Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects

Science.gov (United States)

2014-01-01

Background This study compared efficacy and safety of the selective relaxant binding agent sugammadex (2 mg/kg) with neostigmine (50 μg/kg) for neuromuscular blockade (NMB) reversal in Chinese and Caucasian subjects. Methods This was a randomized, active-controlled, multicenter, safety-assessor-blinded study (NCT00825812) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia. Rocuronium 0.6 mg/kg was administered for endotracheal intubation, with 0.1–0.2 mg/kg maintenance doses given as required. NMB was monitored using TOF-Watch® SX. At second twitch reappearance, after last rocuronium dose, subjects received sugammadex 2 mg/kg or neostigmine 50 μg/kg plus atropine 10–20 μg/kg, according to randomization. Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four (TOF) ratio to 0.9. Results Overall, 230 Chinese subjects (sugammadex, n = 119, neostigmine, n = 111); and 59 Caucasian subjects (sugammadex, n = 29, neostigmine, n = 30) had evaluable data. Geometric mean (95% CI) time to recovery to TOF ratio 0.9 was 1.6 (1.5–1.7) min with sugammadex vs 9.1 (8.0–10.3) min with neostigmine in Chinese subjects. Corresponding times for Caucasian subjects were 1.4 (1.3–1.5) min and 6.7 (5.5–8.0) min, respectively. Sugammadex 2 mg/kg was generally well tolerated, with no serious adverse events reported. There was no residual NMB or recurrence of NMB. Conclusion Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2 mg/kg vs neostigmine 50 μg/kg, with a ~5.7 times (p < 0.0001) faster recovery with sugammadex vs neostigmine in Chinese subjects. Sugammadex was generally well tolerated. Trial registration ClinicalTrials.gov Identifier: NCT00825812. PMID:25187755

The physics of randomness and regularities for languages (lifetimes, family trees, and the second languages); in terms of random matrices

OpenAIRE

Tuncay, Caglar

2007-01-01

The physics of randomness and regularities for languages (mother tongues) and their lifetimes and family trees and for the second languages are studied in terms of two opposite processes; random multiplicative noise [1], and fragmentation [2], where the original model is given in the matrix format. We start with a random initial world, and come out with the regularities, which mimic various empirical data [3] for the present languages.

Color Charts, Esthetics, and Subjective Randomness

Science.gov (United States)

Sanderson, Yasmine B.

2012-01-01

Color charts, or grids of evenly spaced multicolored dots or squares, appear in the work of modern artists and designers. Often the artist/designer distributes the many colors in a way that could be described as "random," that is, without an obvious pattern. We conduct a statistical analysis of 125 "random-looking" art and design color charts and…

Melnikov processes and chaos in randomly perturbed dynamical systems

Science.gov (United States)

Yagasaki, Kazuyuki

2018-07-01

We consider a wide class of randomly perturbed systems subjected to stationary Gaussian processes and show that chaotic orbits exist almost surely under some nondegenerate condition, no matter how small the random forcing terms are. This result is very contrasting to the deterministic forcing case, in which chaotic orbits exist only if the influence of the forcing terms overcomes that of the other terms in the perturbations. To obtain the result, we extend Melnikov’s method and prove that the corresponding Melnikov functions, which we call the Melnikov processes, have infinitely many zeros, so that infinitely many transverse homoclinic orbits exist. In addition, a theorem on the existence and smoothness of stable and unstable manifolds is given and the Smale–Birkhoff homoclinic theorem is extended in an appropriate form for randomly perturbed systems. We illustrate our theory for the Duffing oscillator subjected to the Ornstein–Uhlenbeck process parametrically.

A study on shear behavior of R/C beams subjected to long-term heating

International Nuclear Information System (INIS)

Maruta, M.; Yamazaki, M.

1993-01-01

In nuclear power plants, many structural members are subjected to long term heating. There are few experimental data available on the behavior especially in shear of reinforced concrete (R/C) members subjected to long term heating. This paper describes a study aimed at experimentally determining the shear behavior of R/C members in nuclear power plant facilities following sustained heating at high temperatures

Long-Term Outcome of Amyotrophic Lateral Sclerosis in Korean Subjects.

Science.gov (United States)

Suh, Mi Ri; Choi, Won Ah; Choi, Young-Chul; Lee, Jang Woo; Hong, Jung Hwa; Park, Jihyun; Kang, Seong-Woong

2017-12-01

To report the latest long-term outcome of amyotrophic lateral sclerosis (ALS) and to analyze the predictors of prognosis. Subjects who were diagnosed with ALS between January 2005 and December 2009 at a single institute were followed up until death or up to December 2014. Data regarding age, sex, date of onset, date of diagnosis, presence of bulbar symptoms on onset, date of initiation of non-invasive ventilation (NIV), and the date of tracheostomy were collected. Survival was assessed using Kaplan-Meier curves and multivariate analyses of the risk of death were performed using the Cox proportional hazards model. Among 212 suspicious subjects, definite ALS was diagnosed in 182 subjects. The survival rate at 3 and 5 years from onset was 61.5% and 40.1%, respectively, and the survival rate at 3 and 5 years post-diagnosis was 49.5% and 24.2%, respectively. Further, 134 patients (134/182, 73.6%) were initiated on NIV, and among them, 90 patients (90/182, 49.5%) underwent tracheostomy. Male gender and onset age of ≥65 years were independent predictors of adverse survival. The analysis of long term survival in ALS showed excellent outcomes considering the overall poor prognosis of this disease.

The difference in subjective and objective complexity in the visual short-term memory

DEFF Research Database (Denmark)

Dall, Jonas Olsen; Sørensen, Thomas Alrik

Several studies discuss the influence of complexity on the visual short term memory; some have demonstrated that short-term memory is surprisingly stable regardless of content (e.g. Luck & Vogel, 1997) where others have shown that memory can be influenced by the complexity of stimulus (e.g. Alvarez...... characters. On the contrary expertise or word frequency may reflect what could be termed subjective complexity, as this relate directly to the individual mental categories established. This study will be able to uncover more details on how we should define complexity of objects to be encoded into short-term....... & Cavanagh, 2004). But the term complexity is often not clearly defined. Sørensen (2008; see also Dall, Katsumi, & Sørensen, 2016) suggested that complexity can be related to two different types; objective and subjective complexity. This distinction is supported by a number of studies on the influence...

β-Glucan and Dark Chocolate: A Randomized Crossover Study on Short-Term Satiety and Energy Intake

Directory of Open Access Journals (Sweden)

Asli Akyol

2014-09-01

Full Text Available Aim: The aims of this study were to adapt a traditional recipe into a healthier form by adding 3 g of oat β-glucan, substituting milk chocolate to dark chocolate with 70% cocoa, and to examine the effect of these alterations on short-term satiety and energy intake. Materials and Methods: Study subjects (n = 25 were tested in a randomized, crossover design with four products closely matched for energy content. Four different versions of a traditional recipe including milk chocolate-control (CON, oat β-glucan (B-GLU, dark chocolate (DARK or oat β-glucan and dark chocolate (B-GLU + DARK were given to subjects on different test days. After subjects were asked to report visual analog scale (VAS scores on sensory outcomes and related satiety for four hours ad libitum, lunch was served and energy intake of individuals was measured. Results: VAS scores indicated that none of the test foods exerted an improved effect on satiety feelings. However, energy intake of individuals during ad libitum lunch was significantly lower in dark chocolate groups (CON: 849.46 ± 47.45 kcal versus DARK: 677.69 ± 48.45 kcal and B-GLU + DARK: 691.08 ± 47.45 kcal, p = 0.014. Conclusion: The study demonstrated that substituting dark chocolate for milk chocolate is more effective in inducing satiety during subsequent food intake in healthy subjects.

β-Glucan and dark chocolate: a randomized crossover study on short-term satiety and energy intake.

Science.gov (United States)

Akyol, Asli; Dasgin, Halil; Ayaz, Aylin; Buyuktuncer, Zehra; Besler, H Tanju

2014-09-23

The aims of this study were to adapt a traditional recipe into a healthier form by adding 3 g of oat β-glucan, substituting milk chocolate to dark chocolate with 70% cocoa, and to examine the effect of these alterations on short-term satiety and energy intake. Study subjects (n = 25) were tested in a randomized, crossover design with four products closely matched for energy content. Four different versions of a traditional recipe including milk chocolate-control (CON), oat β-glucan (B-GLU), dark chocolate (DARK) or oat β-glucan and dark chocolate (B-GLU + DARK) were given to subjects on different test days. After subjects were asked to report visual analog scale (VAS) scores on sensory outcomes and related satiety for four hours ad libitum, lunch was served and energy intake of individuals was measured. VAS scores indicated that none of the test foods exerted an improved effect on satiety feelings. However, energy intake of individuals during ad libitum lunch was significantly lower in dark chocolate groups (CON: 849.46 ± 47.45 kcal versus DARK: 677.69 ± 48.45 kcal and B-GLU + DARK: 691.08 ± 47.45 kcal, p = 0.014). The study demonstrated that substituting dark chocolate for milk chocolate is more effective in inducing satiety during subsequent food intake in healthy subjects.

Term breech delivery in The Netherlands

NARCIS (Netherlands)

Rietberg, C.C.

2006-01-01

The management of the term breech delivery has been a subject of discussion for many years. Only a few randomized trials had been performed on outcome in relation to the mode of delivery in case of breech position. In october 2000 the results of the Term Breech Trial (TBT) were published, in which

Size-dependent piezoelectric energy-harvesting analysis of micro/nano bridges subjected to random ambient excitations

Science.gov (United States)

Radgolchin, Moeen; Moeenfard, Hamid

2018-02-01

The construction of self-powered micro-electro-mechanical units by converting the mechanical energy of the systems into electrical power has attracted much attention in recent years. While power harvesting from deterministic external excitations is state of the art, it has been much more difficult to derive mathematical models for scavenging electrical energy from ambient random vibrations, due to the stochastic nature of the excitations. The current research concerns analytical modeling of micro-bridge energy harvesters based on random vibration theory. Since classical elasticity fails to accurately predict the mechanical behavior of micro-structures, strain gradient theory is employed as a powerful tool to increase the accuracy of the random vibration modeling of the micro-harvester. Equations of motion of the system in the time domain are derived using the Lagrange approach. These are then utilized to determine the frequency and impulse responses of the structure. Assuming the energy harvester to be subjected to a combination of broadband and limited-band random support motion and transverse loading, closed-form expressions for mean, mean square, correlation and spectral density of the output power are derived. The suggested formulation is further exploited to investigate the effect of the different design parameters, including the geometric properties of the structure as well as the properties of the electrical circuit on the resulting power. Furthermore, the effect of length scale parameters on the harvested energy is investigated in detail. It is observed that the predictions of classical and even simple size-dependent theories (such as couple stress) appreciably differ from the findings of strain gradient theory on the basis of random vibration. This study presents a first-time modeling of micro-scale harvesters under stochastic excitations using a size-dependent approach and can be considered as a reliable foundation for future research in the field of

A randomized, placebo-controlled, preoperative trial of allopurinol in subjects with colorectal adenoma.

Science.gov (United States)

Puntoni, Matteo; Branchi, Daniela; Argusti, Alessandra; Zanardi, Silvia; Crosta, Cristiano; Meroni, Emanuele; Munizzi, Francesco; Michetti, Paolo; Coccia, Gianni; De Roberto, Giuseppe; Bandelloni, Roberto; Turbino, Laura; Minetti, Egle; Mori, Marco; Salvi, Sandra; Boccardo, Simona; Gatteschi, Beatrice; Benelli, Roberto; Sonzogni, Angelica; DeCensi, Andrea

2013-02-01

Inflammation and oxidative stress play a crucial role in the development of colorectal cancer (CRC) and interference with these mechanisms represents a strategy in CRC chemoprevention. Allopurinol, a safe molecular scavenger largely used as antigout agent, has been shown to increase survival of patients with advanced CRC and to reduce CRC incidence in long-term gout users in epidemiologic studies. We conducted a randomized, double-blind, placebo-controlled preoperative trial in subjects with colorectal adenomatous polyps to assess the activity of allopurinol on biomarkers of colorectal carcinogenesis. After complete colonoscopy and biopsy of the index polyp, 73 subjects with colorectal adenomas were assigned to either placebo or one of two doses of allopurinol (100 mg or 300 mg) and treated for four weeks before polyp removal. Change of Ki-67 labeling index in adenomatous tissue was the primary endpoint. Secondary endpoints were the immunohistochemical (IHC) expression of NF-κB, β-catenin, topoisomerase-II-α, and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) in adenomatous polyps and normal adjacent colonic tissue. Compared with placebo, Ki-67 levels were not significantly modulated by allopurinol, whereas β-catenin and NF-κB expression levels decreased significantly in adenomatous tissue, with a mean change from baseline of -10.6%, 95% confidence interval (CI), -20.5 to -0.7, and -8.1%, 95% CI, -22.7 to 6.5, respectively. NF-κB also decreased significantly in normal adjacent tissue (-16.4%; 95% CI, -29.0 to -3.8). No dose-response relationship was noted, except for NF-κB expression in normal tissue. Allopurinol can inhibit biomarkers of oxidative activation in colon adenomatous polyps and normal adjacent tissue. Further studies should define its potential chemopreventive activity.

Necessary conditions for the invariant measure of a random walk to be a sum of geometric terms

NARCIS (Netherlands)

Chen, Y.; Boucherie, Richardus J.; Goseling, Jasper

We consider the invariant measure of homogeneous random walks in the quarter-plane. In particular, we consider measures that can be expressed as an infinite sum of geometric terms. We present necessary conditions for the invariant measure of a random walk to be a sum of geometric terms. We

Dolutegravir versus placebo in subjects harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study.

Science.gov (United States)

Akil, Bisher; Blick, Gary; Hagins, Debbie P; Ramgopal, Moti N; Richmond, Gary J; Samuel, Rafik M; Givens, Naomi; Vavro, Cindy; Song, Ivy H; Wynne, Brian; Ait-Khaled, Mounir

2015-01-01

The Phase III VIKING-3 study demonstrated that dolutegravir (DTG) 50 mg twice daily was efficacious in antiretroviral therapy (ART)-experienced subjects harbouring raltegravir- and/or elvitegravir-resistant HIV-1. VIKING-4 (ING116529) included a placebo-controlled 7-day monotherapy phase to demonstrate that short-term antiviral activity was attributable to DTG. VIKING-4 is a Phase III randomized, double-blind study in therapy-experienced adults with integrase inhibitor (INI)-resistant virus randomized to DTG 50 mg twice daily or placebo while continuing their failing regimen (without raltegravir or elvitegravir) for 7 days (clinicaltrials.gov identifier NCT01568892). At day 8, all subjects switched to open-label DTG 50 mg twice daily and optimized background therapy including ≥1 fully active drug. The primary end point was change from baseline in plasma HIV-1 RNA at day 8. The study population (n=30) was highly ART-experienced with advanced HIV disease. Patients had extensive baseline resistance to all approved antiretroviral classes. Adjusted mean change in HIV-1 RNA at day 8 was 
-1.06 log10 copies/ml for the DTG arm and 0.10 log10 copies/ml for the placebo arm (treatment difference -1.16 log10 copies/ml [-1.52, -0.80]; PVIKING-3 study.

Random walks, random fields, and disordered systems

CERN Document Server

Černý, Jiří; Kotecký, Roman

2015-01-01

Focusing on the mathematics that lies at the intersection of probability theory, statistical physics, combinatorics and computer science, this volume collects together lecture notes on recent developments in the area. The common ground of these subjects is perhaps best described by the three terms in the title: Random Walks, Random Fields and Disordered Systems. The specific topics covered include a study of Branching Brownian Motion from the perspective of disordered (spin-glass) systems, a detailed analysis of weakly self-avoiding random walks in four spatial dimensions via methods of field theory and the renormalization group, a study of phase transitions in disordered discrete structures using a rigorous version of the cavity method, a survey of recent work on interacting polymers in the ballisticity regime and, finally, a treatise on two-dimensional loop-soup models and their connection to conformally invariant systems and the Gaussian Free Field. The notes are aimed at early graduate students with a mod...

Short-term effect of cocoa product consumption on lipid profile: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Jia, Lei; Liu, Xuan; Bai, Yong Yi; Li, Shao Hua; Sun, Kai; He, Chen; Hui, Rutai

2010-07-01

The effect of cocoa products on lipid changes is controversial. We aimed to identify and quantify the effect of cocoa on total cholesterol, LDL cholesterol, and HDL cholesterol. A comprehensive literature search was conducted for relevant trials of cocoa on lipid profile. Weighted mean differences were calculated for net changes in lipid concentrations by using fixed-effects or random-effects models. Previously defined subgroup analyses were performed to identify the source of heterogeneity. Eight trials (involving 215 participants) were included and evaluated. Because there was only one relatively longer-term study, we focused on the short-term data to evaluate the effects of cocoa on plasma lipid. Cocoa consumption significantly lowered LDL cholesterol by 5.87 mg/dL (95% CI: -11.13, -0.61; P consumption significantly reduced blood cholesterol, but the changes were dependent on the dose of cocoa consumption and the healthy status of participants. There was no dose response and no effect in healthy participants. Future high-quality studies are needed to determine the efficiency of moderate cocoa consumption on lipid profile in long-term intervention and in subjects with other cardiometabolic risk factors.

Selection bias and subject refusal in a cluster-randomized controlled trial

Directory of Open Access Journals (Sweden)

Rochelle Yang

2017-07-01

Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry.

Science.gov (United States)

Torres-Villalobos, Gonzalo; Coss-Adame, Enrique; Furuzawa-Carballeda, Janette; Romero-Hernández, Fernanda; Blancas-Breña, Blanca; Torres-Landa, Samuel; Palacios-Ramírez, Axel; Alejandro-Medrano, Edgar; Hernández-Ávila, Axel; Flores-Najera, Athenea; Ávila Escobedo, Lourdes Margarita; Ramírez Angulo, Cecilia; Rodríguez-Garcés, Angélica; Valdovinos, Miguel Ángel

2018-01-01

Laparoscopic Heller myotomy (LHM) with partial fundoplication is an effective treatment for achalasia. However, the type of fundoplication is still a subject of debate. The aim of the study is to identify which partial fundoplication leads to better control of acid exposure, manometric parameters, and symptoms scores. A randomized controlled trial was performed to compare Dor vs Toupet fundoplication after LHM. The preoperative diagnosis was made by high-resolution manometry (HRM), upper endoscopy, and barium esophagogram. Preoperative and postoperative symptoms were evaluated with Eckardt, GERD-HRQL, and EAT-10 questionnaires. Seventy-three patients were randomized, 38 underwent Dor and 35 Toupet. Baseline characteristics were similar between groups. Postoperative HRM showed that the integrated relaxation pressure (IRP) and basal lower esophageal sphincter (LES) pressure were similar at 6 and 24 months. The number of patients with abnormal acid exposure was significantly lower for Dor (6.9%) than that of Toupet (34.0%) at 6 months, but it was not different at 12 or 24 months. No differences were found in postoperative symptom scores at 1, 6, or 24 months. There were no differences in symptom scores or HRM between fundoplications in the long term. A higher percentage of abnormal 24-h pH test were found for the Toupet group, with no difference in the long term.

Random excitation forces in tube bundles subjected to two-phase cross-flow

International Nuclear Information System (INIS)

Taylor, C.E.; Pettigrew, M.J.; Currie, I.G.

1996-01-01

Data from two experimental programs have been analyzed to determine the characteristics of the random excitation forces associated with two-phase cross-flow in tube bundles. Large-scale air-water flow loops in France and Canada were used to generate the data. Tests were carried out on cantilevered, clamped-pinned, and clamped-clamped tubes in normal-square, parallel-triangular, and normal-triangular configurations. Either strain gages or force transducers were used to measure the vibration response of a centrally located tube as the tue array was subjected to a wide range of void fractions and flow rates. Power spectra were analyzed to determine the effect of parameters such as tube diameter, frequency, flow rate, void fraction, and flow regime on the random excitation forces. Normalized expressions for the excitation force power spectra were found to be flow-regime dependent. In the churn flow regime, flow rate and void fraction had very little effect on the magnitude of the excitation forces. In the bubble-plug flow regime, the excitation forces increased rapidly with flow rate and void fraction

Effects of Whole Grain Wheat Bread on Visceral Fat Obesity in Japanese Subjects: A Randomized Double-Blind Study.

Science.gov (United States)

Kikuchi, Yosuke; Nozaki, Satomi; Makita, Miki; Yokozuka, Shoji; Fukudome, Shin-Ichi; Yanagisawa, Takashi; Aoe, Seiichiro

2018-04-18

Metabolic syndrome is a risk factor for cardiovascular diseases and has become increasingly common in Japan. Epidemiological studies show inverse associations between intake of whole wheat grains and metabolic syndrome, but few dietary intervention trials have investigated the effect of whole wheat grain consumption. It was investigated whether a diet in which refined wheat bread (RW diet) was substituted by whole grain wheat bread (WW diet) would reduce visceral fat obesity in Japanese subjects. A randomized double-blind placebo-controlled intervention study was conducted in 50 Japanese subjects with body mass index (BMI) ≥ 23 kg/m 2 . Subjects were randomly assigned WW (WW group) or RW diets (RW group) for 12 weeks. Blood samples and computed tomography scans were obtained every 6th week. The WW group showed decrease (-4 cm 2 ) in visceral fat area (VFA) (p < 0.05), whereas the RW group showed no significant changes. These time-dependent changes were significantly different between the groups. WW diet led to significant and safe reductions in VFA in subjects with BMI ≥ 23 kg/m 2 . WW diet may contribute to preventing visceral fat obesity.

A general symplectic method for the response analysis of infinitely periodic structures subjected to random excitations

Directory of Open Access Journals (Sweden)

You-Wei Zhang

Full Text Available A general symplectic method for the random response analysis of infinitely periodic structures subjected to stationary/non-stationary random excitations is developed using symplectic mathematics in conjunction with variable separation and the pseudo-excitation method (PEM. Starting from the equation of motion for a single loaded substructure, symplectic analysis is firstly used to eliminate the dependent degrees of the freedom through condensation. A Fourier expansion of the condensed equation of motion is then applied to separate the variables of time and wave number, thus enabling the necessary recurrence scheme to be developed. The random response is finally determined by implementing PEM. The proposed method is justified by comparison with results available in the literature and is then applied to a more complicated time-dependent coupled system.

Fatigue Reliability under Random Loads

DEFF Research Database (Denmark)

Talreja, R.

1979-01-01

We consider the problem of estimating the probability of survival (non-failure) and the probability of safe operation (strength greater than a limiting value) of structures subjected to random loads. These probabilities are formulated in terms of the probability distributions of the loads...... propagation stage. The consequences of this behaviour on the fatigue reliability are discussed....

Antibiotic prophylaxis for term or near-term premature rupture of membranes: metaanalysis of randomized trials.

Science.gov (United States)

Saccone, Gabriele; Berghella, Vincenzo

2015-05-01

The objective of the study was to evaluate the efficacy of antibiotic prophylaxis in women with term or near-term premature rupture of membranes. Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, ScienceDirect.com, MEDSCAPE, and the Cochrane Central Register of Controlled Trials with the use of a combination of key words and text words related to antibiotics, premature rupture of membranes, term, and trials from inception of each database to September 2014. We included all randomized trials of singleton gestations with premature rupture of membranes at 36 weeks or more, who were randomized to antibiotic prophylaxis or control (either placebo or no treatment). The primary outcomes included maternal chorioamnionitis and neonatal sepsis. A subgroup analysis on studies with latency more than 12 hours was planned. Before data extraction, the review was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number CRD42014013928). The metaanalysis was performed following the Preferred Reporting Item for Systematic Reviews and Meta-analyses statement. Women who received antibiotics had the same rate of chorioamnionitis (2.7% vs 3.7%; relative risk [RR], 0.73, 95% confidence interval [CI], 0.48-1.12), endometritis (0.4% vs 0.9%; RR, 0.44, 95% CI, 0.18-1.10), maternal infection (3.1% vs 4.6%; RR, 0.48, 95% CI, 0.19-1.21), and neonatal sepsis (1.0% vs 1.4%; RR, 0.69, 95% CI, 0.34-1.39). In the planned subgroup analysis, women with latency longer than 12 hours, who received antibiotics, had a lower rate of chorioamnionitis (2.9% vs 6.1%; RR, 0.49, 95% CI, 0.27-0.91) and endometritis (0% vs 2.2%; RR, 0.12, 95% CI, 0.02-0.62) compared with the control group. Antibiotic prophylaxis for term or near-term premature rupture of membranes is not associated with any benefits in either maternal or neonatal outcomes. In women with latency longer

The estimation of branching curves in the presence of subject-specific random effects.

Science.gov (United States)

Elmi, Angelo; Ratcliffe, Sarah J; Guo, Wensheng

2014-12-20

Branching curves are a technique for modeling curves that change trajectory at a change (branching) point. Currently, the estimation framework is limited to independent data, and smoothing splines are used for estimation. This article aims to extend the branching curve framework to the longitudinal data setting where the branching point varies by subject. If the branching point is modeled as a random effect, then the longitudinal branching curve framework is a semiparametric nonlinear mixed effects model. Given existing issues with using random effects within a smoothing spline, we express the model as a B-spline based semiparametric nonlinear mixed effects model. Simple, clever smoothness constraints are enforced on the B-splines at the change point. The method is applied to Women's Health data where we model the shape of the labor curve (cervical dilation measured longitudinally) before and after treatment with oxytocin (a labor stimulant). Copyright © 2014 John Wiley & Sons, Ltd.

Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial

Directory of Open Access Journals (Sweden)

Reza Rostami

2017-10-01

Full Text Available Purpose: There are some studies which showed neurofeedback therapy (NFT can be effective in clients with traumatic brain injury (TBI history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA and short-term memory (STM of clients with moderate TBI using a randomized controlled clinical trial (RCT. Methods: In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Results: Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16 years and (27.60 ± 8.17 years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05. Conclusion: Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Keywords: Neurofeedback, Brain injuries, Attention, Short-term memory

Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial

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Priyanka Singh

2013-01-01

Full Text Available Background and Purpose: The purpose of this study was to assess the effectiveness of modified constraint induced movement therapy (m-CIMT in stroke subjects. Materials and Methods: A total of forty sub-acute stroke subjects were randomly assigned to either a m-CIMT (n = 20 or in a control group (n = 20. The m-CIMT group (14 men, 6 women; mean age = 55.2 years consisted of structured 2 h therapy sessions emphasizing affected arm use, occurring 5 times/week for 2 weeks. A mitt was used to restrain the unaffected arm for 10 h/day for 2 week. The control group (11 men, 9 women; mean age = 56.4 years consisted of conventional rehabilitation for time-matched exercise program. The outcome measures were evaluated at pre- and post-intervention by using the Wolf Motor Function Test (WMFT and Fugl-Meyer assessment (FMA of motor recovery after stroke. Results: After intervention significant effects were observed in m-CIMT group on WMFT (pre-test and post-test score was 28.04 ± 6.58, 13.59 ± 2.86; P =0.003. Similarly on FMA (pre- and post-test score was 31.15 ± 6.37, 55.7 ± 6.4; P = 0.00. Conclusion: There is a significant improvem ent in upper extremity function so it indicates that m-CIMT is effective in improving the motor function of the affected arm in stroke subjects. However, its long-term effect has not proved since there was no follow-up after intervention.

Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes.

Directory of Open Access Journals (Sweden)

Denise L Faustman

Full Text Available No targeted immunotherapies reverse type 1 diabetes in humans. However, in a rodent model of type 1 diabetes, Bacillus Calmette-Guerin (BCG reverses disease by restoring insulin secretion. Specifically, it stimulates innate immunity by inducing the host to produce tumor necrosis factor (TNF, which, in turn, kills disease-causing autoimmune cells and restores pancreatic beta-cell function through regeneration.Translating these findings to humans, we administered BCG, a generic vaccine, in a proof-of-principle, double-blind, placebo-controlled trial of adults with long-term type 1 diabetes (mean: 15.3 years at one clinical center in North America. Six subjects were randomly assigned to BCG or placebo and compared to self, healthy paired controls (n = 6 or reference subjects with (n = 57 or without (n = 16 type 1 diabetes, depending upon the outcome measure. We monitored weekly blood samples for 20 weeks for insulin-autoreactive T cells, regulatory T cells (Tregs, glutamic acid decarboxylase (GAD and other autoantibodies, and C-peptide, a marker of insulin secretion. BCG-treated patients and one placebo-treated patient who, after enrollment, unexpectedly developed acute Epstein-Barr virus infection, a known TNF inducer, exclusively showed increases in dead insulin-autoreactive T cells and induction of Tregs. C-peptide levels (pmol/L significantly rose transiently in two BCG-treated subjects (means: 3.49 pmol/L [95% CI 2.95-3.8], 2.57 [95% CI 1.65-3.49] and the EBV-infected subject (3.16 [95% CI 2.54-3.69] vs.1.65 [95% CI 1.55-3.2] in reference diabetic subjects. BCG-treated subjects each had more than 50% of their C-peptide values above the 95(th percentile of the reference subjects. The EBV-infected subject had 18% of C-peptide values above this level.We conclude that BCG treatment or EBV infection transiently modified the autoimmunity that underlies type 1 diabetes by stimulating the host innate immune response. This suggests that BCG or other

Pivmecillinam versus sulfamethizole for short-term treatment of uncomplicated acute cystitis in general practice

DEFF Research Database (Denmark)

Bjerrum, Lars; Gahrn-Hansen, Bente; Grinsted, Per

2009-01-01

Objective. To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI). Design. Randomized controlled trial. Setting. General practice, Denmark. Subjects. Patients (n =167) with uncomplica......Objective. To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI). Design. Randomized controlled trial. Setting. General practice, Denmark. Subjects. Patients (n =167......) with uncomplicated UTI confirmed by positive urine phase-contrast microscopy. Main outcome measures. Drug efficacy based on clinical and bacteriological cure. Results. Urinary symptoms disappeared first in patients treated with pivmecillinam, but after five days there was no significant difference in clinical cure...... in 68.8% of patients randomized to pivmecillinam and in 77.9% randomized to sulfamethizole (difference -9.2%, CI -24.7%; 6.3%). Some 26.8% of patients randomized to pivmecillinam experienced a new UTI within 6 months after treatment compared with 18.4% of patients randomized to sulfamethizole...

Specific terms glossary for subjects taught in Physical Culture first year career

Directory of Open Access Journals (Sweden)

Ana Isel Rodríguez Cruz

2016-08-01

Full Text Available Contents comprehension is an important element in the learning process; present didactic ways demand from teaching styles that favor communicative competence in the students. Taking into account the relevance of this topic in the teaching learning process it was decided to develop the present work, which has the objective to offer the students a tool that allow them an efficient comprehension of the contents they receive in the Physical Culture first year career subjects. To fulfil the goal a glossary with specific terms of basketball, chess, swimming, athletics, basic gymnastics, and morphology was designed starting from the results of the initial diagnosis, the scientific observation, as well as the detail revision of the normative documents that rule Communicative Spanish subject. The glossary use favor the students´ texts comprehension development from the mentioned subject.

25 CFR 900.33 - Are all proposals to renew term contracts subject to the declination criteria?

Science.gov (United States)

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Are all proposals to renew term contracts subject to the... Indian Affairs will not review the renewal of a term contract for declination issues where no material... been proposed by the Indian tribe or tribal organization. Proposals to renew term contracts with DOI...

An adaptive random search for short term generation scheduling with network constraints.

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J A Marmolejo

Full Text Available This paper presents an adaptive random search approach to address a short term generation scheduling with network constraints, which determines the startup and shutdown schedules of thermal units over a given planning horizon. In this model, we consider the transmission network through capacity limits and line losses. The mathematical model is stated in the form of a Mixed Integer Non Linear Problem with binary variables. The proposed heuristic is a population-based method that generates a set of new potential solutions via a random search strategy. The random search is based on the Markov Chain Monte Carlo method. The main key of the proposed method is that the noise level of the random search is adaptively controlled in order to exploring and exploiting the entire search space. In order to improve the solutions, we consider coupling a local search into random search process. Several test systems are presented to evaluate the performance of the proposed heuristic. We use a commercial optimizer to compare the quality of the solutions provided by the proposed method. The solution of the proposed algorithm showed a significant reduction in computational effort with respect to the full-scale outer approximation commercial solver. Numerical results show the potential and robustness of our approach.

Short-Term Effects of Whole-Body Vibration Combined with Task-Related Training on Upper Extremity Function, Spasticity, and Grip Strength in Subjects with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Lee, Jung-Sun; Kim, Chang-Yong; Kim, Hyeong-Dong

2016-08-01

The aim of this study was to determine the effect of whole-body vibration training combined with task-related training on arm function, spasticity, and grip strength in subjects with poststroke hemiplegia. Forty-five subjects with poststroke were randomly allocated to 3 groups, each with 15 subjects as follows: control group, whole-body vibration group, and whole-body vibration plus task-related training group. Outcome was evaluated by clinical evaluation and measurements of the grip strength before and 4 weeks after intervention. Our results show that there was a significantly greater increase in the Fugl-Meyer scale, maximal grip strength of the affected hand, and grip strength normalized to the less affected hand in subjects undergoing the whole-body vibration training compared with the control group after the test. Furthermore, there was a significantly greater increase in the Wolf motor function test and a decrease in the modified Ashworth spasticity total scores in subjects who underwent whole-body vibration plus task-related training compared with those in the other 2 groups after the test. The findings indicate that the use of whole-body vibration training combined with task-related training has more benefits on the improvement of arm function, spasticity, and maximal grip strength than conventional upper limb training alone or with whole-body vibration in people with poststroke hemiplegia.

Long-term functional, subjective and psychological results after single digit replantation

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Jing Chen

2018-03-01

Full Text Available Objective: The aim of this study was to analyse the long-term functional, subjective, and psychological results after single-digit replantation. Methods: Thirty cases of digital replantation (14 thumbs, 12 index fingers, 2 middle fingers, 1 ring finger, and 1 little finger in 30 patients (7 females and 23 males with a mean age of 44.2 years (20–65 years were evaluated at the end of a mean follow-up time of 36 months (19–50 months. The active range of motion of joints, grip and pinch strength, cutaneous sensibility, upper-extremity functioning, and subjective satisfaction were determined using the Disability of Arm, Shoulder, and Hand (DASH questionnaire and the Michigan Hand Outcomes questionnaire (MHQ. Psychological sequelae, including depression, anxiety, and posttraumatic stress disorder (PTSD, were assessed. A correlation analysis among variables was also performed. Results: The mean score for the DASH questionnaire was 6.6 (range: 0–39.2. The symptom of cold intolerance occurred in 53% of the patients. Two patients were diagnosed with depression, and only one patient exhibited PTSD. The DASH score had a good statistical correlation with total grip strength, pinch grip strength, and static two-point discrimination (S-2PD (P < 0.05. Several aspects of the MHQ were also statistically relevant to some or all of the three objective results. Furthermore, the grip strength showed significant correlation with DASH and most aspects of the MHQ in multivariate logistic regression analysis (P < 0.05. Conclusion: Total grip strength is the most important factor positively related to subjective outcomes. The incidence rates of psychological symptoms after digit replantation are very low at long-term follow-up. Level of evidence: Level IV, therapeutic study. Keywords: Digit Replantation, DASH score, Posttraumatic stress disorder

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.

Science.gov (United States)

James, W Philip T; Caterson, Ian D; Coutinho, Walmir; Finer, Nick; Van Gaal, Luc F; Maggioni, Aldo P; Torp-Pedersen, Christian; Sharma, Arya M; Shepherd, Gillian M; Rode, Richard A; Renz, Cheryl L

2010-09-02

The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. Subjects with preexisting

Long-term functional, subjective and psychological results after single digit replantation.

Science.gov (United States)

Chen, Jing; Zhang, Ai Xian; Chen, Qing Zhong; Mu, Shuai; Tan, Jun

2018-03-01

The aim of this study was to analyse the long-term functional, subjective, and psychological results after single-digit replantation. Thirty cases of digital replantation (14 thumbs, 12 index fingers, 2 middle fingers, 1 ring finger, and 1 little finger) in 30 patients (7 females and 23 males) with a mean age of 44.2 years (20-65 years) were evaluated at the end of a mean follow-up time of 36 months (19-50 months). The active range of motion of joints, grip and pinch strength, cutaneous sensibility, upper-extremity functioning, and subjective satisfaction were determined using the Disability of Arm, Shoulder, and Hand (DASH) questionnaire and the Michigan Hand Outcomes questionnaire (MHQ). Psychological sequelae, including depression, anxiety, and posttraumatic stress disorder (PTSD), were assessed. A correlation analysis among variables was also performed. The mean score for the DASH questionnaire was 6.6 (range: 0-39.2). The symptom of cold intolerance occurred in 53% of the patients. Two patients were diagnosed with depression, and only one patient exhibited PTSD. The DASH score had a good statistical correlation with total grip strength, pinch grip strength, and static two-point discrimination (S-2PD) (P digit replantation are very low at long-term follow-up. Level IV, therapeutic study. Copyright © 2017 Turkish Association of Orthopaedics and Traumatology. Production and hosting by Elsevier B.V. All rights reserved.

Correlation between Very Short and Short-Term Blood Pressure Variability in Diabetic-Hypertensive and Healthy Subjects.

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Casali, Karina R; Schaan, Beatriz D; Montano, Nicola; Massierer, Daniela; M F Neto, Flávio; Teló, Gabriela H; Ledur, Priscila S; Reinheimer, Marilia; Sbruzzi, Graciele; Gus, Miguel

2018-02-01

Blood pressure (BP) variability can be evaluated by 24-hour ambulatory BP monitoring (24h-ABPM), but its concordance with results from finger BP measurement (FBPM) has not been established yet. The aim of this study was to compare parameters of short-term (24h-ABPM) with very short-term BP variability (FBPM) in healthy (C) and diabetic-hypertensive (DH) subjects. Cross-sectional study with 51 DH subjects and 12 C subjects who underwent 24h-ABPM [extracting time-rate, standard deviation (SD), coefficient of variation (CV)] and short-term beat-to-beat recording at rest and after standing-up maneuvers [FBPM, extracting BP and heart rate (HR) variability parameters in the frequency domain, autoregressive spectral analysis]. Spearman correlation coefficient was used to correlate BP and HR variability parameters obtained from both FBPM and 24h-ABPM (divided into daytime, nighttime, and total). Statistical significance was set at p ABPM) and LF component of short-term variability (FBPM, total, R = 0.591, p = 0.043); standard deviation (24h-ABPM) with LF component BPV (FBPM, total, R = 0.608, p = 0.036), coefficient of variation (24h-ABPM) with total BPV (FBPM, daytime, -0.585, p = 0.046) and alpha index (FBPM, daytime, -0.592, p = 0.043), time rate (24h-ABPM) and delta LF/HF (FBPM, total, R = 0.636, p = 0.026; daytime R = 0,857, p ABPM (total, daytime) reflect BP and HR variability evaluated by FBPM in healthy individuals. This does not apply for DH subjects.

Fel d 1-derived synthetic peptide immuno-regulatory epitopes show a long-term treatment effect in cat allergic subjects.

Science.gov (United States)

Couroux, P; Patel, D; Armstrong, K; Larché, M; Hafner, R P

2015-05-01

Cat-PAD, the first in a new class of synthetic peptide immuno-regulatory epitopes (SPIREs), was shown to significantly improve rhinoconjunctivitis symptoms in subjects with cat allergy up to 1 year after the start of a short course of treatment. To evaluate the long-term effects of Cat-PAD on rhinoconjunctivitis symptoms following standardized allergen challenge 2 years after treatment. In a randomized, double-blind, placebo-controlled, parallel group study, subjects were exposed to cat allergen in an environmental exposure chamber (EEC) before and after treatment with two regimens of Cat-PAD (either eight doses of 3 nmol or four doses of 6 nmol) given intradermally over a 3-month period. In this follow-up study, changes from baseline in rhinoconjunctivitis symptoms were reassessed 2 years after the start of treatment. The primary endpoint showed a mean reduction in total rhinoconjunctivitis symptom scores of 3.85 units in the 4 × 6 nmol Cat-PAD group compared to placebo 2 years after the start of treatment (P = 0.13), and this difference was statistically significant in the secondary endpoint at the end of day 4 when the cumulative allergen challenge was greatest (P = 0.02). Consistent reductions in nasal symptoms of between 2 and 3 units were observed for 4 × 6 nmol Cat-PAD compared to placebo between the 2 and 3 h time points on days 1-4 of EEC challenge at 2 years (P Cat-PAD. This study is the first to provide evidence of a long-term therapeutic effect with this new class of SPIREs. © 2015 The Authors. Clinical & Experimental Allergy Published by John Wiley & Sons Ltd.

Nonlinear Characteristics of Randomly Excited Transonic Flutter

DEFF Research Database (Denmark)

Christiansen, Lasse Engbo; Lehn-Schiøler, Tue; Mosekilde, Erik

2002-01-01

. When this model is extended by the introduction of nonlinear terms, it can reproduce the subcritical Hopf bifurcation. We hereafter consider the effects of subjecting simplified versions of the model to random external excitations representing the fluctuations present in the airflow. These models can......The paper describes the effects of random external excitations on the onset and dynamical characteristics of transonic flutter (i.e. large-amplitude, self-sustained oscillations) for a high aspect ratio wing. Wind tunnel experiments performed at the National Aerospace Laboratory (NAL) in Japan have...

Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial.

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Seo, Jung-Chul; Lee, Hyun-jong; Kwak, Min-Ah; Park, Sung-Hoon; Shin, ImHee; Yun, Woo-Sung; Park, Kihyuk

2014-09-04

Cold hands sensation is a common disorder within the Korean population. Many Korean family physicians believe that it is a mild early manifestation of Raynaud's phenomenon (RP), or may be related to RP. RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress, and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands. However, this has not shown a clear benefit, and these medications can cause unwanted side effects. It is also reported that traditional Korean medicine, including acupuncture, is widely used to treat cold hands, although the current level of evidence for this approach is also poor and to date, there have been no published randomized controlled clinical trials (RCTs) evaluating the efficacy and safety of acupuncture for cold hands. We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial. The proposed study is a five-week pilot RCT. A total of 14 subjects will be recruited and randomly allocated to two groups: an acupuncture plus medication group (experimental group) and a medication-only group (control group). All subjects will take nifedipine (5 mg once daily) and beraprost (20 mg three times daily) for three weeks. The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks (nine sessions total). The primary outcome will be measured using a visual analogue scale. Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands, frequency and duration of episodes of cold hands, and heart rate variability. Assessments will be made at baseline and at one, three, and five weeks thereafter. This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial. This study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the

Kinesio taping and manual pressure release: Short-term effects in subjects with myofasical trigger point.

Science.gov (United States)

Chao, Yu Wen; Lin, Jiu Jenq; Yang, Jing Lan; Wang, Wendy Tzyy-Jiuan

2016-01-01

Randomized controlled trial. Myofascial pain syndrome is characterized by myofascial trigger points (MTrPs) and fascia tenderness. We investigated the effects of manual pressure release (MPR) alone or in combination with taping (MPR/MKT) in subjects with MTrPs. Fifteen and 16 subjects received MPR and MPR/MKT respectively. Outcomes including Pressure pain threshold, muscle stiffness, mechanomyography were assessed at baseline, post-intervention and 7-days later. Pressure pain threshold improved significantly (d = 1.79, p < 0.005) in both groups. Significant improvement in muscle stiffness in the MPR/MKT group (0.27-0.49 mm) as compared to the MPR group (-0.02-0.23 mm). Mechanomyography amplitude in the MPR/MKT group was significantly higher than that of the MPR group (p < 0.05). MPR and MPR/MKT are effective in reducing pain in these subjects. MPR/MKT has a greater effect on muscle stiffness and contraction amplitude. IV. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Short-Term Effects of Electroconvulsive Therapy on Subjective and Actigraphy-Assessed Sleep Parameters in Severely Depressed Inpatients

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Alexander Hoogerhoud

2015-01-01

Full Text Available Background. Sleep disturbances are a key feature of major depression. Electroconvulsive treatment (ECT may improve polysomnography-assessed sleep characteristics, but its short-term effects on actigraphy-assessed and subjective sleep characteristics are unknown. We therefore aimed to assess the effects of ECT on subjective and objective sleep parameters in a proof-of-principle study. Methods. We assessed subjective and objective sleep parameters in 12 severely depressed patients up to 5 consecutive days during their ECT course, corresponding to a total of 43 nights (including 19 ECT sessions. The 12 patients were 83% female and on average 62 (standard deviation (SD 14 years old and had an average MADRS score of 40 at baseline (SD 21. Results. Subjective and objective sleep parameters were not directly affected by ECT. The subjective sleep efficiency parameter was similar on the day after ECT and other days. ECT did not affect the number of errors in the Sustained Attention to Response Task. Patients subjectively underestimated their total sleep time by 1.4 hours (P<0.001 compared to actigraphy-assessed sleep duration. Conclusion. ECT did not affect subjective and actigraphy-assessed sleep in the short term. Depressed patients profoundly underestimated their sleep duration.

How balance task-specific training contributes to improving physical function in older subjects undergoing rehabilitation following hip fracture: a randomized controlled trial.

Science.gov (United States)

Monticone, Marco; Ambrosini, Emilia; Brunati, Roberto; Capone, Antonio; Pagliari, Giulia; Secci, Claudio; Zatti, Giovanni; Ferrante, Simona

2018-03-01

To evaluate the efficacy of a rehabilitation programme including balance task-specific training in improving physical function, pain, activities of daily living (ADL), balance and quality of life in subjects after a hip fracture. Randomized controlled trial. A total of 52 older subjects selected for internal fixation due to extra-capsular hip fracture were randomized to be included in an experimental ( n = 26) and control group ( n = 26). The experimental group underwent a rehabilitation programme based on balance task-specific training. The control group underwent general physiotherapy, including open kinetic chain exercises and walking training. Both groups individually followed programmes of 90-minute sessions five times/week for three weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a Pain Numerical Rating Scale, the Berg Balance Scale, the Functional Independence Measure and the 36-item Short-Form Health Survey. The participants were evaluated before and after training, and after 12 months. Significant effects of time, group and time × group were found for all outcome measures in favour of the experimental group. A clinically important between-group difference of 25 points was achieved after training and at follow-up in terms of the primary outcome (WOMAC function before treatment, after treatment and at follow-up was 84.8 (3.7), 39.8 (4.9) and 35.7 (6.2) for the experimental group and 80.9 (5.7), 65.2 (7.1) and 61.0 (11.1) for the control group). An inpatient rehabilitation programme based on balance task-specific training is useful in improving physical function, pain, ADL and quality of life in older patients after hip fracture.

Long-Term Quality of Life Improvement in Subjects with Healed Erosive Esophagitis: Treatment with Lansoprazole

Science.gov (United States)

Freston, James W.; Haber, Marian M.; Atkinson, Stuart; Hunt, Barbara; Peura, David A.

2009-01-01

Background Gastroesophageal reflux disease (GERD) is a chronic symptomatic condition and may be associated with erosive esophagitis (EE). Considerable data on the long-term maintenance of healing of EE are available, but data on long-term GERD symptom prevention and patient quality of life (QOL) are limited. Aims To investigate QOL in subjects with healed EE who received 12 months of double-blind maintenance treatment with lansoprazole or ranitidine, followed by long-term open-label lansoprazole therapy to prevent recurrence of EE. Methods Subjects with healed EE received 12 months of double-blind maintenance treatment with lansoprazole 15 mg once daily or ranitidine 150 mg twice daily, followed by dose-titrated, open-label lansoprazole therapy for up to 82 months. Results During double-blind treatment (n = 206), lansoprazole-treated patients showed significantly (P ≤ 0.05) greater improvements than ranitidine-treated patients in the frequency, severity, and ‘bothersomeness’ of heartburn, the symptom index, problems of activity limitation, eating and drinking problems, symptom problems, health distress, and social functioning. During dose-titrated, open-label treatment (n = 195), all disease-specific QOL scales except sleep improved significantly (P lansoprazole for 12 months in healed EE subjects produced significantly greater improvements in QOL indicators than ranitidine. These improvements were sustained during dose-titrated, open-label lansoprazole treatment. PMID:19582579

Fermi sea term in the relativistic linear muffin-tin-orbital transport theory for random alloys

Czech Academy of Sciences Publication Activity Database

Turek, Ilja; Kudrnovský, Josef; Drchal, Václav

2014-01-01

Roč. 89, č. 6 (2014), 064405 ISSN 1098-0121 R&D Projects: GA ČR(CZ) GAP204/11/1228 Institutional support: RVO:68081723 ; RVO:68378271 Keywords : electron transport * anomalous Hall effect * random alloys Subject RIV: BM - Solid Matter Physics ; Magnetism Impact factor: 3.736, year: 2014

Short-term corneal changes with gas-permeable contact lens wear in keratoconus subjects: a comparison of two fitting approaches.

Science.gov (United States)

Romero-Jiménez, Miguel; Santodomingo-Rubido, Jacinto; Flores-Rodríguez, Patricia; González-Méijome, Jose-Manuel

2015-01-01

To evaluate changes in anterior corneal topography and higher-order aberrations (HOA) after 14-days of rigid gas-permeable (RGP) contact lens (CL) wear in keratoconus subjects comparing two different fitting approaches. Thirty-one keratoconus subjects (50 eyes) without previous history of CL wear were recruited for the study. Subjects were randomly fitted to either an apical-touch or three-point-touch fitting approach. The lens' back optic zone radius (BOZR) was 0.4mm and 0.1mm flatter than the first definite apical clearance lens, respectively. Differences between the baseline and post-CL wear for steepest, flattest and average corneal power (ACP) readings, central corneal astigmatism (CCA), maximum tangential curvature (KTag), anterior corneal surface asphericity, anterior corneal surface HOA and thinnest corneal thickness measured with Pentacam were compared. A statistically significant flattening was found over time on the flattest and steepest simulated keratometry and ACP in apical-touch group (all p<0.01). A statistically significant reduction in KTag was found in both groups after contact lens wear (all p<0.05). Significant reduction was found over time in CCA (p=0.001) and anterior corneal asphericity in both groups (p<0.001). Thickness at the thinnest corneal point increased significantly after CL wear (p<0.0001). Coma-like and total HOA root mean square (RMS) error were significantly reduced following CL wearing in both fitting approaches (all p<0.05). Short-term rigid gas-permeable CL wear flattens the anterior cornea, increases the thinnest corneal thickness and reduces anterior surface HOA in keratoconus subjects. Apical-touch was associated with greater corneal flattening in comparison to three-point-touch lens wear. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

Science.gov (United States)

2011-01-01

Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

Directory of Open Access Journals (Sweden)

Arce Roger M

2011-02-01

Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

The invariant measure of random walks in the quarter-plane: respresentation in geometric terms

NARCIS (Netherlands)

Chen, Y.; Boucherie, Richardus J.; Goseling, Jasper

We consider the invariant measure of homogeneous random walks in the quarter-plane. In particular, we consider measures that can be expressed as a finite linear combination of geometric terms and present conditions on the structure of these linear combinations such that the resulting measure may

Glucosamine-containing supplement improves locomotor functions in subjects with knee pain: a randomized, double-blind, placebo-controlled study.

Science.gov (United States)

Kanzaki, Noriyuki; Ono, Yoshiko; Shibata, Hiroshi; Moritani, Toshio

2015-01-01

The aim of this study was to investigate the ability of a glucosamine-containing supplement to improve locomotor functions in subjects with knee pain. A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted for 16 weeks in 100 Japanese subjects (age, 51.8±0.8 years) with knee pain. Subjects were randomly assigned to one of the two supplements containing 1) 1,200 mg of glucosamine hydrochloride, 60 mg of chondroitin sulfate, 45 mg of type II collagen peptides, 90 mg of quercetin glycosides, 10 mg of imidazole peptides, and 5 μg of vitamin D per day (GCQID group, n=50) or 2) a placebo (placebo group, n=50). Japanese Knee Osteoarthritis Measure, visual analog scale score, normal walking speed, and knee-extensor strength were measured to evaluate the effects of the supplement on knee-joint functions and locomotor functions. In subjects eligible for efficacy assessment, there was no significant group × time interaction, and there were improvements in knee-joint functions and locomotor functions in both groups, but there was no significant difference between the groups. In subjects with mild-to-severe knee pain at baseline, knee-extensor strength at week 8 (104.6±5.0% body weight vs 92.3±5.5% body weight, P=0.030) and the change in normal walking speed at week 16 (0.11±0.03 m/s vs 0.05±0.02 m/s, P=0.038) were significantly greater in the GCQID group than in the placebo group. Further subgroup analysis based on Kellgren-Lawrence (K-L) grade showed that normal walking speed at week 16 (1.36±0.05 m/s vs 1.21±0.02 m/s, Pknee pain, GCQID supplementation was effective for relieving knee pain and improving locomotor functions.

Patterns of Change in Interpersonal Problems During and After Short-term and Long-term Psychodynamic Group Therapy: A Randomized Clinical Trial.

Science.gov (United States)

Fjeldstad, Anette; Høglend, Per; Lorentzen, Steinar

2017-05-01

In this study, we compared the patterns of change in interpersonal problems between short-term and long-term psychodynamic group therapy. A total of 167 outpatients with mixed diagnoses were randomized to 20 or 80 weekly sessions of group therapy. Interpersonal problems were assessed with the Inventory of Interpersonal Problems at six time points during the 3-year study period. Using linear mixed models, change was linearly modelled in two steps. Earlier (within the first 6 months) and later (during the last 2.5 years) changes in five subscales were estimated. Contrary to what we expected, short-term therapy induced a significantly larger early change than long-term therapy on the cold subscale and there was a trend on the socially avoidant subscale, using a Bonferroni-adjusted alpha. There was no significant difference between short-term and long-term group therapy for improving problems in the areas cold, socially avoidant, nonassertive, exploitable, and overly nurturant over the 3 years.

Medium-term energy hub management subject to electricity price and wind uncertainty

International Nuclear Information System (INIS)

Najafi, Arsalan; Falaghi, Hamid; Contreras, Javier; Ramezani, Maryam

2016-01-01

Highlights: • A new model for medium-term energy hub management is proposed. • Risk aversion is considered in medium-term energy hub management. • Stochastic programing is used to solve the medium-term energy hub management problem. • Electricity price and wind uncertainty are considered. - Abstract: Energy hubs play an important role in implementing multi-carrier energy systems. More studies are required in both their modeling and operating aspects. In this regard, this paper attempts to develop medium-term management of an energy hub in restructured power systems. A model is presented to manage an energy hub which has electrical energy and natural gas as inputs and electrical and heat energy as outputs. Electricity is procured in various ways, either purchasing it from a pool-based market and bilateral contracts, or producing it from a Combined Heat and Power (CHP) unit, a diesel generator unit and Wind Turbine Generators (WTGs). Pool prices and wind turbine production are subject to uncertainty, which makes energy management a complex puzzle. Heat demand is also procured by a furnace and a CHP unit. Energy hub managers should make decisions whether to purchase electricity from the electricity market and gas from the gas network or to produce electricity using a set of generators to meet the electrical and heat demands in the presence of uncertainties. The energy management objective is to minimize the total cost subject to several technical constraints using stochastic programming. Conditional Value at Risk (CVaR), a well-known risk measure, is used to reduce the unfavorable risk of costs. In doing so, the proposed model is illustrated using a sample test case with actual prices, load and wind speed data. The results show that the minimum cost is obtained by the best decisions involving the electricity market and purchasing natural gas for gas facilities. Considering risk also increases the total expected cost and decreases the CVaR.

