Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Superconducting Qubit with Integrated Single Flux Quantum Controller Part II: Experimental Characterization

NASA Astrophysics Data System (ADS)

Leonard, Edward, Jr.; Beck, Matthew; Thorbeck, Ted; Zhu, Shaojiang; Howington, Caleb; Nelson, Jj; Plourde, Britton; McDermott, Robert

We describe the characterization of a single flux quantum (SFQ) pulse generator cofabricated with a superconducting quantum circuit on a single chip. Resonant trains of SFQ pulses are used to induce coherent qubit rotations on the Bloch sphere. We describe the SFQ drive characteristics of the qubit at the fundamental transition frequency and at subharmonics (ω01 / n , n = 2 , 3 , 4 , ⋯). We address the issue of quasiparticle poisoning due to the proximal SFQ pulse generator, and we characterize the fidelity of SFQ-based rotations using randomized benchmarking. Present address: IBM T.J. Watson Research Center.

[Topiramate in substance-related and addictive disorders].

PubMed

Cohen, Johan; Dervaux, Alain; Laqueille, Xavier

2014-09-01

Drug treatments used in substance use disorders are not effective in all patients. To assess the effectiveness of topiramate use in the treatment of substance use disorders. Medline database from January 1966 to December 2013, Cochrane database and clinicaltrials.gov. We used keywords topiramate, addiction, substance abuse, alcohol, tobacco, nicotine, cocaine, methamphetamine, opiate, heroin, benzodiazepine, cannabis, bulimia nervosa, binge eating disorder, gambling. All clinical trials were included. Animal trials, laboratory tests, reviews, answers to writers, case-reports, case series and publications unrelated to the topic were excluded. Twenty-eight articles investigating the efficacy of topiramate in substance use were included. In alcohol-related disorder, several trials and a meta-analysis showed a reduction of days of consumption. In a single-center trial on tobacco-related disorder, topiramate was not found effective in reducing the carbon monoxide expired. In cocaine-related disorder, one single-center trial showed a reduction of days of consumption and two single-center trials have found a trend in favour of topiramate. In alcohol and cocaine co-dependency, a single-center trial found a trend in favour of topiramate. In methamphetamine-related disorder, a multicenter trial found a trend in favour of topiramate. In bulimia nervosa, two single-center trials showed a reduction in binge eating and compensatory behaviours. In binge eating disorder, several trials showed a reduction of binge eating and weight. In gambling, one single-center trial did not show any significant results. There were no randomized controlled trials found in opioid-related disorder, benzodiazepines-related disorder, and cannabis-related disorder. Definition of abstinence and methods to assess the efficacy of topiramate differed between trials. The methodological quality of included trials was variable, especially with no double-blind procedure in eight trials. Topiramate showed interest mainly in alcoholism, binge eating disorder and bulimia nervosa. No definitive conclusions can be reached for other substance use disorders such as nicotine dependence, cocaine dependence, amphetamine dependence or cannabis dependence and for gambling. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Do soft skills predict surgical performance?: a single-center randomized controlled trial evaluating predictors of skill acquisition in virtual reality laparoscopy.

PubMed

Maschuw, K; Schlosser, K; Kupietz, E; Slater, E P; Weyers, P; Hassan, I

2011-03-01

Virtual reality (VR) training in minimal invasive surgery (MIS) is feasible in surgical residency and beneficial for the performance of MIS by surgical trainees. Research on stress-coping of surgical trainees indicates the additional impact of soft skills on VR performance in the surgical curriculum. The aim of this study was to evaluate the impact of structured VR training and soft skills on VR performance of trainees. The study was designed as a single-center randomized controlled trial. Fifty first-year surgical residents with limited experience in MIS ("camera navigation" in laparoscopic cholecystectomy only) were randomized for either 3 months of VR training or no training. Basic VR performance and defined soft skills (self-efficacy, stress-coping, and motivation) were assessed prior to randomization using basic modules of the VR simulator LapSim(®) and standardized psychological questionnaires. Three months after randomization VR performance was reassessed. Outcome measurement was based on the results derived from the most complex of the basic VR modules ("diathermy cutting") as the primary end point. A correlation analysis of the VR end-point performance and the psychological scores was done in both groups. Structured VR training enhanced VR performance of surgical trainees. An additional correlation to high motivational states (P < 0.05) was found. Low levels of self-efficacy and negative stress-coping were related to poor VR performance in the untrained control group (P < 0.05). This correlation was absent in the trained intervention group (P > 0.05). Low self-efficacy and negative stress-coping strategies seem to predict poor VR performance. However, structured training along with high motivational states is likely to balance out this impairment.

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study

PubMed Central

Churilov, Leonid

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting. PMID:29659631

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study.

PubMed

Chiam, Elizabeth; Bellomo, Rinaldo; Churilov, Leonid; Weinberg, Laurence

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting.

Measuring Child-Staff Ratios in Child Care Centers: Balancing Effort and Representativeness

ERIC Educational Resources Information Center

Le, Vi-Nhuan; Perlman, Michal; Zellman, Gail L.; Hamilton, Laura S.

2006-01-01

Child-staff ratios are an important quality indicator. They are often collected by observing one randomly selected classroom several times during a 2-h period on a single day. However, it is unclear whether these measures represent the ratios that children actually experience during most of their time in care. This study compared ratio data…

Lathosterol to cholesterol ratio in serum predicts cholesterol lowering response to plant sterol consumption in a dual center, randomized, single-blind placebo controlled trial

USDA-ARS?s Scientific Manuscript database

Benefits of plant sterols (PS) for cholesterol lowering are compromised by large variability in efficacy across individuals. High fractional cholesterol synthesis measured by deuterium incorporation has been associated with non-response to PS consumption; however, prospective studies showing this as...

Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study.

PubMed

Bingler, Michael; Erickson, Lori A; Reid, Kimberly J; Lee, Brian; O'Brien, James; Apperson, Johnathan; Goggin, Kathy; Shirali, Girish

2018-05-01

Interstage outcomes for infants with single ventricle remain suboptimal. We have previously described a tablet PC-based platform Cardiac High Acuity Monitoring Program (CHAMP) for remote monitoring which provides immediate access to data, videos, and instant alerts to our single ventricle care team. This study compares traditional three-ring binder monitoring (Binder) to CHAMP using a randomized crossover design to evaluate mortality, resource utilization, and caregiver experience. At discharge, all single ventricle infants were monitored using Binder and randomized to receive CHAMP at either one or two months postdischarge. One month after randomization, caregivers could choose either Binder or CHAMP for the remainder of the interstage period. Caregivers experience was recorded using surveys. Enrollment included 31 single ventricle infants from May 2014 to June 2015. There was no interstage mortality over 4,911 total interstage days (median: 144/patient). Of 73 readmissions, 45 were unplanned. Of the initial 23 unplanned readmissions, 13 were found to have been based on data obtained exclusively through CHAMP (as instant alerts or based on data review) rather than caregiver concerns. Due to concerns regarding patient safety, additional enrollment was stopped. The CHAMP use was associated with significantly fewer unplanned intensive care unit days/100 interstage days, shorter delays in care, lower resource utilization at readmissions, and lower incidence of interstage growth failure and was preferred by a majority of caregivers. These findings suggest that CHAMP may offer benefits over Binder (improved interstage outcomes, delays in care, and caregiver experience). These findings should be tested across multiple centers in larger populations.

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

PubMed Central

Synnot, Anneliese; Maas, Andrew I.; Menon, David K.; Cooper, D. James; Rosenfeld, Jeffrey V.; Gruen, Russell L.

2016-01-01

Abstract Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n > 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative effectiveness research and precision medicine, are needed to fully realize the potential of acute TBI research to benefit patients. PMID:26711675

Scissor-type knife significantly improves self-completion rate of colorectal endoscopic submucosal dissection: Single-center prospective randomized trial.

PubMed

Yamashina, Takeshi; Takeuchi, Yoji; Nagai, Kengo; Matsuura, Noriko; Ito, Takashi; Fujii, Mototsugu; Hanaoka, Noboru; Higashino, Koji; Uedo, Noriya; Ishihara, Ryu; Iishi, Hiroyasu

2017-05-01

Colorectal endoscopic submucosal dissection (C-ESD) is recognized as a difficult procedure. Recently, scissors-type knives were launched to reduce the difficulty of C-ESD. The aim of this study was to evaluate the efficacy and safety of the combined use of a scissors-type knife and a needle-type knife with a water-jet function (WJ needle-knife) for C-ESD compared with using the WJ needle-knife alone. This was a prospective randomized controlled trial in a referral center. Eighty-five patients with superficial colorectal neoplasms were enrolled and randomly assigned to undergo C-ESD using a WJ needle-knife alone (Flush group) or a scissor-type knife-supported WJ needle-knife (SB Jr group). Procedures were conducted by two supervised residents. Primary endpoint was self-completion rate by the residents. Self-completion rate was 67% in the SB Jr group, which was significantly higher than that in the Flush group (39%, P = 0.01). Even after exclusion of four patients in the SB Jr group in whom C-ESD was completed using the WJ needle-knife alone, the self-completion rate was significantly higher (63% vs 39%; P = 0.03). Median procedure time among the self-completion cases did not differ significantly between the two groups (59 vs 51 min; P = 0.14). No fatal adverse events were observed in either group. In this single-center phase II trial, scissor-type knife significantly improved residents' self-completion rate for C-ESD, with no increase in procedure time or adverse events. A multicenter trial would be warranted to confirm the validity of the present study. © 2016 Japan Gastroenterological Endoscopy Society.

Constitutive Modeling of Superalloy Single Crystals and Directionally Solidified Materials

NASA Technical Reports Server (NTRS)

Walker, K. P.; Jordan, E. H.

1985-01-01

A unified viscoplastic constitutive relation based on crystallographic slip theory was developed for the deformation analysis of nickel base face centered cubic superalloy single crystals at elevated temperature. The single crystal theory is embedded in a self consistent method to derive a constitutive relation for a directionally solidified material comprised of a polycrystalline aggregate of columnar cylindrical grains. One of the crystallographic axes of the cylindrical crystals points in the columnar direction while the remaining crystallographic axes are oriented at random in the basal plane perpendicular to the columnar direction. These constitutive formulations are coded in FORTRAN for use in nonlinear finite element and boundary element programs.

Comparison of two nasoalveolar molding techniques in unilateral complete cleft lip patients: a randomized, prospective, single-blind trial to compare nasal outcomes.

