of structures over micro and very large scale in a period of few seconds. Thus the proposed method forms a solid foundation to new pathways for engineering multiscale structures for several scientific applications including efficient gas exchange, heat transport, tissue engineering, organ-on-chip, and so on. Proposal of multi-port Hele-Shaw cell also opens new avenues for investigation of complex multiple finger interactions resulting in interesting fluid patterns.

The effect of images of Michelle Obama's face on trick-or-treaters' dietary choices: A randomized control trial.

PubMed

Aronow, Peter M; Karlan, Dean; Pinson, Lauren E

2018-01-01

To evaluate the microfoundations of a personality-inspired public health campaign's influence on minors. Multi-year randomized control trial. Economics professor's front porch in New Haven, CT. 1223 trick-or-treaters in New Haven over three years; on average, 8.5 years old and 53% male (among children whose gender was identifiable). Trick-or-treaters over the age of three that approached the house. Random assignment to the Michelle Obama side of the porch or the Comparison side of the porch. Selection of fruit over candy. Difference-in-means estimates. We estimate that viewing a photograph of Michelle Obama's face relative to control conditions caused children to be 19% more likely to choose fruit over candy. Michelle Obama's initiative to reduce childhood obesity has influenced children's dietary preferences. Whether this influence extends beyond Halloween trick-or-treating in New Haven, CT on the porch of an economics professor requires further research.

A nonlinear control scheme based on dynamic evolution path theory for improved dynamic performance of boost PFC converter working on nonlinear features.

PubMed

Mohanty, Pratap Ranjan; Panda, Anup Kumar

2016-11-01

This paper is concerned to performance improvement of boost PFC converter under large random load fluctuation, ensuring unity power factor (UPF) at source end and regulated voltage at load side. To obtain such performance, a nonlinear controller based on dynamic evolution path theory is designed and its robustness is examined under both heavy and light loading condition. In this paper, %THD and zero-cross-over dead-zone of input current is significantly reduced. Also, very less response time of input current and output voltage to that of load and reference variation is remarked. A simulation model of proposed system is designed and it is realized using dSPACE 1104 signal processor for a 390V DC , 500W prototype. The relevant experimental and simulation waveforms are presented. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

Psyllium supplementation in adolescents improves fat distribution & lipid profile: a randomized, participant-blinded, placebo-controlled, crossover trial.

PubMed

de Bock, Martin; Derraik, José G B; Brennan, Christine M; Biggs, Janene B; Smith, Greg C; Cameron-Smith, David; Wall, Clare R; Cutfield, Wayne S

2012-01-01

We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test. 45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019), as well as a 0.12 mmol/l (6%) reduction in LDL cholesterol (p = 0.042). No associated adverse events were recorded. Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome) in an at risk population of adolescent males. Australian New Zealand Clinical Trials Registry ACTRN12609000888268.

Coordinated Control of Cross-Flow Turbines

NASA Astrophysics Data System (ADS)

Strom, Benjamin; Brunton, Steven; Polagye, Brian

2016-11-01

Cross-flow turbines, also known as vertical-axis turbines, have several advantages over axial-flow turbines for a number of applications including urban wind power, high-density arrays, and marine or fluvial currents. By controlling the angular velocity applied to the turbine as a function of angular blade position, we have demonstrated a 79 percent increase in cross-flow turbine efficiency over constant-velocity control. This strategy uses the downhill simplex method to optimize control parameter profiles during operation of a model turbine in a recirculating water flume. This optimization method is extended to a set of two turbines, where the blade motions and position of the downstream turbine are optimized to beneficially interact with the coherent structures in the wake of the upstream turbine. This control scheme has the potential to enable high-density arrays of cross-flow turbines to operate at cost-effective efficiency. Turbine wake and force measurements are analyzed for insight into the effect of a coordinated control strategy.

Analytical Models of Cross-Layer Protocol Optimization in Real-Time Wireless Sensor Ad Hoc Networks

NASA Astrophysics Data System (ADS)

Hortos, William S.

The real-time interactions among the nodes of a wireless sensor network (WSN) to cooperatively process data from multiple sensors are modeled. Quality-of-service (QoS) metrics are associated with the quality of fused information: throughput, delay, packet error rate, etc. Multivariate point process (MVPP) models of discrete random events in WSNs establish stochastic characteristics of optimal cross-layer protocols. Discrete-event, cross-layer interactions in mobile ad hoc network (MANET) protocols have been modeled using a set of concatenated design parameters and associated resource levels by the MVPPs. Characterization of the "best" cross-layer designs for a MANET is formulated by applying the general theory of martingale representations to controlled MVPPs. Performance is described in terms of concatenated protocol parameters and controlled through conditional rates of the MVPPs. Modeling limitations to determination of closed-form solutions versus explicit iterative solutions for ad hoc WSN controls are examined.

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

ERIC Educational Resources Information Center

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

2008-01-01

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

A randomized trial of the effect of prayer on depression and anxiety.

PubMed

Boelens, Peter A; Reeves, Roy R; Replogle, William H; Koenig, Harold G

2009-01-01

To investigate the effect of direct contact person-to-person prayer on depression, anxiety, positive emotions, and salivary cortisol levels. Cross-over clinical trial with depression or anxiety conducted in an office setting. Following randomization to the prayer intervention or control groups, subjects (95% women) completed Hamilton Rating Scales for Depression and Anxiety, Life Orientation Test, Daily Spiritual Experiences Scale, and underwent measurement of cortisol levels. Individuals in the direct person-to-person prayer contact intervention group received six weekly 1-hour prayer sessions while those in the control group received none. Rating scales and cortisol levels were repeated for both groups after completion of the prayer sessions, and a month later. ANOVAs were used to compare pre- and post-prayer measures for each group. At the completion of the trial, participants receiving the prayer intervention showed significant improvement of depression and anxiety, as well as increases of daily spiritual experiences and optimism compared to controls (p < 0.01 in all cases). Subjects in the prayer group maintained these significant improvements (p < 0.01 in all cases) for a duration of at least 1 month after the final prayer session. Participants in the control group did not show significant changes during the study. Cortisol levels did not differ significantly between intervention and control groups, or between pre- and post-prayer conditions. Direct contact person-to-person prayer may be useful as an adjunct to standard medical care for patients with depression and anxiety. Further research in this area is indicated.

Aspartame sensitivity? A double blind randomised crossover study.

PubMed

Sathyapalan, Thozhukat; Thatcher, Natalie J; Hammersley, Richard; Rigby, Alan S; Courts, Fraser L; Pechlivanis, Alexandros; Gooderham, Nigel J; Holmes, Elaine; le Roux, Carel W; Atkin, Stephen L

2015-01-01

Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics. Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects. Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of aspartame does not have any detectable psychological or metabolic effects in humans. ISRCTN Registry ISRCTN39650237.

The Design of Cluster Randomized Trials with Random Cross-Classifications

ERIC Educational Resources Information Center

Moerbeek, Mirjam; Safarkhani, Maryam

2018-01-01

Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…

Benchmarking protein classification algorithms via supervised cross-validation.

PubMed

Kertész-Farkas, Attila; Dhir, Somdutta; Sonego, Paolo; Pacurar, Mircea; Netoteia, Sergiu; Nijveen, Harm; Kuzniar, Arnold; Leunissen, Jack A M; Kocsor, András; Pongor, Sándor

2008-04-24

Development and testing of protein classification algorithms are hampered by the fact that the protein universe is characterized by groups vastly different in the number of members, in average protein size, similarity within group, etc. Datasets based on traditional cross-validation (k-fold, leave-one-out, etc.) may not give reliable estimates on how an algorithm will generalize to novel, distantly related subtypes of the known protein classes. Supervised cross-validation, i.e., selection of test and train sets according to the known subtypes within a database has been successfully used earlier in conjunction with the SCOP database. Our goal was to extend this principle to other databases and to design standardized benchmark datasets for protein classification. Hierarchical classification trees of protein categories provide a simple and general framework for designing supervised cross-validation strategies for protein classification. Benchmark datasets can be designed at various levels of the concept hierarchy using a simple graph-theoretic distance. A combination of supervised and random sampling was selected to construct reduced size model datasets, suitable for algorithm comparison. Over 3000 new classification tasks were added to our recently established protein classification benchmark collection that currently includes protein sequence (including protein domains and entire proteins), protein structure and reading frame DNA sequence data. We carried out an extensive evaluation based on various machine-learning algorithms such as nearest neighbor, support vector machines, artificial neural networks, random forests and logistic regression, used in conjunction with comparison algorithms, BLAST, Smith-Waterman, Needleman-Wunsch, as well as 3D comparison methods DALI and PRIDE. The resulting datasets provide lower, and in our opinion more realistic estimates of the classifier performance than do random cross-validation schemes. A combination of supervised and random sampling was used to construct model datasets, suitable for algorithm comparison.

A Randomized Pilot Trial of Remote Ischemic Preconditioning in Heart Failure with Reduced Ejection Fraction

PubMed Central

McDonald, Michael A.; Braga, Juarez R.; Li, Jing; Manlhiot, Cedric; Ross, Heather J.; Redington, Andrew N.

2014-01-01

Background Remote ischemic preconditioning (RIPC) induced by transient limb ischemia confers multi-organ protection and improves exercise performance in the setting of tissue hypoxia. We aimed to evaluate the effect of RIPC on exercise capacity in heart failure patients. Methods We performed a randomized crossover trial of RIPC (4×5-minutes limb ischemia) compared to sham control in heart failure patients undergoing exercise testing. Patients were randomly allocated to either RIPC or sham prior to exercise, then crossed over and completed the alternate intervention with repeat testing. The primary outcome was peak VO2, RIPC versus sham. A mechanistic substudy was performed using dialysate from study patient blood samples obtained after sham and RIPC. This dialysate was used to test for a protective effect of RIPC in a mouse heart Langendorff model of infarction. Mouse heart infarct size with RIPC or sham dialysate exposure was also compared with historical control data. Results Twenty patients completed the study. RIPC was not associated with improvements in peak VO2 (15.6+/−4.2 vs 15.3+/−4.6 mL/kg/min; p = 0.53, sham and RIPC, respectively). In our Langendorff sub-study, infarct size was similar between RIPC and sham dialysate groups from our study patients, but was smaller than expected compared to healthy controls (29.0%, 27.9% [sham, RIPC] vs 51.2% [controls]. We observed less preconditioning among the subgroup of patients with increased exercise performance following RIPC (p<0.04). Conclusion In this pilot study of RIPC in heart failure patients, RIPC was not associated with improvements in exercise capacity overall. However, the degree of effect of RIPC may be inversely related to the degree of baseline preconditioning. These data provide the basis for a larger randomized trial to test the potential benefits of RIPC in patients with heart failure. Trial Registration ClinicalTrials.gov +++++NCT01128790 PMID:25181050

Arthroscopy or ultrasound in undergraduate anatomy education: a randomized cross-over controlled trial.

PubMed

Knobe, Matthias; Carow, John Bennet; Ruesseler, Miriam; Leu, Benjamin Moritz; Simon, Melanie; Beckers, Stefan K; Ghassemi, Alireza; Sönmez, Tolga T; Pape, Hans-Christoph

2012-09-09

The exponential growth of image-based diagnostic and minimally invasive interventions requires a detailed three-dimensional anatomical knowledge and increases the demand towards the undergraduate anatomical curriculum. This randomized controlled trial investigates whether musculoskeletal ultrasound (MSUS) or arthroscopic methods can increase the anatomical knowledge uptake. Second-year medical students were randomly allocated to three groups. In addition to the compulsory dissection course, the ultrasound group (MSUS) was taught by eight, didactically and professionally trained, experienced student-teachers and the arthroscopy group (ASK) was taught by eight experienced physicians. The control group (CON) acquired the anatomical knowledge only via the dissection course. Exposure (MSUS and ASK) took place in two separate lessons (75 minutes each, shoulder and knee joint) and introduced standard scan planes using a 10-MHz ultrasound system as well as arthroscopy tutorials at a simulator combined with video tutorials. The theoretical anatomic learning outcomes were tested using a multiple-choice questionnaire (MCQ), and after cross-over an objective structured clinical examination (OSCE). Differences in student's perceptions were evaluated using Likert scale-based items. The ASK-group (n = 70, age 23.4 (20-36) yrs.) performed moderately better in the anatomical MC exam in comparison to the MSUS-group (n = 84, age 24.2 (20-53) yrs.) and the CON-group (n = 88, 22.8 (20-33) yrs.; p = 0.019). After an additional arthroscopy teaching 1% of students failed the MC exam, in contrast to 10% in the MSUS- or CON-group, respectively. The benefit of the ASK module was limited to the shoulder area (p < 0.001). The final examination (OSCE) showed no significant differences between any of the groups with good overall performances. In the evaluation, the students certified the arthroscopic tutorial a greater advantage concerning anatomical skills with higher spatial imagination in comparison to the ultrasound tutorial (p = 0.002; p < 0.001). The additional implementation of arthroscopy tutorials to the dissection course during the undergraduate anatomy training is profitable and attractive to students with respect to complex joint anatomy. Simultaneous teaching of basic-skills in musculoskeletal ultrasound should be performed by medical experts, but seems to be inferior to the arthroscopic 2D-3D-transformation, and is regarded by students as more difficult to learn. Although arthroscopy and ultrasound teaching do not have a major effect on learning joint anatomy, they have the potency to raise the interest in surgery.

Arthroscopy or ultrasound in undergraduate anatomy education: a randomized cross-over controlled trial

PubMed Central

2012-01-01

Background The exponential growth of image-based diagnostic and minimally invasive interventions requires a detailed three-dimensional anatomical knowledge and increases the demand towards the undergraduate anatomical curriculum. This randomized controlled trial investigates whether musculoskeletal ultrasound (MSUS) or arthroscopic methods can increase the anatomical knowledge uptake. Methods Second-year medical students were randomly allocated to three groups. In addition to the compulsory dissection course, the ultrasound group (MSUS) was taught by eight, didactically and professionally trained, experienced student-teachers and the arthroscopy group (ASK) was taught by eight experienced physicians. The control group (CON) acquired the anatomical knowledge only via the dissection course. Exposure (MSUS and ASK) took place in two separate lessons (75 minutes each, shoulder and knee joint) and introduced standard scan planes using a 10-MHz ultrasound system as well as arthroscopy tutorials at a simulator combined with video tutorials. The theoretical anatomic learning outcomes were tested using a multiple-choice questionnaire (MCQ), and after cross-over an objective structured clinical examination (OSCE). Differences in student’s perceptions were evaluated using Likert scale-based items. Results The ASK-group (n = 70, age 23.4 (20–36) yrs.) performed moderately better in the anatomical MC exam in comparison to the MSUS-group (n = 84, age 24.2 (20–53) yrs.) and the CON-group (n = 88, 22.8 (20–33) yrs.; p = 0.019). After an additional arthroscopy teaching 1% of students failed the MC exam, in contrast to 10% in the MSUS- or CON-group, respectively. The benefit of the ASK module was limited to the shoulder area (p < 0.001). The final examination (OSCE) showed no significant differences between any of the groups with good overall performances. In the evaluation, the students certified the arthroscopic tutorial a greater advantage concerning anatomical skills with higher spatial imagination in comparison to the ultrasound tutorial (p = 0.002; p < 0.001). Conclusions The additional implementation of arthroscopy tutorials to the dissection course during the undergraduate anatomy training is profitable and attractive to students with respect to complex joint anatomy. Simultaneous teaching of basic-skills in musculoskeletal ultrasound should be performed by medical experts, but seems to be inferior to the arthroscopic 2D-3D-transformation, and is regarded by students as more difficult to learn. Although arthroscopy and ultrasound teaching do not have a major effect on learning joint anatomy, they have the potency to raise the interest in surgery. PMID:22958784

A novel image encryption algorithm based on synchronized random bit generated in cascade-coupled chaotic semiconductor ring lasers

NASA Astrophysics Data System (ADS)

Li, Jiafu; Xiang, Shuiying; Wang, Haoning; Gong, Junkai; Wen, Aijun

2018-03-01

In this paper, a novel image encryption algorithm based on synchronization of physical random bit generated in a cascade-coupled semiconductor ring lasers (CCSRL) system is proposed, and the security analysis is performed. In both transmitter and receiver parts, the CCSRL system is a master-slave configuration consisting of a master semiconductor ring laser (M-SRL) with cross-feedback and a solitary SRL (S-SRL). The proposed image encryption algorithm includes image preprocessing based on conventional chaotic maps, pixel confusion based on control matrix extracted from physical random bit, and pixel diffusion based on random bit stream extracted from physical random bit. Firstly, the preprocessing method is used to eliminate the correlation between adjacent pixels. Secondly, physical random bit with verified randomness is generated based on chaos in the CCSRL system, and is used to simultaneously generate the control matrix and random bit stream. Finally, the control matrix and random bit stream are used for the encryption algorithm in order to change the position and the values of pixels, respectively. Simulation results and security analysis demonstrate that the proposed algorithm is effective and able to resist various typical attacks, and thus is an excellent candidate for secure image communication application.

Effect of L-methionine supplementation on plasma homocysteine and other free amino acids: a placebo-controlled double-blind cross-over study.

PubMed

Ditscheid, B; Fünfstück, R; Busch, M; Schubert, R; Gerth, J; Jahreis, G

2005-06-01

The essential amino acid L-methionine is a potential compound in the prophylaxis of recurrent or relapsing urinary tract infection due to acidification of urine. As an intermediate of L-methionine metabolism, homocysteine is formed. The objective was to study the metabolism of L-methionine and homocysteine, and to assess whether there are differences between patients with chronic urinary tract infection and healthy control subjects. A randomized placebo-controlled double-blind intervention study with cross-over design. Department of Nutritional Physiology, Institute of Nutrition in cooperation with the Department of Internal Medicine III, Friedrich Schiller University of Jena, Germany. Eight female patients with chronic urinary tract infection and 12 healthy women (controls). After a methionine-loading test, the volunteers received 500 mg L-methionine or a placebo three times daily for 4 weeks. Serum and urinary concentrations of methionine, homocysteine, cystathionine, cystine, serine, glycine and serum concentrations of vitamin B12, B6 and the state of folate. Homocysteine plasma concentrations increased from 9.4+/-2.7 micromol/l (patients) and 8.9+/-1.8 micromol/l (controls) in the placebo period to 11.2+/-4.1 micromol/l (P=0.031) and 11.0+/-2.3 micromol/l (P=0.000), respectively, during L-methionine supplementation. There were significant increases in serum methionine (53.6+/-22.0 micromol/l; P=0.003; n=20) and cystathionine (0.62+/-0.30 micromol/l; P=0.000; n=20) concentrations compared with the placebo period (33.0+/-12.0 and 0.30+/-0.10 micromol/l; n=20). Simultaneously, renal excretion of methionine and homocysteine was significantly higher during L-methionine intake. Despite an adequate vitamin status, the supplementation of 1500 mg of L-methionine daily significantly increases homocysteine plasma concentrations by an average of 2.0 micromol/l in patients and in control subjects. An optimal vitamin supplementation, especially with folate, might prevent such an increase.

Self-Medication among School Students

ERIC Educational Resources Information Center

ALBashtawy, Mohammed; Batiha, Abdul-Monim; Tawalbeh, Loai; Tubaishat, Ahmad; AlAzzam, Manar

2015-01-01

Self-medication, usually with over-the-counter (OTC) medication, is reported as a community health problem that affects many people worldwide. Most self-medication practice usually begins with the onset of adolescence. A school-based cross-sectional study was conducted in Mafraq Governorate, Jordan, using a simple random sampling method to select…

Natto and viscous vegetables in a Japanese style meal suppress postprandial glucose and insulin responses.

PubMed

Taniguchi, Akiko; Yamanaka-Okumura, Hisami; Nishida, Yuka; Yamamoto, Hironori; Taketani, Yutaka; Takeda, Eiji

2008-01-01

Naturally viscous vegetables and natto, made by fermenting soybeans, are very palatable and considered to be healthy foods in Japan. The objective was to assess whether the consumption of natto and viscous vegetables as part of a traditional Japanese breakfast based on high-glycemic index white rice affects glycemic, insulinemic, lipidemic and satiety responses in healthy subjects. Eleven healthy subjects consumed the reference, control and test meals in a randomized cross-over design. The test meal, comprising 200 g of boiled white rice with viscous meal (50 g natto, 60 g Japanese yams and 40 g okras), and the control meal, comprising 200 g of white rice with non-viscous boiled soybeans, potatoes and broccoli, contained comparable amounts of carbohydrate, fat, protein and fiber. In addition, whiter rice was used as a reference meal. Blood samples over 180 min were analyzed for glucose, insulin, non-esterified free fatty acid and triacylglyceride. Peak glucose and insulin concentrations after the test meal (6.0 mmol/L and 262 pmol/L) were significantly lower than after the control meal (6.8 mmol/L and 360 pmol/L). The incremental areas under the curve for glucose and insulin over 0-120 min after the test meal were also significantly reduced as compared with the control meal (28 and 27%). The consumption of naturally viscous vegetables with white rice reduced acute glycemia and insulinemia. This practical dietary combination would ensure compliance and favorably alter the risk for diabetes and cardiovascular diseases.

A Walnut-Enriched Diet Affects Gut Microbiome in Healthy Caucasian Subjects: A Randomized, Controlled Trial

PubMed Central

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Fischer, Sandra; Altenhofer, Julia; Henze, Kerstin; Parhofer, Klaus G.

2018-01-01

Regular walnut consumption is associated with better health. We have previously shown that eight weeks of walnut consumption (43 g/day) significantly improves lipids in healthy subjects. In the same study, gut microbiome was evaluated. We included 194 healthy subjects (134 females, 63 ± 7 years, BMI 25.1 ± 4.0 kg/m2) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (eight weeks each); 96 subjects first followed a walnut-enriched diet (43 g/day) and then switched to a nut-free diet, while 98 subjects followed the diets in reverse order. While consuming the walnut-enriched diet, subjects were advised to either reduce fat or carbohydrates or both to account for the additional calories. Fecal samples were collected from 135 subjects at the end of the walnut-diet and the control-diet period for microbiome analyses. The 16S rRNA gene sequencing data was clustered with a 97% similarity into Operational Taxonomic Units (OTUs). UniFrac distances were used to determine diversity between groups. Differential abundance was evaluated using the Kruskal–Wallis rank sum test. All analyses were performed using Rhea. Generalized UniFrac distance shows that walnut consumption significantly affects microbiome composition and diversity. Multidimensional scaling (metric and non-metric) indicates dissimilarities of approximately 5% between walnut and control (p = 0.02). The abundance of Ruminococcaceae and Bifidobacteria increased significantly (p < 0.02) while Clostridium sp. cluster XIVa species (Blautia; Anaerostipes) decreased significantly (p < 0.05) during walnut consumption. The effect of walnut consumption on the microbiome only marginally depended on whether subjects replaced fat, carbohydrates or both while on walnuts. Daily intake of 43 g walnuts over eight weeks significantly affects the gut microbiome by enhancing probiotic- and butyric acid-producing species in healthy individuals. Further evaluation is required to establish whether these changes are preserved during longer walnut consumption and how these are linked to the observed changes in lipid metabolism. PMID:29470389

Does a 20-week aerobic exercise training programme increase our capabilities to buffer real-life stressors? A randomized, controlled trial using ambulatory assessment.

PubMed

von Haaren, Birte; Ottenbacher, Joerg; Muenz, Julia; Neumann, Rainer; Boes, Klaus; Ebner-Priemer, Ulrich

2016-02-01

The cross-stressor adaptation hypothesis suggests that regular exercise leads to adaptations in the stress response systems that induce decreased physiological responses to psychological stressors. Even though an exercise intervention to buffer the detrimental effects of psychological stressors on health might be of utmost importance, empirical evidence is mixed. This may be explained by the use of cross-sectional designs and non-personally relevant stressors. Using a randomized controlled trial, we hypothesized that a 20-week aerobic exercise training does reduce physiological stress responses to psychological real-life stressors in sedentary students. Sixty-one students were randomized to either a control group or an exercise training group. The academic examination period (end of the semester) served as a real-life stressor. We used ambulatory assessment methods to assess physiological stress reactivity of the autonomic nervous system (heart rate variability: LF/HF, RMSSD), physical activity and perceived stress during 2 days of everyday life and multilevel models for data analyses. Aerobic capacity (VO2max) was assessed pre- and post-intervention via cardiopulmonary exercise testing to analyze the effectiveness of the intervention. During real-life stressors, the exercise training group showed significantly reduced LF/HF (β = -0.15, t = -2.59, p = .01) and increased RMSSD (β = 0.15, t = 2.34, p = .02) compared to the control group. Using a randomized controlled trial and a real-life stressor, we could show that exercise appears to be a useful preventive strategy to buffer the effects of stress on the autonomic nervous system, which might result into detrimental health outcomes.

Plasma variations in stress markers: Clinical trial of two anesthetics used in regional block in the extraction of impacted inferior third molars

PubMed Central

Arteagoitia, Iciar; Zumarraga, Mercedes; Dávila, Ricardo; Barbier, Luis; Santamaría, Gorka

2014-01-01

Objectives: Was to evaluate the effect of different regional anesthetics (articaine with epinephrine versus prilocaine with felypressin) on stress in the extraction of impacted lower third molars in healthy subjects. Sutdy Desing: A prospective single-blind, split-mouth cross-over randomized study was designed, with a control group. The experimental group consisted of 24 otherwise healthy male volunteers, with two impacted lower third molars which were surgically extracted after inferior alveolar nerve block (regional anesthesia), with a fortnight’s interval: the right using 4% articaine with 1:100.000 epinephrine, and the left 3% prilocaine with 1:1.850.000 felypressin. Patients were randomized for the first surgical procedure. To analyze the variation in four stress markers, homovanillic acid, 3-methoxy-4-hydroxyphenylglycol, prolactin and cortisol, 10-mL blood samples were obtained at t = 0, 5, 60, and 120 minutes. The control group consisted of 12 healthy volunteers, who did not undergo either extractions or anesthetic procedures but from whom blood samples were collected and analyzed in the same way. Results: Plasma cortisol increased in the experimental group (multiple range test, P<0.05), the levels being significantly higher in the group receiving 3% prilocaine with 1:1.850,000 felypressin (signed rank test, p<0.0007). There was a significant reduction in homovanillic acid over time in both groups (multiple range test, P<0.05). No significant differences were observed in homovanillic acid, 3-methoxy-4-hydroxyphenylglycol or prolactin concentrations between the experimental and control groups. Conclusions: The effect of regional anesthesia on stress is lower when 4% articaine with 1:100,000 epinephrine is used in this surgical procedure. Key words:Stress markets, epinephrine versus felypressin. PMID:24316704

The short-term treatment effects on the microbiota at the dorsum of the tongue in intra-oral halitosis patients--a randomized clinical trial.

PubMed

Ademovski, Seida Erovic; Persson, G Rutger; Winkel, Edwin; Tangerman, Albert; Lingström, Peter; Renvert, Stefan

2013-03-01

This study aims to assess the effects of rinsing with zinc- and chlorhexidine-containing mouth rinse with or without adjunct tongue scraping on volatile sulfur compounds (VSCs) in breath air, and the microbiota at the dorsum of the tongue. A randomized single-masked controlled clinical trial with a cross-over study design over 14 days including 21 subjects was performed. Bacterial samples from the dorsum of the tongue were assayed by checkerboard DNA-DNA hybridization. No halitosis (identified by VSC assessments) at day 14 was identified in 12/21 subjects with active rinse alone, in 10/21 with adjunct use of tongue scraper, in 1/21 for negative control rinse alone, and in 3/21 in the control and tongue scraping sequence. At day 14, significantly lower counts were identified only in the active rinse sequence (p < 0.001) for 15/78 species including, Fusobacterium sp., Porphyromonas gingivalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Tannerella forsythia. A decrease in bacteria from baseline to day 14 was found in successfully treated subjects for 9/74 species including: P. gingivalis, Prevotella melaninogenica, S. aureus, and Treponema denticola. Baseline VSC scores were correlated with several bacterial species. The use of a tongue scraper combined with active rinse did not change the levels of VSC compared to rinsing alone. VSC scores were not associated with bacterial counts in samples taken from the dorsum of the tongue. The active rinse alone containing zinc and chlorhexidine had effects on intra-oral halitosis and reduced bacterial counts of species associated with malodor. Tongue scraping provided no beneficial effects on the microbiota studied. Periodontally healthy subjects with intra-oral halitosis benefit from daily rinsing with zinc- and chlorhexidine-containing mouth rinse.

Impact of Probiotics on Necrotizing Enterocolitis

PubMed Central

Underwood, Mark A.

2016-01-01

A large number of randomized placebo-controlled clinical trials and cohort studies have demonstrated a decrease in the incidence of necrotizing enterocolitis with administration of probiotic microbes. These studies have prompted many neonatologists to adopt routine prophylactic administration of probiotics while others await more definitive studies and/or probiotic products with demonstrated purity and stable numbers of live organisms. Cross-contamination and inadequate sample size limit the value of further traditional placebo-controlled randomized controlled trials. Key areas for future research include mechanisms of protection, optimum probiotic species or strains (or combinations thereof) and duration of treatment, interactions between diet and the administered probiotic, and the influence of genetic polymorphisms in the mother and infant on probiotic response. Next generation probiotics selected based on bacterial genetics rather than ease of production and large cluster-randomized clinical trials hold great promise for NEC prevention. PMID:27836423

Extra virgin olive oil phenols and markers of oxidation in Greek smokers: a randomized cross-over study.

PubMed

Moschandreas, J; Vissers, M N; Wiseman, S; van Putte, K P; Kafatos, A

2002-10-01

To examine the effect of a low phenol olive oil and high phenol olive oil on markers of oxidation and plasma susceptibility to oxidation in normolipaemic smokers. Randomized single-blind cross-over trial with two intervention periods. The Medical School and University Hospital of the University of Crete, Heraklion, Crete, Greece. Twenty-five healthy males and females completed the study. Each intervention was of three weeks duration and intervention periods were separated by a two week washout. Seventy grams of extra virgin olive oil was supplied to each subject per day in the intervention periods. The olive oils supplied differed in their phenol content by 18.6 mg/day. Two fasting venous blood samples were taken at the end of each intervention period. The markers of antioxidant capacity measured in fasting plasma samples (total plasma resistance to oxidation, concentrations of protein carbonyl as a marker of protein oxidation, malondialdehyde and lipid hydroperoxides as markers of lipid oxidation and the ferric reducing ability of plasma) did not differ significantly between the low and high phenol olive oil diets. No effect of olive oil phenols on markers of oxidation in smokers was detected. It may be that the natural concentrations of phenols in olive oil are too low to produce an effect in the post-absorptive phase. Possible reasons for period effects and interactions between diet and administration period need attention to aid further cross-over trials of this kind. Unilever Research Vlaardingen, The Netherlands.

A single-dose of oral nattokinase potentiates thrombolysis and anti-coagulation profiles.

PubMed

Kurosawa, Yuko; Nirengi, Shinsuke; Homma, Toshiyuki; Esaki, Kazuki; Ohta, Mitsuhiro; Clark, Joseph F; Hamaoka, Takafumi

2015-06-25

Our aim was to determine the quantitative effects of a single-dose of Nattokinase (NK) administration on coagulation/fibrinolysis parameters comprehensively in healthy male subjects. A double-blind, placebo-controlled cross-over NK intervention study was carried out in 12 healthy young males. Following the baseline blood draw, each subject was randomized to receive either a single-dose of 2,000 FU NK (NSK-SD, Japan Bio Science Laboratory Co., Ltd) or placebo with subsequent cross-over of the groups. Subjects donated blood samples at 2, 4, 6 and 8 hours following administration for analysis of coagulation/fibrinolysis parameters. As a result, D-dimer concentrations at 6, and 8 hours, and blood fibrin/fibrinogen degradation products at 4 hours after NK administration elevated significantly (p < 0.05, respectively). Factor VIII activity declined at 4 and 6 hours (p < 0.05, respectively), blood antithrombin concentration was higher at 2 and 4 hours (p < 0.05, respectively), and the activated partial thromboplastin time prolonged significantly at 2 and 4 hours following NK administration (p < 0.05 and p < 0.01, respectively). All the changes, however, were within the normal range. In conclusion, thus, a single-dose of NK administration appears enhancing fibrinolysis and anti-coagulation via several different pathways simultaneously.

ANTIPLAQUE AND ANTIGINGIVITIS EFFECT OF LIPPIA SIDOIDES. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

PubMed Central

Rodrigues, Ítalo Sarto Carvalho; Tavares, Vinícius Nascimento; Pereira, Sérgio Luís da Silva; da Costa, Flávio Nogueira

2009-01-01

Objectives: The antiplaque and antigingivitis effect of Lippia Sidoides (LS) was evaluated in this in vivo investigation. Material and Methods: Twenty-three subjects participated in a cross-over, double-blind clinical study, using 21-day partial-mouth experimental model of gingivitis. A toothshield was constructed for each volunteer, avoiding the brushing of the 4 experimental posterior teeth in the lower left quadrant. The subjects were randomly assigned initially to use either the placebo gel (control group) or the test gel, containing 10% LS (test group). Results: The clinical results showed statistically significant differences for plaque index (PLI) (p<0.01) between days 0 and 21 in both groups, however only the control group showed statistically significant difference (p<0.01) for the bleeding (IB) and gingival (GI) index within the experimental period of 21 days. On day 21, the test group presented significantly better results than the control group with regard to the GI (p<0.05). Conclusions: The test gel containing 10% LS was effective in the control of gingivitis. PMID:19936516

The Anticaries Effect of a Food Extract (Shiitake) in a Short-Term Clinical Study

PubMed Central

Lingström, Peter; Zaura, Egija; Hassan, Haidar; Buijs, Mark J.; Hedelin, Pamie; Pratten, Jonathan; Spratt, David; Daglia, Maria; Karbowiak, Aneta; Signoretto, Caterina; Rosema, Martijn; van der Weijden, Fridus; Wilson, Michael

2012-01-01

The main objective was to investigate whether low-molecular-weight fraction of edible mushroom shiitake extract (Lentinus edodes) possesses caries-preventive properties. The study was designed as a double-blind, three-leg, cross-over, randomized, controlled clinical trial carried out on two series of volunteers at the University of Gothenburg, and the Academic Centre for Dentistry Amsterdam. Volunteers rinsed twice daily with a solution containing low-molecular-weight fraction of edible mushroom, placebo (negative control without active ingredients), or Meridol (positive control, AmF-SnF2) for two weeks, with a two-week washout period between each rinsing period. Changes in the acidogenicity of dental plaque before and after a sucrose challenge, shifts in microbial composition, and plaque scores were determined. Frequent rinses with shiitake reduced the metabolic activity of dental plaque. No reduction of plaque scores and no inhibition of the production of organic acids in plaque was found. Minor differences in microbial composition between test sessions were found. To conclude, the results indicate that shiitake extract has anticariogenic potential, but not to the same extent as the positive control. PMID:22500081

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

PubMed

Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

2015-01-01

Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

Cross-Layer Adaptive Feedback Scheduling of Wireless Control Systems

PubMed Central

Xia, Feng; Ma, Longhua; Peng, Chen; Sun, Youxian; Dong, Jinxiang

2008-01-01

There is a trend towards using wireless technologies in networked control systems. However, the adverse properties of the radio channels make it difficult to design and implement control systems in wireless environments. To attack the uncertainty in available communication resources in wireless control systems closed over WLAN, a cross-layer adaptive feedback scheduling (CLAFS) scheme is developed, which takes advantage of the co-design of control and wireless communications. By exploiting cross-layer design, CLAFS adjusts the sampling periods of control systems at the application layer based on information about deadline miss ratio and transmission rate from the physical layer. Within the framework of feedback scheduling, the control performance is maximized through controlling the deadline miss ratio. Key design parameters of the feedback scheduler are adapted to dynamic changes in the channel condition. An event-driven invocation mechanism for the feedback scheduler is also developed. Simulation results show that the proposed approach is efficient in dealing with channel capacity variations and noise interference, thus providing an enabling technology for control over WLAN. PMID:27879934

Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials

PubMed Central

Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R.; Ramstad, Erica; Magnusson, Frederik Løgstrup; Krogh, Helle B.; Groth, Camilla; Gillies, Donna; Zwi, Morris; Skoog, Maria; Gluud, Christian; Simonsen, Erik

2017-01-01

Objectives To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. Methods and findings We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. Conclusion Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found. PMID:28617801

Extension of the Haseman-Elston regression model to longitudinal data.

PubMed

Won, Sungho; Elston, Robert C; Park, Taesung

2006-01-01

We propose an extension to longitudinal data of the Haseman and Elston regression method for linkage analysis. The proposed model is a mixed model having several random effects. As response variable, we investigate the sibship sample mean corrected cross-product (smHE) and the BLUP-mean corrected cross product (pmHE), comparing them with the original squared difference (oHE), the overall mean corrected cross-product (rHE), and the weighted average of the squared difference and the squared mean-corrected sum (wHE). The proposed model allows for the correlation structure of longitudinal data. Also, the model can test for gene x time interaction to discover genetic variation over time. The model was applied in an analysis of the Genetic Analysis Workshop 13 (GAW13) simulated dataset for a quantitative trait simulating systolic blood pressure. Independence models did not preserve the test sizes, while the mixed models with both family and sibpair random effects tended to preserve size well. Copyright 2006 S. Karger AG, Basel.

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

PubMed

Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

2017-10-18

The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic information exchange methods, technical assistance through a knowledge broker, and organizational changes to support evidence-based public health approaches. Evaluation methods comprise surveys at baseline and the three crossover time points, abstraction of local-level diabetes and chronic disease control program plans and progress reports, and social network analysis to understand the relationships and contextual issues that influence EBPP adoption. ClinicalTrial.gov, NCT03211832.

H∞ control for uncertain linear system over networks with Bernoulli data dropout and actuator saturation.

PubMed

Yu, Jimin; Yang, Chenchen; Tang, Xiaoming; Wang, Ping

2018-03-01

This paper investigates the H ∞ control problems for uncertain linear system over networks with random communication data dropout and actuator saturation. The random data dropout process is modeled by a Bernoulli distributed white sequence with a known conditional probability distribution and the actuator saturation is confined in a convex hull by introducing a group of auxiliary matrices. By constructing a quadratic Lyapunov function, effective conditions for the state feedback-based H ∞ controller and the observer-based H ∞ controller are proposed in the form of non-convex matrix inequalities to take the random data dropout and actuator saturation into consideration simultaneously, and the problem of non-convex feasibility is solved by applying cone complementarity linearization (CCL) procedure. Finally, two simulation examples are given to demonstrate the effectiveness of the proposed new design techniques. Copyright © 2018 ISA. Published by Elsevier Ltd. All rights reserved.

Does short-term whole-body vibration training affect arterial stiffness in chronic stroke? A preliminary study

PubMed Central

Yule, Christie E.; Stoner, Lee; Hodges, Lynette D.; Cochrane, Darryl J.

2016-01-01

[Purpose] Previous studies have shown that stroke is associated with increased arterial stiffness that can be diminished by a program of physical activity. A novel exercise intervention, whole-body vibration (WBV), is reported to significantly improve arterial stiffness in healthy men and older sedentary adults. However, little is known about its efficacy in reducing arterial stiffness in chronic stroke. [Subjects and Methods] Six participants with chronic stroke were randomly assigned to 4 weeks of WBV training or control followed by cross-over after a 2-week washout period. WBV intervention consisted of 3 sessions of 5 min intermittent WBV per week for 4 weeks. Arterial stiffness (carotid arterial stiffness, pulse wave velocity [PWV], pulse and wave analysis [PWA]) were measured before/after each intervention. [Results] No significant improvements were reported with respect to carotid arterial stiffness, PWV, and PWA between WBV and control. However, carotid arterial stiffness showed a decrease over time following WBV compared to control, but this was not significant. [Conclusion] Three days/week for 4 weeks of WBV seems too short to elicit appropriate changes in arterial stiffness in chronic stroke. However, no adverse effects were reported, indicating that WBV is a safe and acceptable exercise modality for people with chronic stroke. PMID:27134400

Integrated Schistosomiasis and Soil-Transmitted Helminthiasis Control over Five Years on Kome Island, Tanzania

PubMed Central

Kaatano, Godfrey M.; Siza, Julius E.; Mwanga, Joseph R.; Min, Duk-Yong; Yong, Tai-Soon; Chai, Jong-Yil; Ko, Yunsuk; Chang, Su Young; Kullaya, Cyril M.; Rim, Han-Jong; Changalucha, John M.; Eom, Keeseon S.

2015-01-01

Integrated control strategies are important for sustainable control of schistosomiasis and soil-transmitted helminthiasis, despite their challenges for their effective implementation. With the support of Good Neighbors International in collaboration with National Institute of Medical Research, Mwanza, Tanzania, integrated control applying mass drug administration (MDA), health education using PHAST, and improved safe water supply has been implemented on Kome Island over 5 years for controlling schistosomiasis and soil-transmitted helminths (STHs). Baseline surveys for schistosomiasis and STHs was conducted before implementation of any integrated control strategies, followed by 4 cross-sectional follow-up surveys on randomly selected samples of schoolchildren and adults in 10 primary schools and 8 villages, respectively, on Kome islands. Those follow-up surveys were conducted for impact evaluation after introduction of control strategies interventions in the study area. Five rounds of MDA have been implemented from 2009 along with PHAST and improved water supply with pumped wells as other control strategies for complementing MDA. A remarkable steady decline of schistosomiasis and STHs was observed from 2009 to 2012 with significant trends in their prevalence decline, and thereafter infection rate has remained at a low sustainable control. By the third follow-up survey in 2012, Schistosoma mansoni infection prevalence was reduced by 90.5% and hookworm by 93.3% among schoolchildren while in adults the corresponding reduction was 83.2% and 56.9%, respectively. Integrated control strategies have successfully reduced S. mansoni and STH infection status to a lower level. This study further suggests that monitoring and evaluation is a crucial component of any large-scale STH and schistosomiasis intervention. PMID:26537032

Integrated Schistosomiasis and Soil-Transmitted Helminthiasis Control over Five Years on Kome Island, Tanzania.

PubMed

Kaatano, Godfrey M; Siza, Julius E; Mwanga, Joseph R; Min, Duk-Yong; Yong, Tai-Soon; Chai, Jong-Yil; Ko, Yunsuk; Chang, Su Young; Kullaya, Cyril M; Rim, Han-Jong; Changalucha, John M; Eom, Keeseon S

2015-10-01

Integrated control strategies are important for sustainable control of schistosomiasis and soil-transmitted helminthiasis, despite their challenges for their effective implementation. With the support of Good Neighbors International in collaboration with National Institute of Medical Research, Mwanza, Tanzania, integrated control applying mass drug administration (MDA), health education using PHAST, and improved safe water supply has been implemented on Kome Island over 5 years for controlling schistosomiasis and soil-transmitted helminths (STHs). Baseline surveys for schistosomiasis and STHs was conducted before implementation of any integrated control strategies, followed by 4 cross-sectional follow-up surveys on randomly selected samples of schoolchildren and adults in 10 primary schools and 8 villages, respectively, on Kome islands. Those follow-up surveys were conducted for impact evaluation after introduction of control strategies interventions in the study area. Five rounds of MDA have been implemented from 2009 along with PHAST and improved water supply with pumped wells as other control strategies for complementing MDA. A remarkable steady decline of schistosomiasis and STHs was observed from 2009 to 2012 with significant trends in their prevalence decline, and thereafter infection rate has remained at a low sustainable control. By the third follow-up survey in 2012, Schistosoma mansoni infection prevalence was reduced by 90.5% and hookworm by 93.3% among schoolchildren while in adults the corresponding reduction was 83.2% and 56.9%, respectively. Integrated control strategies have successfully reduced S. mansoni and STH infection status to a lower level. This study further suggests that monitoring and evaluation is a crucial component of any large-scale STH and schistosomiasis intervention.

Academic Specialisation and Returns to Education: Evidence from India

ERIC Educational Resources Information Center

Saha, Bibhas; Sensarma, Rudra

2011-01-01

We study returns to academic specialisation for Indian corporate sector workers by analysing cross-sectional data on male employees randomly selected from six large firms. Our analysis shows that going to college pays off, as it brings significant incremental returns over and above school education. However, the increase in returns is more…

Can inhibitory and facilitatory kinesiotaping techniques affect motor neuron excitability? A randomized cross-over trial.

PubMed

Yoosefinejad, Amin Kordi; Motealleh, Alireza; Abbasalipur, Shekoofeh; Shahroei, Mahan; Sobhani, Sobhan

2017-04-01

The aim of this study was to investigate the immediate effects of facilitatory and inhibitory kinesiotaping on motor neuron excitability. Randomized cross-over trial. Twenty healthy people received inhibitory and facilitatory kinesiotaping on two testing days. The H- and M-waves of the lateral gasterocnemius were recorded before and immediately after applying the two modes of taping. The Hmax/Mmax ratio (a measure of motor neuron excitability) was determined and analyzed. The mean Hmax/Mmax ratios were -0.013 (95% CI: -0.033 to 0.007) for inhibitory taping and 0.007 (95% CI: -0.013 to 0.027) for facilitatory taping. The mean difference between groups was -0.020 (95% CI: -0.048 to 0.008). The statistical model revealed no significant differences between the two interventions (P = 0.160). Furthermore, there were no within-group differences in Hmax/Mmax ratio for either group. Our findings did not disclose signs of immediate change in motor neuron excitability in the lateral gasterocnemius. Copyright © 2016. Published by Elsevier Ltd.