A randomized, double-blind, placebo-controlled trial of a traditional herbal formula, Yukmijihwang-tang in elderly subjects with xerostomia.

Science.gov (United States)

Han, Gajin; Ko, Seok-Jae; Kim, Juyeon; Oh, Ja-Young; Park, Jae-Woo; Kim, Jinsung

2016-04-22

Yukmijihwang-tang (YMJ) is a typical herbal formula to treat Yin-deficiency (YD) syndrome by enriching the fluid-humor of the body. YMJ has been used to treat dry mouth symptoms for hundreds of years in traditional East Asian medicine. Xerostomia, a subjective oral dryness, is common in the elderly and results in impaired quality of life. Many conventional treatments for xerostomia provide only temporary symptom relief, and have side effects. The aim of this study is to investigate the efficacy and safety of YMJ for the treatment of xerostomia in the elderly. This study was designed as a randomized, placebo-controlled, double-blinded, two center trial. Ninety-six subjects aged 60-80 years who had experienced xerostomia for at least 3 months and presented with score>40 on the visual analog scale (VAS) for subjective oral dryness were recruited and randomly allocated to YMJ and placebo groups. YMJ or placebo was administered to each group for 8 weeks (3g of YMJ or placebo, three times per day). The primary outcome was change of VAS for xerostomia from 0 to 8 weeks. VAS for xerostomia was decreased by 22.04±22.76 in the YMJ group and 23.58±23.04 in the placebo group. YMJ had no effect on xerostomia. However, participants with BMIs lower than 29.37kg/m(2) showed improvement of xerostomia after 8 weeks of treatment with YMJ compared to placebo. In addition, YMJ improved oral moisture, which is associated with subjective oral dryness in the YMJ group, and the relationship between VAS for xerostomia and YD was significant. A trend was observed in which YMJ improved oral moisture status and subjective oral dryness in elderly subjects with lower BMI and greater tendency toward YD. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program.

NARCIS (Netherlands)

Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

2006-01-01

OBJECTIVE: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. METHOD: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program

NARCIS (Netherlands)

Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

2006-01-01

Objective: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. Method: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

Long-term clearance from small airways in subjects with ciliary dysfunction

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Hjelte Lena

2006-05-01

Full Text Available Abstract The objective of this study was to investigate if long-term clearance from small airways is dependent on normal ciliary function. Six young adults with primary ciliary dyskinesia (PCD inhaled 111 Indium labelled Teflon particles of 4.2 μm geometric and 6.2 μm aerodynamic diameter with an extremely slow inhalation flow, 0.05 L/s. The inhalation method deposits particles mainly in the small conducting airways. Lung retention was measured immediately after inhalation and at four occasions up to 21 days after inhalation. Results were compared with data from ten healthy controls. For additional comparison three of the PCD subjects also inhaled the test particles with normal inhalation flow, 0.5 L/s, providing a more central deposition. The lung retention at 24 h in % of lung deposition (Ret24 was higher (p 24 with slow inhalation flow was 73.9 ± 1.9 % compared to 68.9 ± 7.5 % with normal inhalation flow in the three PCD subjects exposed twice. During day 7–21 the three PCD subjects exposed twice cleared 9 % with normal flow, probably representing predominantly alveolar clearance, compared to 19 % with slow inhalation flow, probably representing mainly small airway clearance. This study shows that despite ciliary dysfunction, clearance continues in the small airways beyond 24 h. There are apparently additional clearance mechanisms present in the small airways.

A report on evaluation of research and development subjects in fiscal year 2001. Evaluation subject on the 'Middle- and long-term business program'

International Nuclear Information System (INIS)

2001-09-01

The middle- and long-term business program determined by the Japan Nuclear Cycle Development Institute (JNC) is for elucidation of middle- and long-term targets to be expanded by JNC and is a base to promote individual R and D. This program is to be revised at a chance established on new long-term plan on research, development and application of nuclear energy on November, 2000 by the Committee of Atomic Energy under consideration of condition change after March, 1999. This report is a summary of evaluation results on the present middle- and long-term business program established by JNC, especially at a center of its revised portion, as a form of opinion. The evaluated results are described on two forms of the subject evaluation committees on the fast reactor and fuel cycle and on the wastes processing and disposal. (G.K.)

Pedagogical Factors Stimulating the Self-Development of Students' Multi-Dimensional Thinking in Terms of Subject-Oriented Teaching

Science.gov (United States)

Andreev, Valentin I.

2014-01-01

The main aim of this research is to disclose the essence of students' multi-dimensional thinking, also to reveal the rating of factors which stimulate the raising of effectiveness of self-development of students' multi-dimensional thinking in terms of subject-oriented teaching. Subject-oriented learning is characterized as a type of learning where…

Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies.

Science.gov (United States)

Studerus, Erich; Kometer, Michael; Hasler, Felix; Vollenweider, Franz X

2011-11-01

Psilocybin and related hallucinogenic compounds are increasingly used in human research. However, due to limited information about potential subjective side effects, the controlled medical use of these compounds has remained controversial. We therefore analysed acute, short- and long-term subjective effects of psilocybin in healthy humans by pooling raw data from eight double-blind placebo-controlled experimental studies conducted between 1999 and 2008. The analysis included 110 healthy subjects who had received 1-4 oral doses of psilocybin (45-315 µg/kg body weight). Although psilocybin dose-dependently induced profound changes in mood, perception, thought and self-experience, most subjects described the experience as pleasurable, enriching and non-threatening. Acute adverse drug reactions, characterized by strong dysphoria and/or anxiety/panic, occurred only in the two highest dose conditions in a relatively small proportion of subjects. All acute adverse drug reactions were successfully managed by providing interpersonal support and did not need psychopharmacological intervention. Follow-up questionnaires indicated no subsequent drug abuse, persisting perception disorders, prolonged psychosis or other long-term impairment of functioning in any of our subjects. The results suggest that the administration of moderate doses of psilocybin to healthy, high-functioning and well-prepared subjects in the context of a carefully monitored research environment is associated with an acceptable level of risk.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial.

Science.gov (United States)

Frass, Michael; Friehs, Helmut; Thallinger, Christiane; Sohal, Narinderjit Kaur; Marosi, Christine; Muchitsch, Ilse; Gaertner, Katharina; Gleiss, Andreas; Schuster, Ernst; Oberbaum, Menachem

2015-06-01

The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Fast state estimation subject to random data loss in discrete-time nonlinear stochastic systems

Science.gov (United States)

Mahdi Alavi, S. M.; Saif, Mehrdad

2013-12-01

This paper focuses on the design of the standard observer in discrete-time nonlinear stochastic systems subject to random data loss. By the assumption that the system response is incrementally bounded, two sufficient conditions are subsequently derived that guarantee exponential mean-square stability and fast convergence of the estimation error for the problem at hand. An efficient algorithm is also presented to obtain the observer gain. Finally, the proposed methodology is employed for monitoring the Continuous Stirred Tank Reactor (CSTR) via a wireless communication network. The effectiveness of the designed observer is extensively assessed by using an experimental tested-bed that has been fabricated for performance evaluation of the over wireless-network estimation techniques under realistic radio channel conditions.

Time domain simulation of the response of geometrically nonlinear panels subjected to random loading

Science.gov (United States)

Moyer, E. Thomas, Jr.

1988-01-01

The response of composite panels subjected to random pressure loads large enough to cause geometrically nonlinear responses is studied. A time domain simulation is employed to solve the equations of motion. An adaptive time stepping algorithm is employed to minimize intermittent transients. A modified algorithm for the prediction of response spectral density is presented which predicts smooth spectral peaks for discrete time histories. Results are presented for a number of input pressure levels and damping coefficients. Response distributions are calculated and compared with the analytical solution of the Fokker-Planck equations. RMS response is reported as a function of input pressure level and damping coefficient. Spectral densities are calculated for a number of examples.

A Solution Method for Linear and Geometrically Nonlinear MDOF Systems with Random Properties subject to Random Excitation

DEFF Research Database (Denmark)

Micaletti, R. C.; Cakmak, A. S.; Nielsen, Søren R. K.

structural properties. The resulting state-space formulation is a system of ordinary stochastic differential equations with random coefficient and deterministic initial conditions which are subsequently transformed into ordinary stochastic differential equations with deterministic coefficients and random......A method for computing the lower-order moments of randomly-excited multi-degree-of-freedom (MDOF) systems with random structural properties is proposed. The method is grounded in the techniques of stochastic calculus, utilizing a Markov diffusion process to model the structural system with random...... initial conditions. This transformation facilitates the derivation of differential equations which govern the evolution of the unconditional statistical moments of response. Primary consideration is given to linear systems and systems with odd polynomial nonlinearities, for in these cases...

The blocked-random effect in pictures and words.

Science.gov (United States)

Toglia, M P; Hinman, P J; Dayton, B S; Catalano, J F

1997-06-01

Picture and word recall was examined in conjunction with list organization. 60 subjects studied a list of 30 items, either words or their pictorial equivalents. The 30 words/pictures, members of five conceptual categories, each represented by six exemplars, were presented either blocked by category or in a random order. While pictures were recalled better than words and a standard blocked-random effect was observed, the interaction indicated that the recall advantage of a blocked presentation was restricted to the word lists. A similar pattern emerged for clustering. These findings are discussed in terms of limitations upon the pictorial superiority effect.

Efficacy of Water Resistance Therapy in Subjects Diagnosed With Behavioral Dysphonia: A Randomized Controlled Trial.

Science.gov (United States)

Guzman, Marco; Jara, Rodrigo; Olavarria, Christian; Caceres, Paloma; Escuti, Geordette; Medina, Fernanda; Medina, Laura; Madrid, Sofia; Muñoz, Daniel; Laukkanen, Anne-Maria

2017-05-01

The purpose of the present study was to determine the efficacy of water resistance therapy (WRT) in a long-term period of voice treatment in subjects diagnosed with voice disorders. Twenty participants, with behavioral dysphonia, were randomly assigned to one of two treatment groups: (1) voice treatment with WRT, and (2) voice treatment with tube phonation with the distal end in air (TPA). Before and after voice therapy, participants underwent aerodynamic, electroglottographic, acoustic, and auditory-perceptual assessments. The Voice Handicap Index and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the WRT group, the exercises consisted of a sequence of five phonatory tasks performed with a drinking straw submerged 5 cm into water. For the TPA, the exercises consisted of the same phonatory tasks, and all of them were performed into the same straw but the distal end was in air. Wilcoxon test showed significant improvements for both groups for Voice Handicap Index (decrease), subglottic pressure (decrease), phonation threshold pressure (decrease), and self-perception of resonant voice quality (increase). Improvement in auditory-perceptual assessment was found only for the TPA group. No significant differences were found for any acoustic or electroglottographic variables. No significant differences were found between WRT and TPA groups for any variable. WRT and TPA may improve voice function and self-perceived voice quality in individuals with behavioral dysphonia. No differences between these therapy protocols should be expected. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Enhancing trunk stability in acute poststroke subjects using physioball exercise and proprioceptive neuromuscular facilitation technique: A pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ravichandran Hariharasudhan

2016-01-01

Full Text Available Background: Stroke is one of the leading causes of death and disability worldwide. Poststroke, most survivors experience trunk control impairment and instability. Previous works on exercise on an unstable surface to improve trunk stability in nonstroke population had proven effective. Thus, physioball exercises (PBEs in poststroke subjects may be useful in the recovery of trunk stability and thereby reduce disability. We hypothesize that PBE is feasible and effective in enhancing trunk stability. Aims: To test the feasibility and successful implementation of conducting a randomized controlled study to assess the clinical effectiveness of PBE and proprioceptive neuromuscular facilitation (PNF technique to enhance trunk control in poststroke subjects. Methods: This study was conducted in a stroke unit of Global Hospitals and Health City, Chennai, India. Thirty patients with the first onset of stroke within 40 days of stroke duration, lesion to one side, and ability to sit independently with or without arm support for 15 days were recruited. All thirty poststroke subjects were randomized either into PBE group or PNF group, and outcome assessors involved in the trail were blinded to allocation. PBE group performed task-oriented activities on an unstable surface and PNF group were treated with PNF-specific trunk stability exercise program for 4 weeks (30 min/day, 5 times/week. Trunk impairment scale (TIS was used as a main outcome measure. Results: Data were analyzed using Wilcoxon signed rank sum test and Mann–Whitney U-test for intra- and inter-group comparison. The baseline characteristics between both groups were statistically nonsignificant. Within groups, there were significant improvements between baseline and at 4 weeks in the measure of TIS. In addition, PBE group showed a significant increase in trunk control (mean 2.33, 95% confidence interval 1.14-3.52, P = 0.002 than the PNF subject. Conclusion: This pilot randomized controlled trial

Radiation Therapy Did Not Induce Long-Term Changes in Rectal Mucosa: Results From the Randomized Scandinavian Prostate Cancer Group 7 Trial

Energy Technology Data Exchange (ETDEWEB)

Slagsvold, Jens Erik, E-mail: Jens.Erik.Slagsvold@stolav.no [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Viset, Trond [Department of Pathology, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Wibe, Arne [Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Department of Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Kaasa, Stein [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Widmark, Anders [Department of Radiation Sciences, Cancercentrum, Umeå (Sweden); Lund, Jo-Åsmund [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway)

2016-07-15

Purpose: To investigate long-term changes in the rectal mucosa after curative external beam radiation therapy in the treatment of prostate cancer. Methods and Materials: In the Scandinavian Prostate Cancer Group 7 trial, 880 men with locally advanced prostate cancer were randomized to hormonal therapy alone versus hormonal therapy plus radiation therapy to 70 Gy. A subcohort from this trial being randomized at our center (n=178) was invited to a study on late anorectal side effects during 2003-2005, approximately 5 years after treatment, including measuring health-reported quality of life and physician-assessed toxicity score by the Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group score. Sixty-seven patients had a rectal mucosa biopsy. Sixty-four biopsies were included in the final analysis, of which 33 patients were randomized to hormonal treatment and 31 to hormonal treatment plus radiation therapy. The presence of fibrosis, number of capillaries, and lymphocyte infiltration was then evaluated by light microscopy. Results: The group receiving radiation therapy had significantly higher LENT/SOMA and function/bother scale scores than the group that only received hormonal treatment, but there was no significant difference in the presence of fibrosis, ectasia, number of capillaries in the lamina propria, or lymphocyte infiltration between the groups. Conclusion: Radiation therapy to 70 Gy to the prostate does not induce long-term microscopic mucosal changes in the rectum 5 years after treatment. This is in contrast to the general assumption that structural changes, including fibrosis, seen after radiation therapy include the mucosa. We speculate that the main late effects of radiation therapy on the structure of the rectum are located in the deeper layers of the rectal wall than the mucosa.

The effects of short-term alpha-ketoisocaproic acid supplementation on exercise performance: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Yarrow Joshua F

2007-07-01

Full Text Available Abstract Background This study examined the efficacy of short-term alpha-ketoisocaproic acid (KIC monotherapy supplementation immediately prior to moderate- and high-intensity single bout exercise performance. Methods Thirteen resistance trained men (22.8 ± 2.5 years; 81.6 ± 12.6 kg participated in a prospective, randomized, double blind, placebo controlled crossover experiment. Each subject completed one familiarization and four experimental trials with either 1.5 g or 9.0 g of either KIC or isocaloric placebo control (CONT, following an overnight fast. During the experimental trials, subjects consumed the supplement regimen and then completed leg and chest press repetitions to failure and 30 s of repeated maximal vertical jumping (VJ on a force plate. Results In this treatment regimen, no significant differences (p > 0.05 were observed between dosages or conditions for leg press (low CONT = 19.8 ± 0.4 SEM, low KIC = 21.0 ± 0.5, high CONT = 20.1 ± 0.3, high KIC = 22.4 ± 0.6 or chest press (low CONT = 18.1 ± 0.2, low KIC = 18.5 ± 0.3, high CONT = 17.8 ± 0.3, high KIC = 18.0 ± 0.3 repetitions to failure. Additionally, no significant differences were observed for peak or mean VJ performance (low CONT = 34.6 ± 2.2 cm and 28.6 ± 1.8 cm; low KIC = 35.6 ± 2.0 cm and 29.4 ± 1.6 cm; high CONT = 35.7 ± 2.1 cm and 29.4 ± 1.7 cm; high KIC = 34.8 ± 2.3 cm and 28.3 ± 1.7 cm, respectively. Conclusion Based on our results, we conclude that acute KIC ingestion by itself with no other ergogenic supplement, immediately prior to exercise, did not alter moderate- nor high-intensity single-bout exercise performance in young resistance-trained males. This study addressed single-dose single-bout performance events; the efficacy of KIC monotherapy supplementation on repeated high-intensity exercise bouts and long-term exercise training remains unknown.

A Logistic Regression Model with a Hierarchical Random Error Term for Analyzing the Utilization of Public Transport

Directory of Open Access Journals (Sweden)

Chong Wei

2015-01-01

Full Text Available Logistic regression models have been widely used in previous studies to analyze public transport utilization. These studies have shown travel time to be an indispensable variable for such analysis and usually consider it to be a deterministic variable. This formulation does not allow us to capture travelers’ perception error regarding travel time, and recent studies have indicated that this error can have a significant effect on modal choice behavior. In this study, we propose a logistic regression model with a hierarchical random error term. The proposed model adds a new random error term for the travel time variable. This term structure enables us to investigate travelers’ perception error regarding travel time from a given choice behavior dataset. We also propose an extended model that allows constraining the sign of this error in the model. We develop two Gibbs samplers to estimate the basic hierarchical model and the extended model. The performance of the proposed models is examined using a well-known dataset.

Using Exponential Random Graph Models to Analyze the Character of Peer Relationship Networks and Their Effects on the Subjective Well-being of Adolescents.

Science.gov (United States)

Jiao, Can; Wang, Ting; Liu, Jianxin; Wu, Huanjie; Cui, Fang; Peng, Xiaozhe

2017-01-01

The influences of peer relationships on adolescent subjective well-being were investigated within the framework of social network analysis, using exponential random graph models as a methodological tool. The participants in the study were 1,279 students (678 boys and 601 girls) from nine junior middle schools in Shenzhen, China. The initial stage of the research used a peer nomination questionnaire and a subjective well-being scale (used in previous studies) to collect data on the peer relationship networks and the subjective well-being of the students. Exponential random graph models were then used to explore the relationships between students with the aim of clarifying the character of the peer relationship networks and the influence of peer relationships on subjective well being. The results showed that all the adolescent peer relationship networks in our investigation had positive reciprocal effects, positive transitivity effects and negative expansiveness effects. However, none of the relationship networks had obvious receiver effects or leaders. The adolescents in partial peer relationship networks presented similar levels of subjective well-being on three dimensions (satisfaction with life, positive affects and negative affects) though not all network friends presented these similarities. The study shows that peer networks can affect an individual's subjective well-being. However, whether similarities among adolescents are the result of social influences or social choices needs further exploration, including longitudinal studies that investigate the potential processes of subjective well-being similarities among adolescents.

Short-term and long-term effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Li, Ruifei; Wang, Rui; Li, Haixia; Sun, Sihao; Zou, Meijuan; Cheng, Gang

2016-09-01

To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12 weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p 1] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015

Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial.

Science.gov (United States)

Rostami, Reza; Salamati, Payman; Yarandi, Kourosh Karimi; Khoshnevisan, Alireza; Saadat, Soheil; Kamali, Zeynab Sadat; Ghiasi, Somaie; Zaryabi, Atefeh; Ghazi Mir Saeid, Seyed Shahab; Arjipour, Mehdi; Rezaee-Zavareh, Mohammad Saeid; Rahimi-Movaghar, Vafa

2017-10-01

There are some studies which showed neurofeedback therapy (NFT) can be effective in clients with traumatic brain injury (TBI) history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA) and short-term memory (STM) of clients with moderate TBI using a randomized controlled clinical trial (RCT). In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV) test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16) years and (27.60 ± 8.17) years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05). Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Copyright © 2017 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Production and hosting by Elsevier B.V. All rights reserved.

Long-term aerobic exercise and omega-3 supplementation modulate osteoporosis through inflammatory mechanisms in post-menopausal women: a randomized, repeated measures study

Directory of Open Access Journals (Sweden)

Kanaley Jill

2011-10-01

Full Text Available Abstract Background Evidence indicates that dietary fats and physical activity influence bone health. The purpose of this study was to examine the effects of long-term aerobic exercise and omega-3 (N-3 supplementation on serum inflammatory markers, bone mineral density (BMD, and bone biomarkers in post-menopausal women. Methods Seventy-nine healthy sedentary post-menopausal women aged 58-78 years participated in this study. Subjects were randomized to one of 4 groups: exercise + supplement (E+S, n = 21, exercise (E, n = 20, supplement (S, n = 20, and control (Con, n = 18 groups. The subjects in the E+S and E groups performed aerobic exercise training (walking and jogging up to 65% of HRmax, three times a week for 24 weeks. Subjects in the E+S and S groups consumed 1000 mg/d N-3 for 24 weeks. The lumbar spine (L2-L4 and femoral neck BMD, serum tumor necrosis factor (TNF α, interleukin (IL 6, prostaglandin (PG E2, estrogen, osteocalcin, 1, 25-dihydroxyvitamin D3 (1, 25 Vit D, C-telopeptide (CTX, parathyroid hormone (PTH and calcitonin (CT were measured at baseline, the end of week 12 and 24. Results Serum estrogen, osteocalcin, 1, 25 Vit D, CT, L2-L4 and femoral neck BMD measures increased (P 2 decreased (P 2-L4 and femoral neck BMD, estrogen, osteocalcin, and CT were negatively (P 2. PTH and CT were correlated positively and negatively with IL-6, respectively (P Conclusions The present study demonstrates that long-term aerobic exercise training plus N-3 supplementation have a synergistic effect in attenuating inflammation and augmenting BMD in post-menopausal osteoporosis.

Remifentanil analgesia during external cephalic version for breech presentation in nulliparous women at term: A randomized controlled trial.

Science.gov (United States)

Wang, Zhi-Hong; Yang, Yi; Xu, Gui-Ping

2017-03-01

The aim of the study was to assess the efficacy and safety of remifentanil for pain relief during external cephalic version (ECV) for breech presentation in nulliparous women at term. A total of 144 nulliparous women with singleton breech presentation were randomly divided into the intervention group and the placebo group, with 72 subjects in each group. The subjects in the intervention group received remifentanil (infused at 0.1 μg kg min with demand boluses of 0.1 μg/kg), whereas those in the placebo group were given saline placebo. This study was conducted from May 2013 to April 2016. The outcomes measures include pain (measured with the visual analog scale, VAS), success rate of ECV, maternal satisfaction for ECV, and adverse events. A total of 137 participants completed the study. The intervention with remifentanil showed greater efficacy than did placebo in decreasing the VAS score immediately after ECV (intervention group 4.3 ± 2.2 vs placebo group 6.4 ± 2.5, P < 0.01). A significant difference in the ECV success rate was also found between the 2 groups (intervention group 56.9% vs placebo group 38.9%, P = 0.03). In addition, a significant difference in the satisfaction score was also detected (intervention group 9.3 ± 0.9 vs placebo group 6.7 ± 1.2, P < 0.01). The observed adverse events were similar between the 2 groups. This study shows that remifentanil could decrease pain, improve the ECV success rate, and improve satisfaction in nulliparous women at term during the period of ECV. Furthermore, it is also well tolerated with few adverse events.

Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting.

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Belsches, Theodore C; Tilly, Alyssa E; Miller, Tonya R; Kambeyanda, Rohan H; Leadford, Alicia; Manasyan, Albert; Chomba, Elwyn; Ramani, Manimaran; Ambalavanan, Namasivayam; Carlo, Waldemar A

2013-09-01

Term infants in resource-poor settings frequently develop hypothermia during the first hours after birth. Plastic bags or wraps are a low-cost intervention for the prevention of hypothermia in preterm and low birth weight infants that may also be effective in term infants. Our objective was to test the hypothesis that placement of term neonates in plastic bags at birth reduces hypothermia at 1 hour after birth in a resource-poor hospital. This parallel-group randomized controlled trial was conducted at University Teaching Hospital, the tertiary referral center in Zambia. Inborn neonates with both a gestational age ≥37 weeks and a birth weight ≥2500 g were randomized 1:1 to either a standard thermoregulation protocol or to a standard thermoregulation protocol with placement of the torso and lower extremities inside a plastic bag within 10 minutes after birth. The primary outcome was hypothermia (plastic bag (n = 135) or to standard thermoregulation care (n = 136) had similar baseline characteristics (birth weight, gestational age, gender, and baseline temperature). Neonates in the plastic bag group had a lower rate of hypothermia (60% vs 73%, risk ratio 0.76, confidence interval 0.60-0.96, P = .026) and a higher axillary temperature (36.4 ± 0.5°C vs 36.2 ± 0.7°C, P plastic bag at birth reduced the incidence of hypothermia at 1 hour after birth in term neonates born in a resource-poor setting, but most neonates remained hypothermic.

Metacognition of visual short-term memory: Dissociation between objective and subjective components of VSTM

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Silvia eBona

2013-02-01

Full Text Available The relationship between the objective accuracy of visual-short term memory (VSTM representations and their subjective conscious experience is unknown. We investigated this issue by assessing how the objective and subjective components of VSTM in a delayed cue-target orientation discrimination task are affected by intervening distracters. On each trial, participants were shown a memory cue (a grating, the orientation of which they were asked to hold in memory. On approximately half of the trials, a distractor grating appeared during the maintenance interval; its orientation was either identical to that of the memory cue, or it differed by 10 or 40 degrees. The distractors were masked and presented briefly, so they were only consciously perceived on a subset of trials. At the end of the delay period, a memory test probe was presented, and participants were asked to indicate whether it was tilted to the left or right relative to the memory cue (VSTM accuracy; objective performance. In order to assess subjective metacognition, participants were asked indicate the vividness of their memory for the original memory cue. Finally, participants were asked rate their awareness of the distracter. Results showed that objective VSTM performance was impaired by distractors only when the distractors were very different from the cue, and that this occurred with both subjectively visible and invisible distractors. Subjective metacognition, however, was impaired by distractors of all orientations, but only when these distractors were subjectively invisible. Our results thus indicate that the objective and subjective components of VSTM are to some extent dissociable.

Quantifying and Characterizing Tonic Thermal Pain Across Subjects From EEG Data Using Random Forest Models.

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Vijayakumar, Vishal; Case, Michelle; Shirinpour, Sina; He, Bin

2017-12-01

Effective pain assessment and management strategies are needed to better manage pain. In addition to self-report, an objective pain assessment system can provide a more complete picture of the neurophysiological basis for pain. In this study, a robust and accurate machine learning approach is developed to quantify tonic thermal pain across healthy subjects into a maximum of ten distinct classes. A random forest model was trained to predict pain scores using time-frequency wavelet representations of independent components obtained from electroencephalography (EEG) data, and the relative importance of each frequency band to pain quantification is assessed. The mean classification accuracy for predicting pain on an independent test subject for a range of 1-10 is 89.45%, highest among existing state of the art quantification algorithms for EEG. The gamma band is the most important to both intersubject and intrasubject classification accuracy. The robustness and generalizability of the classifier are demonstrated. Our results demonstrate the potential of this tool to be used clinically to help us to improve chronic pain treatment and establish spectral biomarkers for future pain-related studies using EEG.

The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial.

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Saral, Ilknur; Sindel, Dilsad; Esmaeilzadeh, Sina; Sertel-Berk, Hanife Ozlem; Oral, Aydan

2016-10-01

We investigated the effects of long- and short-term interdisciplinary treatment approaches for reducing symptoms and improving health-related quality of life (HRQoL) and physical functions of patients with fibromyalgia and compared the effects of two different interdisciplinary treatment approaches. We conducted a prospective, randomized, controlled trial involving 66 women with fibromyalgia eligible for the study at a university hospital setting. The patients were randomized into three groups (allocation ratio 1:1:1) using a computer-generated random numbers: a long-term interdisciplinary treatment group (LG, n = 22) that participated in 10 sessions (3-h once-weekly session for 10 weeks) of cognitive behavioral therapy (CBT) together with exercise training and other fibromyalgia related educational programs (two full days); a short-term interdisciplinary treatment group (SG, n = 22) that received two full days of educational, exercise, and CBT programs; and a control group (CG, n = 22). The patients were evaluated at baseline and 6 months after treatment using the visual analog scale (pain, fatigue, and sleep), Fibromyalgia Impact Questionnaire, Beck Depression Inventory, Short Form-36, tender point numbers, and pressure algometry as primary outcomes. The statistical analysis was confined to the 'per-protocol' set. No blinding was performed. The number of patients analyzed was 21 in the LG, 19 in the SG, and 19 in the CG. The intensity of pain (p treatment approaches when compared with controls; the long-term treatment was found more effective in reducing pain than the short-term. Both, long- and short-term interdisciplinary treatments were effective in reducing the severity of some symptoms and disease activity in patients with fibromyalgia. The short-term program well meets the needs of women with fibromyalgia particularly in relation to pain and health status as measured using FIQ; however, a long-term program may be beneficial in reducing fatigue and

Effect of baking process on postprandial metabolic consequences: randomized trials in normal and type 2 diabetic subjects.

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Rizkalla, S W; Laromiguiere, M; Champ, M; Bruzzo, F; Boillot, J; Slama, G

2007-02-01

To determine the impact of the form, fibre content, baking and processing on the glycaemic, insulinaemic and lipidaemic responses of different French breads. First study: Nine healthy subjects were randomized to consume in a crossover design one of six kinds of French bread (each containing 50 g available carbohydrate): classic baguette, traditional baguette, loaf of wholemeal bread (WM-B), loaf of bread fermented with yeast or with leaven, a sandwich and a glucose challenge as reference. The glycaemic index (GI) values ranged from 57+/-9% (mean+/-s.e.m.), for the traditional baguette, to 85+/-27% for the WM-B. No significant difference was found among the different tested bread. The insulinaemic index (II), however, of the traditional baguette and of the bread fermented with leaven were lower than the other breads (analysis of variance: Pvarieties of French bread (the TB) have lower II, in healthy subjects, and lower GI, in type 2 diabetic subjects, than that of the other varieties. These results might be due to bread processing difference rather than fibre content. Supported by grants from the National French Milling Association.

Noradrenergic α1 Receptor Antagonist Treatment Attenuates Positive Subjective Effects of Cocaine in Humans: A Randomized Trial

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Newton, Thomas F.; De La Garza, Richard; Brown, Gregory; Kosten, Thomas R.; Mahoney, James J.; Haile, Colin N.

2012-01-01

Background Preclinical research implicates dopaminergic and noradrenergic mechanisms in mediating the reinforcing effects of drugs of abuse, including cocaine. The objective of this study was to evaluate the impact of treatment with the noradrenergic α1 receptor antagonist doxazosin on the positive subjective effects of cocaine. Methods Thirteen non-treatment seeking, cocaine-dependent volunteers completed this single-site, randomized, placebo-controlled, within-subjects study. In one study phase volunteers received placebo and in the other they received doxazosin, with the order counterbalanced across participants. Study medication was masked by over-encapsulating doxazosin tablets and matched placebo lactose served as the control. Study medication treatment was initiated at 1 mg doxazosin or equivalent number of placebo capsules PO/day and increased every three days by 1 mg. After receiving 4 mg doxazosin or equivalent number of placebo capsules participants received masked doses of 20 and 40 mg cocaine IV in that order with placebo saline randomly interspersed to maintain the blind. Results Doxazosin treatment was well tolerated and doxazosin alone produced minimal changes in heart rate and blood pressure. During treatment with placebo, cocaine produced dose-dependent increases in subjective effect ratings of “high”, “stimulated”, “like cocaine”, “desire cocaine”, “any drug effect”, and “likely to use cocaine if had access” (p<.001). Doxazosin treatment significantly attenuated the effects of 20 mg cocaine on ratings of “stimulated”, “like cocaine”, and “likely to use cocaine if had access” (p<.05). There were trends for doxazosin to reduce ratings of “stimulated”, “desire cocaine”, and “likely to use cocaine if had access” (p<.10). Conclusions Medications that block noradrenergic α1 receptors, such as doxazosin, may be useful as treatments for cocaine dependence, and should be evaluated further. Trial

Characteristics of men with substance use disorder consequent to illicit drug use: comparison of a random sample and volunteers.

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Reynolds, Maureen D; Tarter, Ralph E; Kirisci, Levent

2004-09-06

Men qualifying for substance use disorder (SUD) consequent to consumption of an illicit drug were compared according to recruitment method. It was hypothesized that volunteers would be more self-disclosing and exhibit more severe disturbances compared to randomly recruited subjects. Personal, demographic, family, social, substance use, psychiatric, and SUD characteristics of volunteers (N = 146) were compared to randomly recruited (N = 102) subjects. Volunteers had lower socioceconomic status, were more likely to be African American, and had lower IQ than randomly recruited subjects. Volunteers also evidenced greater social and family maladjustment and more frequently had received treatment for substance abuse. In addition, lower social desirability response bias was observed in the volunteers. SUD was not more severe in the volunteers; however, they reported a higher lifetime rate of opiate, diet, depressant, and analgesic drug use. Volunteers and randomly recruited subjects qualifying for SUD consequent to illicit drug use are similar in SUD severity but differ in terms of severity of psychosocial disturbance and history of drug involvement. The factors discriminating volunteers and randomly recruited subjects are well known to impact on outcome, hence they need to be considered in research design, especially when selecting a sampling strategy in treatment research.

Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

OpenAIRE

Yadollah Zahed Pasha; Mousa Ahmadpour-kacho; Abes Ahmadi Jazi; Hemmat Gholinia

2017-01-01

Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL) is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for photother...

Visual discrimination and short-term memory for random patterns in patients with a focal cortical lesion

NARCIS (Netherlands)

Greenlee, MW; Koessler, M; Cornelissen, FW; Mergner, T

1997-01-01

Visual discrimination and short-term recognition memory for computer-generated random patterns were explored in 23 patients with a postsurgical lesion in one of the cortical hemispheres. Their results are compared with those of 23 age-matched volunteers. In a same-different forced-choice

The Cardiovascular Function Profile and Physical Fitness in Overweight Subjects

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Megawati, E. R.; Lubis, L. D.; Harahap, F. Y.

2017-03-01

Obesity in children and young adult is associated with cardiovascular risk in short term and long term. The aim of this study was to describe the profile of the cardiovascular functions parameters and physical fitness in overweight. This is an analytical observational study with cross sectional approach. The samples of this study were 85 randomly selected subjects aged 18 to 24 years with normoweight and body mass index <40. The parameters measures were body mass index (BMI), waist circumference (WC), waist-hip ratio (WHR), cardiovascular function parameters (resting pulse, blood pressure, and peak flow meter) and physical fitness parameters (VO2max dengan McArdle step test). The mean BMI was 24,53±4,929. The WC and WHR mean were 86,7±14,10 cms and 0,89±0,073 cm respectively. The mean of resting pulses were higher in normoweight subject (p=0,0209). The mean systole were lower in normoweight subject (p=0,0026). No differences VO2 max between groups (p=0,3888). The peak flow meter was higher in normoweight (p=0,0274). The result of this study indicate that heart rate, systole and peak flow meter are signifantly different between groups. The heart rate and the peak flow meter in the overweight subjects were lower meanwhile the systole blood pressure was higher compared to normoweight subjects.

Does the Temporal Asymmetry of Short-Term Heart Rate Variability Change during Regular Walking? A Pilot Study of Healthy Young Subjects

Directory of Open Access Journals (Sweden)

Xinpei Wang

2018-01-01

Full Text Available The acceleration and deceleration patterns in heartbeat fluctuations distribute asymmetrically, which is known as heart rate asymmetry (HRA. It is hypothesized that HRA reflects the balancing regulation of the sympathetic and parasympathetic nervous systems. This study was designed to examine whether altered autonomic balance during exercise can lead to HRA changes. Sixteen healthy college students were enrolled, and each student undertook two 5-min ECG measurements: one in a resting seated position and another while walking on a treadmill at a regular speed of 5 km/h. The two measurements were conducted in a randomized order, and a 30-min rest was required between them. RR interval time series were extracted from the 5-min ECG data, and HRA (short-term was estimated using four established metrics, that is, Porta’s index (PI, Guzik’s index (GI, slope index (SI, and area index (AI, from both raw RR interval time series and the time series after wavelet detrending that removes the low-frequency component of <~0.03 Hz. Our pilot data showed a reduced PI but unchanged GI, SI, and AI during walking compared to resting seated position based on the raw data. Based on the wavelet-detrended data, reduced PI, SI, and AI were observed while GI still showed no significant changes. The reduced PI during walking based on both raw and detrended data which suggests less short-term HRA may underline the belief that vagal tone is withdrawn during low-intensity exercise. GI may not be sensitive to short-term HRA. The reduced SI and AI based on detrended data suggest that they may capture both short- and long-term HRA features and that the expected change in short-term HRA is amplified after removing the trend that is supposed to link to long-term component. Further studies with more subjects and longer measurements are warranted to validate our observations and to examine these additional hypotheses.

Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

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Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

2017-11-01

The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

Short term effects of kinesiotaping on acromiohumeral distance in asymptomatic subjects: a randomised controlled trial.

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Luque-Suarez, A; Navarro-Ledesma, S; Petocz, P; Hancock, M J; Hush, J

2013-12-01

The first aim of this study was to investigate whether kinesiotaping (KT) can increase the acromiohumeral distance (AHD) in asymptomatic subjects in the short term. The second aim was to investigate whether the direction of kinesiotaping application influences AHD. In recent years, the use of KT has become increasingly popular for a range of musculoskeletal conditions and for sport injuries. To date, we are unaware of any research investigating the effect of kinesiotaping on AHD. Moreover, it is unknown whether the direction of kinesiotaping application for the shoulder is important. Forty nine participants were randomly assigned to one of three groups: kinesiotaping group 1 (KT1), kinesiotaping group 2 (KT2) and sham kinesiotaping (KT3). AHD ultrasound measurements at 0° and 60° of shoulder elevation were collected at baseline and immediately after kinesiotape application. The results showed significant improvements in AHD after kinesiotaping, compared with sham taping. The mean difference in AHD between KT1 and KT3 groups was 1.28 mm (95% CI: 0.55, 2.03), and between KT2 and KT3 was 0.98 mm (95% CI: 0.23, 1.74). Comparison of KT1 and KT2 groups, which was performed to identify whether the direction of taping influences the AHD, indicated there were no significant differences. KT increases AHD in healthy individuals immediately following application, compared with sham kinesiotape. No differences were found with respect to the direction in which KT was applied. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effects of Curcuminoids-Piperine Combination on Systemic Oxidative Stress, Clinical Symptoms and Quality of Life in Subjects with Chronic Pulmonary Complications Due to Sulfur Mustard: A Randomized Controlled Trial.

Science.gov (United States)

Panahi, Yunes; Ghanei, Mostafa; Hajhashemi, Ali; Sahebkar, Amirhossein

2016-01-01

Oxidative stress plays a key role in the development of chronic pulmonary complications of sulfur mustard (SM). Curcuminoids are polyphenols with documented safety and antioxidant activity. The present study aimed to investigate the efficacy of short-term supplementation with curcuminoids (co-administered with piperine to enhance the bioavailability of curcuminoids) in alleviating systemic oxidative stress and clinical symptoms, and improvement of health-related quality of life (HRQoL) in subjects suffering from chronic pulmonary complications due to SM exposure who are receiving standard respiratory treatments. Eighty-nine subjects were recruited to this randomized double-blind placebo-controlled trial, being randomly allocated to either curcuminoids (1500 mg/day) + piperine (15 mg/day) combination (n = 45) or placebo (n = 44) for a period of 4 weeks. High-resolution computed tomography suggested the diagnosis of bronchiolitis obliterans in all subjects. Efficacy measures were changes in serum levels of reduced glutathione (GSH) and malonedialdehyde (MDA). The severity and frequency of respiratory symptoms and HRQoL were also assessed using St. George respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) indices. Serum levels of GSH were increased whilst those of MDA decreased by the end of trial in both groups. Likewise, there were significant improvements in the total as well as subscale (symptoms, activity and impact) SGRQ and CAT scores in both groups. However, comparison of magnitude of changes revealed a greater effect of curcuminoids-piperine combination compared to placebo in elevating GSH, reducing MDA and improving CAT and SGRQ (total and subscale) scores (p stress, clinical symptoms and HRQoL, these phytochemicals may be used as safe adjuvants in patients suffering from chronic SM-induced pulmonary complications who are receiving standard treatments.

Exenatide has a Pronounced Effect on Energy Intake but not Energy Expenditure in Non-Diabetic Subjects with Obesity: A Randomized, Double-blind, Placebo-Controlled Trial.

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Basolo, Alessio; Burkholder, Joshua; Osgood, Kristy; Graham, Alexis; Bundrick, Sarah; Frankl, Joseph; Piaggi, Paolo; Thearle, Marie S; Krakoff, Jonathan

2018-03-26

Exenatide is a glucagon-like peptide 1 (GLP-1) mimetic which induces weight loss predominantly, it is presumed, via decreased food intake. However, circulating GLP-1 is also a determinant of energy expenditure. We sought to quantify the effect of exenatide on energy expenditure (EE) and energy intake. In this single-center, randomized double-blind placebo controlled trial, we randomized 80 healthy, non-diabetic volunteers with obesity (46 women, age: 34.4±8.7 y, body fat by DXA: 44.2±7.8%) to subcutaneous exenatide 10 μg twice daily or placebo. Subjects were admitted to our clinical research unit for measurement of 24h-EE in a whole-room indirect calorimeter and ad libitum food intake using an automated vending machine paradigm before and after randomization. Furthermore, energy expenditure and ad libitum food intake measures were repeated at 24-week after readmission for 7-day inpatient stay. Body weight was obtained weekly for up to 5 weeks and was recorded at each monthly follow up visit up to 24 weeks. Prior to randomization, participants over ate during the 3-day vending machine period in the whole study group (114.6±35.2 %), expressed as percentage of weight maintaining energy needs (WMEN) with those who were eventually randomized to exenatide overeating more (121.6±37.7 %) compared to placebo group (107.6±31.5 %). In the exenatide group, ad libitum absolute energy intake decreased by 1016.1±724.5 kcal/day (95% CI: -1250.9 to -781.2) versus a 245.1±710.5 kcal/day (95% CI: -475.4 to -14.7) decrease in placebo (Δ= -624.8 Kcal/day, p energy intake between exenatide group and placebo group and the treatment group decreased 24-h EE more compared to placebo (β = -160.6 Kcal/day, 95% CI: -307.6 to 13.6, p = 0.03) compared to their pre-randomization measurement. However, this reduction was not present after adjustment for changes in FM and FFM (β = -87 kcal/day, p = 0.14). No difference was observed in body weight (Δ = -1.72 kg, 95% CI: -5.77 to 2.30, p

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

Science.gov (United States)

Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-08-01

We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

Mechanisms within the Parietal Cortex Correlate with the Benefits of Random Practice in Motor Adaptation

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Benjamin Thürer

2017-08-01

Full Text Available The motor learning literature shows an increased retest or transfer performance after practicing under unstable (random conditions. This random practice effect (also known as contextual interference effect is frequently investigated on the behavioral level and discussed in the context of mechanisms of the dorsolateral prefrontal cortex and increased cognitive efforts during movement planning. However, there is a lack of studies examining the random practice effect in motor adaptation tasks and, in general, the underlying neural processes of the random practice effect are not fully understood. We tested 24 right-handed human subjects performing a reaching task using a robotic manipulandum. Subjects learned to adapt either to a blocked or a random schedule of different force field perturbations while subjects’ electroencephalography (EEG was recorded. The behavioral results showed a distinct random practice effect in terms of a more stabilized retest performance of the random compared to the blocked practicing group. Further analyses showed that this effect correlates with changes in the alpha band power in electrodes over parietal areas. We conclude that the random practice effect in this study is facilitated by mechanisms within the parietal cortex during movement execution which might reflect online feedback mechanisms.

Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial.

Science.gov (United States)

Di Cesare, Annalisa; Giombini, Arrigo; Di Cesare, Mariachiara; Ripani, Maurizio; Vulpiani, Maria Chiara; Saraceni, Vincenzo Maria

2011-02-01

The goal of this study was to compare the effects of trigger point (TRP) mesotherapy and acupuncture (ACP) mesotherapy in the treatment of patients with chronic low back pain. Short term randomized controlled trial. 62 subjects with chronic low back pain were recruited at outpatients Physical Medicine and Rehabilitation Clinic at the University of Rome "La Sapienza" in the period between July 2006 and May 2008. Study subjects were assigned to receive 4 weeks treatments with either trigger point mesotherapy (TRP mesotherapy, n=29) or acupoints mesotherapy (ACP mesotherapy, n=33). Pain intensity with a pain visual analogic scale (VAS) and verbal rating scale (VRS) and pain disability with McGill Pain Questionnaire Short Form (SFMPQ), Roland Morris Disability Questionnaire (RMQ) and Oswestry Low Back Pain Disability Questionaire (ODQ). ACP mesotherapy shows a more effective results in VRS and VAS measures in the follow-up (p(VRS)=mesotherapy group. Our results suggest that the response to ACP mesotherapy may be greater than the response to TRP mesotherapy in the short term follow-up. This technique could be nevertheless a viable option as an adjunct treatment in an overall treatment planning of CLBP. Copyright © 2010 Elsevier Ltd. All rights reserved.

Nonparametric Monitoring for Geotechnical Structures Subject to Long-Term Environmental Change

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Hae-Bum Yun

2011-01-01

Full Text Available A nonparametric, data-driven methodology of monitoring for geotechnical structures subject to long-term environmental change is discussed. Avoiding physical assumptions or excessive simplification of the monitored structures, the nonparametric monitoring methodology presented in this paper provides reliable performance-related information particularly when the collection of sensor data is limited. For the validation of the nonparametric methodology, a field case study was performed using a full-scale retaining wall, which had been monitored for three years using three tilt gauges. Using the very limited sensor data, it is demonstrated that important performance-related information, such as drainage performance and sensor damage, could be disentangled from significant daily, seasonal and multiyear environmental variations. Extensive literature review on recent developments of parametric and nonparametric data processing techniques for geotechnical applications is also presented.

Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassaemia major patients: a randomized clinical trial

DEFF Research Database (Denmark)

Maggio, Aurelio; Vitrano, Angela; Capra, Marcello

2009-01-01

A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone-deferoxamine (DFO-DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8-1...

Random walk of passive tracers among randomly moving obstacles

OpenAIRE

Gori, Matteo; Donato, Irene; Floriani, Elena; Nardecchia, Ilaria; Pettini, Marco

2016-01-01

Background: This study is mainly motivated by the need of understanding how the diffusion behaviour of a biomolecule (or even of a larger object) is affected by other moving macromolecules, organelles, and so on, inside a living cell, whence the possibility of understanding whether or not a randomly walking biomolecule is also subject to a long-range force field driving it to its target. Method: By means of the Continuous Time Random Walk (CTRW) technique the topic of random walk in random en...

Random number generation

International Nuclear Information System (INIS)

Coveyou, R.R.

1974-01-01

The subject of random number generation is currently controversial. Differing opinions on this subject seem to stem from implicit or explicit differences in philosophy; in particular, from differing ideas concerning the role of probability in the real world of physical processes, electronic computers, and Monte Carlo calculations. An attempt is made here to reconcile these views. The role of stochastic ideas in mathematical models is discussed. In illustration of these ideas, a mathematical model of the use of random number generators in Monte Carlo calculations is constructed. This model is used to set up criteria for the comparison and evaluation of random number generators. (U.S.)

Markov counting and reward processes for analysing the performance of a complex system subject to random inspections

International Nuclear Information System (INIS)

Ruiz-Castro, Juan Eloy

2016-01-01

In this paper, a discrete complex reliability system subject to internal failures and external shocks, is modelled algorithmically. Two types of internal failure are considered: repairable and non-repairable. When a repairable failure occurs, the unit goes to corrective repair. In addition, the unit is subject to external shocks that may produce an aggravation of the internal degradation level, cumulative damage or extreme failure. When a damage threshold is reached, the unit must be removed. When a non-repairable failure occurs, the device is replaced by a new, identical one. The internal performance and the external damage are partitioned in performance levels. Random inspections are carried out. When an inspection takes place, the internal performance of the system and the damage caused by external shocks are observed and if necessary the unit is sent to preventive maintenance. If the inspection observes minor state for the internal performance and/or external damage, then these states remain in memory when the unit goes to corrective or preventive maintenance. Transient and stationary analyses are performed. Markov counting and reward processes are developed in computational form to analyse the performance and profitability of the system with and without preventive maintenance. These aspects are implemented computationally with Matlab. - Highlights: • A multi-state device is modelled in an algorithmic and computational form. • The performance is partitioned in multi-states and degradation levels. • Several types of failures with repair times according to degradation levels. • Preventive maintenance as response to random inspection is introduced. • The performance-profitable is analysed through Markov counting and reward processes.

On Random Numbers and Design

Science.gov (United States)

Ben-Ari, Morechai

2004-01-01

The term "random" is frequently used in discussion of the theory of evolution, even though the mathematical concept of randomness is problematic and of little relevance in the theory. Therefore, since the core concept of the theory of evolution is the non-random process of natural selection, the term random should not be used in teaching the…

Does a single gait training session performed either overground or on a treadmill induce specific short-term effects on gait parameters in patients with hemiparesis? A randomized controlled study.

Science.gov (United States)

Bonnyaud, Céline; Pradon, Didier; Zory, Raphael; Bensmail, Djamel; Vuillerme, Nicolas; Roche, Nicolas

2013-01-01

Gait training for patients with hemiparesis is carried out independently overground or on a treadmill. Several studies have shown differences in hemiparetic gait parameters during overground versus treadmill walking. However, few studies have compared the effects of these 2 gait training conditions on gait parameters, and no study has compared the short-term effects of these techniques on all biomechanical gait parameters. To determine whether a gait training session performed overground or on a treadmill induces specific short-term effects on biomechanical gait parameters in patients with hemiparesis. Twenty-six subjects with hemiparesis were randomly assigned to a single session of either overground or treadmill gait training. The short-term effects on spatiotemporal, kinematic, and kinetic gait parameters were assessed using gait analysis before and immediately after the training and after a 20-minute rest. Speed, cadence, percentage of single support phase, peak knee extension, peak propulsion, and braking on the paretic side were significantly increased after the gait training session. However, there were no specific changes dependent on the type of gait training performed (overground or on a treadmill). A gait training session performed by subjects with hemiparesis overground or on a treadmill did not induce specific short-term effects on biomechanical gait parameters. The increase in gait velocity that followed a gait training session seemed to reflect specific modifications of the paretic lower limb and adaptation of the nonparetic lower limb.

Random fractional ultrapulsed CO2 resurfacing of photodamaged facial skin: long-term evaluation.

Science.gov (United States)

Tretti Clementoni, Matteo; Galimberti, Michela; Tourlaki, Athanasia; Catenacci, Maximilian; Lavagno, Rosalia; Bencini, Pier Luca

2013-02-01

Although numerous papers have recently been published on ablative fractional resurfacing, there is a lack of information in literature on very long-term results. The aim of this retrospective study is to evaluate the efficacy, adverse side effects, and long-term results of a random fractional ultrapulsed CO2 laser on a large population with photodamaged facial skin. Three hundred twelve patients with facial photodamaged skin were enrolled and underwent a single full-face treatment. Six aspects of photodamaged skin were recorded using a 5 point scale at 3, 6, and 24 months after the treatment. The results were compared with a non-parametric statistical test, the Wilcoxon's exact test. Three hundred one patients completed the study. All analyzed features showed a significant statistical improvement 3 months after the procedure. Three months later all features, except for pigmentations, once again showed a significant statistical improvement. Results after 24 months were similar to those assessed 18 months before. No long-term or other serious complications were observed. From the significant number of patients analyzed, long-term results demonstrate not only how fractional ultrapulsed CO2 resurfacing can achieve good results on photodamaged facial skin but also how these results can be considered stable 2 years after the procedure.

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.

Science.gov (United States)

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.

Correlated Random Systems Five Different Methods : CIRM Jean-Morlet Chair

CERN Document Server

Kistler, Nicola

2015-01-01

This volume presents five different methods recently developed to tackle the large scale behavior of highly correlated random systems, such as spin glasses, random polymers, local times and loop soups and random matrices. These methods, presented in a series of lectures delivered within the Jean-Morlet initiative (Spring 2013), play a fundamental role in the current development of probability theory and statistical mechanics. The lectures were: Random Polymers by E. Bolthausen, Spontaneous Replica Symmetry Breaking and Interpolation Methods by F. Guerra, Derrida's Random Energy Models by N. Kistler, Isomorphism Theorems by J. Rosen and Spectral Properties of Wigner Matrices by B. Schlein. This book is the first in a co-edition between the Jean-Morlet Chair at CIRM and the Springer Lecture Notes in Mathematics which aims to collect together courses and lectures on cutting-edge subjects given during the term of the Jean-Morlet Chair, as well as new material produced in its wake. It is targeted at researchers, i...

The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial

OpenAIRE

Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

2016-01-01

Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47?88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) w...

Steps to Health employee weight management randomized control trial: short-term follow-up results.

Science.gov (United States)

Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

2015-02-01

To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences.

Science.gov (United States)

Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L

2013-11-01

Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.

Randomized random walk on a random walk

International Nuclear Information System (INIS)

Lee, P.A.

1983-06-01

This paper discusses generalizations of the model introduced by Kehr and Kunter of the random walk of a particle on a one-dimensional chain which in turn has been constructed by a random walk procedure. The superimposed random walk is randomised in time according to the occurrences of a stochastic point process. The probability of finding the particle in a particular position at a certain instant is obtained explicitly in the transform domain. It is found that the asymptotic behaviour for large time of the mean-square displacement of the particle depends critically on the assumed structure of the basic random walk, giving a diffusion-like term for an asymmetric walk or a square root law if the walk is symmetric. Many results are obtained in closed form for the Poisson process case, and these agree with those given previously by Kehr and Kunter. (author)

Short and long term effectiveness of a subject's specific novel brain and vestibular rehabilitation treatment modality in combat veterans suffering from PTSD

Directory of Open Access Journals (Sweden)

Frederick Robert Carrick

2015-06-01

Full Text Available AbstractIntroduction: Treatment for post-traumatic stress disorder (PTSD in combat veterans that have a long-term positive clinical effect has the potential to modify the treatment of PTSD. This outcome may result in changed and saved lives of our service personnel and their families. In a previous before-after-intervention study we demonstrated high statistical and substantively significant short-term changes in the Clinician Administered DSM-IV PTSD Scale (CAPS scores after a two week trial of a subject's particular novel brain and vestibular rehabilitation (VR program. The long-term maintenance of PTSD severity reduction was the subject of this study.Material and Methods:We studied the short and long term effectiveness of a subject's particular novel brain and VR treatment of PTSD in subjects who had suffered combat-related traumatic brain injuries in terms of PTSD symptom reduction. The trial was registered as ClinicalTrials.gov Identifier: NCT02003352. We analyzed the difference in the CAPS scores pre and post treatment (one week and three months using our subjects as their matched controls. Results:The generalized least squares (GLS technique demonstrated that with our 26 subjects in the 3 timed groups the R2 within groups was 0.000, R2 between groups was 0.000 and overall the R2 was 0.000. The GLS regression was strongly statistically significant z = 21.29, p < 0.001, 95% CI [58.7, 70.63]. The linear predictive margins over time demonstrated strong statistical and substantive significance of decreasing PTSD severity scores for all timed CAPS tests.Discussion:Our investigation has the promise of the development of superior outcomes of treatments in this area that will benefit a global society. The length of the treatment intervention involved (two weeks is less that other currently available treatments and has profound implications for cost, duration of disability and outcomes in the treatment of PTSD in combat veterans.