PubMed

Chang, Chun-Shin; Wallace, Christopher Glenn; Pai, Betty Chien-Jung; Chiu, Yu-Ting; Hsieh, Yuh-Jia; Chen, I-Ju; Liao, Yu-Fang; Liou, Eric Jen-Wein; Chen, Philip Kuo-Ting

2014-08-01

Nasoalveolar molding became increasingly popular in the 1990s as a means of easing surgery and improving nasal outcomes for cleft lip repairs. In the late 1990s, three orthodontists from our center underwent nasoalveolar molding training: two at the Rush Craniofacial Center, in Chicago; and one at New York University Craniofacial Center. They brought two different nasoalveolar molding techniques back to Chang Gung Craniofacial Center: the modified Figueroa and the modified Grayson techniques. Outcomes following use of these techniques have not previously been compared prospectively. Between May of 2010 and March of 2013, a randomized, prospective, single-blind trial was conducted to compare the number of clinical visits, total costs, complications, and nasal symmetry between the two nasoalveolar molding techniques in 30 patients with unilateral complete cleft lip. There were no differences between nasoalveolar molding techniques in the number of clinical visits, total costs, nostril height, or nostril area ratio. Preoperatively but after nasoalveolar molding, the nostril width ratio was wider for the Figueroa group than for the Grayson group. Six months after surgical correction, there were no differences in nostril height, nostril width, nasal sill height, or nostril area ratio between nasoalveolar molding methods. Alveolar ulceration occurred more frequently in the Grayson group. The modified Grayson technique reduced nostril width more efficiently, but alveolar ulceration was more frequent and no differences in nostril width were found following surgery. Overall, the two nasoalveolar molding techniques produced similar nasal outcomes. Therapeutic, II.

Finding Order in Randomness: Single-Molecule Studies Reveal Stochastic RNA Processing | Center for Cancer Research

Cancer.gov

Producing a functional eukaryotic messenger RNA (mRNA) requires the coordinated activity of several large protein complexes to initiate transcription, elongate nascent transcripts, splice together exons, and cleave and polyadenylate the 3’ end. Kinetic competition between these various processes has been proposed to regulate mRNA maturation, but this model could lead to

Continuous-Time Random Walk Models of DNA Electrophoresis in a Post Array: II. Mobility and Sources of Band Broadening

PubMed Central

Olson, Daniel W.; Dutta, Sarit; Laachi, Nabil; Tian, Mingwei; Dorfman, Kevin D.

2011-01-01

Using the two-state, continuous-time random walk model, we develop expressions for the mobility and the plate height during DNA electrophoresis in an ordered post array that delineate the contributions due to (i) the random distance between collisions and (ii) the random duration of a collision. These contributions are expressed in terms of the means and variances of the underlying stochastic processes, which we evaluate from a large ensemble of Brownian dynamics simulations performed using different electric fields and molecular weights in a hexagonal array of 1 μm posts with a 3 μm center-to-center distance. If we fix the molecular weight, we find that the collision frequency governs the mobility. In contrast, the average collision duration is the most important factor for predicting the mobility as a function of DNA size at constant Péclet number. The plate height is reasonably well-described by a single post rope-over-pulley model, provided that the extension of the molecule is small. Our results only account for dispersion inside the post array and thus represent a theoretical lower bound on the plate height in an actual device. PMID:21290387

Perioperative single high dose ATG-Fresenius S administration as induction immunosuppressive therapy in cadaveric renal transplantation--preliminary results.

PubMed

Samsel, R; Chmura, A; Włodarczyk, Z; Wyzgał, J; Cieciura, T; Lagiewska, B; Pliszczyński, J; Korczak, G; Lazowski, T; Paczek, L; Wałaszewski, J; Lao, M; Rowiński, W

1999-01-01

Monoclonal and polyclonal antilymphocyte antibodies have been used successfully in organ transplantation as induction therapy and in the treatment of acute graft rejection. Used for induction the medication is generally given for the first 7-10 days. The aim of this study was to assess the safety and efficacy of single high dose (9 mg/kg) ATG Fresenius S given perioperatively, before revascularization, to kidney allograft recipients. During last twelve months seventy six, first cadaveric kidney adult recipients were included into the study in two centers (center A-64, center B-12). All patients received triple drug immunosuppression (Neoral, steroids and Cellcept which was replaced by azathioprine after 4 months), and were randomized to receive ATG or not. The follow-up period ranged from 1 month up to 1 year. The preliminary results are very promising, the rejection rate in bolus group was significantly lower than in control. No significant side effects or serious adverse events in both groups were observed.

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

Monitoring of anesthetic depth during surgical correction of acquired valvular disorders: single center, randomized trial.

PubMed

Lenkin, Andrey I; Zaharov, Viktor I; Lenkin, Pavel I; Smetkin, Alexey A; Bjertnaes, Lars J; Kirov, Mikhail Y

2014-04-01

The authors' primary objective was to test the hypothesis that Cerebral State Index (CSI)-guided control of anesthetic depth might reduce the consumption of anesthetics and shorten the duration of ICU and hospital stays after surgical correction of combined valve disorders. Single center, randomized trial. City Hospital Number 1 of Arkhangelsk, Russian Federation. Fifty adult patients with combined valve disorders requiring surgical correction. The patients were randomized into 2 groups. In the CSI group, anesthetic depth was monitored, and the rate of infusion of propofol was titrated to maintain the depth of anesthesia corresponding to a CSI of 40-60. In the control group, the depth of anesthesia was monitored clinically, and the dosage of propofol was administered according to the recommendations of the manufacturer. All patients received standard perioperative monitoring. Consumption of anesthetics and length of ICU and hospital stays were recorded. Preoperative patient characteristics did not differ significantly between the groups. In the CSI group, average intraoperative doses of midazolam and propofol were reduced by 41% and 19%, respectively (p<0.01). Maintenance of anesthesia guided by CSI shortened the time until fit for ICU discharge by 50% and reduced the lengths of ICU and postoperative hospital stays by 35% and 25%, respectively (p< 0.05). Monitoring of anesthetic depth reduces the requirements for midazolam and propofol, resulting in a faster recovery and a shorter postoperative ICU and hospital stay after surgical correction of combined valve disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial.

PubMed

Grover, Samir C; Scaffidi, Michael A; Khan, Rishad; Garg, Ankit; Al-Mazroui, Ahmed; Alomani, Tareq; Yu, Jeffrey J; Plener, Ian S; Al-Awamy, Mohamed; Yong, Elaine L; Cino, Maria; Ravindran, Nikila C; Zasowski, Mark; Grantcharov, Teodor P; Walsh, Catharine M

2017-11-01

A structured comprehensive curriculum (SCC) that uses simulation-based training (SBT) can improve clinical colonoscopy performance. This curriculum may be enhanced through the application of progressive learning, a training strategy centered on incrementally challenging learners. We aimed to determine whether a progressive learning-based curriculum (PLC) would lead to superior clinical performance compared with an SCC. This was a single-blinded randomized controlled trial conducted at a single academic center. Thirty-seven novice endoscopists were recruited and randomized to either a PLC (n = 18) or to an SCC (n = 19). The PLC comprised 6 hours of SBT, which progressed in complexity and difficulty. The SCC included 6 hours of SBT, with cases of random order of difficulty. Both groups received expert feedback and 4 hours of didactic teaching. Participants were assessed at baseline, immediately after training, and 4 to 6 weeks after training. The primary outcome was participants' performance during their first 2 clinical colonoscopies, as assessed by using the Joint Advisory Group Direct Observation of Procedural Skills assessment tool (JAG DOPS). Secondary outcomes were differences in endoscopic knowledge, technical and communication skills, and global performance in the simulated setting. The PLC group outperformed the SCC group during first and second clinical colonoscopies, measured by JAG DOPS (P < .001). Additionally, the PLC group had superior technical and communication skills and global performance in the simulated setting (P < .05). There were no differences between groups in endoscopic knowledge (P > .05). Our findings demonstrate the superiority of a PLC for endoscopic simulation, compared with an SCC. Challenging trainees progressively is a simple, theory-based approach to simulation whereby the performance of clinical colonoscopies can be improved. (Clinical trial registration number: NCT02000180.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Saccharomyces boulardii for the prevention of antibiotic-associated diarrhea in adult hospitalized patients: a single-center, randomized, double-blind, placebo-controlled trial.

PubMed

Pozzoni, Pietro; Riva, Alessia; Bellatorre, Alessandro Giacco; Amigoni, Maria; Redaelli, Elena; Ronchetti, Anna; Stefani, Mariangela; Tironi, Rosangela; Molteni, Edoardo Ennio; Conte, Dario; Casazza, Giovanni; Colli, Agostino

2012-06-01

Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Probiotics were effective in preventing AAD and CDAD in several randomized controlled trials. This study was aimed at testing the effect of Saccharomyces boulardii on the occurrence of AAD and CDAD in hospitalized patients. A single-center, randomized, double-blind, placebo-controlled, parallel-group trial was performed. Patients being prescribed antibiotics or on antibiotic therapy for <48 h were eligible. Exclusion criteria were ongoing diarrhea, recent assumption of probiotics, lack of informed consent, inability to ingest capsules, and severe pancreatitis. Patients received a capsule containing S. boulardii or an indistinguishable placebo twice daily within 48 h of beginning antibiotic therapy, continued treatment for 7 days after antibiotic withdrawal, and were followed for 12 weeks after ending antibiotic treatment. Of 562 consecutive eligible patients, 275 patients aged 79.2 ± 9.8 years (134 on placebo) were randomized and 204 aged 78.4 ± 10.0 years (98 on placebo) completed the follow-up. AAD developed in 13.3% (13/98) of the patients receiving placebo and in 15.1% (16/106) of those receiving S. boulardii (odds ratio for S. boulardii vs. placebo, 1.16; 95% confidence interval (CI), 0.53-2.56). Five cases of CDAD occurred, 2 in the placebo group (2.0%) and 3 in the probiotic group (2.8%; odds ratio for S. boulardii vs. placebo, 1.40; 95% CI, 0.23-8.55). There was no difference in mortality rates (12.7% vs. 15.6%, P=0.60). In elderly hospitalized patients, S. boulardii was not effective in preventing the development of AAD.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial

PubMed Central

2013-01-01

Background To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Methods/design Experimental study. Randomized clinical trial. Follow-up period: one year. Study setting: primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. Intervention components: a) Organizational intervention on the patient/professional relationship. Centered on the Chronic Care Model, the Stanford Expert Patient Program and the Kaiser Permanente model: Teamwork, informed and active patient, decision making shared with the patient, recommendations based on clinical guidelines, single electronic medical history per patient that allows the use of indicators for risk monitoring and stratification. b) Formative strategy for professionals: 4 face-to-face training workshops (one every 3 months), monthly update clinical sessions, online tutorial by a cardiologist, availability through the intranet of the action protocol and related documents. Measurements: Blood pressure, blood glucose, HbA1c, lipid profile and smoking. Frequent health care visits. Number of hospitalizations related to vascular disease. Therapeutic compliance. Drug use. Discussion This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. Trial registration NCT01826929 PMID:23915267

Home-based interventions improve trained, but not novel, dual-task balance performance in older adults: A randomized controlled trial.

PubMed

Wongcharoen, Suleeporn; Sungkarat, Somporn; Munkhetvit, Peeraya; Lugade, Vipul; Silsupadol, Patima

2017-02-01

The purpose of this study was to compare the efficacy of four different home-based interventions on dual-task balance performance and to determine the generalizability of the four trainings to untrained tasks. Sixty older adults, aged 65 and older, were randomly assigned to one of four home-based interventions: single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive training. Participants received 60-min individualized training sessions, 3 times a week for 4 weeks. Prior to and following the training program, participants were asked to walk under two single-task conditions (i.e. narrow walking and obstacle crossing) and two dual-task conditions (i.e. a trained narrow walking while performing verbal fluency task and an untrained obstacle crossing while counting backward by 3s task). A nine-camera motion capture system was used to collect the trajectories of 32 reflective markers placed on bony landmarks of participants. Three-dimensional kinematics of the whole body center of mass and base of support were computed. Results from the extrapolated center of mass displacement indicated that motor-cognitive training was more effective than the single-task motor training to improve dual-task balance performance (p=0.04, ES=0.11). Interestingly, balance performance under both single-task and dual-task conditions can also be improved through a non-motor, single-task cognitive training program (p=0.01, ES=0.13, and p=0.01, ES=0.11, respectively). However, improved dual-task processing skills during training were not transferred to the novel dual task (p=0.15, ES=0.09). This is the first study demonstrating that home-based dual-task training can be effectively implemented to improve balance performance during gait in older adults. Copyright © 2016 Elsevier B.V. All rights reserved.