Phenol-enriched olive oils improve HDL antioxidant content in hypercholesterolemic subjects. A randomized, double-blind, cross-over, controlled trial.

PubMed

Farràs, Marta; Fernández-Castillejo, Sara; Rubió, Laura; Arranz, Sara; Catalán, Úrsula; Subirana, Isaac; Romero, Mari-Paz; Castañer, Olga; Pedret, Anna; Blanchart, Gemma; Muñoz-Aguayo, Daniel; Schröder, Helmut; Covas, Maria-Isabel; de la Torre, Rafael; Motilva, Maria-José; Solà, Rosa; Fitó, Montserrat

2018-01-01

At present, high-density lipoprotein (HDL) function is thought to be more relevant than HDL cholesterol quantity. Consumption of olive oil phenolic compounds (PCs) has beneficial effects on HDL-related markers. Enriched food with complementary antioxidants could be a suitable option to obtain additional protective effects. Our aim was to ascertain whether virgin olive oils (VOOs) enriched with (a) their own PC (FVOO) and (b) their own PC plus complementary ones from thyme (FVOOT) could improve HDL status and function. Thirty-three hypercholesterolemic individuals ingested (25 ml/day, 3 weeks) (a) VOO (80 ppm), (b) FVOO (500 ppm) and (c) FVOOT (500 ppm) in a randomized, double-blind, controlled, crossover trial. A rise in HDL antioxidant compounds was observed after both functional olive oil interventions. Nevertheless, α-tocopherol, the main HDL antioxidant, was only augmented after FVOOT versus its baseline. In conclusion, long-term consumption of phenol-enriched olive oils induced a better HDL antioxidant content, the complementary phenol-enriched olive oil being the one which increased the main HDL antioxidant, α-tocopherol. Complementary phenol-enriched olive oil could be a useful dietary tool for improving HDL richness in antioxidants. Copyright © 2017. Published by Elsevier Inc.

Effect of restricted protein diet supplemented with keto analogues in chronic kidney disease: a systematic review and meta-analysis.

PubMed

Jiang, Zheng; Zhang, Xiaoyan; Yang, Lichuan; Li, Zi; Qin, Wei

2016-03-01

To evaluate the efficacy and safety of the restricted protein diet (low or very low protein diet) supplemented with keto analogues in the treatment of chronic kidney disease (CKD). The Cochrane library, PubMed, Embase, CBM and CENTRAL databases were searched and reviewed up to April 2015. Clinical trials were analyzed using RevMan 5.3 software. Seven random control trials, one cross-over trial and one non-randomized concurrent control trial were selected and included in this study according to our inclusion and exclusion criteria. The changes of eGFR, BUN, Scr, albumin, PTH, triglyceride, cholesterol, calcium, phosphorus and nutrition indexes (BMI, lean body mass and mid-arm muscular circumference) before and after treatment were analyzed. The meta-analysis results indicated that, comparing with normal protein diet, low protein diet (LPD) or very low protein diet (vLPD) supplemented with keto analogues (s(v)LPD) could significantly prevent the deterioration of eGFR (P < 0.001), hyperparathyroidism (P = 0.04), hypertension (P < 0.01) and hyperphosphatemia (P < 0.001). No differences in BUN, Scr, Albumin, triglyceride, cholesterol, hemoglobin, calcium and nutrition indexes were observed between different protein intake groups. Restricted protein diet supplemented with keto analogues (s(v)LPD) could delay the progression of CKD effectively without causing malnutrition.

Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa.

PubMed

Bågesund, Mats; Tabrizi, Parisa

2008-11-01

Topical anaesthetics are important to provide pain control at dental injection. The aim was to evaluate the effectiveness of the intraoral topical anaesthetics lidocaine 20% patch (DentiPatch) and lidocaine 5% gel. The randomized unblinded cross-over study included 31 patients (ten boys, 21 girls) aged 13.5 +/- 2.5 years. Application of lidocaine patch or gel was randomly used at first and second visit in the upper premolar region. Heart rate was measured before and at each needle insertion after 2.5, 5, and 15 min and at injection after 15 min. Discomfort and pain were expressed in visual analogue scales (VAS). Paired t-test and Mann-Whitney U-test were used for statistic analyses. Heart rate at buccal injection decreased more when the patch was used (P = 0.0149). Heart rate was lower at the second visit (P = 0.0287). Patients expressed less discomfort when the patch was used on both buccal (P = 0.0150) and palatal (P = 0.0391) site. Boys had lower heart rate and VAS pain scale ratings than girls. Good pain control can reduce the patients' anxiety level--expressed in heart rate--at the second appointment. The patch and gel seem to provide similar pain reduction at needle stick and injection of local anaesthetics.

A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

PubMed Central

Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

2015-01-01

Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

The effect of chronic progressive-dose sodium bicarbonate ingestion on CrossFit-like performance: A double-blind, randomized cross-over trial

PubMed Central

Zawieja, Emilia E.; Podgórski, Tomasz; Łoniewski, Igor; Zawieja, Bogna E.

2018-01-01

Background Sodium bicarbonate (SB) has been proposed as an ergogenic aid, as it improves high-intensity and resistance exercise performance. However, no studies have yet investigated SB application in CrossFit. This study examined the effects of chronic, progressive-dose SB ingestion on CrossFit-like performance and aerobic capacity. Methods In a randomized, double-blind, cross-over trial, 21 CrossFit-trained participants were randomly allocated to 2 groups and underwent 2 trials separated by a 14-day washout period. Participants ingested either up to 150 mg∙kg-1 of SB in a progressive-dose regimen or placebo for 10 days. Before and after each trial, Fight Gone Bad (FGB) and incremental cycling (ICT) tests were performed. In order to examine biochemical responses, blood samples were obtained prior to and 3 min after completing each exercise test. Results No gastrointestinal (GI) side effects were reported during the entire protocol. The overall FGB performance improved under SB by ~6.1% (p<0.001) and it was ~3.1% higher compared to post placebo (PLApost) (p = 0.040). The number of repetitions completed in each round also improved under SB (mean from baseline: +5.8% to +6.4%). Moreover, in ICT, the time to ventilatory threshold (VT) (~8:25 min SBpost vs. ~8:00 min PLApost, p = 0.020), workload at VT (~218 W SBpost vs. ~208 W PLApost, p = 0.037) and heart rate at VT (~165 bpm SBpost vs. ~161 bpm PLApost, p = 0.030) showed higher SBpost than PLApost. Furthermore, the maximum carbon dioxide production increased under SB by ~4.8% (from ~3604 mL∙min-1 to ~3776 mL∙min-1, p = 0.049). Pyruvate concentration and creatine kinase activity before ICT showed higher SBpost than PLApost (~0.32 mmol∙L-1 vs. ~0.26 mmol∙L-1, p = 0.001; ~275 U∙L-1 vs. ~250 U∙L-1, p = 0.010, respectively). However, the small sample size limits the wide-application of our results. Conclusions Progressive-dose SB ingestion regimen eliminated GI side effects and improved CrossFit-like performance, as well as delayed ventilatory threshold occurrence. PMID:29771966

To Compare PubMed Clinical Queries and UpToDate in Teaching Information Mastery to Clinical Residents: A Crossover Randomized Controlled Trial

PubMed Central

Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

2011-01-01

Purpose To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. Method A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Results Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (P<0.001). The median time to answer retrieval was 17 min (95% CI: 16 to 18) using UpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (P<0.001). The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001). Conclusions For first time users, using UpToDate compared to Pubmed Clinical Querries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient. PMID:21858142

To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

PubMed

Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

2011-01-01

To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (P<0.001). The median time to answer retrieval was 17 min (95% CI: 16 to 18) using UpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (P<0.001). The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001). For first time users, using UpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

Pyridinium cross-links in bone of patients with osteogenesis imperfecta: evidence of a normal intrafibrillar collagen packing.

PubMed

Bank, R A; Tekoppele, J M; Janus, G J; Wassen, M H; Pruijs, H E; Van der Sluijs, H A; Sakkers, R J

2000-07-01

The brittleness of bone in patients with osteogenesis imperfecta (OI) has been attributed to an aberrant collagen network. However, the role of collagen in the loss of tissue integrity has not been well established. To gain an insight into the biochemistry and structure of the collagen network, the cross-links hydroxylysylpyridinoline (HP) and lysylpyridinoline (LP) and the level of triple helical hydroxylysine (Hyl) were determined in bone of OI patients (types I, III, and IV) as well as controls. The amount of triple helical Hyl was increased in all patients. LP levels in OI were not significantly different; in contrast, the amount of HP (and as a consequence the HP/LP ratio and the total pyridinoline level) was significantly increased. There was no relationship between the sum of pyridinolines and the amount of triple helical Hyl, indicating that lysyl hydroxylation of the triple helix and the telopeptides are under separate control. Cross-linking is the result of a specific three-dimensional arrangement of collagens within the fibril; only molecules that are correctly aligned are able to form cross-links. Inasmuch as the total amount of pyridinoline cross-links in OI bone is similar to control bone, the packing geometry of intrafibrillar collagen molecules is not disturbed in OI. Consequently, the brittleness of bone is not caused by a disorganized intrafibrillar collagen packing and/or loss of cross-links. This is an unexpected finding, because mutant collagen molecules with a random distribution within the fibril are expected to result in disruptions of the alignment of neighboring collagen molecules. Pepsin digestion of OI bone revealed that collagen located at the surface of the fibril had lower cross-link levels compared with collagen located at the inside of the fibril, indicating that mutant molecules are not distributed randomly within the fibril but are located preferentially at the surface of the fibril.

Speckle lithography for fabricating Gaussian, quasi-random 2D structures and black silicon structures.

PubMed

Bingi, Jayachandra; Murukeshan, Vadakke Matham

2015-12-18

Laser speckle pattern is a granular structure formed due to random coherent wavelet interference and generally considered as noise in optical systems including photolithography. Contrary to this, in this paper, we use the speckle pattern to generate predictable and controlled Gaussian random structures and quasi-random structures photo-lithographically. The random structures made using this proposed speckle lithography technique are quantified based on speckle statistics, radial distribution function (RDF) and fast Fourier transform (FFT). The control over the speckle size, density and speckle clustering facilitates the successful fabrication of black silicon with different surface structures. The controllability and tunability of randomness makes this technique a robust method for fabricating predictable 2D Gaussian random structures and black silicon structures. These structures can enhance the light trapping significantly in solar cells and hence enable improved energy harvesting. Further, this technique can enable efficient fabrication of disordered photonic structures and random media based devices.

A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse with Injured Emergency Department Patients

PubMed Central

Mello, Michael J.; Baird, Janette; Lee, Christina; Strezsak, Valerie; French, Michael T.; Longabaugh, Richard

2015-01-01

Objective This was a randomized controlled trial to test efficacy of a telephone intervention (TBMI) for injured ED patients with alcohol misuse to decrease alcohol use, impaired driving, alcohol-related injuries and alcohol-related negative consequences. Methods ED patients screening positive for alcohol misuse were randomized to a three-session telephone brief motivational intervention on alcohol (TBMI) delivered by a counselor trained in motivational interviewing over 6 weeks or a control intervention of a scripted home fire and burn safety education delivered in three calls. Patients were followed for 12 months and assessed for changes in alcohol use, impaired driving, alcohol-related injuries and alcohol-related negative consequences. Results 730 ED patients were randomized; 78% received their assigned intervention by telephone and of those, 72% completed 12 months assessments. There were no differential benefits of TBMI intervention versus assessment and a control intervention in all three variables of alcohol use (frequency of binge alcohol use over the prior 30 days, maximum number of drinks at one time in past 30 days, typical alcohol use in past 30 days), alcohol impaired driving, alcohol related injuries and alcohol-related negative consequences. Conclusions Despite the potential advantage of delivering a TBMI in not disrupting ED clinical care, our study found no efficacy for it over an assessment and control intervention. Potential etiologies for our finding include that injury itself or alcohol assessments, or the control intervention had active ingredients for alcohol change. PMID:26585044

Modafinil Improves Real Driving Performance in Patients with Hypersomnia: A Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial

PubMed Central

Philip, Pierre; Chaufton, Cyril; Taillard, Jacques; Capelli, Aurore; Coste, Olivier; Léger, Damien; Moore, Nicholas; Sagaspe, Patricia

2014-01-01

Study Objective: Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance. Design and Participants: Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout. Measurements: Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed. Results: Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P < 0.05 and F(1,25) = 3.87, P = 0.06 tendency). Mean sleep latency at the Maintenance of Wakefulness Test significantly correlated with the mean number of Inappropriate Line Crossings (r = -0.41, P < 0.001). Conclusions: Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population. Citation: Philip P; Chaufton C; Taillard J; Capelli A; Coste O; Léger D; Moore N; Sagaspe P. Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial. SLEEP 2014;37(3):483-487. PMID:24587570

Active Control of the Forced and Transient Response of a Finite Beam. M.S. Thesis

NASA Technical Reports Server (NTRS)

Post, John Theodore

1989-01-01

When studying structural vibrations resulting from a concentrated source, many structures may be modelled as a finite beam excited by a point source. The theoretical limit on cancelling the resulting beam vibrations by utilizing another point source as an active controller is explored. Three different types of excitation are considered, harmonic, random, and transient. In each case, a cost function is defined and minimized for numerous parameter variations. For the case of harmonic excitation, the cost function is obtained by integrating the mean squared displacement over a region of the beam in which control is desired. A controller is then found to minimize this cost function in the control interval. The control interval and controller location are continuously varied for several frequencies of excitation. The results show that control over the entire beam length is possible only when the excitation frequency is near a resonant frequency of the beam, but control over a subregion may be obtained even between resonant frequencies at the cost of increasing the vibration outside of the control region. For random excitation, the cost function is realized by integrating the expected value of the displacement squared over the interval of the beam in which control is desired. This is shown to yield the identical cost function as obtained by integrating the cost function for harmonic excitation over all excitation frequencies. As a result, it is always possible to reduce the cost function for random excitation whether controlling the entire beam or just a subregion, without ever increasing the vibration outside the region in which control is desired. The last type of excitation considered is a single, transient pulse. A cost function representative of the beam vibration is obtained by integrating the transient displacement squared over a region of the beam and over all time. The form of the controller is chosen a priori as either one or two delayed pulses. Delays constrain the controller to be causal. The best possible control is then examined while varying the region of control and the controller location. It is found that control is always possible using either one or two control pulses. The two pulse controller gives better performance than a single pulse controller, but finding the optimal delay time for the additional controllers increases as the square of the number of control pulses.

Controlled clinical trial of cannabidiol in Huntington's disease.

PubMed

Consroe, P; Laguna, J; Allender, J; Snider, S; Stern, L; Sandyk, R; Kennedy, K; Schram, K

1991-11-01

Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.

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

ERIC Educational Resources Information Center

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

2010-01-01

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

Design, analysis, and testing of high frequency passively damped struts

NASA Technical Reports Server (NTRS)

Yiu, Y. C.; Davis, L. Porter; Napolitano, Kevin; Ninneman, R. Rory

1993-01-01

Objectives of the research are: (1) to develop design requirements for damped struts to stabilize control system in the high frequency cross-over and spill-over range; (2) to design, fabricate and test viscously damped strut and viscoelastically damped strut; (3) to verify accuracy of design and analysis methodology of damped struts; and (4) to design and build test apparatus, and develop data reduction algorithm to measure strut complex stiffness. In order to meet the stringent performance requirements of the SPICE experiment, the active control system is used to suppress the dynamic responses of the low order structural modes. However, the control system also inadvertently drives some of the higher order modes unstable in the cross-over and spill-over frequency range. Passive damping is a reliable and effective way to provide damping to stabilize the control system. It also improves the robustness of the control system. Damping is designed into the SPICE testbed as an integral part of the control-structure technology.

Effectiveness of traffic light vs. boom barrier controls at road-rail level crossings: a simulator study.

PubMed

Rudin-Brown, Christina M; Lenné, Michael G; Edquist, Jessica; Navarro, Jordan

2012-03-01

Although collisions at level crossings are relatively uncommon occurrences, the potential severity of their consequences make them a top priority among safety authorities. Twenty-five fully-licensed drivers aged between 20 and 50 years participated in a driving simulator study that compared the efficacy, and drivers' subjective perception, of two active level crossing traffic control devices: flashing lights with boom barriers and standard traffic lights. Because of its common usage in most states in Australia, a stop sign-controlled level crossing served as the passive referent. Although crossing violations were less likely at the level crossings controlled by active devices than at those controlled by stop signs, both kinds of active control were associated with a similar number of violations. Further, the majority (72%) of drivers reported preferring flashing lights to traffic lights. Collectively, results indicate that the installation of traffic lights at real-world level crossings would not be likely to offer safety benefits over and above those provided already by flashing lights with boom barriers. Furthermore, the high rate of violations at passively controlled crossings strongly supports the continued practice of upgrading level crossings with active traffic control devices. Copyright © 2011 Elsevier Ltd. All rights reserved.

Surgery versus physiotherapy for stress urinary incontinence.

PubMed

Labrie, Julien; Berghmans, Bary L C M; Fischer, Kathelijn; Milani, Alfredo L; van der Wijk, Ileana; Smalbraak, Dina J C; Vollebregt, Astrid; Schellart, René P; Graziosi, Giuseppe C M; van der Ploeg, J Marinus; Brouns, Joseph F G M; Tiersma, E Stella M; Groenendijk, Annette G; Scholten, Piet; Mol, Ben Willem; Blokhuis, Elisabeth E; Adriaanse, Albert H; Schram, Aaltje; Roovers, Jan-Paul W R; Lagro-Janssen, Antoine L M; van der Vaart, Carl H

2013-09-19

Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. We performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery. For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.).

Risk of fractures with selective serotonin-reuptake inhibitors or tricyclic antidepressants.

PubMed

Ginzburg, Regina; Rosero, Enma

2009-01-01

To evaluate the literature associating the risk of fracture during antidepressant therapy. Literature was identified via MEDLINE (1970-August 2008) using the search terms selective serotonin-reuptake inhibitors, tricyclic antidepressants, antidepressants, and fracture. Reference citations from publications identified were also reviewed. All articles in English identified from the data sources were evaluated. Selective serotonin-reuptake inhibitors (SSRIs) are generally prescribed over other classes of antidepressants because they are considered to be relatively safer. Recent evidence, however, suggests that SSRIs may be associated with an increased risk of fractures. Thirteen clinical studies were identified in the literature search (7 case controls, 5 prospective cohorts, 1 cross-sectional). Most studies compared SSRIs with tricyclic antidepressants (TCAs) and found similar or greater risk of fracture associated with use of an SSRI. This risk appeared to be highest at the beginning of therapy with TCAs and eventually diminished. SSRI risk tended to increase slightly over time. No risk was seen with other classes of antidepressants. However, the number of patients using antidepressants was low. There may be a possible correlation with SSRI or TCA use and risk of fracture. Prospective, randomized controlled trials with sufficient patient samples are needed to verify this finding.

Snack purchasing is healthier when the cognitive demands of choice are reduced: A randomized controlled trial.

PubMed

Allan, Julia L; Johnston, Marie; Campbell, Neil

2015-07-01

Individuals with inefficient executive (higher level cognitive) function have a reduced ability to resist dietary temptation. The present study aimed to design and test a theory-based point-of-purchase intervention for coffee shops that reduced the calorie content of customers' purchases by reducing the need for executive function (EF) at the moment of choice. Key facets of EF were identified by a multidisciplinary group and used to develop a point-of-purchase intervention (signage). This intervention was evaluated in a randomized controlled trial (RCT) in a public coffee shop on consumer purchases of >20,000 snacks and drinks over 12 weeks. A sample of customers (n = 128) was recruited to complete an embedded cross-sectional study measuring EF strength, dietary intentions, typical purchases, and purchases made after exposure to the intervention. The proportion of snack purchases that were high in calorie reduced significantly (t(10) = 2.34, p = .04) in intervention weeks relative to control. High calorie drink purchases were also lower in intervention than control weeks, however, this difference was not significant (t(10) = 1.56, p = .15). On average, customers purchased items containing 66 calories < usual after exposure to the intervention. The magnitude of the intervention's positive effect on customer behavior increased as EF strength decreased (β = .24, p = .03). The calorie content of cafe purchases can be lowered by reducing the cognitive demands of healthy food choice at the moment of purchase, especially in those with poor EF. Environmental changes like these have the potential to help achieve population weight control. (c) 2015 APA, all rights reserved.

Impaired anticipatory control of grasp during obstacle crossing in Parkinson's disease.

PubMed

McIsaac, Tara L; Diermayr, Gudrun; Albert, Frederic

2012-05-16

During self-paced walking, people with Parkinson's disease maintain anticipatory control during object grasping. However, common functional tasks often include carrying an object while changing step patterns mid-path and maneuvering over obstacles, increasing task complexity and attentional demands. Thus, the present study investigated the effect of Parkinson's disease on the modulation of grasping force changes as a function of gait-related inertial forces. Subjects with Parkinson's disease maintained the ability to scale and to couple over time their grip and inertial forces while walking at irregular step lengths, but were unable to maintain the temporal coupling of grasping forces compared to controls during obstacle crossing. We suggest that this deterioration in anticipatory control is associated with the increased demands of task complexity and attention during obstacle crossing. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Repetitive Transcranial Magnetic Stimulation Improves Handwriting in Parkinson's Disease

PubMed Central

Randhawa, Bubblepreet K.; Farley, Becky G.; Boyd, Lara A.

2013-01-01

Background. Parkinson disease (PD) is characterized by hypometric movements resulting from loss of dopaminergic neurons in the substantia nigra. PD leads to decreased activation of the supplementary motor area (SMA); the net result of these changes is a poverty of movement. The present study determined the impact of 5 Hz repetitive transcranial magnetic stimulation (rTMS) over the SMA on a fine motor movement, handwriting (writing cursive “l”s), and on cortical excitability, in individuals with PD. Methods. In a cross-over design, ten individuals with PD were randomized to receive either 5 Hz or control stimulation over the SMA. Immediately following brain stimulation right handed writing was assessed. Results. 5 Hz stimulation increased vertical size of handwriting and diminished axial pressure. In addition, 5 Hz rTMS significantly decreased the threshold for excitability in the primary motor cortex. Conclusions. These data suggest that in the short term 5 Hz rTMS benefits functional fine motor task performance, perhaps by altering cortical excitability across a network of brain regions. Further, these data may provide the foundation for a larger investigation of the effects of noninvasive brain stimulation over the SMA in individuals with PD. PMID:23841021

From cars to bikes - the feasibility and effect of using e-bikes, longtail bikes and traditional bikes for transportation among parents of children attending kindergarten: design of a randomized cross-over trial.

PubMed

Bjørnarå, Helga Birgit; Berntsen, Sveinung; Te Velde, Saskia J; Fegran, Liv; Fyhri, Aslak; Deforche, Benedicte; Andersen, Lars Bo; Bere, Elling

2017-12-28

The present study aims to increase bicycling and level of physical activity (PA), and thereby promote health in parents of toddlers, by giving access to different bicycle types. There is a need for greater understanding of e-bikes and their role in the transportation network, and further effects on PA levels and health. Moreover, longtail bikes could meet certain practical needs not fulfilled by e-bikes or traditional bikes, hence increased knowledge regarding their feasibility should be obtained. No previous studies have investigated whether providing an e-bike or a longtail bike over an extended period in a sample of parents of toddlers influence objectively assessed amount of bicycling and total PA level, transportation habits, cardiorespiratory fitness, body composition and blood pressure. A randomized cross-over trial will be performed, entailing that participants in the intervention group (n = 18) complete the following intervention arms in random order: (i) three months access to an e-bicycle with trailer for child transportation (n = 6), (ii) three months access to a longtail bicycle (n = 6), and (iii) three months access to a regular bicycle with trailer (n = 6), in total nine months. Also, a control group (n = 18) maintaining usual transportation and PA habits will be included. A convenience sample consisting of 36 parents of toddlers residing in Kristiansand municipality, Southern Norway, will be recruited. Total amount of bicycling (distance and time), total level of PA, and transportation habits will be measured at baseline and in connection to each intervention arm. Cardiorespiratory fitness, body composition and blood pressure will be measured at baseline and post-intervention. Main outcome will be bicycling distance and time spent cycling. New knowledge relevant for the timely issues of public health and environmental sustainability will be provided among parents of toddlers, representing a target group of greatest importance. There is a call for research on the influence of e-bikes and longtail bikes on travel behavior and PA levels, and whether voluntary cycling could improve health. If the present study reveals promising results, it should be replicated in larger and more representative samples. Eventually, inclusion in national public health policies should be considered. ID NCT03131518 , made public 26.04.2017.

Main results of the Ouabain and Adducin for Specific Intervention on Sodium in Hypertension Trial (OASIS-HT): a randomized placebo-controlled phase-2 dose-finding study of rostafuroxin

PubMed Central

2011-01-01

Background The Ouabain and Adducin for Specific Intervention on Sodium in Hypertension (OASIS-HT) Trial was a phase-2 dose-finding study of rostafuroxin, a digitoxygenin derivative, which selectively antagonizes the effects of endogenous ouabain (EO) on Na+,K+-ATPase and mutated adducin. Rostafuroxin lowered blood pressure (BP) in some animal models and in humans. Methods OASIS-HT consisted of 5 concurrently running double-blind cross-over studies. After 4 weeks without treatment, 435 patients with uncomplicated systolic hypertension (140-169 mm Hg) were randomized to rostafuroxin (0.05, 0.15, 0.5, 1.5 or 5.0 mg/d) or matching placebo, each treatment period lasting 5 weeks. The primary endpoint was the reduction in systolic office BP. Among the secondary endpoints were diastolic office BP, 24-h ambulatory BP, plasma EO concentration and renin activity, 24-h urinary sodium and aldosterone excretion, and safety. ANOVA considered treatment sequence (fixed effect), subjects nested within sequence (random), period (fixed), and treatment (fixed). Results Among 410 analyzable patients (40.5% women; mean age, 48.4 years), the differences in the primary endpoint (rostafuroxin minus placebo) ranged from -0.18 mm Hg (P = 0.90) on 0.15 mg/d rostafuroxin to 2.72 mm Hg (P = 0.04) on 0.05 mg/d. In the 5 dosage arms combined, the treatment effects averaged 1.30 mm Hg (P = 0.03) for systolic office BP; 0.70 mm Hg (P = 0.08) for diastolic office BP; 0.36 mm Hg (P = 0.49) for 24-h systolic BP; and 0.05 mm Hg (P = 0.88) for 24-h diastolic BP. In the 2 treatment groups combined, systolic (-1.36 mm Hg) and diastolic (-0.97 mm Hg) office BPs decreased from week 5 to 10 (P for period effect ≤0.028), but carry-over effects were not significant (P ≥ 0.11). All other endpoints were not different on rostafuroxin and placebo. Minor side-effects occurred with similarly low frequency on rostafuroxin and placebo. Conclusions In 5 concurrently running double-blind cross-over studies rostafuroxin did not reduce BP at any dose. Trial Registration ClinicalTrials (NCT): NCT00415038 PMID:21235787

Nigral stimulation for resistant axial motor impairment in Parkinson's disease? A randomized controlled trial.

PubMed

Weiss, Daniel; Walach, Margarete; Meisner, Christoph; Fritz, Melanie; Scholten, Marlieke; Breit, Sorin; Plewnia, Christian; Bender, Benjamin; Gharabaghi, Alireza; Wächter, Tobias; Krüger, Rejko

2013-07-01

Gait and balance disturbances typically emerge in advanced Parkinson's disease with generally limited response to dopaminergic medication and subthalamic nucleus deep brain stimulation. Therefore, advanced programming with interleaved pulses was put forward to introduce concomittant nigral stimulation on caudal contacts of a subthalamic lead. Here, we hypothesized that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata improves axial symptoms compared with standard subthalamic nucleus stimulation. Twelve patients were enrolled in this 2 × 2 cross-over double-blind randomized controlled clinical trial and both the safety and efficacy of combined subthalamic nucleus and substantia nigra pars reticulata stimulation were evaluated compared with standard subthalamic nucleus stimulation. The primary outcome measure was the change of a broad-scaled cumulative axial Unified Parkinson's Disease Rating Scale score (Scale II items 13-15, Scale III items 27-31) at '3-week follow-up'. Secondary outcome measures specifically addressed freezing of gait, balance, quality of life, non-motor symptoms and neuropsychiatric symptoms. For the primary outcome measure no statistically significant improvement was observed for combined subthalamic nucleus and substantia nigra pars reticulata stimulation at the '3-week follow-up'. The secondary endpoints, however, revealed that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata might specifically improve freezing of gait, whereas balance impairment remained unchanged. The combined stimulation of subthalamic nucleus and substantia nigra pars reticulata was safe, and of note, no clinically relevant neuropsychiatric adverse effect was observed. Patients treated with subthalamic nucleus and substantia nigra pars reticulata stimulation revealed no 'global' effect on axial motor domains. However, this study opens the perspective that concomittant stimulation of the substantia nigra pars reticulata possibly improves otherwise resistant freezing of gait and, therefore, highly warrants a subsequent phase III randomized controlled trial.

Lafutidine prevents low-dose aspirin and loxoprofen induced gastric injury: a randomized, double-blinded, placebo controlled study.

PubMed

Kato, Mototsugu; Kamada, Go; Yamamoto, Keiko; Nishida, Urara; Imai, Aki; Yoshida, Takeshi; Ono, Shouko; Nakagawa, Manabu; Nakagawa, Soichi; Shimizu, Yuichi; Asaka, Masahiro

2010-10-01

The concomitant use of non-steroidal anti-inflammatory drugs is a risk factor for low-dose aspirin (LDA)-associated upper gastrointestinal toxicity. Lafutidine is an H2-receptor antagonist with gastroprotective activity, produced by acting on capsaicin-sensitive afferent neurons. To evaluate the preventive effect of lafutidine on gastric damage caused by LDA alone and by the combination of both LDA and loxoprofen, we conducted a clinical study using healthy volunteers. A randomized, double-blinded, placebo-controlled, crossover study was carried out. Sixteen healthy volunteers without Helicobacter pylori infection were randomly assigned to two groups. Both groups received 81 mg of aspirin once daily for 14 days (on days 1 to 14) and 60 mg of loxoprofen three times daily for the last 7 days (on days 8 to 14). Placebo or 10 mg of lafutidine was administered twice daily for 14 days in each group. After a 2-week washout period, placebo and lafutidine were crossed over. Endoscopic findings of gastric mucosal damage were evaluated according to the modified Lanza score. The mean modified Lanza score was 2.19 ± 1.06 (SD) for aspirin plus placebo as compared with 0.50 ± 0.77 for aspirin plus lafutidine (P < 0.001), and 3.00 ± 1.56 for aspirin plus loxoprofen and placebo as compared with 1.25 ± 1.37 for aspirin plus loxoprofen and lafutidine (P < 0.01). The addition of loxoprofen to LDA increases gastric mucosal damage. Standard-dose lafutidine significantly prevents gastric mucosal damage induced by LDA alone or LDA plus loxoprofen in H. pylori-negative volunteers. Larger controlled studies are needed to strengthen these findings. © 2010 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.

Robotically assisted treadmill exercise training for improving peak fitness in chronic motor incomplete spinal cord injury: A randomized controlled trial

PubMed Central

Scott, William; York, Henry; Theyagaraj, Melita; Price-Miller, Naomi; McQuaid, Jean; Eyvazzadeh, Megan; Ivey, Frederick M.; Macko, Richard F.

2016-01-01

Objective To assess the effectiveness of robotically assisted body weight supported treadmill training (RABWSTT) for improving cardiovascular fitness in chronic motor incomplete spinal cord injury (CMISCI). Design Pilot prospective randomized, controlled clinical trial. Setting Outpatient rehabilitation specialty hospital. Participants Eighteen individuals with CMISCI with American Spinal Injury Association (ASIA) level between C4 and L2 and at least one-year post injury. Interventions CMISCI participants were randomized to RABWSTT or a home stretching program (HSP) three times per week for three months. Those in the home stretching group were crossed over to three months of RABWSTT following completion of the initial three month phase. Outcome measures Peak oxygen consumption (peak VO2) was measured during both robotic treadmill walking and arm cycle ergometry: twice at baseline, once at six weeks (mid-training) and twice at three months (post-training). Peak VO2 values were normalized for body mass. Results The RABWSTT group improved peak VO2 by 12.3% during robotic treadmill walking (20.2 ± 7.4 to 22.7 ± 7.5 ml/kg/min, P = 0.018), compared to a non-significant 3.9% within group change observed in HSP controls (P = 0.37). Neither group displayed a significant change in peak VO2 during arm cycle ergometry (RABWSTT, 8.5% (P = 0.25); HSP, 1.76% (P = 0.72)). A repeated measures analysis showed statistically significant differences between treatments for peak VO2 during both robotic treadmill walking (P = 0.002) and arm cycle ergometry (P = 0.001). Conclusion RABWSTT is an effective intervention model for improving peak fitness levels assessed during robotic treadmill walking in persons with CMISCI. PMID:25520035

Differences in highly cross-linked polyethylene wear between zirconia and cobalt-chromium femoral heads in Japanese patients: a prospective, randomized study.

PubMed

Kawate, Kenji; Ohmura, Tetsuji; Kawahara, Ikuo; Tamai, Katsuya; Ueha, Tomoyuki; Takemura, Kazuo

2009-12-01

The purpose of this study was to compare highly cross-linked polyethylene wear between the zirconia head and the cobalt-chromium head in Japanese patients. A prospective, randomized study was performed to evaluate the outcomes in 32 hips that had zirconia heads and in 30 hips that had cobalt-chromium heads. The mean follow-up periods of both groups were same (5 years). There were no significant differences between the zirconia head and the cobalt-chromium head in the mean polyethylene linear wear per year and the mean volumetric polyethylene wear per year in the steady phase. This study indicates that zirconia head offers no benefits over metal head in terms of wear reduction at 5 years in Japanese patients who have lightweight and thin polyethylene liners.

A randomised controlled cross-over trial of aerobic training versus Qigong in advanced Parkinson's disease.

PubMed

Burini, D; Farabollini, B; Iacucci, S; Rimatori, C; Riccardi, G; Capecci, M; Provinciali, L; Ceravolo, M G

2006-09-01

To investigate the effects of an aerobic training in subjects with Parkinson's disease (PD) as compared to a medical Chinese exercise (Qigong). randomized controlled trial with a cross over design. PD out-patients referred to a Neurorehabilitation facility for the management of motor disability. 26 PD patients in Hoehn and Yahr stage II to III under stable medication were randomly allocated to either Group AT1+QG2 (receiving 20 aerobic training sessions followed by 20 ''Qigong'' group sessions with 2 month interval between the interventions), or Group QG1+AT2 (performing the same treatments with an inverted sequence). clinical effects of treatment were sought through the Unified Parkinson's Disease Rating Scale (UPDRS), Brown's Disability Scale (B'DS), six-Minute Walking Test (6MWT), Borg scale for breathlessness, Beck Depression Inventory (BDI) and Parkinson's Disease Questionnaire-39 items (PDQ-39). A spirometry test and maximum cardiopulmonary exercise test (CPET) were also performed to determine the pulmonary function, the metabolic and cardio-respiratory requests at rest and under exercise. All measures were taken immediately before and at the completion of each treatment phase. The statistical analysis focusing on the evolution of motor disability and quality of life revealed a significant interaction effect between group and time for the 6MWT (time x group effect: F: 5.4 P=0.002) and the Borg scale (time x group effect: F: 4.2 P=0.009). Post hoc analysis showed a significant increase in 6MWT and a larger decrease in Borg score after aerobic training within each subgroup, whereas no significant changes were observed during Qigong. No significant changes over time were detected through the analysis of UPDRS, B'DS, BDI and PDQ-39 scores. The analysis of cardiorespiratory parameters showed significant interaction effects between group and time for the Double Productpeak (time x group effect: F: 7.7 P=0.0003), the VO(2peak) (time x group effect: F: 4.8 P=0.007), and the VO(2)/kg ratio (time x group effect: F: 4.3 P=0.009), owing to their decrease after aerobic training to an extent that was never observed after Qigong treatment. Aerobic training exerts a significant impact on the ability of moderately disabled PD patients to cope with exercise, although it does not improve their self-sufficiency and quality of life.

Robust spectral-domain optical coherence tomography speckle model and its cross-correlation coefficient analysis

PubMed Central

Liu, Xuan; Ramella-Roman, Jessica C.; Huang, Yong; Guo, Yuan; Kang, Jin U.

2013-01-01

In this study, we proposed a generic speckle simulation for optical coherence tomography (OCT) signal, by convolving the point spread function (PSF) of the OCT system with the numerically synthesized random sample field. We validated our model and used the simulation method to study the statistical properties of cross-correlation coefficients (XCC) between Ascans which have been recently applied in transverse motion analysis by our group. The results of simulation show that over sampling is essential for accurate motion tracking; exponential decay of OCT signal leads to an under estimate of motion which can be corrected; lateral heterogeneity of sample leads to an over estimate of motion for a few pixels corresponding to the structural boundary. PMID:23456001

Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial.

PubMed

Amini, E; Rafiei, P; Zarei, K; Gohari, M; Hamidi, M

2013-01-01

Music is considered a subset of developmental supportive care. It may act as a suitable auditory stimulant in preterm infants. Also, it may reduce stress responses in autonomic, motor and state systems. To assess and compare the influence of lullaby and classical music on physiologic parameters. This is a randomized clinical trial with cross-over design. A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days. Each infant was exposed to three phases: lullaby music, classical music, and no music (control) for two days each. The sequence of these phases was assigned randomly to each subject. Babies were continuously monitored for heart rate, respiratory rate, and oxygen saturation and changes between phases were analyzed. Lullaby reduced heart rate (p < 0.001) and respiratory rate (p = 0.004). These effects extended in the period after the exposure (p < .001 and p = 0.001, respectively). Classical music reduced heart rate (p = 0.018). The effects of classical music disappeared once the music stopped. Oxygen saturation did not change during intervention. Music can affect vital signs of preterm infants; this effect can possibly be related to the reduction of stress during hospitalization. The implications of these findings on clinical and developmental outcomes need further study.

Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia

PubMed Central

Barnes, Deborah E.; Mehling, Wolf; Wu, Eveline; Beristianos, Matthew; Yaffe, Kristine; Skultety, Karyn; Chesney, Margaret A.

2015-01-01

Background Current dementia medications have small effect sizes, many adverse effects and do not change the disease course. Therefore, it is critically important to study alternative treatment strategies. The goal of this study was to pilot-test a novel, integrative group exercise program for individuals with mild-to-moderate dementia called Preventing Loss of Independence through Exercise (PLIÉ), which focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection. Methods We performed a 36-week cross-over pilot clinical trial to compare PLIÉ with usual care (UC) at an adult day program for individuals with dementia in San Francisco, CA. Assessments of physical performance, cognitive function, physical function, dementia-related behaviors, quality of life and caregiver burden were performed by blinded assessors at baseline, 18 weeks (cross-over) and 36 weeks. Our primary outcomes were effect sizes based on between-group comparisons of change from baseline to 18 weeks; secondary outcomes were within-group comparisons of change before and after cross-over. Results Twelve individuals enrolled (7 PLIÉ, 5 UC) and 2 withdrew (1 PLIÉ, 18 weeks; 1 UC, 36 weeks). Participants were 82% women (mean age, 84 ± 4 years); caregivers were 82% daughters (mean age, 56 ± 13 years). Effect sizes were not statistically significant but suggested potentially clinically meaningful (≥0.25 SDs) improvement with PLIÉ versus UC for physical performance (Cohen’s D: 0.34 SDs), cognitive function (0.76 SDs) and quality of life (0.83 SDs) as well as for caregiver measures of participant’s quality of life (0.33 SDs) and caregiver burden (0.49 SDs). Results were similar when within-group comparisons were made before and after cross-over. Conclusions PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life and caregiver burden in individuals with mild-to-moderate dementia. Larger randomized, controlled trials are warranted. Trial Registration ClinicalTrials.gov NCT01371214 PMID:25671576

A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: A Prospective, Randomized, Controlled Trial

PubMed Central

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Stark, Renée G.; Altenhofer, Julia; Parhofer, Klaus G.

2017-01-01

Studies indicate a positive association between walnut intake and improvements in plasma lipids. We evaluated the effect of an isocaloric replacement of macronutrients with walnuts and the time point of consumption on plasma lipids. We included 194 healthy subjects (134 females, age 63 ± 7 years, BMI 25.1 ± 4.0 kg/m2) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (8 weeks each). Ninety-six subjects first followed a walnut-enriched diet (43 g walnuts/day) and then switched to a nut-free diet. Ninety-eight subjects followed the diets in reverse order. Subjects were also randomized to either reduce carbohydrates (n = 62), fat (n = 65), or both (n = 67) during the walnut diet, and instructed to consume walnuts either as a meal or as a snack. The walnut diet resulted in a significant reduction in fasting cholesterol (walnut vs. control: −8.5 ± 37.2 vs. −1.1 ± 35.4 mg/dL; p = 0.002), non-HDL cholesterol (−10.3 ± 35.5 vs. −1.4 ± 33.1 mg/dL; p ≤ 0.001), LDL-cholesterol (−7.4 ± 32.4 vs. −1.7 ± 29.7 mg/dL; p = 0.029), triglycerides (−5.0 ± 47.5 vs. 3.7 ± 48.5 mg/dL; p = 0.015) and apoB (−6.7 ± 22.4 vs. −0.5 ± 37.7 mg/dL; p ≤ 0.001), while HDL-cholesterol and lipoprotein (a) did not change significantly. Neither macronutrient replacement nor time point of consumption significantly affected the effect of walnuts on lipids. Thus, 43 g walnuts/day improved the lipid profile independent of the recommended macronutrient replacement and the time point of consumption. PMID:28984822

A continuous process to align electrospun nanofibers into parallel and crossed arrays

NASA Astrophysics Data System (ADS)

Laudenslager, Michael J.; Sigmund, Wolfgang M.

2013-04-01

Electrical, optical, and mechanical properties of nanofibers are strongly affected by their orientation. Electrospinning is a nanofiber processing technique that typically produces nonwoven meshes of randomly oriented fibers. While several alignment techniques exist, they are only able to produce either a very thin layer of aligned fibers or larger quantities of fibers with less control over their alignment and orientation. The technique presented herein fills the gap between these two methods allowing one to produce thick meshes of highly oriented nanofibers. In addition, this technique is not limited to collection of fibers along a single axis. Modifications to the basic setup allow collection of crossed fibers without stopping and repositioning the apparatus. The technique works for a range of fiber sizes. In this study, fiber diameters ranged from 100 nm to 1 micron. This allows a few fibers at a time to rapidly deposit in alternating directions creating an almost woven structure. These aligned nanofibers have the potential to improve the performance of energy storage and thermoelectric devices and hold great promise for directed cell growth applications.

Soil-Transmitted Helminths in Pre-School-Aged and School-Aged Children in an Urban Slum: A Cross-Sectional Study of Prevalence, Distribution, and Associated Exposures

PubMed Central

Davis, Stephanie M.; Worrell, Caitlin M.; Wiegand, Ryan E.; Odero, Kennedy O.; Suchdev, Parminder S.; Ruth, Laird J.; Lopez, Gerard; Cosmas, Leonard; Neatherlin, John; Njenga, Sammy M.; Montgomery, Joel M.; Fox, LeAnne M.