A multicomponent exercise program improves physical function in long-term nursing home residents: A randomized controlled trial.

Science.gov (United States)

Arrieta, Haritz; Rezola-Pardo, Chloe; Zarrazquin, Idoia; Echeverria, Iñaki; Yanguas, Jose Javier; Iturburu, Miren; Gil, Susana Maria; Rodriguez-Larrad, Ana; Irazusta, Jon

2018-03-01

To investigate the impact of a multicomponent exercise program on anthropometry, physical function, and physical activity on older adults living in long-term nursing homes (LTNH), we conducted a randomized controlled trial involving 112 participants aged 84.9 ± 6.9 years. Participants were randomly assigned to an intervention (IG) or control group (CG). The IG participated in a 3-month multicomponent exercise intervention focused on strength, balance, stretching exercises, and walking recommendations. Subjects in the CG participated in routine activities. Analyses of outcome parameters were performed in the entire sample and in two subgroups, classified according to participants' physical function score at baseline. The group-by-time interaction, favoring the IG, was significant for the entire sample and for the participants in the low physical function subgroup for the following parameters: waist circumference, 30-s chair-stand, arm-curl, 8-ft timed up-and-go, SPPB score, gait speed, and Berg scale (p < .05). In participants with higher physical function at baseline, significant group-by-time interaction was observed in the SPPB score and Berg scale (p < .05). When differences were analyzed within groups, the IG maintained or improved in all assessed parameters, while participants in the CG showed a marked decline. Our study showed that a multicomponent exercise program is effective for older people living in LTNH. This is especially relevant in those with lower physical function scores. The lower efficacy of the program in participants with better function might be due to the insufficient exercise demands of our intervention for more fit residents. Future studies should analyze the effects of programs with higher intensities in older people with intermediate to high physical function. Copyright © 2018 Elsevier Inc. All rights reserved.

Approximate Forward Difference Equations for the Lower Order Non-Stationary Statistics of Geometrically Non-Linear Systems subject to Random Excitation

DEFF Research Database (Denmark)

Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

Geometrically non-linear multi-degree-of-freedom (MDOF) systems subject to random excitation are considered. New semi-analytical approximate forward difference equations for the lower order non-stationary statistical moments of the response are derived from the stochastic differential equations...... of motion, and, the accuracy of these equations is numerically investigated. For stationary excitations, the proposed method computes the stationary statistical moments of the response from the solution of non-linear algebraic equations....

Effects of delayed cord clamping on residual placental blood volume, hemoglobin and bilirubin levels in term infants: a randomized controlled trial.

Science.gov (United States)

Mercer, J S; Erickson-Owens, D A; Collins, J; Barcelos, M O; Parker, A B; Padbury, J F

2017-03-01

The objective of the study was to measure the effects of a 5-min delay (DCC) versus immediate cord clamping (ICC) on residual placental blood volume (RPBV) at birth, and hemoglobin and serum bilirubin at 24 to 48 h of age. In this prospective randomized controlled trial, 73 women with term (37 to 41 weeks) singleton fetuses were randomized to DCC (⩾5 min; n=37) or ICC (protocol violations. Cord milking was the proxy for DCC (n=11) when the provider could not wait. Infants randomized to DCC compared with ICC had significantly less RPBV (20.0 versus 30.8 ml kg -1 , Phemoglobin levels (19.4 versus 17.8 g dl -1 , P=0.002) at 24 to 48 h, with no difference in bilirubin levels. Term infants had early hematological advantage of DCC without increases in hyperbilirubinemia or symptomatic polycythemia.

Autoshaping, random control, and omission training in the rat.

Science.gov (United States)

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

Orthodontic treatment in periodontitis‐susceptible subjects: a systematic literature review

Science.gov (United States)

Lindsten, Rune; Slotte, Christer; Bjerklin, Krister

2016-01-01

Abstract The aim is to evaluate the literature for clinical scientific data on possible effects of orthodontic treatment on periodontal status in periodontitis‐susceptible subjects. A systematic literature review was performed on studies in English using PubMed, MEDLINE, and Cochrane Library central databases (1965‐2014). By manually searching reference lists of selected studies, we identified additional articles; then we searched these publications: Journal of Periodontology, Periodontology 2000, Journal of Clinical Periodontology, American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, International Journal of Periodontics & Restorative Dentistry, and European Journal of Orthodontics. Search terms included randomized clinical trials, controlled clinical trials, prospective and retrospective clinical studies, case series >5 patients, periodontitis, orthodontics, alveolar bone loss, tooth migration, tooth movement, orthodontic extrusion, and orthodontic intrusion. Only studies on orthodontic treatment in periodontally compromised dentitions were included. One randomized controlled clinical trial, one controlled clinical trial, and 12 clinical studies were included. No evidence currently exists from controlled studies and randomized controlled clinical trials, which shows that orthodontic treatment improves or aggravates the status of periodontally compromised dentitions. PMID:29744163

Subject-Verb Agreement and Verbal Short-Term Memory: A Perspective from Greek Children with Specific Language Impairment

Science.gov (United States)

Lalioti, Marina; Stavrakaki, Stavroula; Manouilidou, Christina; Talli, Ioanna

2016-01-01

This study investigated the performance of school age Greek-speaking children with SLI on verbal short-term memory (VSTM) and Subject-Verb (S-V) agreement in comparison to chronological age controls and younger typically developing children. VSTM abilities were assessed by means of a non-word repetition task (NRT) and an elicited production task,…

A randomized phase II chemoprevention trial of 13-CIS retinoic acid with or without alpha tocopherol or observation in subjects at high risk for lung cancer.

Science.gov (United States)

Kelly, Karen; Kittelson, John; Franklin, Wilbur A; Kennedy, Timothy C; Klein, Catherine E; Keith, Robert L; Dempsey, Edward C; Lewis, Marina; Jackson, Mary K; Hirsch, Fred R; Bunn, Paul A; Miller, York E

2009-05-01

No chemoprevention strategies have been proven effective for lung cancer. We evaluated the effect of 13-cis retinoic acid (13-cis RA), with or without alpha tocopherol, as a lung cancer chemoprevention agent in a phase II randomized controlled clinical trial of adult subjects at high risk for lung cancer as defined by the presence of sputum atypia, history of smoking, and airflow obstruction, or a prior surgically cured nonsmall cell lung cancer (disease free, >3 years). Subjects were randomly assigned to receive either 13-cis RA, 13-cis RA plus alpha tocopherol (13-cis RA/alpha toco) or observation for 12 months. Outcome measures are derived from histologic evaluation of bronchial biopsy specimens obtained by bronchoscopy at baseline and follow-up. The primary outcome measure is treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy. Seventy-five subjects were randomized (27/22/26 to observations/13-cis RA/13-cis RA/alpha toco); 59 completed the trial; 55 had both baseline and follow-up bronchoscopy. The risk of treatment failure was 55.6% (15 of 27) and 50% (24 of 48) in the observation and combined (13 cis RA plus 13 cis RA/alpha toco) treatment arms, respectively (odds ratio adjusted for baseline histology, 0.97; 95% confidence interval, 0.36-2.66; P = 0.95). Among subjects with complete histology data, maximum histology score in the observation arm increased by 0.37 units and by 0.03 units in the treated arms (difference adjusted for baseline, -0.18; 95% confidence interval, -1.16 to 0.81; P = 0.72). Similar (nonsignificant) results were observed for treatment effects on endobronchial proliferation as assessed by Ki-67 immunolabeling. Twelve-month treatment with 13-cis RA produced nonsignificant changes in bronchial histology, consistent with results in other trials. Agents advancing to phase III randomized trials should produce greater histologic changes. The

A Randomized Phase II Chemoprevention Trial of 13-CIS Retinoic Acid with Or without α Tocopherol or Observation in Subjects at High Risk for Lung Cancer

Science.gov (United States)

Kelly, Karen; Kittelson, John; Franklin, Wilbur A.; Kennedy, Timothy C.; Klein, Catherine E.; Keith, Robert L.; Dempsey, Edward C.; Lewis, Marina; Jackson, Mary K.; Hirsch, Fred R.; Bunn, Paul A.; Miller, York E.

2011-01-01

No chemoprevention strategies have been proven effective for lung cancer. We evaluated the effect of 13-cis retinoic acid (13-cis RA), with or without α tocopherol, as a lung cancer chemoprevention agent in a phase II randomized controlled clinical trial of adult subjects at high risk for lung cancer as defined by the presence of sputum atypia, history of smoking, and airflow obstruction, or a prior surgically cured nonsmall cell lung cancer (disease free, >3 years). Subjects were randomly assigned to receive either 13-cis RA, 13-cis RA plus α tocopherol (13-cis RA/α toco) or observation for 12 months. Outcome measures are derived from histologic evaluation of bronchial biopsy specimens obtained by bronchoscopy at baseline and follow-up. The primary outcome measure is treatment “failure” defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy. Seventy-five subjects were randomized (27/22/26 to obervations/13-cis RA/13-cis RA/α toco); 59 completed the trial; 55 had both baseline and follow-up bronchoscopy. The risk of treatment failure was 55.6% (15 of 27) and 50% (24 of 48) in the observation and combined (13 cis RA plus 13 cis RA/α toco) treatment arms, respectively (odds ratio adjusted for baseline histology, 0.97; 95% confidence interval, 0.36–2.66; P = 0.95). Among subjects with complete histology data, maximum histology score in the observation arm increased by 0.37 units and by 0.03 units in the treated arms (difference adjusted for baseline, −0.18; 95% confidence interval, −1.16 to 0.81; P = 0.72). Similar (nonsignificant) results were observed for treatment effects on endobronchial proliferation as assessed by Ki-67 immunolabeling. Twelve-month treatment with 13-cis RA produced nonsignificant changes in bronchial histology, consistent with results in other trials. Agents advancing to phase III randomized trials should produce greater histologic changes. The addition of �

Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

Science.gov (United States)

Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

2012-01-01

This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

Science.gov (United States)

Kiefer, Daniel G; Muscat, Jolene C; Santorelli, Jarrett; Chavez, Martin R; Ananth, Cande V; Smulian, John C; Vintzileos, Anthony M

2016-03-01

The rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking. We report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable adhesion barrier for reduction of adhesions following cesarean delivery. Patients who underwent primary or repeat cesarean delivery were included in this multicenter, single-blinded (patient), randomized controlled trial. Patients were randomized into either HA-CMC (N = 380) or no treatment (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were collected following randomization. The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which can also be used to derive an adhesion score that ranges from 0-12. No differences in baseline characteristics, postoperative course, or incidence of complications between the groups following randomization were noted. Eighty patients from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the HA-CMC group and 75.9% of the controls (P = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .65). One third of the HA-CMC patients met the definition for severe adhesions (adhesion score >4) compared to 15.5% in the control group (P = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60). Although we did not identify any short-term

Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial.

Directory of Open Access Journals (Sweden)

Ning Gu

Full Text Available This study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL and the maximum time for cervical ripening (12 hours vs. 24 hours to improve vaginal delivery rate within 24 hours of induction.We conducted an open-label, randomized controlled trial in a teaching hospital in China. Women with a term singleton pregnancy, cephalic presentation, intact membrane and an unfavorable cervix (Bishop score <6 were randomly allocated, in 1:1:1:1 ratio, to receive either one of the four treatments: (1 30-mL balloon for a maximum of 12 hours, (2 30-mL balloon for a maximum of 24 hours, (3 80-mL balloon for a maximum of 12 hours, and (4 80-mL balloon for a maximum of 24 hours. The primary outcome was vaginal delivery within 24 hours. Secondary outcomes included cesarean section rate and maternal/neonatal morbidity. Data were analyzed on a per-protocol basis.Five hundred and four women were recruited and randomized (126 women in each group; nine women did not receive the assigned intervention. More women achieved vaginal delivery within 24 hours in 12-hour Foley catheter groups than in the 24-hour Foley catheter groups (30-mL/12 hours: 54.5%, 30-mL/24 hours: 33.1%, 80-mL/12 hours: 46.4%, 80-mL/24 hours: 24.0%, p < 0.001. Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL and longer ripening time (24 hours vs. 12 hours would not shorten induction to delivery interval or reduce cesarean section rate.Chinese Clinical trial registry (ChiCTR-TRC-13003044.

Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

Science.gov (United States)

Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

2014-10-01

An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

Short-term effects of glucose and sucrose on cognitive performance and mood in elderly people

NARCIS (Netherlands)

Zwaluw, N.L. van der; Rest, O. van de; Kessels, R.P.C.; Groot, C.P.G.M. de

2014-01-01

In this study we determined the short-term effects of a glucose drink and a sucrose drink compared to a placebo on cognitive performance and mood in elderly people with subjective, mild memory complaints using a randomized crossover study design. In total, 43 nondiabetic older adults with

Effect of Talbinah food consumption on depressive symptoms among elderly individuals in long term care facilities, randomized clinical trial

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Badrasawi MM

2013-03-01

Full Text Available Manal M Badrasawi, Suzana Shahar, Zahara Abd Manaf, Hasnah HaronDietetics program, School of Health Care Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, MalaysiaAbstract: Talbinah is a barley syrup cooked with milk and sweetened by honey. In his famous Hadith on Talbinah, the Prophet Mohammad (SAW recommended it when sad events happen for its effect on soothing hearts and relieving sadness. This 3-week crossover designed, randomized clinical trial was conducted to determine the effect of Talbinah on mood and depression among institutionalized elderly people in Seremban. A sample of 30 depressed elderly subjects (21 men and 9 women was selected from the long term care facility. Three different interview-based validated scales (Geriatric Depression Scale, Depression Anxiety Stress Scales, and Profile of Mood States were used to determine mood, depression, stress, and anxiety at week 0, 3, 4, and 7. The nutritional value of Talbinah was examined using proximate food analysis, minerals content analysis, and differential amino acid analysis. The results indicated that Talbinah is a high carbohydrate food (86.4% and has a high tryptophan: branch chain amino acids ratio (1:2. A Wilcoxon nonparametric test showed that there was a statistically significant decrease on depression, stress, and mood disturbances scores among the intervention group (P < 0.05 for all parameters. In conclusion, Talbinah has the potential to reduce depression and enhance mood among the subjects. Ingestion of functional foods such as Talbinah may provide a mental health benefit to elderly people.Keywords: Talbinah, food and depression, cross over study, elderly

Stress-relieving effects of short-term balneotherapy - a randomized controlled pilot study in healthy adults.

Science.gov (United States)

Matzer, Franziska; Nagele, Eva; Bahadori, Babak; Dam, Karl; Fazekas, Christian

2014-01-01

Stress-relieving effects of balneotherapy compared to progressive muscle relaxation (PMR) and to resting were investigated by measuring subjective relaxation and salivary cortisol. It was also examined whether participants with a high versus low stress level would have a different relaxation response. A sample of healthy volunteers was randomized to balneotherapy, PMR, or a resting control group, each intervention lasting for 25 min. Pre- and post-intervention salivary cortisol samples were collected, and participants rated their status of relaxation on a quantitative scale. In addition, 3 questionnaires were applied to detect participants' stress level and bodily complaints. 49 healthy participants were recruited (65.3% female). In a pre-post comparison, salivary cortisol decreased (F = 23.53, p balneotherapy group rated themselves as more relaxed after the intervention as compared to the other groups (F = 5.22, p balneotherapy seems to be more beneficial with regard to subjective relaxation effects and similarly beneficial with regard to a decrease in salivary cortisol. © 2014 S. Karger GmbH, Freiburg.

Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction.

Science.gov (United States)

Jeuken, Ralph M; Schotanus, Martijn G M; Kort, Nanne P; Deenik, Axel; Jong, Bob; Hendrickx, Roel P M

2016-07-01

Hallux valgus is one of the most common foot deformities. This long-term follow-up study compared the results of 2 widely used operative treatments for hallux valgus: the scarf and chevron osteotomy. Conventional weight bearing anteroposterior (AP) radiographs of the foot were made for evaluating the intermetatarsal angle and hallux valgus angle. For clinical evaluation, the American Orthopaedic Foot & Ankle Society (AOFAS) rating system for the hallux metatarsophalangeal-interphalangeal scale was used together with physical examination of the foot. These data were compared with the results from the original study. The Short Form 36 questionnaire, the Manchester-Oxford Foot Questionnaire (MOXFQ), and a general questionnaire including a visual analog scale (VAS) pain score were used for subjective evaluation. The primary outcome measures were the radiologic recurrence of hallux valgus and reoperation rate of the same toe. Secondary outcome measures were the results from the radiographs and subjective and clinical evaluation. The response rate was 76% at the follow-up of 14 years; in the chevron group, 37 feet were included compared with 36 feet in the scarf group. Twenty-eight feet in the chevron group and 27 in the scarf group developed recurrence of hallux valgus (P = .483). One patient in the scarf group had a reoperation of the same toe compared with none in the chevron group (P = .314). Current VAS pain scores and results from the SF-36, MOXFQ, and AOFAS did not significantly differ between groups. Both techniques showed similar results after 2 years of follow-up. At 14 years of follow-up, neither technique was superior in preventing recurrence. Level II, randomized controlled trial. © The Author(s) 2016.

A new simple technique for improving the random properties of chaos-based cryptosystems

Science.gov (United States)

Garcia-Bosque, M.; Pérez-Resa, A.; Sánchez-Azqueta, C.; Celma, S.

2018-03-01

A new technique for improving the security of chaos-based stream ciphers has been proposed and tested experimentally. This technique manages to improve the randomness properties of the generated keystream by preventing the system to fall into short period cycles due to digitation. In order to test this technique, a stream cipher based on a Skew Tent Map algorithm has been implemented on a Virtex 7 FPGA. The randomness of the keystream generated by this system has been compared to the randomness of the keystream generated by the same system with the proposed randomness-enhancement technique. By subjecting both keystreams to the National Institute of Standards and Technology (NIST) tests, we have proved that our method can considerably improve the randomness of the generated keystreams. In order to incorporate our randomness-enhancement technique, only 41 extra slices have been needed, proving that, apart from effective, this method is also efficient in terms of area and hardware resources.

Autoshaping, random control, and omission training in the rat1

Science.gov (United States)

Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

Immediate effect of nonspecific mandibular mobilization on postural control in subjects with temporomandibular disorder: a single-blind, randomized, controlled clinical trial.

Science.gov (United States)

Amaral, Ana P; Politti, Fabiano; Hage, Yasmin E; Arruda, Eric E C; Amorin, Cesar F; Biasotto-Gonzalez, Daniela A

2013-01-01

Temporomandibular disorder (TMD) is considered multifactorial and is defined as a group of pain conditions characterized by functional stomatognathic system alterations, which may be affected by or related disrupted postural control. Assess the immediate effect of nonspecific mandibular mobilization (NMM) on the postural control of subjects diagnosed or not with TMD. A simple-blind, randomized, controlled clinical trial was performed involving 50 subjects of both genders assigned to two groups: the TMD group and the control group. TMD was diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). A stabilometric assessment was performed by testing subjects in a quiet stance on a dual force platform under two visual conditions (eyes open and eyes closed). The Center of Pressure (CoP)-related variables analyzed were displacement, amplitude, speed of anterior-posterior (AP) and medial-lateral (ML) displacements and CoP sway area. The mean values of each variable were compared, considering the accepted significance value of ppostural control in patients with TMD.

A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

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Ward Loren S

2008-03-01

Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

Long-term outcomes in women with polycystic ovary syndrome initially randomized to receive laparoscopic electrocautery of the ovaries or ovulation induction with gonadotrophins

NARCIS (Netherlands)

Nahuis, M. J.; Kose, N.; Bayram, N.; van Dessel, H. J. H. M.; Braat, D. D. M.; Hamilton, C. J. C. M.; Hompes, P. G. A.; Bossuyt, P. M.; Mol, B. W. J.; van der Veen, F.; van Wely, M.

2011-01-01

Long-term effects of laparoscopic electrocautery of the ovaries are unknown. To study the long-term effects of laparoscopic electrocautery of the ovaries and gonadotrophins, we followed women with clomiphene-resistant polycystic ovary syndrome (PCOS) randomly allocated to one of these treatments

Long-term outcomes in women with polycystic ovary syndrome initially randomized to receive laparoscopic electrocautery of the ovaries or ovulation induction with gonadotrophins

NARCIS (Netherlands)

Nahuis, M.J.; Kose, N.; Bayram, N.; Dessel, H.J. van; Braat, D.D.M.; Hamilton, C.J.C.M.; Hompes, P.G.; Bossuyt, P.M.; Mol, B.W.; Veen, F. van der; Wely, M.H. van

2011-01-01

BACKGROUND: Long-term effects of laparoscopic electrocautery of the ovaries are unknown. To study the long-term effects of laparoscopic electrocautery of the ovaries and gonadotrophins, we followed women with clomiphene-resistant polycystic ovary syndrome (PCOS) randomly allocated to one of these

Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.

Science.gov (United States)

Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

2016-07-29

Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life. Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention. Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea

InfAcrOnt: calculating cross-ontology term similarities using information flow by a random walk.

Science.gov (United States)

Cheng, Liang; Jiang, Yue; Ju, Hong; Sun, Jie; Peng, Jiajie; Zhou, Meng; Hu, Yang

2018-01-19

Since the establishment of the first biomedical ontology Gene Ontology (GO), the number of biomedical ontology has increased dramatically. Nowadays over 300 ontologies have been built including extensively used Disease Ontology (DO) and Human Phenotype Ontology (HPO). Because of the advantage of identifying novel relationships between terms, calculating similarity between ontology terms is one of the major tasks in this research area. Though similarities between terms within each ontology have been studied with in silico methods, term similarities across different ontologies were not investigated as deeply. The latest method took advantage of gene functional interaction network (GFIN) to explore such inter-ontology similarities of terms. However, it only used gene interactions and failed to make full use of the connectivity among gene nodes of the network. In addition, all existent methods are particularly designed for GO and their performances on the extended ontology community remain unknown. We proposed a method InfAcrOnt to infer similarities between terms across ontologies utilizing the entire GFIN. InfAcrOnt builds a term-gene-gene network which comprised ontology annotations and GFIN, and acquires similarities between terms across ontologies through modeling the information flow within the network by random walk. In our benchmark experiments on sub-ontologies of GO, InfAcrOnt achieves a high average area under the receiver operating characteristic curve (AUC) (0.9322 and 0.9309) and low standard deviations (1.8746e-6 and 3.0977e-6) in both human and yeast benchmark datasets exhibiting superior performance. Meanwhile, comparisons of InfAcrOnt results and prior knowledge on pair-wise DO-HPO terms and pair-wise DO-GO terms show high correlations. The experiment results show that InfAcrOnt significantly improves the performance of inferring similarities between terms across ontologies in benchmark set.

Evaluation of safety of excessive intake and efficacy of long-term intake of beverages containing apple polyphenols.

Science.gov (United States)

Akazome, Yoko; Kametani, Norihiro; Kanda, Tomomasa; Shimasaki, Hiroyuki; Kobayashi, Shuhei

2010-01-01

In the present study, a randomized, double-blind, placebo-controlled study was performed to evaluate the safety of an excessive intake and the efficacy of a long-term intake of polyphenols derived from apples for moderately underweight to moderately obese subjects (long-term intake: 94 subjects; excessive intake: 30 subjects). For each trial, the subjects were divided into the following two groups: a group that drank beverages with apple polyphenols (600 mg) (hereinafter referred to as the apple group) and a group that drank beverages without apple polyphenols (hereinafter referred to as the placebo group). For the long-term intake trial, the subjects were given a regular amount of the beverage (340 g) each day for 12 weeks. For the excessive intake trial, the subjects were given three times the regular amount of the beverage each day for 4 weeks. It is noteworthy that the visceral fat area (VFA) of subjects in the apple group for the long-term intake trial had decreased significantly by the 8- and 12-week marks (week 8: p or = 100 cm(2)) had decreased significantly by the 8- and 12-week marks compared to the baseline (week 8: p safety of the beverage with apple polyphenols.

Short- and long-term subjective medical treatment outcome of trauma surgery patients: the importance of physician empathy

Directory of Open Access Journals (Sweden)

Steinhausen S

2014-09-01

Full Text Available Simone Steinhausen,1 Oliver Ommen,2 Sunya-Lee Antoine,1 Thorsten Koehler,3 Holger Pfaff,4 Edmund Neugebauer11Institute for Research in Operative Medicine (IFOM, Witten/Herdecke University, Campus Cologne-Merheim, Germany; 2Federal Centre for Health Education (BZgA, Cologne, Germany; 3Institute for Applied Social Sciences (infas, Bonn, Germany; 4Institute for Medical Sociology, Health Services Research and Rehabilitation Science (IMVR, Faculty of Human Science and Faculty of Medicine, University of Cologne, Germany Purpose: To investigate accident casualties’ long-term subjective evaluation of treatment outcome 6 weeks and 12 months after discharge and its relation to the experienced surgeon’s empathy during hospital treatment after trauma in consideration of patient-, injury-, and health-related factors. The long-term results are compared to the 6-week follow-up outcomes.Patients and methods: Two hundred and seventeen surgery patients were surveyed at 6 weeks, and 206 patients at 12 months after discharge from the trauma surgical general ward. The subjective evaluation of medical treatment outcome was measured 6 weeks and 12 months after discharge with the respective scale from the Cologne Patient Questionnaire. Physician Empathy was assessed with the Consultation and Relational Empathy Measure. The correlation between physician empathy and control variables with the subjective evaluation of medical treatment outcome 12 months after discharge was identified by means of logistic regression analysis under control of sociodemographic and injury-related factors.Results: One hundred and thirty-six patients were included within the logistic regression analysis at the 12-month follow-up. Compared to the 6-week follow-up, the level of subjective evaluation of medical treatment outcome was slightly lower and the association with physician empathy was weaker. Compared to patients who rated the empathy of their surgeon lower than 31 points, patients

Breaking Bad News in obstetrics: a randomized trial of simulation followed by debriefing or lecture.

Science.gov (United States)

Karkowsky, Chavi Eve; Landsberger, Ellen J; Bernstein, Peter S; Dayal, Ashlesha; Goffman, Dena; Madden, Robert C; Chazotte, Cynthia

2016-11-01

Although communication skills represent an increasingly important aspect of medical care, little has been done to assess the best method of teaching these skills. Our study was designed to assess simulation-debriefing compared to lecture in teaching skills for Breaking Bad News (BBN) in obstetrics. This is a randomized prospective trial of house staff from a large academic medical center. Subjects initially underwent baseline simulation, followed by evaluation on BBN skills by themselves, a faculty observer, and the standardized patient (SP). The subjects were then immediately randomized to a debriefing session by faculty or to a lecture about BBN. Subsequently, both groups underwent a second simulation with the same three assessments, yielding post-intervention data. 35 subjects completed both simulations. Both debriefing and lecture curricula showed improvement in scores by self (p = 0.010) and faculty (p < 0.001). The debriefing group improved significantly more than the lecture group for self-evaluation; additionally, improvements were greater for the debrief group in verbal and nonverbal skills. Long-term follow-up three months after both interventions demonstrated continued improvement in BBN. Simulation training with debriefing is effective for teaching communication skills, and superior to lecture for self-perceived improvement. Long-term follow-up suggested retention of confidence in BBN skills.

Data envelopment analysis of randomized ranks

Directory of Open Access Journals (Sweden)

Sant'Anna Annibal P.

2002-01-01

Full Text Available Probabilities and odds, derived from vectors of ranks, are here compared as measures of efficiency of decision-making units (DMUs. These measures are computed with the goal of providing preliminary information before starting a Data Envelopment Analysis (DEA or the application of any other evaluation or composition of preferences methodology. Preferences, quality and productivity evaluations are usually measured with errors or subject to influence of other random disturbances. Reducing evaluations to ranks and treating the ranks as estimates of location parameters of random variables, we are able to compute the probability of each DMU being classified as the best according to the consumption of each input and the production of each output. Employing the probabilities of being the best as efficiency measures, we stretch distances between the most efficient units. We combine these partial probabilities in a global efficiency score determined in terms of proximity to the efficiency frontier.

Emotion-based decision-making in healthy subjects: short-term effects of reducing dopamine levels.

Science.gov (United States)

Sevy, Serge; Hassoun, Youssef; Bechara, Antoine; Yechiam, Eldad; Napolitano, Barbara; Burdick, Katherine; Delman, Howard; Malhotra, Anil

2006-10-01

Converging evidences from animal and human studies suggest that addiction is associated with dopaminergic dysfunction in brain reward circuits. So far, it is unclear what aspects of addictive behaviors are related to a dopaminergic dysfunction. We hypothesize that a decrease in dopaminergic activity impairs emotion-based decision-making. To demonstrate this hypothesis, we investigated the effects of a decrease in dopaminergic activity on the performance of an emotion-based decision-making task, the Iowa gambling task (IGT), in 11 healthy human subjects. We used a double-blind, placebo-controlled, within-subject design to examine the effect of a mixture containing the branched-chain amino acids (BCAA) valine, isoleucine and leucine on prolactin, IGT performance, perceptual competency and visual aspects of visuospatial working memory, visual attention and working memory, and verbal memory. The expectancy-valence model was used to determine the relative contributions of distinct IGT components (attention to past outcomes, relative weight of wins and losses, and choice strategies) in the decision-making process. Compared to placebo, the BCAA mixture increased prolactin levels and impaired IGT performance. BCAA administration interfered with a particular component process of decision-making related to attention to more recent events as compared to more distant events. There were no differences between placebo and BCAA conditions for other aspects of cognition. Our results suggest a direct link between a reduced dopaminergic activity and poor emotion-based decision-making characterized by shortsightedness, and thus difficulties resisting short-term reward, despite long-term negative consequences. These findings have implications for behavioral and pharmacological interventions targeting impaired emotion-based decision-making in addictive disorders.

A double-blind study evaluating the long-term safety of varenicline for smoking cessation.

Science.gov (United States)

Williams, Kathryn E; Reeves, Karen R; Billing, Clare B; Pennington, Ann M; Gong, Jason

2007-04-01

We assessed the safety of long-term varenicline administration for smoking cessation. In this randomized, double-blind, multicenter trial, eligible adult smokers (18-75 years) who smoked an average of > or =10 cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then every 4 weeks until week 52, with a follow-up visit at week 53. The target quit date was the morning of the week 1 clinic visit. Brief counseling was provided at each visit, and vital signs, adverse events (AEs), and smoking status were documented. Other laboratory measures were collected at specified visits. A total of 251 subjects were randomized to varenicline and 126 to placebo. Approximately half of the subjects in each arm completed the study (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% of varenicline- and 82.5% of placebo-treated subjects during the study. Common varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs leading to discontinuation of varenicline treatment included nausea (7.6%), insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo). Varenicline 1 mg BID can be safely administered for up to 1 year. Varenicline was also a more effective smoking cessation aid than placebo throughout the study, supporting both its short- (12-week) and long-term (52-week) efficacy.

Long-Term Use of Probiotics Lactobacillus and Bifidobacterium Has a Prophylactic Effect on the Occurrence and Severity of Pouchitis: A Randomized Prospective Study

Directory of Open Access Journals (Sweden)

Banasiewicz Tomasz

2014-01-01

Full Text Available Aim. The aim of the study was to assess the impact of the long-term use of the composite probiotics in patients after restorative proctocolectomy. Method. Forty-three patients (20 females and 23 males, aged 21 to 68 years after restorative proctocolectomy were included in the study. After randomization patients were divided into placebo group and treatment group with oral intake of probiotic containing Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Bifidobacterium bifidus. Patients were investigated during initial visit and during final visit after 9 months. All patients were subjected to standard clinical and endoscopic examination with microscopic study of the specimens. Concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK were determined in all cases. Results. The average severity of pouchitis and the number of patients with pouchitis significantly decrease after 9 months of the probiotic taking. The concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK significantly decreased after the therapy. Conclusions. Nine months of the probiotic treatment (Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Bifidobacterium bifidus reduced the number of patients with pouchitis, decreased the PDAI score, and also decreased the fecal pyruvate kinase and calprotectin. The long-term probiotics use is safe and well accepted and can be an effective method of the pouchitis prevention.

Is Subjective Status Influenced by Psychosocial Factors?

OpenAIRE

Lundberg, Johanna; Kristenson, Margareta

2008-01-01

Objective Associations between subjective status and health are still relatively unexplored. This study aimed at testing whether subjective status is uniquely confounded by psychosocial factors compared to objective status, and what factors that may predict subjective status. Design A cross-sectional analysis of a population-based, random sample of 795 middle-aged men and women from the southeast of Sweden. Questionnaires included subjective status, objective measures of socioeconomic status,...

Experimental Testing of Monopiles in Sand Subjected to One-Way Long-Term Cyclic Lateral Loading

DEFF Research Database (Denmark)

Roesen, Hanne Ravn; Ibsen, Lars Bo; Andersen, Lars Vabbersgaard

2013-01-01

In the offshore wind turbine industry the most widely used foundation type is the monopile. Due to the wave and wind forces the monopile is subjected to a strong cyclic loading with varying amplitude, maximum loading level, and varying loading period. In this paper the soil–pile interaction...... of a monopile in sand subjected to a long-term cyclic lateral loading is investigated by means of small scale tests. The tests are conducted with a mechanical loading rig capable of applying the cyclic loading as a sine signal with varying amplitude, mean loading level, and loading period for more than 60 000...... cycles. The tests are conducted in dense saturated sand. The maximum moment applied in the cyclic tests is varied from 18% to 36% of the ultimate lateral resistance found in a static loading test. The tests reveal that the accumulated rotation can be expressed by use of a power function. Further, static...

Geopathic stress zones: short-term effects on work performance and well-being?

Science.gov (United States)

Augner, Christoph; Hacker, Gerhard W; Jekel, Ilse

2010-06-01

The aim of the study was to evaluate whether two different locations in the same room as tested by dowsers ("geopathic stress zone" [GSZ] versus "more neutral zone" [NZ]) would show significant short-term effects on work performance and well-being. It was also tested whether a device reported to "neutralize" GSZ would influence results obtained with the specific setup used in this study. This was a blinded, randomized, short-term laboratory experiment using a within-subject design. The study was conducted in the laboratory of the Research Institute for Frontier Questions of Medicine and Biotechnology at Salzburg Federal Hospital. The subjects were 26 persons, aged 20-57. Participants had to accomplish reaction tasks during three different conditions: GSZ, NZ, and GSZ with a device reported to "neutralize" GSZ. These conditions were counterbalanced into six different sequences and randomized to the subjects. At the end of each condition, a standardized well-being questionnaire had to be completed. Dependent variables were reactive stress tolerance (reaction time, timely right answers, right answers, false answers, left out) and well-being (described by six adjectives). No location-dependent effects on performance during reactive stress tolerance test were seen. For well-being, analysis of variance revealed a trend (p = 0.07) and showed significantly poorer well-being during the GSZ condition compared to NZ (p = 0.01). This study shows that well-being can be location dependent and that this might be caused by a so-called GSZ. However, in our short-term experiment, factors of work performance tested remained unaffected.

IPP-rich milk protein hydrolysate lowers blood pressure in subjects with stage 1 hypertension, a randomized controlled trial

Directory of Open Access Journals (Sweden)

Kloek Joris

2010-11-01

Full Text Available Abstract Background Milk derived peptides have been identified as potential antihypertensive agents. The primary objective was to investigate the effectiveness of IPP-rich milk protein hydrolysates (MPH on reducing blood pressure (BP as well as to investigate safety parameters and tolerability. The secondary objective was to confirm or falsify ACE inhibition as the mechanism underlying BP reductions by measuring plasma renin activity and angiotensin I and II. Methods We conducted a randomized, placebo-controlled, double blind, crossover study including 70 Caucasian subjects with prehypertension or stage 1 hypertension. Study treatments consisted of daily consumption of two capsules MPH1 (each containing 7.5 mg Isoleucine-Proline-Proline; IPP, MPH2 (each containing 6.6 mg Methionine-Alanine-Proline, 2.3 mg Leucine-Proline-Proline, 1.8 mg IPP, or placebo (containing cellulose for 4 weeks. Results In subjects with stage 1 hypertension, MPH1 lowered systolic BP by 3.8 mm Hg (P = 0.0080 and diastolic BP by 2.3 mm Hg (P = 0.0065 compared with placebo. In prehypertensive subjects, the differences in BP between MPH1 and placebo were not significant. MPH2 did not change BP significantly compared with placebo in stage I hypertensive or prehypertensive subjects. Intake of MPHs was well tolerated and safe. No treatment differences in hematology, clinical laboratory parameters or adverse effects were observed. No significant differences between MPHs and placebo were found in plasma renin activity, or angiotensin I and II. Conclusions MPH1, containing IPP and no minerals, exerts clinically relevant BP lowering effects in subjects with stage 1 hypertension. It may be included in lifestyle changes aiming to prevent or reduce high BP. Trial registration ClinicalTrials.gov NCT00471263

Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

Directory of Open Access Journals (Sweden)

Puig-Ribera Anna

2009-01-01

Full Text Available Abstract Background Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care. Method and design Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ, self-employed and from 9 Primary Healthcare Centres (PHC. They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session. Participants from each PHC will be randomly allocated to an intervention (IG and control group (CG. The following parameters will be assessed pre and post intervention in both groups: (1 health-related quality of life (SF-12, (2 physical activity stage of change (Prochaska's stages of change, (3 level of physical activity (IPAQ-short version, (4 change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA, (5 level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS, and (6 control based on analysis (HDL, LDL and glycated haemoglobin. Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages

Long-term clinical and bacterial effects of xylitol on patients with fixed orthodontic appliances

OpenAIRE

Masoud, Mohamed I.; Allarakia, Reem; Alamoudi, Najlaa M.; Nalliah, Romesh; Allareddy, Veerasathpurush

2015-01-01

Background The objective of this study was to evaluate long-term clinical and bacterial effects of using 6 g of xylitol per day for 3 months on patients with full fixed orthodontic appliances. Methods The study was a pilot clinical trial that included 41 subjects who were undergoing orthodontic treatment. The subjects were randomly divided into three groups. Group A received xylitol chewing gum, group B received xylitol dissolvable chewable tablets, and Group C served as the control group and...

Short- and long-term forecast for chaotic and random systems (50 years after Lorenz's paper)

International Nuclear Information System (INIS)

Bunimovich, Leonid A

2014-01-01

We briefly review a history of the impact of the famous 1963 paper by E Lorenz on hydrodynamics, physics and mathematics communities on both sides of the iron curtain. This paper was an attempt to apply the ideas and methods of dynamical systems theory to the problem of weather forecast. Its major discovery was the phenomenon of chaos in dissipative dynamical systems which makes such forecasts rather problematic, if at all possible. In this connection we present some recent results which demonstrate that both a short-term and a long-term forecast are actually possible for the most chaotic dynamical (as well as for the most random, like IID and Markov chain) systems. Moreover, there is a sharp transition between the time interval where one may use a short-term forecast and the times where a long-term forecast is applicable. Finally we discuss how these findings could be incorporated into the forecast strategy outlined in the Lorenz's paper. (invited article)

Retrieval-Induced Inhibition in Short-Term Memory.

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Kang, Min-Suk; Choi, Joongrul

2015-07-01

We used a visual illusion called motion repulsion as a model system for investigating competition between two mental representations. Subjects were asked to remember two random-dot-motion displays presented in sequence and then to report the motion directions for each. Remembered motion directions were shifted away from the actual motion directions, an effect similar to the motion repulsion observed during perception. More important, the item retrieved second showed greater repulsion than the item retrieved first. This suggests that earlier retrieval exerted greater inhibition on the other item being held in short-term memory. This retrieval-induced motion repulsion could be explained neither by reduced cognitive resources for maintaining short-term memory nor by continued inhibition between short-term memory representations. These results indicate that retrieval of memory representations inhibits other representations in short-term memory. We discuss mechanisms of retrieval-induced inhibition and their implications for the structure of memory. © The Author(s) 2015.

SCRAED - Simple and Complex Random Assignment in Experimental Designs

OpenAIRE

Alferes, Valentim R.

2009-01-01

SCRAED is a package of 37 self-contained SPSS syntax files that performs simple and complex random assignment in experimental designs. For between-subjects designs, SCRAED includes simple random assignment (no restrictions, forced equal sizes, forced unequal sizes, and unequal probabilities), block random assignment (simple and generalized blocks), and stratified random assignment (no restrictions, forced equal sizes, forced unequal sizes, and unequal probabilities). For within-subject...

Cluster randomization and political philosophy.

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Chwang, Eric

2012-11-01

In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research--cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. © 2011 Blackwell Publishing Ltd.

Mobile access to virtual randomization for investigator-initiated trials.

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Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

A short-term, comprehensive, yoga-based lifestyle intervention is efficacious in reducing anxiety, improving subjective well-being and personality

Directory of Open Access Journals (Sweden)

Raj Kumar Yadav

2012-01-01

Full Text Available Objective: To assess the efficacy of a short-term comprehensive yoga-based lifestyle intervention in reducing anxiety, improving subjective well-being and personality. Materials and Methods: The study is a part of an ongoing larger study at a tertiary care hospital. Participants (n=90 included patients with chronic diseases attending a 10-day, yoga-based lifestyle intervention program for prevention and management of chronic diseases, and healthy controls (n=45 not attending any such intervention. Primary Outcome Measures: Change in state and trait anxiety questionnaire (STAI-Y; 40 items, subjective well-being inventory (SUBI; 40 items, and neuroticism extraversion openness to experience five factor personality inventory revised (NEO-FF PI-R; 60 items at the end of intervention. Results: Following intervention, the STAI-Y scores reduced significantly (P0.01 at Day 10 versus Day 1. Similarly NEO-FF PI-R scores improved significantly (P<0.001 at Day 10 versus Day 1. Control group showed an increase in STAI-Y while SUBI and NEO-FF PI-R scores remained comparable at Day 10 versus Day 1. Conclusions: The observations suggest that a short-term, yoga-based lifestyle intervention may significantly reduce anxiety and improve subjective well-being and personality in patients with chronic diseases.

Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects.

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Fiori, Valentina; Coccia, Michela; Marinelli, Chiara V; Vecchi, Veronica; Bonifazi, Silvia; Ceravolo, M Gabriella; Provinciali, Leandro; Tomaiuolo, Francesco; Marangolo, Paola

2011-09-01

A number of studies have shown that modulating cortical activity by means of transcranial direct current stimulation (tDCS) affects performances of both healthy and brain-damaged subjects. In this study, we investigated the potential of tDCS to enhance associative verbal learning in 10 healthy individuals and to improve word retrieval deficits in three patients with stroke-induced aphasia. In healthy individuals, tDCS (20 min, 1 mA) was applied over Wernicke's area (position CP5 of the International 10-20 EEG System) while they learned 20 new "words" (legal nonwords arbitrarily assigned to 20 different pictures). The healthy subjects participated in a randomized counterbalanced double-blind procedure in which they were subjected to one session of anodic tDCS over left Wernicke's area, one sham session over this location and one session of anodic tDCS stimulating the right occipito-parietal area. Each experimental session was performed during a different week (over three consecutive weeks) with 6 days of intersession interval. Over 2 weeks, three aphasic subjects participated in a randomized double-blind experiment involving intensive language training for their anomic difficulties in two tDCS conditions. Each subject participated in five consecutive daily sessions of anodic tDCS (20 min, 1 mA) and sham stimulation over Wernicke's area while they performed a picture-naming task. By the end of each week, anodic tDCS had significantly improved their accuracy on the picture-naming task. Both normal subjects and aphasic patients also had shorter naming latencies during anodic tDCS than during sham condition. At two follow-ups (1 and 3 weeks after the end of treatment), performed only in two aphasic subjects, response accuracy and reaction times were still significantly better in the anodic than in the sham condition, suggesting a long-term effect on recovery of their anomic disturbances.

Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial.

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Christensen, Pia; Henriksen, Marius; Bartels, Else M; Leeds, Anthony R; Meinert Larsen, Thomas; Gudbergsen, Henrik; Riecke, Birgit F; Astrup, Arne; Heitmann, Berit L; Boesen, Mikael; Christensen, Robin; Bliddal, Henning

2017-09-01

Background: A formula low-energy diet (LED) reduces weight effectively in obese patients with knee osteoarthritis, but the role of LED in long-term weight-loss maintenance is unclear. Objective: We aimed to determine the effect of intermittent LED compared with daily meal replacements on weight-loss maintenance and number of knee replacements over 3 y. Design: The design was a randomized trial with participants aged >50 y who had knee osteoarthritis and a body mass index [BMI (in kg/m 2 )] ≥30. Participants were recruited from the osteoarthritis outpatient clinic at Copenhagen University Hospital in Frederiksberg, Denmark; they had previously completed a 68-wk lifestyle intervention trial and achieved an average weight loss of 10.5 kg (10% of initial body weight). Participants were randomly assigned to either the intermittent treatment (IN) group with LED for 5 wk every 4 mo for 3 y or to daily meal replacements of 1-2 meals for 3 y [regular (RE) group]. Attention by dietitians and the amount of formula products were similar. Primary outcomes were changes in body weight and proportion of participants receiving knee replacements. Outcomes were analyzed on the intention-to-treat-population with the use of baseline-carried-forward imputation for missing data. Results: A total of 153 participants (means ± SDs: BMI: 33.3 ± 4.6; age: 63.8 ± 6.3 y; 83% women) were recruited between June and December 2009 and randomly assigned to the IN ( n = 76) or RE ( n = 77) group. A total of 53 and 56 participants, respectively, completed the trial. Weight increased by 0.68 and 1.75 kg in the IN and RE groups, respectively (mean difference: -1.06 kg; 95% CI: -2.75, 0.63 kg; P = 0.22). Alloplasty rates were low and did not differ (IN group: 8 of 76 participants; RE group: 12 of 77 participants; P = 0.35). Conclusions: After a mean 10% weight-loss and 1-y maintenance, additional use of daily meal replacements or intermittent LED resulted in weight-loss maintenance for 3 y. These

Efficacy and cost-effectiveness of an experimental short-term inpatient Dialectical Behavior Therapy (DBT) program: study protocol for a randomized controlled trial.

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van den Bosch, Louisa M C; Sinnaeve, Roland; Hakkaart-van Roijen, Leona; van Furth, Eric F

2014-05-01

Borderline Personality Disorder (BPD) is a serious psychiatric condition associated with substantial mortality, burden and public health costs. DBT is the treatment model with the largest number of published research articles showing effectiveness. However, some patients are not sufficiently engaged in outpatient treatment while presenting severe parasuicidal behavior, making hospitalization necessary. The Center for Personality Disorders Jelgersma developed an intensive 12-week inpatient DBT program that (i) rapidly reduces core borderline symptoms like suicidal behavior, (ii) minimizes the negative effects of an inpatient setting, and (iii) enhances compliance with outpatient treatment. We evaluate the (cost-) effectiveness of this experimental program. Seventy patients, aged 18 to 45 years with a primary diagnosis of BPD, showing a chronic pattern of parasuicidal gestures and/or reporting high degrees of severity of other borderline symptoms, are randomly allocated to the control and intervention groups. Subjects in the control group receive standard outpatient DBT, provided in one of three regular mental health settings in GGZ Rivierduinen. Subjects in the intervention group receive 12 weeks of intensified inpatient DBT plus six months of standard DBT, provided in the Center for Personality Disorders Jelgersma. The primary outcome is the number of suicide attempts/self-harming acts. Secondary outcomes are severity of other borderline complaints, quality of life, general psychopathological symptoms and health care utilization and productivity costs. Data are gathered using a prospective, two (group: intervention and control) by five (time of measurement) repeated measures factorial design.Participants will complete three-monthly outcome assessments in the course of therapy: at baseline, and 12, 24, 36 and 52 weeks after the start of the treatment. The period of recruitment started in March 2012 and the study will end in December 2014. Highly suicidal

Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care

OpenAIRE

Gallo, Joseph J; Morales, Knashawn H; Bogner, Hillary R; Raue, Patrick J; Zee, Jarcy; Bruce, Martha L; Reynolds, Charles F

2013-01-01

Objective To investigate whether an intervention to improve treatment of depression in older adults in primary care modified the increased risk of death associated with depression. Design Long term follow-up of multi-site practice randomized controlled trial (PROSPECT?Prevention of Suicide in Primary Care Elderly: Collaborative Trial). Setting 20 primary care practices in New York City, Philadelphia, and Pittsburgh, USA, randomized to intervention or usual care. Participants 1226 participants...

Learning where to look: electrophysiological and behavioral indices of visual search in young and old subjects.

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Looren de Jong, H; Kok, A; Woestenburg, J C; Logman, C J; Van Rooy, J C

1988-06-01

The present investigation explores the way young and elderly subjects use regularities in target location in a visual display to guide search for targets. Although both young and old subjects show efficient use of search strategies, slight but reliable differences in reaction times suggest decreased ability in the elderly to use complex cues. Event-related potentials were very different for the young and the old. In the young, P3 amplitudes were larger on trials where the rule that governed the location of the target became evident; this was interpreted as an effect of memory updating. Enhanced positive Slow Wave amplitude indicated uncertainty in random search conditions. Elderly subjects' P3 and SW, however, seemed unrelated to behavioral performance, and they showed a large negative Slow Wave at central and parietal sites to randomly located targets. The latter finding was tentatively interpreted as a sign of increased effort in the elderly to allocate attention in visual space. This pattern of behavioral and ERP results suggests that age-related differences in search tasks can be understood in terms of changes in the strategy of allocating visual attention.

Follow-up into young adulthood after cardiopulmonary resuscitation in term and near-term newborn infants. II. Neuropsychological consequences.

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Viggedal, G; Lundälv, E; Carlsson, G; Kjellmer, I

2002-01-01

Brain injury after neonatal cardiopulmonary resuscitation in the term baby is often described as an all-or-nothing phenomenon, but little is known about possible late cognitive consequences. The aim of this study was therefore to investigate whether children who needed cardiopulmonary resuscitation because of presumed mild and moderate intra-partum asphyxia with no evidence of neurological impairments at 18 mo of age may display neuropsychological impairments later in life. A long-term follow-up of young adults was carried out. A blinded comprehensive neuropsychological assessment of the main aspects of cognitive functions was made. The subjects who were resuscitated were divided into two groups according to the clinical course: 20 cases with mild asphyxia and 11 cases with moderate asphyxia, all followed prospectively and compared with 18 healthy controls. The 31 subjects were born at term or near-term and selected randomly from 59 infants born in 1969-1978 at Sahlgren's Hospital, Göteborg. All infants with early neurological impairments were excluded. No major differences could be established between the two clinical groups and normal controls in any aspects of cognitive function or intelligence. All the groups performed within the normal range in all tests. A tendency toward minor deficits in verbal ability in the mild group compared to the controls was found. Only one subject had a clear, defined memory deficit. Infants who underwent cardiopulmonary resuscitatation at birth without neurological deficits at 18 mo of age did not show any cognitive deficits or neuropsychological impairments in adulthood even though inferior performance on some verbal subtests was observed compared to the control group.

Short-term effects of a standardized glucose load on region-specific aortic pulse wave velocity assessed by MRI

NARCIS (Netherlands)

Jonker, J.T.; Tjeerdema, N.; Hensen, L.C.; Lamb, H.J.; Romijn, J.A.; Smit, J.W.; Westenberg, J.J.; Roos, A. de

2014-01-01

PURPOSE: To assess the short-term effects of a standardized oral glucose load on regional aortic pulse wave velocity (PWV) using two-directional in-plane velocity encoded MRI. MATERIALS AND METHODS: A randomized, controlled intervention was performed in 16 male subjects (mean +/- standard deviation:

Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

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Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

2017-01-01

While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women : A randomized trial

NARCIS (Netherlands)

de Roon, Martijn; van Gemert, Willemijn A; Peeters, Petra H; Schuit, A.J.; Monninkhof, Evelyn M

2017-01-01

The aim of this study was to determine the long-term effects of a weight loss intervention with or without an exercise component on body weight and physical activity. Women were randomized to diet (n = 97) or exercise (N = 98) for 16 weeks. During the intervention, both groups had achieved the set

Effect of whey protein supplementation on long and short term appetite: A meta-analysis of randomized controlled trials.

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Mollahosseini, Mehdi; Shab-Bidar, Sakineh; Rahimi, Mohammad Hossein; Djafarian, Kurosh

2017-08-01

Specific components of dairy, such as whey proteins may have beneficial effects on body composition by suppressing appetite, although the findings of existing studies have been inconsistent. Therefore, a meta-analysis of randomized controlled trials was performed to investigate effect of whey protein supplementation on long and short term appetite. A systematic search was conducted to identify eligible publications. Means and SDs for hunger, fullness, satiety, desire to eat and prospective consumption of food, before and after intervention, were extracted and then composite appetite score (CAS) calculated. To pool data, either a fixed-effects model or a random-effects model and for assessing heterogeneity, Cochran's Q and I 2 tests were used. Eight publications met inclusion criteria that 5 records were on short term and 3 records on long term appetite. The meta-analysis showed a significant reduction in long term appetite by 4.13 mm in combined appetite score (CAS) (95% Confidence interval (CI): -6.57, -1.96; p = 0.001). No significant reduction in short term appetite was also seen (Mean difference (MD) = -0.39 95% CI = -2.07, 1.30; p = 0.653). Subgroup analyses by time showed that compared with carbohydrate, the reduction in appetite following consumption of whey consumption was not significant (MD = -0.39, 95% CI = -2.07, 1.3, p = 0.65, I 2  = 0.0%.)A significant reduction in prospective food consumption was seen (MD = -2.17, 95% CI = -3.86, -0.48). The results of our meta-analysis showed that whey protein may reduce the long and short term appetite, but our finding did not show any significant difference in appetite reduction between whey protein and carbohydrate in short duration. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Random number generation and creativity.

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Bains, William

2008-01-01

A previous paper suggested that humans can generate genuinely random numbers. I tested this hypothesis by repeating the experiment with a larger number of highly numerate subjects, asking them to call out a sequence of digits selected from 0 through 9. The resulting sequences were substantially non-random, with an excess of sequential pairs of numbers and a deficit of repeats of the same number, in line with previous literature. However, the previous literature suggests that humans generate random numbers with substantial conscious effort, and distractions which reduce that effort reduce the randomness of the numbers. I reduced my subjects' concentration by asking them to call out in another language, and with alcohol - neither affected the randomness of their responses. This suggests that the ability to generate random numbers is a 'basic' function of the human mind, even if those numbers are not mathematically 'random'. I hypothesise that there is a 'creativity' mechanism, while not truly random, provides novelty as part of the mind's defence against closed programming loops, and that testing for the effects seen here in people more or less familiar with numbers or with spontaneous creativity could identify more features of this process. It is possible that training to perform better at simple random generation tasks could help to increase creativity, through training people to reduce the conscious mind's suppression of the 'spontaneous', creative response to new questions.

Effect of Guava in Blood Glucose and Lipid Profile in Healthy Human Subjects: A Randomized Controlled Study

Science.gov (United States)

Rakavi, R; Mangaraj, Manaswini

2016-01-01

Introduction The fruit of Psidium guajava (P.guajava) is known to contain free sugars yet the fruit juice showed hypoglycaemic effect. Hypoglycaemic activity of guava leaves has been well documented but not for guava fruit. Aim So we aimed to evaluate the effect of ripe guava (with peel and without peel) fruit supplementation on blood glucose and lipid profile in healthy human subjects. Materials and Methods Randomized Controlled study undertaken in: 1) Baseline; 2) 6 weeks supplementation phase. Forty five healthy MBBS students were included and randomly enrolled into Group A, Group B and Group C. In Baseline phase: Fasting Plasma Glucose (FPG) and serum lipid profile was done in all 3 groups. Group A were supplemented with 400g of ripe guava with peel and group B without peel, for 6 weeks. Rest 15 treated as control i.e., Group C. Result Supplementation of ripe guava fruit with peel reduced BMI as well as blood pressure (pguava pulp supplementation was not significant. Serum Total cholesterol, Triglycerides and Low Density Lipoprotein Cholesterol (LDLc) levels decreased significantly (pguava pulp without peel may have a favourable effect on lipid levels and blood sugar as well. Conclusion Guava fruit without peel is more effective in lowering blood sugar as well as serum total cholesterol, triglycerides and LDLc. It increases HDLc levels also. PMID:27790420

Effects of nanotechnologies-based devices on postural control in healthy subjects.