Double-Pulse Two-Micron IPDA Lidar Simulation for Airborne Carbon Dioxide Measurements

NASA Technical Reports Server (NTRS)

Refaat, Tamer F.; Singh, Upendra N.; Yu, Jirong; Petros, Mulugeta

2015-01-01

An advanced double-pulsed 2-micron integrated path differential absorption lidar has been developed at NASA Langley Research Center for measuring atmospheric carbon dioxide. The instrument utilizes a state-of-the-art 2-micron laser transmitter with tunable on-line wavelength and advanced receiver. Instrument modeling and airborne simulations are presented in this paper. Focusing on random errors, results demonstrate instrument capabilities of performing precise carbon dioxide differential optical depth measurement with less than 3% random error for single-shot operation from up to 11 km altitude. This study is useful for defining CO2 measurement weighting, instrument setting, validation and sensitivity trade-offs.

Multi-party Semi-quantum Key Agreement with Delegating Quantum Computation

NASA Astrophysics Data System (ADS)

Liu, Wen-Jie; Chen, Zhen-Yu; Ji, Sai; Wang, Hai-Bin; Zhang, Jun

2017-10-01

A multi-party semi-quantum key agreement (SQKA) protocol based on delegating quantum computation (DQC) model is proposed by taking Bell states as quantum resources. In the proposed protocol, the participants only need the ability of accessing quantum channel and preparing single photons {|0〉, |1〉, |+〉, |-〉}, while the complicated quantum operations, such as the unitary operations and Bell measurement, will be delegated to the remote quantum center. Compared with previous quantum key agreement protocols, this client-server model is more feasible in the early days of the emergence of quantum computers. In order to prevent the attacks from outside eavesdroppers, inner participants and quantum center, two single photon sequences are randomly inserted into Bell states: the first sequence is used to perform the quantum channel detection, while the second is applied to disorder the positions of message qubits, which guarantees the security of the protocol.

Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study.

PubMed

Falls, Roman; Seman, Michael; Braat, Sabine; Sortino, Joshua; Allen, Jason D; Neil, Christopher J

2017-08-08

Acute heart failure (AHF) is a frequent reason for hospitalization worldwide and effective treatment options are limited. It is known that AHF is a condition characterized by impaired vasorelaxation, together with reduced nitric oxide (NO) bioavailability, an endogenous vasodilatory compound. Supplementation of inorganic sodium nitrate (NaNO 3 ) is an indirect dietary source of NO, through bioconversion. It is proposed that oral sodium nitrate will favorably affect levels of circulating NO precursors (nitrate and nitrite) in AHF patients, resulting in reduced systemic vascular resistance, without significant hypotension. We propose a single center, randomized, double-blind, placebo-controlled pilot trial, evaluating the feasibility of sodium nitrate as a treatment for AHF. The primary hypothesis that sodium nitrate treatment will result in increased systemic levels of nitric oxide pre-cursors (nitrate and nitrite) in plasma, in parallel with improved vasorelaxation, as assessed by non-invasively derived systemic vascular resistance index. Additional surrogate measures relevant to the known pathophysiology of AHF will be obtained in order to assess clinical effect on dyspnea and renal function. The results of this study will provide evidence of the feasibility of this novel approach and will be of interest to the heart failure community. This trial may inform a larger study.

Efficacy and safety of adapalene gel 0.1% and 0.3% and tretinoin gel 0.05% for acne vulgaris: results of a single-center, randomized, double-blinded, placebo-controlled clinical trial on Mexican patients (skin type III-IV).

PubMed

Tirado-Sánchez, Andrés; Espíndola, Yareni Salas; Ponce-Olivera, Rosa María; Bonifaz, Alexandro

2013-06-01

The efficacy of topical retinoids is well known according to several clinical studies conducted predominantly among Caucasian patients. This study aimed to evaluate the efficacy and safety profile of adapalene and tretinoin among Mexican patients. To compare adapalene 0.1 and 0.3% and tretinoin 0.05% in Mexican subjects with acne vulgaris. We enrolled 171 patients in this single-center, randomized, double-blinded, placebo-controlled clinical trial. The patients applied on the face either adapalene 0.1%, adapalene 0.3%, tretinoin 0.05%, or placebo for 90 days and were evaluated for the reduction in total lesion counts and for the level of irritation. Tretinoin 0.05% and adapalene 0.3% were more effective than adapalene 0.1% and placebo in the reduction of both inflammatory and noninflammatory lesions. Most of adverse events to adapalene and many on tretinoin group were related to skin irritation, dry skin, scaling, pruritus, burning, and postinflammatory hyperpigmentation. Adapalene 0.3% and tretinoin 0.05% are comparable in efficacy, and adapalene 0.1% offers a better safety profile in Mexican patients. © 2013 Wiley Periodicals, Inc.

Effect of Chlorhexidine Bathing Every Other Day on Prevention of Hospital-Acquired Infections in the Surgical ICU: A Single-Center, Randomized Controlled Trial.

PubMed

Swan, Joshua T; Ashton, Carol M; Bui, Lan N; Pham, Vy P; Shirkey, Beverly A; Blackshear, Jolene E; Bersamin, Jimmy B; Pomer, Rubie May L; Johnson, Michael L; Magtoto, Audrey D; Butler, Michelle O; Tran, Shirley K; Sanchez, Leah R; Patel, Jessica G; Ochoa, Robert A; Hai, Shaikh A; Denison, Karen I; Graviss, Edward A; Wray, Nelda P

2016-10-01

To test the hypothesis that compared with daily soap and water bathing, 2% chlorhexidine gluconate bathing every other day for up to 28 days decreases the risk of hospital-acquired catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection in surgical ICU patients. This was a single-center, pragmatic, randomized trial. Patients and clinicians were aware of treatment-group assignment; investigators who determined outcomes were blinded. Twenty-four-bed surgical ICU at a quaternary academic medical center. Adults admitted to the surgical ICU from July 2012 to May 2013 with an anticipated surgical ICU stay for 48 hours or more were included. Patients were randomized to bathing with 2% chlorhexidine every other day alternating with soap and water every other day (treatment arm) or to bathing with soap and water daily (control arm). The primary endpoint was a composite outcome of catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection. Of 350 patients randomized, 24 were excluded due to prior enrollment in this trial and one withdrew consent. Therefore, 325 were analyzed (164 soap and water versus 161 chlorhexidine). Patients acquired 53 infections. Compared with soap and water bathing, chlorhexidine bathing every other day decreased the risk of acquiring infections (hazard ratio = 0.555; 95% CI, 0.309-0.997; p = 0.049). For patients bathed with soap and water versus chlorhexidine, counts of incident hospital-acquired infections were 14 versus 7 for catheter-associated urinary tract infection, 13 versus 8 for ventilator-associated pneumonia, 6 versus 3 for incisional surgical site infections, and 2 versus 0 for primary bloodstream infection; the effect was consistent across all infections. The absolute risk reduction for acquiring a hospital-acquired infection was 9.0% (95% CI, 1.5-16.4%; p = 0.019). Incidences of adverse skin occurrences were similar (18.9% soap and water vs 18.6% chlorhexidine; p = 0.95). Compared with soap and water, chlorhexidine bathing every other day decreased the risk of acquiring infections by 44.5% in surgical ICU patients.

Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).

PubMed

Kamal, Ayeesha Kamran; Khoja, Adeel; Usmani, Bushra; Muqeet, Abdul; Zaidi, Fabiha; Ahmed, Masood; Shakeel, Saadia; Soomro, Nabila; Gowani, Ambreen; Asad, Nargis; Ahmed, Asma; Sayani, Saleem; Azam, Iqbal; Saleem, Sarah

2016-01-27

Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle. Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems. NCT02202330 (28 January 2015).

Cervical Disk Replacement With Discover Versus Fusion in a Single-Level Cervical Disk Disease: A Prospective Single-Center Randomized Trial With a Minimum 2-Year Follow-up.

PubMed

Rožanković, Marjan; Marasanov, Sergej M; Vukić, Miroslav

2017-06-01

Prospective randomized study. To compare the clinical outcome after Discover arthroplasty versus anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical disk disease. ACDF is still the gold standard for surgical treatment of cervical spine degenerative disk disease. However, results of many studies suggest that it may cause degenerative changes at levels immediately above and below the fusion, known as adjacent segment degenerative disease. Cervical arthroplasty has recently been introduced as an alternative to standard procedure of ACDF. It showed decreased surgical morbidity, decreased complications from postoperative immobilization, and an earlier return to previous level of function. A total of 105 consecutive patients with single-level cervical disk disease, producing radiculopathy and/or myelopathy were randomly divided into groups to undergo ACDF or Discover arthroplasty. All patients were evaluated with preoperative and postoperative serial radiographic studies and clinically, using Neck Disability Index, Visual Analog Scale and neurological status at 3, 6, 12, and 24 months. The results of our study indicate that cervical arthroplasty using Discover Artificial Cervical Disc provides favorable clinical and radiologic outcomes in a follow-up period of 24 months. There has been significant improvement in clinical parameters, Visual Analog Scale and Neck Disability Index, at 3, 6, 12, and 24 months in arthroplasty group comparing to control group. The Discover artificial cervical disc replacement offers favorable outcome compared with ACDF for a single-level cervical disk disease at short-term and long-term follow-up.