2014-01-01

Soil-transmitted helminths (STHs) are controlled by regular mass drug administration. Current practice targets school-age children (SAC) preferentially over pre-school age children (PSAC) and treats large areas as having uniform prevalence. We assessed infection prevalence in SAC and PSAC and spatial infection heterogeneity, using a cross-sectional study in two slum villages in Kibera, Nairobi. Nairobi has low reported STH prevalence. The SAC and PSAC were randomly selected from the International Emerging Infections Program's surveillance platform. Data included residence location and three stools tested by Kato-Katz for STHs. Prevalences among 692 analyzable children were any STH: PSAC 40.5%, SAC 40.7%; Ascaris: PSAC 24.1%, SAC 22.7%; Trichuris: PSAC 24.0%, SAC 28.8%; hookworm < 0.1%. The STH infection prevalence ranged from 22% to 71% between sub-village sectors. The PSAC have similar STH prevalences to SAC and should receive deworming. Small areas can contain heterogeneous prevalences; determinants of STH infection should be characterized and slums should be assessed separately in STH mapping. PMID:25157123

Improvement in health-related quality of life after therapy with omeprazole in patients with coronary artery disease and recurrent angina-like chest pain. A double-blind, placebo-controlled trial of the SF-36 survey

PubMed Central

2011-01-01

Background Many patients with coronary artery disease (CAD) have overlapping gastroenterological causes of recurrent chest pain, mainly due to gastroesophageal reflux (GER) and aspirin-induced gastrointestinal tract damage. These symptoms can be alleviated by proton pump inhibitors (PPIs). The study addressed whether omeprazole treatment also affects general health-related quality of life (HRQL) in patients with CAD. Study 48 patients with more than 50% narrowing of the coronary arteries on angiography without clinically overt gastrointestinal symptoms were studied. In a double-blind, placebo-controlled, cross-over study design, patients were randomized to take omeprazole 20 mg bid or a placebo for two weeks, and then crossed over to the other study arm. The SF-36 questionnaire was completed before treatment and again after two weeks of therapy. Results Patients treated with omeprazole in comparison to the subjects taking the placebo had significantly greater values for the SF-36 survey (which relates to both physical and mental health), as well as for bodily pain, general health perception, and physical health. In comparison to the baseline values, therapy with omeprazole led to a significant increase in the three summarized health components: total SF-36; physical and mental health; and in the following detailed health concept scores: physical functioning, limitations due to physical health problems, bodily pain and emotional well-being. Conclusions A double dose of omeprazole improved the general HRQL in patients with CAD without severe gastrointestinal symptoms more effectively than the placebo. PMID:21939510

Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial.

PubMed

Vigod, Simone; Dennis, Cindy-Lee; Daskalakis, Zafiris; Murphy, Kellie; Ray, Joel; Oberlander, Tim; Somerton, Sarah; Hussain-Shamsy, Neesha; Blumberger, Daniel

2014-09-18

Women with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population. We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum. Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the feasibility of, acceptability of and adherence with a clinical trial protocol to administer this treatment to pregnant women with moderate to severe depression. Results from this pilot study will guide the development of a larger multicentre trial to definitively test the efficacy and safety of transcranial direct current stimulation for pregnant women with depression. Clinical Trials Gov NCT02116127.

Hypertension prevalence, awareness, treatment, and control in northeast China: a population-based cross-sectional survey.

PubMed

Zhang, Fu-Liang; Guo, Zhen-Ni; Xing, Ying-Qi; Wu, Yan-Hua; Liu, Hao-Yuan; Yang, Yi

2017-12-01

Hypertension has been recognized as a major risk factor for cardiovascular disease. We aimed to analyze the current prevalence, awareness, treatment, and control of hypertension in northeast China. This cross-sectional survey adopted the multistage stratified random cluster sampling method to obtain a representative sample of adults aged 40 years or older in the general population of northeast China. Hypertension was defined as a systolic blood pressure (SBP) ≥ 140 mm Hg, or diastolic blood pressure (DBP) ≥ 90 mm Hg, or self-reported use of antihypertensive medications in the last 2 weeks irrespective of BP. Altogether 4052 participants were included with weighted prevalence of hypertension of 57.3%. Among them, 47.4% were aware of their condition; 78.8% took antihypertensive medication, but only 10.2% had their blood pressure controlled. Individuals who were overweight/obesity, with dyslipidemia, or diabetes were at a higher risk of hypertension; these people also more likely to be aware of their condition. Subjects with a personal history of stroke were more inclined to receive antihypertensive medication, but that did not necessarily translate to well-controlled hypertension. Moreover, dyslipidemia (OR = 0.600; 95% CI: 0.375, 0.960) were associated with poor hypertension control. Subjects using combination of antihypertensive medications (OR = 2.924; 95% CI: 1.606, 5.325) or with a family history of coronary heart disease were more likely to have their blood pressure controlled. Our study identified a high prevalence of hypertension in northeast China. Although awareness and treatment rates improved over the last decade, the control rate remained disproportionately and unacceptably low.

Cognitive changes after saline or plasmalyte infusion in healthy volunteers: a multiple blinded, randomized, cross-over trial.

PubMed

Story, David A; Lees, Lucy; Weinberg, Laurence; Teoh, Soon-Yee; Lee, Katherine J; Velissaris, Sarah; Bellomo, Rinaldo; Wilson, Sarah J

2013-09-01

In an incidental finding, during a study of plasma chemistry after crystalloid infusion, participants reported subjective cognitive changes, particularly slower thinking, after saline but not Hartmann's (Ringer's lactate) solution. The authors tested the hypothesis that saline infusion would produce greater adverse cognitive changes than Plasmalyte infusion. The authors conducted a randomized, cross-over, multiple blinded study of healthy adult volunteers. On separate days, participants received 30 ml/kg over 1 h of either 0.9% saline or Plasmalyte with the order randomly allocated. Plasma chemistry was tested on venous samples. As part of a battery of cognitive tests our primary endpoint was the reaction time index after infusion. The authors studied 25 participants. Plasma chloride was greater after saline than after Plasmalyte: mean difference 5.4 mM (95% CI, 4.1-6.6 mM; P < 0.001). Saline was also associated with greater metabolic acidosis: base-excess 2.5 mM more negative (95% CI, 1.9-3.0 mM more negative; P < 0.001). There was no evidence of a difference in the reaction time index between the two interventions: mean reaction time index 394 ms (SD, 72) after saline versus 385 ms (SD, 55) after Plasmalyte. Difference: saline 9 ms slower (95% CI, 30 ms slower to 12 ms faster; P = 0.39). There were minimal differences in the other cognitive and mood tests. Despite expected differences in plasma chemistry, the authors found that measures of cognition did not differ after infusions of Plasmalyte or saline.

Comparative analysis of the pressure profilometry of vesicocutaneous continent catheterizable conduits between patients with and without rectus abdominis neosphincter (Yachia principle).

PubMed

Rondon, Atila; Leslie, Bruno; Arcuri, Leonardo Javier; Ortiz, Valdemar; Macedo, Antonio

2015-09-01

To assess whether crossing rectus abdominis muscle strips, as proposed by Yachia, would change urinary catheterizable conduit's pressure profilometry, in static and dynamic conditions. Non-randomized selection of 20 continent patients that underwent Macedo's ileum-based reservoir, 10 including Yachia's technique (Study Group) and 10 without this mechanism of continence (Control Group). Demographics and cystometric data were assessed. Conduit's pressure profilometry was obtained by infusing saline through a multichannel catheter, at rest and during Valsalva maneuver. We assessed the pressure: (a) in the bladder; (b) in conduit's proximal segment; and (c) in conduit's distal segment, which is presumably the abdominal wall and crossed muscle strips site. Mean age at surgery was 6.1 years in the Control Group and 7.7 years in the Study Group. There was no statistically significant difference between groups regarding maximum cystometric bladder capacity and leakage point pressure. At rest, the pressure profilometry showed similar results between groups in all segments analyzed. During Valsalva maneuver, pressure profilometry showed similar results between groups in bladder and conduit's proximal segment pressure. In this condition, conduit's distal segment pressure in the Study Group (Mean = 72.9 and Peak = 128.7 cmH2 O) was significantly greater (P < 0.05) than conduit's distal segment pressure in the Control Group (Mean = 48.3 and Peak = 65.1 cmH2 O). Crossing muscle strips over the conduit significantly increases the pressure in its distal segment during contraction of the rectus abdominis muscle, which can be important in moments of sudden increase in abdominal pressure in order to keep continence. © 2014 Wiley Periodicals, Inc.

A Randomized Phase II Study of Concurrent Docetaxel Plus Vaccine Versus Vaccine Alone in Metastatic Androgen Independent Prostate Cancer

PubMed Central

Arlen, Philip M.; Gulley, James L.; Parker, Catherine; Skarupa, Lisa; Pazdur, Mary; Panicali, Dennis; Beetham, Patricia; Tsang, Kwong Y.; Grosenbach, Douglas W.; Feldman, Jarett; Steinberg, Seth M.; Jones, Elizabeth; Chen, Clara; Marte, Jennifer; Schlom, Jeffrey; Dahut, William

2006-01-01

Purpose: Docetaxel has activity against androgen insensitive prostate cancer (AIPC) and preclinical studies have demonstrated that taxane-based chemotherapy can enhance antitumor response of vaccines. The primary objective of this study was to determine if concurrent docetaxel (with dexamethasone) had any effect on generating an immune response to the vaccine. Secondary endpoints were whether vaccine could be given safely with docetaxel and the clinical outcome of the treatment regimen. Experimental Design: The vaccination regimen was composed of (1) recombinant vaccinia virus (rV) that expresses the prostate-specific antigen gene (rV-PSA) admixed with (2) rV that expresses the B7.1 costimulatory gene (rV-B7.1), and (3) sequential booster vaccinations with recombinant fowlpox virus (rF-) containing the PSA gene (rF- PSA). Patients received GM-CSF with each vaccination. Twenty-eight patients with metastatic AIPC were randomized to receive either vaccine and weekly docetaxel or vaccine alone. Patients on the vaccine alone arm were allowed to cross over to receive docetaxel alone at time of disease progression. The ELISPOT assay was used to monitor immune responses for PSA-specific T cells. Results: The median increase in these T-cell precursors to PSA was 3.33-fold in both arms following 3 months of therapy. In addition, immune responses to other prostate cancer associated tumor antigens were also detected post-vaccination. Eleven patients who progressed on vaccine alone crossed over to receive docetaxel at time of progression. Median PFS on docetaxel was 6.1 months after receiving vaccine compared with 3.7 months with the same regimen in a historical control. Conclusion: This is the first clinical trial to demonstrate that docetaxel can be administered safely with immunotherapy without inhibiting vaccine specific T-cell responses. Furthermore, patients previously vaccinated with an anticancer vaccine may respond longer to docetaxel compared with a historical control of patients receiving docetaxel alone. Larger prospective clinical studies will be required to validate these findings. PMID:16489082

Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial.

PubMed

Ulrich, Silvia; Hasler, Elisabeth D; Saxer, Stéphanie; Furian, Michael; Müller-Mottet, Séverine; Keusch, Stephan; Bloch, Konrad E

2017-04-14

The purpose of the current trial was to test the hypothesis that breathing oxygen-enriched air increases exercise performance of patients with pulmonary arterial or chronic thrombo-embolic pulmonary hypertension (PAH/CTEPH) and to investigate involved mechanisms. Twenty-two patients with PAH/CTEPH, eight women, means ± SD 61 ± 14 years, resting mPAP 35 ± 9mmHg, PaO2 ambient air >7.3 kPa, underwent four bicycle ergospirometries to exhaustion on different days, while breathing oxygen-enriched (FiO2 0.50, hyperoxia) or ambient air (FiO2 0.21, normoxia) using progressively increased or constant load protocols (with 75% maximal work rate under FiO2 0.21), according to a randomized, sham-controlled, single-blind, cross-over design. ECG, pulmonary gas-exchange, arterial blood gases, cerebral and quadriceps muscle tissue oxygenation (CTO and QMTO) by near-infrared spectroscopy were measured. In ramp exercise, maximal work rate increased from 113 ± 38 W with normoxia to 132 ± 48 W with hyperoxia, mean difference 19.7 (95% CI 10.5-28.9) W, P < 0.001. Constant load exercise endurance increased from 571 ± 443 to 1242 ± 514 s, mean difference 671 (95% CI 392-951) s, P < 0.001. At end-exercise with hyperoxia PaO2, CTO, QMTO, and PaCO2 were increased, and ventilatory equivalents for CO2 were reduced while the physiological dead space/tidal volume ratio remained unchanged. In patients with PAH/CTEPH, breathing oxygen-enriched air provides major increases in exercise performance. This is related to an improved arterial oxygenation that promotes oxygen availability in muscles and brain and to a reduction of the excessive ventilatory response to exercise thereby enhancing ventilatory efficiency. Patients with PAH/CTEPH may therefore benefit from oxygen therapy during daily physical activities and training. clinicaltrials.gov Identifier: NCT01748474. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions.

PubMed

Wilson, K E; Girdler, N M; Welbury, R R

2003-12-01

The use of benzodiazepines for paediatric dental sedation has received limited attention with regard to research into clinical effectiveness. A study was therefore designed to investigate the use of midazolam, for i.v. sedation in paediatric dental patients. The aim of the study was to assess the effectiveness of i.v. midazolam in a randomized, controlled, cross-over trial. Children aged 12-16 yr (ASA I and II), requiring two appointments for equivalent but contralateral dental extractions for orthodontic purposes, were recruited. Conscious sedation with either i.v. midazolam titrated at 0.5 mg x min(-1), to a maximum of 5 mg, or nitrous oxide/oxygen titrated to 30%/70% inhalation sedation was used at the first visit, the alternative being used at the second visit. Vital signs including blood pressure, arterial oxygen saturation and ventilatory frequency, as well as sedation levels and behavioural scores, were recorded every 2 min. Forty patients, mean age 13.2 yr (range 12-16 yr), participated in the trial. A mean dose of midazolam 2.8 mg was administered in the test group. The median time to the maximum level of sedation was 8 min for midazolam compared with 6 min for nitrous oxide (P<0.001). Vital signs for both treatments were comparable and within acceptable clinical limits and communication with the patient was maintained at all times. The median (range) lowest arterial oxygen saturation level recorded for midazolam was 97 (91-99)% compared with 97 (92-100)% for nitrous oxide. The mean (range) recovery time for midazolam was 51.6 (39-65) min and 23.3 (20-34) min for nitrous oxide (P<0.0001). Fifty-one per cent said they preferred i.v. midazolam, 38% preferred nitrous oxide, and 11% had no preference. I.V. midazolam sedation (0.5 mg x min(-1) to a maximum of 5 mg) appears to be as effective as nitrous oxide sedation in 12-16-yr-old healthy paediatric dental patients.

Measuring Gambling Reinforcers, Over Consumption and Fallacies: The Psychometric Properties and Predictive Validity of the Jonsson-Abbott Scale.

PubMed

Jonsson, Jakob; Abbott, Max W; Sjöberg, Anders; Carlbring, Per

2017-01-01

Traditionally, gambling and problem gambling research relies on cross-sectional and retrospective designs. This has compromised identification of temporal relationships and causal inference. To overcome these problems a new questionnaire, the Jonsson-Abbott Scale (JAS), was developed and used in a large, prospective, general population study, The Swedish Longitudinal Gambling Study (Swelogs). The JAS has 11 items and seeks to identify early indicators, examine relationships between indicators and assess their capacity to predict future problem progression. The aims of the study were to examine psychometric properties of the JAS (internal consistency and dimensionality) and predictive validity with respect to increased gambling risk and problem gambling onset. The results are based on repeated interviews with 3818 participants. The response rate from the initial baseline wave was 74%. The original sample consisted of a random, stratified selection from the Swedish population register aged between 16 and 84. The results indicate an acceptable fit of a three-factor solution in a confirmatory factor analysis with 'Over consumption,' 'Gambling fallacies,' and 'Reinforcers' as factors. Reinforcers, Over consumption and Gambling fallacies were significant predictors of gambling risk potential and Gambling fallacies and Over consumption were significant predictors of problem gambling onset (incident cases) at 12 month follow up. When controlled for risk potential measured at baseline, the predictor Over consumption was not significant for gambling risk potential at follow up. For incident cases, Gambling fallacies and Over consumption remained significant when controlled for risk potential. Implications of the results for the development of problem gambling, early detection, prevention, and future research are discussed.

The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial.

PubMed

Heshmat, Haleh; Banava, Sepideh; Mohammadi, Ebrahim; Kharazifard, Mohammad Javad; Mojtahedzadeh, Faramarz

2014-11-01

Along with their re-mineralizing capacity, calcium phosphopeptide-amorphous calcium phosphate products combined with fluoride (CPP-ACPF) could also be beneficial by neutralizing acidic salivary and plaque pH. The purpose was to evaluate the effect of CPP-ACPF on salivary and plaque pH in orthodontic patients. As a triple-blind, cross-over randomized trial, 30 orthodontic patients with fixed appliances (age range = 15.70 ± 4.08 years) were recruited and randomly assigned to two groups. A CPP-ACPF paste (MI Paste Plus, GC America, Alsip, IL) was used by group 1 (n = 15) and a placebo by group 2 (n = 15) for 1 month. After a 1 month washout period, patients used the alternative paste for another month. Plaque and salivary pH levels were measured at all before and after periods. By applying MI Paste Plus, the plaque pH increased from 5.81 ± 0.45 to 6.60 ± 0.38 (p < 0.05), whereas the before and after salivary pH recordings, which were 6.72 ± 0.43 and 6.71 ± 0.38, respectively, remained statistically unchanged (p > 0.05). MI Paste Plus can be clinically beneficial in increasing plaque pH levels, but has no effect on the salivary pH.

The Safety of Older Pedestrians at Signal-Controlled Crossings.

ERIC Educational Resources Information Center

Harrell, W. Andrew

1996-01-01

Observes the extent to which pedestrians checked for oncoming traffic before crossing signal-controlled intersections on busy city streets. Pedestrians over the age of 50 were the most cautious, especially under dangerous traffic conditions. Older pedestrians were least likely to use other pedestrians as "guides" to safety, instead…

Increased cytokine production by monocytes from human subjects who consumed grape powder was not mediated by differences in dietary intake patterns

USDA-ARS?s Scientific Manuscript database

Recently, in a randomized, double-blind cross-over study, we reported that consumption of grape powder by obese human subjects increased the production of the pro-inflammatory cytokines interleukin-1' and interleukin-6 by ex vivo-derived peripheral blood monocytes after exposure to bacterial lipopol...

Can They Keep Going on Their Own? A Four-Year Randomized Trial of Functional Assessments of Community Residents

ERIC Educational Resources Information Center

Thomas, Roger; Worrall, Graham; Elgar, Frank; Knight, John

2007-01-01

Objectives: Are people 75 or over enabled to stay at home longer through annual assessments and referrals to health/social services than through assessments only or without assessments? Design: Randomized controlled trial. Participants: 520 people 75 or over living in their own homes. Intervention: Four annual RAI-HC computerized functional…

A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

PubMed Central

López-Jaramillo, Patricio; Pradilla, Lina P; Lahera, Vicente; Sieger, Federico A Silva; Rueda-Clausen, Christian F; Márquez, Gustavo A

2006-01-01

Background The raising prevalence of type-2 diabetes mellitus and obesity has been recognized as a major problem for public health, affecting both developed and developing countries. Impaired fasting plasma glucose has been previously associated with endothelial dysfunction, higher levels of inflammatory markers and increased risk of developing insulin resistance and cardiovascular events. Besides life-style changes, the blockade of the renin-angiotensin system has been proposed as a useful alternative intervention to improve insulin resistance and decrease the number of new type-2 diabetes cases. The aim of this clinical trial is to study the effect of the treatment with Candesartan, an angiotensin II receptor antagonist, on the insulin resistance, the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in a group of non diabetic, non hypertensive, dysglycemic and obese subjects. Methods and design A randomized, double blind, cross-over, placebo-controlled, clinical trial was designed to assess the effects of Candesartan (up to 32 mg/day during 6 months) on the Homeostasis Model Assessment (HOMA) index, lipid profile, protrombotic state, oxidative stress and plasma levels of inflammatory markers. The participants will be recruited in the "Fundación Cardiovascular de Colombia". Subjects who fullfil selection criteria will receive permanent educational, nutritional and exercise support during their participation in the study. After a 15 days-run-in period with placebo and life-style recommendations, the patients who have a treatment compliance equal or greater than 80% will be randomlly assigned to one of the treatment groups. Group A will receive Candesartan during 6 months and placebo during 6 months. Group B will receive placebo during the first 6 months, and then, Candesartan during the last 6 months. Control visits will be programed monthly and all parameters of interest will be evaluated every 6 months. Hypothesis Treatment with Candesartan, could improve the HOMA index, the response to the oral glucose tolerance test and reduce the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in non diabetic, non hypertense subjects with dysglycemia and abdominal obesity, recruited from a population at high risk of developing insulin resistance. These effects are independent of the changes in arterial blood pressure. Trial registration: NCT00319202 PMID:16959033

A Randomized Control Study of Responsive Teaching with Young Turkish Children and Their Mothers

ERIC Educational Resources Information Center

Karaaslan, Ozcan; Diken, Ibrahim H.; Mahoney, Gerald

2013-01-01

A randomized control study was conducted to evaluate the effectiveness of responsive teaching (RT) with a sample of 19 Turkish preschool-age children with disabilities and their mothers over a 6-months period. RT is an early intervention curriculum that attempts to promote children's development by encouraging parents to engage in highly…

A Randomized Controlled Study Evaluating a Brief, Bystander Bullying Intervention with Junior High School Students

ERIC Educational Resources Information Center

Midgett, Aida; Doumas, Diana; Trull, Rhiannon; Johnston, April D.

2017-01-01

A randomized controlled study evaluated a brief, bystander bullying intervention for junior high school students. Students in both groups reported an increase in knowledge and confidence to act as defenders and to utilize strategies to intervene on behalf of victims of bullying. Findings suggest possible carry-over effects from the intervention…

Cross-talk free selective reconstruction of individual objects from multiplexed optical field data

NASA Astrophysics Data System (ADS)

Zea, Alejandro Velez; Barrera, John Fredy; Torroba, Roberto

2018-01-01

In this paper we present a data multiplexing method for simultaneous storage in a single package composed by several optical fields of tridimensional (3D) objects, and their individual cross-talk free retrieval. Optical field data are extracted from off axis Fourier holograms, and then sampled by multiplying them with random binary masks. The resulting sampled optical fields can be used to reconstruct the original objects. Sampling causes a loss of quality that can be controlled by the number of white pixels in the binary masks and by applying a padding procedure on the optical field data. This process can be performed using a different binary mask for each optical field, and then added to form a multiplexed package. With the adequate choice of sampling and padding, we can achieve a volume reduction in the multiplexed package over the addition of all individual optical fields. Moreover, the package can be multiplied by a binary mask to select a specific optical field, and after the reconstruction procedure, the corresponding 3D object is recovered without any cross-talk. We demonstrate the effectiveness of our proposal for data compression with a comparison with discrete cosine transform filtering. Experimental results confirm the validity of our proposal.

Structured patient handoff on an internal medicine ward: A cluster randomized control trial.

PubMed

Tam, Penny; Nijjar, Aman P; Fok, Mark; Little, Chris; Shingina, Alexandra; Bittman, Jesse; Raghavan, Rashmi; Khan, Nadia A

2018-01-01

The effect of a multi-faceted handoff strategy in a high volume internal medicine inpatient setting on process and patient outcomes has not been clearly established. We set out to determine if a multi-faceted handoff intervention consisting of education, standardized handoff procedures, including fixed time and location for face-to-face handoff would result in improved rates of handoff compared with usual practice. We also evaluated resident satisfaction, health resource utilization and clinical outcomes. This was a cluster randomized controlled trial in a large academic tertiary care center with 18 inpatient internal medicine ward teams from January-April 2013. We randomized nine inpatient teams to an intervention where they received an education session standardizing who and how to handoff patients, with practice and feedback from facilitators. The control group of 9 teams continued usual non-standardized handoffs. The primary process outcome was the rate of patients handed over per 1000 patient nights. Other process outcomes included perceptions of inadequate handoff by overnight physicians, resource utilization overnight and hospital length of stay. Clinical outcomes included medical errors, frequency of patients requiring higher level of care overnight, and in-hospital mortality. The intervention group demonstrated a significant increase in the rate of patients handed over to the overnight physician (62.90/1000 person-nights vs. 46.86/1000 person-nights, p = 0.002). There was no significant difference in other process outcomes except resource utilization was increased in the intervention group (26.35/1000 person-days vs. 17.57/1000 person-days, p-value = 0.01). There was no significant difference between groups in medical errors (4.8% vs. 4.1%), need for higher level of care or in hospital mortality. Limitations include a dependence of accurate record keeping by the overnight physician, the possibility of cross-contamination in the handoff process, analysis at the cluster level and an overall low number of clinical events. Implementation of a multi-faceted resident handoff intervention did not result in a significant improvement in patient safety although did improve number of patients handed off. Novel methods to improve handoff need to be explored. Registered at ClinicalTrials.gov: NCT01796756.

Randomized Controlled Trials Evaluating Effect of Television Advertising on Food Intake in Children: Why Such a Sensitive Topic is Lacking Top-Level Evidence?

PubMed

Gregori, Dario; Ballali, Simonetta; Vecchio, Maria Gabriella; Sciré, Antonella Silvia; Foltran, Francesca; Berchialla, Paola

2014-01-01

The aim of this study was to perform a systematic review of evidence coming from randomized controlled trials (RCT) aimed at assessing the effect of television advertising on food intake in children from 4 to 12 years old. Randomized controlled trials were searched in PubMed database and included if they assessed the effect of direct exposure to television food advertising over the actual energy intake of children. Seven studies out of 2166 fulfilled the inclusion criteria. The association between television advertising and energy intake is based on a very limited set of randomized researches lacking a solid ground of first-level evidence.

The Fallacy of Average: How Using HbA1c Alone to Assess Glycemic Control Can Be Misleading.

PubMed

Beck, Roy W; Connor, Crystal G; Mullen, Deborah M; Wesley, David M; Bergenstal, Richard M

2017-08-01

HbA 1c is a v aluable metric for comparing treatment groups in a randomized trial, for assessing glycemic trends in a population over time, or for cross-sectional comparisons of glycemic control in different populations. However, what is not widely appreciated is that HbA 1c may not be a good indicator of an individual patient's glycemic control because of the wide range of mean glucose concentrations and glucose profiles that can be associated with a given HbA 1c level. To illustrate this point, we plotted mean glucose measured with continuous glucose monitoring (CGM) versus central laboratory-measured HbA 1c in 387 participants in three randomized trials, showing that not infrequently HbA 1c may underestimate or overestimate mean glucose, sometimes substantially. Thus, if HbA 1c is to be used to assess glycemic control, it is imperative to know the patient's actual mean glucose to understand how well HbA 1c is an indicator of the patient's glycemic control. With knowledge of the mean glucose, an estimated HbA 1c (eA1C) can be calculated with the formula provided in this article to compare with the measured HbA 1c . Estimating glycemic control from HbA 1c alone is in essence applying a population average to an individual, which can be misleading. Thus, a patient's CGM glucose profile has considerable value for optimizing his or her diabetes management. In this era of personalized, precision medicine, there are few better examples with respect to the fallacy of applying a population average to a specific patient rather than using specific information about the patient to determine the optimal approach to treatment. © 2017 by the American Diabetes Association.

A 2-way cross-over, open-labeled trial to compare efficacy and safety of insulin Aspart and Novolin R delivered with CSII in 21 Chinese diabetic patients.

PubMed

Bi, Yu-fang; Zhao, Lie-bin; Li, Xiao-ying; Wang, Wei-qing; Sun, Shou-yue; Chen, Yu-hong; Hong, Jie; Su, Ting-wei; Liu, Jian-min; Ning, Guang

2007-10-05

Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart, which provides good glycemic control with a lower risk of hypoglycemia and less body weight increase. In the present study we investigated the efficacy and safety of a rapid-acting human insulin analogue (insulin Aspart) delivered with continuous subcutaneous insulin infusion (CSII) into Chinese diabetic patients. A total of 21 patients with type 1 or type 2 diabetes were recruited for the 2-way cross-over, open-labeled trial, and then randomized to Group A (n = 10, treated with insulin Aspart) or Group B (n = 11, treated with Novolin R). Insulin Aspart and Novolin R were administered by CSII. Capillary glucose concentrations were measured at 8 time points, pre-prandial and postprandial, bedtime (10 pm), midnight (2 am) every day during the treatment. The average capillary glucose profiles for the day were much better controlled in Group A than in Group B (P < 0.01). The blood glucose levels were particularly better controlled in Group A than in Group B at pre-breakfast ((6.72 +/- 1.24) mmol/L vs (7.84 +/- 1.58) mmol/L, P = 0.014), post-breakfast ((8.96 +/- 2.41) mmol/L vs (11.70 +/- 3.11) mmol/L, P = 0.0028), post-supper ((8.15 +/- 2.10) mmol/L vs (10.07 +/- 2.36) mmol/L, P = 0.008), bed time ((7.73 +/- 1.72) mmol/L vs (9.39 +/- 2.05) mmol/L, P = 0.007) and midnight ((6.32 +/- 1.16) mmol/L vs (7.48 +/- 1.36) mmol/L, P = 0.0049). There was no significant difference in the frequency of hypoglycemic episodes between the two groups. Insulin Aspart results in better control of blood glucose levels than regular human insulin (Novolin R) in diabetic patients during delivery by CSII.

The Effect of a Simulated Commercial Flight Environment with Hypoxia and Low Humidity on Clotting, Platelet, and Endothelial Function in Participants with Type 2 Diabetes - A Cross-over Study.

PubMed

Konya, Judit; Al Qaissi, Ahmed; Sathyapalan, Thozhukat; Ajjan, Ramzi; Madden, Leigh; Naseem, Khalid M; Garrett, Andrew Thomas; Kilpatrick, Eric; Atkin, Stephen L

2018-01-01

To determine if clotting, platelet, and endothelial function were affected by simulated short-haul commercial air flight conditions (SF) in participants with type 2 diabetes (T2DM) compared to controls. 10 participants with T2DM (7 females, 3 males) and 10 controls (3 females, 7 males) completed the study. Participants were randomized to either spend 2 h in an environmental chamber at sea level conditions (temperature: 23°C, oxygen concentration 21%, humidity 45%), or subject to a simulated 2-h simulated flight (SF: temperature: 23°C, oxygen concentration 15%, humidity 15%), and crossed over 7 days later. Main outcome measures: clot formation and clot lysis parameters, functional platelet activation markers, and endothelial function measured by reactive hyperemia index (RHI) by EndoPAT and serum microparticles. Comparing baseline with SF conditions, clot maximal absorption was increased in controls (0.375 ± 0.05 vs. 0.39 ± 0.05, p  < 0.05) and participants with T2DM (0.378 ± 0.089 vs. 0.397 ± 0.089, p  < 0.01), while increased basal platelet activation for both fibrinogen binding and P-selectin expression ( p  < 0.05) was seen in participants with T2DM. Parameters of clot formation and clot lysis, stimulated platelet function (stimulated platelet response to ADP and sensitivity to prostacyclin), and endothelial function were unchanged. While SF resulted in the potential of denser clot formation with enhanced basal platelet activation in T2DM, the dynamic clotting, platelet, and endothelial markers were not affected, suggesting that short-haul commercial flying adds no additional hazard for venous thromboembolism for participants with T2DM compared to controls.

Cellular automata model for urban road traffic flow considering pedestrian crossing street

NASA Astrophysics Data System (ADS)

Zhao, Han-Tao; Yang, Shuo; Chen, Xiao-Xu

2016-11-01

In order to analyze the effect of pedestrians' crossing street on vehicle flows, we investigated traffic characteristics of vehicles and pedestrians. Based on that, rules of lane changing, acceleration, deceleration, randomization and update are modified. Then we established two urban two-lane cellular automata models of traffic flow, one of which is about sections with non-signalized crosswalk and the other is on uncontrolled sections with pedestrians crossing street at random. MATLAB is used for numerical simulation of the different traffic conditions; meanwhile space-time diagram and relational graphs of traffic flow parameters are generated and then comparatively analyzed. Simulation results indicate that when vehicle density is lower than around 25 vehs/(km lane), pedestrians have modest impact on traffic flow, whereas when vehicle density is higher than about 60 vehs/(km lane), traffic speed and volume will decrease significantly especially on sections with non-signal-controlled crosswalk. The results illustrate that the proposed models reconstruct the traffic flow's characteristic with the situation where there are pedestrians crossing and can provide some practical reference for urban traffic management.

Cross-cousin marriage among the Yanomamö shows evidence of parent-offspring conflict and mate competition between brothers.

PubMed

Chagnon, Napoleon A; Lynch, Robert F; Shenk, Mary K; Hames, Raymond; Flinn, Mark V

2017-03-28

Marriage in many traditional societies often concerns the institutionalized exchange of reproductive partners among groups of kin. Such exchanges most often involve cross-cousins-marriage with the child of a parent's opposite-sex sibling-but it is unclear who benefits from these exchanges. Here we analyze the fitness consequences of marrying relatives among the Yanomamö from the Amazon. When individuals marry close kin, we find that ( i ) both husbands and wives have slightly lower fertility; ( ii ) offspring suffer from inbreeding depression; ( iii ) parents have more grandchildren; and ( iv ) siblings, especially brothers, benefit when their opposite-sex siblings marry relatives but not when their same-sex siblings do. Therefore, individuals seem to benefit when their children or opposite-sex siblings marry relatives but suffer costs when they, their parents, or same-sex siblings do. These asymmetric fitness outcomes suggest conflicts between parents and offspring and among siblings over optimal mating strategies. Parental control of marriages is reinforced by cultural norms prescribing cross-cousin marriage. We posit that local mate competition combined with parental control over marriages may escalate conflict between same-sex siblings who compete over mates, while simultaneously forging alliances between opposite-sex siblings. If these relationships are carried forward to subsequent generations, they may drive bilateral cross-cousin marriage rules. This study provides insights into the evolutionary importance of how kinship and reciprocity underlie conflicts over who controls mate choice and the origins of cross-cousin marriage prescriptions.

Cross-cousin marriage among the Yanomamö shows evidence of parent–offspring conflict and mate competition between brothers

PubMed Central

Chagnon, Napoleon A.; Lynch, Robert F.; Shenk, Mary K.; Hames, Raymond; Flinn, Mark V.

2017-01-01

Marriage in many traditional societies often concerns the institutionalized exchange of reproductive partners among groups of kin. Such exchanges most often involve cross-cousins—marriage with the child of a parent’s opposite-sex sibling—but it is unclear who benefits from these exchanges. Here we analyze the fitness consequences of marrying relatives among the Yanomamö from the Amazon. When individuals marry close kin, we find that (i) both husbands and wives have slightly lower fertility; (ii) offspring suffer from inbreeding depression; (iii) parents have more grandchildren; and (iv) siblings, especially brothers, benefit when their opposite-sex siblings marry relatives but not when their same-sex siblings do. Therefore, individuals seem to benefit when their children or opposite-sex siblings marry relatives but suffer costs when they, their parents, or same-sex siblings do. These asymmetric fitness outcomes suggest conflicts between parents and offspring and among siblings over optimal mating strategies. Parental control of marriages is reinforced by cultural norms prescribing cross-cousin marriage. We posit that local mate competition combined with parental control over marriages may escalate conflict between same-sex siblings who compete over mates, while simultaneously forging alliances between opposite-sex siblings. If these relationships are carried forward to subsequent generations, they may drive bilateral cross-cousin marriage rules. This study provides insights into the evolutionary importance of how kinship and reciprocity underlie conflicts over who controls mate choice and the origins of cross-cousin marriage prescriptions. PMID:28289230

Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial.

PubMed

Fletcher, H M; Dawkins, J; Rattray, C; Wharfe, G; Reid, M; Gordon-Strachan, G

2013-01-01

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.

Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

PubMed Central

Fletcher, H. M.; Dawkins, J.; Rattray, C.; Wharfe, G.; Reid, M.; Gordon-Strachan, G.

2013-01-01

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo. PMID:23431314

Economic evaluation of an area-wide integrated pest management program to control the Asian tiger mosquito in New Jersey.

PubMed

Shepard, Donald S; Halasa, Yara A; Fonseca, Dina M; Farajollahi, Ary; Healy, Sean P; Gaugler, Randy; Bartlett-Healy, Kristen; Strickman, Daniel A; Clark, Gary G

2014-01-01

Aedes albopictus is the most invasive mosquito in the world, an important disease vector, and a biting nuisance that limits outdoor activities. Area-wide integrated pest management (AW-IPM) is the recommended control strategy. We conducted an economic evaluation of the AW-IPM project in Mercer and Monmouth Counties, New Jersey with a controlled design (AW-IPM vs. control) from 2009 through 2011. The study analyzed financial documents and staff time for AW-IPM and surveyed an average of 415 randomly chosen households in AW-IPM and control areas each fall from 2008 through 2011. Hours lost from yard and porch activities were calculated as differences between actual and potential hours of these activities in an average summer week if there had been no mosquito concerns. Net estimated benefits of AW-IPM were based on cross-over and difference-in-difference analyses. Reductions in hours lost were valued based on respondents' willingness to pay for a hypothetical extra hour free of mosquitoes spent on yard or porch activities and literature on valuation of a quality adjusted life year (QALY). The incremental cost of AW-IPM per adult was $41.18 per year. Number of hours lost due to mosquitoes in AW-IPM areas between the base year (2008) and the intervention years (2009-2011) declined by 3.30 hours per summer week in AW-IPM areas compared to control areas. Survey respondents valued this improvement at $27.37 per adult per summer week. Over the 13-week summer, an average adult resident gained 42.96 hours of yard and porch time, worth $355.82. The net benefit over the summer was $314.63. With an average of 0.0027 QALYs gained per adult per year, AW-IPM was cost effective at $15,300 per QALY gained. The benefit-cost ratio from hours gained was 8.64, indicating that each $1 spent on AW-IPM gave adults additional porch and yard time worth over $8.

Multi-parameter fiber optic sensors based on fiber random grating

NASA Astrophysics Data System (ADS)

Xu, Yanping; Zhang, Mingjiang; Lu, Ping; Mihailov, Stephen; Bao, Xiaoyi

2017-04-01

Two novel configurations of multi-parameter fiber-optic sensing systems based on the fiber random grating are reported. The fiber random grating is fabricated through femtosecond laser induced refractive index modification over a 10cm standard telecom single mode fiber. In one configuration, the reflective spectrum of the fiber random grating is directly detected and a wavelength-division spectral cross-correlation algorithm is adopted to extract the spectral shifts for simultaneous measurement of temperature, axial strain, and surrounding refractive index. In the other configuration, a random fiber ring laser is constructed by incorporating the random feedback from the random grating. Numerous polarization-dependent spectral filters are formed along the random grating and superimposed to provide multiple lasing lines with high signal-to-noise ratio up to 40dB, which enables a high-fidelity multi-parameter sensing scheme by monitoring the spectral shifts of the lasing lines. Without the need of phase mask for fabrication and with the high physical strength, the random grating based sensors are much simpler and more compact, which could be potentially an excellent alternative for liquid medical sample sensing in biomedical and biochemical applications.

Stimuli-Responsive Intelligent Nanomaterials Self-Assembled from Rigid Flexible Molecules

DTIC Science & Technology

2010-11-19

engineering, and controlled drug delivery . The hydrogels are formed through physical cross-links in a random way of flexible nanofibers . Here we...other to form hydrogels that have a variety of applications including tissue engineering, and controlled drug delivery . The hydrogels are formed through...opportunities in many biological applications including tissue regeneration and drug delivery vehicles. Molecular self-assembly into one-dimensional

Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

PubMed Central

Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

2012-01-01

Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial.

PubMed

Ajimsha, M S; Binsu, D; Chithra, S

2014-06-01

Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain (PHP). However, it is unclear whether myofascial release (MFR) can improve the outcomes in this population. To investigate whether myofascial release (MFR) reduces the pain and functional disability associated with plantar heel pain (PHP) in comparison with a control group receiving sham ultrasound therapy (SUST). Randomized, controlled, double blinded trial. Nonprofit research foundation clinic in India. Sixty-six patients, 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks. The Foot Function Index (FFI) scale was used to assess pain severity and functional disability. The primary outcome measure was the difference in FFI scale scores between week 1 (pretest score), week 4 (posttest score), and follow-up at week 12 after randomization. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation. The simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 (P<0.001). Patients in the MFR and control groups reported a 72.4% and 7.4% reduction, respectively, in their pain and functional disability in week 4 compared with that in week 1, which persisted as 60.6% in the follow-up at week 12 in the MFR group compared to the baseline. The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles, and the calcaneus (P<0.05). This study provides evidence that MFR is more effective than a control intervention for PHP. Copyright © 2014 Elsevier Ltd. All rights reserved.

A population-based dietary intervention trial in a high-risk area for stomach cancer and stroke: changes in intakes and related biomarkers.

PubMed

Takashashi, Yoshiko; Sasaki, Satoshi; Takahashi, Masako; Okubo, Shunji; Hayashi, Masato; Tsugane, Shoichiro

2003-11-01

Dietary intervention is one of the important fields in cancer and cardiovascular disease prevention. The Hiraka Dietary Intervention Study is a community-based randomized cross-over trial designed to develop an effective dietary modification tool and system in an area with high mortality of stomach cancer and stroke. The subjects were 550 healthy volunteers and were randomized into two groups with tailored dietary education to decrease sodium intake and to increase vitamin C and carotene intakes either in the first year (intervention group) or in the second year (control group). Dietary changes were assessed using a validated self-administered diet history questionnaire, fasting blood samples, and 48-hour urine samples, which were obtained before and after the one year period. During the first year, changes differed significantly between the intervention and control group for both dietary sodium intake (-384 and +255 mg/day, intervention and control respectively, p < 0.001) and urinary sodium excretion (-1003 and -84 mg/day, p < 0.001). Although favorable net changes were also observed in dietary carotene (+418 and +220 mug/day, p < 0.05) and vitamin C (+13 and +2 mg/day, p < 0.05), the serum level differences were modest (+13 and -25 mg/L, p = 0.09 for carotene, +0.1 and -0.5 mg/L, p = 0.07 for ascorbic acid). The present dietary intervention strategy effectively decreased sodium and increased carotene and vitamin C intakes, although the former was more distinct.

Sailing Can Improve Quality of Life of People with Severe Mental Disorders: Results of a Cross Over Randomized Controlled Trial

PubMed Central

Carta, Mauro Giovanni; Maggiani, Federica; Pilutzu, Laura; Moro, Maria Francesca; Mura, Gioia; Sancassiani, Federica; Vellante, Vellante; Migliaccio, Gian Mario; Machado, Sergio; Nardi, Antonio Egidio; Preti, Antonio

2014-01-01

The aim of this study was to evaluate the impact of a sailing rehabilitation program on the quality of life (QoL) in a sample of patients with severe mental disorders. The study adopted a randomized, crossover, waiting-list controlled design. The participants enrolled in the study were outpatients diagnosed with severe chronic mental disorders. The participants (N=40) exposed to rehabilitation with sailing took part in a series of supervised cruises near the gulf of Cagliari, South Sardinia, and showed a statistically significant improvement of their quality of life compared to the control group. This improvement was comparable to the improvement in psychopathologic status and social functioning as shown in a previous report of the same research project. The improvement was maintained at follow-up only during the trial and for a few months later: after 12 months, patients returned to their baseline values and their quality of life showed a worsening trend. This is the first study to show that rehabilitation with sailing may improve the quality of life of people with severe chronic mental disorders. In all likelihood, a program grounded on learning how to manage a sailing vessel - during which patients perform cruises that emphasize the exploration of the marine environment by sailing - might be interesting enough and capture the attention of the patients so as to favour greater effectiveness of standard rehabilitation protocols, but this should be specifically tested. PMID:25191521

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock

PubMed Central

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-01-01

Abstract Introduction: Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. Methods and analysis: It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect. PMID:29419665

Flavonoid-Rich Apple Improves Endothelial Function in Individuals at Risk for Cardiovascular Disease: A Randomized Controlled Clinical Trial.

PubMed

Bondonno, Nicola P; Bondonno, Catherine P; Blekkenhorst, Lauren C; Considine, Michael J; Maghzal, Ghassan; Stocker, Roland; Woodman, Richard J; Ward, Natalie C; Hodgson, Jonathan M; Croft, Kevin D

2018-02-01

The cardioprotective effects of apples are primarily attributed to flavonoids, found predominantly in the skin. This study aimed to determine if acute and/or chronic (4 weeks) ingestion of flavonoid-rich apples improves endothelial function, blood pressure (BP), and arterial stiffness in individuals at risk for cardiovascular diseases (CVD). In this randomized, controlled cross-over trial, acute and 4 week intake of apple with skin (high flavonoid apple, HFA) is compared to intake of apple flesh only (low flavonoid apple, LFA) in 30 participants. The primary outcome is endothelial function assessed using flow-mediated dilation (FMD) of the brachial artery, while main secondary outcomes are 24 h ambulatory BP and arterial stiffness. Other outcomes include fasting serum glucose and lipoprotein profile, plasma heme oxygenase-1 (Hmox-1), F 2 -isoprostanes, flavonoid metabolites, and plasma and salivary nitrate (NO 3 - ) and nitrite (NO 2 - ) concentrations. Compared to LFA control, the HFA results in a significant increase in FMD acutely (0.8%, p < 0.001) and after 4 weeks chronic intake (0.5%, p < 0.001), and in plasma flavonoid metabolites (p < 0.0001). Other outcomes are not altered significantly. A lower risk of CVD with higher apple consumption could be mediated by the beneficial effect of apple skin on endothelial function, both acutely and chronically. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A unified perturbation expansion for surface scattering

NASA Technical Reports Server (NTRS)

Rodriguez, Ernesto; Kim, Yunjin

1992-01-01

Starting with the extinction theorem, a perturbation expansion which, to first and second orders, converges over a wider domain than the small perturbation expansion and the momentum transfer expansion is presented. It is shown that, in the appropriate limits, both of these theories, as well as the two-scale expansion, are recovered. There is no adjustable parameter, such as a spectral split, in the theory. This theory is applied to random rough surfaces and derive analytic expressions for the coherent field and the bistatic cross section. Finally, a numerical test of the theory against method of moments results for Gaussian random rough surfaces with a power law spectrum is given. These results show that the expansion is ramarkably accurate over a large range of surface heights and slopes for both horizontal and vertical polarization.

Communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks--a randomized controlled trial.

PubMed

Werner, Anne; Holderried, Friederike; Schäffeler, Norbert; Weyrich, Peter; Riessen, Reimer; Zipfel, Stephan; Celebi, Nora

2013-02-01

Informed consent talks are mandatory before invasive interventions. However, the patients' information recall has been shown to be rather poor. We investigated, whether medical laypersons recalled more information items from a simulated informed consent talk after advanced medical students participated in a communication training aiming to reduce a layperson's cognitive load. Using a randomized, controlled, prospective cross-over-design, 30 5th and 6th year medical students were randomized into two groups. One group received communication training, followed by a comparison intervention (early intervention group, EI); the other group first received the comparison intervention and then communication training (late intervention group, LI). Before and after the interventions, the 30 medical students performed simulated informed consent talks with 30 blinded medical laypersons using a standardized set of information. We then recorded the number of information items the medical laypersons recalled. After the communication training both groups of medical laypersons recalled significantly more information items (EI: 41 ± 9% vs. 23 ± 9%, p < .0001, LI 49 ± 10% vs. 35 ± 6%, p < .0001). After the comparison intervention the improvement was modest and significant only in the LI (EI: 42 ± 9% vs. 40 ± 9%, p = .41, LI 35 ± 6% vs. 29 ± 9%, p = .016). Short communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks.

Communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks – a randomized controlled trial

PubMed Central

2013-01-01

Background Informed consent talks are mandatory before invasive interventions. However, the patients’ information recall has been shown to be rather poor. We investigated, whether medical laypersons recalled more information items from a simulated informed consent talk after advanced medical students participated in a communication training aiming to reduce a layperson’s cognitive load. Methods Using a randomized, controlled, prospective cross-over-design, 30 5th and 6th year medical students were randomized into two groups. One group received communication training, followed by a comparison intervention (early intervention group, EI); the other group first received the comparison intervention and then communication training (late intervention group, LI). Before and after the interventions, the 30 medical students performed simulated informed consent talks with 30 blinded medical laypersons using a standardized set of information. We then recorded the number of information items the medical laypersons recalled. Results After the communication training both groups of medical laypersons recalled significantly more information items (EI: 41 ± 9% vs. 23 ± 9%, p < .0001, LI 49 ± 10% vs. 35 ± 6%, p < .0001). After the comparison intervention the improvement was modest and significant only in the LI (EI: 42 ± 9% vs. 40 ± 9%, p = .41, LI 35 ± 6% vs. 29 ± 9%, p = .016). Conclusion Short communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks. PMID:23374907

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

PubMed

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

A randomized controlled trial of the different impression methods for the complete denture fabrication: Patient reported outcomes.

PubMed

Jo, Ayami; Kanazawa, Manabu; Sato, Yusuke; Iwaki, Maiko; Akiba, Norihisa; Minakuchi, Shunsuke

2015-08-01

To compare the effect of conventional complete dentures (CD) fabricated using two different impression methods on patient-reported outcomes in a randomized controlled trial (RCT). A cross-over RCT was performed with edentulous patients, required maxillomandibular CDs. Mandibular CDs were fabricated using two different methods. The conventional method used a custom tray border moulded with impression compound and a silicone. The simplified used a stock tray and an alginate. Participants were randomly divided into two groups. The C-S group had the conventional method used first, followed by the simplified. The S-C group was in the reverse order. Adjustment was performed four times. A wash out period was set for 1 month. The primary outcome was general patient satisfaction, measured using visual analogue scales, and the secondary outcome was oral health-related quality of life, measured using the Japanese version of the Oral Health Impact Profile for edentulous (OHIP-EDENT-J) questionnaire scores. Twenty-four participants completed the trial. With regard to general patient satisfaction, the conventional method was significantly more acceptable than the simplified. No significant differences were observed between the two methods in the OHIP-EDENT-J scores. This study showed CDs fabricated with a conventional method were significantly more highly rated for general patient satisfaction than a simplified. CDs, fabricated with the conventional method that included a preliminary impression made using alginate in a stock tray and subsequently a final impression made using silicone in a border moulded custom tray resulted in higher general patient satisfaction. UMIN000009875. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial.

PubMed

An, T W; Boone, S L; Boyer, M I; Gelberman, R H; Osei, D A; Calfee, R P

2016-11-01

This prospective, randomized controlled study was designed to determine if applying ice to the site of corticosteroid injections in the hand and wrist reduces post-injection pain. Patients receiving corticosteroid injections in the hand or wrist at a tertiary institution were enrolled. Subjects were randomized to apply ice to the injection site and take scheduled over-the-counter analgesics ( n = 36) or take scheduled over-the-counter analgesics alone ( n = 32). There were no significant differences in the mean pain score between the two groups at any time-point (pre-injection or 1-5 days post-injection). In regression modelling, the application of ice did not predict pain after injection. Visual analogue pain scores increased at least 2 points (0-10 scale) after injection in 17 out of 36 patients in the ice group versus ten out of 32 control patients. We conclude that the application of ice in addition to over-the-counter analgesics does not reduce post-injection pain after corticosteroid injection in the hand or wrist. I Therapeutic Study.

Speckle lithography for fabricating Gaussian, quasi-random 2D structures and black silicon structures

PubMed Central

Bingi, Jayachandra; Murukeshan, Vadakke Matham

2015-01-01

Laser speckle pattern is a granular structure formed due to random coherent wavelet interference and generally considered as noise in optical systems including photolithography. Contrary to this, in this paper, we use the speckle pattern to generate predictable and controlled Gaussian random structures and quasi-random structures photo-lithographically. The random structures made using this proposed speckle lithography technique are quantified based on speckle statistics, radial distribution function (RDF) and fast Fourier transform (FFT). The control over the speckle size, density and speckle clustering facilitates the successful fabrication of black silicon with different surface structures. The controllability and tunability of randomness makes this technique a robust method for fabricating predictable 2D Gaussian random structures and black silicon structures. These structures can enhance the light trapping significantly in solar cells and hence enable improved energy harvesting. Further, this technique can enable efficient fabrication of disordered photonic structures and random media based devices. PMID:26679513

Quantifying fluctuations in economic systems by adapting methods of statistical physics

NASA Astrophysics Data System (ADS)

Stanley, H. E.; Gopikrishnan, P.; Plerou, V.; Amaral, L. A. N.

2000-12-01

The emerging subfield of econophysics explores the degree to which certain concepts and methods from statistical physics can be appropriately modified and adapted to provide new insights into questions that have been the focus of interest in the economics community. Here we give a brief overview of two examples of research topics that are receiving recent attention. A first topic is the characterization of the dynamics of stock price fluctuations. For example, we investigate the relation between trading activity - measured by the number of transactions NΔ t - and the price change GΔ t for a given stock, over a time interval [t, t+ Δt] . We relate the time-dependent standard deviation of price fluctuations - volatility - to two microscopic quantities: the number of transactions NΔ t in Δ t and the variance WΔ t2 of the price changes for all transactions in Δ t. Our work indicates that while the pronounced tails in the distribution of price fluctuations arise from WΔ t, the long-range correlations found in ∣ GΔ t∣ are largely due to NΔ t. We also investigate the relation between price fluctuations and the number of shares QΔ t traded in Δ t. We find that the distribution of QΔ t is consistent with a stable Lévy distribution, suggesting a Lévy scaling relationship between QΔ t and NΔ t, which would provide one explanation for volume-volatility co-movement. A second topic concerns cross-correlations between the price fluctuations of different stocks. We adapt a conceptual framework, random matrix theory (RMT), first used in physics to interpret statistical properties of nuclear energy spectra. RMT makes predictions for the statistical properties of matrices that are universal, that is, do not depend on the interactions between the elements comprising the system. In physics systems, deviations from the predictions of RMT provide clues regarding the mechanisms controlling the dynamics of a given system, so this framework can be of potential value if applied to economic systems. We discuss a systematic comparison between the statistics of the cross-correlation matrix C - whose elements Cij are the correlation-coefficients between the returns of stock i and j - and that of a random matrix having the same symmetry properties. Our work suggests that RMT can be used to distinguish random and non-random parts of C; the non-random part of C, which deviates from RMT results provides information regarding genuine cross-correlations between stocks.

Cone and seed yields from controlled breeding of southern pines

Treesearch

E. B. Snyder; A. E. Squillace

1966-01-01

Over a 10-year period, survivals of cones from controlled cross-pollinations were less than 40 percent, and seed yields per cone averaged about half those from wind-pollinations. Self-pollinations produced about 15 percent as much seed as cross-pollinations. Interspecific pollinations were generally less productive than intraspecific pollinations.

Aspartame Sensitivity? A Double Blind Randomised Crossover Study

PubMed Central

Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

2015-01-01

Background Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. Methods This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics. Results Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects. Conclusion Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of aspartame does not have any detectable psychological or metabolic effects in humans. Trial Registration ISRCTN Registry ISRCTN39650237 PMID:25786106

Action control of exercise behavior: evaluation of social cognition, cross-behavioral regulation, and automaticity.

PubMed

Rhodes, Ryan E; Fiala, Bonnie; Nasuti, Gabriella

2012-01-01

Intention is considered the proximal determinant of behavior in many popular theories applied to understanding physical activity, yet intention-behavior discordance is high. Thus, an understanding of constructs that facilitate or inhibit the successful translation of intentions into behavior is both timely and important. The action control approach of dividing the intention-behavior relationship into quadrants of successful/unsuccessful intenders has shown utility in the past by demonstrating the magnitude of intention-behavior discordance and allowing for an outcome variable to test predictors. The purpose of this article was to evaluate automaticity and cross-behavioral regulation as predictors of exercise action control, in conjunction with other more standard social cognitive predictors of perceived behavioral control and affective and instrumental attitudes. Participants were a random sample of 263 college students who completed predictor measures at time one, followed by exercise behavior two weeks later. Participants were classified into three intention-behavior profiles: (1) nonintenders (14.1%; n = 31), (2) unsuccessful intenders (35.5%; n = 78), and (3) successful intenders (48.6%; n = 107). Affective attitude, perceived behavioral control, automaticity, and cross-behavioral regulation were predictors of action control. The results demonstrate that automaticity and cross-behavioral regulation, constructs not typically used in intention-based theories, predict intention-behavior discordance.

A single-dose of oral nattokinase potentiates thrombolysis and anti-coagulation profiles

PubMed Central

Kurosawa, Yuko; Nirengi, Shinsuke; Homma, Toshiyuki; Esaki, Kazuki; Ohta, Mitsuhiro; Clark, Joseph F.; Hamaoka, Takafumi

2015-01-01

Our aim was to determine the quantitative effects of a single-dose of Nattokinase (NK) administration on coagulation/fibrinolysis parameters comprehensively in healthy male subjects. A double-blind, placebo-controlled cross-over NK intervention study was carried out in 12 healthy young males. Following the baseline blood draw, each subject was randomized to receive either a single-dose of 2,000 FU NK (NSK-SD, Japan Bio Science Laboratory Co., Ltd) or placebo with subsequent cross-over of the groups. Subjects donated blood samples at 2, 4, 6 and 8 hours following administration for analysis of coagulation/fibrinolysis parameters. As a result, D-dimer concentrations at 6, and 8 hours, and blood fibrin/fibrinogen degradation products at 4 hours after NK administration elevated significantly (p < 0.05, respectively). Factor VIII activity declined at 4 and 6 hours (p < 0.05, respectively), blood antithrombin concentration was higher at 2 and 4 hours (p < 0.05, respectively), and the activated partial thromboplastin time prolonged significantly at 2 and 4 hours following NK administration (p < 0.05 and p < 0.01, respectively). All the changes, however, were within the normal range. In conclusion, thus, a single-dose of NK administration appears enhancing fibrinolysis and anti-coagulation via several different pathways simultaneously. PMID:26109079

Acute psychotropic effects of oral cannabis extract with a defined content of Delta9-tetrahydrocannabinol (THC) in healthy volunteers.

PubMed

Kaufmann, R M; Kraft, B; Frey, R; Winkler, D; Weiszenbichler, S; Bäcker, C; Kasper, S; Kress, H G

2010-01-01

The medical use of cannabinoids is limited mainly by their undesirable effects. With respect to acute psychotropic effects, the aim of this study is the comparison of an oral cannabis extract and low-dose diazepam in a cross-over experiment in drug-naïve healthy women. Sixteen healthy females participated in this randomized, double-blind, active comparator-controlled, single-dose, balanced 2-way cross-over study. Cannabis extract with standardised Delta (9)-tetrahydrocannabinol (THC) content (20 mg) or active placebo (5 mg diazepam) was administered orally. Subjects were assessed by self- and observer-rated visual analogue scales (VAS), the BRIEF PSYCHIATRIC RATING SCALE (BPRS) and three psychomotor tests up to 6 h after administration. VAS showed significantly elevated fatigue, drowsiness, dizziness, and "feeling high" after cannabis as compared to baseline and diazepam. BPRS scores were significantly higher after cannabis intake. Only in one psychomotor test a decrease of psychomotor activity after cannabis was evident. One subject in the cannabis condition experienced severe transient psychotic symptoms. Orally administered cannabis produced significant central depressant side-effects compared to diazepam, mostly subjective effects (VAS) but marginal effects in psychomotor performance in 15 healthy females. Regarding the medical use of cannabis, a rigorous benefit-risk analysis and an exact psychiatric assessment before and during treatment are necessary. (c) Georg Thieme Verlag KG Stuttgart . New York.

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

ERIC Educational Resources Information Center

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

2016-01-01

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

A Randomized, Wait-List Controlled Effectiveness Trial Assessing School-Wide Positive Behavior Support in Elementary Schools

ERIC Educational Resources Information Center

Horner, Robert H.; Sugai, George; Smolkowski, Keith; Eber, Lucille; Nakasato, Jean; Todd, Anne W.; Esperanza, Jody

2009-01-01

We report a randomized, wait-list controlled trial assessing the effects of school-wide positive behavior support (SWPBS). An effectiveness analysis was conducted with elementary schools in Hawaii and Illinois where training and technical assistance in SWPBS was provided by regular state personnel over a 3-year period. Results document that the…

Personality-Targeted Interventions Delay Uptake of Drinking and Decrease Risk of Alcohol-Related Problems when Delivered by Teachers

ERIC Educational Resources Information Center

O'Leary-Barrett, Maeve; Mackie, Clare J.; Castellanos-Ryan, Natalie; Al-Khudhairy, Nadia; Conrod, Patricia J.

2010-01-01

Objective: This trial examined the efficacy of teacher-delivered personality-targeted interventions for alcohol-misuse over a 6-month period. Method: This randomized controlled trial randomly allocated participating schools to intervention (n = 11) or control (n = 7) conditions. A total of 2,506 (mean age, 13.7 years) were assessed for elevated…

New distributed fusion filtering algorithm based on covariances over sensor networks with random packet dropouts

NASA Astrophysics Data System (ADS)

Caballero-Águila, R.; Hermoso-Carazo, A.; Linares-Pérez, J.

2017-07-01

This paper studies the distributed fusion estimation problem from multisensor measured outputs perturbed by correlated noises and uncertainties modelled by random parameter matrices. Each sensor transmits its outputs to a local processor over a packet-erasure channel and, consequently, random losses may occur during transmission. Different white sequences of Bernoulli variables are introduced to model the transmission losses. For the estimation, each lost output is replaced by its estimator based on the information received previously, and only the covariances of the processes involved are used, without requiring the signal evolution model. First, a recursive algorithm for the local least-squares filters is derived by using an innovation approach. Then, the cross-correlation matrices between any two local filters is obtained. Finally, the distributed fusion filter weighted by matrices is obtained from the local filters by applying the least-squares criterion. The performance of the estimators and the influence of both sensor uncertainties and transmission losses on the estimation accuracy are analysed in a numerical example.

A randomized controlled cross-over trial investigating the effect of anti-inflammatory diet on disease activity and quality of life in rheumatoid arthritis: the Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study protocol.

PubMed

Winkvist, Anna; Bärebring, Linnea; Gjertsson, Inger; Ellegård, Lars; Lindqvist, Helen M

2018-04-20

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1.0% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. This affects physical as well as mental wellbeing and leads to severely reduced quality of life and reduced work capacity, thus yielding high individual as well as societal costs. As a complement to modern pharmacological treatment, lifestyle intervention should be evaluated as a treatment option. Scientific evidence exists for anti-inflammatory effects by single foods on RA, but no study exists where these foods have been combined to obtain maximum effect and thus offer a substantial improvement in patient life quality. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that an anti-inflammatory diet intervention, compared to a regular diet, will decrease disease activity and improve quality of life in patients with stable established RA. In total, 50 RA patients with moderate disease activity are randomized to receive initially either a portfolio diet based on several food items with suggested anti-inflammatory effects or a control diet during 2 × 10 weeks with 3 months wash-out between diets. Food bags are delivered weekly by a home food delivery chain and referred to as the fiber bag and the protein bag, respectively, to partially blind participants. Both groups continue with regular pharmacological treatment. Known food biomarkers will be analyzed to measure intervention compliance. Impact on disease severity (measured by DAS28, a composite score which predicts disability and progression of RA), risk markers for cardiovascular disease and quality of life are evaluated after each diet regimen. Metabolomics will be used to evaluate the potential to predict responders to dietary treatment. A health economic evaluation is also included. The nutritional status of patients with RA often is poor and many ask their physician for diet advice. No evidence-based dietary guidelines for patients with RA exist because of the paucity of well-conducted sufficiently large diet intervention trials. ADIRA is an efficacy study and will provide evidence as to whether dietary treatment of RA can reduce disease activity and improve quality of life as well as reduce individual and societal costs. ClinicalTrials.gov Registration Number: NCT02941055 .

Muscle activation levels of the gluteus maximus and medius during standing hip-joint strengthening exercises using elastic-tubing resistance.

PubMed

Youdas, James W; Adams, Kady E; Bertucci, John E; Brooks, Koel J; Nelson, Meghan M; Hollman, John H

2014-02-01

No published studies have compared muscle activation levels simultaneously for the gluteus maximus and medius muscles of stance and moving limbs during standing hip-joint strengthening while using elastic-tubing resistance. To quantify activation levels bilaterally of the gluteus maximus and medius during resisted lower-extremity standing exercises using elastic tubing for the cross-over, reverse cross-over, front-pull, and back-pull exercise conditions. Repeated measures. Laboratory. 26 active and healthy people, 13 men (25 ± 3 y) and 13 women (24 ± 1 y). Subjects completed 3 consecutive repetitions of lower-extremity exercises in random order. Surface electromyographic (EMG) signals were normalized to peak activity in the maximum voluntary isometric contraction (MVIC) trial and expressed as a percentage. Magnitudes of EMG recruitment were analyzed with a 2 × 4 repeated-measures ANOVA for each muscle (α = .05). For the gluteus maximus an interaction between exercise and limb factor was significant (F3,75 = 21.5; P < .001). The moving-limb gluteus maximus was activated more than the stance limb's during the back-pull exercise (P < .001), and moving-limb gluteus maximus muscle recruitment was greater for the back-pull exercise than for the cross-over, reverse cross-over, and front-pull exercises (P < .001). For the gluteus medius an interaction between exercise and limb factor was significant (F3,75 = 3.7; P < .03). Gluteus medius muscle recruitment (% MVIC) was greater in the stance limb than moving limb when performing the front-pull exercise (P < .001). Moving-limb gluteus medius muscle recruitment was greater for the reverse cross-over exercise than for the cross-over, front-pull, and back-pull exercises (P < .001). From a clinical standpoint there is no therapeutic benefit to selectively activate the gluteus maximus and gluteus medius muscles on the stance limb by resisting sagittal- and frontal-plane hip movements on the moving limb using resistance supplied by elastic tubing.

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

PubMed Central

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

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial.

PubMed

Corey-Bloom, Jody; Wolfson, Tanya; Gamst, Anthony; Jin, Shelia; Marcotte, Thomas D; Bentley, Heather; Gouaux, Ben

2012-07-10

Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom. We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue. Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial. Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.

Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial

PubMed Central

Corey-Bloom, Jody; Wolfson, Tanya; Gamst, Anthony; Jin, Shelia; Marcotte, Thomas D.; Bentley, Heather; Gouaux, Ben

2012-01-01

Background: Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom. Methods: We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients’ perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue. Results: Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial. Interpretation: Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact. PMID:22586334

Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

PubMed

Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M

2017-04-01

Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects.

PubMed

Nugent, Allison C; Ballard, Elizabeth D; Gould, Todd D; Park, Lawrence T; Moaddel, Ruin; Brutsche, Nancy E; Zarate, Carlos A

2018-02-27

Ketamine's mechanism of action was assessed using gamma power from magnetoencephalography (MEG) as a proxy measure for homeostatic balance in 35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled in a double-blind, placebo-controlled, randomized cross-over trial of 0.5 mg/kg ketamine. MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration. Both groups showed increased resting gamma power following ketamine. In MDD subjects, gamma power was not associated with the magnitude of the antidepressant effect. However, baseline gamma power was found to moderate the relationship between post-ketamine gamma power and antidepressant response; specifically, higher post-ketamine gamma power was associated with better response in MDD subjects with lower baseline gamma, with an inverted relationship in MDD subjects with higher baseline gamma. This relationship was observed in multiple regions involved in networks hypothesized to be involved in the pathophysiology of MDD. This finding suggests biological subtypes based on the direction of homeostatic dysregulation and has important implications for inferring ketamine's mechanism of action from studies of healthy controls alone.

A randomized study on the effect of Vitamin D3 supplementation on skeletal muscle morphology and Vitamin D receptor concentration in older women

USDA-ARS?s Scientific Manuscript database

Studies examining whether vitamin D supplementation increases muscle mass or muscle-specific vitamin D receptor (VDR) concentration are lacking. Our objective was to determine whether vitamin D3 4000 IU/d alters muscle fiber cross-sectional area (FCSA) and intramyonuclear VDR concentration over 4 mo...

Safety of a new compact male intermittent catheter: randomized, cross-over, single-blind study in healthy male volunteers.

PubMed

Bagi, Per; Hannibalsen, Jane; Permild, Rikke; Stilling, Sine; Looms, Dagnia K

2011-01-01

A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p < 0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved. Copyright © 2011 S. Karger AG, Basel.

Statistical optimization of controlled release microspheres containing cetirizine hydrochloride as a model for water soluble drugs.

PubMed

El-Say, Khalid M; El-Helw, Abdel-Rahim M; Ahmed, Osama A A; Hosny, Khaled M; Ahmed, Tarek A; Kharshoum, Rasha M; Fahmy, Usama A; Alsawahli, Majed

2015-01-01

The purpose was to improve the encapsulation efficiency of cetirizine hydrochloride (CTZ) microspheres as a model for water soluble drugs and control its release by applying response surface methodology. A 3(3) Box-Behnken design was used to determine the effect of drug/polymer ratio (X1), surfactant concentration (X2) and stirring speed (X3), on the mean particle size (Y1), percentage encapsulation efficiency (Y2) and cumulative percent drug released for 12 h (Y3). Emulsion solvent evaporation (ESE) technique was applied utilizing Eudragit RS100 as coating polymer and span 80 as surfactant. All formulations were evaluated for micromeritic properties and morphologically characterized by scanning electron microscopy (SEM). The relative bioavailability of the optimized microspheres was compared with CTZ marketed product after oral administration on healthy human volunteers using a double blind, randomized, cross-over design. The results revealed that the mean particle sizes of the microspheres ranged from 62 to 348 µm and the efficiency of entrapment ranged from 36.3% to 70.1%. The optimized CTZ microspheres exhibited a slow and controlled release over 12 h. The pharmacokinetic data of optimized CTZ microspheres showed prolonged tmax, decreased Cmax and AUC0-∞ value of 3309 ± 211 ng h/ml indicating improved relative bioavailability by 169.4% compared with marketed tablets.

Appetite and Gut Hormones Response to a Putative α-Glucosidase Inhibitor, Salacia Chinensis, in Overweight/Obese Adults: A Double Blind Randomized Controlled Trial.

PubMed

Hao, Lihong; Schlussel, Yvette; Fieselmann, Krista; Schneider, Stephen H; Shapses, Sue A

2017-08-12

Animal studies indicate Salacia reduces body weight, possibly due to its α-glucosidase inhibitor (α-GI) properties, but this has not been examined previously. In this study, a randomized, placebo-controlled, three-way cross-over design was used to evaluate whether Salacia Chinensis (SC) reduces appetite in healthy overweight/obese individuals (body mass index 28.8 ±3.6 kg/m²; 32 ± 12 years). Forty-eight participants were fasted overnight and consumed a dose of SC (300 or 500 mg) or placebo with a fixed breakfast meal at each visit. Appetite sensations, glycemic indices and gastrointestinal peptides were measured. Results indicated that SC had no effect on postprandial appetite. However, in women, hunger was reduced by SC compared to placebo at multiple time points (300 mg; p < 0.05), but not in men. Area under the curve (AUC) for serum glucose, insulin and amylin was attenuated with SC compared to placebo ( p < 0.05). Glucagon like peptide-1 had two peaks after the meal, but the AUC did not differ between groups. The AUC of peak areas for peptide YY and ghrelin were greater for SC than placebo ( p < 0.05). These findings indicate that Salacia decreases glycemic indices supporting its role as an α-GI, and affects certain gastrointestinal peptides suggesting it may be an appetite modulator.

Cannabinoid-induced effects on the nociceptive system: a neurophysiological study in patients with secondary progressive multiple sclerosis.

PubMed

Conte, Antonella; Bettolo, Chiara Marini; Onesti, Emanuela; Frasca, Vittorio; Iacovelli, Elisa; Gilio, Francesca; Giacomelli, Elena; Gabriele, Maria; Aragona, Massimiliano; Tomassini, Valentina; Pantano, Patrizia; Pozzilli, Carlo; Inghilleri, Maurizio

2009-05-01

Although clinical studies show that cannabinoids improve central pain in patients with multiple sclerosis (MS) neurophysiological studies are lacking to investigate whether they also suppress these patients' electrophysiological responses to noxious stimulation. The flexion reflex (FR) in humans is a widely used technique for assessing the pain threshold and for studying spinal and supraspinal pain pathways and the neurotransmitter system involved in pain control. In a randomized, double-blind, placebo-controlled, cross-over study we investigated cannabinoid-induced changes in RIII reflex variables (threshold, latency and area) in a group of 18 patients with secondary progressive MS. To investigate whether cannabinoids act indirectly on the nociceptive reflex by modulating lower motoneuron excitability we also evaluated the H-reflex size after tibial nerve stimulation and calculated the H wave/M wave (H/M) ratio. Of the 18 patients recruited and randomized 17 completed the study. After patients used a commercial delta-9-tetrahydrocannabinol (THC) and cannabidiol mixture as an oromucosal spray the RIII reflex threshold increased and RIII reflex area decreased. The visual analogue scale score for pain also decreased, though not significantly. Conversely, the H/M ratio measured before patients received cannabinoids remained unchanged after therapy. In conclusion, the cannabinoid-induced changes in the RIII reflex threshold and area in patients with MS provide objective neurophysiological evidence that cannabinoids modulate the nociceptive system in patients with MS.

An investigation of the effect of an essential oil mouthrinse on induced bacteraemia: a pilot study.

PubMed

Fine, Daniel H; Furgang, David; McKiernan, Marie; Tereski-Bischio, Debra; Ricci-Nittel, Danette; Zhang, Paul; Araujo, Marcelo W B

2010-09-01

This pilot study was designed to assess the effect of an essential oil antiseptic mouthrinse (EOM) in reducing bloodstream bacteria after chewing an apple. From a panel of 200, we screened 62 individuals with mild-to-moderate gingivitis. Twenty-two individuals who showed a bacteraemia after chewing an apple were enrolled. Subjects were recalled, instructed to chew an apple, had blood drawn (first baseline), and were randomly assigned EOM or a control (C) treatment for 2 weeks. Subjects were recalled, given an apple, and had blood taken for bacterial counts. Following a 1-week fluoride dentifrice wash-out, subjects were recalled, given the apple challenge, had blood drawn (second baseline), assigned the alternate treatment, and recalled for testing. Differences between baseline and 2-week post-treatment (EOM versus C) in blood-borne bacteria were assessed by analysis of covariance. Mean aerobic blood-borne bacteria decreased by 68.5% (17.7 viable counts from baseline; p<0.001), while anaerobic counts decreased by 70.7% (14.5 mean viable counts from baseline; p<0.001) for the EOM treatment. No reduction was seen for the C treatment. This double-blind, placebo-controlled, randomized, 2-week cross-over study showed that rinsing with essential oils reduced the level of bloodstream bacteria in subjects with mild-to-moderate gingivitis.

Repeated threat (without direct harm) alters metabolic capacity in select regions that drive defensive behavior.

PubMed

Kim, D J; Lee, A S; Yttredahl, A A; Gómez-Rodríguez, R; Anderson, B J

2017-06-14

To understand the behavioral consequences of intermittent anticipatory stress resulting from threats without accompanying physiological challenges, we developed a semi-naturalistic rodent housing and foraging environment that can include threats that are unpredictable in timing. Behavior is automatically recorded while rats forage for food or water. Over three weeks, the threats have been shown to elicit risk assessment behaviors, increase defensive burying and increase adrenal gland weight. To identify brain regions activated by this manipulation, we measured cytochrome c oxidase (COX), which is tightly coupled to neural activity. Adolescent male Sprague-Dawley rats were randomly assigned to control (CT) or unpredictable threat/stress (ST) housing conditions consisting of two tub cages, one with food and another with water, separated by a tunnel. Over three weeks (P31-P52), the ST group received randomly timed (probability of 0.25), simultaneous presentations of ferret odor, an abrupt light, and sound at the center of the tunnel. The ST group had consistently fewer tunnel crossings than the CT group, but similar body weights. Group differences in COX activity were detected in regions implicated in the control of defensive burying. There was an increase in COX activity in the hypothalamic premammillary dorsal nucleus (PMD) and lateral septum (LS), whereas a decrease was observed in the periaqueductal gray (PAG) and CA3 region of the hippocampus. There were no significant differences in the anterior cingulate cortex, prefrontal cortex, striatum or motor cortex. The sites with changes in metabolic capacity are candidates for the sites of plasticity that may underlie the behavioral adaptations to intermittent threats. Copyright © 2017 IBRO. Published by Elsevier Ltd. All rights reserved.

A Randomized Controlled Pilot Intervention Study of a Mindfulness-Based Self-Leadership Training (MBSLT) on Stress and Performance.

PubMed

Sampl, Juliane; Maran, Thomas; Furtner, Marco R

2017-01-01

The present randomized pilot intervention study examines the effects of a mindfulness-based self-leadership training (MBSLT) specifically developed for academic achievement situations. Both mindfulness and self-leadership have a strong self-regulatory focus and are helpful in terms of stress resilience and performance enhancements. Based on several theoretical points of contact and a specific interplay between mindfulness and self-leadership, the authors developed an innovative intervention program that improves mood as well as performance in a real academic setting. The intervention was conducted as a randomized controlled study over 10 weeks. The purpose was to analyze the effects on perceived stress, test anxiety, academic self-efficacy, and the performance of students by comparing an intervention and control group ( n  = 109). Findings demonstrated significant effects on mindfulness, self-leadership, academic self-efficacy, and academic performance improvements in the intervention group. Results showed that the intervention group reached significantly better grade point averages than the control group. Moreover, the MBSLT over time led to a reduction of test anxiety in the intervention group compared to the control group. Furthermore, while participants of the control group showed an increase in stress over time, participants of the intervention group maintained constant stress levels over time. The combination of mindfulness and self-leadership addressed both positive effects on moods and on objective academic performance. The effects demonstrate the great potential of combining mindfulness with self-leadership to develop a healthy self-regulatory way of attaining achievement-related goals and succeeding in high-stress academic environments.

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: a cross-sectional study.

PubMed

Katz, Kenneth A; Karlawish, Jason H; Chiang, David S; Bognet, Rachel A; Propert, Katherine J; Margolis, David J

2006-11-01

The ethics and science of using placebo control groups in clinical trials have been widely debated. Few studies, however, have examined factors associated with choice of control group. Our aim was to assess the prevalence of use of placebo controls in randomized controlled trials in psoriasis and to identify factors associated with use of placebo controls in these trials. This is a cross-sectional study of randomized controlled trials in psoriasis published from January 1, 2001 to December 20, 2005 and indexed in the Cochrane Central Register of Controlled Trials. We extracted data on types of control groups used, design issues (number of patients enrolled, primary end point), disease characteristics (psoriasis type and severity), and extrascientific issues (trial location, funding source, and year of publication). We used bivariable and multivariable logistic regression to determine factors associated with use of a placebo control group. Of 194 citations, 187 were available for review. One hundred thirty-five trials from 134 articles in 38 journals met inclusion criteria. Eighty-three trials (61.5%) enrolling 8171 subjects (41.7%) used active controls only, and 52 trials (38.5%) enrolling 11,406 subjects (58.3%) used placebo controls. Adjusted for trial location and funding source, trials significantly more likely to have used placebo controls included those conducted in the United States (odds ratio [OR], 5.79; 95% confidence interval [CI], 2.45-13.68; P < .001) and those funded by pharmaceutical companies (OR, 2.61; 95% CI, 1.19-5.73; P = .02). Predicted frequencies of placebo use ranged from 77.6% (industry-funded, conducted trials in the United States) to 18.6% (non-industry-funded trials not conducted in the United States). Our searches may not have identified all published trials, and we did not have access to data from unpublished trials. Use of placebo controls has been more common in psoriasis trials conducted in the United States and funded by pharmaceutical companies. The findings suggest that ethical and scientific issues related to choice of control group in psoriasis trials are interpreted markedly differently depending on trial location and funding source.

Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.

PubMed

Philip, Pierre; Chaufton, Cyril; Taillard, Jacques; Capelli, Aurore; Coste, Olivier; Léger, Damien; Moore, Nicholas; Sagaspe, Patricia

2014-03-01

Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance. Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout. Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed. Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P < 0.05 and F(1,25) = 3.87, P = 0.06 tendency). Mean sleep latency at the Maintenance of Wakefulness Test significantly correlated with the mean number of Inappropriate Line Crossings (r = -0.41, P < 0.001). Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population.

Efficacy of low-frequency low-intensity electrotherapy in the treatment of breast cancer-related lymphoedema: a cross-over randomized trial.

PubMed

Belmonte, Roser; Tejero, Marta; Ferrer, Montse; Muniesa, Josep Maria; Duarte, Esther; Cunillera, Oriol; Escalada, Ferran

2012-07-01

To compare the efficacy of low-frequency low-intensity electrotherapy and manual lymphatic drainage in the treatment of chronic upper limb breast cancer-related lymphoedema. Cross-over single-blind random clinical trial. Rehabilitation service. Thirty-six women with chronic upper limb breast cancer-related lymphoedema. Patients were randomized to undergo 10 sessions of manual lymphatic drainage followed by 10 sessions of low-frequency low-intensity electrotherapy or to undergo first low-frequency low-intensity electrotherapy followed by manual lymphatic drainage. There was a month of washout time between treatments. Each patient was examined just before and after each treatment. Researchers and outcome assessors were blinded for assigned treatment. Outcomes were lymphoedema volume, pain, heaviness and tightness, and health-related quality of life measured with the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4). Carry-over, period and treatment effects were analysed. Treatment effect was assessed using paired t-test. Thirty patients finalized treatment. Comparing the changes in low-frequency low-intensity electrotherapy with manual lymphatic drainage changes, there were no significant differences. Low-frequency low-intensity electrotherapy did not reduce lymphoedema volume (mean of change = 19.77 mL, P = 0.36), but significant reductions were observed in pain, heaviness and tightness (mean of change = 13.1, 16.2 and 6.4 mm, respectively), and FACT-B+4 summaries improved significantly (Trial Outcome Index mean of change = 5.4, P = 0.015). Manual lymphatic drainage showed no significant changes in any of the outcomes Although there are no significant differences between treatment changes, the observed trend towards a better health-related quality of life is remarkable in low-frequency low-intensity electrotherapy.

Efficacy of low-frequency low-intensity electrotherapy in the treatment of breast cancer-related lymphoedema: a cross-over randomized trial

PubMed Central

Tejero, Marta; Ferrer, Montse; Muniesa, Josep M; Duarte, Esther; Cunillera, Oriol; Escalada, Ferran

2012-01-01

Objective: To compare the efficacy of low-frequency low-intensity electrotherapy and manual lymphatic drainage in the treatment of chronic upper limb breast cancer-related lymphoedema. Design: Cross-over single-blind random clinical trial. Setting: Rehabilitation service. Participants: Thirty-six women with chronic upper limb breast cancer-related lymphoedema. Methods: Patients were randomized to undergo 10 sessions of manual lymphatic drainage followed by 10 sessions of low-frequency low-intensity electrotherapy or to undergo first low-frequency low-intensity electrotherapy followed by manual lymphatic drainage. There was a month of washout time between treatments. Each patient was examined just before and after each treatment. Researchers and outcome assessors were blinded for assigned treatment. Measures: Outcomes were lymphoedema volume, pain, heaviness and tightness, and health-related quality of life measured with the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4). Carry-over, period and treatment effects were analysed. Treatment effect was assessed using paired t-test. Results: Thirty patients finalized treatment. Comparing the changes in low-frequency low-intensity electrotherapy with manual lymphatic drainage changes, there were no significant differences. Low-frequency low-intensity electrotherapy did not reduce lymphoedema volume (mean of change = 19.77 mL, P = 0.36), but significant reductions were observed in pain, heaviness and tightness (mean of change = 13.1, 16.2 and 6.4 mm, respectively), and FACT-B+4 summaries improved significantly (Trial Outcome Index mean of change = 5.4, P = 0.015). Manual lymphatic drainage showed no significant changes in any of the outcomes Conclusion: Although there are no significant differences between treatment changes, the observed trend towards a better health-related quality of life is remarkable in low-frequency low-intensity electrotherapy. PMID:22172923

Effectiveness of the bucco-lingual technique within a school-based supervised toothbrushing program on preventing caries: a randomized controlled trial

PubMed Central

2011-01-01

Background Supervised toothbrushing programs using fluoride dentifrice have reduced caries increment. However there is no information about the effectiveness of the professional cross-brushing technique within a community intervention. The aim was to assess if the bucco-lingual technique can increase the effectiveness of a school-based supervised toothbrushing program on preventing caries. Methods A randomized double-blinded controlled community intervention trial to be analyzed at an individual level was conducted in a Brazilian low-income fluoridated area. Six preschools were randomly assigned to the test and control groups and 284 five-year-old children presenting at least one permanent molar with emerged/sound occlusal surface participated. In control group, oral health education and dental plaque dying followed by toothbrushing with fluoride dentifrice supervised directly by a dental assistant, was developed four times per year. At the remaining school days the children brushed their teeth under indirect supervising of the teachers. In test group, children also underwent a professional cross-brushing on surfaces of first permanent molar rendered by a specially trained dental assistant five times per year. Enamel and dentin caries were recorded on buccal, occlusal and lingual surfaces of permanent molars during 18-month follow-up. Exposure time of surfaces was calculated and incidence density ratio was estimated using Poisson regression model. Results Difference of 21.6 lesions per 1,000 children between control and test groups was observed. Among boys whose caries risk was higher compared to girls, incidence density was 50% lower in test group (p = 0.016). Conclusion Modified program was effective among the boys. It is licit to project a relevant effect in a larger period suggesting in a broader population substantial reduction of dental care needs. Trial registration ISRCTN18548869. PMID:21426572

Enhanced bioavailability of lycopene when consumed as cis-isomers from tangerine compared to red tomato juice, a randomized, cross-over clinical trial.

PubMed

Cooperstone, Jessica L; Ralston, Robin A; Riedl, Ken M; Haufe, Thomas C; Schweiggert, Ralf M; King, Samantha A; Timmers, Cynthia D; Francis, David M; Lesinski, Gregory B; Clinton, Steven K; Schwartz, Steven J

2015-04-01

Tangerine tomatoes (Solanum lycopersicum) are rich in tetra-cis-lycopene resulting from natural variation in carotenoid isomerase. Our objective was to compare the bioavailability of lycopene from tangerine to red tomato juice, and elucidate physical deposition forms of these isomers in tomatoes by light and electron microscopy. Following a randomized cross-over design, subjects (n = 11, 6 M/5 F) consumed two meals delivering 10 mg lycopene from tangerine (94% cis) or red tomato juice (10% cis). Blood was sampled over 12 h and triglyceride-rich lipoprotein fractions of plasma were isolated and analyzed using HPLC-DAD-MS/MS. Lycopene was crystalline in red tomato chromoplasts and globular in tangerine tomatoes. With tangerine tomato juice we observed a marked 8.5-fold increase in lycopene bioavailability compared to red tomato juice (p < 0.001). Fractional absorption was 47.70 ± 8.81% from tangerine and 4.98 ± 1.92% from red tomato juices. Large heterogeneity was observed among subjects. Lycopene is markedly more bioavailable from tangerine than from red tomato juice, consistent with a predominance of cis-lycopene isomers and presence in chromoplasts in a lipid dissolved globular state. These results justify using tangerine tomatoes as a lycopene source in studies examining the potential health benefits of lycopene-rich foods. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Random matrix theory and cross-correlations in global financial indices and local stock market indices

NASA Astrophysics Data System (ADS)

Nobi, Ashadun; Maeng, Seong Eun; Ha, Gyeong Gyun; Lee, Jae Woo

2013-02-01

We analyzed cross-correlations between price fluctuations of global financial indices (20 daily stock indices over the world) and local indices (daily indices of 200 companies in the Korean stock market) by using random matrix theory (RMT). We compared eigenvalues and components of the largest and the second largest eigenvectors of the cross-correlation matrix before, during, and after the global financial the crisis in the year 2008. We find that the majority of its eigenvalues fall within the RMT bounds [ λ -, λ +], where λ - and λ + are the lower and the upper bounds of the eigenvalues of random correlation matrices. The components of the eigenvectors for the largest positive eigenvalues indicate the identical financial market mode dominating the global and local indices. On the other hand, the components of the eigenvector corresponding to the second largest eigenvalue are positive and negative values alternatively. The components before the crisis change sign during the crisis, and those during the crisis change sign after the crisis. The largest inverse participation ratio (IPR) corresponding to the smallest eigenvector is higher after the crisis than during any other periods in the global and local indices. During the global financial the crisis, the correlations among the global indices and among the local stock indices are perturbed significantly. However, the correlations between indices quickly recover the trends before the crisis.

Using Cf-252 for single event upset testing

NASA Astrophysics Data System (ADS)

Howard, J. W.; Chen, R.; Block, R. C.; Becker, M.; Costantine, A. G.; Smith, L. S.; Soli, G. A.; Stauber, M. C.

An improved system using Cf-252 and associated nuclear instrumentation has been used to determine single event upset (SEU) cross section versus linear energy transfer (LET) curve for several static random access memory (SRAM) devices. Through the use of a thin-film scintillator, providing energy information on each fission fragment, individual SEU's and ion energy can be associated to calculate the cross section curves. Results are presented from tests of several SRAM's over the 17-43 MeV-cm squared/mg LET range. Values obtained for SEU cross sections and LET thresholds are in good agreement with the results from accelerator testing. The equipment is described, the theory of thin-film scintillation detector response is summarized, experimental procedures are reviewed, and the test results are discussed.

Reduced backscattering cross section (Sigma degree) data from the Skylab S-193 radar altimeter

NASA Technical Reports Server (NTRS)

Brown, G. S.

1975-01-01

Backscattering cross section per unit scattering area data, reduced from measurements made by the Skylab S-193 radar altimeter over the ocean surface are presented. Descriptions of the altimeter are given where applicable to the measurement process. Analytical solutions are obtained for the flat surface impulse response for the case of a nonsymmetrical antenna pattern. Formulations are developed for converting altimeter AGC outputs into values for the backscattering cross section. Reduced data are presented for Missions SL-2, 3 and 4 for all modes of the altimeter where sufficient calibration existed. The problem of interpreting land scatter data is also discussed. Finally, a comprehensive error analysis of the measurement is presented and worst case random and bias errors are estimated.

The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

2016-01-01

Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

Recombinant human bone morphogenetic protein-2 stimulates bone formation during interfrontal suture expansion in rabbits.