Science.gov (United States)

Malchiodi Albedi, Giovanna; Corna, Stefano; Aspesi, Valentina; Clerici, Daniela; Parisio, Cinzia; Seitanidis, Jonathan; Cau, Nicola; Brugliera, Luigia; Capodaglio, Paolo

2017-09-05

The aim of the present preliminary randomized controlled study was to ascertain whether the use of newly developed nanotechnologies-based patches can influence posture control of healthy subjects. Thirty healthy female subjects (age 39.4 years, BMI 22.74 kg/m2) were randomly assigned to two groups: one with active patches and a control group with sham patches. Two patches were applied with a tape: one on the subject's sternum and the other on the C7 apophysis. Body sway during quiet upright stance was recorded with a dynamometric platform. Each subject was tested under two visual conditions, eyes open and closed. We used a blocked stratified randomization procedure conducted by a third party. Subjects wearing the sham patches showed a significant increase of the centre of pressure sway area after 4 hours when they performed the habitual moderate-intensity work activities. In the active patch group, a decrease of the sway path was evident, providing evidence of an enhanced balance control. Our preliminary findings on healthy subjects indicate that nanotechnological devices generating ultra-low electromagnetic fields can improve posture control.

A Comparison between Decision Tree and Random Forest in Determining the Risk Factors Associated with Type 2 Diabetes.

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Esmaily, Habibollah; Tayefi, Maryam; Doosti, Hassan; Ghayour-Mobarhan, Majid; Nezami, Hossein; Amirabadizadeh, Alireza

2018-04-24

We aimed to identify the associated risk factors of type 2 diabetes mellitus (T2DM) using data mining approach, decision tree and random forest techniques using the Mashhad Stroke and Heart Atherosclerotic Disorders (MASHAD) Study program. A cross-sectional study. The MASHAD study started in 2010 and will continue until 2020. Two data mining tools, namely decision trees, and random forests, are used for predicting T2DM when some other characteristics are observed on 9528 subjects recruited from MASHAD database. This paper makes a comparison between these two models in terms of accuracy, sensitivity, specificity and the area under ROC curve. The prevalence rate of T2DM was 14% among these subjects. The decision tree model has 64.9% accuracy, 64.5% sensitivity, 66.8% specificity, and area under the ROC curve measuring 68.6%, while the random forest model has 71.1% accuracy, 71.3% sensitivity, 69.9% specificity, and area under the ROC curve measuring 77.3% respectively. The random forest model, when used with demographic, clinical, and anthropometric and biochemical measurements, can provide a simple tool to identify associated risk factors for type 2 diabetes. Such identification can substantially use for managing the health policy to reduce the number of subjects with T2DM .

Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine.

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Cady, Roger K; Saper, Joel; Dexter, Kent; Cady, Ryan J; Manley, Heather R

2015-04-01

This study aims to determine if repetitive sphenopalatine ganglion (SPG) blockades with 0.5% bupivacaine delivered with the Tx360 device results in long-term improvement in chronic migraine (CM). The SPG is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve. In a previous article, these authors reported repetitive SPG blockades with 0.5% bupivacaine delivered by the Tx360 device, which was an effective and well-tolerated intervention to incrementally decrease baseline headache intensity of subjects with CM. This was a double-blind, parallel-arm, placebo-controlled, randomized pilot study using a novel intervention for acute treatment in CM. A total of 41 subjects were enrolled at two headache specialty clinics in the USA. Eligible subjects were between 18 and 80 years of age and had a history of CM defined by International Classification of Headache Disorders-II definition. Subjects were allowed a stable dose of migraine preventive medications that was maintained throughout the study. Following a 28-day baseline period, subjects were randomized by computer-generated lists 2:1 to receive 0.3 cc of 0.5% bupivacaine or saline, respectively, delivered with the Tx360 twice a week for 6 weeks. Secondary end-points reported in this manuscript include post-treatment measures including number of headache days and quality of life measures. The final data set included 38 subjects: 26 in the bupivacaine group and 12 in the saline group. Our primary end-point for the study, difference in numeric pain rating scale scores, was met and reported in a previous article. The supplemental secondary end-points reported in this manuscript did not reach statistical significance. When looking collectively at these end-points, trends were noticed and worthy of reporting. Subjects receiving bupivacaine reported a decrease in the

The Social Media Political Subject Is an Infant

Directory of Open Access Journals (Sweden)

Athina Karatzogianni

2015-04-01

Full Text Available Any random sampling of a Facebook timeline or Twitter feed, to take the obvious examples, provides a prepackaged view of global politics. It is restrictive because we choose it to reflect our own pet subjects, groups, likes, and world interests. The lens is prejudiced to reflect our race, class, gender, sexuality, ideology, and affective positionality. We enter a social media world as many as 10 or 50 times a day that has ourselves as the center of the universe. This communication world is similar to an infant’s world: Someone else decides what we can see, what we can consume, what is that extra treat we can earn, if we are good: in social media terms, if we pay for it by reputational capital, or simply, if we spend enough money.

Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects.

Science.gov (United States)

Haufe, Sven; Engeli, Stefan; Kast, Petra; Böhnke, Jana; Utz, Wolfgang; Haas, Verena; Hermsdorf, Mario; Mähler, Anja; Wiesner, Susanne; Birkenfeld, Andreas L; Sell, Henrike; Otto, Christoph; Mehling, Heidrun; Luft, Friedrich C; Eckel, Juergen; Schulz-Menger, Jeanette; Boschmann, Michael; Jordan, Jens

2011-05-01

Obesity-related hepatic steatosis is a major risk factor for metabolic and cardiovascular disease. Fat reduced hypocaloric diets are able to relieve the liver from ectopically stored lipids. We hypothesized that the widely used low carbohydrate hypocaloric diets are similarly effective in this regard. A total of 170 overweight and obese, otherwise healthy subjects were randomized to either reduced carbohydrate (n = 84) or reduced fat (n = 86), total energy restricted diet (-30% of energy intake before diet) for 6 months. Body composition was estimated by bioimpedance analyses and abdominal fat distribution by magnetic resonance tomography. Subjects were also submitted to fat spectroscopy of liver and oral glucose tolerance testing. In all, 102 subjects completed the diet intervention with measurements of intrahepatic lipid content. Both hypocaloric diets decreased body weight, total body fat, visceral fat, and intrahepatic lipid content. Subjects with high baseline intrahepatic lipids (>5.56%) lost ≈7-fold more intrahepatic lipids compared with those with low baseline values (diet composition. In contrast, changes in visceral fat mass and insulin sensitivity were similar between subgroups, with low and high baseline intrahepatic lipids. A prolonged hypocaloric diet low in carbohydrates and high in fat has the same beneficial effects on intrahepatic lipid accumulation as the traditional low-fat hypocaloric diet. The decrease in intrahepatic lipids appears to be independent of visceral fat loss and is not tightly coupled with changes in whole body insulin sensitivity during 6 months of an energy restricted diet. Copyright © 2011 American Association for the Study of Liver Diseases.

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

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Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

Relevance of a subjective quality of life questionnaire for long-term homeless persons with schizophrenia.

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Girard, V; Tinland, A; Bonin, J P; Olive, F; Poule, J; Lancon, C; Apostolidis, T; Rowe, M; Greacen, T; Simeoni, M C

2017-02-17

Increasing numbers of programs are addressing the specific needs of homeless people with schizophrenia in terms of access to housing, healthcare, basic human rights and other domains. Although quality of life scales are being used to evaluate such programs, few instruments have been validated for people with schizophrenia and none for people with schizophrenia who experience major social problems such as homelessness. The aim of the present study was to validate the French version of the S-QoL a self-administered, subjective quality of life questionnaire specific to schizophrenia for people with schizophrenia who are homeless. In a two-step process, the S-QoL was first administered to two independent convenience samples of long-term homeless people with schizophrenia in Marseille, France. The objective of the first step was to analyse the psychometric properties of the S-QoL. The objective of the second step was to examine, through qualitative interviews with members of the population in question, the relevance and acceptability of the principle quality of life indicators used in the S-QoL instrument. Although the psychometric characteristics of the S-QoL were found to be globally satisfactory, from the point of view of the people being interviewed, acceptability was poor. Respondents frequently interrupted participation complaining that questionnaire items did not take into account the specific context of life on the streets. Less intrusive questions, more readily understandable vocabulary and greater relevance to subjects' living conditions are needed to improve the S-QoL questionnaire for this population. A modular questionnaire with context specific sections or specific quality of life instruments for socially excluded populations may well be the way forward.

Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial.

Science.gov (United States)

Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M

2013-02-01

The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.

Divergent short- and long-term effects of acute stress in object recognition memory are mediated by endogenous opioid system activation.

Science.gov (United States)

Nava-Mesa, Mauricio O; Lamprea, Marisol R; Múnera, Alejandro

2013-11-01

Acute stress induces short-term object recognition memory impairment and elicits endogenous opioid system activation. The aim of this study was thus to evaluate whether opiate system activation mediates the acute stress-induced object recognition memory changes. Adult male Wistar rats were trained in an object recognition task designed to test both short- and long-term memory. Subjects were randomly assigned to receive an intraperitoneal injection of saline, 1 mg/kg naltrexone or 3 mg/kg naltrexone, four and a half hours before the sample trial. Five minutes after the injection, half the subjects were submitted to movement restraint during four hours while the other half remained in their home cages. Non-stressed subjects receiving saline (control) performed adequately during the short-term memory test, while stressed subjects receiving saline displayed impaired performance. Naltrexone prevented such deleterious effect, in spite of the fact that it had no intrinsic effect on short-term object recognition memory. Stressed subjects receiving saline and non-stressed subjects receiving naltrexone performed adequately during the long-term memory test; however, control subjects as well as stressed subjects receiving a high dose of naltrexone performed poorly. Control subjects' dissociated performance during both memory tests suggests that the short-term memory test induced a retroactive interference effect mediated through light opioid system activation; such effect was prevented either by low dose naltrexone administration or by strongly activating the opioid system through acute stress. Both short-term memory retrieval impairment and long-term memory improvement observed in stressed subjects may have been mediated through strong opioid system activation, since they were prevented by high dose naltrexone administration. Therefore, the activation of the opioid system plays a dual modulating role in object recognition memory. Copyright © 2013 Elsevier Inc. All rights

Short-term effects of an anti-inflammatory treatment on clinical parameters and serum levels of C-reactive protein and proinflammatory cytokines in subjects with periodontitis.

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Renvert, Stefan; Lindahl, Christel; Roos-Jansåker, Ann-Marie; Lessem, Jan

2009-06-01

Periodontal disease is the most common multifactorial disease, afflicting a very large proportion of the adult population. Periodontal disease secondarily causes increases in the serum levels of C-reactive protein (CRP) and other markers of inflammation. An increased level of CRP reflects an increased risk for cardiovascular disease. The aim of the current randomized clinical trial was to evaluate the short-term effect of a combination of dipyridamole and prednisolone (CRx-102) on the levels of high-sensitivity (hs)-CRP, proinflammatory markers in blood, and clinical signs of periodontal disease. Fifty-seven patients with >/=10 pockets with probing depths >/=5 mm were randomized into two groups in this masked single-center placebo-controlled study: CRx-102 (n = 28) and placebo (n = 29). hs-CRP levels, inflammatory markers (interleukin [IL]-6, -1beta, -8, and -12, tumor necrosis factor-alpha, and interferon-gamma [IFN-gamma]), bleeding on probing (BOP), and changes in probing depths were evaluated. The subjects received mechanical non-surgical therapy after 42 days, and the study was completed after 49 days. At day 42, the differences in the hs-CRP, IFN-gamma, and IL-6 levels between the two groups were statistically significant (P <0.05), whereas no difference was found for the other inflammatory markers. There was no change in probing depth or BOP between the two groups. The administration of CRx-102 resulted in significant decreases in hs-CRP, IFN-gamma, and IL-6, but it did not significantly change BOP or probing depths.

Random walk of passive tracers among randomly moving obstacles.

Science.gov (United States)

Gori, Matteo; Donato, Irene; Floriani, Elena; Nardecchia, Ilaria; Pettini, Marco

2016-04-14

This study is mainly motivated by the need of understanding how the diffusion behavior of a biomolecule (or even of a larger object) is affected by other moving macromolecules, organelles, and so on, inside a living cell, whence the possibility of understanding whether or not a randomly walking biomolecule is also subject to a long-range force field driving it to its target. By means of the Continuous Time Random Walk (CTRW) technique the topic of random walk in random environment is here considered in the case of a passively diffusing particle among randomly moving and interacting obstacles. The relevant physical quantity which is worked out is the diffusion coefficient of the passive tracer which is computed as a function of the average inter-obstacles distance. The results reported here suggest that if a biomolecule, let us call it a test molecule, moves towards its target in the presence of other independently interacting molecules, its motion can be considerably slowed down.

Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial.

Science.gov (United States)

Hurtado, R; Celani, M; Geber, S

2016-10-01

To evaluate the effect of short-term hormone replacement therapy with 0.625 mg conjugated estrogens daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. We performed a double-blinded, randomized, controlled trial over 3 years. Randomization was performed using computer-generated sorting. All participants were blinded to the use of conjugated equine estrogens (CEE) or placebo and FMD was assessed by a blinded examiner, before and after 28 days of medication. A total of 64 healthy postmenopausal women were selected and randomly assigned into two groups of treatment: 0.625 mg of CEE or placebo. FMD values were statistically different between the groups (p = 0.025): the group receiving CEE showed a FMD value of 0.011 compared to the placebo group (FMD = -0.082). The two groups were additionally evaluated for homogeneity through the Shapiro-Wilk test in respect to variables that could interfere with endothelial function such as age (p = 0.729), body mass index (p = 0.891), and time since menopause (p = 0.724). Other variables were excluded during selection of the participants such as chronic vascular conditions, smoking, and sedentary lifestyle. Our results demonstrate that the administration of 0.625 mg CEE for 28 days is effective in improving vascular nitric oxide-dependent dilation assessed by FMD of the brachial artery in postmenopausal women. NCT01482416.

A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes.

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Guess, Nicola D; Dornhorst, Anne; Oliver, Nick; Bell, Jimmy D; Thomas, E Louise; Frost, Gary S

2015-01-01

Fat infiltration of the liver, muscle and pancreas is associated with insulin resistance and risk of diabetes. Weight loss reduces ectopic fat deposition and risk of diabetes, but is difficult to sustain to due to compensatory increases in appetite. Fermentable carbohydrates have been shown to decrease appetite and food intake, and promote weight loss in overweight subjects. In animal studies, fermentable carbohydrate reduces ectopic fat independent of weight loss. We aimed to investigate the effect of the fermentable carbohydrate inulin on weight maintenance, appetite and ectopic fat in subjects with prediabetes. Forty-four subjects with prediabetes were randomized to 18 weeks' inulin or cellulose supplementation. During weeks 1-9 (weight loss phase) all subjects had four visits with a dietitian to guide them towards a 5 % weight loss. During weeks 10-18 (weight maintenance phase) subjects continued taking their assigned supplementation and were asked to maintain the weight they had lost but were offered no further support. All subjects attended study sessions at baseline, 9 and 18 weeks for measurement of weight; assessment of adipose tissue and ectopic fat content by magnetic resonance imaging and magnetic resonance spectroscopy; glucose, insulin and GLP-1 levels following a meal tolerance test; and appetite by ad libitum meal test and visual analogue scales. Both groups lost approximately 5 % of their body weight by week nine (-5.3 ± 0.1 % vs -4.3 ± 0.4 %, p = 0.13, but the inulin group lost significantly more weight between 9 and 18 weeks (-2.3 ± 0.5 % vs -0.6 ± 0.4 %, p = 0.012). Subjects taking inulin had lower hepatic (p = 0.02) and soleus muscle (p fat content at 18 weeks compared to control even after controlling for weight loss and consumed less at the ad libitum meal test (p = 0.027). Fasting glucose significantly decreased at week nine only (p = 0.005), insulin concentrations did not change, and there

Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments

Directory of Open Access Journals (Sweden)

Babak Vahdatpour

2012-01-01

Full Text Available Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm 2 in 3 sessions at weekly intervals or sham therapy (n = 20 in each group. Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients′ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results : The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P < 0.001, but slightly increased in the sham group (4.1 ± 0.8 to 4.5 ± 0.9 mm, P = 0.03. Both groups showed significant pain improvement over the course of the study (P < 0.001, though pain scores were significantly more reduced in the ESWT than the sham group (-4.2 ± 2.9 vs. -2.7 ± 1.8, P = 0.049. Conclusions: Extracorporeal shock wave therapy contributes to healing and pain reduction in plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy.

Comparison of Short Term with Long Term Catheterization after Anterior Colporrhaphy Surgery

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F. Movahed

2010-07-01

Full Text Available Introduction & Objective: This belief that overfilling the bladder after anterior colporrhaphy might have a negative influence on surgical outcome, causes routine catheterization after operation. This study was done to compare short term (24h with long term (72h catheterization after anterior colporrhaphy.Materials & Methods: This randomized clinical trial was carried out at Kosar Hospital , Qazvin (Iran in 2005-2006. One hundred cases candidating for anterior colporrhaphy , were divided in two equal groups . In the first group foley catheter was removed 24 hours and in the second group 72 hours after the operation. Before removing catheter, urine sample was obtained for culture . After removal and urination, residual volume was determinded. If the volume exceeded 200 ml or retention occured, the catheter would be fixed for more 72 hours. Need for recatheterization, urinary retention, positive urine culture,and hospital stay were surveyed. The data was analyzed using T and Fisher tests.Results: Residual volume exceeding 200 ml and the need for recatheterization occurred in one case (2% in the short term group but in the long term group none of the subjects needed recatheterization (P=1. Retention was not seen. In the both groups, one case (2% had positive urine culture with no statistically significant difference (P=1. Mean hospital stay was short in the first group (P=0.00.Conclusion: Short term catheterization after anterior colporrhaphy does not cause urinary retention and decreases hospital stay.

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

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Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

2013-02-01

The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

Subjective poverty line definitions

NARCIS (Netherlands)

J. Flik; B.M.S. van Praag (Bernard)

1991-01-01

textabstractIn this paper we will deal with definitions of subjective poverty lines. To measure a poverty threshold value in terms of household income, which separates the poor from the non-poor, we take into account the opinions of all people in society. Three subjective methods will be discussed

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

Science.gov (United States)

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing

Random Decrement

DEFF Research Database (Denmark)

Asmussen, J.C.; Ibrahim, S.R.; Brincker, Rune

Abstraet Thispaper demansirates how to use the Random Decrement (RD) technique for identification o flinear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing...

Subject search study. Final report

International Nuclear Information System (INIS)

Todeschini, C.

1995-01-01

The study gathered information on how users search the database of the International Nuclear Information System (INIS), using indicators such as Subject categories, Controlled terms, Subject headings, Free-text words, combinations of the above. Users participated from the Australian, French, Russian and Spanish INIS Centres, that have different national languages. Participants, both intermediaries and end users, replied to a questionnaire and executed search queries. The INIS Secretariat at the IAEA also participated. A protocol of all search strategies used in actual searches in the database was kept. The thought process for Russian and Spanish users is predominantly non-English and also the actual initial search formulation is predominantly non-English among Russian and Spanish users while it tends to be more in English among French users. A total of 1002 searches were executed by the five INIS centres including the IAEA. The search protocols indicate the following search behaviour: 1) free text words represent about 40% of search points on an average query; 2) descriptors used as search keys have the widest range as percentage of search points, from a low of 25% to a high of 48%; 3) search keys consisting of free text that coincides with a descriptor account for about 15% of search points; 4) Subject Categories are not used in many searches; 5) free text words are present as search points in about 80% of all searches; 6) controlled terms (descriptors) are used very extensively and appear in about 90% of all searches; 7) Subject Headings were used in only a few percent of searches. From the results of the study one can conclude that there is a greater reluctance on the part of non-native English speakers in initiating their searches by using free text word searches. Also: Subject Categories are little used in searching the database; both free text terms and controlled terms are the predominant types of search keys used, whereby the controlled terms are used more

Influence of the Lactotripeptides Isoleucine-Proline-Proline and Valine-Proline-Proline on Systolic Blood Pressure in Japanese Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Directory of Open Access Journals (Sweden)

Aurelie Chanson-Rolle

Full Text Available The lactotripeptides isoleucine-proline-proline (IPP and valine-proline-proline (VPP have been shown to decrease systolic blood pressure (SBP in several populations, but the size of the effect varies among studies. We performed a meta-analysis including all published studies to evaluate the SBP-lowering effect of IPP/VPP in Japanese subjects more comprehensively.Eligible randomized controlled trials were searched for within four bibliographic databases, including two Japanese ones. Eighteen studies (including a total of 1194 subjects were included in the meta-analysis. A random effect model using the restricted maximum likelihood (REML estimator was used for the analysis. The analysis showed that consumption of IPP/VPP induced a significant reduction in SBP as compared with placebo in Japanese subjects, with an estimated effect of -5.63 mm Hg (95% CI, -6.87 to -4.39, P<0.0001 and no evidence of publication bias. A significant heterogeneity between series was evident, which could be explained by a significant influence of the baseline blood pressure status of the subjects, the effect of IPP/VPP on SBP being stronger in hypertensive subjects (-8.35 mm Hg, P<0.0001 than in non-hypertensive subjects (-3.42mm Hg, P<0.0001. Furthermore, the effect of IPP/VPP on SBP remained significant when limiting the analysis to series that tested the usual doses of IPP/VPP consumed daily (below 5 mg/d, with estimated effects of -6.01 mm Hg in the overall population and -3.32 mm Hg in non-hypertensive subjects.Results from this meta-analysis show that IPP/VPP lactotripeptides can significantly reduce office SBP in Japanese subjects with or without overt hypertension, and for doses that can potentially be consumed as an everyday supplement. This suggests that these peptides could play a role in controlling blood pressure in Japanese subjects. The systematic review protocol was published on the PROSPERO register (CRD42014014322.

Effects of short- and long-term Mediterranean-based dietary treatment on plasma LC-QTOF/MS metabolic profiling of subjects with metabolic syndrome features: The Metabolic Syndrome Reduction in Navarra (RESMENA) randomized controlled trial.

Science.gov (United States)

Bondia-Pons, Isabel; Martinez, José Alfredo; de la Iglesia, Rocio; Lopez-Legarrea, Patricia; Poutanen, Kaisa; Hanhineva, Kati; Zulet, Maria de los Ángeles

2015-04-01

Adherence to the Mediterranean diet has been associated with a reduced risk of metabolic syndrome (MetS). Metabolomics approach may contribute to identify beneficial associations of metabolic changes affected by Mediterranean diet-based interventions with inflammatory and oxidative-stress markers related to the etiology and development of the MetS. Liquid chromatography coupled to quadrupole-time of flight-MS metabolic profiling was applied to plasma from a 6-month randomized intervention with two sequential periods, a 2-month nutritional-learning intervention period, and a 4-month self-control period, with two energy-restricted diets; the RESMENA diet (based on the Mediterranean dietary pattern) and the Control diet (based on the American Heart Association guidelines), in 72 subjects with a high BMI and at least two features of MetS. The major contributing biomarkers of each sequential period were lipids, mainly phospholipids and lysophospholipids. Dependency network analysis showed a different pattern of associations between metabolic changes and clinical variables after 2 and 6 month of intervention, with a highly interconnected network during the nutritional-learning intervention period of the study. The 2-month RESMENA diet produced significant changes in the plasma metabolic profile of subjects with MetS features. However, at the end of the 6-month study, most of the associations between metabolic and clinical variables disappeared; suggesting that adherence to healthy dietary habits had declined during the self-control period. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial.

Science.gov (United States)

van Klink, Jeanine M M; van Veen, Suzanne J; Smits-Wintjens, Vivianne E H J; Lindenburg, Irene T M; Rijken, Monique; Oepkes, Dick; Lopriore, Enrico

2016-01-01

Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo. All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness. Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00]. The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings. © 2015 S. Karger AG, Basel.

Use of ready-made insoles in the treatment of lesser metatarsalgia: a prospective randomized controlled trial.

Science.gov (United States)

Kelly, A; Winson, I

1998-04-01

Two insoles designed to treat primary lesser metatarsalgia were compared in terms of their effect on plantar pressures and the subjective symptom relief. A prospective single blind randomized trial of 8 weeks' treatment in 46 feet in 33 patients was performed. Subjective outcome measures were visual analogue pain scores and estimated compliance. Objective outcome measures were dynamic plantar pressures using the Musgrave Footprint System. In group 1 (Viscoped), 6 of 18 patients rated themselves much improved or somewhat improved, and in group 2 (Langer) the proportion was 12 of 15 (P = 0.02). Reported mean compliance was 16% higher in the Langer group. Plantar forefoot pressure was lowered by the insoles in all cases. The reduction was significantly greater (P < 0.001) in group 2, both in absolute pressure and as a percentage of initial pressure. Group 2 (Langer) was significantly better in terms of reduction of peak metatarsal pressure. All the subjective outcome measures were better for the group 2 (Langer).

Memory and subjective workload assessment

Science.gov (United States)

Staveland, L.; Hart, S.; Yeh, Y. Y.

1986-01-01

Recent research suggested subjective introspection of workload is not based upon specific retrieval of information from long term memory, and only reflects the average workload that is imposed upon the human operator by a particular task. These findings are based upon global ratings of workload for the overall task, suggesting that subjective ratings are limited in ability to retrieve specific details of a task from long term memory. To clarify the limits memory imposes on subjective workload assessment, the difficulty of task segments was varied and the workload of specified segments was retrospectively rated. The ratings were retrospectively collected on the manipulations of three levels of segment difficulty. Subjects were assigned to one of two memory groups. In the Before group, subjects knew before performing a block of trials which segment to rate. In the After group, subjects did not know which segment to rate until after performing the block of trials. The subjective ratings, RTs (reaction times) and MTs (movement times) were compared within group, and between group differences. Performance measures and subjective evaluations of workload reflected the experimental manipulations. Subjects were sensitive to different difficulty levels, and recalled the average workload of task components. Cueing did not appear to help recall, and memory group differences possibly reflected variations in the groups of subjects, or an additional memory task.

Random Decrement

DEFF Research Database (Denmark)

Asmussen, J. C.; Ibrahim, S. R.; Brincker, Rune

This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

Random Decrement

DEFF Research Database (Denmark)

Asmussen, J. C.; Ibrahim, R.; Brincker, Rune

1998-01-01

This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

Impaired basal glucose effectiveness but unaltered fasting glucose release and gluconeogenesis during short-term hypercortisolemia in healthy subjects

DEFF Research Database (Denmark)

Nielsen, Michael F; Caumo, Andrea; Chandramouli, Visvanathan

2004-01-01

Excess cortisol has been demonstrated to impair hepatic and extrahepatic insulin action. To determine whether glucose effectiveness and, in terms of endogenous glucose release (EGR), gluconeogenesis, also are altered by hypercortisolemia, eight healthy subjects were studied after overnight infusion...... resistance. Postabsorptive glucose production (P = 0.64) and the fractional....... Hepatic GE was lower during cortisol than during saline infusion (2.39 +/- 0.24 vs. 3.82 +/- 0.51 ml.kg-1.min-1; P

People's Intuitions about Randomness and Probability: An Empirical Study

Science.gov (United States)

Lecoutre, Marie-Paule; Rovira, Katia; Lecoutre, Bruno; Poitevineau, Jacques

2006-01-01

What people mean by randomness should be taken into account when teaching statistical inference. This experiment explored subjective beliefs about randomness and probability through two successive tasks. Subjects were asked to categorize 16 familiar items: 8 real items from everyday life experiences, and 8 stochastic items involving a repeatable…

Dissecting the circle, at random*

Directory of Open Access Journals (Sweden)

Curien Nicolas

2014-01-01

Full Text Available Random laminations of the disk are the continuous limits of random non-crossing configurations of regular polygons. We provide an expository account on this subject. Initiated by the work of Aldous on the Brownian triangulation, this field now possesses many characters such as the random recursive triangulation, the stable laminations and the Markovian hyperbolic triangulation of the disk. We will review the properties and constructions of these objects as well as the close relationships they enjoy with the theory of continuous random trees. Some open questions are scattered along the text.

The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

Science.gov (United States)

Lengacher, Cecile A; Reich, Richard R; Paterson, Carly L; Jim, Heather S; Ramesar, Sophia; Alinat, Carissa B; Budhrani, Pinky H; Farias, Jerrica R; Shelton, Melissa M; Moscoso, Manolete S; Park, Jong Y; Kip, Kevin E

2015-04-01

The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p sleep parameters in BCS. Copyright © 2014 John Wiley & Sons, Ltd.

Beneficial effects of dark chocolate on exercise capacity in sedentary subjects: underlying mechanisms. A double blind, randomized, placebo controlled trial.

Science.gov (United States)

Taub, Pam R; Ramirez-Sanchez, Israel; Patel, Minal; Higginbotham, Erin; Moreno-Ulloa, Aldo; Román-Pintos, Luis Miguel; Phillips, Paul; Perkins, Guy; Ceballos, Guillermo; Villarreal, Francisco

2016-09-14

In heart failure patients the consumption of (-)-epicatechin ((-)-Epi)-rich cocoa can restore skeletal muscle (SkM) mitochondrial structure and decrease biomarkers of oxidative stress. However, nothing is known about its effects on exercise capacity and underlying mechanisms in normal, sedentary subjects. Twenty normal, sedentary subjects (∼50 years old) were randomized to placebo or dark chocolate (DC) groups and consumed 20 g of the products for 3 months. Subjects underwent before and after treatment, bicycle ergometry to assess VO2 max and work, SkM biopsy to assess changes in mitochondrial density, function and oxidative stress and blood sampling to assess metabolic endpoints. Seventeen subjects completed the trial. In the DC group (n = 9), VO2 max increased (17% increase, p = 0.056) as well as maximum work (watts) achieved (p = 0.026) with no changes with placebo (n = 8). The DC group evidenced increases in HDL levels (p = 0.005) and decreased triglycerides (p = 0.07). With DC, SkM evidenced significant increases in protein levels for LKB1, AMPK and PGC1α and in their active forms (phosphorylated AMPK and LKB1) as well as in citrate synthase activity while no changes were observed in mitochondrial density. With DC, significant increases in SkM reduced glutathione levels and decreases in protein carbonylation were observed. Improvements in maximum work achieved and VO2 max may be due to DC activation of upstream control systems and enhancement of SkM mitochondria efficiency. Larger clinical studies are warranted to confirm these observations.

The long-term effects of naprapathic manual therapy on back and neck pain - Results from a pragmatic randomized controlled trial

Directory of Open Access Journals (Sweden)

Bohman Tony

2010-02-01

Full Text Available Abstract Background Back and neck pain are very common, disabling and recurrent disorders in the general population and the knowledge of long-term effect of treatments are sparse. The aim of this study was to compare the long-term effects (up to one year of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain. Naprapathy, a health profession mainly practiced in Sweden, Finland, Norway and in the USA, is characterized by a combination of manual musculoskeletal manipulations, aiming to decrease pain and disability in the neuromusculoskeletal system. Methods Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409, recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group, and advice to stay active and on how to cope with pain, provided by a physician (Control Group. Pain intensity, disability and health status were measured by questionnaires. Results 89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD = 21%, 95% CI: 10-30 and disability (RD = 11%, 95% CI: 4-22 at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28. The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p ≤ 0.005. There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status favoring the Index Group. Conclusions Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck

Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial

NARCIS (Netherlands)

de Jong, Zuzana; Munneke, Marten; Zwinderman, Aeilko H.; Kroon, Herman M.; Jansen, Annemarie; Ronday, Karel H.; van Schaardenburg, Dirkjan; Dijkmans, Ben A. C.; van den Ende, Cornelia H. M.; Breedveld, Ferdinand C.; Vliet Vlieland, Theodora P. M.; Hazes, Johanna M. W.

2003-01-01

OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial.

NARCIS (Netherlands)

Jong, Z. de; Munneke, M.; Zwinderman, A.H.; Kroon, H.M.; Jansen, A.; Ronday, K.H.; Schaardenburg, D. van; Dijkmans, B.A.C.; Ende, C.H.M. van den; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

2003-01-01

OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

The coping with depression course: Short term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

NARCIS (Netherlands)

Allart-van Dam, E.; Hosman, C.M.H.; Hoogduin, C.A.L.; Schaap, C.P.D.R.

2003-01-01

This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

The Coping with Depression course : Short-term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

NARCIS (Netherlands)

Allart-van Dam, E; Hosman, CMH; Hoogduin, CAL; Schaap, CPDR

2003-01-01

This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

Staggered chiral random matrix theory

International Nuclear Information System (INIS)

Osborn, James C.

2011-01-01

We present a random matrix theory for the staggered lattice QCD Dirac operator. The staggered random matrix theory is equivalent to the zero-momentum limit of the staggered chiral Lagrangian and includes all taste breaking terms at their leading order. This is an extension of previous work which only included some of the taste breaking terms. We will also present some results for the taste breaking contributions to the partition function and the Dirac eigenvalues.

Prevention of fall-related injuries in long-term care: a randomized controlled trial of staff education.

Science.gov (United States)

Ray, Wayne A; Taylor, Jo A; Brown, Anne K; Gideon, Patricia; Hall, Kathi; Arbogast, Patrick; Meredith, Sarah

2005-10-24

Fall-related injuries, a major public health problem in long-term care, may be reduced by interventions that improve safety practices. Previous studies have shown that safety practice interventions can reduce falls; however, in long-term care these have relied heavily on external funding and staff. The aim of this study was to test whether a training program in safety practices for staff could reduce fall-related injuries in long-term care facilities. A cluster randomization clinical trial with 112 qualifying facilities and 10,558 study residents 65 years or older and not bedridden. The intervention was an intensive 2-day safety training program with 12-month follow-up. The training program targeted living space and personal safety; wheelchairs, canes, and walkers; psychotropic medication use; and transferring and ambulation. The main outcome measure was serious fall-related injuries during the follow-up period. There was no difference in injury occurrence between the intervention and control facilities (adjusted rate ratio, 0.98; 95% confidence interval, 0.83-1.16). For residents with a prior fall in facilities with the best program compliance, there was a nonsignificant trend toward fewer injuries in the intervention group (adjusted rate ratio, 0.79; 95% confidence interval, 0.57-1.10). More intensive interventions are required to prevent fall-related injuries in long-term care facilities.

Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

Science.gov (United States)

Greenlee, Heather; Ogden Gaffney, Ann; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M; Blaner, William S; Clugston, Robin D; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

2016-11-01

Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR. ©2016 American Association for Cancer Research.

Long-term outcomes and recurrence patterns of standard versus extended pancreatectomy for pancreatic head cancer: a multicenter prospective randomized controlled study.

Science.gov (United States)

Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe

2017-07-01

Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Traditional Chinese Herbal Patch for Short-Term Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

Directory of Open Access Journals (Sweden)

Xuezong Wang

2012-01-01

Full Text Available Objective. To assess the short-term efficacy and safety of two kinds of Traditional Chinese herbal patches, Fufang Nanxing Zhitong Gao (FNZG and Shangshi Jietong Gao (SJG, for painful knee osteoarthritis (OA. Methods. Patients were randomly enrolled in a double-blind, placebo-controlled study to receive FNZG (n=60, SJG (n=60, or placebo patch (n=30 for 7 days. Outcome measures included visual analogue scale (VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, and Traditional Chinese Medicine Syndrome Questionnaire (TCMSQ subscale. Results. Although there was no significant difference among, three groups in short-term pain management, patients receiving FNZG got significant improvement in symptom of fear of coldness as compared with placebo patch (P=0.029. The most common local adverse events of rash, itching, erythema, and slightly damaged skin were observed in 7% of participants. Conclusions. FNZG may be a useful treatment for symptom of knee OA and merits long-term study in broader populations.

Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial

NARCIS (Netherlands)

Y. van Pareren; M. Houdijk; M. Jansen (Maarten); M. Reeser; P.G.H. Mulder (Paul); A.C.S. Hokken-Koelega (Anita)

2003-01-01

textabstractThe GH dose-response effect of long-term continuous GH treatment on adult height (AH) was evaluated in 54 short children born small for gestational age (SGA) who were participating in a randomized, double-blind, dose-response trial. Patients were randomly and blindly

Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up

International Nuclear Information System (INIS)

Clarke, Richard E.; Tenorio, L. M. Catalina; Hussey, James R.; Toklu, Akin S.; Cone, D. Lindsie; Hinojosa, Jose G.; Desai, Samir P.; Dominguez Parra, Luis; Rodrigues, Sylvia D.; Long, Robert J.; Walker, Margaret B.

2008-01-01

Purpose: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis. Methods and Materials: Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life. Results: Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group 1 had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover. Conclusion: Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted

Clinical trials with rasagiline: evidence for short-term and long-term effects.

Science.gov (United States)

Siderowf, Andrew; Stern, Matthew

2006-05-23

Rasagiline (N-propargyl-1 (R)-aminoindan) is a selective, potent irreversible inhibitor of MAO-B that possesses neuroprotective and anti-apoptotic properties in a variety of in vitro and in vivo animal models relevant to Parkinson's disease (PD). Several randomized controlled clinical trials have demonstrated the safety and efficacy of rasagiline as monotherapy in PD and as adjunctive therapy for patients receiving levodopa. In addition, the 1-year randomized, delayed-start analysis of the TEMPO study suggests that rasagiline may slow the rate of progression of PD. The randomized delayed-start paradigm has potential to differentiate short-term symptomatic effects from long-term effects of anti-parkinsonian agents. In the future, long-term trials to examine the potential disease-modifying effects of rasagiline, which incorporate biological markers as well as clinical endpoints, may further elucidate the role of rasagiline in the treatment of both early and advanced PD.

Uncertainty analysis of flexible rotors considering fuzzy parameters and fuzzy-random parameters

Directory of Open Access Journals (Sweden)

Fabian Andres Lara-Molina

Full Text Available Abstract The components of flexible rotors are subjected to uncertainties. The main sources of uncertainties include the variation of mechanical properties. This contribution aims at analyzing the dynamics of flexible rotors under uncertain parameters modeled as fuzzy and fuzzy random variables. The uncertainty analysis encompasses the modeling of uncertain parameters and the numerical simulation of the corresponding flexible rotor model by using an approach based on fuzzy dynamic analysis. The numerical simulation is accomplished by mapping the fuzzy parameters of the deterministic flexible rotor model. Thereby, the flexible rotor is modeled by using both the Fuzzy Finite Element Method and the Fuzzy Stochastic Finite Element Method. Numerical simulations illustrate the methodology conveyed in terms of orbits and frequency response functions subject to uncertain parameters.

Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial.

Science.gov (United States)

Maki, P M; Gast, M J; Vieweg, A J; Burriss, S W; Yaffe, K

2007-09-25

To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints. Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4. The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.

Evaluation of dentin hypersensitivity treatment with glass ionomer cements: A randomized clinical trial

Directory of Open Access Journals (Sweden)

Marina de Matos MADRUGA

Full Text Available Abstract A randomized, double-blind, split-mouth clinical trial was performed compared the desensitizing efficacy of the resin-modified glass ionomer cement (GIC ClinproTM XT (3M ESPE, Minnesota, USA and the conventional GIC Vidrion R (SS White, Gloucester, UK in a 6-month follow-up. Subjects were required to have at least two teeth with dentin hypersensitivity. Teeth were divided at random into 2 groups, one group received Clinpro XT and the other conventional GIC Vidrion R. Treatments were assessed by tactile and air blast tests using Visual Analogue Scale (VAS at baseline, after 20 minutes, and at 7, 15, 21, 30, 90 and 180 days post-treatment. Twenty subjects (152 teeth were included. Both tests (tactile and air blast showed a significant reduction of dentin hypersensitivity immediately after the application of Vidrion R and Clinpro XT (20 min. VAS scores obtained along the 6-month follow-up were statistically lower when compared to initial rates (p 0.05. Both cements provided satisfactory results in long-term dental sensitivity reduction.

Symptom Severity and Quality of Life Among Long-term Colorectal Cancer Survivors Compared With Matched Control Subjects: A Population-Based Study.

Science.gov (United States)

Hart, Tae L; Charles, Susan T; Gunaratne, Mekhala; Baxter, Nancy N; Cotterchio, Michelle; Cohen, Zane; Gallinger, Steven

2018-03-01

Data are lacking regarding physical functioning, psychological well-being, and quality of life among colorectal cancer survivors >10 years postdiagnosis. The purpose of this study was to examine self-reported physical functioning, quality of life, and psychological well-being in long-term colorectal cancer survivors compared with age- and sex-matched unaffected control subjects. Participants completed a cross-sectional survey. The colorectal cancer survivors and unaffected control subjects were recruited from the Ontario Familial Colorectal Cancer Registry. A population-based sample of colorectal cancer survivors (N = 296) and their age- and sex-matched unaffected control subjects (N = 255) were included. Survivors were, on average, 15 years postdiagnosis. Quality of life was measured with the Functional Assessment of Cancer Therapy-General scale, bowel dysfunction with the Memorial Sloan-Kettering Cancer Center scale, urinary dysfunction with the International Consultation on Incontinence Questionnaire-Short Form, fatigue with the Functional Assessment of Chronic Illness Therapy-Fatigue scale, and depression with the Center for Epidemiologic Studies-Depression scale. In linear mixed-model analyses adjusting for income, education, race, and comorbid medical conditions, survivors reported good emotional, functional, physical, and overall quality of life, comparable to control subjects. Fatigue and urinary functioning did not differ significantly between survivors and control subjects. Survivors reported significantly higher social quality of life and lower depression compared with unaffected control subjects. The only area where survivors reported significantly worse deficits was in bowel dysfunction, but the magnitude of differences was relatively small. Generalizability is limited by moderately low participation rates. Findings are likely biased toward healthy participants. No baseline assessment was available to examine change in outcomes over time. Long-term

The immediate and long-term effects of exercise and patient education on physical, functional, and quality-of-life outcome measures after single-level lumbar microdiscectomy: a randomized controlled trial protocol.

Science.gov (United States)

Selkowitz, David M; Kulig, Kornelia; Poppert, Elizabeth M; Flanagan, Sean P; Matthews, Ndidiamaka D; Beneck, George J; Popovich, John M; Lona, Jose R; Yamada, Kimiko A; Burke, Wendy S; Ervin, Carolyn; Powers, Christopher M

2006-08-25

Low back pain remains a costly quality-of-life-related health problem. Microdiscectomy is often the surgical procedure of choice for a symptomatic, single-level, lumbar disc herniation in younger and middle-aged adults. The question of whether a post-microdiscectomy exercise program enhances function, quality of life, and disability status has not been systematically explored. Thus, the overall purpose of this study is to assess immediate and long-term outcomes of an exercise program, developed at University of Southern California (USC), targeting the trunk and lower extremities (USC Spine Exercise Program) for persons who have undergone a single-level microdiscectomy for the first time. One hundred individuals between the ages of 18 and 60 who consent to undergo lumbar microdiscectomy will be recruited to participate in this study. Subjects will be randomly assigned to one of two groups: 1) one session of back care education, or 2) a back care education session followed by the 12-week USC Spine Exercise Program. The outcome examiners (evaluators), as well as the data managers, will be blinded to group allocation. Education will consist of a one-hour "one-on-one" session with the intervention therapist, guided by an educational booklet specifically designed for post-microdiscectomy care. This session will occur four to six weeks after surgery. The USC Spine Exercise Program consists of two parts: back extensor strength and endurance, and mat and upright therapeutic exercises. This exercise program is goal-oriented, performance-based, and periodized. It will begin two to three days after the education session, and will occur three times a week for 12 weeks. Primary outcome measures include the Oswestry Disability Questionnaire, Roland-Morris Disability Questionnaire, SF-36 quality of life assessment, Subjective Quality of Life Scale, 50-foot Walk, Repeated Sit-to-Stand, and a modified Sorensen test. The outcome measures in the study will be assessed before and after

Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Legemate, Catherine M; Goei, Harold; Middelkoop, Esther; Oen, Irma M M H; Nijhuis, Tim H J; Kwa, Kelly A A; van Zuijlen, Paul P M; Beerthuizen, Gerard I J M; Nieuwenhuis, Marianne K; van Baar, Margriet E; van der Vlies, Cornelis H

2018-04-19

Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. This study will contribute to

Personality disorder moderates outcome in short- and long-term group analytic psychotherapy: A randomized clinical trial.

Science.gov (United States)

Lorentzen, Steinar; Ruud, Torleif; Fjeldstad, Anette; Høglend, Per A

2015-06-01

In a randomized clinical trial, short- and long-term psychodynamic group psychotherapy (STG and LTG, respectively) schedules were equally effective for the 'typical' patient during a 3-year study period. Although several studies have reported good effects for patients with personality disorders (PD) in diverse forms of psychotherapy, the significance of treatment duration is unclear. Therefore, we tested the hypothesis that PD patients would improve more during and after LTG than STG. A randomized, longitudinal, prospective study contrasting the outcomes during and after short- and long-term dynamic group psychotherapies. One hundred and sixty-seven outpatients with mood disorders, anxiety disorders, or PD were randomized to STG or LTG (respectively, 20 or 80 weekly sessions of 90 min each). Outcome measures are as follows: symptoms (SCL-90-R), interpersonal problems (IIP-C), and psychosocial functioning (GAF split version: GAF-Symptom and GAF-Function). PD pathology (number of PD criteria items) was selected a priori as a putative moderator of treatment effects. Change during the 3-year study period was assessed using linear mixed models. The study was registered at ClinicalTrials.gov as NCT 00021417. Our hypothesis was supported, as patients with PD improved significantly more regarding all outcome variables in LTG than STG. For patients without PD, the rate of change was similar across 3 years; however, the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months. The effectiveness of LTG is higher for patients with co-morbid PD. Patients without PD do not appear to experience additional gain from LTG. Clinical implications: LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity (PD). Patients without PD do not appear to experience additional gain from attending LTG. Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both

Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: A cluster randomized controlled trial

NARCIS (Netherlands)

S.J.W. Robroek (Suzan); S. Polinder (Suzanne); F.J. Bredt (Folef); A. Burdorf (Alex)

2012-01-01

textabstractThis study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the

Effect of commercial breakfast fibre cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized blinded crossover trial

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Almér Lars-Olof

2007-09-01

Full Text Available Abstract Background Dietary fibre food intake is related to a reduced risk of developing diabetes mellitus. However, the mechanism of this effect is still not clear. The aim of this study was to evaluate the effect of commercial fibre cereals on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. Methods Gastric emptying rate (GER was measured by standardized real time ultrasonography. Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hour fast and after assessment of normal fasting blood glucose level. Satiety scores were estimated and blood glucose measurements were taken before and at 0, 20, 30, 40, 60, 80, 100 and 120 min after the end of the meal. GER was calculated as the percentage change in the antral cross-sectional area 15 and 90 min after ingestion of sour milk with corn flakes (GER1, cereal bran flakes (GER2 or wholemeal oat flakes (GER3. Results The median value was, respectively, 42% for GER1, 33 % for GER2 and 51% for GER3. The difference between the GER after ingestion of bran flakes compared to wholemeal oat flakes was statistically significant (p = 0.023. The postprandial delta blood glucose level was statistically significantly lower at 40 min (p = 0.045 and 120 min (p = 0.023 after the cereal bran flakes meal. There was no statistical significance between the areas under the curve (AUCs of the cereals as far as blood glucose and satiety were concerned. Conclusion The result of this study demonstrates that the intake of either bran flakes or wholemeal oat flakes has no effect on the total postprandial blood glucose response or satiety when compared to corn flakes. However, the study does show that the intake of cereal bran flakes slows the GER when compared to oat flakes and corn flakes, probably due to a higher fibre content. Since these products do not differ in terms of glucose response and satiety on healthy

Duration of remission after halving of the etanercept dose in patients with ankylosing spondylitis: a randomized, prospective, long-term, follow-up study

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Nannini C

2013-01-01

Full Text Available Fabrizio Cantini, Laura Niccoli, Emanuele Cassarà, Olga Kaloudi, Carlotta NanniniDivision of Rheumatology, Misericordia e Dolce Hospital, Prato, ItalyBackground: The aim of this study was to evaluate the proportion of patients with ankylosing spondylitis maintaining clinical remission after reduction of their subcutaneous etanercept dose to 50 mg every other week compared with that in patients receiving etanercept 50 mg weekly.Methods: In the first phase of this randomized, prospective, follow-up study, all biologic-naïve patients identified between January 2005 and December 2009 as satisfying the modified New York clinical criteria for ankylosing spondylitis treated with etanercept 50 mg weekly were evaluated for disease remission in January 2010. In the second phase, patients meeting the criteria for remission were randomized to receive subcutaneous etanercept as either 50 mg weekly or 50 mg every other week. The randomization allocation was 1:1. Remission was defined as Bath Ankylosing Spondylitis Disease Activity Index < 4, no extra-axial manifestations of peripheral arthritis, dactylitis, tenosynovitis, or iridocyclitis, and normal acute-phase reactants. The patients were assessed at baseline, at weeks 4 and 12, and every 12 weeks thereafter. The last visit constituted the end of the follow-up.Results: During the first phase, 78 patients with ankylosing spondylitis (57 males and 21 females, median age 38 years, median disease duration 12 years were recruited. In January 2010, after a mean follow-up of 25 ± 11 months, 43 (55.1% patients achieving clinical remission were randomized to one of the two treatment arms. Twenty-two patients received etanercept 50 mg every other week (group 1 and 21 received etanercept 50 mg weekly (group 2. At the end of follow-up, 19 of 22 (86.3% subjects in group 1 and 19 of 21 (90.4% in group 2 were still in remission, with no significant difference between the two groups. The mean follow-up duration in group

Ferulic Acid Supplementation Improves Lipid Profiles, Oxidative Stress, and Inflammatory Status in Hyperlipidemic Subjects: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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Akkarach Bumrungpert

2018-06-01

Full Text Available Ferulic acid is the most abundant phenolic compound found in vegetables and cereal grains. In vitro and animal studies have shown ferulic acid has anti-hyperlipidemic, anti-oxidative, and anti-inflammatory effects. The objective of this study is to investigate the effects of ferulic acid supplementation on lipid profiles, oxidative stress, and inflammatory status in hyperlipidemia. The study design is a randomized, double-blind, placebo-controlled trial. Subjects with hyperlipidemia were randomly divided into two groups. The treatment group (n = 24 was given ferulic acid (1000 mg daily and the control group (n = 24 was provided with a placebo for six weeks. Lipid profiles, biomarkers of oxidative stress and inflammation were assessed before and after the intervention. Ferulic acid supplementation demonstrated a statistically significant decrease in total cholesterol (8.1%; p = 0.001, LDL-C (9.3%; p < 0.001, triglyceride (12.1%; p = 0.049, and increased HDL-C (4.3%; p = 0.045 compared with the placebo. Ferulic acid also significantly decreased the oxidative stress biomarker, MDA (24.5%; p < 0.001. Moreover, oxidized LDL-C was significantly decreased in the ferulic acid group (7.1%; p = 0.002 compared with the placebo group. In addition, ferulic acid supplementation demonstrated a statistically significant reduction in the inflammatory markers hs-CRP (32.66%; p < 0.001 and TNF-α (13.06%; p < 0.001. These data indicate ferulic acid supplementation can improve lipid profiles and oxidative stress, oxidized LDL-C, and inflammation in hyperlipidemic subjects. Therefore, ferulic acid has the potential to reduce cardiovascular disease risk factors.

First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica.

Science.gov (United States)

Rolan, Paul E; O'Neill, Gilmore; Versage, Eve; Rana, Jitesh; Tang, Yongqiang; Galluppi, Gerald; Aycardi, Ernesto

2015-01-01

To evaluate the safety, tolerability, and pharmacokinetics of single doses of BG00010 (neublastin, artemin, enovin) in subjects with unilateral sciatica. This was a single-center, blinded, placebo-controlled, randomized Phase 1 sequential-cohort, dose-escalation study (ClinicalTrials.gov identifier NCT00961766; funded by Biogen Idec). Adults with unilateral sciatica were enrolled at The Royal Adelaide Hospital, Australia. Four subjects were assigned to each of eleven cohorts (intravenous BG00010 0.3, 1, 3, 10, 25, 50, 100, 200, 400, or 800 μg/kg, or subcutaneous BG00010 50 μg/kg) and were randomized 3:1 to receive a single dose of BG00010 or placebo. The primary safety and tolerability assessments were: adverse events; clinical laboratory parameters and vital signs; pain as measured by a Likert rating scale; intra-epidermal nerve fiber density; and longitudinal assessment of quantitative sensory test parameters. Blood, serum, and plasma samples were collected for pharmacokinetic and pharmacodynamic assessments. Subjects were blinded to treatment assignment throughout the study. The investigator was blinded to treatment assignment until the Data Safety Review Committee review of unblinded data, which occurred after day 28. Beyond the planned enrollment of 44 subjects, four additional subjects were enrolled into to the intravenous BG00010 200 μg/kg cohort after one original subject experienced mild generalized pruritus. Therefore, a total of 48 subjects were enrolled between August 2009 and December 2011; all were included in the safety analyses. BG00010 was generally well tolerated: in primary analyses, the most common treatment-emergent adverse events were changes in temperature perception, pruritus, rash, or headache; no trends were observed in clinical laboratory parameters, vital signs, intra-epidermal nerve fiber density, or quantitative sensory testing. BG00010 was not associated with any clear, dose-dependent trends in Likert pain scores. BG00010 was

Random vibrations theory and practice

CERN Document Server

Wirsching, Paul H; Ortiz, Keith

1995-01-01

Random Vibrations: Theory and Practice covers the theory and analysis of mechanical and structural systems undergoing random oscillations due to any number of phenomena— from engine noise, turbulent flow, and acoustic noise to wind, ocean waves, earthquakes, and rough pavement. For systems operating in such environments, a random vibration analysis is essential to the safety and reliability of the system. By far the most comprehensive text available on random vibrations, Random Vibrations: Theory and Practice is designed for readers who are new to the subject as well as those who are familiar with the fundamentals and wish to study a particular topic or use the text as an authoritative reference. It is divided into three major sections: fundamental background, random vibration development and applications to design, and random signal analysis. Introductory chapters cover topics in probability, statistics, and random processes that prepare the reader for the development of the theory of random vibrations a...

Random queues and risk averse users

DEFF Research Database (Denmark)

de Palma, André; Fosgerau, Mogens

2013-01-01

We analyze Nash equilibrium in time of use of a congested facility. Users are risk averse with general concave utility. Queues are subject to varying degrees of random sorting, ranging from strict queue priority to a completely random queue. We define the key “no residual queue” property, which...

Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg.