Lifestyle Modification for Resistant Hypertension: The TRIUMPH Randomized Clinical Trial

PubMed Central

Blumenthal, James A.; Sherwood, Andrew; Smith, Patrick J.; Mabe, Stephanie; Watkins, Lana; Lin, Pao-Hwa; Craighead, Linda W.; Babyak, Michael; Tyson, Crystal; Young, Kenlyn; Ashworth, Megan; Kraus, William; Liao, Lawrence; Hinderliter, Alan

2015-01-01

Background Resistant hypertension (RH) is a growing health burden in this country affecting as many as one in five adults being treated for hypertension. RH is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure in this high risk population are a national priority. Methods TRIUMPH is a single site, prospective, randomized clinical trial (RCT) to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie DASH eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (N=150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic blood pressure; secondary endpoints include ambulatory blood pressure and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, blood pressure and CVD risk factors also will be measured at one year follow-up. Conclusions The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on blood presssure and CVD biomarkers in patients with RH after 4 months of treatment, and will determine whether lifestyle changes can be maintained for a year. PMID:26542509

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

Current Limitations and Perspectives in Single Port Surgery: Pros and Cons Laparo-Endoscopic Single-Site Surgery (LESS) for Renal Surgery

PubMed Central

Weibl, Peter; Klingler, Hans-Christoph; Klatte, Tobias; Remzi, Mesut

2010-01-01

Laparo-Endoscopic Single-Site surgery (LESS) for kidney diseases is quickly evolving and has a tendency to expand the urological armory of surgical techniques. However, we should not be overwhelmed by the surgical skills only and weight it against the basic clinical and oncological principles when compared to standard laparoscopy. The initial goal is to define the ideal candidates and ideal centers for LESS in the future. Modification of basic instruments in laparoscopy presumably cannot result in better functional and oncological outcomes, especially when the optimal working space is limited with the same arm movements. Single port surgery is considered minimally invasive laparoscopy; on the other hand, when using additional ports, it is no more single port, but hybrid traditional laparoscopy. Whether LESS is a superior or equally technique compared to traditional laparoscopy has to be proven by future prospective randomized trials. PMID:20169054

A multi-center randomized trial of two different intravenous fluids during labor

PubMed Central

DAPUZZO-ARGIRIOU, Lisa M.; SMULIAN, John C.; ROCHON, Meredith L.; GALDI, Luisa; KISSLING, Jessika M.; SCHNATZ, Peter F.; RIOS, Angel GONZALEZ; AIROLDI, James; CARRILLO, Mary Anne; MAINES, Jaimie; KUNSELMAN, Allen R.; REPKE, John; LEGRO, Richard S.

2017-01-01

Objective To determine if the intrapartum use of a 5% glucose-containing intravenous solution decreases the chance of a cesarean delivery for women presenting in active labor. Methods This was a multi-center, prospective, single (patient) blind, randomized study design implemented at 4 obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6cm were randomized to lactated Ringer's with or without 5% glucose (LR versus D5LR) as their maintenance intravenous fluid. The primary outcome was the cesarean birth rate. Secondary outcomes included labor characteristics, as well as maternal or neonatal complications. Results There were 309 women analyzed. Demographic variables and admitting cervical dilation were similar among study groups. There was no significant difference in the cesarean delivery rate for the D5LR group (23/153 or 15.0%) versus the LR arm (18/156 or 11.5%), [RR (95%CI) of 1.32 (0.75, 2.35), P=0.34]. There were no differences in augmentation rates or intrapartum complications. Conclusions The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor. PMID:25758624

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de). PMID:24884848

Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.

PubMed

Ha, Chul-Won; Park, Yong-Beom; Choi, Chong-Hyuk; Kyung, Hee-Soo; Lee, Ju-Hong; Yoo, Jae Doo; Yoo, Ju-Hyung; Choi, Choong-Hyeok; Kim, Chang-Wan; Kim, Hee-Chun; Oh, Kwang-Jun; Bin, Seong-Il; Lee, Myung Chul

2017-05-26

This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.

Dual dietary intake problems among under-five years old children living in an armed conflict area of southern Thailand.

PubMed

Jeharsae, Rohani; Sangthong, Rassamee; Chongsuvivatwong, Virasakdi

2011-09-01

This survey examined nutritional intake and the effects of armed conflict on energy-protein inadequacy amonng children aged one to less than five years. Fifty health centers were randomly selected. Three children were randomly selected from each 12-month old interval age groups in each health center. Four hundred seventy eight children and their primary caregivers were recruited. Food intake was collected from a single 24-hour food recall and was computed to percentage of the Thai Dietary Reference Intake (DRI). Violent event rates were classified by quartiles. Dietary intake stratified by age groups was examined. Logistic regression was used to examine association between armed conflict and inadequacy of food intake. Average of DRI was above 100% for both energy and protein intake. Snacks contributed to one-fourth of energy intake. Inadequacy of energy and protein intake was 27% and 7%, respectively. There was no association between armed conflict and inadequacy of energy and protein consumption.

Effect of a governmentally-led physical activity program on motor skills in young children attending child care centers: a cluster randomized controlled trial.

PubMed

Bonvin, Antoine; Barral, Jérôme; Kakebeeke, Tanja H; Kriemler, Susi; Longchamp, Anouk; Schindler, Christian; Marques-Vidal, Pedro; Puder, Jardena J

2013-07-08

To assess the effect of a governmentally-led center based child care physical activity program (Youp'là Bouge) on child motor skills. We conducted a single blinded cluster randomized controlled trial in 58 Swiss child care centers. Centers were randomly selected and 1:1 assigned to a control or intervention group. The intervention lasted from September 2009 to June 2010 and included training of the educators, adaptation of the child care built environment, parental involvement and daily physical activity. Motor skill was the primary outcome and body mass index (BMI), physical activity and quality of life secondary outcomes. The intervention implementation was also assessed. At baseline, 648 children present on the motor test day were included (age 3.3 ± 0.6, BMI 16.3 ± 1.3 kg/m2, 13.2% overweight, 49% girls) and 313 received the intervention. Relative to children in the control group (n = 201), children in the intervention group (n = 187) showed no significant increase in motor skills (delta of mean change (95% confidence interval: -0.2 (-0.8 to 0.3), p = 0.43) or in any of the secondary outcomes. Not all child care centers implemented all the intervention components. Within the intervention group, several predictors were positively associated with trial outcomes: (1) free-access to a movement space and parental information session for motor skills (2) highly motivated and trained educators for BMI (3) free-access to a movement space and purchase of mobile equipment for physical activity (all p < 0.05). This "real-life" physical activity program in child care centers confirms the complexity of implementing an intervention outside a study setting and identified potentially relevant predictors that could improve future programs. Clinical trials.gov NCT00967460.

The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial.

PubMed

Kanazawa, Manabu; Tanoue, Mariko; Miyayasu, Anna; Takeshita, Shin; Sato, Daisuke; Asami, Mari; Lam, Thuy Vo; Thu, Khaing Myat; Oda, Ken; Komagamine, Yuriko; Minakuchi, Shunsuke; Feine, Jocelyne

2018-05-01

Mandibular overdentures retained by a single implant placed in the midline of edentulous mandible have been reported to be more comfortable and function better than complete dentures. Although single-implant overdentures are still more costly than conventional complete dentures, there are a few studies which investigated whether mandibular single-implant overdentures are superior to complete dentures when patient general satisfaction is compared. The aim of this study is to assess patient general satisfaction with mandibular single-implant overdentures and complete dentures. This study is a randomized crossover trial to compare mandibular single-implant overdentures and complete dentures in edentulous individuals. Participant recruitment is ongoing at the time of this submission. Twenty-two participants will be recruited. New mandibular complete dentures will be fabricated. A single implant will be placed in the midline of the edentulous mandible. The mucosal surface of the complete denture around the implant will be relieved for 3 months. The participants will then be randomly allocated into 2 groups according to the order of the interventions; group 1 will receive single-implant overdentures first and will wear them for 2 months, followed by complete dentures for 2 months. Group 2 will receive the same treatments in a reverse order. After experiencing the 2 interventions, the participants will choose one of the mandibular prostheses, and yearly follow-up visits are planned for 5 years. The primary outcome of this trial is patient ratings of general satisfaction on 100 mm visual analog scales. Assessments of the prostheses and oral health-related quality of life will also be recorded as patient-reported outcomes. The secondary outcomes are cost and time for treatment. Masticatory efficiency and cognitive capacity will also be recorded. Furthermore, qualitative research will be performed to investigate the factors associated with success of these mandibular denture types. Clinical outcomes, such as implant survival rate, marginal bone loss, and prosthodontic complications, will also be recorded. The results of this randomized crossover trial will clarify whether mandibular single implants and overdentures for edentulous individuals provide better patient general satisfaction when compared to conventional complete dentures. This clinical trial was registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000017883).

Management of Patients With Histologic Transformation.

PubMed

Reddy, Nishitha M

2017-07-01

The incidence of histological transformation is up to 30% over a period of 10 years. This risk persists even beyond the initial decade of diagnosis of an indent lymphoma. In this era of emerging novel therapies, one could hope for an improved survival. There are currently no randomized trials guiding therapy for transformed lymphoma. Treatment recommendations are based on observational studies or non-randomized single arm clinical trials. To that extent, although routinely recommended and performed at transplant centers, voluminous evidence to suggest the timing or type (autologous or allogeneic) of transplant is lacking. In this article, we discuss the clinical features, treatment approach and role of stem cell transplant in transformed lymphoma. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial

PubMed Central

Lazzari, Roberta Delasta; Politti, Fabiano; Santos, Cibele Alimedia; Dumont, Arislander Jonathan Lopes; Rezende, Fernanda Lobo; Grecco, Luanda André Collange; Braun Ferreira, Luiz Alfredo; Oliveira, Claudia Santos

2015-01-01

[Purpose] The aim of the present study was to investigate the effects of a single session of transcranial direct current stimulation combined with virtual reality training on the balance of children with cerebral palsy. [Subjetcs and Methods] Children with cerebral palsy between four and 12 years of age were randomly allocated to two groups: an experimental group which performed a single session of mobility training with virtual reality combined with active transcranial direct current stimulation; and a control group which performed a single session of mobility training with virtual reality combined with placebo transcranial direct current stimulation. The children were evaluated before and after the training protocols. Static balance (sway area, displacement, velocity and frequency of oscillations of the center of pressure on the anteroposterior and mediolateral axes) was evaluated using a force plate under four conditions (30-second measurements for each condition): feet on the force plate with the eyes open, and with the eyes closed; feet on a foam mat with the eyes open, and with the eyes closed. [Results] An increase in sway velocity was the only significant difference found. [Conclusion] A single session of anodal transcranial direct current stimulation combined with mobility training elicited to lead to an increase in the body sway velocity of children with cerebral palsy. PMID:25931726

Gaming in risk-adjusted mortality rates: effect of misclassification of risk factors in the benchmarking of cardiac surgery risk-adjusted mortality rates.

PubMed

Siregar, Sabrina; Groenwold, Rolf H H; Versteegh, Michel I M; Noyez, Luc; ter Burg, Willem Jan P P; Bots, Michiel L; van der Graaf, Yolanda; van Herwerden, Lex A

2013-03-01

Upcoding or undercoding of risk factors could affect the benchmarking of risk-adjusted mortality rates. The aim was to investigate the effect of misclassification of risk factors on the benchmarking of mortality rates after cardiac surgery. A prospective cohort was used comprising all adult cardiac surgery patients in all 16 cardiothoracic centers in The Netherlands from January 1, 2007, to December 31, 2009. A random effects model, including the logistic European system for cardiac operative risk evaluation (EuroSCORE) was used to benchmark the in-hospital mortality rates. We simulated upcoding and undercoding of 5 selected variables in the patients from 1 center. These patients were selected randomly (nondifferential misclassification) or by the EuroSCORE (differential misclassification). In the random patients, substantial misclassification was required to affect benchmarking: a 1.8-fold increase in prevalence of the 4 risk factors changed an underperforming center into an average performing one. Upcoding of 1 variable required even more. When patients with the greatest EuroSCORE were upcoded (ie, differential misclassification), a 1.1-fold increase was sufficient: moderate left ventricular function from 14.2% to 15.7%, poor left ventricular function from 8.4% to 9.3%, recent myocardial infarction from 7.9% to 8.6%, and extracardiac arteriopathy from 9.0% to 9.8%. Benchmarking using risk-adjusted mortality rates can be manipulated by misclassification of the EuroSCORE risk factors. Misclassification of random patients or of single variables will have little effect. However, limited upcoding of multiple risk factors in high-risk patients can greatly influence benchmarking. To minimize "gaming," the prevalence of all risk factors should be carefully monitored. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Porous Electrodes I: Numerical Simulation Using Random Network and Single Pore Models.