PubMed

Liu, Sean Shih-Yao; Xu, Haisong; Sun, Jun; Kontogiorgos, Elias; Whittington, Patrick R; Misner, Kenner G; Kyung, Hee-Moon; Buschang, Peter H; Opperman, Lynne A

2013-08-01

Suture expansion stimulates bone growth to correct craniofacial deficiencies but has a high potential of treatment relapse. The objective of this study was to investigate whether there is a dose-dependent relationship between the recombinant human bone morphogenetic protein-2 (rhBMP-2) and bone formation during suture expansion. Fifty 6-week-old male New Zealand white rabbits were randomly assigned to 5 groups to receive 0 (control), 0.01, 0.025, 0.1, or 0.4 mg/mL of rhBMP-2 delivered by absorbable collagen sponge placed over the interfrontal suture. The suture was expanded for 33 days by 200 g of constant force via a spring anchored with 2 miniscrew implants. Distance of suture expansion, suture volume, and cross-sectional area after expansion were measured using radiographs with bone markers and microcomputed tomography. Suture widths and mineralization appositional rates were calculated based on the widths between bone labels under an epifluorescent microscope. Software (Multilevel Win 2.0; University of Bristol, Bristol, United Kingdom) was used to model distance of suture expansion over time as polynomials to compare group differences. Wilcoxon signed rank tests were performed to compare the suture volume and cross-sectional area, mineral apposition rate, and suture width between groups. The significance level was set at P = 0.05. Whereas the sutures were expanded in all groups, sutures were expanded by significantly greater amounts in the control and the 0.01 mg/mL groups without fusing the sutures than in the 0.025, 0.1, and 0.4 mg/mL groups with fusing sutures. Compared with the controls, the 0.01 mg/mL group showed significantly lower suture volumes, cross-sectional areas, and suture widths after expansion. The mineral apposition rate was significantly higher in the 0.01 mg/mL group than in the controls from days 10 to 30. The 0.01 mg/mL dose of rhBMP-2 delivered by absorbable collagen sponge can stimulate bone formation at the bony edges of the suture during suture expansion; however, higher concentrations cause suture fusion. With an appropriate concentration, rhBMP-2 might facilitate suture expansion for clinical uses. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Oxidative stress in hemodialysis patients receiving intravenous iron therapy and the role of N-acetylcysteine in preventing oxidative stress.

PubMed

Swarnalatha, G; Ram, R; Neela, Prasad; Naidu, M U R; Dakshina Murty, K V

2010-09-01

To determine the contribution of injectable iron administered to hemodialysis (HD) patients in causing oxidative stress and the beneficial effect of N-acetylcysteine (NAC) in reducing it, we studied in a prospective, double blinded, randomized controlled, cross over trial 14 adult HD patients who were randomized into two groups; one group received NAC in a dose of 600 mgs twice daily for 10 days prior to intravenous iron therapy and the other group received placebo. Both the groups were subjected to intravenous iron therapy, 100 mg of iron sucrose in 100 mL of normal saline given over a period of one hour. Blood samples for the markers of oxidative stress were taken before and after iron therapy. After the allowance of a week of wash out period for the effect of N-acetylcysteine we crossed over the patients to the opposite regimen. We measured the lipid peroxidation marker, malondiaaldehyde (MDA), to evaluate the oxidative stress and total anti-oxidant capacity (TAC) for the antioxidant level in addition to the highly sensitive C-reactive protein (HsCRP). Non-invasive assessment of endothelial dysfunction was measured by digital plethysmography before and after intravenous iron therapy. There was an increase of MDA (21.97 + 3.65% vs 7.06 + 3.65%) and highly sensitive C-reactive protein (HsCRP) (11.19 + 24.63% vs 13.19 + 7.7%) after iron administration both in the placebo and the NAC groups. NAC reduced the baseline acute systemic generation of oxidative stress when compared to placebo, which was statistically significant with MDA (12.76 + 4.4% vs 9.37 + 4.40%: P = 0.032) but not with HsCRP though there was a declining trend (2.85 + 22.75 % vs 8.93 + 5.19%: P = 0.112). Pre-treatment with NAC reduced the endothelial dysfunction when compared to placebo, but it was not statistically significant, except for reflection index (RI). We conclude that in our HD patients NAC reduced the oxidative stress before and after the administration of intravenous iron therapy in addition to the endothelial dysfunction induced by this treatment.

Baseline adjustments for binary data in repeated cross-sectional cluster randomized trials.

PubMed

Nixon, R M; Thompson, S G

2003-09-15

Analysis of covariance models, which adjust for a baseline covariate, are often used to compare treatment groups in a controlled trial in which individuals are randomized. Such analysis adjusts for any baseline imbalance and usually increases the precision of the treatment effect estimate. We assess the value of such adjustments in the context of a cluster randomized trial with repeated cross-sectional design and a binary outcome. In such a design, a new sample of individuals is taken from the clusters at each measurement occasion, so that baseline adjustment has to be at the cluster level. Logistic regression models are used to analyse the data, with cluster level random effects to allow for different outcome probabilities in each cluster. We compare the estimated treatment effect and its precision in models that incorporate a covariate measuring the cluster level probabilities at baseline and those that do not. In two data sets, taken from a cluster randomized trial in the treatment of menorrhagia, the value of baseline adjustment is only evident when the number of subjects per cluster is large. We assess the generalizability of these findings by undertaking a simulation study, and find that increased precision of the treatment effect requires both large cluster sizes and substantial heterogeneity between clusters at baseline, but baseline imbalance arising by chance in a randomized study can always be effectively adjusted for. Copyright 2003 John Wiley & Sons, Ltd.

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

PubMed Central

Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

2015-01-01

Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group. PMID:26300719

[Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial].

PubMed

Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger

2014-10-21

To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Lactobacillus paracasei F19 versus placebo for the prevention of proton pump inhibitor-induced bowel symptoms: a randomized clinical trial.

PubMed

Compare, Debora; Rocco, Alba; Sgamato, Costantino; Coccoli, Pietro; Campo, Salvatore Maria Antonio; Nazionale, Immacolata; Larussa, Tiziana; Luzza, Francesco; Chiodini, Paolo; Nardone, Gerardo

2015-04-01

Proton pump inhibitors may foster intestinal dysbiosis and related bowel symptoms. To evaluate the effect of Lactobacillus paracasei F19 on bowel symptom onset in patients on long-term proton pump inhibitors. In this randomized, double-blind, placebo-controlled study, patients with typical gastroesophageal reflux disease symptoms receiving pantoprazole 40 mg/d for six months were randomly assigned to receive: (A) Lactobacillus paracasei F19 bid for three days/week for six months; (B) placebo bid for three days/week for six months; (C) Lactobacillus paracasei F19 bid for three days/week for three months and placebo bid for three days/week for the following three months; (D) placebo bid for three days/week for three months and Lactobacillus paracasei F19 bid for three days/week for the following three months. Bloating, flatulence, abdominal pain and bowel habit were assessed monthly. 100/312 patients were enrolled. In the parallel groups, the treatment-by-time interaction affected bloating (p = 0.015), while Lactobacillus paracasei F19 treatment alone affected flatulence (p = 0.011). Moreover, the treatment-by-time interaction significantly affected the mean score of bloating (p = 0.01) and flatulence (p < 0.0001), the mean stool form (p = 0.03) and mean stool frequency/week (p = 0.016). Analysis of the cross-over groups, limited to the first three months because of carry-over effect, confirmed these results. Lactobacillus paracasei F19 supplementation prevents bowel symptom onset in patients on long-term proton pump inhibitors. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Erlotinib 150 mg daily plus chemotherapy in advanced pancreatic cancer: an interim safety analysis of a multicenter, randomized, cross-over phase III trial of the 'Arbeitsgemeinschaft Internistische Onkologie'.

PubMed

Boeck, Stefan; Vehling-Kaiser, Ursula; Waldschmidt, Dirk; Kettner, Erika; Märten, Angela; Winkelmann, Cornelia; Klein, Stefan; Kojouharoff, Georgi; Gauler, Thomas; Fischer von Weikersthal, Ludwig; Clemens, Michael R; Geissler, Michael; Greten, Tim F; Hegewisch-Becker, Susanna; Neugebauer, Sascha; Heinemann, Volker

2010-01-01

To date, only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer. Within a randomized phase III trial, 281 treatment-naive patients were randomly assigned between capecitabine (2000 mg/m/day, for 14 days, once every 3 weeks) plus erlotinib (150 mg/day, arm A) and gemcitabine (1000 mg/m as a 30-min infusion) plus erlotinib (150 mg/day, arm B). In case of treatment failure, patients were crossed over to a second-line treatment with the comparator cytostatic drug without erlotinib. The primary study endpoint was the time to treatment failure of second-line therapy (TTF2). This interim analysis of toxicity contains safety data from the first 127 randomized patients. During first-line therapy, patients received a median number of three treatment cycles (range 0-13) in both the arms. Regarding chemotherapy, a treatment delay was observed in 12% of the cycles in arm A and in 22% of the cycles in arm B. Dose reductions of the cytostatic drug were performed in 18 and 27% of treatment cycles, respectively. Erlotinib dose reductions were performed in 6 and 11% of all cycles. Grade 3/4 hematological toxicity was <10% in both the arms; major grade 3/4 toxicities in arms A and B were diarrhea (9 vs. 7%), skin rash (4 vs. 12%), and hand-foot syndrome (7 vs. 0%). No treatment-related death was observed. In conclusion, this interim safety analysis suggests that treatment with erlotinib 150 mg/day is feasible in combination with capecitabine or gemcitabine.

Chest Compression With Personal Protective Equipment During Cardiopulmonary Resuscitation: A Randomized Crossover Simulation Study.

PubMed

Chen, Jie; Lu, Kai-Zhi; Yi, Bin; Chen, Yan

2016-04-01

Following a chemical, biological, radiation, and nuclear incident, prompt cardiopulmonary resuscitation (CPR) procedure is essential for patients who suffer cardiac arrest. But CPR when wearing personal protection equipment (PPE) before decontamination becomes a challenge for healthcare workers (HCW). Although previous studies have assessed the impact of PPE on airway management, there is little research available regarding the quality of chest compression (CC) when wearing PPE.A present randomized cross-over simulation study was designed to evaluate the effect of PPE on CC performance using mannequins.The study was set in one university medical center in the China.Forty anesthesia residents participated in this randomized cross-over study.Each participant performed 2 min of CC on a manikin with and without PPE, respectively. Participants were randomized into 2 groups that either performed CC with PPE first, followed by a trial without PPE after a 180-min rest, or vice versa.CPR recording technology was used to objectively quantify the quality of CC. Additionally, participants' physiological parameters and subjective fatigue score values were recorded.With the use of PPE, a significant decrease of the percentage of effective compressions (41.3 ± 17.1% with PPE vs 67.5 ± 15.6% without PPE, P < 0.001) and the percentage of adequate compressions (67.7 ± 18.9% with PPE vs 80.7 ± 15.5% without PPE, P < 0.001) were observed. Furthermore, the increases in heart rate, mean arterial pressure, and subjective fatigue score values were more obvious with the use of PPE (all P < 0.01).We found significant deterioration of CC performance in HCW with the use of a level-C PPE, which may be a disadvantage for enhancing survival of cardiac arrest.

A national cross-sectional study on effects of fluoride-safe water supply on the prevalence of fluorosis in China.

PubMed

Wang, Cheng; Gao, Yanhui; Wang, Wei; Zhao, Lijun; Zhang, Wei; Han, Hepeng; Shi, Yuxia; Yu, Guangqian; Sun, Dianjun

2012-01-01

To assess the effects of provided fluoride-safe drinking-water for the prevention and control of endemic fluorosis in China. A national cross-sectional study in China. In 1985, randomly selected villages in 27 provinces (or cities and municipalities) in 5 geographic areas all over China. Involved 81 786 children aged from 8 to 12 and 594 698 adults aged over 16. The prevalence of dental fluorosis and clinical skeletal fluorosis, the fluoride concentrations in the drinking-water in study villages and in the urine of subjects. The study showed that in the villages where the drinking-water fluoride concentrations were higher than the government standard of 1.2 mg/l, but no fluoride-safe drinking-water supply scheme was provided (FNB areas), the prevalence rate and index of dental fluorosis in children, and prevalence rate of clinical skeletal fluorosis in adults were all significantly higher than those in the historical endemic fluorosis villages after the fluoride-safe drinking-water were provided (FSB areas). Additionally, the prevalence rate of dental fluorosis as well as clinical skeletal fluorosis, and the concentration of fluoride in urine were found increased with the increase of fluoride concentration in drinking-water, with significant positive correlations in the FNB areas. While, the prevalence rate of dental fluorosis and clinical skeletal fluorosis in different age groups and their degrees of prevalence were significantly lower in the FSB areas than those in the FNB areas. The provision of fluoride-safe drinking-water supply schemes had significant effects on the prevention and control of dental fluorosis and skeletal fluorosis. The study also indicated that the dental and skeletal fluorosis is still prevailing in the high-fluoride drinking-water areas in China.

Bright light therapy and melatonin in motor restless behaviour in dementia: a placebo-controlled study.

PubMed

Haffmans, P M; Sival, R C; Lucius, S A; Cats, Q; van Gelder, L

2001-01-01

The purpose of this study was to evaluate the effects of bright light therapy combined with melatonin on motor restless behaviour in dementia. Double-blind, placebo-controlled, cross-over trial consisting of four periods. One week wash-out was followed by a 2-week period of light therapy in combination with placebo or melatonin. The second wash-out period of 1 week was followed by 2 weeks of treatment (cross-over). Twenty-four bed medium-stay psychogeriatric ward at a Dutch psychiatric teaching hospital. Ten patients, who met the criteria for dementia (DSM-IV) and motor restless behaviour (subscale 10 of the GIP), were included. Informed consent was obtained by proxy. All subjects were exposed during 2x5 consecutive days for 30 minutes to 10,000 lux bright light and randomly administered 2.5 mg melatonin or placebo at 22.00 h. Clinical Global Impression (CGI), Dutch version of the geriatric behavioural observation scale (GIP), Social Dysfunction and Aggression Scale (SDAS) were assessed after each wash-out and treatment period. Outcome criteria were CGI, assessing motor restless behaviour, the SDAS, measuring extrovert aggression and the GIP, assessing social, psychomotor and emotional behaviour. Six demented inpatients completed the trial. Positive effects were found for the treatment combined with placebo. Patients were less restless and more co-operative. The condition with melatonin showed no additional positive effects, additionally, patients became more aggressive and showed the same or more disturbed behaviour. Bright light therapy has a positive effect on motor restless behaviour. Light therapy in combination with melatonin has no positive effects. The results might be explained by a possible overshoot of chronobiological synchronisation or the timing of the melatonin intake. Copyright 2001 John Wiley & Sons, Ltd.

A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

PubMed

Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

2003-12-01

The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P < 0.0001), and heterogeneous staining (P = 0.137) or no staining (P = 0.005) were associated with dysplasia and/or carcinoma detection. The MBDB technique prolonged the endoscopy examination by an average of 6 min. The diagnostic accuracy of the MBDB technique was superior to that of the random biopsy technique for identifying specialized intestinal metaplasia, but not dysplasia or carcinoma. The intensity of methylene blue staining has an influence on the detection of specialized intestinal metaplasia and dysplasia or carcinoma, which may help in targeting the biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

Effects of consumer-oriented health information technologies in diabetes management over time: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Tao, Da; Wang, Tieyan; Wang, Tieshan; Liu, Shuang; Qu, Xingda

2017-09-01

To reveal the effects of consumer-oriented health information technologies (CHITs) on patient outcomes in diabetes management over time through systematic review and meta-analysis. We searched 5 electronic databases (from database inception to July 2016) for studies that reported on randomized controlled trials examining the effects of CHITs on glycemic control and other patient outcomes in diabetes management. Data were analyzed using either meta-analysis or a narrative synthesis approach. Eighty randomized controlled trial studies, representing 87 individual trials, were identified and included for analysis. Overall, the meta-analysis showed that the use of CHITs resulted in significant improvement in glycemic control compared to usual care (standardized mean difference = -0.31%, 95% confidence interval -0.38 to -0.23, P  < .001) in patients with diabetes. Specifically, improvement in glycemic control was significant at intervention durations of 3, 6, 8, 9, 12, 15, 30, and 60 months, while no significant differences were found at other time points reported. The narrative synthesis provided mixed effects of CHITs on other clinical, psychosocial, behavioral, and knowledge outcomes. The use of CHITs appears to be more effective than usual care in improving glycemic control for patients with diabetes. However, their effectiveness did not remain consistent over time and in other patient outcomes. Further efforts are required to examine long-term effects of CHITs and to explore factors that can moderate the effects over time. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial.

PubMed

Asher, Gary N; Viera, Anthony J; Weaver, Mark A; Dominik, Rosalie; Caughey, Melissa; Hinderliter, Alan L

2012-03-29

Hawthorn extract has been used for cardiovascular diseases for centuries. Recent trials have demonstrated its efficacy for the treatment of heart failure, and the results of several small trials suggest it may lower blood pressure. However, there is little published evidence to guide its dosing. The blood pressure lowering effect of hawthorn has been linked to nitric oxide-mediated vasodilation. The aim of this study was to investigate the relationship between hawthorn extract dose and brachial artery flow mediated dilation (FMD), an indirect measure of nitric oxide release. We used a four-period cross-over design to evaluate brachial artery FMD in response to placebo or hawthorn extract (standardized to 50 mg oligomeric procyanidin per 250 mg extract). Randomly sequenced doses of hawthorn extract (1000 mg, 1500 mg, and 2500 mg) and placebo were assigned to each participant. Doses were taken twice daily for 3 1/2 days followed by FMD and a 4-day washout before proceeding to the next dosing period. Twenty-one prehypertensive or mildly hypertensive adults completed the study. There was no evidence of a dose-response effect for our main outcome (FMD percent) or any of our secondary outcomes (absolute change in brachial artery diameter and blood pressure). Most participants indicated that if given evidence that hawthorn could lower their blood pressure, they would be likely to use it either in conjunction with or instead of lifestyle modification or anti-hypertensive medications. We found no evidence of a dose-response effect of hawthorn extract on FMD. If hawthorn has a blood pressure lowering effect, it is likely to be mediated via an NO-independent mechanism. This trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health: NCT01331486.

Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial

PubMed Central

2012-01-01

Background Hawthorn extract has been used for cardiovascular diseases for centuries. Recent trials have demonstrated its efficacy for the treatment of heart failure, and the results of several small trials suggest it may lower blood pressure. However, there is little published evidence to guide its dosing. The blood pressure lowering effect of hawthorn has been linked to nitric oxide-mediated vasodilation. The aim of this study was to investigate the relationship between hawthorn extract dose and brachial artery flow mediated dilation (FMD), an indirect measure of nitric oxide release. Methods We used a four-period cross-over design to evaluate brachial artery FMD in response to placebo or hawthorn extract (standardized to 50 mg oligomeric procyanidin per 250 mg extract). Randomly sequenced doses of hawthorn extract (1000 mg, 1500 mg, and 2500 mg) and placebo were assigned to each participant. Doses were taken twice daily for 3 1/2 days followed by FMD and a 4-day washout before proceeding to the next dosing period. Results Twenty-one prehypertensive or mildly hypertensive adults completed the study. There was no evidence of a dose-response effect for our main outcome (FMD percent) or any of our secondary outcomes (absolute change in brachial artery diameter and blood pressure). Most participants indicated that if given evidence that hawthorn could lower their blood pressure, they would be likely to use it either in conjunction with or instead of lifestyle modification or anti-hypertensive medications. Conclusion We found no evidence of a dose-response effect of hawthorn extract on FMD. If hawthorn has a blood pressure lowering effect, it is likely to be mediated via an NO-independent mechanism. Trial Registration This trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health: NCT01331486. PMID:22458601

Measuring Gambling Reinforcers, Over Consumption and Fallacies: The Psychometric Properties and Predictive Validity of the Jonsson-Abbott Scale

PubMed Central

Jonsson, Jakob; Abbott, Max W.; Sjöberg, Anders; Carlbring, Per

2017-01-01

Traditionally, gambling and problem gambling research relies on cross-sectional and retrospective designs. This has compromised identification of temporal relationships and causal inference. To overcome these problems a new questionnaire, the Jonsson-Abbott Scale (JAS), was developed and used in a large, prospective, general population study, The Swedish Longitudinal Gambling Study (Swelogs). The JAS has 11 items and seeks to identify early indicators, examine relationships between indicators and assess their capacity to predict future problem progression. The aims of the study were to examine psychometric properties of the JAS (internal consistency and dimensionality) and predictive validity with respect to increased gambling risk and problem gambling onset. The results are based on repeated interviews with 3818 participants. The response rate from the initial baseline wave was 74%. The original sample consisted of a random, stratified selection from the Swedish population register aged between 16 and 84. The results indicate an acceptable fit of a three-factor solution in a confirmatory factor analysis with ‘Over consumption,’ ‘Gambling fallacies,’ and ‘Reinforcers’ as factors. Reinforcers, Over consumption and Gambling fallacies were significant predictors of gambling risk potential and Gambling fallacies and Over consumption were significant predictors of problem gambling onset (incident cases) at 12 month follow up. When controlled for risk potential measured at baseline, the predictor Over consumption was not significant for gambling risk potential at follow up. For incident cases, Gambling fallacies and Over consumption remained significant when controlled for risk potential. Implications of the results for the development of problem gambling, early detection, prevention, and future research are discussed. PMID:29085320

Lasting effects of short-term training on preschoolers' street-crossing behavior.

PubMed

Albert, Rachel R; Dolgin, Kim G

2010-03-01

Can short-term training improve preschoolers' knowledge of road-crossing concepts as well as behavior in a real traffic situation? Forty children, aged four to five years, were assigned to one of four conditions (game, story, song, and control). Each condition participated in four 15-min classroom-based lessons over four weeks. Two assessments measuring knowledge of street-crossing concepts and one assessment measuring behavior on a real street were used to evaluate performance at baseline and one week and six months post-training. Children in all three experimental conditions showed a significant improvement over the control on the two conceptual assessments. Only children in the game condition significantly improved their behavior on the street-crossing assessment. Furthermore, children in all three experimental conditions retained the same levels of improvement at the six-month follow-up. These results demonstrate that one hour of training can create lasting improvements on preschool children's conceptual knowledge of traffic safety and road-crossing behavior on a real street. Copyright 2009 Elsevier Ltd. All rights reserved.

Acute and subchronic effects of bilastine (20 and 40 mg) and hydroxyzine (50 mg) on actual driving performance in healthy volunteers.

PubMed

Conen, Silke; Theunissen, Eef L; Van Oers, Anita C M; Valiente, Román; Ramaekers, Johannes G

2011-11-01

Bilastine is a new second-generation H1 antagonist. Although bilastine has been demonstrated to produce little or no performance impairment in laboratory tests, it cannot be excluded that it produces impairments in real-life performance such as driving. This study aims to assess the effects of two doses of bilastine (20 and 40 mg) on actual driving after single and repeated administration. Hydroxyzine 50 mg was included as an active control. Twenty-two participants (11 females, 11 males) were tested in a placebo-controlled, randomized, double-blind, four-way cross-over design. Participants were treated with once-daily doses for eight consecutive days. On day 1 and 8 of each treatment period participants performed an actual highway driving test. The primary variable was standard deviation of lateral position (SDLP), a measure of weaving. Results demonstrated that hydroxyzine significantly increased SDLP on days 1 and 8 of treatment. Bilastine did not affect SDLP. It is concluded that hydroxyzine produces severe driving impairment after single doses and that this impairment only partly mitigates over time due to a lack of complete tolerance. Bilastine did not produce any driving impairment after single and repeated doses and can be safely used in traffic in doses up to 40 mg.

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial

PubMed Central

Miller, Janis M.; Guo, Ying; Ashton-Miller, James A.; DeLancey, John O. L.; Sampselle, Carolyn M.

2014-01-01

Introduction and hypothesis The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. Methods This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. Results No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value=0.57) or in combination with prenatal perineal massage (P value=0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. Conclusions Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups. PMID:22829349

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial.

PubMed

Low, Lisa Kane; Miller, Janis M; Guo, Ying; Ashton-Miller, James A; DeLancey, John O L; Sampselle, Carolyn M

2013-03-01

The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value = 0.57) or in combination with prenatal perineal massage (P value = 0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups.

Mapping Soil Properties of Africa at 250 m Resolution: Random Forests Significantly Improve Current Predictions

PubMed Central

Hengl, Tomislav; Heuvelink, Gerard B. M.; Kempen, Bas; Leenaars, Johan G. B.; Walsh, Markus G.; Shepherd, Keith D.; Sila, Andrew; MacMillan, Robert A.; Mendes de Jesus, Jorge; Tamene, Lulseged; Tondoh, Jérôme E.

2015-01-01

80% of arable land in Africa has low soil fertility and suffers from physical soil problems. Additionally, significant amounts of nutrients are lost every year due to unsustainable soil management practices. This is partially the result of insufficient use of soil management knowledge. To help bridge the soil information gap in Africa, the Africa Soil Information Service (AfSIS) project was established in 2008. Over the period 2008–2014, the AfSIS project compiled two point data sets: the Africa Soil Profiles (legacy) database and the AfSIS Sentinel Site database. These data sets contain over 28 thousand sampling locations and represent the most comprehensive soil sample data sets of the African continent to date. Utilizing these point data sets in combination with a large number of covariates, we have generated a series of spatial predictions of soil properties relevant to the agricultural management—organic carbon, pH, sand, silt and clay fractions, bulk density, cation-exchange capacity, total nitrogen, exchangeable acidity, Al content and exchangeable bases (Ca, K, Mg, Na). We specifically investigate differences between two predictive approaches: random forests and linear regression. Results of 5-fold cross-validation demonstrate that the random forests algorithm consistently outperforms the linear regression algorithm, with average decreases of 15–75% in Root Mean Squared Error (RMSE) across soil properties and depths. Fitting and running random forests models takes an order of magnitude more time and the modelling success is sensitive to artifacts in the input data, but as long as quality-controlled point data are provided, an increase in soil mapping accuracy can be expected. Results also indicate that globally predicted soil classes (USDA Soil Taxonomy, especially Alfisols and Mollisols) help improve continental scale soil property mapping, and are among the most important predictors. This indicates a promising potential for transferring pedological knowledge from data rich countries to countries with limited soil data. PMID:26110833

Mapping Soil Properties of Africa at 250 m Resolution: Random Forests Significantly Improve Current Predictions.

PubMed

Hengl, Tomislav; Heuvelink, Gerard B M; Kempen, Bas; Leenaars, Johan G B; Walsh, Markus G; Shepherd, Keith D; Sila, Andrew; MacMillan, Robert A; Mendes de Jesus, Jorge; Tamene, Lulseged; Tondoh, Jérôme E

2015-01-01

80% of arable land in Africa has low soil fertility and suffers from physical soil problems. Additionally, significant amounts of nutrients are lost every year due to unsustainable soil management practices. This is partially the result of insufficient use of soil management knowledge. To help bridge the soil information gap in Africa, the Africa Soil Information Service (AfSIS) project was established in 2008. Over the period 2008-2014, the AfSIS project compiled two point data sets: the Africa Soil Profiles (legacy) database and the AfSIS Sentinel Site database. These data sets contain over 28 thousand sampling locations and represent the most comprehensive soil sample data sets of the African continent to date. Utilizing these point data sets in combination with a large number of covariates, we have generated a series of spatial predictions of soil properties relevant to the agricultural management--organic carbon, pH, sand, silt and clay fractions, bulk density, cation-exchange capacity, total nitrogen, exchangeable acidity, Al content and exchangeable bases (Ca, K, Mg, Na). We specifically investigate differences between two predictive approaches: random forests and linear regression. Results of 5-fold cross-validation demonstrate that the random forests algorithm consistently outperforms the linear regression algorithm, with average decreases of 15-75% in Root Mean Squared Error (RMSE) across soil properties and depths. Fitting and running random forests models takes an order of magnitude more time and the modelling success is sensitive to artifacts in the input data, but as long as quality-controlled point data are provided, an increase in soil mapping accuracy can be expected. Results also indicate that globally predicted soil classes (USDA Soil Taxonomy, especially Alfisols and Mollisols) help improve continental scale soil property mapping, and are among the most important predictors. This indicates a promising potential for transferring pedological knowledge from data rich countries to countries with limited soil data.

Comparison of the instructional efficacy of an internet-based temporomandibular joint (TMJ) tutorial with a traditional seminar.

PubMed

Al-Riyami, S; Moles, D R; Leeson, R; Cunningham, S J

2010-12-11

There has been growing interest in the use of virtual learning environments (VLEs) by universities over the past decade to supplement traditional teaching methods. In this study a tutorial providing information about the temporomandibular joint (TMJ), temporomandibular disorders and teaching of a thorough TMJ examination was developed on a VLE platform to enable students to enhance their examination and diagnostic skills. The success of this VLE tutorial was compared with conventional teaching by a cross-over trial. Thirty students were initially randomly allocated to one of two groups; Group 1 completed the VLE tutorial and Group 2 attended the face-to-face seminar in the first instance. The groups then crossed over and had the other method of teaching provided. The findings from the cross-over trial and the students' feedback indicated that no differences were found between either teaching modes, and both are equally effective at delivering information to students. In addition, the order in which the students received the teaching did not make a difference, but giving the teaching twice reinforced their knowledge. There is a strong case to be made for introducing clinical lectures on a VLE platform, and this form of e-learning is, in general, well perceived by new generations of students.

Wanted: A Positive Control for Anomalous Subdiffusion

PubMed Central

Saxton, Michael J.

2012-01-01

Anomalous subdiffusion in cells and model systems is an active area of research. The main questions are whether diffusion is anomalous or normal, and if it is anomalous, its mechanism. The subject is controversial, especially the hypothesis that crowding causes anomalous subdiffusion. Anomalous subdiffusion measurements would be strengthened by an experimental standard, particularly one able to cross-calibrate the different types of measurements. Criteria for a calibration standard are proposed. First, diffusion must be anomalous over the length and timescales of the different measurements. The length-scale is fundamental; the time scale can be adjusted through the viscosity of the medium. Second, the standard must be theoretically well understood, with a known anomalous subdiffusion exponent, ideally readily tunable. Third, the standard must be simple, reproducible, and independently characterizable (by, for example, electron microscopy for nanostructures). Candidate experimental standards are evaluated, including obstructed lipid bilayers; aqueous systems obstructed by nanopillars; a continuum percolation system in which a prescribed fraction of randomly chosen obstacles in a regular array is ablated; single-file diffusion in pores; transient anomalous subdiffusion due to binding of particles in arrays such as transcription factors in randomized DNA arrays; and computer-generated physical trajectories. PMID:23260043

The Effects of Binge Drinking on College Students’ Next-Day Academic Test-Taking Performance and Mood State

PubMed Central

Howland, Jonathan; Rohsenow, Damaris J; Greece, Jacey A; Littlefield, Caroline A; Almeida, Alissa; Heeren, Timothy; Winter, Michael; Bliss, Caleb A.; Hunt, Sarah; Hermos, John

2010-01-01

Aim To assess the effects of binge drinking on students’ next-day academic test-taking performance. Design A placebo-controlled cross-over design with randomly assigned order of conditions. Participants were randomized to either alcoholic beverage (mean =.12 g% breath alcohol concentration [BrAC]) or placebo on the first night and then received the other beverage a week later. The next day, participants were assessed on test-taking, neurocognitive performance and mood state. Participants 193 college students (≥ 21 years) recruited from greater Boston. Setting The trial was conducted at the General Clinical Research Center at the Boston Medical Center. Measurements The Graduate Record Exams © (GREs) and a quiz on a lecture presented the previous day measured test-taking performance; the Neurobehavioral Evaluation System (NES3) and the Psychomotor Vigilance Test (PVT) measured neurocognitive performance; and, the Profile of Mood States (POMS) measured mood. Findings Test-taking performance was not affected the morning after alcohol administration, but mood state and attention/reaction time were. Conclusion Drinking to a level of .12 g% BrAC does not affect next-day test-taking performance, but does affect some neurocognitive measures and mood state. PMID:20403018

Timed picture naming in seven languages

PubMed Central

BATES, ELIZABETH; D’AMICO, SIMONA; JACOBSEN, THOMAS; SZÉKELY, ANNA; ANDONOVA, ELENA; DEVESCOVI, ANTONELLA; HERRON, DAN; LU, CHING CHING; PECHMANN, THOMAS; PLÉH, CSABA; WICHA, NICOLE; FEDERMEIER, KARA; GERDJIKOVA, IRINI; GUTIERREZ, GABRIEL; HUNG, DAISY; HSU, JEANNE; IYER, GOWRI; KOHNERT, KATHERINE; MEHOTCHEVA, TEODORA; OROZCO-FIGUEROA, ARACELI; TZENG, ANGELA; TZENG, OVID

2012-01-01

Timed picture naming was compared in seven languages that vary along dimensions known to affect lexical access. Analyses over items focused on factors that determine cross-language universals and cross-language disparities. With regard to universals, number of alternative names had large effects on reaction time within and across languages after target–name agreement was controlled, suggesting inhibitory effects from lexical competitors. For all the languages, word frequency and goodness of depiction had large effects, but objective picture complexity did not. Effects of word structure variables (length, syllable structure, compounding, and initial frication) varied markedly over languages. Strong cross-language correlations were found in naming latencies, frequency, and length. Other-language frequency effects were observed (e.g., Chinese frequencies predicting Spanish reaction times) even after within-language effects were controlled (e.g., Spanish frequencies predicting Spanish reaction times). These surprising cross-language correlations challenge widely held assumptions about the lexical locus of length and frequency effects, suggesting instead that they may (at least in part) reflect familiarity and accessibility at a conceptual level that is shared over languages. PMID:12921412

Advanced Cancer Detection Center

DTIC Science & Technology

2007-10-01

therapy in children: A Phase II randomized double blinded cross-over study (HLMCC 0708) • Risperidone for the Treatment of Cerebellar Mutism Syndrome...each question, the participant selects the answer by using the left and right arrow keys and then pressing the Choose button. The next question is...transformed to a quantitative scale measure for transmission. Numeric responses can be entered directly or can be selected from a list of

The Effect of Repetitive Rhythmic Precision Grip Task-Oriented Rehabilitation in Chronic Stroke Patients: A Pilot Study

ERIC Educational Resources Information Center

Dispa, Delphine; Lejeune, Thierry; Thonnard, Jean-Louis

2013-01-01

Most chronic stroke patients present with difficulty in the manipulation of objects. The aim of this study was to test whether an intensive program of precision grip training could improve hand functioning of patients at more than 6 months after a stroke. This was a cross-over study; hence, at inclusion, the patients were randomly divided into two…

Differential Impact of Unguided versus Guided Use of a Multimedia Introduction to Equine Obstetrics in Veterinary Education

ERIC Educational Resources Information Center

Govaere Jan, L. J.; de Kruif, Aart; Valcke, Martin

2012-01-01

In view of supporting the study of the complex domain of equine obstetrics, a Foal"in"Mare multimedia package with 3D designs has been developed. The present study centers on questions as to the most optimal implementation of the multimedia package in veterinary education. In a pretest-posttest cross-over design, students were randomly assigned to…

To Cross-Link or Not to Cross-Link? Cross-Linking Associated Foreign Body Response of Collagen-Based Devices

PubMed Central

Delgado, Luis M.; Bayon, Yves; Pandit, Abhay

2015-01-01

Collagen-based devices, in various physical conformations, are extensively used for tissue engineering and regenerative medicine applications. Given that the natural cross-linking pathway of collagen does not occur in vitro, chemical, physical, and biological cross-linking methods have been assessed over the years to control mechanical stability, degradation rate, and immunogenicity of the device upon implantation. Although in vitro data demonstrate that mechanical properties and degradation rate can be accurately controlled as a function of the cross-linking method utilized, preclinical and clinical data indicate that cross-linking methods employed may have adverse effects on host response, especially when potent cross-linking methods are employed. Experimental data suggest that more suitable cross-linking methods should be developed to achieve a balance between stability and functional remodeling. PMID:25517923

Intrinsic polarization control in rectangular GaN nanowire lasers

DOE PAGES

Li, Changyi; Liu, Sheng; Luk, Ting S.; ...

2016-02-01

In this study, we demonstrate intrinsic, linearly polarized lasing from single GaN nanowires using cross-sectional shape control. A two-step top-down fabrication approach was employed to create straight nanowires with controllable rectangular cross-sections. A clear lasing threshold of 444kW/cm 2 and a narrow spectral line width of 0.16 nm were observed under optical pumping at room temperature, indicating the onset of lasing. The polarization was along the short dimension (y-direction) of the nanowire due to the higher transverse confinement factors for y-polarized transverse modes resulting from the rectangular nanowire cross-section. The results show that cross-sectioned shape control can enable inherent controlmore » over the polarization of nanowire lasers without additional environment requirements, such as placement onto lossy substrates.« less

Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers.

PubMed

Schück, Stéphane; Bentué-Ferrer, Danièle; Kleinermans, Diane; Reymann, Jean-Michel; Polard, Elisabeth; Gandon, Jean-Marc; Allain, Hervé

2002-02-01

Piribedil is a dopamine agonist acting on D2 and D3 central nervous system dopamine receptors. This drug has been administered to 12 young healthy male volunteers (age 22 +/- 2 years) according to a single center randomized, double-blind, two ways cross-over, placebo controlled trial, including a washout period of one week. Placebo and piribedil were administered by a single intravenous infusion over 2 h (3 mg). Psychomotor performance and cognitive functions were assessed through a standardized and computerized psychometric tests battery and a continuous electroencephalogram (EEG) mapping. Piribedil improved simple reaction time (P=0.02), immediate (P=0.045 and 0.004), and delayed free recall (P=0.05), dual coding test (P=0.02) and increased theta and fast beta waves on the EEG (P < 0.05 and 0.001, respectively). No deleterious effect was observed on the tests exploring attention and concentration via the other procedures. It is concluded that a single intravenous perfusion of piribedil 3 mg improves alertness and the information processing speed within the central nervous system, in healthy volunteers.

Cross-over clinical trial for evaluating the safety of camel's milk intake in patients who are allergic to cow's milk protein.

PubMed

Navarrete-Rodríguez, E M; Ríos-Villalobos, L A; Alcocer-Arreguín, C R; Del-Rio-Navarro, B E; Del Rio-Chivardi, J M; Saucedo-Ramírez, O J; Sienra-Monge, J J L; Frias, R V

Cow's milk protein allergy (CMPA) affects between 0.6 and 0.9% of the general population, and its treatment implies the total elimination of the intake of this protein. Camel's milk has been suggested as an alternative for patients over one year of age who suffer from CMPA due to the difference in the amino acid sequence from that of cow's milk. The objective of this study was to evaluate the safety and tolerability of camel's milk in children with CMPA. Crossed clinical trial for the use of camel's milk vs. amino acid formula, carried out at the Dr. Federico Gómez Children's Hospital of Mexico (HIMFG) on patients between one and 18 years of age with diagnosed CMPA confirmed through double-blind, placebo-controlled food challenges (DBPCFCs). Only those whose allergies were confirmed were randomly placed into two groups: those to be administered camel's milk and those to be administered the amino-acid formula for two weeks, followed by a six-week wash-out period, and then a group crossing for a further two weeks. 49 patients with suspected CMPA were included in the study; the diagnosis was confirmed through DBPCFCs in 15 patients, who were those who participated in the study. After having been administered camel's milk, none of the patients presented adverse effects. Camel's milk is safe and tolerable in patients above one year of age with CMPA and can be considered as a good alternative given the benefit of its taste compared to other formulas. Copyright © 2017 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.

An enriched, cereal-based bread affects appetite ratings and glycemic, insulinemic, and gastrointestinal hormone responses in healthy adults in a randomized, controlled trial.

PubMed

Gonzalez-Anton, Carolina; Lopez-Millan, Belen; Rico, Maria C; Sanchez-Rodriguez, Estefania; Ruiz-Lopez, Maria D; Gil, Angel; Mesa, Maria D

2015-02-01

Bread can contribute to the regulation of appetite. The objective of this study was to investigate the appetite ratings and postprandial glucose, insulin, and gastrointestinal hormone responses related to hunger and satiety after the intake of a cereal-based bread. A randomized, controlled crossover trial was conducted in 30 healthy adults (17 men and 13 women) aged 19-32 y with body mass index of 19.2-28.5. Each volunteer consumed the cereal-based bread and the control bread 2 times, with a 1-wk wash-out period, over a total of 4 sessions. The cereal-based bread contained a variety of cereal flours (wheat, oat, and spelt) and consisted of 22% dried fruits (figs, apricots, raisins, and prunes). It was also enriched with both fiber (7% from wheat cross-linked maltodextrins and pea) and protein (10-11% from wheat gluten and hydrolyzed wheat proteins). The control bread consisted of white bread with margarine and jam to control for energy density, fat, and sugar content. We measured appetite ratings using standardized visual analogue scales and glucose, insulin, and gastrointestinal hormone responses over a postprandial time of 4 h after the ingestion of each bread. Linear mixed-effects models were used to compare the areas under the curve (AUCs) for different variables. Consuming the cereal-based bread decreased prospective consumption more than consumption of the control bread (-5.3 ± 0.6 m · min and -4.4 ± 0.6 m · min, respectively; P = 0.02) and increased satiety more (6.2 ± 0.7 m · min and 5.2 ± 0.6 m · min, respectively; P = 0.04), although subsequent ad libitum energy intake 4 h later did not differ. Postprandial blood glucose, insulin, ghrelin, glucagon-like peptide 1 and gastric inhibitory polypeptide AUCs were lower after the ingestion of the cereal-based bread, whereas the pancreatic polypeptide AUC was higher than with the control bread (P < 0.05). Consumption of the cereal-based bread contributed to appetite control by reducing hunger and enhancing satiety. In addition, consumption of this bread improved glycemic, insulinemic, and gastrointestinal hormone responses in healthy adults. This trial was registered at clinicaltrials.gov as NCT02090049. © 2015 American Society for Nutrition.

Baseline Serum Estradiol and Fracture Reduction During Treatment With Hormone Therapy: The Women’s Health Initiative Randomized Trial

PubMed Central

Cauley, Jane A.; LaCroix, Andrea Z.; Robbins, John A.; Larson, Joseph; Wallace, Robert; Wactawski-Wende, Jean; Chen, Zhao; Bauer, Douglas C.; Cummings, Steven R.; Jackson, Rebecca

2009-01-01

Purpose To test the hypothesis that the reduction in fractures with hormone therapy (HT) is greater in women with lower estradiol levels. Methods We conducted a nested case-control study within the Women’s Health Initiative HT Trials. The sample included 231 hip fracture case-control pairs and a random sample of 519 all fracture case-control pairs. Cases and controls were matched for age, ethnicity, randomization date, fracture history and hysterectomy status. Hormones were measured prior to randomization. Incident cases of fracture identified over an average follow-up of 6.53 years. Results There was no evidence that the effect of HT on fracture differed by baseline estradiol (E2) or sex hormone binding globulin (SHBG). Across all quartiles of E2 and SHBG, women randomized to HT had about a 50% lower risk of fracture including hip fracture, compared to placebo. Conclusion The effect of HT on fracture reduction is independent of estradiol and SHBG levels. PMID:19436934

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

PubMed

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

2014-01-01

This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study.

PubMed

Schmidt, Jennifer; Martin, Alexandra

2015-12-01

Overeating episodes, despite of intentions to control weight, are a common problem among women. Recurring episodes of overeating and dietary failure have been reported to result in higher Body Mass Indexes and to induce severe distress even in non-clinical groups. Based on findings from physiological research on eating behavior and craving, as well as previous biofeedback studies, we derived a cue exposure based EEG neurofeedback protocol to target overeating episodes. The treatment was evaluated in a randomized controlled trial, comparing a neurofeedback group (NFG; n = 14) with a waiting list control group (WLG; n = 13) in a sub-clinical sample of female restrained eaters. At post-treatment, the number of weekly overeating episodes and subsequent distress were significantly reduced in the NFG compared to the WLG (p < .01; r > .50). In a 3 month follow-up, effects in the NFG remained stable. As secondary outcomes, perceived dieting success was enhanced after the treatment. At follow-up, additional beneficial effects on trait food craving were observed. Altogether, we found preliminary evidence for the cue exposure neurofeedback against overeating episodes in female restrained eaters, although specific effects and underlying mechanisms still have to be explored in future research.

A Randomized Controlled Trial of the First Step to Success Early Intervention: Demonstration of Program Efficacy Outcomes in a Diverse, Urban School District

ERIC Educational Resources Information Center

Walker, Hill M.; Seeley, John R.; Small, Jason; Severson, Herbert H.; Graham, Bethany A.; Feil, Edward G.; Serna, Loretta; Golly, Annemieke M.; Forness, Steven R.

2009-01-01

This article reports on a randomized controlled trial of the First Step to Success early intervention that was conducted over a 4-year period in Albuquerque Public Schools. First Step is a selected intervention for students in Grades 1 through 3 with externalizing behavior problems, and it addresses secondary prevention goals and objectives. It…

Moderating Effects of Parental Characteristics on the Effectiveness of a Theory of Mind Training for Children with Autism: A Randomized Controlled Trial

ERIC Educational Resources Information Center

de Veld, Danielle M. J.; Howlin, Patricia; Hoddenbach, Elske; Mulder, Fleur; Wolf, Imke; Koot, Hans M.; Lindauer, Ramón; Begeer, Sander

2017-01-01

This RCT investigated whether the effect of a Theory of Mind (ToM) intervention for children with ASD was moderated by parental education level and employment, family structure, and parental ASD. Children with autism aged 8-13 years (n = 136) were randomized over a waitlist control or treatment condition. At posttest, children in the treatment…

Randomized controlled trial in rural Ethiopia to assess a portable water treatment device.