Science.gov (United States)

Katz, Philip O; Le Moigne, Anne; Pollack, Charles

2017-05-01

These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days). At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P heartburn relief were significantly greater with esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001). The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with

Effect of oral zinc on hyperbilirubinemia in full term neonates

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Patton Patton

2011-04-01

Full Text Available Background Oral zinc has been shown to reduce serum unconjugated bilirubin in animals, adolescents and low birth weight neonates. However, studies in healthy tenn neonates given oral zinc showed no reduction in hyperbilirubinemia based on time measurement in days. In order to improve accuracy, hyperbilirubinemia may be determined based on time measurements in hours. Objective To determine the effect of oral zinc on hyperbiliru-binemia in full term neonates, based on time measurement in hours, rather than days. Methods We conducted a randomized, double-blind clinical trial on healthy term neonates born spontaneously or through elective caesarean section in Hasan Sadikin Hospital from June to July 2010. Subjects were randomized into two groups: those receiving 5 mg of zinc sulphate and those receiving a placebo, sucrose, each twice daily. Serum total bilirubin level was examined at discharge and upon followup at day 5 of life. Factors which may be related to hyperbilirubinemia such as maternal age, infants' gender, umbilical cord bilirubin levels and type of feeding, were analyzed by Chi-square test. Hyperbilirubinemia persistence and comparison of survival distributions were analyzed by Kaplan-Meier survival analysis and Logrank test. Results Out of 60 subjects, 26 had hyperbilirubinemia. The mean duration of hyperbilirubinemia in the 15 subjects in the zinc group and 11 in the placebo group were 116.5 hours and 117.3 hours, respectively. There was no significant difference in hyperbilirubinemia duration between the two groups ( P=0.496, 95% CI 111.5 to 122.7. In addition, Chi-square analysis of factors which may be related to hyperbilirubinemia showed no significant difference between the two groups (P > 0.05. Conclusions Oral zinc 5 mg tMce daily made no significant difference in hyperbilirubinemia duration in full tenn neonates despite measuring in hours.

Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication

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Katz LJ

2015-12-01

Full Text Available L Jay Katz,1 Carl Erb,2 Amadeu Carceller Guillamet,3 Antonio M Fea,4 Lilit Voskanyan,5 Jeffrey M Wells,6 Jane Ellen Giamporcaro6 1Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 2Eye Clinic Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology, Hospital d’Hebron, Barcelona, Spain; 4University Eye Clinic of the University of Turin, Turin, Italy; 5SV Malayan Opthalmology Centre, Yerevan, Armenia; 6Glaukos Corporation, Laguna Hills, CA, USA Purpose: To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively.Materials and methods: Subjects with medicated intraocular pressure (IOP 18–30 mmHg and postmedication-washout baseline IOP 22–38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg.Results: A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001 with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96�

What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

Science.gov (United States)

Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

2015-02-01

This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

Hysteroscopic Endometrial Resection Versus Laparoscopic Supracervical Hysterectomy for Abnormal Uterine Bleeding: Long-term Follow-up of a Randomized Trial.

Science.gov (United States)

Zupi, Errico; Centini, Gabriele; Lazzeri, Lucia; Finco, Andrea; Exacoustos, Caterina; Afors, Karolina; Zullo, Fulvio; Petraglia, Felice

2015-01-01

To compare long-term efficacy of laparoscopic supracervical hysterectomy (LSH) and hysteroscopic endometrial ablation (HEA) in treating persistent abnormal uterine bleeding. Canadian Task Force II-2. University hospital. One hundred fifty-three women treated for abnormal uterine bleeding by LSH or HEA. Long-term follow-up assessment of reintervention rate and quality of life (QoL) using the Quality Metric's Health Survey Short Form 12. This study is the long-term follow-up of a randomized control trial conducted in 2003 comparing LSH and HEA in terms of reoperation rate and QoL. Starting from November 2010 all patients included in the first trial were invited to participate in this study and clinically evaluated through vaginal examination and transvaginal ultrasound. After a mean follow-up of 14.4 years, 29% of patients (20/71) treated with HEA underwent further surgery, whereas no patients after LSH had symptom recurrence. The reintervention rate was significantly higher in the HEA group (p abnormal uterine bleeding when compared with HEA. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of a mild compared with a standard strategy for IVF: a randomized comparison using cumulative term live birth as the primary endpoint.

Science.gov (United States)

Polinder, S; Heijnen, E M E W; Macklon, N S; Habbema, J D F; Fauser, B J C M; Eijkemans, M J C

2008-02-01

BACKGROUND Conventional ovarian stimulation and the transfer of two embryos in IVF exhibits an inherent high probability of multiple pregnancies, resulting in high costs. We evaluated the cost-effectiveness of a mild compared with a conventional strategy for IVF. METHODS Four hundred and four patients were randomly assigned to undergo either mild ovarian stimulation/GnRH antagonist co-treatment combined with single embryo transfer, or standard stimulation/GnRH agonist long protocol and the transfer of two embryos. The main outcome measures are total costs of treatment within a 12 months period after randomization, and the relationship between total costs and proportion of cumulative pregnancies resulting in term live birth within 1 year of randomization. RESULTS Despite a significantly increased average number of IVF cycles (2.3 versus 1.7; P costs over a 12-month period (8333 versus euro10 745; P = 0.006) were observed using the mild strategy. This was mainly due to higher costs of the obstetric and post-natal period for the standard strategy, related to multiple pregnancies. The costs per pregnancy leading to term live birth were euro19 156 in the mild strategy and euro24 038 in the standard. The incremental cost-effectiveness ratio of the standard strategy compared with the mild strategy was euro185 000 per extra pregnancy leading to term live birth. CONCLUSIONS Despite an increased mean number of IVF cycles within 1 year, from an economic perspective, the mild treatment strategy is more advantageous per term live birth. It is unlikely, over a wide range of society's willingness-to-pay, that the standard treatment strategy is cost-effective, compared with the mild strategy.

The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial

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Lingler Jacqui

2009-03-01

Full Text Available Abstract Background The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder. Methods Eligible subjects ages 12–17 years with either a current major depressive disorder (MDD or a depressive disorder that were also suffering from a comorbid substance-related disorder were randomized to receive either fluoxetine or placebo in this single site, 8-week double-blind, placebo-controlled study. The primary outcome analysis was a random effects mixed model for repeated measurements of Children's Depression Rating Scale-Revised (CDRS-R scores compared between treatment groups across time. Results An interim analysis was performed after 34 patients were randomized. Based on the results of a futility analysis, study enrollment was halted. Twenty-nine males and 5 females were randomized to receive fluoxetine (n = 18 or placebo (n = 16. Their mean age was 16.5 (1.1 years. Overall, patients who received fluoxetine and placebo had a reduction in CDRS-R scores. However, there was no significant difference in mean change in CDRS-R total score in those subjects treated with fluoxetine and those who received placebo (treatment difference = 0.19, S.E. = 0.58, F = 0.14, p = .74. Furthermore, there was not a significant difference in rates of positive urine drug toxicology results between treatment groups at any post-randomization visit (F = 0.22, df = 1, p = 0.65. The main limitation of this study is its modest sample size and resulting low statistical power. Other significant limitations to this study include, but are not limited to, the brevity of the trial, high placebo response rate, limited dose range of fluoxetine, and the inclusion of youth who met criteria for depressive disorders other than MDD. Conclusion Fluoxetine was not superior to placebo in alleviating depressive symptoms or in decreasing

Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials.

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Yongchuan Li

Full Text Available A few studies focused on statin therapy as specific prophylactic measures of contrast-induced nephropathy have been published with conflicting results. In this meta-analysis of randomized controlled trials, we aimed to assess the effectiveness of short-term high-dose statin treatment for the prevention of CIN and clinical outcomes and re-evaluate of the potential benefits of statin therapy.We searched PubMed, OVID, EMBASE, Web of science and the Cochrane Central Register of Controlled Trials databases for randomized controlled trials comparing short-term high-dose statin treatment versus low-dose statin treatment or placebo for preventing CIN. Our outcome measures were the risk of CIN within 2-5 days after contrast administration and need for dialysis.Seven randomized controlled trials with a total of 1,399 patients were identified and analyzed. The overall results based on fixed-effect model showed that the use of short-term high-dose statin treatment was associated with a significant reduction in risk of CIN (RR =0.51, 95% CI 0.34-0.76, p =0.001; I(2 = 0%. The incidence of acute renal failure requiring dialysis was not significant different after the use of statin (RR = 0.33, 95% CI 0.05-2.10, p = 0.24; I(2 = 0%. The use of statin was not associated with a significant decrease in the plasma C-reactive protein level (SMD -0.64, 95% CI: -1.57 to 0.29, P = 0.18, I(2 = 97%.Although this meta-analysis supports the use of statin to reduce the incidence of CIN, it must be considered in the context of variable patient demographics. Only a limited recommendation can be made in favour of the use of statin based on current data. Considering the limitations of included studies, a large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for statin in CIN prevention.

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

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Nuria eRuffini

2015-08-01

Full Text Available 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 ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, 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, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 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 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (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.

Impact of Short- and Long-term Tai Chi Mind-Body Exercise Training on Cognitive Function in Healthy Adults: Results From a Hybrid Observational Study and Randomized Trial.

Science.gov (United States)

Walsh, Jacquelyn N; Manor, Brad; Hausdorff, Jeffrey; Novak, Vera; Lipsitz, Lewis; Gow, Brian; Macklin, Eric A; Peng, Chung-Kang; Wayne, Peter M

2015-07-01

Cognitive decline amongst older adults is a significant public health concern. There is growing interest in behavioral interventions, including exercise, for improving cognition. Studies to date suggest tai chi (TC) may be a safe and potentially effective exercise for preserving cognitive function with aging; however, its short-term and potential long-term impact on physically active, healthy adults is unclear. To compare differences in cognitive function among long-term TC expert practitioners and age-matched and gender-matched TC-naïve adults and to determine the effects of short-term TC training on measures of cognitive function in healthy, nonsedentary adults. A hybrid design including an observational comparison and a 2-arm randomized clinical trial (RCT). Healthy, nonsedentary, TC-naive adults (50 y-79 y) and age-matched and gender-matched long-term TC experts. A cross-sectional comparison of cognitive function in healthy TC-naïve (n=60) and TC expert (24.5 y ÷ 12 y experience; n=27) adults: TC-naïve adults then completed a 6-month, 2-arm, wait-list randomized clinical trial of TC training. Six measures of cognitive function were assessed for both cross-sectional and longitudinal comparisons. TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03). In contrast, random assignment to 6 months of TC training in TC-naïve adults did not significantly improve any measures of cognitive function. In healthy nonsedentary adults, long-term TC training may help preserve cognitive function; however, the effect of short-term TC training in healthy adults remains unclear. ClinicalTrials.gov NCT01340365.

Random maintenance policies

CERN Document Server

Nakagawa, Toshio

2014-01-01

Exploring random maintenance models, this book provides an introduction to the implementation of random maintenance, and it is one of the first books to be written on this subject.  It aims to help readers learn new techniques for applying random policies to actual reliability models, and it provides new theoretical analyses of various models including classical replacement, preventive maintenance and inspection policies. These policies are applied to scheduling problems, backup policies of database systems, maintenance policies of cumulative damage models, and reliability of random redundant systems. Reliability theory is a major concern for engineers and managers, and in light of Japan’s recent earthquake, the reliability of large-scale systems has increased in importance. This also highlights the need for a new notion of maintenance and reliability theory, and how this can practically be applied to systems. Providing an essential guide for engineers and managers specializing in reliability maintenance a...

Metabolic effects of dietary fructose and surcose in types I and II diabetic subjects

International Nuclear Information System (INIS)

Bantle, J.P.; Laine, D.C.; Thomas, J.W.

1986-01-01

To learn more about the metabolic effects of dietary fructose and sucrose, 12 type 1 and 12 type II diabetic subjects were fed three isocaloric (or isoenergic) diets for eight days each according to a randomized, crossover design. The three diets provided, respectively, 21% of the energy as fructose, 23% of the energy as sucrose, and almost all carbohydrate energy as starch. The fructose diet resulted in significantly lower one- and two-hour postprandial plasma glucose levels, overall mean plasma glucose levels, and urinary glucose excretion in both type I and type II subjects than did the starch diet. There were no significant differences between the sucrose and starch diets in any of the measures of glycemic control in either subject group. The fructose and sucrose diets did not significantly increase serum triglyceride values when compared with the starch diet, but both increased postprandial serum lactate levels. The authors conclude that short-term replacement of other carbohydrate sources in the diabetic diet with fructose will improve glycemic control, whereas replacement with sucrose will not aggravate glycemic control

Subjective and objective peer approval evaluations and self-esteem development: A test of reciprocal, prospective, and long-term effects.

Science.gov (United States)

Gruenenfelder-Steiger, Andrea E; Harris, Michelle A; Fend, Helmut A

2016-10-01

A large body of literature suggests a clear, concurrent association between peer approval and self-esteem in adolescence. However, little empirical work exists on either the prospective or reciprocal relation between peer approval and self-esteem during this age period. Moreover, it is unclear from past research whether both subjectively perceived peer approval and objectively measured peer approval are related to subsequent self-esteem over time (and vice versa) and whether these paths have long-term associations into adulthood. Using data from a large longitudinal study that covers a time span of 2 decades, we examined reciprocal, prospective relations between self-esteem and peer approval during ages 12-16 in addition to long-term relations between these variables and later social constructs at age 35. Cross-lagged regression analyses revealed small but persistent effect sizes from both types of peer approval to subsequent self-esteem in adolescence, controlling for prior self-esteem. However, effects in the reverse direction were not confirmed. These findings support the notion that peer relationships serve an important function for later self-esteem, consistent with many theoretical tenets of the importance of peers for building a strong identity. Finally, we found long-term relations between adult social constructs and adolescent objective and subjective peer approval as well as self-esteem. Therefore, not only do peer relationships play a role in self-esteem development across adolescence, but they remain impactful throughout adulthood. In sum, the current findings highlight the lasting, yet small link between peer relationships and self-esteem development and call for investigations of further influential factors for self-esteem over time. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized Trial.

Science.gov (United States)

Cusi, Kenneth; Orsak, Beverly; Bril, Fernando; Lomonaco, Romina; Hecht, Joan; Ortiz-Lopez, Carolina; Tio, Fermin; Hardies, Jean; Darland, Celia; Musi, Nicolas; Webb, Amy; Portillo-Sanchez, Paola

2016-09-06

The metabolic defects of nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes mellitus (T2DM) seem to be specifically targeted by pioglitazone. However, information about its long-term use in this population is limited. To determine the efficacy and safety of long-term pioglitazone treatment in patients with NASH and prediabetes or T2DM. Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT00994682). University hospital. Patients (n = 101) with prediabetes or T2DM and biopsy-proven NASH were recruited from the general population and outpatient clinics. All patients were prescribed a hypocaloric diet (500-kcal/d deficit from weight-maintaining caloric intake) and then randomly assigned to pioglitazone, 45 mg/d, or placebo for 18 months, followed by an 18-month open-label phase with pioglitazone treatment. The primary outcome was a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score in 2 histologic categories without worsening of fibrosis. Secondary outcomes included other histologic outcomes, hepatic triglyceride content measured by magnetic resonance and proton spectroscopy, and metabolic parameters. Among patients randomly assigned to pioglitazone, 58% achieved the primary outcome (treatment difference, 41 percentage points [95% CI, 23 to 59 percentage points]) and 51% had resolution of NASH (treatment difference, 32 percentage points [CI, 13 to 51 percentage points]) (P < 0.001 for each). Pioglitazone treatment also was associated with improvement in individual histologic scores, including the fibrosis score (treatment difference, -0.5 [CI, -0.9 to 0.0]; P = 0.039); reduced hepatic triglyceride content from 19% to 7% (treatment difference, -7 percentage points [CI, -10 to -4 percentage points]; P < 0.001); and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 vs. placebo for all). All 18-month metabolic and histologic improvements persisted over 36 months of

Antioxidant supplement and long-term reduction of recurrent adenomas of the large bowel. A double-blind randomized trial.

Science.gov (United States)

Bonelli, Luigina; Puntoni, Matteo; Gatteschi, Beatrice; Massa, Paolo; Missale, Guido; Munizzi, Francesco; Turbino, Laura; Villanacci, Vincenzo; De Censi, Andrea; Bruzzi, Paolo

2013-06-01

Patients who undergo polypectomy are at increased risk of adenoma recurrence. The preventive potential of vitamins (A, C and E) and selenium supplementation represent an interesting opportunity for colorectal cancer prevention. To assess the efficacy of a combination of these micronutrients in reducing the incidence of recurrent adenomas in subjects on post-polypectomy endoscopic follow-up, a double-blind placebo-controlled randomized trial was started in Italy in 1988. A total of 411 patients were randomized to receive either an active compound (200 μg selenium, 30 mg zinc, 2 mg vitamin A, 180 mg vitamin C, 30 mg vitamin E) or a placebo daily for 5 years. Of them, 330 had follow-up colonoscopy (164 in the intervention and 166 in the placebo group). After a median follow-up of 4 years (range 1-15 years), 100 patients had recurrence: 38 in the intervention and 62 in the placebo arm. The 15-year cumulative incidence of recurrence was 48.3% in the intervention and 64.5% in the placebo arm (HR = 0.59; log-rank P = 0.009). A 39% reduction of the risk of recurrence was observed in the intervention compared to the placebo group (adjusted HR = 0.61; 95% CI 0.41-0.92): the risk reduction was similar for small tubular (adjusted HR = 0.61; 95% CI 0.37-0.99) and advanced adenomas (adjusted HR = 0.50; 95% CI 0.24-1.01). Our study showed a statistically significant effect of antioxidant supplementation on adenoma recurrence. Further clinical trials are needed to address the role of antioxidants in subgroups of subjects at increased risk for colorectal cancer.

Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

NARCIS (Netherlands)

Navarese, E.P.; Kowalewski, M.; Cortese, B.; Kandzari, D.; Dias, S.; Wojakowski, W.; Buffon, A.; Lansky, A.; Angelini, P.; Torguson, R.; Kubica, J.; Kelm, M.; Boer, M.J. de; Waksman, R.; Suryapranata, H.

2014-01-01

BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy

Iterated random walks with shape prior

DEFF Research Database (Denmark)

Pujadas, Esmeralda Ruiz; Kjer, Hans Martin; Piella, Gemma

2016-01-01

the parametric probability density function. Then, random walks is performed iteratively aligning the prior with the current segmentation in every iteration. We tested the proposed approach with natural and medical images and compared it with the latest techniques with random walks and shape priors......We propose a new framework for image segmentation using random walks where a distance shape prior is combined with a region term. The shape prior is weighted by a confidence map to reduce the influence of the prior in high gradient areas and the region term is computed with k-means to estimate....... The experiments suggest that this method gives promising results for medical and natural images....

Comparison of primary and delayed primary closure in dirty abdominal wounds in terms of frequency of surgical site infection

International Nuclear Information System (INIS)

Aziz, O.B.A.; Ahmed, N.; Butt, M.W.U.D.; Saleem, M.R.

2013-01-01

Objective: Objective of this study was to compare primary and delayed primary wound closure for dirty abdominal wounds in terms of frequency of surgical site infection. Study Design: Randomized Controlled Trial. Place and Duration of Study: Combined Military Hospital, Multan. From 16 Sep 2010 to 15 Mar 2011. Patients and Methods: A total of 110 patients were randomly divided into two groups of 55 patients each using random numbers table. Abdominal wounds of one group were closed primarily and of other group were subjected to delayed primary wound closure. The wounds were then checked for surgical site infection for seven post operative days. Results: A higher frequency of surgical site infection was observed in primary closure group (27.3%) as compared to delayed primary closure group (9.1%) which was statistically significant (p=0.013). Conclusion: Delayed primary closure is superior to primary closure in dirty abdominal wounds in terms of frequency of surgical site infection. (author)

Do Subjects with Whiplash-Associated Disorders Respond Differently in the Short-Term to Manual Therapy and Exercise than Those with Mechanical Neck Pain?

Science.gov (United States)

Castaldo, Matteo; Catena, Antonella; Chiarotto, Alessandro; Fernández-de-Las-Peñas, César; Arendt-Nielsen, Lars

2017-04-01

To compare the short-term effects of manual therapy and exercise on pain, related disability, range of motion, and pressure pain thresholds between subjects with mechanical neck pain and whiplash-associated disorders. Twenty-two subjects with mechanical neck pain and 28 with whiplash-associated disorders participated. Clinical and physical outcomes including neck pain intensity, neck-related disability, and pain area, as well as cervical range of motion and pressure pain thresholds over the upper trapezius and tibialis anterior muscles, were obtained at baseline and after the intervention by a blinded assessor. Each subject received six sessions of manual therapy and specific neck exercises. Mixed-model repeated measures analyses of covariance (ANCOVAs) were used for the analyses. Subjects with whiplash-associated disorders exhibited higher neck-related disability ( P  = 0.021), larger pain area ( P  = 0.003), and lower pressure pain thresholds in the tibialis anterior muscle ( P  = 0.009) than those with mechanical neck pain. The adjusted ANCOVA revealed no between-group differences for any outcome (all P  > 0.15). A significant main effect of time was demonstrated for clinical outcomes and cervical range of motion with both groups experiencing similar improvements (all P   0.222). The current clinical trial found that subjects with mechanical neck pain and whiplash-associated disorders exhibited similar clinical and neurophysiological responses after a multimodal physical therapy intervention, suggesting that although greater signs of central sensitization are present in subjects with whiplash-associated disorders, this does not alter the response in the short term to manual therapy and exercises. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Paliperidone palmitate once-monthly maintains improvement in functioning domains of the Personal and Social Performance scale compared with placebo in subjects with schizoaffective disorder.

Science.gov (United States)

Fu, Dong-Jing; Turkoz, Ibrahim; Walling, David; Lindenmayer, Jean-Pierre; Schooler, Nina R; Alphs, Larry

2018-02-01

Evaluate the effect of paliperidone palmitate once-monthly (PP1M) injectable on the specific functioning domains of the Personal and Social Performance (PSP) scale in patients with schizoaffective disorder (SCA) participating in a long-term study. This study (NCT01193153) included both in- and outpatient subjects with SCA experiencing an acute exacerbation of psychotic and mood symptoms. Subjects were treated with PP1M either as monotherapy or in combination with antidepressants or mood stabilizers during a 25-week open-label (OL) phase. Stabilized subjects were randomly assigned 1:1 (PP1M or placebo) into a 15-month double-blind (DB) relapse-prevention period. Functioning of the randomized subjects during OL and DB phases was evaluated using the PSP scale (four domains: socially useful activities, personal/social relationships, self-care, and disturbing/aggressive behaviors). Three statistical approaches were utilized to analyze PSP scores to assess robustness and consistency of findings. No adjustments were made for multiplicity. 334 of 667 enrolled subjects were stabilized with PP1M, randomly assigned to PP1M (n=164) or placebo (n=170) in the DB phase, and included in this analysis. Improvements in all PSP domain scores were observed during the OL phase and were maintained during the DB phase with PP1M, but decreased with placebo. Differences compared to placebo were significant in all four PSP domains during the DB phase (P≤0.008). The analysis in this study showed that PP1M improves functioning, as measured by the four PSP domain scores, in symptomatic subjects with SCA. Functioning was maintained compared with placebo. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

Directory of Open Access Journals (Sweden)

Yadollah Zahed Pasha

2017-10-01

Full Text Available Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for phototherapy in Amirkola Children’s Hospital, Babol- Iran, during October 5, 2016 till May 19, 2017. Eligible neonates were randomly divided into two; intervention (n=75, and control (n=75 groups. Both groups received standard conventional phototherapy, but the intervention group received 10 drop/day of probiotics (Pedilact Zisttakhmir. Co. Iran, until hospital discharge. The outcome variables were SBL and the duration of phototherapy. The data was analyzed by SPSS 22.0 and   the P 0.05.After 24, 48 and 72hours it decreased to 13.73±1.72, 10.92±1.87 and 10.25±1.32 in the intervention and 13.66±1.91, 11.01±1.69 and10.09 ±1.38 in the control groups, respectively but comparison of the amount of SBL reduction  between the two groups was not significant (P>0.05. The duration of phototherapy in the intervention group and the control group was 3.61±1.17 days and 3.72±1.18 days respectively (P>0.05. Conclusion Oral probiotics in neonates with jaundice has no significant effect on SBL and the duration of phototherapy. Further studies are needed to with longer time follow-up.

Short- and long-term effects of mud-bath treatment on hand osteoarthritis: a randomized clinical trial

Science.gov (United States)

Fioravanti, Antonella; Tenti, Sara; Giannitti, Chiara; Fortunati, Nicola Angelo; Galeazzi, Mauro

2014-01-01

The aim of this study was to evaluate both the short-term and the long-term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA). This was a prospective randomized, single blind controlled trial. Sixty outpatients with primary bilateral hand OA were included in the study and randomized to one of two groups. One group ( n = 30) was treated with 12 daily local mud packs and generalized thermal baths with a sulfate-calcium-magnesium-fluorides mineral water added to usual treatment. The control group ( n = 30) continued regular outpatient care routine (exercise, NSAIDs and/or analgesics). Each patient was examined at baseline, after 2 weeks, and after 3, 6, 9 and 12 months. Primary outcome measures were global spontaneous hand pain on a visual analogue scale (VAS) and the functional index for hand osteoarthritis (FIHOA) score; secondary outcomes were health assessment questionnaire (HAQ), duration of morning stiffness, medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption. Our results demonstrated that the efficacy of spa therapy was significant in all the assessed parameters, both at the end of therapy and after 3 months; the values of FIHOA, HAQ and drugs consumption continued to be significantly better after 6 months in comparison with baseline. There were no significant modifications of the parameters throughout the follow-up in the control group. Differences between the two groups were significant for all parameters at the 15th day and at 3 months follow-up; regarding FIHOA, HAQ, and symptomatic drugs consumption, the difference between the two groups persisted and was significant at 6month follow-up. Tolerability of spa therapy seemed to be good. In conclusion, our results confirm that the beneficial effects of spa therapy in patients with hand OA last over time.

Prevention of colonic neoplasia with polyethylene glycol: A short term randomized placebo-controlled double-blinded trial.

Science.gov (United States)

Wali, Ramesh K; Bianchi, Laura; Kupfer, Sonia; De La Cruz, Mart; Jovanovic, Borko; Weber, Christopher; Goldberg, Michael J; Rodriguez, L M; Bergan, Raymond; Rubin, David; Tull, Mary Beth; Richmond, Ellen; Parker, Beth; Khan, Seema; Roy, Hemant K

2018-01-01

Chemoprevention represents an attractive modality against colorectal cancer (CRC) although widespread clinical implementation of promising agents (e.g. aspirin/NSAIDS) have been stymied by both suboptimal efficacy and concerns over toxicity. This highlights the need for better agents. Several groups, including our own, have reported that the over-the-counter laxative polyethylene glycol (PEG) has remarkable efficacy in rodent models of colon carcinogenesis. In this study, we undertook the first randomized human trial to address the role of PEG in prevention of human colonic neoplasia. This was a double-blind, placebo-controlled, three-arm trial where eligible subjects were randomized to 8g PEG-3350 (n = 27) or 17g PEG-3350 (n = 24), or placebo (n = 24; maltodextrin) orally for a duration of six months. Our initial primary endpoint was rectal aberrant crypt foci (ACF) but this was changed during protocol period to rectal mucosal epidermal growth factor receptor (EGFR). Of the 87 patients randomized, 48 completed study primary endpoints and rectal EGFR unchanged PEG treatment. Rectal ACF had a trend suggesting potentially reduction with PEG treatment (pre-post change 1.7 in placebo versus -0.3 in PEG 8+ 17g doses, p = 0.108). Other endpoints (proliferation, apoptosis, expression of SNAIL and E-cadherin), previously noted to be modulated in rodent models, appeared unchanged with PEG treatment in this clinical trial. We conclude that PEG was generally well tolerated with the trial failing to meet primary efficacy endpoints. However, rectal ACFs demonstrated a trend (albeit statistically insignificant) for suppression with PEG. Moreover, all molecular assays including EGFR were unaltered with PEG underscoring issues with lack of translatability of biomarkers from preclinical to clinical trials. This data may provide the impetus for future clinical trials on PEG using more robust biomarkers of chemoprevention. ClinicalTrials.gov NCT00828984.

Long-term indoor air conditioner filtration and cardiovascular health: A randomized crossover intervention study.

Science.gov (United States)

Chuang, Hsiao-Chi; Ho, Kin-Fai; Lin, Lian-Yu; Chang, Ta-Yuan; Hong, Gui-Bing; Ma, Chi-Ming; Liu, I-Jung; Chuang, Kai-Jen

2017-09-01

The association of short-term air pollution filtration with cardiovascular health has been documented. However, the effect of long-term indoor air conditioner filtration on the association between air pollution and cardiovascular health is still unclear. We recruited 200 homemakers from Taipei and randomly assigned 100 of them to air filtration or control intervention; six home visits were conducted per year from 2013 to 2014. The participants under air filtration intervention during 2013 were reassigned to control intervention in 2014. The air pollution measurements consisted of particulate matter less than or equal to 2.5μm in diameter (PM 2.5 ) and total volatile organic compounds (VOCs); blood pressure was monitored for each participant during each visit. The following morning, blood samples were collected after air pollution monitoring. The blood samples were used to analyze biological markers, including high sensitivity-C-reactive protein (hs-CRP), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and fibrinogen. Household information, including cleaning, cooking, and air conditioning, was collected by a questionnaire. Mixed-effects models were used to investigate the associations among air pollution measurements, blood pressure and biological markers. The results showed that increased levels of PM 2.5 and total VOCs were associated with increased hs-CRP, 8-OHdG and blood pressure. The health variables were higher among participants in the control intervention phase than among those in the air filtration intervention phase. We concluded that air pollution exposure was associated with systemic inflammation, oxidative stress and elevated blood pressure. The long-term filtration of air pollution with an air conditioner filter was associated with cardiovascular health of adults. Copyright © 2017 Elsevier Ltd. All rights reserved.

Predictors of Short- and Long-Term Attrition From the Parents as Agents of Change Randomized Controlled Trial for Managing Pediatric Obesity.

Science.gov (United States)

Spence, Nicholas D; Newton, Amanda S; Keaschuk, Rachel A; Ambler, Kathryn A; Jetha, Mary M; Holt, Nicholas L; Rosychuk, Rhonda J; Spence, John C; Sharma, Arya M; Ball, Geoff D C

Attrition in pediatric weight management is a substantial problem. This study examined factors associated with short- and long-term attrition from a lifestyle and behavioral intervention for parents of children with overweight or obesity. Fifty-two families with children ages 6 to 12 years old and body mass index at or above the 85th percentile participated in a randomized controlled trial focused on parents, comparing parent-based cognitive behavioral therapy with parent-based psychoeducation for pediatric weight management. We examined program attrition using two clinical phases of the intervention: short-term and long-term attrition, modeled using the general linear model. Predictors included intervention type, child/parent weight status, sociodemographic factors, and health of the family system. Higher self-assessed health of the family system was associated with lower short-term attrition; higher percentage of intervention sessions attended by parents was associated with lower long-term attrition. Different variables were significant in our short- and long-term models. Attrition might best be conceptualized based on short- and long-term phases of clinical, parent-based interventions for pediatric weight management. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Do TETRA (Airwave) base station signals have a short-term impact on health and well-being? A randomized double-blind provocation study.

Science.gov (United States)

Wallace, Denise; Eltiti, Stacy; Ridgewell, Anna; Garner, Kelly; Russo, Riccardo; Sepulveda, Francisco; Walker, Stuart; Quinlan, Terence; Dudley, Sandra; Maung, Sithu; Deeble, Roger; Fox, Elaine

2010-06-01

"Airwave" is the new communication system currently being rolled out across the United Kingdom for the police and emergency services, based on the Terrestrial Trunked Radio Telecommunications System (TETRA). Some police officers have complained about skin rashes, nausea, headaches, and depression as a consequence of using their Airwave handsets. In addition, a small subgroup in the population self-report being sensitive to electromagnetic fields (EMFs) in general. We conducted a randomized double-blind provocation study to establish whether short-term exposure to a TETRA base station signal has an impact on the health and well-being of individuals with self-reported "electrosensitivity" and of participants who served as controls. Fifty-one individuals with self-reported electrosensitivity and 132 age- and sex-matched controls participated in an open provocation test; 48 sensitive and 132 control participants went on to complete double-blind tests in a fully screened semianechoic chamber. Heart rate, skin conductance, and blood pressure readings provided objective indices of short-term physiological response. Visual analog scales and symptom scales provided subjective indices of well-being. We found no differences on any measure between TETRA and sham (no signal) under double-blind conditions for either controls or electrosensitive participants, and neither group could detect the presence of a TETRA signal at rates greater than chance (50%). When conditions were not double blind, however, the self-reported electrosensitive individuals did report feeling worse and experienced more severe symptoms during TETRA compared with sham. Our findings suggest that the adverse symptoms experienced by electrosensitive individuals are due to the belief of harm from TETRA base stations rather than to the low-level EMF exposure itself.

Functional independence of residents in urban and rural long-term care facilities in Taiwan.

Science.gov (United States)

Lin, Kwan-Hwa; Wu, Shiao-Chi; Hsiung, Chia-Ling; Hu, Ming-Hsia; Hsieh, Ching-Lin; Lin, Jau-Hong; Kuo, Mei-Ying

2004-02-04

To compare the score of functional independence measure (FIM) between urban and rural residents living in long-term care facilities (LTCF) in Taiwan. A total of 437 subjects in 112 licensed LTCF in Taiwan were randomly selected by stratification strategy. Physical therapists interviewed the subjects in nursing homes (NH) and intermediate care facilities (ICF) to obtain the basic data, and the FIM score. (1) There was no significant difference in basic demographic data between urban and rural LTC subjects. (2) Most of the subjects in urban and rural LTCF were males, less than 80 years old, single/widowed, having multiple diseases, using more than one assistive devices, and having social welfare financial support. (3) Motor abilities (eating, grooming, and transfer) and cognition (comprehension, social interaction and problem solving) in rural LTCF subjects were significantly (p institutions is better than those in urban areas. Our results may provide guidelines for the manpower and equipment supply estimation.

Effect of Short-Term Fasting on Systemic Cytochrome P450-Mediated Drug Metabolism in Healthy Subjects: A Randomized, Controlled, Crossover Study Using a Cocktail Approach

NARCIS (Netherlands)

Lammers, Laureen A.; Achterbergh, Roos; van Schaik, Ron H. N.; Romijn, Johannes A.; Mathôt, Ron A. A.

2017-01-01

Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic clearance of different drugs. In a

Short-term dehydroepiandrosterone treatment increases platelet cGMP production in elderly male subjects.

Science.gov (United States)

Martina, Valentino; Benso, Andrea; Gigliardi, Valentina Ramella; Masha, Andi; Origlia, Carla; Granata, Riccarda; Ghigo, Ezio

2006-03-01

Several clinical and population-based studies suggest that dehydroepiandrosterone (DHEA) and its sulphate (DHEA-S) play a protective role against atherosclerosis and coronary artery disease in human. However, the mechanisms underlying this action are still unknown. It has recently been suggested that DHEA-S could delay atheroma formation through an increase in nitric oxide (NO) production. Twenty-four aged male subjects [age (mean +/- SEM): 65.4 +/- 0.7 year; range: 58.2-67.6 years] underwent a blinded placebo controlled study receiving DHEA (50 mg p.o. daily at bedtime) or placebo for 2 months. Platelet cyclic guanosine-monophosphate (cGMP) concentration (as marker of NO production) and serum levels of DHEA-S, DHEA, IGF-I, insulin, glucose, oestradiol (E(2)), testosterone, plasminogen activator inhibitor (PAI)-1 antigen (PAI-1 Ag), homocysteine and lipid profile were evaluated before and after the 2-month treatment with DHEA or placebo. At the baseline, all variables in the two groups were overlapping. All parameters were unchanged after treatment with placebo. Conversely, treatment with DHEA (a) increased (P < 0.001 vs. baseline) platelet cGMP (111.9 +/- 7.1 vs. 50.1 +/- 4.1 fmol/10(6) plts), DHEA-S (13.6 +/- 0.8 vs. 3.0 +/- 0.3 micromol/l), DHEA (23.6 +/- 1.7 vs. 15.3 +/- 1.4 nmol/l), testosterone (23.6 +/- 1.0 vs. 17.7 +/- 1.0 nmol/l) and E(2) (72.0 +/- 5.0 vs. 60.0 +/- 4.0 pmol/l); and (b) decreased (P < 0.05 vs. baseline) PAI-1 Ag (27.4 +/- 3.8 vs. 21.5 +/- 2.5 ng/ml) and low-density lipoprotein (LDL) cholesterol (3.4 +/- 0.2 vs. 3.0 +/- 0.2 mmol/l). IGF-I, insulin, glucose, triglycerides, total cholesterol, HDL cholesterol, HDL2 cholesterol, HDL3 cholesterol, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and homocysteine levels were not modified by DHEA treatment. This study shows that short-term treatment with DHEA increased platelet cGMP production, a marker of NO production, in healthy elderly subjects. This effect is coupled with a decrease in PAI-1

A Panel Data Model for Subjective Information on Household Income Growth

NARCIS (Netherlands)

Das, J.W.M.; van Soest, A.H.O.

1996-01-01

Subjective expectations about future income changes are analyzed, using household panel data.The models used are extensions of existing binary choice panel data models to the case of ordered response.We consider both random and fixed individual effects.The random effects model is estimated by

Short-term tibolone does not interfere with endothelial function: a double-blinded, randomized, controlled trial.

Science.gov (United States)

Celani, M F S; Hurtado, R; Brandão, A H F; Maciel da Fonseca, A M R; Geber, S

2016-06-01

Objective To evaluate the effect of short-term hormone replacement therapy with tibolone 2.5 mg daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. Methods We performed a randomized, double-blinded, placebo-controlled study. A total of 100 healthy postmenopausal women were randomly allocated to receive tibolone (n = 50) or placebo (n = 50) for 28 days. Measurement of the FMD of the brachial artery was performed before and after the use of tibolone and placebo. Results A total of 31 women completed the study in the tibolone group, and 32 women completed the study in the control group. The results of the FMD measurements obtained from the women in the two groups before treatment were similar (0.018 and 0.091, for tibolone and placebo, p = 0.57). The values of the FMD in women who used tibolone and placebo, before and after the treatment, were similar in both groups. The numbers of women who presented an increase in the values of the FMD in both groups were also similar. Conclusion Our results demonstrate that the administration of 2.5 mg tibolone to healthy postmenopausal women for 28 days does not promote endothelial-dependent vasodilation, measured by FMD of the brachial artery.

External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial.

Science.gov (United States)

Weiniger, Carolyn F; Ginosar, Yehuda; Elchalal, Uriel; Sharon, Einav; Nokrian, Malka; Ezra, Yossef

2007-12-01

To compare the success of external cephalic version using spinal analgesia with no analgesia among nulliparas. A prospective randomized controlled trial was performed in a tertiary referral center delivery suite. Nulliparous women at term requesting external cephalic version for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia before the external cephalic version. An experienced obstetrician performed the external cephalic version. Primary outcome was successful conversion to vertex presentation. Seventy-four women were enrolled, and 70 analyzed (36 spinal, 34 no analgesia). Successful external cephalic version occurred among 24 of 36 (66.7%) women randomized to receive spinal analgesia compared with 11 of 34 (32.4%) without, P=.004 (95% confidence interval [CI] of the difference: 0.0954-0.5513). External cephalic version with spinal analgesia resulted in a lower visual analog pain score, 1.76+/-2.74 compared with 6.84+/-3.08 without, Pexternal cephalic version success was 4.0-fold higher when performed with spinal analgesia P=.02 (95% CI, odds ratio [OR] 1.2-12.9). Complete breech presentation before attempting external cephalic version increased the odds of success 8.2-fold, P=.001 (95% CI, OR 2.2-30.3). Placental position, estimated fetal weight, and maternal weight did not contribute to the success rate when spinal analgesia was used. There were no cases of placental abruption or fetal distress. Administration of spinal analgesia significantly increases the success rate of external cephalic version among nulliparous women at term, which allows possible normal vaginal delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00119184 I.

Nasal hyperresponders and atopic subjects report different symptom intensity to air quality: a climate chamber study

DEFF Research Database (Denmark)

Bodin, Lennart; Andersson, K.; Bønløkke, Jakob Hjort

2009-01-01

Short-term exposure to dust and dust added with beta-(1,3)-d-glucan or aldehydes may cause sensory reactions. In random order, we exposed 36 volunteers in a climate chamber to clean air, office dust, dust with glucan, and dust with aldehydes. Three groups of subjects were exposed, eleven were non......, significance mainly because of the nasal hyperreactive group). Exposure to dust, with or without glucan or aldehydes, showed increased discomfort measured by the index for Constant Indoor Climate, and dust with glucan had a similar effect for the index for Lower Respiratory Effects. For Psychological...

Subjective, behavioral, and physiological effects of acute caffeine in light, nondependent caffeine users.

Science.gov (United States)

Childs, Emma; de Wit, Harriet

2006-05-01

Caffeine produces mild psychostimulant effects that are thought to underlie its widespread use. However, the direct effects of caffeine are difficult to evaluate in regular users of caffeine because of tolerance and withdrawal. Indeed, some researchers hypothesize that the psychostimulant effects of caffeine are due largely to the reversal of withdrawal and question whether there are direct effects of caffeine consumption upon mood, alertness, or mental performance in nondependent individuals. This study investigated the physiological, subjective, and behavioral effects of 0, 50, 150, and 450 mg caffeine in 102 light, nondependent caffeine users. Using a within-subjects design, subjects participated in four experimental sessions, in which they received each of the four drug conditions in random order under double blind conditions. Participants completed subjective effects questionnaires and vital signs were measured before and at repeated time points after drug administration. Forty minutes after the capsules were ingested, subjects completed behavioral tasks that included tests of sustained attention, short-term memory, psychomotor performance, and behavioral inhibition. Caffeine significantly increased blood pressure, and produced feelings of arousal, positive mood, and high. Caffeine increased the number of hits and decreased reaction times in a vigilance task, but impaired performance on a memory task. We confirm that acute doses of caffeine, at levels typically found in a cup of coffee, produce stimulant-like subjective effects and enhance performance in light, nondependent caffeine users. These findings support the idea that the drug has psychoactive effects even in the absence of withdrawal.

The benefits of giving a massage on the mental state of massage therapists: a randomized, controlled trial.

Science.gov (United States)

Jensen, Anne M; Ramasamy, Adaikalavan; Hotek, Judith; Roel, Brian; Riffe, Drew

2012-12-01

The objective of this study was to determine whether giving a massage had an impact of the mental state of the massage therapist. The design of this study was a randomized, controlled, blinded study with two parallel groups. This study was conducted at an accredited school of therapeutic massage in Dallas, Texas. The study comprised healthy female and male final-term massage students between ages 18 and 65 years. The participants were randomized into two groups: (1) the experimental group who gave a 1-hour Swedish massage to a massage client (Massage group), or (2) the control group who sat in a room doing normal, daily activities (Control group). Both these activities were a normal part of the daily routine for these massage students. The primary outcomes were the change in the Depression Anxiety and Stress Scale (DASS) scores pre- and postparticipation. Twenty-two (22) participants were randomized in this trial. The baseline characteristics were comparable between the two groups. A statistically significant advantage for the massage group was found relative to the control group in subjective anxiety (DASS Anxiety Subscale, p=0.014). There were no significant differences between the groups with regard to total DASS score (p=0.540), subjective depressive symptoms (DASS Depression Subscale, p=0.472) and subjective stress-related symptoms (DASS Stress Subscale, p=0.919). There were no adverse events reported by any participant. This study shows that massage therapists themselves may benefit from giving a therapeutic massage by experiencing less subjective anxiety following the giving of a massage.

A retrospective, pooled data analysis of the safety of pegaptanib sodium in the treatment of age-related macular degeneration in subjects with or without diabetes mellitus

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Dombi Theresa

2012-08-01

Full Text Available Abstract Background To evaluate the safety of pegaptanib sodium 0.3 mg intravitreal injection in the treatment of neovascular age-related macular degeneration in subjects with or without diabetes mellitus. Methods A pooled, retrospective, analysis was conducted of data from 9 sponsor-administered, randomized, open-label trials. Subjects who received pegaptanib by randomization or change in dose assignment, crossover design, or protocol amendment, were included. Reports of endophthalmitis, increased intraocular pressure, retinal injury, intraocular hemorrhage, traumatic cataract, hypersensitivity reactions, stroke, myocardial infarction, and other arterial thromboembolic events defined by the Antiplatelet Trialists’ Collaboration were identified by Medical Dictionary for Regulatory Activities preferred terms. Adverse events were summarized from the first injection to 42 days after the last injection. The incidence of adverse events was stratified by the presence/absence of diabetes. Results Of 1,586 subjects enrolled, 165 (10.4% had a history of diabetes mellitus and 1,421 (89.6% did not. The 2 populations were similar at baseline. Based on the comparison of prespecified ocular, hypersensitivity, and Antiplatelet Trialists’ Collaboration event terms, the safety review did not identify any notable differences between the 2 populations. Conclusions This retrospective analysis found no increased safety risk resulting from treatment with pegaptanib 0.3 mg in individuals with neovascular age-related macular degeneration and concomitant diabetes mellitus.

Influence of cilazapril on memory functions and sleep behaviour in comparison with metoprolol and placebo in healthy subjects.

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Dietrich, B; Herrmann, W M

1989-01-01

1. In a controlled, randomized, double-blind study the influence of cilazapril and metoprolol on learning and memory functions and on sleep behaviour was investigated in healthy young volunteers under steady-state conditions. Twenty-three subjects were given either 2.5 mg cilazapril, 200 mg metoprolol, or placebo for 14 days in a latin square design separated by washout periods of 7 days. 2. To test memory functions different modalities--verbal, visual, numerical associative and two dimensional spatial memory were tested for recent anterograde recall, both short-term (less than 10 s) and middle-term (up to 15 min) were selected. The test had a content similar to that used in daily life situations. The sleep behaviour was tested both by objective (all night sleep EEG) and subjective measures. 3. Neither antihypertensive drug had an observable influence on memory performance at the dosages used under steady-state conditions. However, sleep was disturbed during metoprolol, while cilazapril could not be differentiated from placebo. The effects of metoprolol on sleep behaviour were observed in the objective and subjective measures. There was more frequent awakening during the night with the subjective complaint of difficulties in sleeping through. 4. From this study it is concluded that cilazapril has no major effect on memory functions and sleep behaviour. This is only true for the dosages given and under steady-state conditions.

Objective and Subjective Measures of Simultaneous vs Sequential Bilateral Cochlear Implants in Adults: A Randomized Clinical Trial.

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Kraaijenga, Véronique J C; Ramakers, Geerte G J; Smulders, Yvette E; van Zon, Alice; Stegeman, Inge; Smit, Adriana L; Stokroos, Robert J; Hendrice, Nadia; Free, Rolien H; Maat, Bert; Frijns, Johan H M; Briaire, Jeroen J; Mylanus, E A M; Huinck, Wendy J; Van Zanten, Gijsbert A; Grolman, Wilko

2017-09-01

To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential BiCIs. A multicenter randomized clinical trial was conducted between January 12, 2010, and September 2, 2012, at 5 tertiary referral centers among 40 participants eligible for BiCIs. Main inclusion criteria were postlingual severe to profound hearing loss, age 18 to 70 years, and a maximum duration of 10 years without hearing aid use in both ears. Data analysis was conducted from May 24 to June 12, 2016. The simultaneous BiCI group received 2 cochlear implants during 1 surgical procedure. The sequential BiCI group received 2 cochlear implants with an interval of 2 years between implants. First, the results 1 year after receiving simultaneous BiCIs were compared with the results 1 year after receiving sequential BiCIs. Second, the results of 3 years of follow-up for both groups were compared separately. The primary outcome measure was speech intelligibility in noise from straight ahead. Secondary outcome measures were speech intelligibility in noise from spatially separated sources, speech intelligibility in silence, localization capabilities, and self-reported benefits assessed with various hearing and quality of life questionnaires. Nineteen participants were randomized to receive simultaneous BiCIs (11 women and 8 men; median age, 52 years [interquartile range, 36-63 years]), and another 19 participants were randomized to undergo sequential BiCIs (8 women and 11 men; median age, 54 years [interquartile range, 43-64 years]). Three patients did not receive a second cochlear implant and were unavailable for follow-up. Comparable results were found 1 year after simultaneous or sequential BiCIs for speech intelligibility in noise from straight ahead (difference, 0.9 dB [95% CI, -3.1 to 4.4 dB]) and

Effect of multi axis vibration and subject postures on sketching ...

African Journals Online (AJOL)

Sedentary activities such as reading, writing, sketching, etc. are affected due to the train vibrations. Therefore, the present study investigates the extent of perceived difficulty and distortion in a sketching task by seated subjects in two postures under low frequency, multi axial random vibrations. Thirty male voluntary subjects ...

Perceptual Computing Aiding People in Making Subjective Judgments

CERN Document Server

Mendel, Jerry

2010-01-01

Explains for the first time how "computing with words" can aid in making subjective judgments. Lotfi Zadeh, the father of fuzzy logic, coined the phrase "computing with words" (CWW) to describe a methodology in which the objects of computation are words and propositions drawn from a natural language. Perceptual Computing explains how to implement CWW to aid in the important area of making subjective judgments, using a methodology that leads to an interactive device—a "Perceptual Computer"—that propagates random and linguistic uncertainties into the subjective judg

The relationship between randomness and power-law distributed move lengths in random walk algorithms

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Sakiyama, Tomoko; Gunji, Yukio-Pegio

2014-05-01

Recently, we proposed a new random walk algorithm, termed the REV algorithm, in which the agent alters the directional rule that governs it using the most recent four random numbers. Here, we examined how a non-bounded number, i.e., "randomness" regarding move direction, was important for optimal searching and power-law distributed step lengths in rule change. We proposed two algorithms: the REV and REV-bounded algorithms. In the REV algorithm, one of the four random numbers used to change the rule is non-bounded. In contrast, all four random numbers in the REV-bounded algorithm are bounded. We showed that the REV algorithm exhibited more consistent power-law distributed step lengths and flexible searching behavior.

Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate.

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Singh, Satinder Pal; Jena, Ashok Kumar; Rattan, Vidya; Utreja, Ashok Kumar

2012-04-01

To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 months (mean 25.5 ± 1.94 months) after distraction osteogenesis were used for the evaluation of treatment outcome and long-term stability of the skeletal changes. Descriptive analysis, ANOVA, and post-hoc test were used, and P-value 0.05 was considered as a statistically significant level. Maxillary distraction resulted in significant advancement of maxilla (Pmaxillary distraction. The position of the mandible and facial heights were stable during distraction. During the first 6 months of the post-distraction period, the maxilla showed relapse of approximately 30%. However, after 6 months post distraction, the relapse was very negligible. Successful advancement of maxilla was achieved by distraction osteogenesis in adult subjects with cleft lip and palate. Most of the relapse occurred during the first 6 months of post-distraction period, and after that the outcomes were stable.

Decompounding random sums: A nonparametric approach

DEFF Research Database (Denmark)

Hansen, Martin Bøgsted; Pitts, Susan M.

Observations from sums of random variables with a random number of summands, known as random, compound or stopped sums arise within many areas of engineering and science. Quite often it is desirable to infer properties of the distribution of the terms in the random sum. In the present paper we...... review a number of applications and consider the nonlinear inverse problem of inferring the cumulative distribution function of the components in the random sum. We review the existing literature on non-parametric approaches to the problem. The models amenable to the analysis are generalized considerably...

Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial.

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Denny, Lynette; Kuhn, Louise; Hu, Chih-Chi; Tsai, Wei-Yann; Wright, Thomas C

2010-10-20

Screen-and-treat approaches to cervical cancer prevention are an attractive option for low-resource settings, but data on their long-term efficacy are lacking. We evaluated the efficacy of two screen-and-treat approaches through 36 months of follow-up in a randomized trial. A total of 6637 unscreened South African women aged 35-65 years who were tested for the presence of high-risk human papillomavirus (HPV) DNA in cervical samples underwent visual inspection of the cervix using acetic acid staining and HIV serotesting. Of these, 6555 were randomly assigned to three study arms: 1) HPV-and-treat, in which all women with a positive HPV DNA test result underwent cryotherapy; 2) visual inspection-and-treat, in which all women with a positive visual inspection test result underwent cryotherapy; or 3) control, in which further evaluation or treatment was delayed for 6 months. All women underwent colposcopy with biopsy at 6 months. All women who were HPV DNA- or visual inspection-positive at enrollment, and a subset of all other women had extended follow-up to 36 months (n = 3639) with yearly colposcopy. The endpoint-cervical intraepithelial neoplasia grade 2 or worse (CIN2+)-was analyzed using actuarial life-table methods. All statistical tests were two-sided. After 36 months, there was a sustained statistically significant decrease in the cumulative detection of CIN2+ in the HPV-and-treat arm compared with the control arm (1.5% vs 5.6%, difference = 4.1%, 95% confidence interval [CI] = 2.8% to 5.3%, P cryotherapy.

Psychophysiological tests and provocation of subjects with mobile phone related symptoms.

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Wilén, Jonna; Johansson, Amanda; Kalezic, Nebojsa; Lyskov, Eugene; Sandström, Monica

2006-04-01

The aim of the present study was to investigate the effect of exposure to a mobile phone-like radiofrequency (RF) electromagnetic field on persons experiencing subjective symptoms when using mobile phones (MP). Twenty subjects with MP-related symptoms were recruited and matched with 20 controls without MP-related symptoms. Each subject participated in two experimental sessions, one with true exposure and one with sham exposure, in random order. In the true exposure condition, the test subjects were exposed for 30 min to an RF field generating a maximum SAR(1g) in the head of 1 W/kg through an indoor base station antenna attached to a 900 MHz GSM MP. The following physiological and cognitive parameters were measured during the experiment: heart rate and heart rate variability (HRV), respiration, local blood flow, electrodermal activity, critical flicker fusion threshold (CFFT), short-term memory, and reaction time. No significant differences related to RF exposure conditions were detected. Also no differences in baseline data were found between subject groups, except for the reaction time, which was significantly longer among the cases than among the controls the first time the test was performed. This difference disappeared when the test was repeated. However, the cases differed significantly from the controls with respect to HRV as measured in the frequency domain. The cases displayed a shift in low/high frequency ratio towards a sympathetic dominance in the autonomous nervous system during the CFFT and memory tests, regardless of exposure condition. This might be interpreted as a sign of differences in the autonomous nervous system regulation between persons with MP related subjective symptoms and persons with no such symptoms. (c) 2005 Wiley-Liss, Inc.

The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

Science.gov (United States)

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.…

Effects of Ganglioside on Working Memory and the Default Mode Network in Individuals with Subjective Cognitive Impairment: A Randomized Controlled Trial.

Science.gov (United States)

Jeon, Yujin; Kim, Binna; Kim, Jieun E; Kim, Bori R; Ban, Soonhyun; Jeong, Jee Hyang; Kwon, Oran; Rhie, Sandy Jeong; Ahn, Chang-Won; Kim, Jong-Hoon; Jung, Sung Ug; Park, Soo-Hyun; Lyoo, In Kyoon; Yoon, Sujung

2016-01-01

This randomized, double-blind, placebo-controlled trial examined whether the administration of ganglioside, an active ingredient of deer bone extract, can improve working memory performance by increasing gray matter volume and functional connectivity in the default mode network (DMN) in individuals with subjective cognitive impairment. Seventy-five individuals with subjective cognitive impairment were chosen to receive either ganglioside (330[Formula: see text][Formula: see text]g/day or 660[Formula: see text][Formula: see text]g/day) or a placebo for 8 weeks. Changes in working memory performance with treatment of either ganglioside or placebo were assessed as cognitive outcome measures. Using voxel-based morphometry and functional connectivity analyses, changes in gray matter volume and functional connectivity in the DMN were also assessed as brain outcome measures. Improvement in working memory performance was greater in the ganglioside group than in the placebo group. The ganglioside group, relative to the placebo group, showed greater increases in gray matter volume and functional connectivity in the DMN. A significant relationship between increased functional connectivity of the precuneus and improved working memory performance was observed in the ganglioside group. The current findings suggest that ganglioside has cognitive-enhancing effects in individuals with subjective cognitive impairment. Ganglioside-induced increases in gray matter volume and functional connectivity in the DMN may partly be responsible for the potential nootropic effects of ganglioside. The clinical trial was registered with ClinicalTrials.gov (identifier: NCT02379481).