DTIC Science & Technology

1984-01-31

characteristic of Zn and ZnO ) and scaling them down to the magnitude of a unit pore size- approximately 10i in diameter. We define a characteristic...supported by the Office of Naval Research under contract N00014-81-K-0339. 11 - 15 - REFERENCES 1. R. de Levis in Advances in Electrochemistry and...P. 3. Hendra Dr. C. E. Mueller Department of Chemistry The Electrochemistry Branch University of Southampton Naval Surface Weapons Center

Efficacy of continuous versus intermittent subglottic secretion drainage in preventing ventilator-associated pneumonia in patients requiring mechanical ventilation: A single-center randomized controlled trial.

PubMed

Fujimoto, Hiroko; Yamaguchi, Osamu; Hayami, Hajime; Shimosaka, Mika; Tsuboi, Sayaka; Sato, Mitsunori; Takebayashi, Shigeo; Morita, Satoshi; Saito, Mari; Goto, Takahisa; Kurahashi, Kiyoyasu

2018-03-23

Aspiration of subglottic secretion is a widely used intervention to prevent ventilator-associated pneumonia (VAP). This study aimed to compare the efficacy of continuous and intermittent subglottic secretion drainage (SSD) in preventing VAP. A single-center randomized controlled trial was conducted on adult postoperative patients who were expected to undergo mechanical ventilation for more than 48 hours. Primary outcome measure was incidence of VAP and secondary outcome measures were length of mechanical ventilation and intensive-care unit (ICU) stay. Fifty-nine patients received continuous SSD, while 60 patients received intermittent SSD. Of these 119 patients, 88 (74%) were excluded and 15 and 16 patients were allocated to receive continuous and intermittent SSD, respectively. VAP was detected in 4 (26.7%) and 7 (43.8%) patients in the continuous and intermittent groups, respectively, (p=0.320). The length of mechanical ventilation was significantly shorter (p=0.034) in the continuous group (99.5±47.1 h) than in the intermittent group (159.9±94.5 h). The length of ICU stay was also shorter (p=0.0097) in the continuous group (6.3±2.1 days) than the intermittent group (9.8±4.8 days). Although continuous SSD did not reduce the incidence of VAP, it reduced the length of mechanical ventilation and ICU stay when compared to intermittent SSD.

Random walk to a nonergodic equilibrium concept

NASA Astrophysics Data System (ADS)

Bel, G.; Barkai, E.

2006-01-01

Random walk models, such as the trap model, continuous time random walks, and comb models, exhibit weak ergodicity breaking, when the average waiting time is infinite. The open question is, what statistical mechanical theory replaces the canonical Boltzmann-Gibbs theory for such systems? In this paper a nonergodic equilibrium concept is investigated, for a continuous time random walk model in a potential field. In particular we show that in the nonergodic phase the distribution of the occupation time of the particle in a finite region of space approaches U- or W-shaped distributions related to the arcsine law. We show that when conditions of detailed balance are applied, these distributions depend on the partition function of the problem, thus establishing a relation between the nonergodic dynamics and canonical statistical mechanics. In the ergodic phase the distribution function of the occupation times approaches a δ function centered on the value predicted based on standard Boltzmann-Gibbs statistics. The relation of our work to single-molecule experiments is briefly discussed.

Far field beam pattern of one MW combined beam of laser diode array amplifiers for space power transmission

NASA Technical Reports Server (NTRS)

Kwon, Jin H.; Lee, Ja H.

1989-01-01

The far-field beam pattern and the power-collection efficiency are calculated for a multistage laser-diode-array amplifier consisting of about 200,000 5-W laser diode arrays with random distributions of phase and orientation errors and random diode failures. From the numerical calculation it is found that the far-field beam pattern is little affected by random failures of up to 20 percent of the laser diodes with reference of 80 percent receiving efficiency in the center spot. The random differences in phases among laser diodes due to probable manufacturing errors is allowed to about 0.2 times the wavelength. The maximum allowable orientation error is about 20 percent of the diffraction angle of a single laser diode aperture (about 1 cm). The preliminary results indicate that the amplifier could be used for space beam-power transmission with an efficiency of about 80 percent for a moderate-size (3-m-diameter) receiver placed at a distance of less than 50,000 km.

The effect of night extension orthoses following surgical release of Dupuytren contracture: a single-center, randomized, controlled trial.

PubMed

Collis, Julie; Collocott, Shirley; Hing, Wayne; Kelly, Edel

2013-07-01

To clarify the efficacy and detrimental effects of orthoses used to maintain finger extension following surgical release of Dupuytren contracture. We conducted a single-center, randomized, controlled trial to investigate the effect of night extension orthoses on finger range of motion and hand function for 3 months following surgical release of Dupuytren contracture. We also wanted to determine how well finger extension was maintained in the total sample. We randomized 56 patients to receive a night extension orthosis plus hand therapy (n = 26) or hand therapy alone (n = 30). The primary outcome was total active extension of the operated fingers (°). Secondary outcomes were total active flexion of the operated fingers (°), active distal palmar crease (cm), grip strength (kg), and self-reported hand function using the Disabilities of the Arm, Shoulder, and Hand questionnaire (0-100 scale). There were no statistically significant differences between the no-orthosis and orthosis groups for total active extension or for any of the secondary outcomes. Between the first postoperative measure and 3 months after surgery, 62% of little fingers had maintained or improved total active extension. The use of a night extension orthosis in combination with standard hand therapy has no greater effect on maintaining finger extension than hand therapy alone in the 3 months following surgical release of Dupuytren contracture. Our results indicate that the practice of providing every patient with a night extension orthosis following surgical release of Dupuytren contracture may not be justified except for cases in which extension loss occurs after surgery. Our results also challenge clinicians to research ways of maintaining finger extension in a greater number of patients. Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Phase Behavior of a Single Structured Ionomer Chain in Solution

DOE PAGES

Aryal, Dipak; Etampawala, Thusitha; Perahia, Dvora; ...

2014-08-14

Structured polymers offer a means to tailor transport pathways within mechanically stable manifolds. Here we examine the building block of such a membrane, namely a single large pentablock co-polymer that consist of a center block of a randomly sulfonated polystyrene, designed for transport, tethered to poly-ethylene-r-propylene and end-capped by poly-t-butyl styrene, for mechanical stability,using molecular dynamics simulations. The polymer structure in a cyclohexane-heptane mixture, a technologically viable solvent, and in water, a poor solvent for all segments and a ubiquitous substance is extracted. In all solvents the pentablock collapsed into nearly spherical aggregates where the ionic block is segregated. Inmore » hydrophobic solvents, the ionic block resides in the center, surrounded by swollen intermix of flexible and end blocks. In water all blocks are collapsed with the sulfonated block residing on the surface. Our results demonstrate that solvents drive different local nano-segregation, providing a gateway to assemble membranes with controlled topology.« less

A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

PubMed Central

Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

2014-01-01

Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

MRI evaluation following partial HIFU therapy for localized prostate cancer: A single-center study.

PubMed

Hoquetis, L; Malavaud, B; Game, X; Beauval, J B; Portalez, D; Soulie, M; Rischmann, P

2016-09-01

To evaluate the value of MRI for surveillance of primary hemi-HIFU therapy for localized PCa in a single-center. Patients with localized prostate cancer were treated with hemi-HIFU from October 2009 to March 2014. All patients performed MRI before focal therapy, the reader was blinded to the treatment. Oncological failure was defined as positive biopsy or biochemical recurrence (Phoenix). Twenty-five patients were treated with hemi-HIFU in one center. The median nadir PSA was 1.45±1.4ng/mL. Prostate volume decreased from 45 cc to 25 cc on MRI findings. At 20 months, none of the patients had histological recurrence. Biochemical-free survival rate was 88%. MRI evaluation had a negative predictive value of 100% on the treated area and 81% on the untreated area. PSAd≥0.1ng/mL(2) was a predictive factor for cancer on untreated area (P=0.042). MRI control at 6 months is a potentially effective evaluation of treated area after hemi-HIFU and may replace randomized biopsies if PSAd<0.1ng/mL(2) during follow-up. 4. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial.

PubMed

Tonttila, Panu P; Lantto, Juha; Pääkkö, Eija; Piippo, Ulla; Kauppila, Saila; Lammentausta, Eveliina; Ohtonen, Pasi; Vaarala, Markku H

2016-03-01

Multiparametric magnetic resonance imaging (MP-MRI) may improve the detection of clinically significant prostate cancer (PCa). To compare MP-MRI transrectal ultrasound (TRUS)-fusion targeted biopsy with routine TRUS-guided random biopsy for overall and clinically significant PCa detection among patients with suspected PCa based on prostate-specific antigen (PSA) values. This institutional review board-approved, single-center, prospective, randomized controlled trial (April 2011 to December 2014) included 130 biopsy-naive patients referred for prostate biopsy based on PSA values (PSA <20 ng/ml or free-to-total PSA ratio ≤0.15 and PSA <10 ng/ml). Patients were randomized 1:1 to the MP-MRI or control group. Patients in the MP-MRI group underwent prebiopsy MP-MRI followed by 10- to 12-core TRUS-guided random biopsy and cognitive MRI/TRUS fusion targeted biopsy. The control group underwent TRUS-guided random biopsy alone. MP-MRI 3-T phased-array surface coil. The primary outcome was the number of patients with biopsy-proven PCa in the MP-MRI and control groups. Secondary outcome measures included the number of positive prostate biopsies and the proportion of clinically significant PCa in the MP-MRI and control groups. Between-group analyses were performed. Overall, 53 and 60 patients were evaluable in the MP-MRI and control groups, respectively. The overall PCa detection rate and the clinically significant cancer detection rate were similar between the MP-MRI and control groups, respectively (64% [34 of 53] vs 57% [34 of 60]; 7.5% difference [95% confidence interval (CI), -10 to 25], p=0.5, and 55% [29 of 53] vs 45% [27 of 60]; 9.7% difference [95% CI, -8.5 to 27], p=0.8). The PCa detection rate was higher than assumed during the planning of this single-center trial. MP-MRI/TRUS-fusion targeted biopsy did not improve PCa detection rate compared with TRUS-guided biopsy alone in patients with suspected PCa based on PSA values. In this randomized clinical trial, additional prostate magnetic resonance imaging (MRI) before prostate biopsy appeared to offer similar diagnostic accuracy compared with routine transrectal ultrasound-guided random biopsy in the diagnosis of prostate cancer. Similar numbers of cancers were detected with and without MRI. ClinicalTrials.gov identifier: NCT01357512. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Provable classically intractable sampling with measurement-based computation in constant time

NASA Astrophysics Data System (ADS)

Sanders, Stephen; Miller, Jacob; Miyake, Akimasa

We present a constant-time measurement-based quantum computation (MQC) protocol to perform a classically intractable sampling problem. We sample from the output probability distribution of a subclass of the instantaneous quantum polynomial time circuits introduced by Bremner, Montanaro and Shepherd. In contrast with the usual circuit model, our MQC implementation includes additional randomness due to byproduct operators associated with the computation. Despite this additional randomness we show that our sampling task cannot be efficiently simulated by a classical computer. We extend previous results to verify the quantum supremacy of our sampling protocol efficiently using only single-qubit Pauli measurements. Center for Quantum Information and Control, Department of Physics and Astronomy, University of New Mexico, Albuquerque, NM 87131, USA.