PubMed

Boisson, Sophie; Schmidt, Wolf-Peter; Berhanu, Tsegahiwot; Gezahegn, Henock; Clasen, Thomas

2009-08-01

We conducted a randomized controlled trial to assess the Lifestraw Personal pipe-style water treatment device among a rural population in Ethiopia. A total of 313 households (including 1516 persons) were randomly assigned either to an intervention group in which each householder received a Lifestraw Personal or a control. Households were visited fortnightly over a five-month intervention period and asked to report any episode of diarrhea during the previous week. A random sample of 160 devices was tested each month to assess the presence of thermotolerant coliforms (TTC) and residual iodine in treated water and to measure flow rate under simulated use. Members of the intervention group had 25% fewer weeks with diarrhea than those of the control group (longitudinal prevalence ratio = 0.75; 95% CI 0.60; 0.95). All 718 filtered water samples were free of TTC, were free of detectable iodine disinfectant, and showed a constant flow rate over time. After the five-month intervention period, 34% of participants reported use of device in the preceding week and 13% reported consistent use. While the device was associated with a 25% reduction in longitudinal prevalence of diarrhea, low levels of use suggest that much of this effect is likely to be attributable to reporting bias that is common in open trials with nonobjective outcomes.

A facility specialist model for improving retention of nursing home staff: results from a randomized, controlled study.

PubMed

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

2008-07-01

This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and Connecticut and randomly assigned to treatment and control conditions. Staff outcomes were measured through certified nursing assistant interviews, and turnover rates were measured over the course of the year. In the intervention condition, a staff member was selected to be the facility retention specialist, who would advocate for and implement programs to improve staff retention and commitment throughout the facility. Retention specialists received an intensive 3-day training in retention leadership and in a number of evidence-based retention programs. Ongoing support was provided throughout the project. Treatment facilities experienced significant declines in turnover rates compared to control facilities. As predicted, we found positive effects on certified nursing assistant assessments of the quality of retention efforts and of care provided in the facility; we did not find effects for job satisfaction or stress. The study provides evidence for the effectiveness of the retention specialist model. Findings from a detailed process evaluation suggest modifications of the program that may increase program effects.

Stress, Health Risk Behaviors, and Weight Status among Community College Students

ERIC Educational Resources Information Center

Pelletier, Jennifer E.; Lytle, Leslie A.; Laska, Melissa N.

2016-01-01

The objective of this study was to describe the relationship between stress, weight-related health risk behaviors (e.g., eating behaviors, physical activity, sedentary behavior, sleep, cigarette smoking, and binge drinking), and weight status using cross-sectional data on 2-year community college students enrolled in a randomized controlled weight…

Examining the Relationship between Family Meal Frequency and Individual Dietary Intake: Does Family Cohesion Play a Role?

ERIC Educational Resources Information Center

Welsh, Ericka M.; French, Simone A.; Wall, Melanie

2011-01-01

Objective: To confirm previously reported associations between family meal frequency and dietary intake, and to examine family cohesion as a potential mediator of this relationship. Design: Cross-sectional observational study. Data collected at baseline via questionnaire. Setting: Randomized, controlled household weight gain prevention trial.…

Molecular mapping of resistance to blight in an interspecific cross in the genus Castanea

Treesearch

Thomas L. Kubisiak; F.V. Hebard; C. Dana Nelson; Jiansu Zhang; R. Bernatzky; H. Huang; S.L. Anagnostakis; R.L. Doudrick

1997-01-01

A three-generation American chestnut x Chinese chestnut pedigree was used to construct a genetic linkage map for chestnut and to investigate the control of resistance to Endothia parasitica (chestnut blight fungus). DNA genotypes for 241 polymorphic markers (eight isozymes, 17 restriction fragment length polymorphisms [RFLPs], and 216 random...

Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

PubMed

Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

2014-12-01

To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p < 0.05) over the study period in both groups in total; changes (p < 0.05) were seen only in dimension D (group B) and E (both groups) during regular therapy. Physiotherapy may be more effective when provided regularly rather than in blocks.

Soil-transmitted helminths in pre-school-aged and school-aged children in an urban slum: a cross-sectional study of prevalence, distribution, and associated exposures.

PubMed

Davis, Stephanie M; Worrell, Caitlin M; Wiegand, Ryan E; Odero, Kennedy O; Suchdev, Parminder S; Ruth, Laird J; Lopez, Gerard; Cosmas, Leonard; Neatherlin, John; Njenga, Sammy M; Montgomery, Joel M; Fox, LeAnne M

2014-11-01

Soil-transmitted helminths (STHs) are controlled by regular mass drug administration. Current practice targets school-age children (SAC) preferentially over pre-school age children (PSAC) and treats large areas as having uniform prevalence. We assessed infection prevalence in SAC and PSAC and spatial infection heterogeneity, using a cross-sectional study in two slum villages in Kibera, Nairobi. Nairobi has low reported STH prevalence. The SAC and PSAC were randomly selected from the International Emerging Infections Program's surveillance platform. Data included residence location and three stools tested by Kato-Katz for STHs. Prevalences among 692 analyzable children were any STH: PSAC 40.5%, SAC 40.7%; Ascaris: PSAC 24.1%, SAC 22.7%; Trichuris: PSAC 24.0%, SAC 28.8%; hookworm < 0.1%. The STH infection prevalence ranged from 22% to 71% between sub-village sectors. The PSAC have similar STH prevalences to SAC and should receive deworming. Small areas can contain heterogeneous prevalences; determinants of STH infection should be characterized and slums should be assessed separately in STH mapping. © The American Society of Tropical Medicine and Hygiene.

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

PubMed

Werner, Gerald S; Martin-Yuste, Victoria; Hildick-Smith, David; Boudou, Nicolas; Sianos, Georgios; Gelev, Valery; Rumoroso, Jose Ramon; Erglis, Andrejs; Christiansen, Evald Høj; Escaned, Javier; di Mario, Carlo; Hovasse, Thomas; Teruel, Luis; Bufe, Alexander; Lauer, Bernward; Bogaerts, Kris; Goicolea, Javier; Spratt, James C; Gershlick, Anthony H; Galassi, Alfredo R; Louvard, Yves

2018-05-02

The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. NCT01760083.

RF-Phos: A Novel General Phosphorylation Site Prediction Tool Based on Random Forest.

PubMed

Ismail, Hamid D; Jones, Ahoi; Kim, Jung H; Newman, Robert H; Kc, Dukka B

2016-01-01

Protein phosphorylation is one of the most widespread regulatory mechanisms in eukaryotes. Over the past decade, phosphorylation site prediction has emerged as an important problem in the field of bioinformatics. Here, we report a new method, termed Random Forest-based Phosphosite predictor 2.0 (RF-Phos 2.0), to predict phosphorylation sites given only the primary amino acid sequence of a protein as input. RF-Phos 2.0, which uses random forest with sequence and structural features, is able to identify putative sites of phosphorylation across many protein families. In side-by-side comparisons based on 10-fold cross validation and an independent dataset, RF-Phos 2.0 compares favorably to other popular mammalian phosphosite prediction methods, such as PhosphoSVM, GPS2.1, and Musite.

Impact of Sativex(®) on quality of life and activities of daily living in patients with multiple sclerosis spasticity.

PubMed

Arroyo, Rafael; Vila, Carlos; Dechant, Kerry L

2014-07-01

In individuals with multiple sclerosis (MS) spasticity, associated symptoms such as spasms, pain, mobility restrictions and sleep disturbances can interfere with the ability to perform activities of daily living and reduce quality of life (QoL). Recent cross-sectional studies from Europe have confirmed that advancing severity of MS spasticity correlates directly with worsening QoL. The treatment effect of Sativex(®) (GW Pharmaceuticals PLC, Porton Down, UK; Laboratorios Almirall, SA, Barcelona, Spain) on QoL has been evaluated in randomized controlled trials, observational studies conducted under everyday clinical practice conditions and a survey in long-term users. Symptomatic relief of MS spasticity in responders to Sativex was associated with quantifiable improvements in QoL and activities of daily living that were maintained over time. Benefits were perceived by both patients and caregivers.

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines

PubMed Central

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-01-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4–10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child’s health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. PMID:24134922

Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV

PubMed Central

Moskowitz, Judith T.; Carrico, Adam W.; Duncan, Larissa G.; Cohn, Michael A.; Cheung, Elaine O.; Batchelder, Abigail; Martinez, Lizet; Segawa, Eisuke; Acree, Michael; Folkman, Susan

2017-01-01

Objective We conducted a randomized controlled trial to determine whether IRISS (Intervention for those Recently Informed of their Seropositive Status), a positive affect skills intervention, improved positive emotion, psychological health, physical health, and health behaviors in people newly diagnosed with HIV. Method 159 participants who had received an HIV diagnosis in the past 3 months were randomized to a 5-session, in-person, individually-delivered positive affect skills intervention or an attention-matched control condition. Results For the primary outcome of positive affect, the group difference in change from baseline over time did not reach statistical significance (p = .12; d = .30). Planned secondary analyses within assessment point showed that the intervention led to higher levels of past-day positive affect at 5, 10, and 15 months post diagnosis compared to an attention control. For antidepressant use, the between group difference in change from baseline was statistically significant (p = .006; d = −.78 baseline to 15 months) and the difference in change over time for intrusive and avoidant thoughts related to HIV was also statistically significant (p = .048; d = .29). Contrary to findings for most health behavior interventions in which effects wane over the follow up period, effect sizes in IRISS seemed to increase over time for most outcomes. Conclusions This comparatively brief positive affect skills intervention achieved modest improvements in psychological health, and may have the potential to support adjustment to a new HIV diagnosis. PMID:28333512

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

PubMed Central

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Olive (Olea europaea L.) leaf polyphenols improve insulin sensitivity in middle-aged overweight men: a randomized, placebo-controlled, crossover trial.

PubMed

de Bock, Martin; Derraik, José G B; Brennan, Christine M; Biggs, Janene B; Morgan, Philip E; Hodgkinson, Steven C; Hofman, Paul L; Cutfield, Wayne S

2013-01-01

Olive plant leaves (Olea europaea L.) have been used for centuries in folk medicine to treat diabetes, but there are very limited data examining the effects of olive polyphenols on glucose homeostasis in humans. To assess the effects of supplementation with olive leaf polyphenols (51.1 mg oleuropein, 9.7 mg hydroxytyrosol per day) on insulin action and cardiovascular risk factors in middle-aged overweight men. Randomized, double-blinded, placebo-controlled, crossover trial in New Zealand. 46 participants (aged 46.4 ± 5.5 years and BMI 28.0 ± 2.0 kg/m(2)) were randomized to receive capsules with olive leaf extract (OLE) or placebo for 12 weeks, crossing over to other treatment after a 6-week washout. Primary outcome was insulin sensitivity (Matsuda method). Secondary outcomes included glucose and insulin profiles, cytokines, lipid profile, body composition, 24-hour ambulatory blood pressure, and carotid intima-media thickness. Treatment evaluations were based on the intention-to-treat principle. All participants took >96% of prescribed capsules. OLE supplementation was associated with a 15% improvement in insulin sensitivity (p = 0.024) compared to placebo. There was also a 28% improvement in pancreatic β-cell responsiveness (p = 0.013). OLE supplementation also led to increased fasting interleukin-6 (p = 0.014), IGFBP-1 (p = 0.024), and IGFBP-2 (p = 0.015) concentrations. There were however, no effects on interleukin-8, TNF-α, ultra-sensitive CRP, lipid profile, ambulatory blood pressure, body composition, carotid intima-media thickness, or liver function. Supplementation with olive leaf polyphenols for 12 weeks significantly improved insulin sensitivity and pancreatic β-cell secretory capacity in overweight middle-aged men at risk of developing the metabolic syndrome.

Drooling in Parkinson's disease: A randomized controlled trial of incobotulinum toxin A and meta-analysis of Botulinum toxins.

PubMed

Narayanaswami, Pushpa; Geisbush, Thomas; Tarulli, Andrew; Raynor, Elizabeth; Gautam, Shiva; Tarsy, Daniel; Gronseth, Gary

2016-09-01

Botulinum toxins are a therapeutic option for drooling in Parkinson's Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. 1. Primary study: Randomized, double blind, placebo controlled, cross over trial. Incobotulinum toxin (100 units) or saline was injected into the parotid (20 units) and submandibular (30 units) glands. Subjects returned monthly for three evaluations after each injection. Outcome measures were saliva weight and Drooling Frequency and Severity Scale. 2. Systematic review of literature, followed by inverse variance meta-analyses using random effects models. 1. Primary Study: Nine of 10 subjects completed both arms. There was no significant change in the primary outcome of saliva weight one month after injection in the treatment period compared to placebo period (mean difference, gm ± SD: -0.194 ± 0.61, range: -1.28 to 0.97, 95% CI -0.71 to 0.32). Secondary outcomes also did not change. 2. Meta-analysis of six studies demonstrated significant benefit of Botulinum toxin on functional outcomes (effect size, Cohen's d: -1.32, CI -1.86 to -0.78). The other studies used a higher dose of Botulinum toxin A into the parotid glands. This study did not demonstrate efficacy of incobotulinum toxin A for drooling in PD, but lacked precision to exclude moderate benefit. The parotid/submandibular dose-ratio may have influenced results. Studies evaluating higher doses of incobotulinum toxin A into the parotid glands may be useful. Copyright © 2016 Elsevier Ltd. All rights reserved.

Does topical amethocaine gel reduce pain from heel prick blood sampling in premature infants? A randomized double-blind cross-over controlled study

PubMed Central

Patel, Amita; Czerniawski, Barbara; Gray, Shari; Lui, Eric

2003-01-01

BACKGROUND: Heel prick blood sampling is the most common painful invasive procedure performed on neonates. Currently, there are no effective ways to provide pain relief from this painful procedure. OBJECTIVE: To assess the efficacy of the topical anesthetic amethocaine 4% gel (Ametop, Smith & Nephew Inc, St Laurent) in reducing the pain of heel prick blood sampling in neonates. METHODS: A randomized, double-blind, placebo controlled, crossover trial was conducted. Neonates between 33 to 37 weeks’ gestational age in their first seven days of life were eligible. Heel prick blood sampling was performed on each participant twice. Each infant was randomly assigned to receive either amethocaine 4% gel or placebo to the heel for the first prick, and then received the alternative agent for the second prick. Prick pain was assessed using both Premature Infant Pain Profile (PIPP) and Neonatal Infant Pain Scale (NIPS). Squeeze pain was assessed by NIPS. RESULTS: Ten babies were recruited. There were no significant differences in the average PIPP and NIPS scores between the treatment and placebo groups for both prick and squeeze pains from heel prick blood sampling. For prick pain, linear-regression showed significant correlation between the PIPP and NIPS scores. No adverse reactions were observed after application of either the active or placebo agents. CONCLUSION: Topical amethocaine 4% gel is not shown to reduce prick and squeeze pains significantly from heel prick blood sampling in neonates between 33 to 37 weeks’ gestational age. Further studies are needed to find ways to provide effective pain relief from this common procedure. PMID:20020001

Nonlinear dual-axis biodynamic response of the semi-supine human body during longitudinal horizontal whole-body vibration

NASA Astrophysics Data System (ADS)

Huang, Ya; Griffin, Michael J.

2008-04-01

The resonance frequencies in frequency response functions of the human body (e.g. apparent mass and transmissibility) decrease with increasing vibration magnitude. This nonlinear biodynamic response is found with various sitting and standing postures requiring postural control. The present study measured the apparent mass of the body in a relaxed semi-supine posture with two types of longitudinal horizontal vibration (in the z-axis of the semi-supine body): (i) continuous random excitation (0.25-20 Hz) at five magnitudes (0.125, 0.25, 0.5, 0.75 and 1.0 ms -2 rms); (ii) intermittent random excitation (0.25-20 Hz) alternately at 0.25 and 1.0 ms -2 rms. With continuous random vibration, the dominant primary resonance frequency in the median normalised apparent mass decreased from 3.7 to 2.4 Hz as the vibration magnitude increased from 0.125 to 1.0 ms -2 rms. A nonlinear response was apparent in both the horizontal ( z-axis) apparent mass and the vertical ( x-axis) cross-axis apparent mass. With intermittent random vibration, as the vibration magnitude increased from 0.25 to 1.0 ms -2 rms, the median resonance frequency of the apparent mass decreased from 3.2 to 2.5 Hz whereas, with continuous random vibration over the same range of magnitudes, the resonance frequency decreased from 3.4 to 2.4 Hz. The median change in the resonance frequency (between 0.25 and 1.0 ms -2 rms) was 0.6 Hz with the intermittent random vibration and 0.9 Hz with the continuous random vibration. With intermittent vibration, the resonance frequency was higher at the high magnitude and lower at the low magnitude than with continuous vibration at the same magnitudes. The responses were consistent with passive thixotropy being a primary cause of nonlinear biodynamic responses to whole-body vibration, although reflex activity of the muscles may also have an influence.

Nonlinear dual-axis biodynamic response of the semi-supine human body during vertical whole-body vibration

NASA Astrophysics Data System (ADS)

Huang, Ya; Griffin, Michael J.

2008-04-01

Nonlinear biodynamic responses are evident in many studies of the apparent masses of sitting and standing subjects in static postures that require muscle activity for postural control. In the present study, 12 male subjects adopted a relaxed semi-supine posture assumed to involve less muscle activity than during static sitting and standing. The supine subjects were exposed to two types of vertical vibration (in the x-axis of the semi-supine body): (i) continuous random vibration (0.25-20 Hz) at five magnitudes (0.125, 0.25, 0.5, 0.75, and 1.0 m s -2 rms); (ii) intermittent random vibration (0.25-20 Hz) alternately at 0.25 and 1.0 m s -2 rms. With continuous random vibration, the dominant primary resonance frequency in the median normalised apparent mass decreased from 10.35 to 7.32 Hz as the vibration magnitude increased from 0.125 to 1.0 m s -2 rms. This nonlinear response was apparent in both the vertical ( x-axis) apparent mass and in the horizontal ( z-axis) cross-axis apparent mass. As the vibration magnitude increased from 0.25 to 1.0 m s -2 rms, the median resonance frequency of the apparent mass with intermittent random vibration decreased from 9.28 to 8.06 Hz whereas, over the same range of magnitudes with continuous random vibration, the resonance frequency decreased from 9.62 to 7.81 Hz. The median change in the resonance frequency (between 0.25 and 1.0 m s -2 rms) was 1.37 Hz with the intermittent random vibration and 1.71 with the continuous random vibration. With the intermittent vibration, the resonance frequency was higher at the high magnitude and lower at the low magnitude than with continuous vibration of the same magnitudes. The response was typical of thixotropy that may be a primary cause of the nonlinear biodynamic responses to whole-body vibration.

Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

PubMed

Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

2010-02-01

This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

PubMed Central

Minnis, Alexandra M.; Gandham, Sharavi; Richardson, Barbra A.; Guddera, Vijayanand; Chen, Beatrice A.; Salata, Robert; Nakabiito, Clemensia; Hoesley, Craig; Justman, Jessica; Soto-Torres, Lydia; Patterson, Karen; Gomez, Kailazarid; Hendrix, Craig

2012-01-01

We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94%), but serum TFV concentrations indicated only 64% of participants used tablets consistently. Most women in the U.S. (72%) favored tablets over gel; while preferences varied at the African sites (42% preferred gel and 40% tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. PMID:23065145

Sport stacking in auditory and visual attention of grade 3 learners.

PubMed

Mortimer, J; Krysztofiak, J; Custard, S; McKune, A J

2011-08-01

The effect of sport stacking on auditory and visual attention in 32 Grade 3 children was examined using a randomised, cross-over design. Children were randomly assigned to a sport stacking (n=16) or arts/crafts group (n=16) with these activities performed over 3 wk. (12 30-min. sessions, 4 per week). This was followed by a 3-wk. wash-out period after which there was a cross-over and the 3-wk. intervention repeated, with the sports stacking group performing arts/crafts and the arts/crafts group performing sports stacking. Performance on the Integrated Visual and Auditory Continuous Performance Test, a measure of auditory and visual attention, was assessed before and after each of the 3-wk. interventions for each group. Comparisons indicated that sport stacking resulted in significant improvement in high demand function and fine motor regulation, while it caused a significant reduction in low demand function. Auditory and visual attention adaptations to sport stacking may be specific to the high demand nature of the task.

Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults.

PubMed

Costello, Joseph T; Baker, Philip R A; Minett, Geoffrey M; Bieuzen, Francois; Stewart, Ian B; Bleakley, Chris

2015-09-18

Recovery strategies are often used with the intention of preventing or minimising muscle soreness after exercise. Whole-body cryotherapy, which involves a single or repeated exposure(s) to extremely cold dry air (below -100 °C) in a specialised chamber or cabin for two to four minutes per exposure, is currently being advocated as an effective intervention to reduce muscle soreness after exercise. To assess the effects (benefits and harms) of whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, the British Nursing Index and the Physiotherapy Evidence Database. We also searched the reference lists of articles, trial registers and conference proceedings, handsearched journals and contacted experts.The searches were run in August 2015. We aimed to include randomised and quasi-randomised trials that compared the use of whole-body cryotherapy (WBC) versus a passive or control intervention (rest, no treatment or placebo treatment) or active interventions including cold or contrast water immersion, active recovery and infrared therapy for preventing or treating muscle soreness after exercise in adults. We also aimed to include randomised trials that compared different durations or dosages of WBC. Our prespecified primary outcomes were muscle soreness, subjective recovery (e.g. tiredness, well-being) and adverse effects. Two review authors independently screened search results, selected studies, assessed risk of bias and extracted and cross-checked data. Where appropriate, we pooled results of comparable trials. The random-effects model was used for pooling where there was substantial heterogeneity. We assessed the quality of the evidence using GRADE. Four laboratory-based randomised controlled trials were included. These reported results for 64 physically active predominantly young adults (mean age 23 years). All but four participants were male. Two trials were parallel group trials (44 participants) and two were cross-over trials (20 participants). The trials were heterogeneous, including the type, temperature, duration and frequency of WBC, and the type of preceding exercise. None of the trials reported active surveillance of predefined adverse events. All four trials had design features that carried a high risk of bias, potentially limiting the reliability of their findings. The evidence for all outcomes was classified as 'very low' quality based on the GRADE criteria.Two comparisons were tested: WBC versus control (rest or no WBC), tested in four studies; and WBC versus far-infrared therapy, also tested in one study. No studies compared WBC with other active interventions, such as cold water immersion, or different types and applications of WBC.All four trials compared WBC with rest or no WBC. There was very low quality evidence for lower self-reported muscle soreness (pain at rest) scores after WBC at 1 hour (standardised mean difference (SMD) -0.77, 95% confidence interval (CI) -1.42 to -0.12; 20 participants, 2 cross-over trials); 24 hours (SMD -0.57, 95% CI -1.48 to 0.33) and 48 hours (SMD -0.58, 95% CI -1.37 to 0.21), both with 38 participants, 2 cross-over studies, 1 parallel group study; and 72 hours (SMD -0.65, 95% CI -2.54 to 1.24; 29 participants, 1 cross-over study, 1 parallel group study). Of note is that the 95% CIs also included either no between-group differences or a benefit in favour of the control group. One small cross-over trial (9 participants) found no difference in tiredness but better well-being after WBC at 24 hours post exercise. There was no report of adverse events.One small cross-over trial involving nine well-trained runners provided very low quality evidence of lower levels of muscle soreness after WBC, when compared with infrared therapy, at 1 hour follow-up, but not at 24 or 48 hours. The same trial found no difference in well-being but less tiredness after WBC at 24 hours post exercise. There was no report of adverse events. There is insufficient evidence to determine whether whole-body cryotherapy (WBC) reduces self-reported muscle soreness, or improves subjective recovery, after exercise compared with passive rest or no WBC in physically active young adult males. There is no evidence on the use of this intervention in females or elite athletes. The lack of evidence on adverse events is important given that the exposure to extreme temperature presents a potential hazard. Further high-quality, well-reported research in this area is required and must provide detailed reporting of adverse events.

Effects of a nitrate-rich meal on arterial stiffness and blood pressure in healthy volunteers.

PubMed

Liu, Alex H; Bondonno, Catherine P; Croft, Kevin D; Puddey, Ian B; Woodman, Richard J; Rich, Lisa; Ward, Natalie C; Vita, Joseph A; Hodgson, Jonathan M

2013-11-30

An increase in nitrate intake can augment circulating nitrite and nitric oxide. This may lead to lower blood pressure and improved vascular function. Green leafy vegetables, such as spinach, are rich sources of nitrate. We aimed to assess the acute effects of a nitrate-rich meal containing spinach on arterial stiffness and blood pressure in healthy men and women. Twenty-six participants aged 38-69years were recruited to a randomized controlled cross-over trial. The acute effects of two energy-matched (2000kJ) meals, administered in random order, were compared. The meals were either high nitrate (220mg of nitrate derived from spinach [spinach]) or low nitrate [control]. Outcome measurements were performed pre-meal and at specific time points up to 210min post meal. Spinach resulted in an eightfold increase in salivary nitrite and a sevenfold increase in salivary nitrate concentrations from pre-meal (P<0.001) to 120min post meal. Spinach compared with control resulted in higher large artery elasticity index (P<0.001), and lower pulse pressure (P<0.001) and systolic blood pressure (P<0.001). Post meal carotid-femoral pulse wave velocity (P=0.07), augmentation index (P=0.63), small artery elasticity index (P=0.98) and diastolic blood pressure (P=0.13) were not significantly altered by spinach relative to control. Therefore, consumption of a nitrate-rich meal can lower systolic blood pressure and pulse pressure and increase large artery compliance acutely in healthy men and women. If sustained, these effects could contribute to better cardiovascular health. Copyright © 2013 Elsevier Inc. All rights reserved.

Hesperidin displays relevant role in the nutrigenomic effect of orange juice on blood leukocytes in human volunteers: a randomized controlled cross-over study.

PubMed

Milenkovic, Dragan; Deval, Christiane; Dubray, Claude; Mazur, Andrzej; Morand, Christine

2011-01-01

We previously showed, in healthy, middle-aged, moderately overweight men, that orange juice decreases diastolic blood pressure and significantly improves postprandial microvascular endothelial reactivity and that hesperidin could be causally linked to the observed beneficial effect of orange juice. The objective was to determine the effect of chronic consumption of orange juice on the gene expression profile of leukocytes in healthy volunteers and to assess to what extent hesperidin is involved in the effect of orange juice. Volunteers were included in a randomized, controlled, crossover study. Throughout three 4-week periods, volunteers consumed daily: 500 ml orange juice, 500 ml control drink plus hesperidin or 500 ml control drink and placebo. Blood samplings were performed on 10 overnight-fasted subjects after the 4-week treatment period. Global gene expression profiles were determined using human whole genome cDNA microarrays. Both orange juice and hesperidin consumption significantly affected leukocyte gene expression. Orange juice consumption induced changes in expression of, 3,422 genes, while hesperidin intake modulated the expression of 1,819 genes. Between the orange juice and hesperidin consumption groups, 1,582 regulated genes were in common. Many of these genes are implicated in chemotaxis, adhesion, infiltration and lipid transport, which is suggestive of lower recruitment and infiltration of circulating cells to vascular wall and lower lipid accumulation. This study shows that regular consumption of orange juice for 4 weeks alters leukocyte gene expression to an anti-inflammatory and anti-atherogenic profile, and hesperidin displays a relevant role in the genomic effect of this beverage. ClinicalTrials.gov NCT 00983086.

Hesperidin Displays Relevant Role in the Nutrigenomic Effect of Orange Juice on Blood Leukocytes in Human Volunteers: A Randomized Controlled Cross-Over Study

PubMed Central

Milenkovic, Dragan; Deval, Christiane; Dubray, Claude; Mazur, Andrzej; Morand, Christine

2011-01-01

Background We previously showed, in healthy, middle-aged, moderately overweight men, that orange juice decreases diastolic blood pressure and significantly improves postprandial microvascular endothelial reactivity and that hesperidin could be causally linked to the observed beneficial effect of orange juice. The objective was to determine the effect of chronic consumption of orange juice on the gene expression profile of leukocytes in healthy volunteers and to assess to what extent hesperidin is involved in the effect of orange juice. Methodology/Principal Findings Volunteers were included in a randomized, controlled, crossover study. Throughout three 4-week periods, volunteers consumed daily: 500 ml orange juice, 500 ml control drink plus hesperidin or 500 ml control drink and placebo. Blood samplings were performed on 10 overnight-fasted subjects after the 4-week treatment period. Global gene expression profiles were determined using human whole genome cDNA microarrays. Both orange juice and hesperidin consumption significantly affected leukocyte gene expression. Orange juice consumption induced changes in expression of, 3,422 genes, while hesperidin intake modulated the expression of 1,819 genes. Between the orange juice and hesperidin consumption groups, 1,582 regulated genes were in common. Many of these genes are implicated in chemotaxis, adhesion, infiltration and lipid transport, which is suggestive of lower recruitment and infiltration of circulating cells to vascular wall and lower lipid accumulation. Conclusions This study shows that regular consumption of orange juice for 4 weeks alters leukocyte gene expression to an anti-inflammatory and anti-atherogenic profile, and hesperidin displays a relevant role in the genomic effect of this beverage. Trial Registration ClinicalTrials.gov NCT 00983086 PMID:22110589

Protein Supplementation to Augment the Effects of High Intensity Resistance Training in Untrained Middle-Aged Males: The Randomized Controlled PUSH Trial.

PubMed

Wittke, Andreas; von Stengel, Simon; Hettchen, Michael; Fröhlich, Michael; Giessing, Jürgen; Lell, Michael; Scharf, Michael; Bebenek, Michael; Kohl, Matthias; Kemmler, Wolfgang

2017-01-01

High intensity (resistance exercise) training (HIT) defined as a "single set resistance exercise to muscular failure" is an efficient exercise method that allows people with low time budgets to realize an adequate training stimulus. Although there is an ongoing discussion, recent meta-analysis suggests the significant superiority of multiple set (MST) methods for body composition and strength parameters. The aim of this study is to determine whether additional protein supplementation may increase the effect of a HIT-protocol on body composition and strength to an equal MST-level. One hundred and twenty untrained males 30-50 years old were randomly allocated to three groups: (a) HIT, (b) HIT and protein supplementation (HIT&P), and (c) waiting-control (CG) and (after cross-over) high volume/high-intensity-training (HVHIT). HIT was defined as "single set to failure protocol" while HVHIT consistently applied two equal sets. Protein supplementation provided an overall intake of 1.5-1.7 g/kg/d/body mass. Primary study endpoint was lean body mass (LBM). LBM significantly improved in all exercise groups ( p ≤ 0.043); however only HIT&P and HVHIT differ significantly from control ( p ≤ 0.002). HIT diverges significantly from HIT&P ( p = 0.017) and nonsignificantly from HVHIT ( p = 0.059), while no differences were observed for HIT&P versus HVHIT ( p = 0.691). In conclusion, moderate to high protein supplementation significantly increases the effects of a HIT-protocol on LBM in middle-aged untrained males.

A Double-Blind, Randomized Pilot Trial of Chromium Picolinate for Overweight Individuals with Binge-Eating Disorder: Effects on Glucose Regulation.

PubMed

Sala, Margarita; Breithaupt, Lauren; Bulik, Cynthia M; Hamer, Robert M; La Via, Maria C; Brownley, Kimberly A

2017-03-04

Chromium treatment has been shown to improve glucose regulation in some populations. The purpose of this study was to evaluate whether chromium picolinate (CrPic) supplementation improves glucose regulation in overweight individuals with binge-eating disorder (BED). In this double-blinded randomized pilot trial, participants (N = 24) were randomized to high (HIGH, 1000 mcg/day, n = 8) or moderate (MOD, 600 mcg/day, n = 9) dose of CrPic or placebo (PL, n = 7) for 6 months. Participants completed an oral glucose tolerance test (OGTT) at baseline, 3 months, and 6 months. Fixed effects models were used to estimate mean change in glucose area under the curve (AUC), insulin AUC , and insulin sensitivity index (ISI). Results revealed a significant group and time interaction (p < 0.04) for glucose AUC , with glucose AUC increasing significantly in the PL group (p < 0.02) but decreasing significantly in the MOD group (p < 0.03) at 6 months. Insulin AUC increased significantly over time (main effect, p < 0.02), whereas ISI decreased significantly over time (main effect, p < 0.03). As anticipated, a moderate dose of CrPic was associated with improved glycemic control, whereas PL was associated with decreased glycemic control. It was unexpected that the improved glycemic control seen in the MOD dose group was not seen in the HIGH dose group. However, although participants randomized to the HIGH dose group did not have improved glycemic control, they had better glycemic control than participants randomized to the PL group. These findings support the need for larger trials.

Health-Related Quality-of-Life Findings for the Prostate Cancer Prevention Trial

PubMed Central

2012-01-01

Background The Prostate Cancer Prevention Trial (PCPT)—a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer—offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial. Methods We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form–36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided. Results For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = −0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = −5.64, 95% CI = −7.96 to −3.32, P < .001), leg pain (estimate = −2.57, 95% CI = −3.04 to −2.10, P < .001), and diabetes (estimate = −1.31, 95% CI = −2.04 to −0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = −2.34, 95% CI = −2.97 to −1.71, P < .001) and time on study (estimate = −1.20, 95% CI = −1.36 to −1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points. Conclusion Finasteride did not negatively affect SF–36 Physical Functioning, Mental Health, or Vitality scores. PMID:22972968

Transcranial Electrical Stimulation over Dorsolateral Prefrontal Cortex Modulates Processing of Social Cognitive and Affective Information.

PubMed

Conson, Massimiliano; Errico, Domenico; Mazzarella, Elisabetta; Giordano, Marianna; Grossi, Dario; Trojano, Luigi

2015-01-01

Recent neurofunctional studies suggested that lateral prefrontal cortex is a domain-general cognitive control area modulating computation of social information. Neuropsychological evidence reported dissociations between cognitive and affective components of social cognition. Here, we tested whether performance on social cognitive and affective tasks can be modulated by transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC). To this aim, we compared the effects of tDCS on explicit recognition of emotional facial expressions (affective task), and on one cognitive task assessing the ability to adopt another person's visual perspective. In a randomized, cross-over design, male and female healthy participants performed the two experimental tasks after bi-hemispheric tDCS (sham, left anodal/right cathodal, and right anodal/left cathodal) applied over DLPFC. Results showed that only in male participants explicit recognition of fearful facial expressions was significantly faster after anodal right/cathodal left stimulation with respect to anodal left/cathodal right and sham stimulations. In the visual perspective taking task, instead, anodal right/cathodal left stimulation negatively affected both male and female participants' tendency to adopt another's point of view. These findings demonstrated that concurrent facilitation of right and inhibition of left lateral prefrontal cortex can speed-up males' responses to threatening faces whereas it interferes with the ability to adopt another's viewpoint independently from gender. Thus, stimulation of cognitive control areas can lead to different effects on social cognitive skills depending on the affective vs. cognitive nature of the task, and on the gender-related differences in neural organization of emotion processing.

Weight Gain Prevention among Midlife Women: A Randomized Controlled Trial to Address Needs Related to the Physical and Social Environment.

PubMed

Perry, Courtney D; Degeneffe, Dennis; Davey, Cynthia; Kollannoor-Samuel, Grace; Reicks, Marla

2016-05-25

Women tend to gain weight at midlife (40-60 years) increasing risk of obesity-related chronic diseases. Within specific eating occasions, needs related to the physical and social environment may result in less healthy eating behavior, which can lead to weight gain over time. The purpose of this study was to determine if a dietitian-delivered nutrition counseling intervention tailored to eating occasion needs could improve diet and prevent weight gain among midlife women over two years. A randomized controlled trial was conducted with healthy midlife women (n = 354) in one U.S. metropolitan area. The intervention group (n = 185) received ten hours of individual nutrition counseling from dietitians over six months, while women in a control group (n = 169) received no counseling. Measured height, weight and waist circumference, and dietary intakes were collected at baseline and every six months over two years. Mixed linear models were used to test for intervention effect on change in outcome variables over time. Dietary intakes of fruit, reduced/low-fat dairy foods and refined grains were significantly improved over time in the intervention compared to control group. However, the intervention had no effect on weight over time (p = 0.48). Nutrition counseling tailored to address eating occasion needs improved self-reported diet but did not significantly affect weight change.

MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.

PubMed

Bivard, Andrew; Lillicrap, Thomas; Krishnamurthy, Venkatesh; Holliday, Elizabeth; Attia, John; Pagram, Heather; Nilsson, Michael; Parsons, Mark; Levi, Christopher R

2017-05-01

This study aimed to assess the efficacy of modafinil, a wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. This single-center phase 2 trial used a randomized, double-blind, placebo-controlled, crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of ≥60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy, then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment, the Depression, Anxiety, and Stress Scale (DASS), and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person, baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, -7.38; 95% CI, -21.76 to -2.99; P <0.001) and improved quality of life (SSQoL, 11.81; 95% CI, 2.31 to 21.31; P =0.0148) compared with placebo. Montreal cognitive assessment and DASS were not significantly improved with modafinil therapy during the study period ( P >0.05). Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527. © 2017 The Authors.

A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: a Prospective, Randomized, Controlled Trial.

PubMed

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Stark, Renée G; Altenhofer, Julia; Henze, Kerstin; Parhofer, Klaus G

2017-10-06

Studies indicate a positive association between walnut intake and improvements in plasma lipids. We evaluated the effect of an isocaloric replacement of macronutrients with walnuts and the time point of consumption on plasma lipids. We included 194 healthy subjects (134 females, age 63 ± 7 years, BMI 25.1 ± 4.0 kg/m²) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (8 weeks each). Ninety-six subjects first followed a walnut-enriched diet (43 g walnuts/day) and then switched to a nut-free diet. Ninety-eight subjects followed the diets in reverse order. Subjects were also randomized to either reduce carbohydrates ( n = 62), fat ( n = 65), or both ( n = 67) during the walnut diet, and instructed to consume walnuts either as a meal or as a snack. The walnut diet resulted in a significant reduction in fasting cholesterol (walnut vs. -8.5 ± 37.2 vs. -1.1 ± 35.4 mg/dL; p = 0.002), non-HDL cholesterol (-10.3 ± 35.5 vs. -1.4 ± 33.1 mg/dL; p ≤ 0.001), LDL-cholesterol (-7.4 ± 32.4 vs. -1.7 ± 29.7 mg/dL; p = 0.029), triglycerides (-5.0 ± 47.5 vs. 3.7 ± 48.5 mg/dL; p = 0.015) and apoB (-6.7 ± 22.4 vs. -0.5 ± 37.7; p ≤ 0.001), while HDL-cholesterol and lipoprotein (a) did not change significantly. Neither macronutrient replacement nor time point of consumption significantly affected the effect of walnuts on lipids. Thus, 43 g walnuts/d improved the lipid profile independent of the recommended macronutrient replacement and the time point of consumption.

Recording devices for interconnected grade crossing and intersection signal systems : an informational report.

DOT National Transportation Integrated Search

2012-10-01

Over 15 years ago, the National Transportation Safety Board (NTSB) issued 29 recommendations : to improve safety at active controlled highway-rail grade crossings following the school buscommuter : train collision in Fox River Grove, Illinois. The ob...

Effects of intranasal oxytocin on the neural basis of face processing in autism spectrum disorder.

PubMed

Domes, Gregor; Heinrichs, Markus; Kumbier, Ekkehardt; Grossmann, Annette; Hauenstein, Karlheinz; Herpertz, Sabine C

2013-08-01

Autism spectrum disorder (ASD) is associated with altered face processing and decreased activity in brain regions involved in face processing. The neuropeptide oxytocin has been shown to promote face processing and modulate brain activity in healthy adults. The present study examined the effects of oxytocin on the neural basis of face processing in adults with Asperger syndrome (AS). A group of 14 individuals with AS and a group of 14 neurotypical control participants performed a face-matching and a house-matching task during functional magnetic resonance imaging. The effects of a single dose of 24 IU intranasally administered oxytocin were tested in a randomized, placebo-controlled, within-subject, cross-over design. Under placebo, the AS group showed decreased activity in the right amygdala, fusiform gyrus, and inferior occipital gyrus compared with the control group during face processing. After oxytocin treatment, right amygdala activity to facial stimuli increased in the AS group. These findings indicate that oxytocin increases the saliency of social stimuli and in ASD and suggest that oxytocin might promote face processing and eye contact in individuals with ASD as prerequisites for neurotypical social interaction. Copyright © 2013 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Implementation of cross correlation for energy discrimination on the time-of-flight spectrometer CORELLI.

PubMed

Ye, Feng; Liu, Yaohua; Whitfield, Ross; Osborn, Ray; Rosenkranz, Stephan

2018-04-01

The CORELLI instrument at Oak Ridge National Laboratory is a statistical chopper spectrometer designed and optimized to probe complex disorder in crystalline materials through diffuse scattering experiments. On CORELLI, the high efficiency of white-beam Laue diffraction combined with elastic discrimination have enabled an unprecedented data collection rate to obtain both the total and the elastic-only scattering over a large volume of reciprocal space from a single measurement. To achieve this, CORELLI is equipped with a statistical chopper to modulate the incoming neutron beam quasi-randomly, and then the cross-correlation method is applied to reconstruct the elastic component from the scattering data. Details of the implementation of the cross-correlation method on CORELLI are given and its performance is discussed.

Implementation of cross correlation for energy discrimination on the time-of-flight spectrometer CORELLI

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ye, Feng; Liu, Yaohua; Whitfield, Ross

The CORELLI instrument at Oak Ridge National Laboratory is a statistical chopper spectrometer designed and optimized to probe complex disorder in crystalline materials through diffuse scattering experiments. On CORELLI, the high efficiency of white-beam Laue diffraction combined with elastic discrimination have enabled an unprecedented data collection rate to obtain both the total and the elastic-only scattering over a large volume of reciprocal space from a single measurement. To achieve this, CORELLI is equipped with a statistical chopper to modulate the incoming neutron beam quasi-randomly, and then the cross-correlation method is applied to reconstruct the elastic component from the scattering data.more » Lastly, details of the implementation of the cross-correlation method on CORELLI are given and its performance is discussed.« less

Implementation of cross correlation for energy discrimination on the time-of-flight spectrometer CORELLI

DOE PAGES

Ye, Feng; Liu, Yaohua; Whitfield, Ross; ...

2018-03-26

The CORELLI instrument at Oak Ridge National Laboratory is a statistical chopper spectrometer designed and optimized to probe complex disorder in crystalline materials through diffuse scattering experiments. On CORELLI, the high efficiency of white-beam Laue diffraction combined with elastic discrimination have enabled an unprecedented data collection rate to obtain both the total and the elastic-only scattering over a large volume of reciprocal space from a single measurement. To achieve this, CORELLI is equipped with a statistical chopper to modulate the incoming neutron beam quasi-randomly, and then the cross-correlation method is applied to reconstruct the elastic component from the scattering data.more » Lastly, details of the implementation of the cross-correlation method on CORELLI are given and its performance is discussed.« less

Carnitine for fatigue in multiple sclerosis.

PubMed

Tejani, Aaron M; Wasdell, Michael; Spiwak, Rae; Rowell, Greg; Nathwani, Shabita

2010-02-17

Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients. To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose. A literature search was performed using Cochrane MS Group Trials Register (21 May 2009), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2009, issue 2, MEDLINE (PubMed) (1966-21 May 2009), EMBASE (1974-21 May 2009). Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied. Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults with a clinical diagnosis of fatigue associated with multiple sclerosis were included. Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer however this was not necessary. The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up. The search identified one randomized cross-over trial. In this study patients were exposed to both acetyl L-carnitine (ALCAR(tm)) 2 grams daily and amantadine 200 mg daily in adult patients with relapsing-remitting and secondary progressive MS. The effects of carnitine on fatigue are not clear based on the one included crossover RCT. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55. Mortality, serious adverse events, total adverse events, and quality of life were not reported. There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators.

Uncertainty-driven nuclear data evaluation including thermal (n,α) applied to 59Ni

NASA Astrophysics Data System (ADS)

Helgesson, P.; Sjöstrand, H.; Rochman, D.