Long-term effects of serial anodal tDCS on motion perception in subjects with occipital stroke measured in the unaffected visual hemifield

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Manuel C Olma

2013-06-01

Full Text Available Transcranial direct current stimulation (tDCS is a novel neuromodulatory tool that has seen early transition to clinical trials, although the high variability of these findings necessitates further studies in clincally-relevant populations. The majority of evidence into effects of repeated tDCS is based on research in the human motor system, but it is unclear whether the long-term effects of serial tDCS are motor-specific or transferable to other brain areas. This study aimed to examine whether serial anodal tDCS over the visual cortex can exogenously induce long-term neuroplastic changes in the visual cortex. However, when the visual cortex is affected by a cortical lesion, up-regulated endogenous neuroplastic adaptation processes may alter the susceptibility to tDCS. To this end, motion perception was investigated in the unaffected hemifield of subjects with unilateral visual cortex lesions. Twelve subjects with occipital ischaemic lesions participated in a within-subject, sham-controlled, double-blind study. MRI-registered sham or anodal tDCS (1.5 mA, 20 minutes was applied on five consecutive days over the visual cortex. Motion perception was tested before and after stimulation sessions and at 14- and 28-day follow-up. After a 16-day interval an identical study block with the other stimulation condition (anodal or sham tDCS followed. Serial anodal tDCS over the visual cortex resulted in an improvement in motion perception, a function attributed to MT/V5. This effect was still measurable at 14- and 28-day follow-up measurements. Thus, this may represent evidence for long-term tDCS-induced plasticity and has implications for the design of studies examining the time course of tDCS effects in both the visual and motor systems.

Effects of 4-Week Intervention with Ulmus macrocarpa Hance Extract on Immune Function Biomarkers in Healthy Adults: A Randomized Controlled Trial

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A Ra Cho

2018-01-01

Full Text Available Ulmus macrocarpa extract has been shown to have immune-related effects in animals, but no studies have yet been performed in humans. This randomized, double-blind, placebo-controlled trial was conducted to determine the effect of short-term administration of Ulmus macrocarpa Hance extract (UME on immune function biomarkers and its safety in human subjects. Fifty-eight subjects were randomly assigned to a UME group or a placebo group. Subjects in the UME group were given 500 mg per day of UME orally for 4 weeks. Mean fluorescence intensity (MFI of tumor necrotic factor-α increased only in the UME group at 1 week (P=0.027. The MFI of interleukin-2 decreased less significantly in the UME group than in the placebo group at 1 week (P=0.028. However, unfortunately, at 4 weeks, no intergroup differences were detected in MFIs of cytokine. In conclusion, administration of UME for 1 week increased serum TNF-α and sustains IL-2 in human, which suggests that UME increases Th1-related immune function in the short term in healthy people. However, additional studies are needed to confirm the results of this first-stage study and further trials are required to decide on optimal dosage and duration of administration. This trial is registered with ClinicalTrials.gov Identifier: NCT02414412.

Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.

Science.gov (United States)

Berteau, Cecile; Schwarzenbach, Florence; Donazzolo, Yves; Latreille, Mathilde; Berube, Julie; Abry, Herve; Cotten, Joël; Feger, Celine; Laurent, Philippe E

2010-10-05

A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe. This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects' preferred system for a final study injection or future treatment. A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment. This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.

Effect of short-term low- and high-fat diets on low-density lipoprotein particle size in normolipidemic subjects.

Science.gov (United States)

Guay, Valérie; Lamarche, Benoît; Charest, Amélie; Tremblay, André J; Couture, Patrick

2012-01-01

High-fat, low-carbohydrate diets have been shown to raise plasma cholesterol levels, an effect associated with the formation of large low-density lipoprotein (LDL) particles. However, the impact of dietary intervention on time-course changes in LDL particle size has not been investigated. To test whether a short-term dietary intervention affects LDL particle size, we conducted a randomized, double-blind, crossover study using an intensive dietary modification in 12 nonobese healthy men with normal plasma lipid profile. Participants were subjected to 2 isocaloric 3-day diets: high-fat diet (37% energy from fat and 50% from carbohydrates) and low-fat diet (25% energy from fat and 62% from carbohydrates). Plasma lipid levels and LDL particle size were assessed on fasting blood samples after 3 days of feeding on each diet. The LDL particles were characterized by polyacrylamide gradient gel electrophoresis. Compared with the low-fat diet, plasma cholesterol, LDL cholesterol, and high-density lipoprotein cholesterol were significantly increased (4.45 vs 4.78 mmol/L, P = .04; 2.48 vs 2.90 mmol/L, P = .005; and 1.29 vs 1.41 mmol/L, P = .005, respectively) following the 3-day high-fat diet. Plasma triglycerides and fasting apolipoprotein B-48 levels were significantly decreased after the high-fat diet compared with the low-fat diet (1.48 vs 1.01 mmol/L, P = .0003 and 9.6 vs 5.5 mg/L, P = .008, respectively). The high-fat diet was also associated with a significant increase in LDL particle size (255.0 vs 255.9 Å;P = .01) and a significant decrease in the proportion of small LDL particle (vs 44.6%, P = .01). As compared with a low-fat diet, the cholesterol-raising effect of a high-fat diet is associated with the formation of large LDL particles after only 3 days of feeding. Copyright © 2012 Elsevier Inc. All rights reserved.

Experimental gingivitis, bacteremia and systemic biomarkers: a randomized clinical trial.

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Kinane, D F; Zhang, P; Benakanakere, M; Singleton, J; Biesbrock, A; Nonnenmacher, C; He, T

2015-12-01

Bacteremia and systemic inflammatory markers are associated with periodontal and systemic diseases and may be linking mechanisms between these conditions. We hypothesized that in the development of gingival inflammation, systemic markers of inflammation and bacteremia would increase. To study the effect of bacteremia on systemic inflammatory markers, we recruited 80 subjects to participate in an experimental gingivitis study. Subjects were stratified based on gender, smoking and the number of bleeding sites and then randomized to one of two groups: control group (n = 40) or experimental gingivitis group (n = 40). Subjects in the control group conducted an oral hygiene regimen: brushing twice daily with a regular sodium fluoride cavity protection dentifrice and a standard manual toothbrush, flossing twice daily, and mouth rinsing with an anti-cavity fluoride rinse once daily. The experimental group stopped brushing and flossing, and used only the fluoride anti-cavity mouth rinse for 21 d. Seventy-nine of 80 subjects were evaluable. One subject in the control group was excluded from the results due to antibiotic use during the study. Our data showed the experimental gingivitis group exhibited a significant (p gingival inflammatory indices relative to baseline and the control group but a decrease in bacteremia and soluble intercellular adhesion molecule-1 levels vs. baseline. Bacteremia was negatively correlated with gingival inflammatory indices and soluble intercellular adhesion molecule-1 levels in the experimental gingivitis group, thus negating our hypothesis. We conclude that there are marked differences in systemic cytokine levels over the course of short-term experimentally induced gingivitis and further conclude that a long-term periodontitis study must be considered to address mechanisms whereby oral diseases may affect systemic diseases. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

Science.gov (United States)

Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

2016-01-01

Purpose The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. Methods A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. Results At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Conclusion Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery. PMID:27920490

Impact of long-term and short-term therapies on seminal parameters

Directory of Open Access Journals (Sweden)

Jlenia Elia

2013-04-01

Full Text Available Aim: The aim of this work was: i to evaluate the prevalence of male partners of subfertile couples being treated with long/short term therapies for non andrological diseases; ii to study their seminal profile for the possible effects of their treatments on spermatogenesis and/or epididymal maturation. Methods: The study group was made up of 723 subjects, aged between 25 and 47 years. Semen analysis was performed according to World Health Organization (WHO guidelines (1999. The Superimposed Image Analysis System (SIAS, which is based on the computerized superimposition of spermatozoa images, was used to assess sperm motility parameters. Results: The prevalence of subjects taking pharmacological treatments was 22.7% (164/723. The prevalence was 3.7% (27/723 for the Short-Term Group and 18.9% (137/723 for the Long-Term Group. The subjects of each group were also subdivided into subgroups according to the treatments being received. Regarding the seminal profile, we did not observe a significant difference between the Long-Term, Short-Term or the Control Group. However, regarding the subgroups, we found a significant decrease in sperm number and progressive motility percentage in the subjects receiving treatment with antihypertensive drugs compared with the other subgroups and the Control Group. Conclusions: In the management of infertile couples, the potential negative impact on seminal parameters of any drugs being taken as Long-Term Therapy should be considered. The pathogenic mechanism needs to be clarified.

Wii Fit® training vs. Adapted Physical Activities: which one is the most appropriate to improve the balance of independent senior subjects? A randomized controlled study.

Science.gov (United States)

Toulotte, Claire; Toursel, Cindy; Olivier, Nicolas

2012-09-01

To compare the effectiveness of three protocols (Adapted Physical Activities, Wii Fit(®), Adapted Physical Activities + Wii Fit(®)) on the balance of independent senior subjects. Case comparison study. Healthy elderly subjects living in independent community dwellings. Thirty-six subjects, average age 75.09 ± 10.26 years, took part in this study, and were randomly assigned to one of the four experimental groups: G1 followed an Adapted Physical Activities training programme, while the second group (G2) participated in Wii Fit(®) training and the third one (G3) combined both methods. There was no training for the fourth group (G4). All subjects trained once a week (1 hour) for 20 weeks and were assessed before and after treatment. The Tinetti test, unipedal tests and the Wii Fit(®) tests. After training, the scores in the Tinetti test decreased significantly (P Wii Fit(®)) and G3 (Adapted Physical Activities and Wii Fit(®)) improved their balance. In addition, G1 and G3 increased their dynamic balance. The findings suggest that Adapted Physical Activities training limits the decline in sensorial functions in the elderly.

A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy.

Science.gov (United States)

Wood, Robert A; Kim, Jennifer S; Lindblad, Robert; Nadeau, Kari; Henning, Alice K; Dawson, Peter; Plaut, Marshall; Sampson, Hugh A

2016-04-01

Although studies of oral immunotherapy (OIT) for food allergy have shown promise, treatment is frequently complicated by adverse reactions and, even when successful, has limited long-term efficacy because benefits usually diminish when treatment is discontinued. We sought to examine whether the addition of omalizumab to milk OIT reduces treatment-related reactions, improves outcomes, or both. This was a double-blind, placebo-controlled trial with subjects randomized to omalizumab or placebo. Open-label milk OIT was initiated after 4 months of omalizumab/placebo with escalation to maintenance over 22 to 40 weeks, followed by daily maintenance dosing through month 28. At month 28, omalizumab was discontinued, and subjects passing an oral food challenge (OFC) continued OIT for 8 weeks, after which OIT was discontinued with rechallenge at month 32 to assess sustained unresponsiveness (SU). Fifty-seven subjects (7-32 years) were randomized, with no significant baseline differences in age, milk-specific IgE levels, skin test results, or OFC results. At month 28, 24 (88.9%) omalizumab-treated subjects and 20 (71.4%) placebo-treated subjects passed the 10-g "desensitization" OFC (P = .18). At month 32, SU was demonstrated in 48.1% in the omalizumab group and 35.7% in the placebo group (P = .42). Adverse reactions were markedly reduced during OIT escalation in omalizumab-treated subjects for percentages of doses per subject provoking symptoms (2.1% vs 16.1%, P = .0005), dose-related reactions requiring treatment (0.0% vs 3.8%, P = .0008), and doses required to achieve maintenance (198 vs 225, P = .008). In this first randomized, double-blind, placebo-controlled trial of omalizumab in combination with food OIT, we found significant improvements in measurements of safety but not in outcomes of efficacy (desensitization and SU). Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Safety and long-term immunological effects of CryJ2-LAMP plasmid vaccine in Japanese red cedar atopic subjects: A phase I study.

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Su, Yan; Romeu-Bonilla, Eliezer; Anagnostou, Athanasia; Fitz-Patrick, David; Hearl, William; Heiland, Teri

2017-12-02

Japanese Red Cedar (JRC) pollen induced allergy affects one third of Japanese and the development of effective therapies remains an unachieved challenge. We designed a DNA vaccine encoding CryJ2 allergen from the JRC pollen and Lysosomal Associated Membrane Protein 1 (LAMP-1) to treat JRC allergy. These Phase IA and IB trials assessed safety and immunological effects of the investigational CryJ2-LAMP DNA vaccine in both non-sensitive and sensitive Japanese expatriates living in Honolulu, Hawaii. In the Phase IA trial, 6 JRC non-sensitive subjects and 9 JRC and/or Mountain Cedar (MC) sensitive subjects were given 4 vaccine doses (each 4mg/1ml) intramuscularly (IM) at 14-day intervals. Nine JRC and/or MC sensitive subjects were given 4 doses (2 mg/0.5 ml) IM at 14-day intervals. The safety and functional biomarkers were followed for 132 d. Following this, 17 of 24 subjects were recruited into the IB trial and received one booster dose (2 mg/0.5 ml) IM approximately 300 d after the first vaccination dose to which they were randomized in the first phase of the trial. All safety endpoints were met and all subjects tolerated CryJ2-LAMP vaccinations well. At the end of the IA trial, 10 out of 12 JRC sensitive and 6 out of 11 MC sensitive subjects experienced skin test negative conversion, possibly related to the CryJ2-LAMP vaccinations. Collectively, these data suggested that the CryJ2-LAMP DNA vaccine is safe and may be immunologically effective in treating JRC induced allergy.

FIVE-YEAR OUTCOMES AFTER LONG-TERM OXANDROLONE ADMINISTRATION IN SEVERELY BURNED CHILDREN: A RANDOMIZED CLINICAL TRIAL.

Science.gov (United States)

Reeves, Patrick T; Herndon, David N; Tanksley, Jessica D; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Clayton, Robert P; Crites, Nancy N; Hays, Joshua P; Andersen, Clark; Lee, Jong O; Meyer, Walter; Suman, Oscar E; Finnerty, Celeste C

2016-04-01

Administration of oxandrolone, a nonaromatizable testosterone analog, to children for 12 months following severe burn injury has been shown to improve height, increase bone mineral content (BMC), reduce cardiac work, and augment muscle strength. Surprisingly, the increase in BMC persists well beyond the period of oxandrolone administration. This study was undertaken to determine if administration of oxandrolone for 2 years yields greater effects on long-term BMC and bone mineral density (BMD). Patients between 0 and 18 years of age with ≥30% of total body surface area burned were consented to an IRB-approved protocol and randomized to receive either placebo (n = 84) or 0.1 mg/kg oxandrolone orally twice daily for 24 months (n = 35). Patients were followed prospectively from the time of admission until 5 years postburn in a single-center, intent-to-treat setting. Height, weight, BMC, and BMD were recorded annually through 5 years postinjury. The long-term administration of oxandrolone for 16 ± 1 months postburn (range, 12.1-25.2 months) significantly increased whole-body (WB) BMC (p patients who were in growth spurt years (7-18 years). When adjusted for height, sex, and age, LS BMD was found to significantly increase with long-term oxandrolone administration (p patients receiving oxandrolone exhibited LS BMD z scores below -2.0 as compared with controls, indicating a significantly reduced risk for future fracture with oxandrolone administration. Long-term oxandrolone patients had significantly greater height velocity than controls throughout the first 2-year postburn (p patients receiving long-term oxandrolone to previously described patients receiving 12 months of oxandrolone revealed that long-term oxandrolone administration imparted significantly greater increases in WB-BMC, WB-BMD, and LS-BMD (p burned pediatric patients significantly improves WB BMC, LS BMC, LS BMD, and height velocity. The administration of long-term oxandrolone was more efficacious than

Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate

OpenAIRE

Satinder Pal Singh; Ashok Kumar Jena; Vidya Rattan; Ashok Kumar Utreja

2012-01-01

Aim : To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Materials and Methods: Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 month...

Beneficial Effects of Long-Term CPAP Treatment on Sleep Quality and Blood Pressure in Adherent Subjects With Obstructive Sleep Apnea.

Science.gov (United States)

Yang, Mei-Chen; Huang, Yi-Chih; Lan, Chou-Chin; Wu, Yao-Kuang; Huang, Kuo-Feng

2015-12-01

Obstructive sleep apnea (OSA) is associated with increased risk of cardiovascular diseases. Although CPAP is the first treatment choice for moderate-to-severe OSA, acceptance of and adherence to CPAP remain problematic. High CPAP adherence is generally defined as ≥4 h of use/night for ≥70% of the nights monitored. We investigated the long-term beneficial effects of CPAP on sleep quality and blood pressure in subjects with moderate-to-severe OSA according to high or low CPAP adherence. We retrospectively analyzed 121 subjects with moderate-to-severe OSA from August 2008 to July 2012. These subjects were divided into 3 groups: (1) no CPAP treatment (n = 29), (2) low CPAP adherence (n = 28), and (3) high CPAP adherence (n = 64). All subjects were followed up for at least 1 y. The 3 groups were compared regarding anthropometric and polysomnographic variables, presence of cardiovascular comorbidities, and blood pressure at baseline and at the last follow-up. The no-treatment group showed significant increases in oxygen desaturation index and blood pressure. The high-adherence group showed significant improvement in daytime sleepiness, apnea-hypopnea index (AHI), oxygen desaturation index, and blood pressure. Although the AHI was also significantly decreased after CPAP treatment in the low-adherence group, blood pressure remained unchanged. CPAP treatment had beneficial effects on both sleep quality and blood pressure only in subjects with OSA and high CPAP adherence who used CPAP for ≥4 h/night for ≥70% of nights monitored. Subjects with low CPAP adherence received beneficial effects on AHI, but not blood pressure. Copyright © 2015 by Daedalus Enterprises.

Effectiveness of zinc supplementation to full term normal infants: a community based double blind, randomized, controlled, clinical trial.

Directory of Open Access Journals (Sweden)

K V Radhakrishna

Full Text Available The study was aimed to test whether zinc supplementation, if initiated early, can prevent stunting and promote optimum body composition in full term infants. For this, full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum. Body mass index (BMI was calculated from maternal weight and height that were collected one month after delivery. Infants' weight, and length, head, chest and mid upper arm circumferences and skin fold thicknesses at triceps, biceps and subscapular area were collected at baseline (before randomization and once in three months up till 24 months. Three hundred and twenty four infants were randomized and allocated to zinc (163 or placebo (161 groups respectively. Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months. The control (placebo group of children received riboflavin 0.5 mg/day, whereas the intervention (zinc group received 5 mg zinc plus riboflavin 0.5 mg/day. When infants were 18 months old, dietary intakes (in 78 children were calculated by 24 hour diet recall method and hemoglobin, zinc, copper and vitamin A were quantified in blood samples collected from 70 children. The results showed prevalence of undernutrition (body mass index <18.5 in 37% of the mothers. Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively. Multiple linear regression models demonstrated maternal weight as a strong predictor of infants' weight and length at 18 months of age. As expected, diarrhea duration impacted infants' linear growth and weight gain adversely. Zinc supplementation for a mean period of 190 days, starting from 4 months up to 18 months of age, in full term normal infants, consuming an average energy of 590 Kcal/day, had significant effect on the skin fold thicknesses, but not on their linear growth.Clinical Trail Registration India (CTRI CTRI

Effects by daily long term provision of ghrelin to unselected weight-losing cancer patients: a randomized double-blind study.

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Lundholm, Kent; Gunnebo, Lena; Körner, Ulla; Iresjö, Britt-Marie; Engström, Cecilia; Hyltander, Anders; Smedh, Ulrika; Bosaeus, Ingvar

2010-04-15

The short-term provision of ghrelin to patients with cancer indicates that there may be benefits from long-term provision of ghrelin for the palliative treatment of weight-losing cancer patients. This hypothesis was evaluated in a randomized, double-blind, phase 2 study. Weight-losing cancer patients with solid gastrointestinal tumors were randomized to receive either high-dose ghrelin treatment (13 microg/kg daily; n = 17 patients) or low-dose ghrelin treatment (0.7 microg/kg daily; n = 14 patients) for 8 weeks as a once-daily, subcutaneous injections. Appetite was scored on a visual analog scale; and food intake, resting energy expenditure, and body composition (dual x-ray absorpitometry) were measured before the start of treatment and during follow-up. Serum levels of ghrelin, insulin, insulin-like growth factor 1, growth hormone (GH), triglycerides, free fatty acids, and glucose were measured. Health-related quality of life, anxiety, and depression were assessed by using standardized methods (the 36-item Short Form Health Survey and the Hospital Anxiety and Depression Scale). Physical activity, rest, and sleep were measured by using a multisensor body monitor. Treatment groups were comparable at inclusion. Appetite scores were increased significantly by high-dose ghrelin analyzed both on an intent-to-treat basis and according to the protocol. High-dose ghrelin reduced the loss of whole body fat (P losing cancer patients with solid tumors supports host metabolism, improves appetite, and attenuates catabolism. (c) 2010 American Cancer Society.

Zinc monotherapy increases serum brain-derived neurotrophic factor (BDNF) levels and decreases depressive symptoms in overweight or obese subjects: a double-blind, randomized, placebo-controlled trial.

Science.gov (United States)

Solati, Zahra; Jazayeri, Shima; Tehrani-Doost, Mehdi; Mahmoodianfard, Salma; Gohari, Mahmood Reza

2015-05-01

Previous studies have shown a positive effect of zinc as an adjunctive therapy on reducing depressive symptoms. However, to our knowledge, no study has examined the effect of zinc monotherapy on mood. The aim of the present study was to determine the effects of zinc monotherapy on depressive symptoms and serum brain-derived neurotrophic factor (BDNF) levels in overweight or obese subjects. Fifty overweight or obese subjects were randomly assigned into two groups and received either 30 mg zinc or placebo daily for 12 weeks. At baseline and post-intervention, depression severity was assessed using Beck depression inventory II (BDI II), and serum BDNF and zinc levels were determined by enzyme-linked immunosorbent assay and atomic absorption spectrophotometry, respectively. The trial was completed with 46 subjects. After a 12-week supplementation, serum zinc and BDNF levels increased significantly in the zinc-supplemented group compared with the placebo group. BDI scores declined in both the groups at the end of the study, but reduction in the zinc-supplemented group was significantly higher than the placebo group. More analysis revealed that following supplementation, BDI scores decreased in subgroup of subjects with depressive symptoms (BDI ≥ 10) (n = 30), but did not change in the subgroup of non-depressed subjects (BDI BDNF levels and depression severity in all participants. Interestingly, a significant positive correlation was found between serum BDNF and zinc levels at baseline. Zinc monotherapy improves mood in overweight or obese subjects most likely through increasing BDNF levels.

The role of internal and external factors on management students’ subject choices

Directory of Open Access Journals (Sweden)

David AL Coldwell

2013-09-01

Full Text Available The aim of the study is to investigate undergraduates’ perceptions of the comparative worth/utility of studying Business Science disciplines at a prominent South African University in terms of: (i internal factors comprising aptitudes, values and interests; and (ii external factors comprising job attractiveness (job prospects, earning potential, non-salary benefits and work-life balance, and (iii university and discipline academic reputations. The study utilises a specifically designed instrument to measure internal and external factors impinging on career choice. A purposive non-random sample, consisting of 130 second and third year students in Human Resource Management (HRM and Management, is used. Findings suggest that, while perceptions of aspects of careers, such as job and career prospects generally dominate the choice of major subjects, students studying HRM majors hold community orientated values that distinguish them from their peers. Many students are found to make choices primarily on the basis of their perceptions of ‘external factors’, rather than their interests. The findings are discussed in terms of extant theory and potential practical outcomes.

Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate

Directory of Open Access Journals (Sweden)

Satinder Pal Singh

2012-01-01

Full Text Available Aim : To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Materials and Methods: Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 months (mean 25.5 ± 1.94 months after distraction osteogenesis were used for the evaluation of treatment outcome and long-term stability of the skeletal changes. Descriptive analysis, ANOVA, and post-hoc test were used, and P-value 0.05 was considered as a statistically significant level. Results: Maxillary distraction resulted in significant advancement of maxilla (P<0.001. Counterclockwise rotation of the palatal plane took place after maxillary distraction. The position of the mandible and facial heights were stable during distraction. During the first 6 months of the post-distraction period, the maxilla showed relapse of approximately 30%. However, after 6 months post distraction, the relapse was very negligible. Conclusions: Successful advancement of maxilla was achieved by distraction osteogenesis in adult subjects with cleft lip and palate. Most of the relapse occurred during the first 6 months of post-distraction period, and after that the outcomes were stable.

[Deep needling and shallow needling at three acupoints around ear for subjective tinnitus: a randomized controlled trial].

Science.gov (United States)

Yin, Tao; Ni, Jinxia; Zhu, Wenzeng

2015-10-01

To compare the effective differences between deep needling and shallow needling at three acupoints around ear for subjective tinnitus. Fifty patients with subjective tinnitus were randomized divided into a deep needling group and a shallow needling group, 25 cases in each group. Twenty-two patients in the deep needling group and 20 patients in the shallow needling group were brought into statistic in the end. In the two groups, the three acupoints around ear and distal acupoints were both selected. The acupoints of the affected side such as Yifeng (TE 17), Tinghui (GB 2), Ermen (TE 21), Zhigou (TE 6), Zhongzhu (TE 3) and Hegu (LI 4) were adopted. Yifeng (TE 17), Tinghui (GB 2) and Ermen (TE 21) were acupunctured 30-38 mm in the deep needling group and 15-20 mm in the shallow needling group. The other acupoints were conventionally acupunctured in the two groups. The needles were retained for 30 min,once a day and five times a week for all patients. The treatment was continuously for 4 weeks in the two groups. Tinnitus handicap inventory (THI) scores, tinnitus grades and visual analogue scale (VAS) for tinnitus sound levels were observed before and after treatment, and the effects of the two groups were compared. The total effective rate in the deep needling group was 59.1% (13/22), and it was better than 20.0% (4/20) in the shallow needling group (P deep needling, group, the THI score, tinnitus grade and the VAS score were improved than those before treatment (all P shallow needling group, the three above indices before and after treatment were not different in statistical significance (all P > 0.05). After treatment, all the three indices in the deep needling group were superior to those in the shallow needling group (all P shallow needling at the three acupoints.

Long-term follow-up of a randomized clinical trial comparing Beger with pylorus-preserving Whipple procedure for chronic pancreatitis.

Science.gov (United States)

Müller, M W; Friess, H; Martin, D J; Hinz, U; Dahmen, R; Büchler, M W

2008-03-01

Duodenum-preserving pancreatic head resection according to Beger and the pylorus-preserving Whipple (ppWhipple) procedure were compared in patients with chronic pancreatitis (CP) in a randomized clinical trial. Perioperative data and short-term outcome have been reported previously. The present study evaluated long-term follow-up. Forty patients were enrolled originally, 20 in each group. Long-term follow-up included mortality, morbidity, pain status, occupational rehabilitation, quality of life (QoL), and endocrine and exocrine function at median follow-up of 7 and 14 years. One patient who had a ppWhipple procedure was lost to follow-up. There were five late deaths in each group. No differences were noted in pain status and exocrine pancreatic function. Loss of appetite was significantly worse in the ppWhipple group at 14 years' follow-up, but there were no other differences in QoL parameters examined. After 14 years, diabetes mellitus was present in seven of 15 patients who had the Beger procedure and 11 of 14 patients after ppWhipple resection (P = 0.128). After long-term follow-up of up to 14 years early advantages of the Beger procedure were no longer present. 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Negative emotion enhances mnemonic precision and subjective feelings of remembering in visual long-term memory.

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Xie, Weizhen; Zhang, Weiwei

2017-09-01

Negative emotion sometimes enhances memory (higher accuracy and/or vividness, e.g., flashbulb memories). The present study investigates whether it is the qualitative (precision) or quantitative (the probability of successful retrieval) aspect of memory that drives these effects. In a visual long-term memory task, observers memorized colors (Experiment 1a) or orientations (Experiment 1b) of sequentially presented everyday objects under negative, neutral, or positive emotions induced with International Affective Picture System images. In a subsequent test phase, observers reconstructed objects' colors or orientations using the method of adjustment. We found that mnemonic precision was enhanced under the negative condition relative to the neutral and positive conditions. In contrast, the probability of successful retrieval was comparable across the emotion conditions. Furthermore, the boost in memory precision was associated with elevated subjective feelings of remembering (vividness and confidence) and metacognitive sensitivity in Experiment 2. Altogether, these findings suggest a novel precision-based account for emotional memories. Copyright © 2017 Elsevier B.V. All rights reserved.

Functional diversity of Collembola is reduced in soils subjected to short-term, but not long-term, geothermal warming

DEFF Research Database (Denmark)

Holmstrup, Martin; Ehlers, Bodil K.; Slotsbo, Stine

2018-01-01

the extent of such effects in long-term field-based experiments. In this study we make use of both recent (short-term) and long-term geothermal warming of Icelandic soils to examine the responses of Collembola, an ecologically important group of soil invertebrates, to warming. 2. On the basis of metabolic...

Sensory retraining: burden in daily life related to altered sensation after orthognathic surgery, a randomized clinical trial.

Science.gov (United States)

Phillips, C; Kim, S H; Tucker, M; Turvey, T A

2010-08-01

Assess the long-term effect of sensory retraining exercises, age, gender, type of surgery, and pre-surgical psychological distress on patients' perception of the interference related to altered sensation 2 years after orthognathic surgery. A total of 186 subjects with a developmental dentofacial disharmony were enrolled in a multicenter randomized clinical trial: one center was a community-based practice and the other a university-based center. Subjects were randomly allocated to two groups: standard of care mouth opening exercises after BSSO or a progressive series of sensory retraining facial exercises in addition to the opening exercises. At 1, 3, 6, 12, and 24 months after surgery, subjects scored unusual feelings on the face, numbness, and loss of lip sensitivity from 'no problem (1)' to 'serious problem (7)'. A marginal proportional odds model was fit for each of the ordinal outcomes. Up to 2 years after surgery, the opening exercise only group had a higher likelihood of reporting interference in daily activities related to numbness and loss of lip sensitivity than the sensory retraining exercise group. The difference between the two groups was relatively constant. Older subjects and those with elevated psychological distress before surgery reported higher burdens related to unusual facial feelings, numbness, and loss of lip sensitivity (p pre-surgical counseling regarding the impact on daily life of persistent altered sensation following a mandibular osteotomy.

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.

Science.gov (United States)

Yoon, Chang Ho; Lee, Hyun Ju; Lee, Eun Young; Lee, Eun Bong; Lee, Won-Woo; Kim, Mee Kum; Wee, Won Ryang

2016-07-01

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028).

Circumferential fusion is dominant over posterolateral fusion in a long-term perspective: cost-utility evaluation of a randomized controlled trial in severe, chronic low back pain

DEFF Research Database (Denmark)

Soegaard, Rikke; Bünger, Cody E; Christiansen, Terkel

2007-01-01

STUDY DESIGN: Cost-utility evaluation of a randomized, controlled trial with a 4- to 8-year follow-up. OBJECTIVE: To investigate the incremental cost per quality-adjusted-life-year (QALY) when comparing circumferential fusion to posterolateral fusion in a long-term, societal perspective. SUMMARY...... OF BACKGROUND DATA: The cost-effectiveness of circumferential fusion in a long-term perspective is uncertain but nonetheless highly relevant as the ISSLS prize winner 2006 in clinical studies reported the effect of circumferential fusion superior to the effect of posterolateral fusion. A recent trial found...... no significant difference between posterolateral and circumferential fusion reporting cost-effectiveness from a 2-year viewpoint. METHODS: A total of 146 patients were randomized to posterolateral or circumferential fusion and followed 4 to 8 years after surgery. The mean age of the cohort was 46 years (range...

Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial.

Science.gov (United States)

Heinitz, Sascha; Reinhardt, Martin; Piaggi, Paolo; Weise, Christopher M; Diaz, Enrique; Stinson, Emma J; Venti, Colleen; Votruba, Susanne B; Wassermann, Eric M; Alonso-Alonso, Miguel; Krakoff, Jonathan; Gluck, Marci E

2017-12-01

Background: Obesity is associated with reduced activation in the left dorsolateral prefrontal cortex (DLPFC), a region of the brain that plays a key role in the support of self-regulatory aspects of eating behavior and inhibitory control. Transcranial direct current stimulation (tDCS) is a noninvasive technique used to modulate brain activity. Objectives: We tested whether repeated anodal tDCS targeted at the left DLPFC (compared with sham tDCS) has an immediate effect on eating behavior during ad libitum food intake, resulting in weight change, and whether it might influence longer-term food intake-related appetite ratings in individuals with obesity. Design: In a randomized parallel-design study combining inpatient and outpatient assessments over 31 d, 23 individuals with obesity [12 men; mean ± SD body mass index (BMI; in kg/m 2 ): 39.3 ± 8.42] received 15 sessions of anodal (i.e., enhancing cortical activity) or sham tDCS aimed at the left DLPFC. Ad libitum food intake was assessed through the use of a vending machine paradigm and snack food taste tests (SFTTs). Appetite was evaluated with a visual analog scale (VAS). Body weight was measured. We examined the effect of short-term (i.e., 3 sessions) and long-term (i.e., 15 sessions) tDCS on these variables. Results: Relative to sham tDCS, short-term anodal tDCS did not influence ad libitum intake of food from the vending machines. Accordingly, no effect on short-term or 4-wk weight change was observed. In the anodal tDCS group, compared with the sham group, VAS ratings for hunger and the urge to eat declined significantly more ( P = 0.01 and P = 0.05, respectively), and total energy intake during an SFTT was relatively lower in satiated individuals ( P = 0.01), after long-term tDCS. Conclusions: Short-term anodal tDCS of the left DLPFC did not have an immediate effect on ad libitum food intake or thereby weight change, relative to sham tDCS. Hunger and snack food intake were reduced only after a longer period

Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

Science.gov (United States)

Persson-Kjerstadius, N; Forsgren, H; Westgren, M

1999-02-01

To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up.

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Kushnir, Vladyslav; Selby, Peter; Zawertailo, Laurie; Tyndale, Rachel F; Leatherdale, Scott T; Cunningham, John A

2017-07-18

Our group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT. Trained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline. If the study finds that the mailed

Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results.

Science.gov (United States)

Rebecchi, Fabrizio; Giaccone, Claudio; Farinella, Eleonora; Campaci, Roberto; Morino, Mario

2008-12-01

To compare in a prospective, randomized trial the long-term results of laparoscopic Heller myotomy plus Dor fundoplication versus laparoscopic Heller myotomy plus floppy-Nissen for achalasia. Anterior fundoplication is usually performed after Heller myotomy to control GER; however, the incidence of postoperative GER ranges between 10% and 30%. Total fundoplication may aid in reducing GER rates. From December 1993 to September 2002, 153 patients with achalasia underwent Heller laparoscopic myotomy plus antireflux fundoplication. Of these, 9 were excluded from the study. The remaining 144 patients were randomly assigned to 2 treatment groups: Heller laparoscopic myotomy plus anterior fundoplication (Dor procedure) or Heller laparoscopic myotomy plus total fundoplication (floppy-Nissen procedure). The primary end point was incidence of clinical and instrumental GER after a minimum of 60 months follow-up. The secondary end point was recurrence of dysphagia. Follow-up clinical assessments were performed at 1, 3, 12, and 60 months using a modified DeMeester Symptom Scoring System (MDSS). Esophageal manometry and 24-hour pH monitoring were performed at 3, 12, and 60 months postoperative. Of the 144 patients originally included in the study, 138 were available for long-term analysis: 71 (51%) underwent antireflux fundoplication plus a Dor procedure (H + D group) and 67 (49%) antireflux fundoplication plus a Nissen procedure (H + N group). No mortality was observed. The mean follow-up period was 125 months. No statistically significant differences in clinical (5.6% vs. 0%) or instrumental GER (2.8% vs. 0%) were found between the 2 groups; however, a statistically significant difference in dysphagia rates was noted (2.8% vs. 15%; P Heller myotomy.

Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

Science.gov (United States)

Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

2015-03-26

An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

The effect of reduced atmospheric deposition on soil and soil solution chemistry at a site subjected to long-term acidification, Nacetin, Czech Republic

Czech Academy of Sciences Publication Activity Database

Oulehle, F.; Hofmeister, J.; Cudlín, Pavel; Hruška, J.

2006-01-01

Roč. 370, 2-3 (2006), s. 532-544 ISSN 0048-9697 R&D Projects: GA ČR(CZ) GA526/03/0058 Institutional research plan: CEZ:AV0Z60870520 Keywords : long-term monitoring Norway spruce * Recovery * Soil solution * Base cations * Nitrogen * Norway spruce Subject RIV: DD - Geochemistry Impact factor: 2.359, year: 2006

Effects of a long-term lifestyle intervention program with Mediterranean diet and exercise for the management of patients with metabolic syndrome in a primary care setting.

Science.gov (United States)

Gomez-Huelgas, R; Jansen-Chaparro, S; Baca-Osorio, A J; Mancera-Romero, J; Tinahones, F J; Bernal-López, M R

2015-06-01

The impact of a lifestyle intervention (LSI) program for the long-term management of subjects with metabolic syndrome in a primary care setting is not known. This 3-year prospective controlled trial randomized adult subjects with metabolic syndrome to receive intensive LSI or to usual care in a community health centre in Malaga, Spain. LSI subjects received instruction on Mediterranean diet and a regular aerobic exercise program by their primary care professionals. Primary outcome included changes from baseline on different components of metabolic syndrome (abdominal circumference, blood pressure, HDL-cholesterol, fasting plasma glucose and triglycerides). Among the 2,492 subjects screened, 601 subjects with metabolic syndrome (24.1%) were randomized to LSI (n = 298) or to usual care (n = 303); of them, a 77% and a 58%, respectively, completed the study. At the end of the study period, LSI resulted in significant differences vs. usual care in abdominal circumference (-0.4 ± 6 cm vs. + 2.1 ± 6.7 cm, p metabolic syndrome. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone

Directory of Open Access Journals (Sweden)

Van Vliet Guy

2011-05-01

Full Text Available Abstract Background There are limited long-term randomized controlled trials of growth hormone (GH supplementation to adult height and few published reports of the health-related quality of life (HRQOL following treatment. The present follow-up study of young adults from a long-term controlled trial of GH treatment in patients with Turner syndrome (TS yielded data to examine whether GH supplementation resulted in a higher HRQOL (either due to taller stature or from the knowledge that active treatment and not placebo had been received or alternatively a lower HRQOL (due to medicalization from years of injections. Methods The original trial randomized 154 Canadian girls with TS aged 7-13 years from 13 centres to receive either long-term GH injections at the pharmacologic dose of 0.3 mg/kg/week or to receive no injections; estrogen prescription for induction of puberty was standardized. Patients were eligible for the follow-up study if they were at least 16 years old at the time of follow-up. The instrument used to study HRQOL was the SF-36, summarized into physical and mental component scales (PCS and MCS; higher scores indicate better HRQOL. Results Thirty-four of the 48 eligible participants (71% consented to participate; data were missing for one patient. Both groups (GH and no treatment had normal HRQOL at this post-treatment assessment. The GH group had a (mean ± SD PCS score of 56 ± 5; the untreated group 58 ± 4; mean score for 16-24 year old females in the general population 53.5 ± 6.9. The GH group had a mean MCS score of 52 ± 6; the untreated group 49 ± 13; mean score for 16-24 year old females in the general population 49.6 ± 9.8. Secondary analyses showed no relationship between HRQOL and height. Conclusions We found no benefit or adverse effect on HRQOL either from receiving or not receiving growth hormone injections in a long-term randomized controlled trial, confirming larger observational studies. We suggest that it remains

Control of Lower Extremity Edema in Patients with Diabetes: Double Blind Randomized Controlled Trial Assessing the Efficacy of Mild Compression Diabetic Socks

Science.gov (United States)

Wu, Stephanie C.; Crews, Ryan T.; Skratsky, Melissa; Overstreet, Julia; Yalla, Sai V.; Winder, Michelle; Ortiz, Jacquelyn; Andersen, Charles A.

2017-01-01

Aims Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. Methods Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18–25mmHg) or non-compression knee high diabetic socks. Subjects were instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumferences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). Results Seventy-seven subjects (39 controls and 38 mild-compression subjects) successfully completed the study. No statistical differences between the two groups in terms of age, body mass index, gender, and ethnicity. Repeated measures analysis of variance and Sidak corrections for multiple comparisons were used for data analyses. Subjects randomized to mild-compression diabetic socks demonstrated significant decreases in calf and ankle circumferences at the end of treatment as compared to baseline. LE circulation did not diminish throughout the study with no significant decreases in ABI, TBI or SPP for either group. Conclusions Results of this RCT suggest that mild compression diabetic sock may be effectively and safely used in patients with diabetes and LE edema. PMID:28315576

Random processes in nuclear reactors

CERN Document Server

Williams, M M R

1974-01-01

Random Processes in Nuclear Reactors describes the problems that a nuclear engineer may meet which involve random fluctuations and sets out in detail how they may be interpreted in terms of various models of the reactor system. Chapters set out to discuss topics on the origins of random processes and sources; the general technique to zero-power problems and bring out the basic effect of fission, and fluctuations in the lifetime of neutrons, on the measured response; the interpretation of power reactor noise; and associated problems connected with mechanical, hydraulic and thermal noise sources

The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials

DEFF Research Database (Denmark)

Krogh, Jesper; Nordentoft, Merete; Sterne, Jonathan A C

2011-01-01

SH) and text word terms depression, depressive disorder and exercise, aerobic, non-aerobic, physical activity, physical fitness, walk*, jog*, run*, bicycling, swim*, strength, and resistance. STUDY SELECTION: Randomized trials including adults with clinical depression according to any diagnostic system were......OBJECTIVE: To assess the effectiveness of exercise in adults with clinical depression. DATA SOURCES: The databases CINAHL, Embase, Cochrane Database of Systematic reviews, Cochrane Controlled Trials Register, MEDLINE, and PsycINFO were searched (1806-2008) using medical subject headings (Me...... with depression (P = .002). No other characteristics were related to between-study heterogeneity. Pooled analysis of 5 trials with long-term follow-up (ie, that examined outcomes beyond the end of the intervention) suggested no long-term benefit (SMD, -0.01; 95% CI, -0.28 to 0.26), with no strong evidence...

Short-term changes in temporomandibular joint function in subjects with cleft lip and palate treated with maxillary distraction osteogenesis.

Science.gov (United States)

Hashimoto, K; Otsuka, R; Minato, A; Sato-Wakabayashi, M; Takada, J; Inoue-Arai, M S; Miyamoto, J J; Ono, T; Ohyama, K; Moriyama, K

2008-05-01

To investigate the short-term effects of maxillary distraction osteogenesis (DO) on temporomandibular joint (TMJ) function in 21 subjects with cleft lip and palate (CLP). Design - Morphological changes in the maxillofacial region were measured using lateral cephalometric radiographs taken immediately before (pre-DO) and after DO (post-DO) and 1 year after DO (1-year follow-up). A questionnaire was evaluated using a visual analog scale. A chi-square test was used to compare the prevalence of TMJ symptoms between pre-DO and 1-year follow-up. The Spearman correlation coefficient was used to determine the correlation between changes in cephalometric variables and TMJ symptoms in association with maxillary DO. Statistical significance was set at p < 0.05. Results - The ANB (anteroposterior relationship of the maxilla with the mandible) angle and the mandibular plane angle at pre-DO, post-DO, and 1-year follow-up were -4.3 degrees , +5.8 degrees , +4.3 degrees and 32.1 degrees , 33.5 degrees , 33.6 degrees , respectively. The average amounts of anterior and downward movement of the maxilla at post-DO and 1-year follow-up were 8.3, -1.3 and 0.9, 1.1 mm, respectively. The prevalence of TMJ symptoms showed no significant increase in association with maxillary DO. Moreover, there was no significant correlation between changes in cephalometric variables and TMJ symptoms. Conclusion - These results suggest that there was no short-term (i.e., up to 1 year after DO) effect of maxillary DO on TMJ function in subjects with CLP.

Controlled Terms or Free Terms? A JavaScript Library to Utilize Subject Headings and Thesauri on the Web

Directory of Open Access Journals (Sweden)

Shun Nagaya

2011-10-01

Full Text Available There are two types of keywords used as metadata: controlled terms and free terms. Free terms have the advantage that metadata creators can freely select keywords, but there also exists a disadvantage that the information retrieval recall ratio might be reduced. The recall ratio can be improved by using controlled terms. But creating and maintaining controlled vocabularies has an enormous cost. In addition, many existing controlled vocabularies are published in formats less suitable for programming. We introduce a JavaScript library called “covo.js” that enables us to make use of controlled vocabularies as metadata for the organization of web pages.

Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

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Jae-Young Shin

2015-01-01

Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

Active intervention in patients with whiplash-associated disorders improves long-term prognosis: a randomized controlled clinical trial.

Science.gov (United States)

Rosenfeld, Mark; Seferiadis, Aris; Carlsson, Jane; Gunnarsson, Ronny

2003-11-15

Three-year follow-up of a prospective randomized trial in 97 patients exposed to whiplash trauma in motor vehicle collisions. To compare the long-term efficacy of active intervention with that of standard intervention and the effect of early versus delayed initiation of intervention. There is no strong evidence for many treatments for whiplash-associated disorders. Some studies provide weak evidence supporting active intervention. Patients were randomized to an intervention using frequent active cervical rotation complemented by assessment and treatment according to McKenzie's principles or to a standard intervention of initial rest, recommended soft collar, and gradual self-mobilization. To test the time factor, interventions were either made within 96 hours or delayed 14 days from collision. The effects of the two interventions and the time factor on pain intensity, cervical range of motion, and sick leave were analyzed at 6 months and 3 years. Cervical range of motion at 3 years was also compared with that in matched, unexposed individuals. Pain intensity and sick leave were significantly (P whiplash-associated disorders, active intervention is more effective in reducing pain intensity and sick leave, and in retaining/regaining total range of motion than a standard intervention. Active intervention can be carried out as home exercises initiated and supported by appropriately trained health professionals.

Peri-apatite coating decreases uncemented tibial component migration: long-term RSA results of a randomized controlled trial and limitations of short-term results.

Science.gov (United States)

Van Hamersveld, Koen T; Marang-Van De Mheen, Perla J; Nelissen, Rob G H H; Toksvig-Larsen, Sören

2018-05-09

Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.

Training-induced changes in muscle CSA,muscle strength, EMG and rate of force development in elderly subjects after long-term unilateral disuse

DEFF Research Database (Denmark)

Suetta, Charlotte; Aagaard, Per; Rosted, Anne

2004-01-01

, maximal isometric strength, RFD, and muscle activation in elderly men and women recovering from long-term muscle disuse and subsequent hip surgery. The improvement in both muscle mass and neural function is likely to have important functional implications for elderly individuals........ Thirty subjects completed the trial. In the strength-training group, significant increases were observed in maximal isometric muscle strength (24%, P impulse (27-32%, P

Comparative randomized open-label trial on efficacy and safety of Persen® and Persen® Night herbal extracts in patients with short-term insomnia

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A. P. Rachin

2016-01-01

Full Text Available Herbal sedatives serve an alternative to antipsychotics and hypnotics aimed to alleviate symptoms of anxious disorders and insomnia. Valeriana officinalis L., Mentha piperita L. and Melissa officinalis are most widely used in neurology as sedatives of herbal origin. We present the results of a randomized open-label trial on efficiency and safety of Persen® and Persen® Night containing extracts of the above mentioned plants in patients with short-term insomnia. The study consisted of 60 subjects of 18–65 y.o. (mean 42.4 ± 6.9 y.o. with short-term insomnia due to adjustment disorder or mixed anxiety-depressive disorders: 30 of them got Persen® 2 tablets a day and 30 – Persen® Night, 1 capsule 30–60 min before sleep during 4 weeks. The majority (76.5 % of patients referred the onset of insomnia with psychosocial traumatic stressor. Persen® Night’s main action was found on superficial sleep, number of night awakenings, sleep onset rate. At the end of the therapy with this substance 39.7 % of patients fell asleep in 10–15 min, and 92.2 % – in 30 min, accordingly, while for Persen® at 17.4 and 80.3 % accordingly (р < 0.05. In the meantime Persen® decreased the bad sleep perception at awakening and day somnolence, mostly attributed to the mood improvement and decrease of anxiety. Levels of efficacy and safety for both substances were significant, allowing to regard them as potential phytotherapeutic agent in the treatment of insomnia and mixed anxiety-depressive disorders.

Insights from random vibration analyses using multiple earthquake components

International Nuclear Information System (INIS)

DebChaudhury, A.; Gasparini, D.A.

1981-01-01

The behavior of multi-degree-of-freedom systems subjected to multiple earthquake components is studied by the use of random vibration dynamic analyses. A linear system which has been decoupled into modes and has both translational and rotational degrees of freedom is analyzed. The seismic excitation is modelled as a correlated or uncorrelated, vector-valued, non-stationary random process having a Kanai-Tajimi type of frequency content. Non-stationarity is achieved by using a piece wise linear strength function. Therefore, almost any type of evolution and decay of an earthquake may be modelled. Also, in general, the components of the excitation have different frequency contents and strength functions; i.e. intensities and durations and the correlations between components can vary with time. A state-space, modal, random vibration approach is used. Exact analytical expressions for both the state transition matrix and the evolutionary modal covariance matrix are utilized to compute time histories of modal RMS responses. Desired responses are then computed by modal superposition. Specifically, relative displacement, relative velocity and absolute acceleration responses are studied. An important advantage of such analyses is that RMS responses vary smoothly in time therefore large time intervals may be used to generate response time histories. The modal superposition is exact; that is, all cross correlation terms between modal responses are included. (orig./RW)

Long Term Follow-Up after a Randomized Integrated Educational and Psychosocial Intervention in Patient-Partner Dyads Affected by Heart Failure.

Directory of Open Access Journals (Sweden)

Maria Liljeroos

Full Text Available To date, contemporary heart failure care remains patient-focused, but awareness of the partners' and families' situation is increasing. Randomized studies have mainly evaluated the short-term effects of dyadic interventions. Therefore, the aim of this study was to determine the 24-month effects of an intervention with psych-educational support in dyads of heart failure patients and their partners.This study used a randomized study design and 155 patient-partner dyads were enrolled. The intervention included a nurse-led program of three sessions addressing psychoeducational support.The intervention did not have any effect on health, depressive symptoms or perceived control among the patient-partner dyads after 24 months. Furthermore, time to first event did not differ significantly between the intervention group and the control patients.This study may be regarded as a first step in trying to understand dyads' need for supportive care. Individualized and more targeted interventions seem necessary to achieve a higher impact on dyad outcomes.ClinicalTrials.gov NCT02398799.

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

Science.gov (United States)

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

Impact of Vitamin D Supplementation on Gross Motor Development of Healthy Term Infants: A Randomized Dose-Response Trial.

Science.gov (United States)

Wicklow, Brandy; Gallo, Sina; Majnemer, Annette; Vanstone, Catherine; Comeau, Kathryn; Jones, Glenville; L'Abbe, Mary; Khamessan, Ali; Sharma, Atul; Weiler, Hope; Rodd, Celia

2016-08-01

In addition to benefits for bone health, vitamin D is implicated in muscle function in children and adults. To determine if vitamin D dosage positively correlated with gross motor development at 3 and 6 months of age. We hypothesized that higher doses would be associated with higher scores for gross motor skills. A consecutive sample of 55 healthy, term, and breastfed infants from Montreal, Canada were recruited from a randomized trial of vitamin D supplementation between 2009 and 2012. Infants were randomized to 400 International Units (IU) (n = 19), 800 IU (n = 18) or 1,200 IU (n = 18) vitamin D3/day. Motor performance at 3 and 6 months was quantified by the Alberta Infant Motor Scale (AIMS). Plasma vitamin D3 metabolites were measured by tandem mass spectrometry. AIMS scores did not differ at 3 months. However, total AIMS scores and sitting subscores were significantly higher at 6 months in infants receiving 400 IU/day compared to 800 IU/day and 1,200 IU/day groups (p gross motor achievements were significantly higher in infants receiving 400 IU/day vitamin D. Our findings also support longer infants being slightly delayed.

Long-term follow-up of a randomized trial of family foundations: effects on children's emotional, behavioral, and school adjustment.

Science.gov (United States)

Feinberg, Mark E; Jones, Damon E; Roettger, Michael E; Solmeyer, Anna; Hostetler, Michelle L

2014-12-01

This study examines long-term effects of a transition to parenthood program, Family Foundations, designed to enhance child outcomes through a strategic focus on supporting the coparenting relationship. Roughly 5 to 7 years after baseline (pregnancy), parent and teacher reports of internalizing and externalizing problems and school adjustment were collected by mail for 98 children born to couples enrolled in the randomized trial. Teachers reported significantly lower levels of internalizing problems among children in the intervention group compared with children in the control group and, consistent with prior findings at age 3, lower levels of externalizing problems for boys in the intervention group. Baseline level of observed couple negative communication moderated intervention effects for parent and teacher report of child adjustment and teacher report of school adjustment and adaptation. Effect sizes ranged from 0.40 to 0.98. Results indicate that relatively brief preventive programs for couples at the transition to parenthood have the capacity to promote long-term positive benefits for children's adjustment. Although we attended to missing data issues in several ways, high levels of attrition in this long-term follow-up study is a cause for caution.

Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial.

Science.gov (United States)

Yang, Wenying; Zhu, Lvyun; Meng, Bangzhu; Liu, Yu; Wang, Wenhui; Ye, Shandong; Sun, Li; Miao, Heng; Guo, Lian; Wang, Zhanjian; Lv, Xiaofeng; Li, Quanmin; Ji, Qiuhe; Zhao, Weigang; Yang, Gangyi

2016-01-01

The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.

Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study.

Science.gov (United States)

Papp, Kim A; Krueger, James G; Feldman, Steven R; Langley, Richard G; Thaci, Diamant; Torii, Hideshi; Tyring, Stephen; Wolk, Robert; Gardner, Annie; Mebus, Charles; Tan, Huaming; Luo, Yingchun; Gupta, Pankaj; Mallbris, Lotus; Tatulych, Svitlana

2016-05-01

Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis. Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. There was no dose comparison beyond week 52. Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Redox proteomics and physiological responses in Cistus albidus shrubs subjected to long-term summer drought followed by recovery.

Science.gov (United States)

Brossa, Ricard; Pintó-Marijuan, Marta; Francisco, Rita; López-Carbonell, Marta; Chaves, Maria Manuela; Alegre, Leonor

2015-04-01

The interaction between enzymatic and non-enzymatic antioxidants, endogenous levels of ABA and ABA-GE, the rapid recuperation of photosynthetic proteins under re-watering as well the high level of antioxidant proteins in previously drought-stressed plants under re-watering conditions, will contribute to drought resistance in plants subjected to a long-term drought stress under Mediterranean field conditions. This work provides an overview of the mechanisms of Cistus albidus acclimation to long-term summer drought followed by re-watering in Mediterranean field conditions. To better understand the molecular mechanisms of drought resistance in these plants, a proteomic study using 2-DE and MALDI-TOF/TOF MS/MS was performed on leaves from these shrubs. The analysis identified 57 differentially expressed proteins in water-stressed plants when contrasted to well watered. Water-stressed plants showed an increase, both qualitatively and quantitatively, in HSPs, and downregulation of photosynthesis and carbon metabolism enzymes. Under drought conditions, there was considerable upregulation of enzymes related to redox homeostasis, DHA reductase, Glyoxalase, SOD and isoflavone reductase. However, upregulation of catalase was not observed until after re-watering was carried out. Drought treatment caused an enhancement in antioxidant defense responses that can be modulated by ABA, and its catabolites, ABA-GE, as well as JA. Furthermore, quantification of protein carbonylation was shown to be a useful marker of the relationship between water and oxidative stress, and showed that there was only moderate oxidative stress in C. albidus plants subjected to water stress. After re-watering plants recovered although the levels of ABA-GE and antioxidant enzymes still remain higher than in well-watered plants. We expect that our results will provide new data on summer acclimation to drought stress in Mediterranean shrubs.