Efficacy of elastic memory chains versus nickel-titanium coil springs in canine retraction: A two-center split-mouth randomized clinical trial.

PubMed

Khanemasjedi, Mashallah; Moradinejad, Mehrnaz; Javidi, Pedram; Niknam, Ozra; Jahromi, Nima Haghighat; Rakhshan, Vahid

2017-12-01

The use of newly-introduced elastic memory chains (EMCs) in space closure is increasingly gaining popularity. However, no clinical studies have evaluated their efficacy. Therefore, this study was conducted. In this two-center split-mouth single-blind randomized controlled trial, 21 jaws were divided into 42 quadrants. The two treatments [canine retraction using EMCs versus nickel-titanium (NiTi) coil springs (as control)] were randomly assigned to two quadrants of each jaw. The premolar space was measured at the baseline, and in the 1st, 2nd, and 3rd months of canine retraction, by a blinded orthodontist. Space closure rates were compared using a paired t-test. The rates of space closure using NiTi springs were 1.93±0.62, 1.71±0.75, and 1.36±0.51mm/month, during the 1st, 2nd, and 3rd months of treatment, respectively. The 3-month average rates of space closure were 1.67±0.39 and 1.89±0.36mm/month in the NiTi and elastic groups, respectively (faster in the elastic group, P=0.022). The application of elastic memory chains is as effective as NiTi springs. Copyright © 2017. Published by Elsevier Masson SAS.

Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs.

PubMed

Kahan, Brennan C; Harhay, Michael O

2015-12-01

Adjustment for center in multicenter trials is recommended when there are between-center differences or when randomization has been stratified by center. However, common methods of analysis (such as fixed-effects, Mantel-Haenszel, or stratified Cox models) often require a large number of patients or events per center to perform well. We reviewed 206 multicenter randomized trials published in four general medical journals to assess the average number of patients and events per center and determine whether appropriate methods of analysis were used in trials with few patients or events per center. The median number of events per center/treatment arm combination for trials using a binary or survival outcome was 3 (interquartile range, 1-10). Sixteen percent of trials had less than 1 event per center/treatment combination, 50% fewer than 3, and 63% fewer than 5. Of the trials which adjusted for center using a method of analysis which requires a large number of events per center, 6% had less than 1 event per center-treatment combination, 25% fewer than 3, and 50% fewer than 5. Methods of analysis that allow for few events per center, such as random-effects models or generalized estimating equations (GEEs), were rarely used. Many multicenter trials contain few events per center. Adjustment for center using random-effects models or GEE with model-based (non-robust) standard errors may be beneficial in these scenarios. Copyright © 2015 Elsevier Inc. All rights reserved.

Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study.

PubMed

Fernando, Disala; Siederer, Sarah; Singh, Sunita; Schneider, Ian; Gupta, Ashutosh; Powell, Marcy; Richards, Duncan; McIntosh, Michelle P; Lambert, Peter; Fowles, Susan

2017-08-01

The utility of intramuscular (IM) oxytocin for the prevention of postpartum hemorrhage in resource-poor settings is limited by the requirement for temperature-controlled storage and skilled staff to administer the injection. We evaluated the safety, tolerability and pharmacokinetics (PK) of a heat-stable, inhaled (IH) oxytocin formulation. This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years. Subjects initially received IM oxytocin 10 international units (IU) on day 1, IH placebo on day 2, and IH oxytocin 50μg on day 3. Subjects were then randomized 4:1 using validated GSK internal software to IH placebo or ascending doses of IH oxytocin (200, 400, 600μg). PK was assessed by comparing systemic exposure (maximum observed plasma concentration, area under the concentration-time curve, and plasma concentrations at 10 and 30min post dose) for IH versus IM oxytocin. Adverse events (AEs), spirometry, laboratory tests, vital signs, electrocardiograms, physical examinations, and cardiac telemetry were assessed. Subjects were recruited between September 14, 2015 and October 12, 2015. Of the 16 subjects randomized following initial dosing, 15 (IH placebo n=3; IH oxytocin n=12) completed the study. IH (all doses) and IM oxytocin PK profiles were comparable in shape. However, systemic exposure with IH oxytocin 400μg most closely matched IM oxytocin 10IU. Systemic exposure was approximately dose proportional for IH oxytocin. No serious AEs were reported. No clinically significant findings were observed for any safety parameters. These data suggest that similar oxytocin systemic exposure can be achieved with IM and IH administration routes, and no safety concerns were identified with either route. The inhalation route may offer the opportunity to increase access to oxytocin for women giving birth in resource-poor settings. Copyright © 2017. Published by Elsevier B.V.

Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges.

PubMed

Lentz, Robert J; Argento, A Christine; Colby, Thomas V; Rickman, Otis B; Maldonado, Fabien

2017-07-01

Transbronchial lung biopsy with a cryoprobe, or cryobiopsy, is a promising new bronchoscopic biopsy technique capable of obtaining larger and better-preserved samples than previously possible using traditional biopsy forceps. Over two dozen case series and several small randomized trials are now available describing experiences with this technique, largely for the diagnosis of diffuse parenchymal lung disease (DPLD), in which the reported diagnostic yield is typically 70% to 80%. Cryobiopsy technique varies widely between centers and this predominantly single center-based retrospective literature heterogeneously defines diagnostic yield and complications, limiting the degree to which this technique can be compared between centers or to surgical lung biopsy (SLB). This review explores the broad range of cryobiopsy techniques currently in use, their rationale, the current state of the literature, and suggestions for the direction of future study into this promising but unproven procedure.

Effect of the cognitive-motor dual-task using auditory cue on balance of surviviors with chronic stroke: a pilot study.

PubMed

Choi, Wonjae; Lee, GyuChang; Lee, Seungwon

2015-08-01

To investigate the effect of a cognitive-motor dual-task using auditory cues on the balance of patients with chronic stroke. Randomized controlled trial. Inpatient rehabilitation center. Thirty-seven individuals with chronic stroke. The participants were randomly allocated to the dual-task group (n=19) and the single-task group (n=18). The dual-task group performed a cognitive-motor dual-task in which they carried a circular ring from side to side according to a random auditory cue during treadmill walking. The single-task group walked on a treadmill only. All subjects completed 15 min per session, three times per week, for four weeks with conventional rehabilitation five times per week over the four weeks. Before and after intervention, both static and dynamic balance were measured with a force platform and using the Timed Up and Go (TUG) test. The dual-task group showed significant improvement in all variables compared to the single-task group, except for anteroposterior (AP) sway velocity with eyes open and TUG at follow-up: mediolateral (ML) sway velocity with eye open (dual-task group vs. single-task group: 2.11 mm/s vs. 0.38 mm/s), ML sway velocity with eye close (2.91 mm/s vs. 1.35 mm/s), AP sway velocity with eye close (4.84 mm/s vs. 3.12 mm/s). After intervention, all variables showed significant improvement in the dual-task group compared to baseline. The study results suggest that the performance of a cognitive-motor dual-task using auditory cues may influence balance improvements in chronic stroke patients. © The Author(s) 2014.

A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation.

PubMed

Stevens, R B; Wrenshall, L E; Miles, C D; Farney, A C; Jie, T; Sandoz, J P; Rigley, T H; Osama Gaber, A

2016-06-01

A previous nonblinded, randomized, single-center renal transplantation trial of single-dose rabbit anti-thymocyte globulin induction (SD-rATG) showed improved efficacy compared with conventional divided-dose (DD-rATG) administration. The present multicenter, double-blind/double-dummy STAT trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated SD-rATG versus DD-rATG induction for noninferiority in early (7-day) safety and tolerability. Ninety-five patients (randomized 1:1) received 6 mg/kg SD-rATG or 1.5 mg/kg/dose DD-rATG, with tacrolimus-mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12-month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of SD-rATG induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown SD-rATG induction to be noninferior to DD-rATG induction in early tolerability and equivalent in 12-month safety. (Clinical Trials.gov #NCT00906204.). © Copyright 2016 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of the American Society of Transplantation and the American Society of Transplant Surgeons.

Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

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

Arruda Viani, Gustavo, E-mail: gusviani@gmail.com; Carrara Fonseca, Ellen; Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo

2012-03-01

Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment,more » both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.« less

Apical Transportation, Centering Ability, and Cleaning Effectiveness of Reciprocating Single-file System Associated with Different Glide Path Techniques.

PubMed

de Carvalho, Guilherme Moreira; Sponchiado Junior, Emílio Carlos; Garrido, Angela Delfina Bittencourt; Lia, Raphael Carlos Comelli; Garcia, Lucas da Fonseca Roberti; Marques, André Augusto Franco

2015-12-01

The aim of this study was to evaluate the apical transportation, the centering ability, and the cleaning effectiveness of a reciprocating single-file system associated to different glide path techniques. The mesial root canals of 52 mandibular molars were randomly distributed into 4 groups (n = 13) according to the different glide path techniques used before biomechanical preparation with Reciproc System (RS): KF/RS (sizes 10 and 15 K-files), NGP/RS (no glide path, only reciprocating system), PF/RS (sizes 13, 16, and 19 PathFile instruments), and NP (no preparation). Cone-beam computed tomography analysis was performed before and after instrumentation for apical third images acquisition. Apical transportation and its direction were evaluated by using the formula D = (X1 - X2) - (Y1 - Y2), and the centering ability was analyzed by the formula CC = (X1 - X2/Y1 - Y2 or Y1 - Y2/X1 - X2). The samples were submitted to histologic processing and analyzed under a digital microscope for debris quantification. The values were statistically analyzed (Kruskal-Wallis, the Dunn multiple comparisons test, P < .05). All groups had similar apical transportation values, with no significant difference among them (P > .05). Groups had a tendency toward transportation in the mesial direction. No technique had perfect centering ability (=1.0), with no significant difference among them. KF/RS had larger amount of debris, with statistically significant difference in comparison with NGP/RS (P > .05). The different glide path techniques promoted minimal apical transportation, and the reciprocating single-file system tested remained relatively centralized within the root canal. Also, the different techniques interfered in the cleaning effectiveness of the reciprocating system. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Single Dose Versus 3 Doses of Intramuscular Benzathine Penicillin for Early Syphilis in HIV: A Randomized Clinical Trial.