2017-11-01

This paper presents a novel approach to the evaluation of nuclear data (ND), combining experimental data for thermal cross sections with resonance parameters and nuclear reaction modeling. The method involves sampling of various uncertain parameters, in particular uncertain components in experimental setups, and provides extensive covariance information, including consistent cross-channel correlations over the whole energy spectrum. The method is developed for, and applied to, 59Ni, but may be used as a whole, or in part, for other nuclides. 59Ni is particularly interesting since a substantial amount of 59Ni is produced in thermal nuclear reactors by neutron capture in 58Ni and since it has a non-threshold (n,α) cross section. Therefore, 59Ni gives a very important contribution to the helium production in stainless steel in a thermal reactor. However, current evaluated ND libraries contain old information for 59Ni, without any uncertainty information. The work includes a study of thermal cross section experiments and a novel combination of this experimental information, giving the full multivariate distribution of the thermal cross sections. In particular, the thermal (n,α) cross section is found to be 12.7 ± . 7 b. This is consistent with, but yet different from, current established values. Further, the distribution of thermal cross sections is combined with reported resonance parameters, and with TENDL-2015 data, to provide full random ENDF files; all of this is done in a novel way, keeping uncertainties and correlations in mind. The random files are also condensed into one single ENDF file with covariance information, which is now part of a beta version of JEFF 3.3. Finally, the random ENDF files have been processed and used in an MCNP model to study the helium production in stainless steel. The increase in the (n,α) rate due to 59Ni compared to fresh stainless steel is found to be a factor of 5.2 at a certain time in the reactor vessel, with a relative uncertainty due to the 59Ni data of 5.4%.

Pedestrian signalization and the risk of pedestrian-motor vehicle collisions in Lima, Peru

PubMed Central

Quistberg, D. Alex; Koepsell, Thomas D.; Boyle, Linda Ng; Miranda, J. Jaime; Johnston, Brian D.; Ebel, Beth E.

2014-01-01

Safe walking environments are essential for protecting pedestrians and promoting physical activity. In Peru, pedestrians comprise of over three-quarters of road fatality victims. Pedestrian signalization plays an important role managing pedestrian and vehicle traffic and may help improve pedestrian safety. We examined the relationship between pedestrian-motor vehicle collisions and the presence of visible traffic signals, pedestrian signals, and signal timing to determine whether these countermeasures improved pedestrian safety. A matched case-control design was used where the units of study were crossing locations. We randomly sampled 97 control-matched collisions (weighted N=1134) at intersections occurring from October, 2010 to January, 2011 in Lima. Each case-control pair was matched on proximity, street classification, and number of lanes. Sites were visited between February, 2011 and September, 2011. Each analysis accounted for sampling weight and matching and was adjusted for vehicle and pedestrian traffic flow, crossing width, and mean vehicle speed. Collisions were more common where a phased pedestrian signal (green or red-lit signal) was present compared to no signalization (odds ratio [OR] 8.88, 95% Confidence Interval [CI] 1.32–59.6). A longer pedestrian-specific signal duration was associated with collision risk (OR 5.31, 95% CI 1.02–9.60 per 15-second interval). Collisions occurred more commonly in the presence of any signalization visible to pedestrians or pedestrian-specific signalization, though these associations were not statistically significant. Signalization efforts were not associated with lower risk for pedestrians; rather, they were associated with an increased risk of pedestrian-vehicle collisions. PMID:24821630

Pedestrian signalization and the risk of pedestrian-motor vehicle collisions in Lima, Peru.

PubMed

Quistberg, D Alex; Koepsell, Thomas D; Boyle, Linda Ng; Miranda, J Jaime; Johnston, Brian D; Ebel, Beth E

2014-09-01

Safe walking environments are essential for protecting pedestrians and promoting physical activity. In Peru, pedestrians comprise over three-quarters of road fatality victims. Pedestrian signalization plays an important role managing pedestrian and vehicle traffic and may help improve pedestrian safety. We examined the relationship between pedestrian-motor vehicle collisions and the presence of visible traffic signals, pedestrian signals, and signal timing to determine whether these countermeasures improved pedestrian safety. A matched case-control design was used where the units of study were crossing locations. We randomly sampled 97 control-matched collisions (weighted N=1134) at intersections occurring from October, 2010 to January, 2011 in Lima. Each case-control pair was matched on proximity, street classification, and number of lanes. Sites were visited between February, 2011 and September, 2011. Each analysis accounted for sampling weight and matching and was adjusted for vehicle and pedestrian traffic flow, crossing width, and mean vehicle speed. Collisions were more common where a phased pedestrian signal (green or red-light signal) was present compared to no signalization (odds ratio [OR] 8.88, 95% Confidence Interval [CI] 1.32-59.6). A longer pedestrian-specific signal duration was associated with collision risk (OR 5.31, 95% CI 1.02-9.60 per 15-s interval). Collisions occurred more commonly in the presence of any signalization visible to pedestrians or pedestrian-specific signalization, though these associations were not statistically significant. Signalization efforts were not associated with lower risk for pedestrians; rather, they were associated with an increased risk of pedestrian-vehicle collisions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Distributed Synchronization in Networks of Agent Systems With Nonlinearities and Random Switchings.

PubMed

Tang, Yang; Gao, Huijun; Zou, Wei; Kurths, Jürgen

2013-02-01

In this paper, the distributed synchronization problem of networks of agent systems with controllers and nonlinearities subject to Bernoulli switchings is investigated. Controllers and adaptive updating laws injected in each vertex of networks depend on the state information of its neighborhood. Three sets of Bernoulli stochastic variables are introduced to describe the occurrence probabilities of distributed adaptive controllers, updating laws and nonlinearities, respectively. By the Lyapunov functions method, we show that the distributed synchronization of networks composed of agent systems with multiple randomly occurring nonlinearities, multiple randomly occurring controllers, and multiple randomly occurring updating laws can be achieved in mean square under certain criteria. The conditions derived in this paper can be solved by semi-definite programming. Moreover, by mathematical analysis, we find that the coupling strength, the probabilities of the Bernoulli stochastic variables, and the form of nonlinearities have great impacts on the convergence speed and the terminal control strength. The synchronization criteria and the observed phenomena are demonstrated by several numerical simulation examples. In addition, the advantage of distributed adaptive controllers over conventional adaptive controllers is illustrated.

A cross-sectional observational study of the nutritional intake of UK primary school children from deprived and non-deprived backgrounds: implications for school breakfast schemes.

PubMed

Jenkins, Kim T; Benton, David; Tapper, Katy; Murphy, Simon; Moore, Laurence

2015-06-25

This study examined the nutritional intake of 9-11 year old children in Wales, UK, to assess the rationale for, and potential of, school breakfast initiatives. It also examined the possible unintended consequence of over consumption. The study employed a cross-sectional observational design within a randomized controlled trial of a free school breakfast programme. A total of 111 primary schools were randomly assigned to an intervention condition (in which a free school breakfast programme was implemented) or a control condition (in which implementation of the scheme was delayed). Sub-samples of children completed multiple-pass 24-hr dietary recall interviews at baseline (n = 581), and 12 months later (n = 582). Deprivation was assessed for each child in terms of whether or not they were entitled to free school meals. Prior to the introduction of the programme, rates of breakfast skipping were low and there was little evidence of widespread nutritional deficiency. However, there was a subset of children who consumed inadequate levels of a range of vitamins and minerals and 29 % of children ate very little for breakfast (less than 100 kcal). Children that ate larger breakfasts, had higher daily intakes of all nutrients that were examined. Children from deprived backgrounds consumed significantly lower levels of several vitamins and minerals at breakfast. Following the introduction of the breakfast scheme in intervention schools, there was little difference in the nutritional quality of school versus home breakfasts (n = 35 and 211 respectively). Where children ate breakfast at both school and home (n = 33), their overall energy intake was higher, but not significantly so. Although the overall diet of this group of children was generally good prior to the breakfast scheme, the results suggest that such schemes could be beneficial for a subset of children who are poorly nourished and for those children who consume very little for breakfast. Current Controlled Trials ISRCTN18336527.

Controlling Laser-Plasma Instabilities and CBET Using STUD Pulses in the Strong Coupling Regime for Direct and Indirect Drive ICF

NASA Astrophysics Data System (ADS)

Afeyan, Bedros; Meezan, N.; MacLaren, S.; Hammer, J.; Montgomery, D.; Heebner, J.

2015-11-01

We will show theoretical results on the behavior of SBS in the strong damping regime and CBET in mid-Z plasmas (around 20) where ion Landau damping and collisional damping are both higher order effects and strong coupling is dominant in laser hot spots and near Mach -1 surfaces in appropriately tuned pairs of crossing beams. The spatially dependent frequency shits that ensue and the reductions in growth rate allow the control of LPI even downstream beyond the crossing volumes. Multiple successive crossings between O(100) beams can be used to change the space-time intensity distributions of lasers used entirely differently in direct and indirect drive geometries. In the former case, due to the existence of many angles, a statistical Sqrt(N) gain is expected. with randomly phased beams via STUD pulses. On the other hand, for indirect drive, with 2-4 cone angles to contend with, turning off interactions by staggering crossing beam spikes, achieved with STUD pulses, is a key deterministic element for the success of the plan. Changing the speckle statistics at will and with fine control is a grand challenge of this set of techniques.

Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women

PubMed Central

Evans, Ellen M.; Racette, Susan B.; Van Pelt, Rachael E.; Peterson, Linda R.; Villareal, Dennis T.

2008-01-01

Objective The aim of this study was to assess the independent and additive effects of soy protein isolate (SPI) and moderate-intensity exercise (EX) on bone turnover and bone mineral density (BMD). Design This study used a placebo-controlled, double-blind (soy), randomized 2 (SPI vs milk protein isolate [MPI]) × 2 (EX vs no EX) design. Sixty-one postmenopausal women were randomized, and 43 (62 ± 5 y) completed the 9-month intervention (SPI, n = 10; MPI, n = 12; SPI + EX, n = 11; MPI + EX, n = 10). Serum C-terminal cross-linked telopeptides of type I collagen and serum bone-specific alkaline phosphatase were measured as markers of bone resorption and formation, respectively. BMD was measured by dual-energy x-ray absorptiometry. Results At 9 months, SPI reduced serum C-terminal cross-linked telopeptides (−13.3% ± 15.3% vs −1.5% ± 21.0%; P = 0.02) and serum bone-specific alkaline phosphatase (−4.7% ± 14.7% vs 6.5% ± 17.7%; P = 0.02) compared to milk protein isolate. EX attenuated the reduction in serum C-terminal cross-linked telopeptides (−1.9% ± 21.6% vs −12.4% ± 15.3%; P = 0.04); however, no EX effects were apparent in serum bone-specific alkaline phosphatase at 9 months (2.8% ± 16.1% vs −1.0% ± 18.3%; P = 0.28). Neither SPI nor EX affected BMD at any site; however, change in BMD was related to change in fat mass (r = 0.40, P < 0.05). Conclusions In postmenopausal women (1) SPI reduces bone turnover with no impact on BMD over 9 months; (2) moderate-intensity endurance exercise training did not favorably alter bone turnover and had no impact on BMD; and (3) there were no additive effects of soy and exercise on bone turnover or BMD. PMID:17213752

ANTIPLAQUE AND ANTIGINGIVITIS EFFECTS OF A GEL CONTAINING PUNICA GRANATUM LINN EXTRACT. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

PubMed Central

Salgado, Alexandre Daher Yunes; Maia, Juliana Lemos; Pereira, Sérgio Luís da Silva; de Lemos, Telma Leda Gomes; Mota, Olívia Morais de Lima

2006-01-01

Objectives: The antiplaque and antigingivitis effects of a gel containing 10% Punica granatum Linn extract were evaluated using a 21-day partial-mouth experimental model of gingivitis. Methods: 23 volunteers participated in this cross-over, doubleblind study, carried out in 2 phases of 21 days each. For each period of the experiment, an acrylic toothshield was made for each volunteer to carry the test or placebo gel as well as to avoid brushing of the 4 experimental teeth (posterior teeth in the lower left quadrant). The subjects were randomly assigned to use either the placebo gel (control group) or the test gel (experimental group) and were instructed to brush the remaining teeth normally 3 times a day. On days 0 and 21, the visible plaque index (VPI) and gingival bleeding index (GBI) were recorded. Results: The results did not show statistically significant difference between control and experimental groups for either of the indices (VPI and GBI). Conclusion: The gel containing 10% Punica granatum Linn extract was not efficient in preventing supragingival dental plaque formation and gingivitis. PMID:19089066

Comparison of the clinical effects of white brand toothbrushes versus Vitis Suave®

PubMed Central

Segarra-Vidal, Marta; Lucas-Alcahuz, Eduardo; López-Roldán, Andrés; Gil-Loscos, Francisco; Alpiste-Illueca, Francisco

2015-01-01

Background There has been an increase in the use of white label manual toothbrushes and a greater increase in inquiries for discomfort of the gingiva and mucosa. Material and Methods A randomized, double-blind, cross-over clinical trial was made of four white brand toothbrushes versus a control brush (Vitis Suave®), with the recording of plaque index, bleeding upon probing, and gingival abrasions following utilization of the different brushes. Results All the brushes except Deliplus® were equally effective in terms of plaque removal (p<0.05). Vitis Suave® and Veckia® were the brushes associated to the greatest increase in minor abrasions (p<0.01), while Veckia®, Carrefour® and Deluxe® significantly increased the number of medium intensity abrasions (p<0.05). These brushes also increased the number of large abrasions, though statistical significance was not reached in this case. Conclusions The white brand brushes proved effective in controlling bacterial plaque, but were associated to more intense soft tissue abrasion. Key words:Gingival abrasions, manual tooth brushing, white brand, clinical effects. PMID:26535095

Randomized Trial of Suicide Gatekeeper Training for Social Work Students

ERIC Educational Resources Information Center

Jacobson, Jodi M.; Osteen, Phillip J.; Sharpe, Tanya L.; Pastoor, Jennifer B.

2012-01-01

Problem: Education and research on social work's role in preventing client suicide is limited. Method: Seventy advanced master of social work students were randomly assigned to either the training group (Question, Persuade, and Referral suicide gatekeeper training) or the control group. Outcomes measured over time included suicide knowledge,…

Protein from Meat or Vegetable Sources in Meals Matched for Fiber Content has Similar Effects on Subjective Appetite Sensations and Energy Intake-A Randomized Acute Cross-Over Meal Test Study.

PubMed

Nielsen, Lone V; Kristensen, Marlene D; Klingenberg, Lars; Ritz, Christian; Belza, Anita; Astrup, Arne; Raben, Anne

2018-01-16

Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy intake and appetite sensations, compared to macronutrient-balanced, iso-caloric meals based on animal protein (veal/pork or eggs). Thirty-five healthy men were enrolled in this acute cross-over study. On each test day, participants were presented with one of four test meals (~3550 kilojoules (kJ) 19% of energy from protein), based on fava beans/split peas (28.5 g fiber), pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber), or eggs without supplementation of fiber (6.0 g fiber). Subjective appetite sensations were recorded at baseline and every half hour until the ad libitum meal three hours later. There were no differences in ad libitum energy intake across test meals ( p > 0.05). Further, no differences were found across meals for hunger, satiety, fullness, prospective food consumption, or composite appetite score (all p > 0.05). Iso-caloric, macronutrient-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations.

Protein from Meat or Vegetable Sources in Meals Matched for Fiber Content has Similar Effects on Subjective Appetite Sensations and Energy Intake—A Randomized Acute Cross-Over Meal Test Study

PubMed Central

Nielsen, Lone V.; Kristensen, Marlene D.; Klingenberg, Lars; Belza, Anita

2018-01-01

Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy intake and appetite sensations, compared to macronutrient-balanced, iso-caloric meals based on animal protein (veal/pork or eggs). Thirty-five healthy men were enrolled in this acute cross-over study. On each test day, participants were presented with one of four test meals (~3550 kilojoules (kJ) 19% of energy from protein), based on fava beans/split peas (28.5 g fiber), pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber), or eggs without supplementation of fiber (6.0 g fiber). Subjective appetite sensations were recorded at baseline and every half hour until the ad libitum meal three hours later. There were no differences in ad libitum energy intake across test meals (p > 0.05). Further, no differences were found across meals for hunger, satiety, fullness, prospective food consumption, or composite appetite score (all p > 0.05). Iso-caloric, macronutrient-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations. PMID:29337861

Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.

PubMed

Skingley, Ann; Bungay, Hilary; Clift, Stephen; Warden, June

2014-12-01

Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research. © The Author (2013). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The Quality of Reporting of Abstracts in Physical Therapy Literature is Suboptimal: Cross-Sectional, Bibliographic Analysis.

PubMed

Richter, Randy R; Sebelski, Chris A; Austin, Tricia M

2016-09-01

The quality of abstract reporting in physical therapy literature is unknown. The purpose of this study was to provide baseline data for judging the future impact of the 2010 Consolidated Standards of Reporting Trials statement specifically referencing the 2008 Consolidated Standards of Reporting Trials statement for reporting of abstracts of randomized controlled trials across and between a broad sample and a core sample of physical therapy literature. A cross-sectional, bibliographic analysis was conducted. Abstracts of randomized controlled trials from 2009 were retrieved from PubMed, PEDro, and CENTRAL. Eligibility was determined using PEDro criteria. For outcomes measures, items from the Consolidated Standards of Reporting Trials statement for abstract reporting were used for assessment. Raters were not blinded to citation details. Using a computer-generated set of random numbers, 150 abstracts from 112 journals comprised the broad sample. A total of 53 abstracts comprised the core sample. Fourteen of 20 Consolidated Standards of Reporting Trials items for both samples were reported in less than 50% of the abstracts. Significantly more abstracts in the core sample reported (% difference core - broad; 95% confidence interval) title (28.4%; 12.9%-41.2%), blinding (15.2%; 1.6%-29.8%), setting (47.6%; 32.4%-59.4%), and confidence intervals (13.1%; 5.0%-25.1%). These findings provide baseline data for determining if continuing efforts to improve abstract reporting are heeded.

Vegetable versus animal protein diet in cirrhotic patients with chronic encephalopathy. A randomized cross-over comparison.

PubMed

Bianchi, G P; Marchesini, G; Fabbri, A; Rondelli, A; Bugianesi, E; Zoli, M; Pisi, E

1993-05-01

In a randomized cross-over comparison, the effects of a mainly vegetable protein diet were compared with an animal protein diet in eight patients with cirrhosis and chronic permanent encephalopathy, under optimum lactulose therapy. After a run-in period, patients were fed two equi-caloric, equi-nitrogenous diets for 7 days (71 g total proteins), containing either 50 g protein of animal origin or 50 g vegetable proteins. In the last 3 days of each period, nitrogen balance was significantly better during the vegetable protein diet (+0.2 (SD 1.4) g vs. -1.7 (2.4); P < 0.01), the difference being entirely due to a reduced urinary nitrogen excretion. Average daytime integrated blood glucose was slightly higher during vegetable proteins, whereas insulin, plasma amino acids and ammonia were lower. The clinical grading of encephalopathy improved slightly on vegetable proteins, and psychometric tests improved significantly, but remained grossly abnormal. Compliance to dietary manipulation was good. The data prove that a mainly vegetable protein diet is worthwhile in cirrhotic patients with chronic encephalopathy under optimum lactulose therapy. Improved nitrogen balance may be related to more effective nitrogen use for protein synthesis, probably due to blunted hormonal response, and largely outweighs the effects on encephalopathy.

Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

PubMed

Iimura, Kaori; Watanabe, Nobuhiro; Masunaga, Koichi; Miyazaki, Shogo; Hotta, Harumi; Kim, Hunkyung; Hisajima, Tatsuya; Takahashi, Hidenori; Kasuya, Yutaka

2016-01-01

Somatic afferent nerve stimuli are used for treating an overactive bladder (OAB), a major cause of nocturia in the elderly. Clinical evidence for this treatment is insufficient because of the lack of appropriate control stimuli. Recent studies on anesthetized animals show that gentle stimuli applied to perineal skin with a roller could inhibit micturition contractions depending on the roller's surface material. We examined the efficacy of gentle skin stimuli for treating nocturia. The study was a cross-over, placebo-controlled, double-blind randomized clinical study using two rollers with different effects on micturition contractions. Participants were elderly women (79-89 years) with nocturia. Active (soft elastomer roller) or placebo (hard polystyrene roller) stimuli were applied to perineal skin by participants for 1 min at bedtime. A 3-day baseline assessment period was followed by 3-day stimulation and 4-day resting periods, after which the participants were subjected to other stimuli for another 3 days. The primary outcome was change in the frequency of nighttime urination, for which charts were maintained during each 3-day period. Twenty-four participants were randomized, of which 22 completed all study protocols. One participant discontinued treatment because of an adverse event (abdominal discomfort). In participants with OAB (n = 9), change from baseline in the mean frequency of urination per night during the active stimuli period (mean ± standard deviation, -0.74 ± 0.7 times) was significantly greater than that during placebo stimuli periods (-0.15 ± 0.8 times [p < 0.05]). In contrast, this difference was not observed in participants without OAB (n = 13). These results suggest that gentle perineal stimulation with an elastomer roller is effective for treating OAB-associated nocturia in elderly women. Here the limitation was a study period too short to assess changes in the quality of sleep and life. UMIN Clinical Trial Registry (CTR) UMIN000015809.

Nigral stimulation for resistant axial motor impairment in Parkinson’s disease? A randomized controlled trial

PubMed Central

Walach, Margarete; Meisner, Christoph; Fritz, Melanie; Scholten, Marlieke; Breit, Sorin; Plewnia, Christian; Bender, Benjamin; Gharabaghi, Alireza; Wächter, Tobias

2013-01-01

Gait and balance disturbances typically emerge in advanced Parkinson’s disease with generally limited response to dopaminergic medication and subthalamic nucleus deep brain stimulation. Therefore, advanced programming with interleaved pulses was put forward to introduce concomittant nigral stimulation on caudal contacts of a subthalamic lead. Here, we hypothesized that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata improves axial symptoms compared with standard subthalamic nucleus stimulation. Twelve patients were enrolled in this 2 × 2 cross-over double-blind randomized controlled clinical trial and both the safety and efficacy of combined subthalamic nucleus and substantia nigra pars reticulata stimulation were evaluated compared with standard subthalamic nucleus stimulation. The primary outcome measure was the change of a broad-scaled cumulative axial Unified Parkinson’s Disease Rating Scale score (Scale II items 13–15, Scale III items 27–31) at ‘3-week follow-up’. Secondary outcome measures specifically addressed freezing of gait, balance, quality of life, non-motor symptoms and neuropsychiatric symptoms. For the primary outcome measure no statistically significant improvement was observed for combined subthalamic nucleus and substantia nigra pars reticulata stimulation at the ‘3-week follow-up’. The secondary endpoints, however, revealed that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata might specifically improve freezing of gait, whereas balance impairment remained unchanged. The combined stimulation of subthalamic nucleus and substantia nigra pars reticulata was safe, and of note, no clinically relevant neuropsychiatric adverse effect was observed. Patients treated with subthalamic nucleus and substantia nigra pars reticulata stimulation revealed no ‘global’ effect on axial motor domains. However, this study opens the perspective that concomittant stimulation of the substantia nigra pars reticulata possibly improves otherwise resistant freezing of gait and, therefore, highly warrants a subsequent phase III randomized controlled trial. PMID:23757762

Effects of exercise with or without blueberries in the diet on cardio-metabolic risk factors: An exploratory pilot study in healthy subjects

PubMed Central

Nyberg, Sofia; Gerring, Edvard; Gjellan, Solveig; Vergara, Marta; Lindström, Torbjörn

2013-01-01

Background. The improvement of insulin sensitivity by exercise has been shown to be inhibited by supplementation of vitamins acting as antioxidants. Objective. To examine effects of exercise with or without blueberries, containing natural antioxidants, on cardio-metabolic risk factors. Methods. Fifteen healthy men and 17 women, 27.6 ± 6.5 years old, were recruited, and 26 completed a randomized cross-over trial with 4 weeks of exercise by running/jogging 5 km five times/week and 4 weeks of minimal physical activity. Participants were also randomized to consume 150 g of blueberries, or not, on exercise days. Laboratory variables were measured before and after a 5 km running-race at maximal speed at the beginning and end of each period, i.e. there were four maximal running-races and eight samplings in total for each participant. Results. Insulin and triglyceride levels were reduced while HDL-cholesterol increased by exercise compared with minimal physical activity. Participants randomized to consume blueberries showed an increase in fasting glucose levels compared with controls, during the exercise period (blueberries: from 5.12 ± 0.49 mmol/l to 5.32 ± 0.29 mmol/l; controls: from 5.24 ± 0.27 mmol/l to 5.17 ± 0.23 mmol/l, P = 0.04 for difference in change). Triglyceride levels fell in the control group (from 1.1 ± 0.49 mmol/l to 0.93 ± 0.31 mmol/l, P = 0.02), while HDL-cholesterol increased in the blueberry group (from 1.51 ± 0.29 mmol/l to 1.64 ± 0.33 mmol/l, P = 0.006). Conclusions. Ingestion of blueberries induced differential effects on cardio-metabolic risk factors, including increased levels of both fasting glucose and HDL-cholesterol. However, since it is possible that indirect effects on food intake were induced, other than consumption of blueberries, further studies are needed to confirm the findings. PMID:23977864

Effects of exercise with or without blueberries in the diet on cardio-metabolic risk factors: an exploratory pilot study in healthy subjects.

PubMed

Nyberg, Sofia; Gerring, Edvard; Gjellan, Solveig; Vergara, Marta; Lindström, Torbjörn; Nystrom, Fredrik H

2013-11-01

The improvement of insulin sensitivity by exercise has been shown to be inhibited by supplementation of vitamins acting as antioxidants. To examine effects of exercise with or without blueberries, containing natural antioxidants, on cardio-metabolic risk factors. Fifteen healthy men and 17 women, 27.6 ± 6.5 years old, were recruited, and 26 completed a randomized cross-over trial with 4 weeks of exercise by running/jogging 5 km five times/week and 4 weeks of minimal physical activity. Participants were also randomized to consume 150 g of blueberries, or not, on exercise days. Laboratory variables were measured before and after a 5 km running-race at maximal speed at the beginning and end of each period, i.e. there were four maximal running-races and eight samplings in total for each participant. Insulin and triglyceride levels were reduced while HDL-cholesterol increased by exercise compared with minimal physical activity. Participants randomized to consume blueberries showed an increase in fasting glucose levels compared with controls, during the exercise period (blueberries: from 5.12 ± 0.49 mmol/l to 5.32 ± 0.29 mmol/l; controls: from 5.24 ± 0.27 mmol/l to 5.17 ± 0.23 mmol/l, P = 0.04 for difference in change). Triglyceride levels fell in the control group (from 1.1 ± 0.49 mmol/l to 0.93 ± 0.31 mmol/l, P = 0.02), while HDL-cholesterol increased in the blueberry group (from 1.51 ± 0.29 mmol/l to 1.64 ± 0.33 mmol/l, P = 0.006). Ingestion of blueberries induced differential effects on cardio-metabolic risk factors, including increased levels of both fasting glucose and HDL-cholesterol. However, since it is possible that indirect effects on food intake were induced, other than consumption of blueberries, further studies are needed to confirm the findings.

The role of vitamin D in the prevention of late-life depression.

PubMed

Okereke, Olivia I; Singh, Ankura

2016-07-01

In this article, we review current evidence regarding potential benefits of vitamin D for improving mood and reducing depression risk in older adults. We summarize gaps in knowledge and describe future efforts that may clarify the role of vitamin D in late-life depression prevention. MEDLINE and PsychINFO databases were searched for all articles on vitamin D and mood that had been published up to and including May 2015. Observational studies and randomized trials with 50 or more participants were included. We excluded studies that involved only younger adults and/or exclusively involved persons with current depression. Twenty observational (cross-sectional and prospective) studies and 10 randomized trials (nine were randomized placebo-controlled trials [RCTs]; one was a randomized blinded comparison trial) were reviewed. Inverse associations of vitamin D blood level or vitamin D intake with depression were found in 13 observational studies; three identified prospective relations. Results from all but one of the RCTs showed no statistically significant differences in depression outcomes between vitamin D and placebo groups. Observational studies were mostly cross-sectional and frequently lacked adequate control of confounding. RCTs often featured low treatment doses, suboptimal post-intervention changes in biochemical levels of vitamin D, and/or short trial durations. Vitamin D level-mood associations were observed in most, but not all, observational studies; results indicated that vitamin D deficiency may be a risk factor for late-life depression. However, additional data from well-designed RCTs are required to determine the impact of vitamin D in late-life depression prevention. Copyright © 2016 Elsevier B.V. All rights reserved.

A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study - Alimentation and Diabetes in Lanzarote -ADILAN

PubMed Central

2014-01-01

Background Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants’ weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. Methods/Design We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral glucose tolerance test, blood lipids, blood pressure, C-reactive protein, body composition, quality of life, subjective experience with the two diets, satiety scores and changes in medication. Discussion Using these results, we will assess the need to conduct larger and longer studies with similar design. Trial registration This trial was registered at clinicaltrials.gov as NCT01891955 and Spanish Agency of Medication and Sanitary Products (AEMPS) registration code: MFV-ADI-2013-01. PMID:24383431

A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN.

PubMed

Fontes-Villalba, Maelán; Jönsson, Tommy; Granfeldt, Yvonne; Frassetto, Lynda A; Sundquist, Jan; Sundquist, Kristina; Carrera-Bastos, Pedro; Fika-Hernándo, María; Picazo, Óscar; Lindeberg, Staffan

2014-01-02

Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants' weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral glucose tolerance test, blood lipids, blood pressure, C-reactive protein, body composition, quality of life, subjective experience with the two diets, satiety scores and changes in medication. Using these results, we will assess the need to conduct larger and longer studies with similar design. This trial was registered at clinicaltrials.gov as NCT01891955 and Spanish Agency of Medication and Sanitary Products (AEMPS) registration code: MFV-ADI-2013-01.

Statistical properties of cross-correlation in the Korean stock market

NASA Astrophysics Data System (ADS)

Oh, G.; Eom, C.; Wang, F.; Jung, W.-S.; Stanley, H. E.; Kim, S.

2011-01-01

We investigate the statistical properties of the cross-correlation matrix between individual stocks traded in the Korean stock market using the random matrix theory (RMT) and observe how these affect the portfolio weights in the Markowitz portfolio theory. We find that the distribution of the cross-correlation matrix is positively skewed and changes over time. We find that the eigenvalue distribution of original cross-correlation matrix deviates from the eigenvalues predicted by the RMT, and the largest eigenvalue is 52 times larger than the maximum value among the eigenvalues predicted by the RMT. The β_{473} coefficient, which reflect the largest eigenvalue property, is 0.8, while one of the eigenvalues in the RMT is approximately zero. Notably, we show that the entropy function E(σ) with the portfolio risk σ for the original and filtered cross-correlation matrices are consistent with a power-law function, E( σ) σ^{-γ}, with the exponent γ 2.92 and those for Asian currency crisis decreases significantly.

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

PubMed Central

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

2013-01-01

The efficacy of insecticide-treated window curtains (ITCs) for dengue vector control was evaluated in Thailand in a cluster-randomized controlled trial. A total of 2,037 houses in 26 clusters was randomized to receive the intervention or act as control (no treatment). Entomological surveys measured Aedes infestations (Breteau index, house index, container index, and pupae per person index) and oviposition indices (mean numbers of eggs laid in oviposition traps) immediately before and after intervention, and at 3-month intervals over 12 months. There were no consistent statistically significant differences in entomological indices between intervention and control clusters, although oviposition indices were lower (P < 0.01) in ITC clusters during the wet season. It is possible that the open housing structures in the study reduced the likelihood of mosquitoes making contact with ITCs. ITCs deployed in a region where this house design is common may be unsuitable for dengue vector control. PMID:23166195

Cross-resistance to prosulfocarb + S-metolachlor and pyroxasulfone selected by either herbicide in Lolium rigidum.

PubMed

Busi, Roberto; Powles, Stephen B

2016-09-01

Weeds can be a greater constraint to crop production than animal pests and pathogens. Pre-emergence herbicides are crucial in many cropping systems to control weeds that have evolved resistance to selective post-emergence herbicides. In this study we assessed the potential to evolve resistance to the pre-emergence herbicides prosulfocarb + S-metolachlor or pyroxasulfone in 50 individual field Lolium rigidum populations collected in a random survey in Western Australia prior to commercialisation of these pre-emergence herbicides. This study shows for the first time that in randomly collected L. rigidum field populations the selection with either prosulfocarb + S-metolachlor or pyroxasulfone can result in concomitant evolution of resistance to both prosulfocarb + S-metolachlor and pyroxasulfone after three generations. In the major weed L. rigidum, traits conferring resistance to new herbicides can be present before herbicide commercialisation. Proactive and multidisciplinary research (evolutionary ecology, modelling and molecular biology) is required to detect and analyse resistant populations before they can appear in the field. Several studies show that evolved cross-resistance in weeds is complex and often unpredictable. Thus, long-term management of cross-resistant weeds must be achieved through heterogeneity of selection by effective chemical, cultural and physical weed control strategies that can delay herbicide resistance evolution. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Effects of Baseplates of Orthodontic Appliances with in situ generated Silver Nanoparticles on Cariogenic Bacteria: A Randomized, Double-blind Cross-over Clinical Trial.

PubMed

Ghorbanzadeh, Roghayeh; Pourakbari, Babak; Bahador, Abbas

2015-04-01

Polymethyl-methacrylate (PMMA) is commonly used primarily for baseplates of orthodontic appliances (BOA). The activities of cariogenic bacteria in biofilm on these surfaces may contribute to dental caries, gingival inflammation and periodontal disease. The PMMA incorporated with nanoparticles of silver (NanoAg-I-PMMA) and NanoAg in situ in PMMA (NanoAg-IS-PMMA) have been shown to control the growth of cariogenic bacteria, but clinical trial of anti-cariogenic application of these novel materials in orthodontics has not been evaluated. The main aim of the study is to compare the clinical effectiveness of using NanoAg-IS-PMMA and NanoAg-I-PMMA for construction of new BOA in inhibiting the planktonic growth and biofilm formation of the cariogenic bacteria. Twenty four patients with a median age of 12.6 years (7-15) harboring Streptococcus mutans, Streptococcus sobrinus and Lactobacillus acidophilus as well as Lactobacillus casei participated in the randomized, double-blind, cross-over study. The experimental BOA, NanoAg-IS-BOA and NanoAg-I-BOA, contained 0.5% w/w NanoAg while the control BOA was standard PMMA. Antibacterial effect of NanoAg-IS-BOA and NanoAg-I-BOA was assessed against test cariogenic bacteria by planktonic and biofilm bacterial cells growth inhibition. The average levels of test cariogenic bacteria in saliva decreased about 2 to 70 fold (30.9-98.4%) compared to baseline depending on the microorganism type and test BOA. Biofilm inhibition analysis demonstrated that NanoAg-I-BOA and NanoAg-IS-BOA inhibited the biofilm of all test bacteria by 20.1 to 79.9% compared to BOA. NanoAg-IS-BOA had a strong anti-biofilm effect against S. mutans, S. sobrinus and L. casei. However, NanoAg-I-BOA showed only slight anti-biofilm effects on test bacteria. Most notably, at all period of the clinical trial, NanoAg-IS-BOA showed a higher antibacterial activity than NanoAg-I-BOA. Based on the novel data that presented here, the NanoAg-IS-BOA had strong antimicrobial activity in the planktonic phase and subsequent biofilm formation of the cariogenic bacteria. Wearing of NanoAg-IS-BOA has the potential to minimize dental plaque formation and caries during orthodontic treatment.

What puts them at risk? A cross-sectional case-control survey of demographic profile and sexual behavior of patients with sexually transmitted infections at a tertiary care center in North India.

PubMed

Raj, Rama; Gupta, Vishal; Pathak, Mona; Sreenivas, Vishnubhatla; Sood, Seema; Singh, Sarman; Verma, Kaushal K; Khanna, Neena; Das, Bimal K; Gupta, Somesh

2017-01-01

Sexually transmitted infections (STIs) are a major public health problem in developing nations. Identification of risk factors can help in formulating effective strategies against them. The present study was conducted in a tertiary care hospital in North India over 1 year to identify the risk factors associated with STIs. A questionnaire-based cross-sectional case-control survey was conducted where participants answered questions on demographic details, sexual behavior, and awareness of STIs. Cases were patients with STIs whereas controls were randomly selected from healthy individuals accompanying patients with nonvenereal complaints attending our hospital. There were 106 cases and 64 controls. STI patients had sexual debut 2 years before controls. A higher proportion of STI cases had lower education, multiple sexual partners, lived separately from their partner, had nonregular partners, had protected sex in the last month, had sex under influence of alcohol/illicit drugs, sex in unstructured settings, and engaged in transactional sex, in comparison to controls ( P < 0.05). More cases were aware of the symptoms/preventive measures of STIs ( P < 0.001). On multivariate analysis, multiple sexual partners, sex under influence of alcohol/illicit drugs with nonregular partner, protected sex in the last month, and knowledge of preventive measures were found to be statistically associated with STIs ( P < 0.05). Our study identifies risk-behavior patterns in patients with STIs, which should be modified to reduce the burden of these diseases. Increasing the knowledge about STIs in these patients can translate into more common condom usage that lends support for strengthening sexual health programs at grass-root levels. The small size of the study population could have led to decreased power of the study to detect differences between cases and controls. The external validity of our results needs to be tested in different population groups involving larger sample sizes.

Influence of erythropoietin on cognitive performance during experimental hypoglycemia in patients with type 1 diabetes mellitus: a randomized cross-over trial.

PubMed

Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Kjær, Troels Wesenberg; Olsen, Niels Vidiendal; Dela, Flemming; Holst, Jens Juul; Faber, Jens; Tarnow, Lise; Thorsteinsson, Birger

2013-01-01

The incidence of severe hypoglycemia in type 1 diabetes has not decreased over the past decades. New treatment modalities minimizing the risk of hypoglycemic episodes and attenuating hypoglycemic cognitive dysfunction are needed. We studied if treatment with the neuroprotective hormone erythropoietin (EPO) enhances cognitive function during hypoglycemia. Eleven patients with type 1 diabetes, hypoglycemia unawareness and recurrent severe hypoglycemia completed the study. In a double-blind, randomized, balanced, cross-over study using clamped hypoglycemia they were treated with 40,000 IU of EPO or placebo administered intravenously six days before the two experiments. Cognitive function (primary endpoint), hypoglycemic symptoms, and counter-regulatory hormonal response were recorded. Compared with placebo, EPO treatment was associated with a significant reduction in errors in the most complex reaction time task (-4.7 (-8.1 to -1.3), p = 0.01) and a less reaction time prolongation (-66 (-117 to -16) msec, p = 0.02). EPO treatment did not change performance in other measures of cognition. Hypoglycemic symptoms, EEG-changes, and counter-regulatory hormone concentrations did not differ between EPO and placebo treatment. In patients with type 1 diabetes and hypoglycemia unawareness, treatment with EPO is associated with a beneficial effect on cognitive function in a complex reaction time task assessing sustained attention/working memory. Hypoglycemic symptoms and hormonal responses were not changed by EPO treatment. ClinicalTrials.gov NCT00615368.

Atomistic modeling of thermomechanical properties of SWNT/Epoxy nanocomposites

NASA Astrophysics Data System (ADS)

Fasanella, Nicholas; Sundararaghavan, Veera

2015-09-01

Molecular dynamics simulations are performed to compute thermomechanical properties of cured epoxy resins reinforced with pristine and covalently functionalized carbon nanotubes. A DGEBA-DDS epoxy network was built using the ‘dendrimer’ growth approach where 75% of available epoxy sites were cross-linked. The epoxy model is verified through comparisons to experiments, and simulations are performed on nanotube reinforced cross-linked epoxy matrix using the CVFF force field in LAMMPS. Full stiffness matrices and linear coefficient of thermal expansion vectors are obtained for the nanocomposite. Large increases in stiffness and large decreases in thermal expansion were seen along the direction of the nanotube for both nanocomposite systems when compared to neat epoxy. The direction transverse to nanotube saw a 40% increase in stiffness due to covalent functionalization over neat epoxy at 1 K whereas the pristine nanotube system only saw a 7% increase due to van der Waals effects. The functionalized SWNT/epoxy nanocomposite showed an additional 42% decrease in thermal expansion along the nanotube direction when compared to the pristine SWNT/epoxy nanocomposite. The stiffness matrices are rotated over every possible orientation to simulate the effects of an isotropic system of randomly oriented nanotubes in the epoxy. The randomly oriented covalently functionalized SWNT/Epoxy nanocomposites showed substantial improvements over the plain epoxy in terms of higher stiffness (200% increase) and lower thermal expansion (32% reduction). Through MD simulations, we develop means to build simulation cells, perform annealing to reach correct densities, compute thermomechanical properties and compare with experiments.

The Poor Get Richer: Heterogeneity in the Efficacy of a School-Level Intervention for Academic Language

ERIC Educational Resources Information Center

Lawrence, Joshua F.; Francis, David; Paré-Blagoev, Juliana; Snow, Catherine E.

2017-01-01

We investigate the impact of a relatively brief cross-curricular intervention, Word Generation, on middle school students' development of taught academic vocabulary. Students (n = 8382) in forty-four middle schools in three urban districts were randomly assigned to treatment or control conditions. Treatment teachers implemented the program with…

Controlled irrigation of a structured packing as a method for increasing the efficiency of liquid mixture separation in the distillation column

NASA Astrophysics Data System (ADS)

Pavlenko, A. N.; Zhukov, V. E.; Pecherkin, N. I.; Nazarov, A. D.; Li, X.; Li, H.; Gao, X.; Sui, H.

2017-09-01

The use of modern structured packing in the distillation columns allows much more even distribution of the liquid film over the packing surface, but it does not completely solve the problem of uniform distribution of flow parameters over the entire height of the packing. Negative stratification of vapor along the packing height caused by different densities of vapor mixture components and higher temperature in the lower part of the column leads to formation of large-scale maldistributions of temperature and mixture composition over the column cross-section even under the conditions of uniform irrigation of packing with liquid. In these experiments, the idea of compensatory action of liquid distributor on the large-scale maldistribution of mixture composition over the column cross-section was implemented. The experiments were carried out in the distillation column with the diameter of 0.9 m on 10 layers of the Mellapak 350Y packing with the total height of 2.1 m. The mixture of R-21 and R-114 was used as the working mixture. To irrigate the packing, the liquid distributorr with 126 independently controlled solenoid valves overlapping the holes with the diameter of 5 mm, specially designed by the authors, was used. Response of the column to the action of liquid distributor was observed in real time according to the indications of 3 groups of thermometers mounted in 3 different cross-sections of the column. The experiments showed that the minimal correction of the drip point pattern in the controlled liquid distributor can significantly affect the pattern of flow parameter distribution over the cross-section and height of the mass transfer surface and increase separation efficiency of the column within 20%.

Cross-layer protocol design for QoS optimization in real-time wireless sensor networks

NASA Astrophysics Data System (ADS)

Hortos, William S.

2010-04-01

The metrics of quality of service (QoS) for each sensor type in a wireless sensor network can be associated with metrics for multimedia that describe the quality of fused information, e.g., throughput, delay, jitter, packet error rate, information correlation, etc. These QoS metrics are typically set at the highest, or application, layer of the protocol stack to ensure that performance requirements for each type of sensor data are satisfied. Application-layer metrics, in turn, depend on the support of the lower protocol layers: session, transport, network, data link (MAC), and physical. The dependencies of the QoS metrics on the performance of the higher layers of the Open System Interconnection (OSI) reference model of the WSN protocol, together with that of the lower three layers, are the basis for a comprehensive approach to QoS optimization for multiple sensor types in a general WSN model. The cross-layer design accounts for the distributed power consumption along energy-constrained routes and their constituent nodes. Following the author's previous work, the cross-layer interactions in the WSN protocol are represented by a set of concatenated protocol parameters and enabling resource levels. The "best" cross-layer designs to achieve optimal QoS are established by applying the general theory of martingale representations to the parameterized multivariate point processes (MVPPs) for discrete random events occurring in the WSN. Adaptive control of network behavior through the cross-layer design is realized through the parametric factorization of the stochastic conditional rates of the MVPPs. The cross-layer protocol parameters for optimal QoS are determined in terms of solutions to stochastic dynamic programming conditions derived from models of transient flows for heterogeneous sensor data and aggregate information over a finite time horizon. Markov state processes, embedded within the complex combinatorial history of WSN events, are more computationally tractable and lead to simplifications for any simulated or analytical performance evaluations of the cross-layer designs.

Oxytocin administration enhances controlled social cognition in patients with schizophrenia

PubMed Central

Woolley, J.D.; Chuang, B.; Lam, O.; Lai, W.; O’Donovan, A.; Rankin, K.P.; Mathalon, D.H.; Vinogradov, S.