Generating equilateral random polygons in confinement III

International Nuclear Information System (INIS)

Diao, Y; Ernst, C; Montemayor, A; Ziegler, U

2012-01-01

In this paper we continue our earlier studies (Diao et al 2011 J. Phys. A: Math. Theor. 44 405202, Diao et al J. Phys. A: Math. Theor. 45 275203) on the generation methods of random equilateral polygons confined in a sphere. The first half of this paper is concerned with the generation of confined equilateral random walks. We show that if the selection of a vertex is uniform subject to the position of its previous vertex and the confining condition, then the distributions of the vertices are not uniform, although there exists a distribution such that if the initial vertex is selected following this distribution, then all vertices of the random walk follow this same distribution. Thus in order to generate a confined equilateral random walk, the selection of a vertex cannot be uniform subject to the position of its previous vertex and the confining condition. We provide a simple algorithm capable of generating confined equilateral random walks whose vertex distribution is almost uniform in the confinement sphere. In the second half of this paper we show that any process generating confined equilateral random walks can be turned into a process generating confined equilateral random polygons with the property that the vertex distribution of the polygons approaches the vertex distribution of the walks as the polygons get longer and longer. In our earlier studies, the starting point of the confined polygon is fixed at the center of the sphere. The new approach here allows us to move the starting point of the confined polygon off the center of the sphere. (paper)

Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program.

Science.gov (United States)

Hewitt, Jennifer; Goodall, Stephen; Clemson, Lindy; Henwood, Timothy; Refshauge, Kathryn

2018-04-01

Falls prevention is an international priority, and residents of long-term aged care fall approximately 3 times more often than community dwellers. There is a relative scarcity of published trials in this setting. Our objective was to undertake a randomized controlled trial to test the effect of published best practice exercise in long-term residential aged care. The trial was designed to determine if combined high level balance and moderate intensity progressive resistance training (the Sunbeam Program) is effective in reducing the rate of falls in residents of aged care facilities. A cluster randomized controlled trial of 16 residential aged care facilities and 221 participants was conducted. The broad inclusion criterion was permanent residents of aged care. Exclusions were diagnosed terminal illness, no medical clearance, permanent bed- or wheelchair-bound status, advanced Parkinson's disease, or insufficient cognition to participate in group exercise. Assessments were taken at baseline, after intervention, and at 12 months. Randomization was performed by computer-generated sequence to receive either the Sunbeam program or usual care. A cluster refers to an aged care facility. The program consisted of individually prescribed progressive resistance training plus balance exercise performed in a group setting for 50 hours over a 25-week period, followed by a maintenance period for 6 months. The primary outcome measure was the rate of falls (number of falls and days followed up). Secondary outcomes included physical performance (Short Physical Performance Battery), quality of life (36-item Short-Form Health Survey), functional mobility (University of Alabama Life Space Assessment), fear of falling (Falls Efficacy Scale International), and cognition (Addenbrooke's Cognitive Evaluation-revised). The rate of falls was reduced by 55% in the exercise group (incidence rate ratio = 0.45, 95% confidence interval 0.17-0.74); an improvement was also seen in physical

How edge-reinforced random walk arises naturally

NARCIS (Netherlands)

Rolles, S.W.W.

2003-01-01

We give a characterization of a modified edge-reinforced random walk in terms of certain partially exchangeable sequences. In particular, we obtain a characterization of an edge-reinforced random walk (introduced by Coppersmith and Diaconis) on a 2-edge-connected graph. Modifying the notion of

Bromocriptine and insulin sensitivity in lean and obese subjects

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L Bahler

2016-11-01

Full Text Available Bromocriptine is a glucose-lowering drug, which was shown to be effective in obese subjects with insulin resistance. It is usually administered in the morning. The exact working mechanism of bromocriptine still has to be elucidated. Therefore, in this open-label randomized prospective cross-over mechanistic study, we assessed whether the timing of bromocriptine administration (morning vs evening results in different effects and whether these effects differ between lean and obese subjects. We studied the effect of bromocriptine on insulin sensitivity in 8 lean and 8 overweight subjects using an oral glucose tolerance test. The subjects used bromocriptine in randomized cross-over order for 2 weeks in the morning and 2 weeks in the evening. We found that in lean subjects, bromocriptine administration in the evening resulted in a significantly higher post-prandial insulin sensitivity as compared with the pre-exposure visit (glucose area under the curve (AUC 742 mmol/L * 120 min (695–818 vs 641 (504–750, P = 0.036, AUC for insulin did not change, P = 0.575. In obese subjects, both morning and evening administration of bromocriptine resulted in a significantly higher insulin sensitivity: morning administration in obese: insulin AUC (55,900 mmol/L * 120 min (43,236–96,831 vs 36,448 (25,213–57,711, P = 0.012 and glucose AUC P = 0.069; evening administration in obese: glucose AUC (735 mmol/L * 120 min (614–988 vs 644 (568–829, P = 0.017 and insulin AUC, P = 0.208. In conclusion, bromocriptine increases insulin sensitivity in both lean and obese subjects. In lean subjects, this effect only occurred when bromocriptine was administrated in the evening, whereas in the obese, insulin sensitivity increased independent of the timing of bromocriptine administration.

Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus.

Science.gov (United States)

Schreuder, Tim H A; Duncker, Dirk J; Hopman, Maria T E; Thijssen, Dick H J

2014-11-01

In type 2 diabetes patients, endothelin (ET) receptor blockade may enhance blood flow responses to exercise training. The combination of exercise training and ET receptor blockade may represent a more potent stimulus than training alone to improve vascular function, physical fitness and glucose homeostasis. We assessed the effect of an 8 week exercise training programme combined with either ET blockade or placebo on vasculature, fitness and glucose homeostasis in people with type 2 diabetes. In a double-blind randomized controlled trial, brachial endothelium-dependent and ‑independent dilatation (using flow-mediated dilatation and glyceryl trinitrate, respectively), glucose homeostasis (using Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)) and physical fitness (maximal cycling test) were assessed in 18 men with type 2 diabetes (60 ± 6 years old). Subjects underwent an 8 week exercise training programme, with half of the subjects receiving ET receptor blockade (bosentan) and the other half a placebo, followed by reassessment of the tests above. Exercise training improved physical fitness to a similar extent in both groups, but we did not detect changes in vascular function in either group. This study suggests that there is no adaptation in brachial and femoral artery endothelial function after 8 weeks of training in type 2 diabetes patients. Endothelin receptor blockade combined with exercise training does not additionally alter conduit artery endothelial function or physical fitness in type 2 diabetes. © 2014 The Authors. Experimental Physiology © 2014 The Physiological Society.

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

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Gordon Adam L

2012-06-01

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

The Immediate Effects of Conventional Physical Therapy on the Knee Joint Load in Subjects with Moderate Knee Osteoarthritis; A Preliminary Single Blinded Randomized Control Trial

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Leila Fattahi

2015-12-01

Full Text Available Background: Subjects with knee osteoarthritis typically have higher knee adduction moment. Current research efforts are mainly focused on therapeutic procedures that potentially may modify disease progression. This preliminary study was designed as a single blind (examiner randomized control trial to investigate the impact of conventional physical therapy on pain, and knee joint load in subjects with moderate knee osteoarthritis. Methods: Twelve participants diagnosed with moderate knee OA were randomly assigned into control and intervention groups. Three-dimensional knee kinematic and kinetic data were recorded during the gait before and after 10 sessions of conventional physical therapy. In addition, pain intensity was evaluated by visual analog scale and pain subscale of KOOS questionnaire. The control group did not receive any intervention during the same period. Gait parameters were analyzed within and between groups using nonparametric tests. Results: There was a significant difference between groups in baseline KOOS-pain Score and ML knee force (P=0.048 and P=0.01. Immediately after ten sessions of physical therapy the initial (first peak of knee adduction moment was significantly (P=0.03 lower than that of the control group while the first and second peak of knee AP velocity were significantly (P=0.02, P=0.01 respectively higher. In the intervention group, the second peaks of vertical and anteroposterior (AP knee forces were strongly correlated with the pretest KOOS-pain Score (r=0.99 and r=0.98, P<0.001. Therefore a multivariate general linear model was adopted with adjustment to baseline KOOS-pain. By this adjustment, 51% alleviation of VAS pain score and 81% decrement of first peak of knee adduction moment in comparison to control group was statistically significant (P=0.02, P=0.03 respectively. Conclusion: It seems that ten sessions of conventional physical therapy may modify knee joint load in subjects with moderate knee

Prediction of the effect of atrasentan on renal and heart failure outcomes based on short-term changes in multiple risk markers

DEFF Research Database (Denmark)

Schievink, Bauke; de Zeeuw, Dick; Smink, Paul A

2016-01-01

from the RADAR/JAPAN study to predict the effect of atrasentan on renal and heart failure outcomes. METHODS: We performed a post-hoc analysis of the RADAR/JAPAN randomized clinical trials in which 211 patients with type-2 diabetes and nephropathy were randomly assigned to atrasentan 0.75 mg/day, 1......BACKGROUND: A recent phase II clinical trial (Reducing Residual Albuminuria in Subjects with Diabetes and Nephropathy with AtRasentan trial and an identical trial in Japan (RADAR/JAPAN)) showed that the endothelin A receptor antagonist atrasentan lowers albuminuria, blood pressure, cholesterol......, hemoglobin, and increases body weight in patients with type 2 diabetes and nephropathy. We previously developed an algorithm, the Parameter Response Efficacy (PRE) score, which translates short-term drug effects into predictions of long-term effects on clinical outcomes. DESIGN: We used the PRE score on data...

Pre-Meal Effect of Whey Proteins on Metabolic Parameters in Subjects with and without Type 2 Diabetes: A Randomized, Crossover Trial

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Ann Bjørnshave

2018-01-01

Full Text Available Diabetic dyslipidemia with elevated postprandial triglyceride (TG responses is characteristic in type 2 diabetes (T2D. Diet and meal timing can modify postprandial lipemia (PPL. The impact of a pre-meal of whey proteins (WP on lipid metabolism is unidentified. We determined whether a WP pre-meal prior to a fat-rich meal influences TG and apolipoprotein B-48 (ApoB-48 responses differentially in patients with and without T2D. Two matched groups of 12 subjects with and without T2D accomplished an acute, randomized, cross-over trial. A pre-meal of WP (20 g or water (control was consumed 15 min before a fat-rich meal (supplemented with 20 g WP in case of water pre-meal. Postprandial responses were examined during a 360-min period. A WP pre-meal significantly increased postprandial concentrations of insulin (P < 0.0001, glucagon (P < 0.0001 and glucose-dependent insulinotropic peptide (GIP (P < 0.0001 in subjects with and without T2D. We detected no effects of the WP pre-meal on TG, ApoB-48, or non-esterified fatty acids (NEFA responses to the fat-rich meal in either group. Paracetamol absorption i.e. gastric emptying was delayed by the WP pre-meal (P = 0.039. In conclusion, the WP pre-meal induced similar hormone and lipid responses in subjects with and without T2D. Thus, the WP pre-meal enhanced insulin, glucagon and GIP responses but did not influence lipid or glucose responses. In addition, we demonstrated that a WP pre-meal reduced gastric emptying in both groups.

Effects of selenium on short-term control of hyperthyroidism due to Graves' disease treated with methimazole: results of a randomized clinical trial.

Science.gov (United States)

Leo, M; Bartalena, L; Rotondo Dottore, G; Piantanida, E; Premoli, P; Ionni, I; Di Cera, M; Masiello, E; Sassi, L; Tanda, M L; Latrofa, F; Vitti, P; Marcocci, C; Marinò, M

2017-03-01

In spite of previous conflicting results, an adjuvant role of selenium in the treatment of Graves' disease (GD) hyperthyroidism has been proposed. To address this issue, a randomized clinical trial was carried out aimed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole (MMI). Thirty newly diagnosed hyperthyroid GD patients were randomly assigned to treatment with: (i) MMI or (ii) MMI plus selenium. Primary outcomes were: control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [heart rate, cholesterol, sex hormone-binding globulin (SHBG), hyperthyroidism symptoms] at 90 days. Baseline features of the two groups did not differ. Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency. Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group. Serum malondialdehyde, a marker of oxidative stress, was similar in the two groups and decreased significantly with treatment, with no difference between groups. Administration of MMI was followed by a reduction of FT 3 and FT 4 , with no difference between groups. Heart rate, SHBG and symptoms of hyperthyroidism decreased, whereas total cholesterol increased in both groups with no difference between groups. Our study, carried out in a selenium-sufficient cohort of GD patients, failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism. However, selenium might be beneficial in patients from selenium-deficient areas, as well as in the long-term outcome of antithyroid treatment.

[Comparison of short term results of TVT-O and TVT-S in the surgical treatment of stress urinary incontinence].

Science.gov (United States)

Mašata, J; Svabík, K; Zvára, K; Drahodrádová, P; Hubka, P; Elhaddad, R; Martan, A

2012-08-01

To compare short term results of tension free vaginal tape - obturator (TVT-O) and the tension free vaginal tape Seccure in the treatment of urodynamic stress urinary incontinence (USI). Randomize trial. Department of Gynecology and Obstetrics, First Medical Faculty, Charles University; General Teaching Hospital, Prague. This single-centre randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire-Short form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on evaluation of ICIQ - UI SH (when patients ticked "Never" / "Urine does not leak" in answer to Question 6: When does urine leak?). 197 women with proved SUI were randomized into three groups - TVT-O (68), TVT-S H (64) and TVT-S U (65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in pre-operative characteristics. Three months after surgery were analyzed 65 women in TVT-O group, 61 in TVT-S H and 60 in TVT-S U. 95.4% subjects in the TVT-O group, 82% in the TVT-S H group and 76.7% in the TVT-S U group had stress test negative (p=0.006). 90.8% subjects in the TVT-O group, 82% in the TVT-S H group and 78.3% in the TVT-S U group were subjectively continent (NS). Our study demonstrated a significantly lower objective cure rate in the single incision TVT S group compared to the TVT-O group three months after surgery.

Hibiscus and lemon verbena polyphenols modulate appetite-related biomarkers in overweight subjects: a randomized controlled trial.

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Boix-Castejón, Marina; Herranz-López, María; Pérez Gago, Alberto; Olivares-Vicente, Mariló; Caturla, Nuria; Roche, Enrique; Micol, Vicente

2018-06-04

Plant-derived polyphenols have shown potential to alleviate obesity-related pathologies by a multi-targeted mechanism in animal models and human intervention studies. A dietary supplement based on a combination of Lippia citriodora (LC) and Hibiscus sabdariffa (HS) polyphenolic extracts was assayed in a double blind and placebo-controlled intervention study with 54 overweight subjects. Blood pressure, body weight, height, triceps, biceps and abdominal skinfold thickness, and arm and abdominal circumferences were taken at the baseline, 30 and 60 days of the intervention period. The validated Visual Analogue Scale used to record hunger and satiety-related sensations was passed at the beginning and at 15, 30, 45 and 60 days of the intervention. Subjective health status was assessed through the validated SF-36 questionnaire at the beginning and end of the study. Finally, plasma from fasting blood samples was obtained at the beginning, 30 and 60 days of the study. The results showed an improvement of anthropometric measurements, decreased blood pressure and heart rate and a more positive perception in the overall health status. We also observed that plant polyphenols increased anorexigenic hormones (glucagon-like peptide-1) and decreased orexigenic hormones (ghrelin). Based on previous evidence we postulate that AMP-activated protein kinase may have a role in such effects through its capability to modulate energy homeostasis, total daily energy expenditure and lipid management. Although further research may be required, we propose that this polyphenolic combination may be used for weight management by increasing long-term weight loss maintenance through the modulation of appetite biomarkers. This may help to avoid the undesired weight regain typical of calorie restriction diets.

Power Spectral Analysis of Short-Term Heart Rate Variability in Healthy and Arrhythmia Subjects by the Adaptive Continuous Morlet Wavelet Transform

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Ram Sewak SINGH

2017-12-01

Full Text Available Power spectral analysis of short-term heart rate variability (HRV can provide instant valuable information to understand the functioning of autonomic control over the cardiovascular system. In this study, an adaptive continuous Morlet wavelet transform (ACMWT method has been used to describe the time-frequency characteristics of the HRV using band power spectra and the median value of interquartile range. Adaptation of the method was based on the measurement of maximum energy concentration. The ACMWT has been validated on synthetic signals (i.e. stationary, non-stationary as slow varying and fast changing frequency with time modeled as closest to dynamic changes in HRV signals. This method has been also tested in the presence of additive white Gaussian noise (AWGN to show its robustness towards the noise. From the results of testing on synthetic signals, the ACMWT was found to be an enhanced energy concentration estimator for assessment of power spectral of short-term HRV time series compared to adaptive Stockwell transform (AST, adaptive modified Stockwell transform (AMST, standard continuous Morlet wavelet transform (CMWT and Stockwell transform (ST estimators at statistical significance level of 5%. Further, the ACMWT was applied to real HRV data from Fantasia and MIT-BIH databases, grouped as healthy young group (HYG, healthy elderly group (HEG, arrhythmia controlled medication group (ARCMG, and supraventricular tachycardia group (SVTG subjects. The global results demonstrate that spectral indices of low frequency power (LFp and high frequency power (HFp of HRV were decreased in HEG compared to HYG subjects (p<0.0001. While LFp and HFp indices were increased in ARCMG compared to HEG (p<0.00001. The LFp and HFp components of HRV obtained from SVTG were reduced compared to other group subjects (p<0.00001.

Chemical evolution and the origin of life: cumulative keyword subject index 1970-1986

Science.gov (United States)

Roy, A. C.; Powers, J. V.; Rummel, J. D. (Principal Investigator)

1990-01-01

This cumulative subject index encompasses the subject indexes of the bibliographies on Chemical Evolution and the Origin of Life that were first published in 1970 and have continued through publication of the 1986 bibliography supplement. Early bibliographies focused on experimental and theoretical material dealing directly with the concepts of chemical evolution and the origin of life, excluding the broader areas of exobiology, biological evolution, and geochemistry. In recent years, these broader subject areas have also been incorporated as they appear in literature searches relating to chemical evolution and the origin of life, although direct attempts have not been made to compile all of the citations in these broad areas. The keyword subject indexes have also undergone an analogous change in scope. Compilers of earlier bibliographies used the most specific term available in producing the subject index. Compilers of recent bibliographies have used a number of broad terms relating to the overall subject content of each citation and specific terms where appropriate. The subject indexes of these 17 bibliographies have, in general, been cumulatively compiled exactly as they originally appeared. However, some changes have been made in an attempt to correct errors, combine terms, and provide more meaningful terms.

Infinite Random Graphs as Statistical Mechanical Models

DEFF Research Database (Denmark)

Durhuus, Bergfinnur Jøgvan; Napolitano, George Maria

2011-01-01

We discuss two examples of infinite random graphs obtained as limits of finite statistical mechanical systems: a model of two-dimensional dis-cretized quantum gravity defined in terms of causal triangulated surfaces, and the Ising model on generic random trees. For the former model we describe a ...

Towards the characterization of short-term memory of zebrafish: effect of fixed versus random reward location.

Science.gov (United States)

Fernandes, Yohaan; Talpos, Andrea; Gerlai, Robert

2015-01-02

The zebrafish has been proposed as an efficient tool for the analysis of behavioral and neurobiological mechanisms of learning and memory. However, compared to traditional laboratory rodents, it is a relatively newcomer. In fact, only limited information on its mnemonic and cognitive abilities has been obtained, and only a small number of learning and memory paradigms have been available for its testing. Previously, we have shown that zebrafish are capable of learning the systematic alternating sequence of reward location in a shuttle box task in which we evaluated behavioral responses manually. Here, we employ a computerized, automated version of this task. We study whether zebrafish can remember the prior location of a reward (the sight of conspecifics) when the location is fixed (constant), or when the sequence of the location of presentation randomly changes between the left and the right side of the experimental tank. We also analyze performance features including the swim speed of experimental fish as well as the temporal changes of the position of fish when the reward (stimulus) is not presented. Our results show that under both the fixed and randomly changing reward location conditions zebrafish exhibit a significant preference for the prior location of reward, albeit the preference is stronger under the fixed location condition. We conclude that adult zebrafish have short-term associative memory that can be induced and quantified in an automated manner. Copyright © 2014 Elsevier Inc. All rights reserved.

Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial.

Science.gov (United States)

Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

2017-01-01

Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been studied. The objective of this randomized controlled study was to examine the effect of a post-discharge individualized nutritional intervention on survival in malnourished older patients. Malnourished older patients, aged ≥ 60 years, were randomized during hospitalization to a three-months post-discharge nutritional intervention group (protein and energy enriched diet, oral nutritional supplements, vitamin D3/calcium supplement and telephone counseling by a dietitian) or to a usual care regimen (control group). Survival data were collected 4 years after enrollment. Survival analyses were performed using intention-to-treat analysis by Log-rank tests and Cox regression adjusted for confounders. The study population consisted of 94 men (45%) and 116 women with a mean age of 74.5 (SD 9.5) years. There were no statistically significant differences in baseline characteristics. Survival data was available in 208 out of 210 patients. After 1 and 4 years of follow-up, survival rates were respectively 66% and 29% in the intervention group (n=104) and 73% and 30% in the control group (n=104). There were no statistically significant differences in survival between the two groups 1 year (HR= 0.933, 95% CI=0.675-1.289) and 4 years after enrollment (HR=0.928, 95% CI=0.671-1.283). The current study failed to show an effect of a three-months post-discharge multi-component nutritional intervention in malnourished older patients on long-term survival, despite the positive effects on short-term outcome such as functional limitations and falls.

A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects.

Science.gov (United States)

Spierings, Egilius L H; Volkerts, Edmund R; Heitland, Ivo; Thomson, Heather

2014-02-01

The maximum plasma concentration (Cmax ) of oxymorphone extended release (ER) 20 mg and 40 mg is approximately 50% higher in fed than in fasted subjects, with most of the difference in area-under-the-curve (AUC) occurring in the first 4 hours post-dose. Hence, the US FDA recommends in the approved labeling that oxymorphone ER is taken at least 1 hour before or 2 hours after eating. In order to determine the potential impact on cognitive performance of the increased absorption of oxymorphone ER, fed versus fasting, we conducted a randomized, rater-blinded, crossover study in 30 opioid-tolerant subjects, using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB). The subjects randomly received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal or after fasting for 8-12 hours, and were tested 1 hour and 3 hours post-dose. The CANTAB tests, Spatial Recognition Memory (SRM) and Spatial Working Memory (SWM), showed no statistically significant differences between the fed and fasting conditions. However, sustained attention, as measured by the Rapid Visual Information Processing (RVP) CANTAB test, showed a statistically significant interaction of fed versus fasting and post-dose time of testing (F[1,28] = 6.88, P = 0.01), suggesting that 40 mg oxymorphone ER after a high-fat meal versus fasting mitigates the learning effect in this particular cognition domain from 1 hour to 3 hours post-dose. Oxymorphone 40 mg ER affected cognitive performance similarly within 3 hours post-dose, whether given on an empty stomach or after a high-fat meal, suggesting that the effect of food on plasma concentration may not be relevant in the medication's impact on cognition. Wiley Periodicals, Inc.

Fall Preventive Exercise With or Without Behavior Change Support for Community-Dwelling Older Adults: A Randomized Controlled Trial With Short-Term Follow-up.

Science.gov (United States)

Arkkukangas, Marina; Söderlund, Anne; Eriksson, Staffan; Johansson, Ann-Christin

2017-02-27

In Western countries, falls and fall-related injuries are a well-known threat to health in the aging population. Studies indicate that regular exercise improves strength and balance and can therefore decrease the incidence of falls and fall-related injuries. The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population. The aim of this study was to investigate the short-term effect of a home-based exercise program with or without motivational interviewing (MI) compared with standard care on physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency. A total of 175 older adults participated in this randomized controlled study. They were randomly allocated for the Otago Exercise Program (OEP) (n = 61), OEP combined with MI (n = 58), or a control group (n = 56). The participants' mean age was 83 years. The recruitment period was from October 2012 to May 2015. Measurements of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency were done before and 12 weeks after randomization. A total of 161 participants were followed up, and there were no significant differences between groups after a period of 12 weeks of regular exercise. Within the OEP + MI group, physical performance, fall self-efficacy, physical activity level, and handgrip strength improved significantly; likewise, improved physical performance and fall self-efficacy were found in the control group. A corresponding difference did not occur in the OEP group. Adherence to the exercise was generally high in both exercise groups. In the short-term perspective, there were no benefits of an exercise program with or without MI regarding physical performance, fall self-efficacy, activity level, handgrip strength, adherence to the exercise, and fall frequency in comparison to a control group. However, some small

Convergence of a random walk method for the Burgers equation

International Nuclear Information System (INIS)

Roberts, S.

1985-10-01

In this paper we consider a random walk algorithm for the solution of Burgers' equation. The algorithm uses the method of fractional steps. The non-linear advection term of the equation is solved by advecting ''fluid'' particles in a velocity field induced by the particles. The diffusion term of the equation is approximated by adding an appropriate random perturbation to the positions of the particles. Though the algorithm is inefficient as a method for solving Burgers' equation, it does model a similar method, the random vortex method, which has been used extensively to solve the incompressible Navier-Stokes equations. The purpose of this paper is to demonstrate the strong convergence of our random walk method and so provide a model for the proof of convergence for more complex random walk algorithms; for instance, the random vortex method without boundaries

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren’s Syndrome: a Double-Blind Randomized Control Study

Science.gov (United States)

2016-01-01

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

Objective and subjective sleep quality

DEFF Research Database (Denmark)

Baandrup, Lone; Glenthøj, Birte Yding; Jennum, Poul Jørgen

2016-01-01

and subjective sleep quality during benzodiazepine discontinuation and whether sleep variables were associated with benzodiazepine withdrawal. Eligible patients included adults with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder and long-term use of benzodiazepines in combination...

Exposure of healthy subjects with emissions from a gas metal arc welding process: part 3--biological effect markers and lung function.

Science.gov (United States)

Brand, P; Bischof, K; Siry, L; Bertram, J; Schettgen, T; Reisgen, U; Kraus, T; Gube, M

2013-01-01

Metal active gas welding (MAG) is a widely-used welding technique resulting in high emissions of welding fume particles. This study investigated whether short-term exposure to these fume particles results in changes in lung function and early stages of inflammatory reactions. Twelve healthy, young male subjects were exposed to MAG fumes for 6 h with three different exposure concentrations in a three-fold cross-over study design. Exposure was performed in the "Aachen Workplace Simulation Laboratory" under controlled conditions with constant fume concentration. Fume concentrations were 0, 1, and 2.5 mg m(-3) in randomized order. Before and after each exposure, spirometry, and impulse oscillometry were performed and breath condensate samples were collected in order to quantify inflammatory markers like Nitrate, Nitrite, Nitrotyrosine, Hydroxyprolin and Malondialdehyde. A significant dependency on the exposure concentration could not be established for any of the endpoint parameters. In healthy, young subjects neither changes in spirometry nor changes in inflammatory markers measured in exhaled breath condensate could be detected after short-term exposure.

List of U.S. Army Research Institute Research and Technical Publications for Public Release/Unlimited Distribution. Fiscal Year 2007 (October 1, 2006 to September 30, 2007) With Author Index and Report Titles and Subject Terms Index

Science.gov (United States)

2008-04-01

Year 2007 October 1, 2006 to September 30, 2007 With Author Index and Report Titles and Subject Terms Index United States Army Research Institute for...Fiscal Year 2007 October 1, 2006 to September 30, 2007 With Author Index and Report Titles and Subject Terms Index CONTENTS Page Introduction...39 Author Index .................................................................................................................. 39

Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency

Directory of Open Access Journals (Sweden)

Brissette Suzanne

2011-07-01

Full Text Available Abstract Background Substitution with opioid-agonists (e.g., methadone has shown to be an effective treatment for chronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improved addiction treatment outcomes. However, there is a paucity of studies evaluating patients' satisfaction with Opioid Substitution Treatment (OST. In the present study, participants' satisfaction with OST was evaluated at 3 and 12 months. We sought to test the relationship between satisfaction and patients' characteristics, the treatment modality received and treatment outcomes. Methods Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI, conducted in Vancouver and Montreal (Canada between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone vs. injectable diacetylmorphine over 12 months. A small sub-group of patients received injectable hydromorphone on a double blind basis with diacetylmorphine. The Client Satisfaction Questionnaire (CSQ-8 was used to measure satisfaction with treatment. CSQ-8 scores, as well as retention and response to treatment, did not differ between those receiving hydromorphone and diacetylmorphine at 3 or 12 months assessments; therefore, these two groups were analyzed together as the 'injectable' treatment group. Results A total of 232 (92% and 237 (94% participants completed the CSQ-8 at 3 and 12 months, respectively. Participants in both groups were highly satisfied with treatment. Independent of treatment group, participants satisfied with treatment at 3 months were more likely to be retained at 12 months. Multivariate analysis indicated that satisfaction was greater among those randomized to the injection group after controlling for treatment effectiveness. Participants who were retained, responded to treatment, and had fewer psychological symptoms were more satisfied with treatment. Finally, open-ended comments were made by

Hoeffding’s Inequality for Sums of Dependent Random Variables

Czech Academy of Sciences Publication Activity Database

Pelekis, Christos; Ramon, J.

2017-01-01

Roč. 14, č. 6 (2017), č. článku 243. ISSN 1660-5446 Institutional support: RVO:67985807 Keywords : dependent random variables * Hoeffding’s inequality * k-wise independent random variables * martingale differences Subject RIV: BA - General Mathematics OBOR OECD: Pure mathematics Impact factor: 0.868, year: 2016

Medical students as human subjects in educational research

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Adina L. Kalet

2013-02-01

Full Text Available Introduction: Special concerns often arise when medical students are themselves the subjects of education research. A recently completed large, multi-center randomized controlled trial of computer-assisted learning modules for surgical clerks provided the opportunity to explore the perceived level of risk of studies where medical students serve as human subjects by reporting on: 1 the response of Institutional Review Boards (IRBs at seven institutions to the same study protocol; and 2 the thoughts and feelings of students across study sites about being research subjects. Methods: From July 2009 to August 2010, all third-year medical students at seven collaborating institutions were eligible to participate. Patterns of IRB review of the same protocol were compared. Participation burden was calculated in terms of the time spent interacting with the modules. Focus groups were conducted with medical students at each site. Transcripts were coded by three independent reviewers and analyzed using Atlas.ti. Results: The IRBs at the seven participating institutions granted full (n=1, expedited (n=4, or exempt (n=2 review of the WISE Trial protocol. 995 (73% of those eligible consented to participate, and 207 (20% of these students completed all outcome measures. The average time to complete the computer modules and associated measures was 175 min. Common themes in focus groups with participant students included the desire to contribute to medical education research, the absence of coercion to consent, and the low-risk nature of the research. Discussion: Our findings demonstrate that risk assessment and the extent of review utilized for medical education research vary among IRBs. Despite variability in the perception of risk implied by differing IRB requirements, students themselves felt education research was low risk and did not consider themselves to be vulnerable. The vast majority of eligible medical students were willing to participate as research

A randomized trial of a low-carbohydrate diet for obesity.

Science.gov (United States)

Foster, Gary D; Wyatt, Holly R; Hill, James O; McGuckin, Brian G; Brill, Carrie; Mohammed, B Selma; Szapary, Philippe O; Rader, Daniel J; Edman, Joel S; Klein, Samuel

2003-05-22

Despite the popularity of the low-carbohydrate, high-protein, high-fat (Atkins) diet, no randomized, controlled trials have evaluated its efficacy. We conducted a one-year, multicenter, controlled trial involving 63 obese men and women who were randomly assigned to either a low-carbohydrate, high-protein, high-fat diet or a low-calorie, high-carbohydrate, low-fat (conventional) diet. Professional contact was minimal to replicate the approach used by most dieters. Subjects on the low-carbohydrate diet had lost more weight than subjects on the conventional diet at 3 months (mean [+/-SD], -6.8+/-5.0 vs. -2.7+/-3.7 percent of body weight; P=0.001) and 6 months (-7.0+/-6.5 vs. -3.2+/-5.6 percent of body weight, P=0.02), but the difference at 12 months was not significant (-4.4+/-6.7 vs. -2.5+/-6.3 percent of body weight, P=0.26). After three months, no significant differences were found between the groups in total or low-density lipoprotein cholesterol concentrations. The increase in high-density lipoprotein cholesterol concentrations and the decrease in triglyceride concentrations were greater among subjects on the low-carbohydrate diet than among those on the conventional diet throughout most of the study. Both diets significantly decreased diastolic blood pressure and the insulin response to an oral glucose load. The low-carbohydrate diet produced a greater weight loss (absolute difference, approximately 4 percent) than did the conventional diet for the first six months, but the differences were not significant at one year. The low-carbohydrate diet was associated with a greater improvement in some risk factors for coronary heart disease. Adherence was poor and attrition was high in both groups. Longer and larger studies are required to determine the long-term safety and efficacy of low-carbohydrate, high-protein, high-fat diets. Copyright 2003 Massachusetts Medical Society

Multivariate stochastic simulation with subjective multivariate normal distributions

Science.gov (United States)

P. J. Ince; J. Buongiorno

1991-01-01

In many applications of Monte Carlo simulation in forestry or forest products, it may be known that some variables are correlated. However, for simplicity, in most simulations it has been assumed that random variables are independently distributed. This report describes an alternative Monte Carlo simulation technique for subjectively assesed multivariate normal...

Enhancing Security of Double Random Phase Encoding Based on Random S-Box

Science.gov (United States)

Girija, R.; Singh, Hukum

2018-06-01

In this paper, we propose a novel asymmetric cryptosystem for double random phase encoding (DRPE) using random S-Box. While utilising S-Box separately is not reliable and DRPE does not support non-linearity, so, our system unites the effectiveness of S-Box with an asymmetric system of DRPE (through Fourier transform). The uniqueness of proposed cryptosystem lies on employing high sensitivity dynamic S-Box for our DRPE system. The randomness and scalability achieved due to applied technique is an additional feature of the proposed solution. The firmness of random S-Box is investigated in terms of performance parameters such as non-linearity, strict avalanche criterion, bit independence criterion, linear and differential approximation probabilities etc. S-Boxes convey nonlinearity to cryptosystems which is a significant parameter and very essential for DRPE. The strength of proposed cryptosystem has been analysed using various parameters such as MSE, PSNR, correlation coefficient analysis, noise analysis, SVD analysis, etc. Experimental results are conferred in detail to exhibit proposed cryptosystem is highly secure.

Effect of Sucrose Analgesia, for Repeated Painful Procedures, on Short-term Neurobehavioral Outcome of Preterm Neonates: A Randomized Controlled Trial.

Science.gov (United States)

Banga, Shreshtha; Datta, Vikram; Rehan, Harmeet Singh; Bhakhri, Bhanu Kiran

2016-04-01

Safety of oral sucrose, commonly used procedural analgesic in neonates, is questioned. To evaluate the effect of sucrose analgesia, for repeated painful procedures, on short-term neurobehavioral outcome of preterm neonates. Stable preterm neonates were randomized to receive either sucrose or distilled water orally, for every potentially painful procedure during the first 7 days after enrollment. Neurodevelopmental status at 40 weeks postconceptional age (PCA) measured using the domains of Neurobehavioral Assessment of Preterm Infants scale. A total of 93 newborns were analyzed. The baseline characteristics of the groups were comparable. No statistically significant difference was observed in the assessment at 40 weeks PCA, among the groups. Use of sucrose analgesia, for repeated painful procedures on newborns, does not lead to any significant difference in the short-term neurobehavioral outcome. © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

Directory of Open Access Journals (Sweden)

Hosseini K

2016-11-01

Full Text Available Kamran Hosseini,1 Thomas Walters,2 Robert DaVanzo,3 Richard L Lindstrom4 1InSite Vision Inc., Alameda, CA, 2Texan Eye, Austin, TX, 3Cornerstone Health Care, High Point, NC, 4Minnesota Eye Consultants, Bloomington, MN, USA Purpose: The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075% compared with DuraSite® vehicle (vehicle alone for the treatment of postoperative inflammation and ocular pain after cataract surgery.Methods: A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC and anterior chamber flare (ACF. The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS assessment and the proportion of subjects with an ACF grade of 0 at Day 15.Results: At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001. At each of the postsurgical time points (Days 1, 8, 15, and 29, proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively had no pain (a VAS score of 0 compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively, and at each time point, these differences in proportions were statistically significant (P<0.001. More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4% compared to those in the vehicle group (54/85; 63

Does green tea affect postprandial glucose, insulin and satiety in healthy subjects: a randomized controlled trial

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Lindstedt Sandra

2010-11-01

Full Text Available Abstract Background Results of epidemiological studies have suggested that consumption of green tea could lower the risk of type 2 diabetes. Intervention studies show that green tea may decrease blood glucose levels, and also increase satiety. This study was conducted to examine the postprandial effects of green tea on glucose levels, glycemic index, insulin levels and satiety in healthy individuals after the consumption of a meal including green tea. Methods The study was conducted on 14 healthy volunteers, with a crossover design. Participants were randomized to either 300 ml of green tea or water. This was consumed together with a breakfast consisting of white bread and sliced turkey. Blood samples were drawn at 0, 15, 30, 45, 60, 90, and 120 minutes. Participants completed several different satiety score scales at the same times. Results Plasma glucose levels were higher 120 min after ingestion of the meal with green tea than after the ingestion of the meal with water. No significant differences were found in serum insulin levels, or the area under the curve for glucose or insulin. Subjects reported significantly higher satiety, having a less strong desire to eat their favorite food and finding it less pleasant to eat another mouthful of the same food after drinking green tea compared to water. Conclusions Green tea showed no glucose or insulin-lowering effect. However, increased satiety and fullness were reported by the participants after the consumption of green tea. Trial registration number NCT01086189

The many ways sputum flows - Dealing with high within-subject variability in cystic fibrosis sputum rheology.

Science.gov (United States)

Radtke, Thomas; Böni, Lukas; Bohnacker, Peter; Fischer, Peter; Benden, Christian; Dressel, Holger

2018-08-01

We evaluated test-retest reliability of sputum viscoelastic properties in clinically stable patients with cystic fibrosis (CF). Data from a prospective, randomized crossover study was used to determine within-subject variability of sputum viscoelasticity (G', storage modulus and G", loss modulus at 1 and 10 rad s -1 ) and solids content over three consecutive visits. Precision of sputum properties was quantified by within-subject standard deviation (SD ws ), coefficient of variation (CV) and intraclass correlation coefficients (ICC). Fifteen clinically stable adults with CF (FEV 1 range 24-94% predicted) were included. No differences between study visits (mean ± SD 8 ± 2 days) were observed for any sputum rheology measure. CV's for G', G" and solids content ranged between 40.3-45.3% and ICC's between 0.21-0.42 indicating poor to fair test-retest reliability. Short-term within-subject variability of sputum properties is high in clinically stable adults with CF. Investigators applying shear rheology experiments in future prospective studies should consider using multiple measurements aiming to increase precision of sputum rheological outcomes. Copyright © 2018 Elsevier B.V. All rights reserved.

Objective and Subjective Measures of Simultaneous vs Sequential Bilateral Cochlear Implants in Adults A Randomized Clinical Trial : A Randomized Clinical Trial

NARCIS (Netherlands)

Kraaijenga, Véronique J C; Ramakers, Geerte G J; Smulders, Yvette E; van Zon, Alice; Stegeman, Inge; Smit, Adriana L; Stokroos, Robert J; Hendrice, Nadia; Free, Rolien H; Maat, Bert; Frijns, Johan H M; Briaire, Jeroen J; Mylanus, E A M; Huinck, Wendy J; Van Zanten, Gijsbert A; Grolman, Wilko

IMPORTANCE To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. OBJECTIVE To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential

Lower urinary tract symptoms after subtotal versus total abdominal hysterectomy: exploratory analyses from a randomized clinical trial with a 14-year follow-up.

Science.gov (United States)

Andersen, Lea Laird; Møller, Lars Mikael Alling; Gimbel, Helga

2015-12-01

Lower urinary tract symptoms (LUTS) are common after hysterectomy and increase after menopause. We aimed to compare subtotal with total abdominal hysterectomy regarding LUTS, including urinary incontinence (UI) subtypes, 14 years after hysterectomy. Main results from this randomized clinical trial have been published previously; the analyses covered in this paper are exploratory. We performed a long-term questionnaire follow-up of women in a randomized clinical trial (n = 319), from 1996 to 2000 comparing subtotal with total abdominal hysterectomy. Of the randomized women, ten had died and five had left Denmark; 304 women were contacted. For univariate analyses, a χ(2)-test was used, and for multivariate analyses, we used logistic regression. The questionnaire was answered by 197 (64.7 %) women (subtotal 97; total 100). More women had subjective stress UI (SUI) in the subtotal group (n = 60; 62.5 %) compared with the total group (n = 45; 45 %), with a relative risk (RR) of 1.39 [95 % confidence interval (CI) 1.06-1.81; P = 0.014]. No difference was seen between subtotal and total abdominal hysterectomy in other LUTS. Factors associated with UI were UI prior to hysterectomy, local estrogen treatment, and body mass index (BMI) > 25 kg/m(2). High BMI was primarily associated with mixed UI (MUI) and urgency symptoms. Predictors of bothersome LUTS were UI and incomplete bladder emptying. The difference in the frequency of subjectively assessed UI between subtotal and total abdominal hysterectomy (published previously) is caused by a difference in subjectively assessed SUI; UI prior to hysterectomy and high BMI are related to UI 14 years after hysterectomy. The trial is registered on clinicaltrials.gov under Nykoebing Falster County Hospital Record sj-268: Total versus subtotal hysterectomy: http://clinicaltrials.gov/ct2/show/NCT01880710?term=hysterectomy&rank=27.

A controlled, randomized, comparative study of a radiant heat bandage on the healing of stage 3-4 pressure ulcers: a pilot study.

Science.gov (United States)

Thomas, David R; Diebold, Marilyn R; Eggemeyer, Linda M

2005-01-01

Pressure ulcers, like other chronic wounds, fail to proceed through an orderly and timely process to produce anatomical or functional integrity. Treatment of pressure ulcers is directed to improving host factors and providing an optimum wound environment. In addition to providing a moist wound environment, it has been theorized that preventing hypothermia in a wound and maintaining a normothermic state might improve wound healing. Forty-one subjects with a stage 3 or stage 4 truncal pressure ulcer >1.0 cm(2) were recruited from outpatient clinics, long-term care nursing homes, and a rehabilitation center. The experimental group was randomized to a radiant-heat dressing device and the control group was randomized to a hydrocolloid dressing, with or without a calcium alginate filler. Subjects were followed until healed or for 12 weeks. Eight subjects (57%) in the experimental group had complete healing of their pressure ulcer compared with 7 subjects (44%) with complete healing in the control group (P = .46). Although a 13% difference in healing rate between the two arms of the study was found, this difference was not statistically significant. At almost all points along the healing curve, the proportion not healed was higher in the control arm.

Many random walks are faster than one

Czech Academy of Sciences Publication Activity Database

Alon, N.; Avin, Ch.; Koucký, Michal; Kozma, G.; Lotker, Z.; Tuttle, M.R.

2011-01-01

Roč. 20, č. 4 (2011), s. 481-502 ISSN 0963-5483 R&D Projects: GA ČR GP201/07/P276; GA ČR GA201/05/0124 Institutional research plan: CEZ:AV0Z10190503 Keywords : multiple random walks * parallel random walks Subject RIV: BA - General Mathematics Impact factor: 0.778, year: 2011 http://journals.cambridge.org/ action /displayAbstract?fromPage=online&aid=8280727

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

Science.gov (United States)

Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

2016-08-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

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

Science.gov (United States)

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

2002-09-01

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

Transcending Library Catalogs: A Comparative Study of Controlled Terms in Library of Congress Subject Headings and User-Generated Tags in LibraryThing for Transgender Books

Science.gov (United States)

Adler, Melissa

2009-01-01

Perhaps the greatest power of folksonomies, especially when set against controlled vocabularies like the Library of Congress Subject Headings, lies in their capacity to empower user communities to name their own resources in their own terms. This article analyzes the potential and limitations of both folksonomies and controlled vocabularies for…

Effect of a participatory organizational-level occupational health intervention on short-term sickness absence: a cluster randomized controlled trial.

Science.gov (United States)

Framke, Elisabeth; Sørensen, Ole Henning; Pedersen, Jacob; Rugulies, Reiner

2016-05-01

The aim of this study was to examine whether employees in pre-schools that implemented a participatory organizational-level intervention focusing on the core task at work had a lower incidence of short-term sickness absence compared to employees in the control group. The cluster randomized controlled trial (RCT) comprised 78 pre-schools that were allocated to the intervention (44 pre-schools with 1760 employees) or control (34 pre-schools with 1279 employees) group. The intervention lasted 25 months and followed a stepwise and structured approach, consisting of seminars, workshops, and workplace-directed intervention activities focusing on the core task at work. Using Poisson regression, we tested differences in incidence rates in short-term sickness absence between the intervention and control groups during a 29-months follow-up. Estimated short-term sickness absence days per person-year during follow-up were 8.68 and 9.17 in the intervention and control groups, respectively. The rate ratio (RR) for comparing incident sickness absence in the intervention to control groups during follow-up was 0.93 [95% confidence interval (95% CI) 0.86-1.00] in the crude analysis and 0.89 (95% CI 0.83-0.96) when adjusting for age, sex, job group, type and size of workplace, and workplace average level of previous short-term sickness absence. A supplementary analysis showed that the intervention also was associated with a reduced risk of long-term sickness absence with a crude RR of 0.83 (95% CI 0.69-0.99) and an adjusted RR of 0.84 (95% CI 0.69-1.01). Pre-school employees participating in an organizational-level occupational health intervention focusing on the core task at work had a lower incidence of short-term sickness absence during a 29-month follow-up compared with control group employees.

Housing First improves subjective quality of life among homeless adults with mental illness: 12-month findings from a randomized controlled trial in Vancouver, British Columbia.

Science.gov (United States)

Patterson, Michelle; Moniruzzaman, Akm; Palepu, Anita; Zabkiewicz, Denise; Frankish, Charles J; Krausz, Michael; Somers, Julian M

2013-08-01

This study used an experimental design to examine longitudinal changes in subjective quality of life (QoL) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual (TAU, no housing or supports through the study). We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU, regardless of the type of supported housing received or participants' level of need. Participants (n = 497) were stratified by level of need ("high" or "moderate") and randomly assigned to Housing First (HF) in scattered-site apartments, HF in a congregate setting (high needs only), or TAU. Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level. Based on the adjusted overall score on the QoL measure, participants randomized to HF reported significantly greater overall QoL as compared to TAU, regardless of need level or type of supported housing at both 6 and 12 months post-baseline. Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU. Despite multiple health and social challenges faced by homeless individuals with mental illness, HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time.

The long-term outcomes of interventions for the management of attention-deficit hyperactivity disorder in children and adolescents: a systematic review of randomized controlled trials

Directory of Open Access Journals (Sweden)

Parker J

2013-09-01

Full Text Available Jack Parker,1 Gill Wales,2 Nevyne Chalhoub,1 Val Harpin2 1Child and Adolescent Mental Health Service, Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 2Paediatric Neurodisability, Ryegate Children’s Centre, Sheffield Children’s NHS Foundation Trust, Sheffield, UK Purpose: To systematically identify and review the currently available evidence on the long-term outcomes of recommended attention-deficit hyperactivity disorder (ADHD interventions following randomized controlled trials with children and young people. Method: A systematic search was conducted to identify trials >1 year in length using the following databases: CINAHL (January 1982– July 2012, MEDLINE (Ovid and Cambridge Scientific Abstracts [CSA], Psych info, Science Direct (Elsevier, and Cochrane Library. Hand searches of key journals in the subject, book chapters, and conference proceedings were also carried out. Relevant papers were critically appraised using the Cochrane risk of bias tool. Results: Eight controlled trials were identified as being relevant, of duration ranging from 1 year to 8 years (at follow up. The total number of participants in the studies was 1,057, of whom 579 (54.7% were from one cohort and included 26 different outcome measures. Results suggest there is moderate-to-high-level evidence that combined pharmacological and behavioral interventions, and pharmacological interventions alone can be effective in managing the core ADHD symptoms and academic performance at 14 months. However, the effect size may decrease beyond this period. Conclusion: This review has highlighted the paucity and limitations of the evidence investigating the long-term outcomes of recommended interventions for managing ADHD symptoms. There is little evidence to suggest that the effects observed over the relatively short term are maintained throughout longer periods of impairment. Furthermore, much of the existing evidence examining effectiveness beyond 12 months does not

Randomized Block Cubic Newton Method

KAUST Repository

Doikov, Nikita; Richtarik, Peter

2018-01-01

We study the problem of minimizing the sum of three convex functions: a differentiable, twice-differentiable and a non-smooth term in a high dimensional setting. To this effect we propose and analyze a randomized block cubic Newton (RBCN) method, which in each iteration builds a model of the objective function formed as the sum of the natural models of its three components: a linear model with a quadratic regularizer for the differentiable term, a quadratic model with a cubic regularizer for the twice differentiable term, and perfect (proximal) model for the nonsmooth term. Our method in each iteration minimizes the model over a random subset of blocks of the search variable. RBCN is the first algorithm with these properties, generalizing several existing methods, matching the best known bounds in all special cases. We establish ${\\cal O}(1/\\epsilon)$, ${\\cal O}(1/\\sqrt{\\epsilon})$ and ${\\cal O}(\\log (1/\\epsilon))$ rates under different assumptions on the component functions. Lastly, we show numerically that our method outperforms the state-of-the-art on a variety of machine learning problems, including cubically regularized least-squares, logistic regression with constraints, and Poisson regression.

Randomized Block Cubic Newton Method

KAUST Repository

Doikov, Nikita

2018-02-12

We study the problem of minimizing the sum of three convex functions: a differentiable, twice-differentiable and a non-smooth term in a high dimensional setting. To this effect we propose and analyze a randomized block cubic Newton (RBCN) method, which in each iteration builds a model of the objective function formed as the sum of the natural models of its three components: a linear model with a quadratic regularizer for the differentiable term, a quadratic model with a cubic regularizer for the twice differentiable term, and perfect (proximal) model for the nonsmooth term. Our method in each iteration minimizes the model over a random subset of blocks of the search variable. RBCN is the first algorithm with these properties, generalizing several existing methods, matching the best known bounds in all special cases. We establish ${\\\\cal O}(1/\\\\epsilon)$, ${\\\\cal O}(1/\\\\sqrt{\\\\epsilon})$ and ${\\\\cal O}(\\\\log (1/\\\\epsilon))$ rates under different assumptions on the component functions. Lastly, we show numerically that our method outperforms the state-of-the-art on a variety of machine learning problems, including cubically regularized least-squares, logistic regression with constraints, and Poisson regression.

The Effects of 6 Isocaloric Meals on Body Weight, Lipid Profiles, Leptin, and Adiponectin in Overweight Subjects (BMI > 25)

OpenAIRE

Zeynab Hatami Zargaran; Moosa Salehi; Seyed Taghi Heydari; Siavash Babajafari

2014-01-01

Background: It seems that meal frequency is negatively related to body weight, but the relationship between meal frequency and weight loss is not clearly known yet. Objectives: The present study aimed to investigate whether 6 isocaloric meals affected body weight, lipid profiles, leptin, and adiponectin in overweight subjects. Methods: The present randomized controlled trial was conducted on 90 overweight subjects in 3 months. The subjects were randomly divided into two groups. The co...

Changes of Insulin Resistance and Adipokines Following Supplementation with Glycyrrhiza Glabra L. Extract in Combination with a Low-Calorie Diet in Overweight and Obese Subjects: a Randomized Double Blind Clinical Trial

Directory of Open Access Journals (Sweden)

Mohammad Alizadeh

2018-03-01

Full Text Available Purpose: Adipose tissue is a highly active endocrine organ which plays a key role in energy homeostasis. The aim of this study was to determine the effects of dried licorice extract along with a calorie restricted diet on body composition, insulin resistance and adipokines in overweight and obese subjects. Methods: Sixty-four overweight and obese volunteers (27 men, 37 women were recruited into this double-blind, placebo-controlled, randomized, clinical trial. Participants were randomly allocated to the Licorice (n=32 or the placebo group (n=32, and each group received a low-calorie diet with either 1.5 g/day of Licorice extract or placebo for 8 weeks. Biochemical parameters, anthropometric indices, body composition and dietary intake were measured at baseline and at the end of the study. Results: A total of 58 subjects completed the trial. No side effects were observed following licorice supplementation. At the end of the study, waist circumference, fat mass, serum levels of vaspin, zinc-α2 glycoprotein, insulin and HOMA-IR were significantly decreased in the intervention group, but only the reduction in serum vaspin levels in the licorice group was significant when compared to the placebo group (p<0.01. Conclusion: Supplementation with dried licorice extract plus a low-calorie diet can increase vaspin levels in obese subjects. However, the anti-obesity effects of the intervention were not stronger than a low-calorie diet alone in the management of obesity.

[Research on Chinese orthodontic specialists' subjective evaluation of orthodontic treatment outcome].

Science.gov (United States)

Song, Guang-ying; Zhao, Zhi-he; Ding, Yin; Bai, Yu-xing; Wang, Lin; He, Hong; Qian, Yu-fen; Li, Wei-ran; Xu, Tian-min

2012-03-01

To analyze the results of multiple Chinese orthodontic specialists' subjective evaluation of orthodontic treatment outcome, to investigate the relevance of different experiment items and to explore the weight of each monomial material. As a randomized clinical trial, with six orthodontic treatment centers and Angle's classification being regarded as two stratification factors, it contained 108 cases with integrity data, which was random extracted from 2383 cases that received orthodontic treatment in six orthodontic treatment centers during the past five years, gathering post-treatment study casts, cephalometrics and photographs of 48 cases as the research subject. Similarly taking Angle's classification as a stratification factor, 108 cases were randomly divided into 9 groups. The randomization of sampling and grouping were both generated by a pseudo-random number generator. According to the monomial and combined subjects, 69 orthodontic specialists were regarded as the raters to rank the 12 cases in each group, and to judge whether the case was qualified. Correlation analysis: the Spearman r between Post-M + C and Post-M + C + P and the Spearman r between Post-M + P and Post-M + C + P were both greater than 0.950. The Spearman r between Post-M and Post-P and the Spearman r between Post-M and Post-C were about 0.300. The Spearman r between Post-P and Post-C was 0.505. Regression analysis: the linear regression results: M + C = 0.782M + 0.308C - 0.150, M + P = 0.804M + 0.233P - 0.091, M + C + P = 0.764M + 0.243P + 0.131C - 0.291. The r(2) of above three models was greater than 0.9. It was applicable to use M + C and M + P instead of M + C + P. Study casts could not replace cephalometrics or photographs when doing subjective evaluation. Cephalometrics and photographs could not substitute for each other either. In the combined materials evaluation, model accounted for the largest percentage. Based on the regression model, for the greater part, the integration of

Characterization of Friction Joints Subjected to High Levels of Random Vibration

Science.gov (United States)

deSantos, Omar; MacNeal, Paul

2012-01-01

This paper describes the test program in detail including test sample description, test procedures, and vibration test results of multiple test samples. The material pairs used in the experiment were Aluminum-Aluminum, Aluminum- Dicronite coated Aluminum, and Aluminum-Plasmadize coated Aluminum. Levels of vibration for each set of twelve samples of each material pairing were gradually increased until all samples experienced substantial displacement. Data was collected on 1) acceleration in all three axes, 2) relative static displacement between vibration runs utilizing photogrammetry techniques, and 3) surface galling and contaminant generation. This data was used to estimate the values of static friction during random vibratory motion when "stick-slip" occurs and compare these to static friction coefficients measured before and after vibration testing.