PubMed

Andrade, Roberto; Rodriguez-Barradas, Maria C; Yasukawa, Kosuke; Villarreal, Erick; Ross, Michael; Serpa, Jose A

2017-03-15

Patients coinfected with syphilis and human immunodeficiency virus (HIV) may have a slower decrease in rapid plasma reagin (RPR) titers. Currently a single dose of 2.4 million units of intramuscular benzathine penicillin G (BPG) is recommended for the treatment of early syphilis. Some observational studies have suggested that this regimen may lead to high failure rates in coinfected patients. We conducted an open-label randomized clinical trial to compare the efficacy of single-dose and 3-dose regimens of BPG for the treatment of early syphilis in HIV-infected individuals. RPR titers were monitored every 3 months. Treatment success was defined as a decrease in RPR titers of ≥2 dilutions (4-fold) during a 12-month follow-up period. Sixty-four patients were included. In the intention-to-treat analysis, treatment success rates were 80% (28 of 35 subjects) and 93% (27 of 29 subjects) in the single-dose and 3-dose regimens, respectively (absolute difference, 13% [95% confidence interval {CI}, -5% to 30%; P = .17). In the per-protocol analysis, success rates were 93% (27 of 29) and 100% in the single-dose and 3-dose regimens, respectively (absolute difference, 7% [95% CI, -7% to 22%]; P = .49). CD4 T-cell count, RPR titer and syphilis stage did not affect treatment results. When compared with a single dose of BPG, a 3-dose regimen did not improve syphilis serological outcomes. Our results support the Centers for Disease Control and Prevention recommendation of a single dose of BPG in HIV-infected patients with early syphilis. NCT02611765. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

[Topical hemostatic devices in surgery: between science and marketing].

PubMed

González, Héctor Daniel; Figueras Felip, Joan

2009-06-01

Topical hemostatic agents have been used in surgery with varying degrees of success. These agents include oxidized cellulose, absorbable gelatin sponges, microfibrillar collagen and fibrin seals. Fibrin seals have become widely used as they improve perioperative hemostasis, reduce the need for red blood cell transfusions and prevent biliary leaks. Their widespread use, however, contrasts with the scarcity of data from controlled studies to support their clinical effectiveness. Therefore, a prospective, randomized, controlled, single-center study was performed in 300 patients who underwent elective hepatectomy, with and without application of fibrin seal on the raw liver surface. None of the variables evaluated (blood loss, transfusions, biliary fistulas and postoperative results) differed between the two groups. We conclude that the application of fibrin seal does not seem justified and that discontinuing its routine use would substantially reduce costs. The use of a new agent, Tachosil, is supported by a single multicenter, prospective, randomized, controlled trial, which is limited by the small number of patients and by the fact that the variable analyzed--time from application to hemostasis--may not be clinically relevant.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

PubMed

Shirinsky, Ivan V; Biryukova, Anastasia A; Shirinsky, Valery S

2017-12-01

Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluating statins' efficacy and safety in uveitis. In this study, we aimed to investigate efficacy and safety of simvastatin in patients with uveitis. For this single-center, open-label, randomized study, we enrolled patients with acute non-infectious uveitis. The patients were randomized to receive 40 mg simvastatin per day for 2 months in addition to conventional treatment or conventional treatment alone. The studied outcomes were the rate of steroid-sparing control of ocular inflammation, measures of ocular inflammation, intraocular pressure, and visual acuity. Fifty patients were enrolled in the study. Twenty-five patients were randomly assigned to receive simvastatin with conventional treatment and 25 to conventional treatment alone. Simvastatin was associated with significantly higher rates of steroid-sparing ocular inflammation control, decrease in anterior chamber inflammation, and improvement in visual acuity. The treatment was well tolerated, no serious adverse effects were observed. Our findings suggest that statins may have therapeutic potential in uveitis. These results need to be confirmed in double-blind, randomized, controlled studies.

Representation of limb kinematics in Purkinje cell simple spike discharge is conserved across multiple tasks

PubMed Central

Hewitt, Angela L.; Popa, Laurentiu S.; Pasalar, Siavash; Hendrix, Claudia M.

2011-01-01

Encoding of movement kinematics in Purkinje cell simple spike discharge has important implications for hypotheses of cerebellar cortical function. Several outstanding questions remain regarding representation of these kinematic signals. It is uncertain whether kinematic encoding occurs in unpredictable, feedback-dependent tasks or kinematic signals are conserved across tasks. Additionally, there is a need to understand the signals encoded in the instantaneous discharge of single cells without averaging across trials or time. To address these questions, this study recorded Purkinje cell firing in monkeys trained to perform a manual random tracking task in addition to circular tracking and center-out reach. Random tracking provides for extensive coverage of kinematic workspaces. Direction and speed errors are significantly greater during random than circular tracking. Cross-correlation analyses comparing hand and target velocity profiles show that hand velocity lags target velocity during random tracking. Correlations between simple spike firing from 120 Purkinje cells and hand position, velocity, and speed were evaluated with linear regression models including a time constant, τ, as a measure of the firing lead/lag relative to the kinematic parameters. Across the population, velocity accounts for the majority of simple spike firing variability (63 ± 30% of Radj2), followed by position (28 ± 24% of Radj2) and speed (11 ± 19% of Radj2). Simple spike firing often leads hand kinematics. Comparison of regression models based on averaged vs. nonaveraged firing and kinematics reveals lower Radj2 values for nonaveraged data; however, regression coefficients and τ values are highly similar. Finally, for most cells, model coefficients generated from random tracking accurately estimate simple spike firing in either circular tracking or center-out reach. These findings imply that the cerebellum controls movement kinematics, consistent with a forward internal model that predicts upcoming limb kinematics. PMID:21795616

Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial.

PubMed

Tao, Jing; Rao, Ting; Lin, Lili; Liu, Wei; Wu, Zhenkai; Zheng, Guohua; Su, Yusheng; Huang, Jia; Lin, Zhengkun; Wu, Jinsong; Fang, Yunhua; Chen, Lidian

2015-02-25

Balance dysfunction after stroke limits patients' general function and participation in daily life. Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals' balance function and reduce the risk of falls. But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate. Considering the difficulties for stroke patients to complete the whole exercise, the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization, parallel-controlled design. A single-blind, cluster-randomized, parallel-controlled trial will be conducted. A total of 10 community health centers (5 per arm) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group. Each community health centers will be asked to enroll 25 eligible patients into the trial. 60 minutes per each session, 1 session per day, 5 times per week and the total training round is 12 weeks. Primary and secondary outcomes will be measured at baseline and 4-weeks, 8-weeks, 12-weeks, 6-week follow-up, 12-week follow-up after randomization. Safety and economic evaluation will also be assessed. This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke. If the outcome is positive, this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients. Chinese Clinical Trial Registry: ChiCTR-TRC-13003641. Registration date: 22 August, 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .

Comparative evaluation of canal transportation, centering ability, and remaining dentin thickness between WaveOne and ProTaper rotary by using cone beam computed tomography: An in vitro study

PubMed Central

Jain, Aditi; Asrani, Hemant; Singhal, Abhinav Chand; Bhatia, Taranjeet Kaur; Sharma, Vaibhav; Jaiswal, Pragya

2016-01-01

Aims: To compare the canal transportation, centering ability, and remaining dentin thickness of WaveOne and ProTaper systems using cone beam computed tomography. Subjects and Methods: Forty extracted human single-rooted premolars were used in the present study. Preinstrumentation scanning of all teeth was taken; canal curvatures were calculated, and the samples were randomly divided into two groups, with twenty samples in each group; one group was instrumented with WaveOne system and the other group with ProTaper rotary system. Postinstrumentation scans were performed, and the two scans were compared to determine canal transportation, centering ability, and remaining dentin thickness at 3 mm, 6 mm, and 9 mm from the root apex. Statistical Analysis Used: Student's unpaired t-test. Results: Using Student's unpaired t-test, results were as follows: for canal transportation, Group 1 showed significant difference at 3 mm and 6 mm and insignificant difference at 9 mm while Group 2 showed insignificant difference in all the three regions. For centering ability and remaining dentin thickness, Group 1 showed insignificant difference at 3 mm and 9 mm while significant difference at 6 mm was obtained. When comparison of remaining dentin thickness was done at three levels using two groups WaveOne and ProTaper, there was no significant difference between two groups. Conclusions: (1) WaveOne single reciprocation file system respected better canal anatomy better than ProTaper. (2) Individually, centering ability of WaveOne was better at 3 mm, 6 mm, and 9 mm levels. (3) However, ProTaper individually was better centered at 3 mm (apical third) and 9 mm (coronal 3rd) levels than 6 mm level (middle third). PMID:27656063

A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol.

PubMed

Hickey, Kathleen T; Hauser, Nicole R; Valente, Laura E; Riga, Teresa C; Frulla, Ashton P; Masterson Creber, Ruth; Whang, William; Garan, Hasan; Jia, Haomiao; Sciacca, Robert R; Wang, Daniel Y

2016-07-16

Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia, affecting an estimated 2.7 million Americans. The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic; therefore, it is challenging to detect and record an occurrence in a "real world" setting. To date, mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated. This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality-adjusted life years. Furthermore, sending a daily electrocardiogram transmission, coupled with receiving educational and motivational text messages aimed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions (e.g., hypertension, diabetes, heart failure, etc.). Therefore, we are currently conducting a randomized controlled trial to assess the efficacy of a mobile health intervention, iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) versus usual cardiac care. The iHEART study is a single center, prospective, randomized controlled trial. A total of 300 participants with a recent history of atrial fibrillation will be enrolled. Participants will be randomized 1:1 to receive the iHEART intervention, receiving an iPhone® equipped with an AliveCor® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months. This will be the first study to investigate the utility of a mobile health intervention in a "real world" setting. We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention's impact on improving clinical outcomes, quality of life, quality-adjusted life-years and disease-specific knowledge. NCT02731326 ; Verified April 2016.

Combined Cognitive-Strategy and Task-Specific Training Affects Cognition and Upper-Extremity Function in Subacute Stroke: An Exploratory Randomized Controlled Trial

PubMed Central

Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; McEwen, Sara

2016-01-01

The purpose of this study was to estimate the effect of Cognitive Orientation to Daily Occupational Performance (CO–OP) compared with usual occupational therapy on upper-extremity movement, cognitive flexibility, and stroke impact in people less than 3 mo after stroke. An exploratory, single-blind randomized controlled trial was conducted with people referred to outpatient occupational therapy services at two rehabilitation centers. Arm movement was measured with the Action Research Arm Test, cognitive flexibility with the Delis–Kaplan Executive Function System Trail Making subtest, and stroke impact with subscales of the Stroke Impact Scale. A total of 35 participants were randomized, and 26 completed the intervention. CO–OP demonstrated measurable effects over usual care on all measures. These data provide early support for the use of CO–OP to improve performance and remediate cognitive and arm movement impairments after stroke over usual care; however, future study is warranted to confirm the effects observed in this trial. PMID:26943113

Mashing up metals with carbothermal shock

NASA Astrophysics Data System (ADS)

Skrabalak, Sara E.

2018-03-01

Different materials and the capabilities they enabled have marked the ages of civilization. For example, the malleable copper alloys of the Bronze Age provided harder and more durable tools. Most exploration of new alloys has focused on random alloys, in which the alloying metal sites have no metal preference. In binary and ternary metal systems, dissimilar elements do not mix readily at high concentrations, which has limited alloying studies to intermetallics (ordered multimetallic phases) and random alloys, in which minor components are added to a principal element. In 2004, crystalline metal alloys consisting of five or more principal elements in equal or nearly equal amounts (1, 2) were reported that were stabilized by their high configurational entropy. Unlike most random alloys, the “high-entropy” alloys (3, 4) reside in the centers of their multidimensional phase diagrams (see the figure, right). On page 1489 of this issue, Yao et al. (5) present an innovative and general route to high-entropy alloys that can mix up to eight elements into single-phase, size-controlled nanoparticles (NPs).