2014-01-01

Summary Background Individuals with schizophrenia have functionally significant deficits in automatic and controlled social cognition, but no currently available pharmacologic treatments reduce these deficits. The neuropeptide oxytocin has multiple prosocial effects when administered intranasally in humans and there is growing interest in its therapeutic potential in schizophrenia. Methods We administered 40 IU of oxytocin and saline placebo intranasally to 29 male subjects with schizophrenia and 31 age-matched, healthy controls in a randomized, double-blind, placebo-controlled, cross-over study. Social cognition was assessed with The Awareness of Social Inference Test (TASIT) and the Reading the Mind in the Eyes Test (RMET). We examined the effects of oxytocin administration on automatic social cognition (the ability to rapidly interpret and understand emotional cues from the voice, face, and body); controlled social cognition (the ability to comprehend indirectly expressed emotions, thoughts, and intentions through complex deliberations over longer time periods); and a control task (the ability to comprehend truthful dialog and perform general task procedures) in individuals with and without schizophrenia using mixed factorial analysis of variance models. Results Patients with schizophrenia showed significant impairments in automatic and controlled social cognition compared to healthy controls, and administration of oxytocin significantly improved their controlled, but not automatic, social cognition, F(1, 58) = 8.75; p = 0.004. Conversely, oxytocin administration had limited effects on social cognition in healthy participants. Patients and controls performed equally well and there were no effects of oxytocin administration on the control task. Discussion Intact social cognitive abilities are associated with better functional outcomes in individuals with schizophrenia. Our data highlight the potentially complex effects of oxytocin on some but not all aspects of social cognition, and support the exploration of intranasal oxytocin as a potential adjunct treatment to improve controlled social cognition in schizophrenia. Published by Elsevier Ltd. PMID:25001961

The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study.

PubMed

Bauersfeld, Stephan P; Kessler, Christian S; Wischnewsky, Manfred; Jaensch, Annette; Steckhan, Nico; Stange, Rainer; Kunz, Barbara; Brückner, Barbara; Sehouli, Jalid; Michalsen, Andreas

2018-04-27

This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A;n = 18) or vice versa (group B;n = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. This trial was registered at clinicaltrials.gov: NCT01954836 .

The acute effects of graded physiological strain on soccer kicking performance: a randomized, controlled cross-over study.

PubMed

Radman, Ivan; Wessner, Barbara; Bachl, Norbert; Ruzic, Lana; Hackl, Markus; Prpic, Tomislav; Markovic, Goran

2016-02-01

The aim of the present study was to examine the acute effects of graded physiological strain on soccer kicking performance. Twenty-eight semi-professional soccer players completed both experimental and control procedure. The experimental protocol incorporated repeated shooting trials combined with a progressive discontinuous maximal shuttle-run intervention. The initial running velocity was 8 km/h and increasing for 1 km/h every 3 min until exhaustion. The control protocol comprised only eight subsequent shooting trials. The soccer-specific kicking accuracy (KA; average distance from the ball-entry point to the goal center), kicking velocity (KV), and kicking quality (KQ; kicking accuracy divided by the time elapsed from hitting the ball to the point of entry) were evaluated via reproducible and valid test over five individually determined exercise intensity zones. Compared with baseline or exercise at intensities below the second lactate threshold (LT2), physiological exertion above the LT2 (blood lactate > 4 mmol/L) resulted in meaningful decrease in KA (11-13%; p < 0.05), KV (3-4%; p < 0.05), and overall KQ (13-15%; p < 0.01). The light and moderate-intensity exercise below the LT2 had no significant effect on soccer kicking performance. The results suggest that high-intensity physiological exertion above the player's LT2 impairs soccer kicking performance. In contrast, light to moderate physiological stress appears to be neither harmful nor beneficial for kicking performance.

PyCCF: Python Cross Correlation Function for reverberation mapping studies

NASA Astrophysics Data System (ADS)

Sun, Mouyuan; Grier, C. J.; Peterson, B. M.

2018-05-01

PyCCF emulates a Fortran program written by B. Peterson for use with reverberation mapping. The code cross correlates two light curves that are unevenly sampled using linear interpolation and measures the peak and centroid of the cross-correlation function. In addition, it is possible to run Monto Carlo iterations using flux randomization and random subset selection (RSS) to produce cross-correlation centroid distributions to estimate the uncertainties in the cross correlation results.

Experimental investigation of a new device to control the asymmetric flowfield on forebodies at large angles of attack

NASA Technical Reports Server (NTRS)

Moskovitz, Cary A.; Hall, Robert M.; Dejarnette, F. R.

1990-01-01

An exploratory experimental investigation of a new device to control the asymmetric flowfield on forebodies at large angles of attack has been conducted. The device is a rotatable forebody tip, which varies in cross section from circular at its base to elliptic at its tip. The device itself extends over a small portion of the aircraft or missile forebody. The device provides two important improvements. First, it replaced the normally random behavior of the nose side force as a function of nose tip orientation with a predictable and generally sinusoidal distribution and, second, the device showed promise for use as part of a vehicle control system, to be deflected in a prescribed manner to provide additional directional control for the vehicle. The device was tested on a cone/cylinder model having a 10 deg semiapex angle and on a 3.0 caliber tangent ogive model, each with a base diameter of 3.5 in, for angles of attack from 30 to 60 deg. Data were taken from 3 circumferential rows of pressure taps on each model at a Reynolds number of 84,000 based on cylinder diameter and by a helium-bubble flow visualization technique at a Reynolds number of 24,000.

Sustainability of a water, sanitation and hygiene education project in rural Bangladesh: a 5-year follow-up.

PubMed Central

Hoque, B. A.; Juncker, T.; Sack, R. B.; Ali, M.; Aziz, K. M.

1996-01-01

An integrated water supply, sanitation and hygiene (WSH) education intervention project was run by the International Centre for Diarrhoeal Disease Research, Bangladesh, over the period 1983-87. In the intervention area the project provided handpumps, pit latrines, and hygiene education to about 800 households. The control population did not receive any interventions, but had access to the usual government and private WSH facilities. After 1987 no external support was provided to maintain these provisions. A cross-sectional follow-up survey, which was carried out in 1992, involved about 500 randomly selected households from the intervention and control areas. In 1992 about 82% of the pumps were still in good functional condition and of these, 94% had been functioning well in 1987. Fewer latrines were functional in 1992 (64%) than at the end of 1987 (93%). In the former intervention area about 84% of the adults were using sanitary latrines in 1992 compared with only 7% in the control area. Knowledge related to disease transmission, however, was poor and similar in both areas. People claimed that they used the WSH facilities to improve the quality of their lives. The prevalence of diarrhoeal diseases in the 1992 survey among the control population was about twice that among those in the intervention area. PMID:8823966

Randomized controlled open-label trial of vitamin E-bonded polysulfone dialyzer and erythropoiesis-stimulating agent response.

PubMed

Sanaka, Tsutomu; Mochizuki, Takahiro; Kinugasa, Eriko; Kusano, Eiji; Ohwada, Shigeru; Kuno, Tsutomu; Kojima, Kenichiro; Kobayashi, Shuzo; Satoh, Minoru; Shimada, Noriaki; Nakao, Kazushi; Nakazawa, Ryoichi; Nishimura, Hideki; Noiri, Eisei; Shigematsu, Takashi; Tomo, Tadashi; Maeda, Teiryo

2013-06-01

A 1-year multicenter prospective randomized controlled study was conducted on the effects of vitamin E-bonded polysulfone dialyzers on erythropoiesis-stimulating agent response in hemodialysis patients. Major inclusion criteria were use of high-flux polysulfone dialyzers with 50-70 ml/min β2-microglobulin clearance over 3 months, transferrin saturation over 20%, same erythropoiesis-stimulating agent for over 3 months, and hemoglobin at 10-12 g/dl. Hemodialysis patients were placed in four interventional groups: two hemoglobin ranges (10.0-10.9 or 11.0-11.9 g/dl) and two dialyzers. Patients were randomly assigned by central registration to a vitamin E-bonded polysulfone dialyzers or polysulfone control group. Primary end point was relative erythropoiesis resistance index at baseline between groups at 12 months. Erythropoiesis resistance index was defined as total weekly erythropoiesis-stimulating agent dose divided by hemoglobin. There were no statistically significant differences in age or sex. There was no significant difference in relative erythropoiesis resistance index between vitamin E-bonded polysulfone dialyzers and control groups at 12 months (vitamin E-bonded polysulfone dialyzers: 1.1, control: 1.3). The vitamin E-bonded polysulfone dialyzers group showed better relative erythropoiesis resistance index than the control group at 11.0-11.9 g/dl hemoglobin (vitamin E-bonded polysulfone dialyzers: 1.0, control: 1.4 at 12 months, significant difference) but no difference at 10.0-10.9 g/dl hemoglobin. The overall relative erythropoiesis resistance index showed no difference between the vitamin E-bonded polysulfone dialyzers and control groups, although the change in relative erythropoiesis resistance index differed according to hemoglobin level.

Randomized Controlled Open-Label Trial of Vitamin E-Bonded Polysulfone Dialyzer and Erythropoiesis-Stimulating Agent Response

PubMed Central

Mochizuki, Takahiro; Kinugasa, Eriko; Kusano, Eiji; Ohwada, Shigeru; Kuno, Tsutomu; Kojima, Kenichiro; Kobayashi, Shuzo; Satoh, Minoru; Shimada, Noriaki; Nakao, Kazushi; Nakazawa, Ryoichi; Nishimura, Hideki; Noiri, Eisei; Shigematsu, Takashi; Tomo, Tadashi; Maeda, Teiryo

2013-01-01

Summary Background and objectives A 1-year multicenter prospective randomized controlled study was conducted on the effects of vitamin E-bonded polysulfone dialyzers on erythropoiesis-stimulating agent response in hemodialysis patients. Design, setting, participants, & measurements Major inclusion criteria were use of high-flux polysulfone dialyzers with 50–70 ml/min β2-microglobulin clearance over 3 months, transferrin saturation over 20%, same erythropoiesis-stimulating agent for over 3 months, and hemoglobin at 10–12 g/dl. Hemodialysis patients were placed in four interventional groups: two hemoglobin ranges (10.0–10.9 or 11.0–11.9 g/dl) and two dialyzers. Patients were randomly assigned by central registration to a vitamin E-bonded polysulfone dialyzers or polysulfone control group. Primary end point was relative erythropoiesis resistance index at baseline between groups at 12 months. Erythropoiesis resistance index was defined as total weekly erythropoiesis-stimulating agent dose divided by hemoglobin. Results There were no statistically significant differences in age or sex. There was no significant difference in relative erythropoiesis resistance index between vitamin E-bonded polysulfone dialyzers and control groups at 12 months (vitamin E-bonded polysulfone dialyzers: 1.1, control: 1.3). The vitamin E-bonded polysulfone dialyzers group showed better relative erythropoiesis resistance index than the control group at 11.0–11.9 g/dl hemoglobin (vitamin E-bonded polysulfone dialyzers: 1.0, control: 1.4 at 12 months, significant difference) but no difference at 10.0–10.9 g/dl hemoglobin. Conclusions The overall relative erythropoiesis resistance index showed no difference between the vitamin E-bonded polysulfone dialyzers and control groups, although the change in relative erythropoiesis resistance index differed according to hemoglobin level. PMID:23599410

Social marketing and student documentation of asthma care: a quasi-randomized controlled trial.

PubMed

Gimbel, Ronald W; Olsen, Cara H; Williams, Pamela M; Stephens, Mark B

2012-02-01

The study's objective was to determine the effectiveness of a social marketing intervention in influencing use of a targeted electronic medical record (EMR) template to document a standard asthma encounter. This quasi-randomized controlled trial used intervention groups exposed to an educational workshop on EMR documentation with embedded social marketing messages aimed at persuading behavior. Conducted in July 2009 to June 2010, participants in the study included third-year medical students. The primary outcome was the number of participants using a target EMR template. (Clinicaltrials.gov identifier: NCT01043113). A total of 155 participants randomized across eight clusters. Following the workshop, intervention groups were more likely to use the target asthma template than the control group (PR 3.97, 95% CI=1.34--11.79). At slightly over 30 days following the workshop, the intervention group continued to use the asthma template more often than the control group (PR 2.40, 95% CI=1.10--5.21). Stratifying by gender, intervention group females used the asthma template more after the interventions than control group females (PR 10.79, 95% CI=1.18--64.27). In follow-up at slightly over 30 days after the intervention, intervention group female participant asthma template use continued to be used more than control group females (PR 2.82, 95% CI=1.58--5.02). There were no significant differences in group use of asthma template use by intervention group males immediately after the intervention compared to control group males (PR 2.55, 95% CI=0.80--8.14) or similarly at slightly over 30 day follow-up (PR 2.18, 95% CI=0.74-6.42). Social marketing can effectively influence medical student use of EMR templates for clinical documentation in a controlled setting.

Calcium ketoglutarate versus calcium acetate for treatment of hyperphosphataemia in patients on maintenance haemodialysis: a cross-over study.

PubMed

Birck, R; Zimmermann, E; Wassmer, S; Nowack, R; van der Woude, F J

1999-06-01

Since dietary restrictions and phosphorus removal by haemodialysis (HD) are not sufficient to control serum phosphate (s-phosphate) levels in dialysis patients the use of oral phosphate binders is mandatory. Calcium ketoglutarate (CaKE) is an analogue of glutamic acid exerting phosphate binding properties. Therefore we compared this substance to calcium acetate (CaAC) in a 24-weeks open cross-over trial in 28 maintenance HD patients. Medications and HD prescriptions were kept unchanged during the trial. Following 2 weeks of withdrawal of phosphate binders, patients were randomly assigned to one of the calcium salts for 12 weeks; after a second withdrawal of 2 weeks, all patients were shifted to the other treatment for another 12 weeks. All patients received equimolar doses of CaKE and CaAC with respect to the amount of prescribed elemental calcium. Treatment with CaAC and CaKE significantly reduced s-phosphate levels after 4 weeks (CaAC 1.95+/-0.6 vs. 2.4+/-0.53 mmol/l, P = 0.004; CaKE 1.95+/-0.4 vs. 2.47+/-0.63 mmol/l, P = 0.0001) reaching a virtually stable plateau over the remaining observation time without significant differences between the groups. The incidence of hypercalcaemia defined as a serum calcium level > or =2.8 mmol/l was significantly higher in CaAC than in CaKE treated patients (n = 8 vs. n = 1, P = 0.03). There were no significant differences in serum intact parathyroid hormone (PTH) bicarbonate, albumin or calcitriol levels between the groups after 12 weeks treatment. We conclude that CaKE is as effective as CaAC for treatment of hyperphosphataemia in chronic HD patients and may be particularly helpful in patients who are prone to develop hypercalcaemia.

Thermally Cross-Linked Anion Exchange Membranes from Solvent Processable Isoprene Containing Ionomers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tsai, Tsung-Han; Ertem, S. Piril; Maes, Ashley M.

2015-01-28

Random copolymers of isoprene and 4-vinylbenzyl chloride (VBCl) with varying compositions were synthesized via nitroxide-mediated polymerization. Subsequent quaternization afforded solvent processable and cross-linkable ionomers with a wide range of ion exchange capacities (IECs). Solution cast membranes were thermally cross-linked to form anion exchange membranes. Cross-linking was achieved by taking advantage of the unsaturations on the polyisoprene backbone, without added cross-linkers. A strong correlation was found between water uptake and ion conductivity of the membranes: conductivities of the membranes with IECs beyond a critical value were found to be constant related to their high water absorption. Environmentally controlled small-angle X-ray scatteringmore » experiments revealed a correlation between the average distance between ionic clusters and the ion conductivity, indicating that a well-connected network of ion clusters is necessary for efficient ion conduction and high ion conductivity.« less

Economic Evaluation of an Area-Wide Integrated Pest Management Program to Control the Asian Tiger Mosquito in New Jersey

PubMed Central

Shepard, Donald S.; Halasa, Yara A.; Fonseca, Dina M.; Farajollahi, Ary; Healy, Sean P.; Gaugler, Randy; Bartlett-Healy, Kristen; Strickman, Daniel A.; Clark, Gary G.

2014-01-01

Aedes albopictus is the most invasive mosquito in the world, an important disease vector, and a biting nuisance that limits outdoor activities. Area-wide integrated pest management (AW-IPM) is the recommended control strategy. We conducted an economic evaluation of the AW-IPM project in Mercer and Monmouth Counties, New Jersey with a controlled design (AW-IPM vs. control) from 2009 through 2011. The study analyzed financial documents and staff time for AW-IPM and surveyed an average of 415 randomly chosen households in AW-IPM and control areas each fall from 2008 through 2011. Hours lost from yard and porch activities were calculated as differences between actual and potential hours of these activities in an average summer week if there had been no mosquito concerns. Net estimated benefits of AW-IPM were based on cross-over and difference-in-difference analyses. Reductions in hours lost were valued based on respondents' willingness to pay for a hypothetical extra hour free of mosquitoes spent on yard or porch activities and literature on valuation of a quality adjusted life year (QALY). The incremental cost of AW-IPM per adult was $41.18 per year. Number of hours lost due to mosquitoes in AW-IPM areas between the base year (2008) and the intervention years (2009-2011) declined by 3.30 hours per summer week in AW-IPM areas compared to control areas. Survey respondents valued this improvement at $27.37 per adult per summer week. Over the 13-week summer, an average adult resident gained 42.96 hours of yard and porch time, worth $355.82. The net benefit over the summer was $314.63. With an average of 0.0027 QALYs gained per adult per year, AW-IPM was cost effective at $15,300 per QALY gained. The benefit-cost ratio from hours gained was 8.64, indicating that each $1 spent on AW-IPM gave adults additional porch and yard time worth over $8. PMID:25338065

Work time control and sleep disturbances: prospective cohort study of Finnish public sector employees.

PubMed

Salo, Paula; Ala-Mursula, Leena; Rod, Naja Hulvej; Tucker, Philip; Pentti, Jaana; Kivimäki, Mika; Vahtera, Jussi

2014-07-01

Employee control over work times has been associated with favorable psychosocial and health-related outcomes, but the evidence regarding sleep quality remains inconclusive. We examined cross-sectional and prospective associations between work time control and sleep disturbances in a large working population, taking into account total hours worked. The data were from a full-panel longitudinal cohort study of Finnish public sector employees who responded to questions on work time control and sleep disturbances in years 2000-2001, 2004-2005, 2008-2009, and 2012. The analysis of cross-sectional associations was based on 129,286 person measurements from 68,089 participants (77% women) aged 17-73 years (mean 43.1). Data from 16,503 participants were used in the longitudinal analysis. Log-binomial regression analysis with the generalized estimating equations method was used. Consistently in both cross-sectional and longitudinal models, less control over work time was associated with greater sleep disturbances in the total population and among those working normal 40-hour weeks. Among participants working more than 40 hours a week, work time that was both very high (cross-sectional prevalence ratio compared to intermediate work time control [PR] 1.32, 95% confidence interval [CI] 1.05-1.65) and very low (PR 1.23, 95% CI 1.08-1.39) was associated with sleep disturbances, after adjustment for potential confounding factors. These data suggest that having few opportunities to influence the duration and positioning of work time may increase the risk of sleep disturbances among employees. For persons working long hours, very high levels of control over working times were also associated with increased risk of sleep disturbances. Salo P, Ala-Mursula L, Rod NH, Tucker P, Pentti J, Kivimäki M, Vahtera J. Work time control and sleep disturbances: prospective cohort study of Finnish public sector employees. SLEEP 2014;37(7):1217-1225.

Work Time Control and Sleep Disturbances: Prospective Cohort Study of Finnish Public Sector Employees

PubMed Central

Salo, Paula; Ala-Mursula, Leena; Rod, Naja Hulvej; Tucker, Philip; Pentti, Jaana; Kivimäki, Mika; Vahtera, Jussi

2014-01-01

Objectives: Employee control over work times has been associated with favorable psychosocial and health-related outcomes, but the evidence regarding sleep quality remains inconclusive. We examined cross-sectional and prospective associations between work time control and sleep disturbances in a large working population, taking into account total hours worked. Methods: The data were from a full-panel longitudinal cohort study of Finnish public sector employees who responded to questions on work time control and sleep disturbances in years 2000-2001, 2004-2005, 2008-2009, and 2012. The analysis of cross-sectional associations was based on 129,286 person measurements from 68,089 participants (77% women) aged 17-73 years (mean 43.1). Data from 16,503 participants were used in the longitudinal analysis. Log-binomial regression analysis with the generalized estimating equations method was used. Results: Consistently in both cross-sectional and longitudinal models, less control over work time was associated with greater sleep disturbances in the total population and among those working normal 40-hour weeks. Among participants working more than 40 hours a week, work time that was both very high (cross-sectional prevalence ratio compared to intermediate work time control [PR] 1.32, 95% confidence interval [CI] 1.05-1.65) and very low (PR 1.23, 95% CI 1.08-1.39) was associated with sleep disturbances, after adjustment for potential confounding factors. Conclusions: These data suggest that having few opportunities to influence the duration and positioning of work time may increase the risk of sleep disturbances among employees. For persons working long hours, very high levels of control over working times were also associated with increased risk of sleep disturbances. Citation: Salo P, Ala-Mursula L, Rod NH, Tucker P, Pentti J, Kivimäki M, Vahtera J. Work time control and sleep disturbances: prospective cohort study of Finnish public sector employees. SLEEP 2014;37(7):1217-1225. PMID:25061250

Arterial blood pressure responses to short-term exposure to fine and ultrafine particles from indoor sources - A randomized sham-controlled exposure study of healthy volunteers.

PubMed

Soppa, Vanessa J; Schins, Roel P F; Hennig, Frauke; Nieuwenhuijsen, Mark J; Hellack, Bryan; Quass, Ulrich; Kaminski, Heinz; Sasse, Birgitta; Shinnawi, Samir; Kuhlbusch, Thomas A J; Hoffmann, Barbara

2017-10-01

Particulate air pollution is linked to adverse cardiovascular effects. The aim of the study was to investigate the effect of short-term exposure to indoor particles on blood pressure (BP). We analyzed the association of particle emissions from indoor sources (candle burning, toasting bread, frying sausages) with BP changes in 54 healthy volunteers in a randomized cross-over controlled exposure study. Particle mass concentration (PMC), size-specific particle number concentration (PNC) and lung-deposited particle surface area concentration (PSC) were measured during the 2h exposure. Systolic and diastolic blood pressure were measured before, during, directly, 2, 4 and 24h after exposure. We performed multiple mixed linear regression analyses of different particle metrics and BP. BP significantly increased with increasing PMC, PSC and PNC resulting from toasting bread. For example, an increase per 10µg/m 3 PM 10 and PM 2.5 , systolic BP increased at all time points with largest changes 1h after exposure initiation of 1.5mmHg (95%-CI: 1.1; 1.9) and of 2.2mmHg (95%-CI: 1.3; 3.1), respectively. Our study suggests an association of short-term exposure to fine and ultrafine particles emitted from toasting bread with increases in BP. Particles emitted from frying sausages and candle burning did not consistently affect BP. Copyright © 2017. Published by Elsevier Inc.

The Effects of Supplementation with a Vitamin and Mineral Complex with Guaraná Prior to Fasted Exercise on Affect, Exertion, Cognitive Performance, and Substrate Metabolism: A Randomized Controlled Trial.

PubMed

Veasey, Rachel C; Haskell-Ramsay, Crystal F; Kennedy, David O; Wishart, Karl; Maggini, Silvia; Fuchs, Caspar J; Stevenson, Emma J

2015-07-27

Exercise undertaken in a fasted state can lead to higher post-exercise mental fatigue. The administration of a vitamin and mineral complex with guaraná (MVM + G) has been shown to attenuate mental fatigue and improve performance during cognitively demanding tasks. This placebo-controlled, double-blind, randomized, balanced cross-over study examined the effect of MVM + G consumed prior to morning exercise on cognitive performance, affect, exertion, and substrate metabolism. Forty active males (age 21.4 ± 3.0 year; body mass index (BMI) 24.0 ± 2.4 kg/m2; maximal oxygen consumption (V̇O2max) 57.6 ± 7.3 mL/min/kg) completed two main trials, consuming either MVM + G or placebo prior to a 30-min run at 60% V̇O2max. Supplementation prior to exercise led to a small but significant reduction in Rating of Perceived Exertion (RPE) during exercise compared to the placebo. The MVM + G combination also led to significantly increased accuracy of numeric working memory and increased speed of picture recognition, compared to the placebo. There were no significant effects of supplementation on any other cognitive or mood measures or on substrate metabolism during exercise. These findings demonstrate that consuming a vitamin and mineral complex containing guaraná, prior to exercise, can positively impact subsequent memory performance and reduce perceived exertion during a moderate-intensity run in active males.

Consumption of cranberry beverage improved endogenous antioxidant status and protected against bacteria adhesion in healthy humans: a randomized controlled trial.

PubMed

Mathison, Bridget D; Kimble, Lindsey L; Kaspar, Kerrie L; Khoo, Christina; Chew, Boon P

2014-05-01

Consumption of polyphenol-rich foods is associated with lower risk from many chronic diseases. We hypothesized that a single dose of cranberry beverage would improve indices of oxidative stress, inflammation, and urinary antibacterial adhesion activity in healthy humans. Six males and 6 females (18-35 years; body mass index, 19-25 kg/m(2)) consumed placebo, cranberry leaf extract beverage, or low-calorie cranberry juice cocktail (LCJC) once in a randomized, double-blind, placebo-controlled cross-over experimental design trial. The washout period between beverages was 1 week. Blood was collected 0, 2, 4, 8, and 24 hours after beverage consumption for measuring oxidative and inflammatory biomarkers. Urine was collected at 0, 0 to 3, 3 to 6, 6 to 9, 9 to 12, and 24 hours postintervention to assess antibacterial adhesion activity. Consumption of cranberry leaf extract beverage elevated (P < .05) blood glutathione peroxidase activity, whereas LCJC consumption increased (P < .05) glutathione concentrations and superoxide dismutase activity compared with placebo. Cranberry leaf extract beverage and LCJC consumption had no effect on the inflammatory biomarkers measured as compared with placebo. At 0 to 3 hours postconsumption, urine from participants who consumed cranberry beverages had higher (P < .05) ex vivo antiadhesion activity against P-fimbriated Escherichia coli compared with placebo. An acute dose of cranberry beverages improved biomarkers of antioxidant status and inhibition of bacterial adhesion in urine. Copyright © 2014 Elsevier Inc. All rights reserved.

Respiratory Effects of Fine and Ultrafine Particles from Indoor Sources—A Randomized Sham-Controlled Exposure Study of Healthy Volunteers

PubMed Central

Soppa, Vanessa J.; Schins, Roel P. F.; Hennig, Frauke; Hellack, Bryan; Quass, Ulrich; Kaminski, Heinz; Kuhlbusch, Thomas A. J.; Hoffmann, Barbara; Weinmayr, Gudrun

2014-01-01

Particulate air pollution is linked to impaired respiratory health. We analyzed particle emissions from common indoor sources (candles burning (CB), toasting bread (TB), frying sausages (FS)) and lung function in 55 healthy volunteers (mean age 33.0 years) in a randomized cross-over controlled exposure study. Lung-deposited particle surface area concentration (PSC), size-specific particle number concentration (PNC) up to 10 µm, and particle mass concentration (PMC) of PM1, PM2.5 and PM10 were determined during exposure (2 h). FEV1, FVC and MEF25%–75% was measured before, 4 h and 24 h after exposure. Wilcoxon-rank sum tests (comparing exposure scenarios) and mixed linear regression using particle concentrations and adjusting for personal characteristics, travel time and transportation means before exposure sessions were performed. While no effect was seen comparing the exposure scenarios and in the unadjusted model, inverse associations were found for PMC from CB and FS in relation to FEV1 and MEF25%–75%. with a change in 10 µg/m3 in PM2.5 from CB being associated with a change in FEV1 of −19 mL (95%-confidence interval:−43; 5) after 4 h. PMC from TB and PNC of UFP were not associated with lung function changes, but PSC from CB was. Elevated indoor fine particles from certain sources may be associated with small decreases in lung function in healthy adults. PMID:25000149

The Effects of Supplementation with a Vitamin and Mineral Complex with Guaraná Prior to Fasted Exercise on Affect, Exertion, Cognitive Performance, and Substrate Metabolism: A Randomized Controlled Trial

PubMed Central

Veasey, Rachel C.; Haskell-Ramsay, Crystal F.; Kennedy, David O.; Wishart, Karl; Maggini, Silvia; Fuchs, Caspar J.; Stevenson, Emma J.

2015-01-01

Exercise undertaken in a fasted state can lead to higher post-exercise mental fatigue. The administration of a vitamin and mineral complex with guaraná (MVM + G) has been shown to attenuate mental fatigue and improve performance during cognitively demanding tasks. This placebo-controlled, double-blind, randomized, balanced cross-over study examined the effect of MVM + G consumed prior to morning exercise on cognitive performance, affect, exertion, and substrate metabolism. Forty active males (age 21.4 ± 3.0 year; body mass index (BMI) 24.0 ± 2.4 kg/m2; maximal oxygen consumption (V̇O2max) 57.6 ± 7.3 mL/min/kg) completed two main trials, consuming either MVM + G or placebo prior to a 30-min run at 60% V̇O2max. Supplementation prior to exercise led to a small but significant reduction in Rating of Perceived Exertion (RPE) during exercise compared to the placebo. The MVM + G combination also led to significantly increased accuracy of numeric working memory and increased speed of picture recognition, compared to the placebo. There were no significant effects of supplementation on any other cognitive or mood measures or on substrate metabolism during exercise. These findings demonstrate that consuming a vitamin and mineral complex containing guaraná, prior to exercise, can positively impact subsequent memory performance and reduce perceived exertion during a moderate-intensity run in active males. PMID:26225993

Black Tea Increases Circulating Endothelial Progenitor Cells and Improves Flow Mediated Dilatation Counteracting Deleterious Effects from a Fat Load in Hypertensive Patients: A Randomized Controlled Study

PubMed Central

Grassi, Davide; Draijer, Richard; Schalkwijk, Casper; Desideri, Giovambattista; D’Angeli, Anatolia; Francavilla, Sandro; Mulder, Theo; Ferri, Claudio

2016-01-01

(1) Background: Endothelial dysfunction predicts cardiovascular events. Circulating angiogenic cells (CACs) maintain and repair the endothelium regulating its function. Tea flavonoids reduce cardiovascular risk. We investigated the effects of black tea on the number of CACs and on flow-mediated dilation (FMD) before and after an oral fat in hypertensives; (2) Methods: In a randomized, double-blind, controlled, cross-over study, 19 patients were assigned to black tea (150 mg polyphenols) or a placebo twice a day for eight days. Measurements were obtained in a fasted state and after consuming whipping cream, and FMD was measured at baseline and after consumption of the products; (3) Results: Compared with the placebo, black tea ingestion increased functionally active CACs (36 ± 22 vs. 56 ± 21 cells per high-power field; p = 0.006) and FMD (5.0% ± 0.3% vs. 6.6% ± 0.3%, p < 0.0001). Tea further increased FMD 1, 2, 3, and 4 h after consumption, with maximal response 2 h after intake (p < 0.0001). Fat challenge decreased FMD, while tea consumption counteracted FMD impairment (p < 0.0001); (4) Conclusions: We demonstrated the vascular protective properties of black tea by increasing the number of CACs and preventing endothelial dysfunction induced by acute oral fat load in hypertensive patients. Considering that tea is the most consumed beverage after water, our findings are of clinical relevance and interest. PMID:27854314

Intervention-Based Stochastic Disease Eradication

NASA Astrophysics Data System (ADS)

Billings, Lora; Mier-Y-Teran-Romero, Luis; Lindley, Brandon; Schwartz, Ira

2013-03-01

Disease control is of paramount importance in public health with infectious disease extinction as the ultimate goal. Intervention controls, such as vaccination of susceptible individuals and/or treatment of infectives, are typically based on a deterministic schedule, such as periodically vaccinating susceptible children based on school calendars. In reality, however, such policies are administered as a random process, while still possessing a mean period. Here, we consider the effect of randomly distributed intervention as disease control on large finite populations. We show explicitly how intervention control, based on mean period and treatment fraction, modulates the average extinction times as a function of population size and the speed of infection. In particular, our results show an exponential improvement in extinction times even though the controls are implemented using a random Poisson distribution. Finally, we discover those parameter regimes where random treatment yields an exponential improvement in extinction times over the application of strictly periodic intervention. The implication of our results is discussed in light of the availability of limited resources for control. Supported by the National Institute of General Medical Sciences Award No. R01GM090204

Comparing the Psychometric Properties of Two Physical Activity Self-Efficacy Instruments in Urban, Adolescent Girls: Validity, Measurement Invariance, and Reliability

PubMed Central

Voskuil, Vicki R.; Pierce, Steven J.; Robbins, Lorraine B.

2017-01-01

Aims: This study compared the psychometric properties of two self-efficacy instruments related to physical activity. Factorial validity, cross-group and longitudinal invariance, and composite reliability were examined. Methods: Secondary analysis was conducted on data from a group randomized controlled trial investigating the effect of a 17-week intervention on increasing moderate to vigorous physical activity among 5th–8th grade girls (N = 1,012). Participants completed a 6-item Physical Activity Self-Efficacy Scale (PASE) and a 7-item Self-Efficacy for Exercise Behaviors Scale (SEEB) at baseline and post-intervention. Confirmatory factor analyses for intervention and control groups were conducted with Mplus Version 7.4 using robust weighted least squares estimation. Model fit was evaluated with the chi-square index, comparative fit index, and root mean square error of approximation. Composite reliability for latent factors with ordinal indicators was computed from Mplus output using SAS 9.3. Results: Mean age of the girls was 12.2 years (SD = 0.96). One-third of the girls were obese. Girls represented a diverse sample with over 50% indicating black race and an additional 19% identifying as mixed or other race. Both instruments demonstrated configural invariance for simultaneous analysis of cross-group and longitudinal invariance based on alternative fit indices. However, simultaneous metric invariance was not met for the PASE or the SEEB instruments. Partial metric invariance for the simultaneous analysis was achieved for the PASE with one factor loading identified as non-invariant. Partial metric invariance was not met for the SEEB. Longitudinal scalar invariance was achieved for both instruments in the control group but not the intervention group. Composite reliability for the PASE ranged from 0.772 to 0.842. Reliability for the SEEB ranged from 0.719 to 0.800 indicating higher reliability for the PASE. Reliability was more stable over time in the control group for both instruments. Conclusions: Results suggest that the intervention influenced how girls responded to indicator items. Neither of the instruments achieved simultaneous metric invariance making it difficult to assess mean differences in PA self-efficacy between groups. PMID:28824487

Effect of transcutaneous electrical nerve stimulation for pain control after total knee arthroplasty: A systematic review and meta-analysis.

PubMed

Zhu, Yongjun; Feng, Yuxing; Peng, Lihua

2017-11-21

Transcutaneous electrical nerve stimulation is a possible adjunctive therapy to pharmacological treatment for controlling pain after total knee arthroplasty. However, the results are controversial. A systematic review and meta-analysis was conducted to explore the effect of transcutaneous electrical nerve stimulation on patients with total knee arthroplasty. PubMed, Embase, Web of Science, EBSCO, and Cochrane Library databases were searched systematically. Randomized controlled trials assessing the effect of transcutaneous electrical nerve stimulation on patients with total knee arthroplasty were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. Primary outcome was visual analogue scale (VAS) score over a period of 24 h. Meta-analysis was performed using a random-effect model. Six randomized controlled trials involving 529 patients were included in the meta-analysis. Overall, compared with control intervention, transcutaneous electrical nerve stimulation supplementation intervention was found to significantly reduce VAS scores and total postoperative morphine dose over a period of 24 h, and to improve active range of knee motion (standard mean difference (SMD) = 0.37; 95% confidence interval (95% CI) = 0.06-0.68; p = 0.02), but had no effect on VAS scores at 2 weeks (SMD = 0.20; 95% CI = -0.07 to 0.48; p = 0.15). Compared with control intervention, transcutaneous electrical nerve stimulation supplementation intervention was found to significantly reduce pain and morphine requirement over a period of 24 h and to promote functional recovery in patients who have undergone total knee arthroplasty.

AcrySof Natural SN60AT versus AcrySof SA60AT intraocular lens in patients with color vision defects.

PubMed

Raj, Shetal M; Vasavada, Abhay R; Nanavaty, Mayank A

2005-12-01

To determine whether implantation of the AcrySof Natural intraocular lens (IOL) worsened the severity of existing color deficit in congenital partial red-green color deficient individuals (CPRG). A prospective controlled randomized double-masked analysis of 30 consecutive patients with CPRG defect and bilateral cataracts received a Natural IOL (test group) in 1 eye and a single-piece AcrySof IOL (control group) in the other eye. Patients were tested unilaterally to detect CPRG defect using Ishihara pseudoisochromatic plates and the Farnsworth D-15 test. Plates 1 to 21 measured the Ishihara error score; plates 22 to 25 indicated severity of defect based on clarity of both numerals as partial mild/moderate (both visible), partial severe defect (only 1 visible). The D-15 test is based on number of diametrical crossings on the circular diagram; severity is graded as mild (1 crossing), moderate (2 crossings), or severe (>2 crossings). Tests were performed before and after IOL implantation at 1, 3, and 6 months. At mean follow-up of 6.13 months +/- 1.2 (SD), analysis of variance test judged the difference in error scores and cross tabulation represented change in number of diametrical crossings. The mean age was 62.3 +/- 8.5 years. All patients were men. Before IOL implantation, all patients had moderate CPRG defect on both tests. The Ishihara error score in the test and control groups did not reveal statistically significant differences (P = .505 and P = .119, respectively). With D-15, none of the patients in the test or control group showed >2 crossings. The implantation of AcrySof Natural IOL did not worsen the preexisting severity of color defect in CPRG individuals.

A randomized, controlled clinical trial of intravenous lipid emulsion as an adjunctive treatment for permethrin toxicosis in cats.

PubMed

Peacock, Rachel E; Hosgood, Giselle; Swindells, Katrin L; Smart, Lisa

2015-01-01

To assess for any clinical benefit of intravenous lipid emulsion (ILE) for permethrin toxicosis in cats by comparing the progression of clinical signs of cats before and after treatment with ILE to cats treated with a saline control. To accomplish this objective, a clinical staging system for cats with permethrin toxicosis was developed and validated. Prospective, multicenter, randomized, controlled clinical trial. University veterinary teaching hospital and 12 private veterinary emergency hospitals. Thirty-four client-owned cats with permethrin toxicosis. A clinical staging system was designed based on abnormalities found on physical examination of cats with permethrin toxicosis. The clinical staging system had 6 stages, ranging from Stage A for cats with no abnormalities to Stage F for cats with grand mal seizures. The system was validated for intraviewer and interviewer variability. Cats in the clinical trial were randomized to receive 15 mL/kg of either intravenous 0.9% saline (control) or 20% ILE over 60 minutes. For each cat, a clinical stage was recorded at set time points before and after the randomized treatment was administered. The distribution of clinical stage stratified over time was compared across treatment groups. The clinical staging system showed excellent repeatability (P = 1.0) and reliability (P = 1.0). In the clinical trial, there was a significant difference in the distribution of clinical stages over time (P < 0.001) and from presentation stage to Stage B (P = 0.006), with ILE-treated cats (n = 20) having lower clinical stages earlier than control cats (n = 14). There was no significant difference in signalment, body weight, or supportive treatment between the groups. The clinical staging system was repeatable and reliable. Clinical stages of permethrin toxicosis in ILE-treated cats improved earlier compared to control cats, suggesting ILE may be a useful adjunctive therapy in the treatment of permethrin toxicosis in cats. © Veterinary Emergency and Critical Care Society 2015.

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

PubMed Central

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

2014-01-01

Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

Supplemental Reading Strategy Instruction for Adolescents: A Randomized Trial and Follow-up Study

ERIC Educational Resources Information Center

Cantrell, Susan Chambers; Almasi, Janice F.; Rintamaa, Margaret; Carter, Janis C.

2016-01-01

In this study, the authors examine the impact of a yearlong supplemental reading course involving daily instruction in the learning strategies curriculum on lower achieving adolescent students' reading achievement and motivation. Using a multiple-cohort randomized treatment-control group design over 4 years, they compared achievement and…

Teaching cross-cultural communication skills online: a multi-method evaluation.

PubMed

Lee, Amy L; Mader, Emily M; Morley, Christopher P

2015-04-01

Cultural competency education is an important and required part of undergraduate medical education. The objective of this study was to evaluate whether an online cross-cultural communication module could increase student use of cross-cultural communication questions that assess the patient's definition of the problem, the way the problem affects their life, their concerns about the problem, and what the treatment should be (PACT). We used multi-method assessment of students assigned to family medicine clerkship blocks that were randomized to receive online cultural competency and PACT training added to their standard curriculum or to a control group receiving the standard curriculum only. Outcomes included comparison, via analysis of variance, of number of PACT questions used during an observed Standardized Patient Exercise, end-of-year OSCE scores, and qualitative analysis of student narratives. Students (n=119) who participated in the online module (n=60) demonstrated increased use of cross-cultural communication PACT questions compared to the control group (n=59) and generally had positive themes emerge from their reflective writing. The module had the biggest impact on students who later went on to match in high communication specialties. Online teaching of cross-cultural communication skills can be effective at changing medical student behavior.

The Misconception of Case-Control Studies in the Plastic Surgery Literature: A Literature Audit.

PubMed

Hatchell, Alexandra C; Farrokhyar, Forough; Choi, Matthew

2017-06-01

Case-control study designs are commonly used. However, many published case-control studies are not true case-controls and are in fact mislabeled. The purpose of this study was to identify all case-control studies published in the top three plastic surgery journals over the past 10 years, assess which were truly case-control studies, clarify the actual design of the articles, and address common misconceptions. MEDLINE, Embase, and Web of Science databases were searched for case-control studies in the three highest-impact factor plastic surgery journals (2005 to 2015). Two independent reviewers screened the resulting titles, abstracts, and methods, if applicable, to identify articles labeled as case-control studies. These articles were appraised and classified as true case-control studies or non-case-control studies. The authors found 28 articles labeled as case-control studies. However, only six of these articles (21 percent) were truly case-control designs. Of the 22 incorrectly labeled studies, one (5 percent) was a randomized controlled trial, three (14 percent) were nonrandomized trials, two (9 percent) were prospective comparative cohort designs, 14 (64 percent) were retrospective comparative cohort designs, and two (9 percent) were cross-sectional designs. The mislabeling was worse in recent years, despite increases in evidence-based medicine awareness. The majority of published case-control studies are not in fact case-control studies. This misunderstanding is worsening with time. Most of these studies are actually comparative cohort designs. However, some studies are truly clinical trials and thus a higher level of evidence than originally proposed.

Smartphone app design for the wireless control of a neuromuscular electrical stimulator device with integrated randomization allocation process for RCT applications.

PubMed

Sweeney, Dean; Quinlan, Leo R; OLaighin, Gearoid

2015-08-01

The use of NMES has evolved over the last five decades. Technological advancements have transformed these once complex systems into user-friendly devices with enhanced control functions, leading to new applications of NMES being investigated. The use of Randomized Control Trial (RCT) methodology in evaluating the effectiveness of new and existing applications of NMES is a demanding process adding time and cost to a translation into clinical practice. Poor quality trials may result in poor evidence of NMES effectiveness. In this paper some of the key challenges encountered in NMES clinical trials are identified with the aim of purposing a solution to address these challenges through the adoption of Smartphone technology. The design and evaluation of a smartphone application to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled NMES is presented.

Benchmark of Machine Learning Methods for Classification of a SENTINEL-2 Image

NASA Astrophysics Data System (ADS)

Pirotti, F.; Sunar, F.; Piragnolo, M.

2016-06-01

Thanks to mainly ESA and USGS, a large bulk of free images of the Earth is readily available nowadays. One of the main goals of remote sensing is to label images according to a set of semantic categories, i.e. image classification. This is a very challenging issue since land cover of a specific class may present a large spatial and spectral variability and objects may appear at different scales and orientations. In this study, we report the results of benchmarking 9 machine learning algorithms tested for accuracy and speed in training and classification of land-cover classes in a Sentinel-2 dataset. The following machine learning methods (MLM) have been tested: linear discriminant analysis, k-nearest neighbour, random forests, support vector machines, multi layered perceptron, multi layered perceptron ensemble, ctree, boosting, logarithmic regression. The validation is carried out using a control dataset which consists of an independent classification in 11 land-cover classes of an area about 60 km2, obtained by manual visual interpretation of high resolution images (20 cm ground sampling distance) by experts. In this study five out of the eleven classes are used since the others have too few samples (pixels) for testing and validating subsets. The classes used are the following: (i) urban (ii) sowable areas (iii) water (iv) tree plantations (v) grasslands. Validation is carried out using three different approaches: (i) using pixels from the training dataset (train), (ii) using pixels from the training dataset and applying cross-validation with the k-fold method (kfold) and (iii) using all pixels from the control dataset. Five accuracy indices are calculated for the comparison between the values predicted with each model and control values over three sets of data: the training dataset (train), the whole control dataset (full) and with k-fold cross-validation (kfold) with ten folds. Results from validation of predictions of the whole dataset (full) show the random forests method with the highest values; kappa index ranging from 0.55 to 0.42 respectively with the most and least number pixels for training. The two neural networks (multi layered perceptron and its ensemble) and the support vector machines - with default radial basis function kernel - methods follow closely with comparable performance.