Compositions, Random Sums and Continued Random Fractions of Poisson and Fractional Poisson Processes

Science.gov (United States)

Orsingher, Enzo; Polito, Federico

2012-08-01

In this paper we consider the relation between random sums and compositions of different processes. In particular, for independent Poisson processes N α ( t), N β ( t), t>0, we have that N_{α}(N_{β}(t)) stackrel{d}{=} sum_{j=1}^{N_{β}(t)} Xj, where the X j s are Poisson random variables. We present a series of similar cases, where the outer process is Poisson with different inner processes. We highlight generalisations of these results where the external process is infinitely divisible. A section of the paper concerns compositions of the form N_{α}(tauk^{ν}), ν∈(0,1], where tauk^{ν} is the inverse of the fractional Poisson process, and we show how these compositions can be represented as random sums. Furthermore we study compositions of the form Θ( N( t)), t>0, which can be represented as random products. The last section is devoted to studying continued fractions of Cauchy random variables with a Poisson number of levels. We evaluate the exact distribution and derive the scale parameter in terms of ratios of Fibonacci numbers.

Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: long-term symptomatic follow-up of a prospective randomized controlled trial.

Science.gov (United States)

Kummerow Broman, Kristy; Phillips, Sharon E; Faqih, Adil; Kaiser, Joan; Pierce, Richard A; Poulose, Benjamin K; Richards, William O; Sharp, Kenneth W; Holzman, Michael D

2018-04-01

Our prior randomized controlled trial of Heller myotomy alone versus Heller plus Dor fundoplication for achalasia from 2000 to 2004 demonstrated comparable postoperative resolution of dysphagia but less gastroesophageal reflux after Heller plus Dor. Patient-reported outcomes are needed to determine whether the findings are sustained long-term. We actively engaged participants from the prior randomized cohort, making up to six contact attempts per person using telephone, mail, and electronic messaging. We collected patient-reported measures of dysphagia and gastroesophageal reflux using the Dysphagia Score and the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) instrument. Patient-reported re-interventions for dysphagia were verified by obtaining longitudinal medical records. Among living participants, 27/41 (66%) were contacted and all completed the follow-up study at a mean of 11.8 years postoperatively. Median Dysphagia Scores and GERD-HRQL scores were slightly worse for Heller than Heller plus Dor but were not statistically different (6 vs 3, p = 0.08 for dysphagia, 15 vs 13, p = 0.25 for reflux). Five patients in the Heller group and 6 in Heller plus Dor underwent re-intervention for dysphagia with most occurring more than five years postoperatively. One patient in each group underwent redo Heller myotomy and subsequent esophagectomy. Nearly all patients (96%) would undergo operation again. Long-term patient-reported outcomes after Heller alone and Heller plus Dor for achalasia are comparable, providing support for either procedure.

[Long-term outcome analysis of subjective and objective parameters after breast reduction in 159 cases: Patients judge differently from plastic surgeons].

Science.gov (United States)

Osinga, Rik; Babst, Doris; Bodmer, Elvira S; Link, Bjoern C; Fritsche, Elmar; Hug, Urs

2017-12-01

This work assessed both subjective and objective postoperative parameters after breast reduction surgery and compared between patients and plastic surgeons. After an average postoperative observation period of 6.7 ± 2.7 (2 - 13) years, 159 out of 259 patients (61 %) were examined. The mean age at the time of surgery was 37 ± 14 (15 - 74) years. The postoperative anatomy of the breast and other anthropometric parameters were measured in cm with the patient in an upright position. The visual analogue scale (VAS) values for symmetry, size, shape, type of scar and overall satisfaction both from the patient's and from four plastic surgeons' perspectives were assessed and compared. Patients rated the postoperative result significantly better than surgeons. Good subjective ratings by patients for shape, symmetry and sensitivity correlated with high scores for overall assessment. Shape had the strongest influence on overall satisfaction (regression coefficient 0.357; p reduction surgery, long-term outcome is rated significantly better by patients than by plastic surgeons. Good subjective ratings by patients for shape, symmetry and sensitivity correlated with high scores for overall assessment. Shape had the strongest influence on overall satisfaction, followed by symmetry and sensitivity of the breast. Postoperative size of the breast, resection weight, type of scar, age or BMI was not of significant influence. Symmetry was the only assessed subjective parameter of this study that could be objectified by postoperative measurements. Georg Thieme Verlag KG Stuttgart · New York.

Exploring total cardiac variability in healthy and pathophysiological subjects using improved refined multiscale entropy.

Science.gov (United States)

Marwaha, Puneeta; Sunkaria, Ramesh Kumar

2017-02-01

Multiscale entropy (MSE) and refined multiscale entropy (RMSE) techniques are being widely used to evaluate the complexity of a time series across multiple time scales 't'. Both these techniques, at certain time scales (sometimes for the entire time scales, in the case of RMSE), assign higher entropy to the HRV time series of certain pathologies than that of healthy subjects, and to their corresponding randomized surrogate time series. This incorrect assessment of signal complexity may be due to the fact that these techniques suffer from the following limitations: (1) threshold value 'r' is updated as a function of long-term standard deviation and hence unable to explore the short-term variability as well as substantial variability inherited in beat-to-beat fluctuations of long-term HRV time series. (2) In RMSE, entropy values assigned to different filtered scaled time series are the result of changes in variance, but do not completely reflect the real structural organization inherited in original time series. In the present work, we propose an improved RMSE (I-RMSE) technique by introducing a new procedure to set the threshold value by taking into account the period-to-period variability inherited in a signal and evaluated it on simulated and real HRV database. The proposed I-RMSE assigns higher entropy to the age-matched healthy subjects than that of patients suffering from atrial fibrillation, congestive heart failure, sudden cardiac death and diabetes mellitus, for the entire time scales. The results strongly support the reduction in complexity of HRV time series in female group, old-aged, patients suffering from severe cardiovascular and non-cardiovascular diseases, and in their corresponding surrogate time series.

Effects of a dietary intervention on gastrointestinal symptoms after prostate cancer radiotherapy: Long-term results from a randomized controlled trial

International Nuclear Information System (INIS)

Pettersson, Anna; Nygren, Peter; Persson, Christina; Berglund, Anders; Turesson, Ingela; Johansson, Birgitta

2014-01-01

Background and purpose: To evaluate the long-term effects of dietary intervention on gastrointestinal symptoms after highly dose-escalated radiotherapy for localized prostate cancer, using boost with protons or high-dose-rate brachytherapy. Materials and methods: Patients were randomized to an intervention group (n = 64) advised to reduce insoluble dietary fiber and lactose intake, or to a standard care group (n = 66) advised to continue their usual diet. Gastrointestinal symptoms, other domains of health-related quality of life (HRQOL), and dietary intake were evaluated for ⩽24 months post-radiotherapy with the European Organization for Research and Treatment of Cancer quality-of-life questionnaires QLQ-C30 and QLQ-PR25, Gastrointestinal Side Effects Questionnaire, and Food Frequency Questionnaire. The effect of the intervention on gastrointestinal symptoms was evaluated using generalized estimating equations. Results: Dietary intervention had no obvious effect on long-term gastrointestinal symptoms or HRQOL. The intervention group markedly reduced their dietary fiber and lactose intake during radiotherapy, but adherence tended to decline over time. The vast majority of long-term gastrointestinal symptoms were reported as ‘a little’, with a noticeable difference from pre-treatment only for unintentional stool leakage, limitations on daily activities, and mucus discharge. Conclusion: Long-term gastrointestinal symptoms were predominantly mild, and dietary intervention was not superior to a usual diet in preventing these symptoms

The non-linear dynamics of vortices subjected to correlated and ...

Indian Academy of Sciences (India)

Understanding the dynamics of vortex matter subjected to random and .... The authors thank the support provided by a joint grant (USIF-funds) from the ... of Naval Research and the Department of Science and Technology, Government of India ...

Influence of visual and auditory biofeedback on partial body weight support treadmill training of individuals with chronic hemiparesis: a randomized controlled clinical trial.

Science.gov (United States)

Brasileiro, A; Gama, G; Trigueiro, L; Ribeiro, T; Silva, E; Galvão, É; Lindquist, A

2015-02-01

Stroke is an important causal factor of deficiency and functional dependence worldwide. To determine the immediate effects of visual and auditory biofeedback, combined with partial body weight supported (PBWS) treadmill training on the gait of individuals with chronic hemiparesis. Randomized controlled trial. Outpatient rehabilitation hospital. Thirty subjects with chronic hemiparesis and ability to walk with some help. Participants were randomized to a control group that underwent only PBWS treadmill training; or experimental I group with visual biofeedback from the display monitor, in the form of symbolic feet as the subject took a step; or experimental group II with auditory biofeedback associated display, using a metronome at 115% of the individual's preferred cadence. They trained for 20 minutes and were evaluated before and after training. Spatio-temporal and angular gait variables were obtained by kinematics from the Qualisys Motion Analysis system. Increases in speed and stride length were observed for all groups over time (speed: F=25.63; Phemiparesis, in short term. Additional studies are needed to determine whether, in long term, the biofeedback will promote additional benefit to the PBWS treadmill training. The findings of this study indicate that visual and auditory biofeedback does not bring immediate benefits on PBWS treadmill training of individuals with chronic hemiparesis. This suggest that, for additional benefits are achieved with biofeedback, effects should be investigated after long-term training, which may determine if some kind of biofeedback is superior to another to improve the hemiparetic gait.

The average inter-crossing number of equilateral random walks and polygons

International Nuclear Information System (INIS)

Diao, Y; Dobay, A; Stasiak, A

2005-01-01

In this paper, we study the average inter-crossing number between two random walks and two random polygons in the three-dimensional space. The random walks and polygons in this paper are the so-called equilateral random walks and polygons in which each segment of the walk or polygon is of unit length. We show that the mean average inter-crossing number ICN between two equilateral random walks of the same length n is approximately linear in terms of n and we were able to determine the prefactor of the linear term, which is a = 3ln2/8 ∼ 0.2599. In the case of two random polygons of length n, the mean average inter-crossing number ICN is also linear, but the prefactor of the linear term is different from that of the random walks. These approximations apply when the starting points of the random walks and polygons are of a distance ρ apart and ρ is small compared to n. We propose a fitting model that would capture the theoretical asymptotic behaviour of the mean average ICN for large values of ρ. Our simulation result shows that the model in fact works very well for the entire range of ρ. We also study the mean ICN between two equilateral random walks and polygons of different lengths. An interesting result is that even if one random walk (polygon) has a fixed length, the mean average ICN between the two random walks (polygons) would still approach infinity if the length of the other random walk (polygon) approached infinity. The data provided by our simulations match our theoretical predictions very well

Effect of the cumin cyminum L. Intake on Weight Loss, Metabolic Profiles and Biomarkers of Oxidative Stress in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Science.gov (United States)

Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah; Esmaillzadeh, Ahmad

2015-01-01

The current study was performed to determine the effects of cumin cyminum L. intake on weight loss and metabolic profiles among overweight subjects. This randomized double-blind placebo-controlled clinical trial was conducted among 78 overweight subjects (male, n = 18; female, n = 60) aged 18-60 years old. Participants were randomly assigned into three groups to receive: (1) cumin cyminum L. capsule (n = 26); (2) orlistat120 capsule (n = 26) and (3) placebo (n = 26) three times a day for 8 weeks. Anthropometric measures and fasting blood samples were taken at baseline and after 8 weeks of intervention. Consumption of the Cuminum cyminum L. and orlistat120 resulted in a similar significant decrease in weight (-1.1 ± 1.2 and -0.9 ± 1.5 vs. 0.2 ± 1.5 kg, respectively, p = 0.002) and BMI (-0.4 ± 0.5 and -0.4 ± 0.6 vs. 0.1 ± 0.6 kg/m(2), respectively, p = 0.003) compared with placebo. In addition, taking Cuminum cyminum L., compared with orlistat and placebo, led to a significant reduction in serum insulin levels (-1.4 ± 4.5 vs. 1.3 ± 3.3 and 0.3 ± 2.2 µIU/ml, respectively, p = 0.02), HOMA-B (-5.4 ± 18.9 vs. 5.8 ± 13.3 and 1.0 ± 11.0, respectively, p = 0.02) and a significant rise in QUICKI (0.01 ± 0.01 vs. -0.005 ± 0.01 and -0.004 ± 0.01, respectively, p = 0.02). Taking cumin cyminum L. for eight weeks among overweight subjects had the same effects of orlistat120 on weight and BMI and beneficial effects on insulin metabolism compared with orlistat120 and placebo. © 2015 S. Karger AG, Basel.

A Randomized Double-Blind Placebo-Controlled Study of Omalizumab Combined with Oral Immunotherapy for the Treatment of Cow’s Milk Allergy

Science.gov (United States)

Wood, Robert A.; Kim, Jennifer S.; Lindblad, Robert; Nadeau, Kari; Henning, Alice K.; Dawson, Peter; Plaut, Marshall; Sampson, Hugh A.

2017-01-01

Background Although studies of oral immunotherapy (OIT) for food allergy have shown promise, treatment is frequently complicated by adverse reactions and, even when successful, has limited long-term efficacy as benefits usually diminish when treatment is discontinued. Objective We sought to examine whether the addition of omalizumab to milk OIT (MOIT) reduces treatment-related reactions and/or improves outcomes. Methods This was a double-blind placebo-controlled trial with subjects randomized to omalizumab or placebo. Open-label MOIT was initiated after 4 months of omalizumab/placebo with escalation to maintenance over 22–40 weeks, followed by daily maintenance dosing through month-28. At month-28, omalizumab was discontinued and subjects passing an oral food challenge (OFC) continued OIT for 8 weeks, after which OIT was discontinued with re-challenge at month-32 to assess sustained unresponsiveness (SU). Results Fifty-seven subjects (7–32 years) were randomized, with no significant baseline differences in age, milk-specific IgE, skin tests, or OFCs. At month-28, 24 (88.9%) omalizumab-treated subjects and 20 (71.4%) placebo-treated subjects passed the 10 gram “desensitization” OFC (p=0.18). At month-32, SU was demonstrated in 48.1% in the omalizumab group and 35.7% in the placebo group (p=0.42). Adverse reactions were markedly reduced during OIT escalation in omalizumab subjects for percent doses/subject provoking symptoms (2.1% versus 16.1%; p=0.0005), dose-related reactions requiring treatment (0.0% versus 3.8%, p=0.0008), and doses required to achieve maintenance (198 versus 225; p=0.008). Conclusions In this first randomized double-blinded placebo-controlled trial of omalizumab in combination with food OIT, we found significant improvements in measurements of safety, but not in outcomes of efficacy (desensitization and SU). Trial Registration OIT and XolairR (Omalizumab) in Cow’s Milk Allergy, NCT01157117, http://clinicaltrials.gov/show/NCT01157117

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects

DEFF Research Database (Denmark)

James, W Philip T; Caterson, Ian D; Coutinho, Walmir

2010-01-01

The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established.......The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established....

Seeing the Wood for the Trees: Enhancing Metadata Subject Elements with Weights

Directory of Open Access Journals (Sweden)

Hong Zhang

2011-06-01

Full Text Available Subject indexing has been conducted in a dichotomous way in terms of what the information object is primarily about/of or not, corresponding to the presence or absence of a particular subject term, respectively. With more subject terms brought into information systems via social tagging, manual cataloging, or automated indexing, many more partially relevant results can be retrieved. Using examples from digital image collections and online library catalog systems, we explore the problem and advocate for adding a weighting mechanism to subject indexing and tagging to make web search and navigation more effective and efficient. We argue that the weighting of subject terms is more important than ever in today’s world of growing collections, more federated searching, and expansion of social tagging. Such a weighting mechanism needs to be considered and applied not only by indexers, catalogers, and taggers, but also needs to be incorporated into system functionality and metadata schemas.

93-106, 2015 93 Multilevel random effect and marginal models

African Journals Online (AJOL)

Multilevel random effect and marginal models for longitudinal data ... and random effect models that take the correlation among measurements of the same subject ... comparing the level of redness, pain and irritability ... clinical trial evaluating the safety profile of a new .... likelihood-based methods to compare models and.

Predicting Long-Term Cognitive Outcome Following Breast Cancer with Pre-Treatment Resting State fMRI and Random Forest Machine Learning.

Science.gov (United States)

Kesler, Shelli R; Rao, Arvind; Blayney, Douglas W; Oakley-Girvan, Ingrid A; Karuturi, Meghan; Palesh, Oxana

2017-01-01

We aimed to determine if resting state functional magnetic resonance imaging (fMRI) acquired at pre-treatment baseline could accurately predict breast cancer-related cognitive impairment at long-term follow-up. We evaluated 31 patients with breast cancer (age 34-65) prior to any treatment, post-chemotherapy and 1 year later. Cognitive testing scores were normalized based on data obtained from 43 healthy female controls and then used to categorize patients as impaired or not based on longitudinal changes. We measured clustering coefficient, a measure of local connectivity, by applying graph theory to baseline resting state fMRI and entered these metrics along with relevant patient-related and medical variables into random forest classification. Incidence of cognitive impairment at 1 year follow-up was 55% and was predicted by classification algorithms with up to 100% accuracy ( p breast cancer. This information could inform treatment decision making by identifying patients at highest risk for long-term cognitive impairment.

Perceptions of randomized security schedules.

Science.gov (United States)

Scurich, Nicholas; John, Richard S

2014-04-01

Security of infrastructure is a major concern. Traditional security schedules are unable to provide omnipresent coverage; consequently, adversaries can exploit predictable vulnerabilities to their advantage. Randomized security schedules, which randomly deploy security measures, overcome these limitations, but public perceptions of such schedules have not been examined. In this experiment, participants were asked to make a choice between attending a venue that employed a traditional (i.e., search everyone) or a random (i.e., a probability of being searched) security schedule. The absolute probability of detecting contraband was manipulated (i.e., 1/10, 1/4, 1/2) but equivalent between the two schedule types. In general, participants were indifferent to either security schedule, regardless of the probability of detection. The randomized schedule was deemed more convenient, but the traditional schedule was considered fairer and safer. There were no differences between traditional and random schedule in terms of perceived effectiveness or deterrence. Policy implications for the implementation and utilization of randomized schedules are discussed. © 2013 Society for Risk Analysis.

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Barone Mark A

2012-03-01

Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

Lactobacillus reuteri supplements do not affect salivary IgA or cytokine levels in healthy subjects: A randomized, double-blind, placebo-controlled cross-over trial

DEFF Research Database (Denmark)

Jørgensen, Mette Rose; Keller, Mette Kirstine; Kragelund, Camilla

2016-01-01

Objectives: To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. Materials and methods: The study group consisted of 47 healthy adults (18–32 years) who volunteered for a randomize....... reuteri do not seem to modulate the salivary oral immune response in healthy young subjects (ClinicalTrials.gov NCT02017886).......Objectives: To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. Materials and methods: The study group consisted of 47 healthy adults (18–32 years) who volunteered for a randomized...... and 3 weeks post-intervention levels. No side- or adverse effects were reported. Conclusions: Supplementation with two strains of the probiotic L. reuteri did not affect sIgA or cytokine levels in whole saliva in healthy young adults. The results thereby indicate that daily oral supplementation with L...

The short- and long-term outcomes of percutaneous intervention with drug-eluting stent vs bare-metal stent in saphenous vein graft disease: An updated meta-analysis of all randomized clinical trials.

Science.gov (United States)

Kheiri, Babikir; Osman, Mohammed; Abdalla, Ahmed; Ahmed, Sahar; Bachuwa, Ghassan; Hassan, Mustafa

2018-05-11

The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up. © 2018 Wiley Periodicals, Inc.

Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial.

Directory of Open Access Journals (Sweden)

Sanne M van der Made

Full Text Available In vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.The primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.This randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25 and women (n = 20 with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.Compliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791, apoB100; -0.01 ± 0.11 g/L (P = 0.545, HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721, LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718, triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687, glucose; -0.08 ± 0.28 mmol/L (P = 0.064, insulin; -0.3 ± 2.5 mU/L (P = 0.516. Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.ClinicalTrials.gov NCT01364961.

Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

Science.gov (United States)

Jonsdottir, Johanna; Thorsen, Rune; Aprile, Irene; Galeri, Silvia; Spannocchi, Giovanna; Beghi, Ettore; Bianchi, Elisa; Montesano, Angelo; Ferrarin, Maurizio

2017-01-01

Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Multicenter randomized controlled trial. Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

Long-Term Monitoring of Physical Behavior Reveals Different Cardiac Responses to Physical Activity among Subjects with and without Chronic Neck Pain

Science.gov (United States)

Hallman, David M.; Mathiassen, Svend Erik; Lyskov, Eugene

2015-01-01

Background. We determined the extent to which heart rate variability (HRV) responses to daily physical activity differ between subjects with and without chronic neck pain. Method. Twenty-nine subjects (13 women) with chronic neck pain and 27 age- and gender-matched healthy controls participated. Physical activity (accelerometry), HRV (heart rate monitor), and spatial location (Global Positioning System (GPS)) were recorded for 74 hours. GPS data were combined with a diary to identify periods of work and of leisure at home and elsewhere. Time- and frequency-domain HRV indices were calculated and stratified by period and activity type (lying/sitting, standing, or walking). ANCOVAs with multiple adjustments were used to disclose possible group differences in HRV. Results. The pain group showed a reduced HRV response to physical activity compared with controls (p = .001), according to the sympathetic-baroreceptor HRV index (LF/HF, ratio between low- and high-frequency power), even after adjustment for leisure time physical activity, work stress, sleep quality, mental health, and aerobic capacity (p = .02). The parasympathetic response to physical activity did not differ between groups. Conclusions. Relying on long-term monitoring of physical behavior and heart rate variability, we found an aberrant sympathetic-baroreceptor response to daily physical activity among subjects with chronic neck pain. PMID:26557711

Long-Term Monitoring of Physical Behavior Reveals Different Cardiac Responses to Physical Activity among Subjects with and without Chronic Neck Pain

Directory of Open Access Journals (Sweden)

David M. Hallman

2015-01-01

Full Text Available Background. We determined the extent to which heart rate variability (HRV responses to daily physical activity differ between subjects with and without chronic neck pain. Method. Twenty-nine subjects (13 women with chronic neck pain and 27 age- and gender-matched healthy controls participated. Physical activity (accelerometry, HRV (heart rate monitor, and spatial location (Global Positioning System (GPS were recorded for 74 hours. GPS data were combined with a diary to identify periods of work and of leisure at home and elsewhere. Time- and frequency-domain HRV indices were calculated and stratified by period and activity type (lying/sitting, standing, or walking. ANCOVAs with multiple adjustments were used to disclose possible group differences in HRV. Results. The pain group showed a reduced HRV response to physical activity compared with controls (p=.001, according to the sympathetic-baroreceptor HRV index (LF/HF, ratio between low- and high-frequency power, even after adjustment for leisure time physical activity, work stress, sleep quality, mental health, and aerobic capacity (p=.02. The parasympathetic response to physical activity did not differ between groups. Conclusions. Relying on long-term monitoring of physical behavior and heart rate variability, we found an aberrant sympathetic-baroreceptor response to daily physical activity among subjects with chronic neck pain.

HIGHER EDUCATIONAL INSTITUTION AS A SUBJECT OF ADAPTATION OF RURAL STUDENTS TO THE TERMS OF THE CITY

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Alyona Aleksandrovna Antipova

2014-11-01

Full Text Available The article is devoted to the difficulties of adaptation of rural students to the various spheres of life of the modern city. These difficulties are considered as a field of activity of higher educational institution, acting as the subject of adaptation of students coming to study from rural areas to the terms of the city. The authors ' point of view on this issue is substantiated by the analysis of data of several sociological surveys conducted in various regions of theRussian Federation. Also the experience of assistance in adaptation of the Mordovia state University named after N. P. Ogarev of the city ofSaransk, which is the largest in the Republic of Mordovia University and which accommodates a large number of rural youth. The relevance and scientific novelty of research consists in allocation of areas of adaptation support of students from rural areas by the higher educational institution.

Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

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Wirta D

2011-06-01

Full Text Available David Wirta1, Amanda M VanDenburgh2, Emily Weng3, Scott M Whitcup4, Sef Kurstjens5, Frederick C Beddingfield III4,61Private Practice, Newport Beach, CA, USA; 2Clinical Development, 3Biostatistics, 4Research and Development, 5Global Drug Development, Allergan, Inc, Irvine, CA, USA; 6Department of Medicine, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, CA, USABackground: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥ 12months were conducted; however, the aggregate safety profile of the six studies has not been reported.Methods: Adverse events (AEs were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD or twice daily (BID as an eyedrop. AE terms were converted to MedDRA (V.11.0 Preferred Terms and analyzed.Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD and 94.8% (BID of subjects (≤ 12 months of treatment. AEs reported through month 12 (aggregate incidence of ≥ 5% were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment.Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation.Keywords: intraocular pressure, eyelids, pharmacology, clinical trial, medical treatment

A multifunctional diet improves cardiometabolic-related biomarkers independently of weight changes: an 8-week randomized controlled intervention in healthy overweight and obese subjects.

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Tovar, Juscelino; Johansson, Maria; Björck, Inger

2016-10-01

A multifunctional diet (MFD) was previously shown to reduce blood lipids, CRP and blood pressure in a 4-week intervention under weight-maintenance conditions. Here, MFD effects were evaluated in an 8-week intervention with no restriction for weight changes. Healthy subjects consumed MFD (23 subjects) or a control diet (CD) devoid of the functional components (24 subjects) in a "free-living" randomized controlled experiment. MFD included several functional concepts: low-glycemic-impact meals, antioxidant-rich foods, oily fish, viscous dietary fibers, soybean and whole barley kernel products, almonds and plant stanols. Measured outcomes were fasting blood values of lipids, glucose, insulin, GGT, CRP, HbA1c, PAI-1, GLP-1, GLP-2, body weight, blood pressure and breath hydrogen. At baseline, participants were 51-72 years old, with BMI between 25 and 34 and fasting glycemia  ≤ 6.1 mmol/L. Consumption of both diets resulted in similar weight loss after 8 weeks (-4 %; P  diets, which remained significant after adjustment for body weight. Reduced systolic blood pressure, circulating GGT, HbA1c and insulin concentrations were observed with both MFD and CD with no difference between diets. The Reynolds cardiovascular risk score was decreased by 36 % (P  <  0.0001) with MFD. MFD increased breath hydrogen levels (120 %; P  <  0.05). Consumption of MFD decreased blood lipids and improved several other aspects of the cardiometabolic risk profile. This effect was not dependent on weight loss.

Nonstationary interference and scattering from random media

International Nuclear Information System (INIS)

Nazikian, R.

1991-12-01

For the small angle scattering of coherent plane waves from inhomogeneous random media, the three dimensional mean square distribution of random fluctuations may be recovered from the interferometric detection of the nonstationary modulational structure of the scattered field. Modulational properties of coherent waves scattered from random media are related to nonlocal correlations in the double sideband structure of the Fourier transform of the scattering potential. Such correlations may be expressed in terms of a suitability generalized spectral coherence function for analytic fields

The Long-Term Consequences of Relationship Formation for Subjective Well-Being

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Soons, Judith P. M.; Liefbroer, Aart C.; Kalmijn, Matthijs

2009-01-01

This study examines how relationship transitions affect subjective well-being (SWB) and how this effect changes over time. We used prospective data containing information about 18 years of young adults' lives (PSIN, N = 5, 514). SWB was measured with the Satisfaction with Life Scale. Within-person multilevel regression analyses showed that dating,…

Weight loss maintenance in overweight subjects on ad libitum diets with high or low protein content and glycemic index

DEFF Research Database (Denmark)

Aller, E E J G; Larsen, Thomas Meinert; Holst, Claus

2014-01-01

Background:A high dietary protein (P) content and low glycemic index (GI) have been suggested to be beneficial for weight management, but long-term studies are scarce.Objective:The DIOGENES randomized clinical trial investigated the effect of P and GI on weight loss maintenance in overweight...... or obese adults in 8 centers across Europe. This study reports the 1-year results in 2 of the centers that extended the intervention to 1 year.Method:After an 8-week low calorie diet (LCD), 256 adults (BMI>27 kg/m(2)) were randomized to 5 ad libitum diets for 12 months: high P/low GI (HP/LGI), high P/high...... GI (HP/HGI), low P/low GI (LP/LGI), low P/high GI (LP/HGI) and a control diet. During the first 6 months foods were provided for free through a shop system, during the whole 12-month period subjects received guidance by a dietician. Primary outcome variable was the change in body weight over the 12...

Youth Homelessness and Individualised Subjectivity

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Farrugia, David

2011-01-01

This article aims to contribute to understandings of youth homelessness and subjectivity by analysing identity construction in terms of young people's negotiation of the structural and institutional environment of youth homelessness. I suggest that while existing literature on this topic concentrates mainly on micro-social encounters, the…

A more randomly organized grey matter network is associated with deteriorating language and global cognition in individuals with subjective cognitive decline.

Science.gov (United States)

Verfaillie, Sander C J; Slot, Rosalinde E R; Dicks, Ellen; Prins, Niels D; Overbeek, Jozefien M; Teunissen, Charlotte E; Scheltens, Philip; Barkhof, Frederik; van der Flier, Wiesje M; Tijms, Betty M

2018-03-30

Grey matter network disruptions in Alzheimer's disease (AD) are associated with worse cognitive impairment cross-sectionally. Our aim was to investigate whether indications of a more random network organization are associated with longitudinal decline in specific cognitive functions in individuals with subjective cognitive decline (SCD). We included 231 individuals with SCD who had annually repeated neuropsychological assessment (3 ± 1 years; n = 646 neuropsychological investigations) available from the Amsterdam Dementia Cohort (54% male, age: 63 ± 9, MMSE: 28 ± 2). Single-subject grey matter networks were extracted from baseline 3D-T1 MRI scans and we computed basic network (size, degree, connectivity density) and higher-order (path length, clustering, betweenness centrality, normalized path length [lambda] and normalized clustering [gamma]) parameters at whole brain and/or regional levels. We tested associations of network parameters with baseline and annual cognition (memory, attention, executive functioning, language composite scores, and global cognition [all domains with MMSE]) using linear mixed models, adjusted for age, sex, education, scanner and total gray matter volume. Lower network size was associated with steeper decline in language (β ± SE = 0.12 ± 0.05, p organized grey matter network was associated with a steeper decline of cognitive functioning, possibly indicating the start of cognitive impairment. © 2018 The Authors Human Brain Mapping Published by Wiley Periodicals, Inc.

Short- and Long-Term Effects of CBT-I in Groups for School-Age Children Suffering From Chronic Insomnia: The KiSS-Program.

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Schlarb, Angelika A; Bihlmaier, Isabel; Velten-Schurian, Kerstin; Poets, Christian F; Hautzinger, Martin

2018-01-01

This intervention study evaluates the short- and long-term effects of cognitive behavior therapy for insomnia (CBT-I) in groups for school-age children and their parents, named the KiSS-program. CBT-I was implemented in three sessions for children and three sessions for parents. All in all, 112 children with chronic childhood insomnia were randomly assigned to a wait-list (WL) control or treatment condition. According to subjective measures as well as objective wrist actigraphy, children in the CBT-I condition reported greater improvements in sleep behavior immediately after the treatment compared to the WL group. Improvements in sleep behavior after CBT-I persisted over the 3-, 6-, and 12-month follow-up assessments. The present study is the first randomized controlled trial that provides evidence for the long-term effectiveness of CBT-I in treating school-age children with chronic insomnia.

Effects of hybrid cycling versus handcycling on wheelchair-specific fitness and physical activity in people with long-term spinal cord injury : a 16-week randomized controlled trial

NARCIS (Netherlands)

Bakkum, A. J. T.; de Groot, S.; Stolwijk-Swuste, J. M.; van Kuppevelt, D. J.; van der Woude, L. H. V.; Janssen, T. W. J.

Study design: This is an open randomized controlled trial. Objective: The objective of this study was to investigate the effects of a 16-week hybrid cycle versus handcycle exercise program on fitness and physical activity in inactive people with long-term spinal cord injury (SCI). Setting: The study

Effects of hybrid cycling versus handcycling on wheelchair-specific fitness and physical activity in people with long-term spinal cord injury: a 16-week randomized controlled trial

NARCIS (Netherlands)

Bakkum, A.J.T.; de Groot, S.; Stolwijk-Swuste, J.M.; van Kuppevelt, D.J.; van der Woude, L.H.V.; Janssen, T.W.J.

2015-01-01

Study design:This is an open randomized controlled trial.Objective:The objective of this study was to investigate the effects of a 16-week hybrid cycle versus handcycle exercise program on fitness and physical activity in inactive people with long-term spinal cord injury (SCI).Setting:The study was

PARAMETRIC IDENTIFICATION OF STOCHASTIC SYSTEM BY NON-GRADIENT RANDOM SEARCHING

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A. A. Lobaty

2017-01-01

Full Text Available At this moment we know a great variety of identification objects, tasks and methods and its significance is constantly increasing in various fields of science and technology.  The identification problem is dependent on a priori information about identification object, besides that  the existing approaches and methods of identification are determined by the form of mathematical models (deterministic, stochastic, frequency, temporal, spectral etc.. The paper considers a problem for determination of system parameters  (identification object which is assigned by the stochastic mathematical model including random functions of time. It has been shown  that while making optimization of the stochastic systems subject to random actions deterministic methods can be applied only for a limited approximate optimization of the system by taking into account average random effects and fixed structure of the system. The paper proposes an algorithm for identification of  parameters in a mathematical model of  the stochastic system by non-gradient random searching. A specific  feature  of the algorithm is its applicability  practically to mathematic models of any type because the applied algorithm does not depend on linearization and differentiability of functions included in the mathematical model of the system. The proposed algorithm  ensures searching of  an extremum for the specified quality criteria in terms of external uncertainties and limitations while using random searching of parameters for a mathematical model of the system. The paper presents results of the investigations on operational capability of the considered identification method  while using mathematical simulation of hypothetical control system with a priori unknown parameter values of the mathematical model. The presented results of the mathematical simulation obviously demonstrate the operational capability of the proposed identification method.

A delay time model for a mission-based system subject to periodic and random inspection and postponed replacement

International Nuclear Information System (INIS)

Yang, Li; Ma, Xiaobing; Zhai, Qingqing; Zhao, Yu

2016-01-01

We propose an inspection and replacement policy for a single component system that successively executes missions with random durations. The failure process of the system can be divided into two states, namely, normal and defective, following the delay time concept. Inspections are carried out periodically and immediately after the completion of each mission (random inspections). The failed state is always identified immediately, whereas the defective state can only be revealed by an inspection. If the system fails or is defective at a periodic inspection, then replacement is immediate. If, however, the system is defective at a random inspection, then replacement will be postponed if the time to the subsequent periodic inspection is shorter than a pre-determined threshold, and immediate otherwise. We derive the long run expected cost per unit time and then investigate the optimal periodic inspection interval and postponement threshold. A numerical example is presented to demonstrate the applicability of the proposed maintenance policy. - Highlights: • A delay time model of inspection is introduced for mission-based systems. • Periodic and random inspections are performed to check the state. • Replacement of the defective system at a random inspection can be postponed.

On the pertinence to Physics of random walks induced by random dynamical systems: a survey

International Nuclear Information System (INIS)

Petritis, Dimitri

2016-01-01

Let be an abstract space and a denumerable (finite or infinite) alphabet. Suppose that is a family of functions such that for all we have and a family of transformations . The pair (( S_a)_a , ( p_a)_a ) is termed an iterated function system with place dependent probabilities. Such systems can be thought as generalisations of random dynamical systems. As a matter of fact, suppose we start from a given ; we pick then randomly, with probability p_a (x) , the transformation S_a and evolve to S_a (x) . We are interested in the behaviour of the system when the iteration continues indefinitely. Random walks of the above type are omnipresent in both classical and quantum Physics. To give a small sample of occurrences we mention: random walks on the affine group, random walks on Penrose lattices, random walks on partially directed lattices, evolution of density matrices induced by repeated quantum measurements, quantum channels, quantum random walks, etc. In this article, we review some basic properties of such systems and provide with a pathfinder in the extensive bibliography (both on mathematical and physical sides) where the main results have been originally published. (paper)

Modelling subject-specific childhood growth using linear mixed-effect models with cubic regression splines.

Science.gov (United States)

Grajeda, Laura M; Ivanescu, Andrada; Saito, Mayuko; Crainiceanu, Ciprian; Jaganath, Devan; Gilman, Robert H; Crabtree, Jean E; Kelleher, Dermott; Cabrera, Lilia; Cama, Vitaliano; Checkley, William

2016-01-01

Childhood growth is a cornerstone of pediatric research. Statistical models need to consider individual trajectories to adequately describe growth outcomes. Specifically, well-defined longitudinal models are essential to characterize both population and subject-specific growth. Linear mixed-effect models with cubic regression splines can account for the nonlinearity of growth curves and provide reasonable estimators of population and subject-specific growth, velocity and acceleration. We provide a stepwise approach that builds from simple to complex models, and account for the intrinsic complexity of the data. We start with standard cubic splines regression models and build up to a model that includes subject-specific random intercepts and slopes and residual autocorrelation. We then compared cubic regression splines vis-à-vis linear piecewise splines, and with varying number of knots and positions. Statistical code is provided to ensure reproducibility and improve dissemination of methods. Models are applied to longitudinal height measurements in a cohort of 215 Peruvian children followed from birth until their fourth year of life. Unexplained variability, as measured by the variance of the regression model, was reduced from 7.34 when using ordinary least squares to 0.81 (p linear mixed-effect models with random slopes and a first order continuous autoregressive error term. There was substantial heterogeneity in both the intercept (p modeled with a first order continuous autoregressive error term as evidenced by the variogram of the residuals and by a lack of association among residuals. The final model provides a parametric linear regression equation for both estimation and prediction of population- and individual-level growth in height. We show that cubic regression splines are superior to linear regression splines for the case of a small number of knots in both estimation and prediction with the full linear mixed effect model (AIC 19,352 vs. 19

Regression analysis utilizing subjective evaluation of emotional experience in PET studies on emotions.

Science.gov (United States)

Aalto, Sargo; Wallius, Esa; Näätänen, Petri; Hiltunen, Jaana; Metsähonkala, Liisa; Sipilä, Hannu; Karlsson, Hasse

2005-09-01

A methodological study on subject-specific regression analysis (SSRA) exploring the correlation between the neural response and the subjective evaluation of emotional experience in eleven healthy females is presented. The target emotions, i.e., amusement and sadness, were induced using validated film clips, regional cerebral blood flow (rCBF) was measured using positron emission tomography (PET), and the subjective intensity of the emotional experience during the PET scanning was measured using a category ratio (CR-10) scale. Reliability analysis of the rating data indicated that the subjects rated the intensity of their emotional experience fairly consistently on the CR-10 scale (Cronbach alphas 0.70-0.97). A two-phase random-effects analysis was performed to ensure the generalizability and inter-study comparability of the SSRA results. Random-effects SSRAs using Statistical non-Parametric Mapping 99 (SnPM99) showed that rCBF correlated with the self-rated intensity of the emotional experience mainly in the brain regions that were identified in the random-effects subtraction analyses using the same imaging data. Our results give preliminary evidence of a linear association between the neural responses related to amusement and sadness and the self-evaluated intensity of the emotional experience in several regions involved in the emotional response. SSRA utilizing subjective evaluation of emotional experience turned out a feasible and promising method of analysis. It allows versatile exploration of the neurobiology of emotions and the neural correlates of actual and individual emotional experience. Thus, SSRA might be able to catch the idiosyncratic aspects of the emotional response better than traditional subtraction analysis.

Pharmacokinetics and Safety of Intravenous Murepavadin Infusion in Healthy Adult Subjects Administered Single and Multiple Ascending Doses.

Science.gov (United States)

Wach, Achim; Dembowsky, Klaus; Dale, Glenn E

2018-04-01

Murepavadin is the first in class of the outer membrane protein-targeting antibiotics (OMPTA) and a pathogen-specific peptidomimetic antibacterial with a novel, nonlytic mechanism of action targeting Pseudomonas aeruginosa Murepavadin is being developed for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The pharmacokinetics (PK) and safety of single and multiple doses of murepavadin were investigated in healthy male subjects. Part A of the study was a double-blind, randomized, placebo-controlled, single-ascending-dose investigation in 10 sequential cohorts where each cohort comprised 6 healthy male subjects; 4 subjects were randomized to murepavadin, and 2 subjects were randomized to placebo. Part B was a double-blind, randomized, placebo-controlled, multiple-ascending-dose investigation in 3 sequential cohorts. After a single dose of murepavadin, the geometric mean half-life (2.52 to 5.30 h), the total clearance (80.1 to 114 ml/h/kg), and the volume of distribution (415 to 724 ml/kg) were consistent across dose levels. The pharmacokinetics of the dosing regimens evaluated were dose proportional and linear. Murepavadin was well tolerated, adverse events were transient and generally mild, and no dose-limiting toxicity was identified. Copyright © 2018 American Society for Microbiology.

Effects of Food on the Pharmacokinetics of Omega-3-Carboxylic Acids in Healthy Japanese Male Subjects: A Phase I, Randomized, Open-label, Three-period, Crossover Trial.

Science.gov (United States)

Shimada, Hitoshi; Nilsson, Catarina; Noda, Yoshinori; Kim, Hyosung; Lundström, Torbjörn; Yajima, Toshitaka

2017-09-01

Omega-3-carboxylic acids (OM3-CA) contain omega-3 free fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as carboxylic acids. Food intake is known to affect the bioavailability of ethyl ester fatty acid formulations. We conducted a phase I study to investigate the effects of the timing of OM3-CA administration relative to food intake on the pharmacokinetics of EPA and DHA. In this randomized, open-label, three-period crossover study, Japanese healthy male subjects were administered 4×1 g OM3-CA capsules with continued fasting, before a meal, or after a meal. All subjects fasted for ≥10 h prior to drug/meal administration. The primary objective was to examine the effect of meal timing on the pharmacokinetics of EPA and DHA after OM3-CA administration. The secondary objectives were to examine the safety and tolerability of OM3-CA. A total of 42 Japanese subjects was enrolled in the study. The baseline-adjusted maximum concentration and area under the concentration-time curve from 0 to 72 h for EPA, DHA, and EPA +DHA were lower in the fasting and before meal conditions than in the after meal condition. The maximum total EPA, total DHA, and total EPA+DHA concentrations were reached later when administered in fasting conditions than in fed conditions, indicating slower absorption in fasting conditions. Diarrhea was reported by five, six, and no subjects in the fasting, before meal, and after meal conditions, respectively. The timing of OM3-CA administration relative to food intake influences the systemic bioavailability of EPA and DHA in healthy Japanese male subjects. NCT02372344.

Lotka-Volterra system in a random environment

Science.gov (United States)

Dimentberg, Mikhail F.

2002-03-01

Classical Lotka-Volterra (LV) model for oscillatory behavior of population sizes of two interacting species (predator-prey or parasite-host pairs) is conservative. This may imply unrealistically high sensitivity of the system's behavior to environmental variations. Thus, a generalized LV model is considered with the equation for preys' reproduction containing the following additional terms: quadratic ``damping'' term that accounts for interspecies competition, and term with white-noise random variations of the preys' reproduction factor that simulates the environmental variations. An exact solution is obtained for the corresponding Fokker-Planck-Kolmogorov equation for stationary probability densities (PDF's) of the population sizes. It shows that both population sizes are independent γ-distributed stationary random processes. Increasing level of the environmental variations does not lead to extinction of the populations. However it may lead to an intermittent behavior, whereby one or both population sizes experience very rare and violent short pulses or outbreaks while remaining on a very low level most of the time. This intermittency is described analytically by direct use of the solutions for the PDF's as well as by applying theory of excursions of random functions and by predicting PDF of peaks in the predators' population size.

Long-term outcomes in women with polycystic ovary syndrome initially randomized to receive laparoscopic electrocautery of the ovaries or ovulation induction with gonadotrophins.

Science.gov (United States)

Nahuis, M J; Kose, N; Bayram, N; van Dessel, H J H M; Braat, D D M; Hamilton, C J C M; Hompes, P G A; Bossuyt, P M; Mol, B W J; van der Veen, F; van Wely, M

2011-07-01

Long-term effects of laparoscopic electrocautery of the ovaries are unknown. To study the long-term effects of laparoscopic electrocautery of the ovaries and gonadotrophins, we followed women with clomiphene-resistant polycystic ovary syndrome (PCOS) randomly allocated to one of these treatments until 8-12 years after their initial treatment. Between February 1998 and October 2001 168 women with clomiphene citrate-resistant PCOS were included in a randomized controlled trial comparing an electrocautery strategy to a strategy starting with rFSH. In 2009 these women were contacted about their reproductive outcome and menstrual cycle regularity. Analysis was by intention-to-treat. We compared time to conception resulting in live birth, subsequent pregnancies, ectopic and multiple pregnancies, menopause, as well as minimal and maximal menstrual cycle length. After 8-12 years, the cumulative proportion of women with a first child was 86% in women who had been allocated to electrocautery versus 81% in women who had been allocated to immediate rFSH [relative ratio (RR): 1.1; 95% confidence interval (CI): 0.92-1.2]. Treatment with electrocautery resulted in a significantly lower need for stimulated cycles to reach a live birth; 53% after electrocautery versus 76% after rFSH (RR: 0.69; 95% CI: 0.55-0.88).The cumulative proportion of women with a second child was 61% after electrocautery versus 46% after immediate rFSH (RR: 1.4; 95% CI: 1.00-1.9). Overall, there were 7 twins out of 134 deliveries (5%) after electrocautery versus 10 twins out of 124 deliveries (8%) in the rFSH group (RR: 0.65; 95% CI: 0.25-1.6). Fifty-four per cent of the women allocated to electrocautery had a regular menstrual cycle 8-12 years after randomization versus 36% in those allocated to rFSH (RR: 1.5; 95% CI: 0.87-2.6). In women with clomiphene-resistant PCOS, laparoscopic electrocautery of the ovaries is as effective as ovulation induction with FSH treatment in terms of live births, but reduces

Electromagnetic scattering from random media

CERN Document Server

Field, Timothy R

2009-01-01

- ;The book develops the dynamical theory of scattering from random media from first principles. Its key findings are to characterize the time evolution of the scattered field in terms of stochastic differential equations, and to illustrate this framework

The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial

Directory of Open Access Journals (Sweden)

Hamid Reza Rahimi

2016-08-01

Full Text Available Objective: Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both or insulin resistance. Curcumin inhibits NF-κB signaling pathway. The aim of this study is evaluation of the effect of Nano-curcumin on HbA1C, fast blood glucose and lipid profile in diabetic patients. Materials and Methods: Seventy type-2 diabetic patients (fasting blood glucose (FBG ≥ 126 mg/dL or 2-hr postprandial blood glucose ≥200 mg/dl randomly receivedeither Curcumin (as nano-micelle 80 mg/day or placebo for 3 months in a double blind randomized clinical trial. Fasting blood glucose, HbA1C, and lipids profile were checked before and after the intervention. Data analyses, including parametric and nonparametric tests were done using the SPSS 11.5 software. A p value < 0.05 was regarded as statistically significant. (RCT registration code: IRCT2013081114330N1 Results: Mean age, BMI, FBG, total cholesterol (TC, triglyceride (TG, LDL, HDL, HbA1c , and  sex and had no significant difference at the baseline between the groups. In Nano-curcumin group, a significant decrease was found in HbA1C, FBG, TG, and BMI comparing results of each subject before and after the treatment (p

A Long-Term Follow-Up of the Efficacy of Nature-Based Therapy for Adults Suffering from Stress-Related Illnesses on Levels of Healthcare Consumption and Sick-Leave Absence: A Randomized Controlled Trial

Science.gov (United States)

Corazon, Sus Sola; Nyed, Patrik Karlsson; Sidenius, Ulrik

2018-01-01

Stress-related illnesses are a growing health problem in the Western world; which also has economic significance for society. As a consequence; there is a growing demand for effective treatments. The study investigates the long-term efficacy of the Nacadia® nature-based therapy (NNBT) by comparing it to the efficacy of a validated cognitive behavioral therapy, called STreSS. The study is designed as a randomized controlled trial in which 84 participants are randomly allocated between the treatments. Long-term efficacy is investigated through data extracts from the national database of Statistics Denmark on the sick leave and the health-care consumption. The results show that both the NNBT and the STreSS lead to a significant decrease in number of contacts with a general practitioner in the period from twelve months prior to treatment to twelve months after treatment; and, a significant decrease in long-term sick leave from the month prior to treatment to twelve months after treatment. The positive long-term effects provide validation for the NNBT as an efficient treatment of stress-related illnesses. PMID:29342952

A Long-Term Follow-Up of the Efficacy of Nature-Based Therapy for Adults Suffering from Stress-Related Illnesses on Levels of Healthcare Consumption and Sick-Leave Absence: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Sus Sola Corazon

2018-01-01

Full Text Available Stress-related illnesses are a growing health problem in the Western world; which also has economic significance for society. As a consequence; there is a growing demand for effective treatments. The study investigates the long-term efficacy of the Nacadia® nature-based therapy (NNBT by comparing it to the efficacy of a validated cognitive behavioral therapy, called STreSS. The study is designed as a randomized controlled trial in which 84 participants are randomly allocated between the treatments. Long-term efficacy is investigated through data extracts from the national database of Statistics Denmark on the sick leave and the health-care consumption. The results show that both the NNBT and the STreSS lead to a significant decrease in number of contacts with a general practitioner in the period from twelve months prior to treatment to twelve months after treatment; and, a significant decrease in long-term sick leave from the month prior to treatment to twelve months after treatment. The positive long-term effects provide validation for the NNBT as an efficient treatment of stress-related illnesses.

A Long-Term Follow-Up of the Efficacy of Nature-Based Therapy for Adults Suffering from Stress-Related Illnesses on Levels of Healthcare Consumption and Sick-Leave Absence: A Randomized Controlled Trial.

Science.gov (United States)

Corazon, Sus Sola; Nyed, Patrik Karlsson; Sidenius, Ulrik; Poulsen, Dorthe Varning; Stigsdotter, Ulrika Karlsson

2018-01-15

Stress-related illnesses are a growing health problem in the Western world; which also has economic significance for society. As a consequence; there is a growing demand for effective treatments. The study investigates the long-term efficacy of the Nacadia ® nature-based therapy (NNBT) by comparing it to the efficacy of a validated cognitive behavioral therapy, called STreSS. The study is designed as a randomized controlled trial in which 84 participants are randomly allocated between the treatments. Long-term efficacy is investigated through data extracts from the national database of Statistics Denmark on the sick leave and the health-care consumption. The results show that both the NNBT and the STreSS lead to a significant decrease in number of contacts with a general practitioner in the period from twelve months prior to treatment to twelve months after treatment; and, a significant decrease in long-term sick leave from the month prior to treatment to twelve months after treatment. The positive long-term effects provide validation for the NNBT as an efficient treatment of stress-related illnesses.

Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

Science.gov (United States)

Harada, Tasuku; Momoeda, Mikio

2016-12-01

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites. Two hundred fifteen subjects with dysmenorrhea. Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. NCT01129102. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial.

Directory of Open Access Journals (Sweden)

Jill M Hamilton-Reeves

Full Text Available We describe the effects of soy isoflavone consumption on prostate specific antigen (PSA, hormone levels, total cholesterol, and apoptosis in men with localized prostate cancer.We conducted a double-blinded, randomized, placebo-controlled trial to examine the effect of soy isoflavone capsules (80 mg/d of total isoflavones, 51 mg/d aglucon units on serum and tissue biomarkers in patients with localized prostate cancer. Eighty-six men were randomized to treatment with isoflavones (n=42 or placebo (n=44 for up to six weeks prior to scheduled prostatectomy. We performed microarray analysis using a targeted cell cycle regulation and apoptosis gene chip (GEArrayTM. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol were analyzed at baseline, mid-point, and at the time of radical prostatectomy. In this preliminary analysis, 12 genes involved in cell cycle control and 9 genes involved in apoptosis were down-regulated in the treatment tumor tissues versus the placebo control. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol in the isoflavone-treated group compared to men receiving placebo were not statistically significant.These data suggest that short-term intake of soy isoflavones did not affect serum hormone levels, total cholesterol, or PSA.ClinicalTrials.gov NCT00255125.

Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial

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Kjersti M. Blytt

2018-02-01

Full Text Available Objective: Previous research indicates that pain treatment may improve sleep among nursing home patients. We aimed to investigate the long-term effect of pain treatment on 24-h sleep patterns in patients with comorbid depression and dementia.Design: A 13-week, multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial conducted between August 2014 and September 2016.Setting: Long-term patients from 47 nursing homes in Norway.Participants: We included 106 patients with comorbid dementia and depression according to the Mini Mental Status Examination (MMSE and the Cornell Scale for Depression in Dementia (CSDD.Intervention: Patients who were not using analgesics were randomized to receive either paracetamol (3 g/day or placebo tablets. Those who already received pain treatment were randomized to buprenorphine transdermal system (maximum 10 μg/h/7 days or placebo transdermal patches.Measurements: Sleep was assessed continuously for 7 days by actigraphy, at baseline and in week 13. Total sleep time (TST, sleep efficiency (SE, sleep onset latency (SOL, wake after sleep onset (WASO, early morning awakening (EMA, and number of wake bouts (NoW were evaluated. In addition, daytime total sleep time (DTS was estimated. Pain was assessed with Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2.Results: The linear mixed model analyses for TST, SE, SOL, WASO, EMA, NoW and DTS showed no statistically significant differences between patients who received active pain treatment and those who received placebo. Post hoc subgroup analyses showed that there were no statistically significant differences between active treatment and placebo from baseline to week 13 in patients who were in pain (MOBID-2 ≥ 3 at baseline, or in patients who had poor sleep (defined as SE < 85% at baseline. Patients who received active buprenorphine showed an increase in TST and SE compared to those who received active paracetamol

Using Random Numbers in Science Research Activities.

Science.gov (United States)

Schlenker, Richard M.; And Others

1996-01-01

Discusses the importance of science process skills and describes ways to select sets of random numbers for selection of subjects for a research study in an unbiased manner. Presents an activity appropriate for grades 5-12. (JRH)

A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis.

Science.gov (United States)

Sánchez, Mikel; Fiz, Nicolás; Azofra, Juan; Usabiaga, Jaime; Aduriz Recalde, Enmanuel; Garcia Gutierrez, Antonio; Albillos, Javier; Gárate, Ramón; Aguirre, Jose Javier; Padilla, Sabino; Orive, Gorka; Anitua, Eduardo

2012-08-01

This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis. We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety. The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups. Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee. Level I, randomized controlled multicenter trial. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.