High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study.

PubMed

Luo, Fang; Wang, Tao; Shen, Ying; Meng, Lan; Lu, Jingjing; Ji, Nan

2017-05-01

A recent study showed that 50% of patients who suffered from refractory neuralgia of the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment. A pilot study showed that increasing the output voltage of PRF significantly improved the efficacy for trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve the treatment outcomes for neuralgia of the infraorbital nerve is unknown. To evaluate the efficacy and safety of high voltage PRF treatment in comparison with standard voltage PRF for neuralgia of the infraorbital nerve. Prospective, single-center, double-blinded, randomized, controlled trial. Beijing Tiantan Hospital, Capital Medical University. A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomly divided into the high voltage PRF group and the standard voltage PRF group to treat their infraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew the patient group assignments. The primary outcome measure was the one-year response rate. The secondary outcome measures included the time to take effect after PRF, the one-month, 3-month, and 6-month response rates, the relapse rate, and adverse reactions. The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and one-year response rates were all 90% in the high voltage group, which were significantly higher than the rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60% [P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% of the patients in the standard voltage group experienced minor transient (10 - 30 days) numbness in the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups (P > 0.05). We did not investigate the dose-effect relationship between the output voltage and efficacy or the effect of a higher pulse dose on efficacy. This study was a single-center study, and multi-center, randomized, controlled studies are needed to obtain the highest level of empirical evidence. Additionally, the follow-up period lasted only one year in this study; thus, long-term efficacy needs to be further confirmed. The results showed that high voltage PRF was effective and safe for patients with refractory neuralgia of the infraorbital nerve and could become a treatment option in patients who do not respond to conservative treatment.

Patient-centered outcomes comparing digital and conventional implant impression procedures: a randomized crossover trial.

PubMed

Joda, Tim; Brägger, Urs

2016-12-01

The aim of this randomized controlled trial was to compare patient-centered outcomes during digital and conventional implant impressions. In a crossover study design, intraoral scanning (IOS) [test] as well as classical polyether impressions [control] were both performed on 20 patients for single-tooth replacement with implant-supported crowns. The sequential distribution of either starting with the test or the control procedure was randomly selected. Patients' perception and satisfaction on the level of convenience-related factors were assessed with visual analogue scale (VAS) questionnaires. In addition, clinical work time was separately recorded for test and control procedures. Statistical analyses were performed with Wilcoxon signed-rank tests and corrected for multiple testing by the method of Holm. On VAS ranging from 0 to 100, patients scored a mean convenience level of 78.6 (SD ± 14.0) in favor of IOS compared to conventional impressions with 53.6 (SD ± 15.4) [P = 0.0001]. All included patients would prefer the digital workflow if in the future they could choose between the two techniques. Secondary, IOS was significantly faster with 14.8 min (SD ± 2.2) compared to the conventional approach with 17.9 min (SD ± 1.1) [P = 0.0001]. Based on the findings of this investigation, both impression protocols worked successfully for all study participants capturing the 3D implant positions. However, the digital technique emerges as the most preferred one according to patient-centered outcomes and was more time-effective compared to conventional impressions. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Obstacles in Using Randomization Tests in Single-Case Experimentation.

ERIC Educational Resources Information Center

Kazdin, Alan E.

1980-01-01

Problems associated with randomization tests in single- case experiments are discussed. This article follows a discussion of randomization tests in single case studies in the same issue of this journal. (See TM 505 799; 505 801).(Author/JKS)

A comparative assessment of enamel mineral content and Streptococcus mutans population between conventional composites and composites containing nano amorphous calcium phosphate in fixed orthodontic patients: a split-mouth randomized clinical trial.

PubMed

Jahanbin, Arezoo; Farzanegan, Fahimeh; Atai, Mohammad; Jamehdar, Saeed Amel; Golfakhrabadi, Parvaneh; Shafaee, Hooman

2017-02-01

The aim of this 'split-mouth design' trial was to evaluate the effect of the nano amorphous calcium phosphate (NACP) containing composite on enamel mineral contents and streptococcus mutans population in fixed orthodontic patients. Randomized, prospective, single-center controlled trial. Twenty-four patients between the ages of 13-18 years participated in this study. The control and test sides were randomly selected by a coin toss (1:1 ratio). On the control side orthodontic brackets were bonded on the buccal surfaces of upper premolars and laterals using an orthodontic composite (Transbond XT), and on the study side NACP-containing composite was used. Outcome measures were the mineral content around the brackets and S.mutans count. The later were calculated in the plaque around the brackets by real-time PCR at 3 months, and 6 months after the initiation of treatment. All stages of the study were blind using coding system. Paired t-test and repeated measurements were used for data analysis. In the third and sixth month, the bacterial population was significantly lower in the study side than the control side (P = 0.01 and 0.000).The mineral content of the study side was significantly higher than the controls, 6 months after brocket bonding (P = 0.004). There were no significant differences between the premolars and lateral teeth for all measurements. This research was performed in a single-center by one experienced clinician. NACP-containing composites have the potential to inhibit mineral content loss and S.mutans colonization around orthodontic brackets during fixed orthodontic treatments. This trial was not registered. The protocol was not published before trial commencement. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.

PubMed

Mathiassen, Ole N; Vase, Henrik; Bech, Jesper N; Christensen, Kent L; Buus, Niels H; Schroeder, Anne P; Lederballe, Ole; Rickers, Hans; Kampmann, Ulla; Poulsen, Per L; Hansen, Klavs W; Btker, Hans E; Peters, Christian D; Engholm, Morten; Bertelsen, Jannik B; Lassen, Jens F; Langfeldt, Sten; Andersen, Gratien; Pedersen, Erling B; Kaltoft, Anne

2016-08-01

Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ± 18.8 mmHg (RDN) vs. -6.0 ± 13.5 mmHg (SHAM)] and at 6 months [-6.1 ± 18.9 mmHg (RDN) vs. -4.3 ± 15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ± 2.7 (RDN) vs. 7.0 ± 2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

Transcutaneous Electrical Nerve Stimulation Reduces Post-Thoractomy Ipsilateral Shoulder Pain. A Prospective Randomized Study.

PubMed

Esteban González, Pedro; Novoa, Nuria M; Varela, Gonzalo

2015-12-01

The patient's position during an axillary thoracotomy can cause postoperative pain and decrease mobility of the ipsilateral shoulder. In this study, we assessed whether the implementation of a standardized analgesia program using transcutaneous electrical nerve stimulation (TENS) decreases local pain and improves ipsilateral shoulder mobility. Randomized, single-blind, single-center clinical trial of 50 patients who had undergone anatomical lung resection via axillary muscle-sparing thoracotomy. Patients were treated with TENS devices for 30 minutes every 8 hours, beginning on postoperative day 1. Pain and mobility of the affected limb were recorded at the same time on postoperative days 1 through 3. A visual analogue scale was used for pain assessment and shoulder mobility was assessed with a goniometer. Results were compared using a non-parametric test. Twenty-five patients were randomized to each group. Mean age of the control group was 62.7±9.3 years and 63.4±10.2 years in the experimental group. Shoulder mobility parameters were similar in both groups on all postoperative days. However, pain during flexion significantly decreased on day 2 (P=.03) and day 3 (P=.04) in the experimental group. The use of TENS decreases pain from shoulder flexion in patients undergoing axillary thoracotomy for pulmonary resection. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial.

PubMed

Kloeckner, Roman; Ruckes, Christian; Kronfeld, Kai; Wörns, Marcus Alexander; Weinmann, Arndt; Galle, Peter Robert; Lang, Hauke; Otto, Gerd; Eichhorn, Waltraud; Schreckenberger, Mathias; Dueber, Christoph; Pitton, Michael Bernhard

2014-08-06

Cholangiocellular carcinoma is the second most common primary liver cancer after hepatocellular carcinoma. Over the last 30 years, the incidence of intrahepatic cholangiocellular carcinoma has risen continuously worldwide. Meanwhile, the intrahepatic cholangiocellular carcinoma has become more common than the extrahepatic growth type and currently accounts for 10-15% of all primary hepatic malignancies. Intrahepatic cholangiocellular carcinoma is typically diagnosed in advanced stages due to late clinical symptoms and an absence of classic risk factors. A late diagnosis precludes curative surgical resection. There is evidence that transarterial chemoembolization leads to better local tumor control and prolongs survival compared to systemic chemotherapy. New data indicates that selective internal radiotherapy, also referred to as radioembolization, provides promising results for treating intrahepatic cholangiocellular carcinoma. This pilot study is a randomized, controlled, single center, phase II trial. Twenty-four patients with intrahepatic cholangiocellular carcinoma will be randomized in a 1:1 ratio to receive either chemoembolization or radioembolization. Randomization will be stratified according to tumor load. Progression-free survival is the primary endpoint; overall survival and time to progression are secondary endpoints. To evaluate treatment success, patients will receive contrast enhanced magnetic resonance imaging every 3 months. Currently, chemoembolization is routinely performed in many centers instead of systemic chemotherapy for treating intrahepatic cholangiocellular carcinoma confined to the liver. Recently, radioembolization has been increasingly applied to cholangiocellular carcinoma as second line therapy after TACE failure or even as an alternative first line therapy. Nonetheless, no randomized studies have compared radioembolization and chemoembolization. Considering all this background information, we recognized a strong need for a randomized controlled trial (RCT) to compare the two treatments. Therefore, the present protocol describes the design of a RCT that compares SIRT and TACE as the first line therapy for inoperable CCC confined to the liver. ClinicalTrials.gov, Identifier: NCT01798147, registered 16th of February 2013.

Donepezil improved memory in multiple sclerosis in a randomized clinical trial.

PubMed

Krupp, L B; Christodoulou, C; Melville, P; Scherl, W F; MacAllister, W S; Elkins, L E

2004-11-09

To determine the effect of donepezil in treating memory and cognitive dysfunction in multiple sclerosis (MS). This single-center double-blind placebo-controlled clinical trial evaluated 69 MS patients with cognitive impairment who were randomly assigned to receive a 24-week treatment course of either donepezil (10 mg daily) or placebo. Patients underwent neuropsychological assessment at baseline and after 24 weeks of treatment. The primary outcome was change in verbal learning and memory on the Selective Reminding Test (SRT). Secondary outcomes included other tests of cognitive function, patient-reported change in memory, and clinician-reported impression of cognitive change. Donepezil-treated patients showed significant improvement in memory performance on the SRT compared to placebo (p = 0.043). The benefit of donepezil remained significant after controlling for various covariates including age, Expanded Disability Status Scale, baseline SRT score, reading ability, MS subtype, and sex. Donepezil-treated patients did not show significant improvements on other cognitive tests, but were more than twice as likely to report memory improvement than those in the placebo group (p = 0.006). The clinician also reported cognitive improvement in almost twice as many donepezil vs placebo patients (p = 0.036). No serious adverse events related to study medication occurred, although more donepezil (34.3%) than placebo (8.8%) subjects reported unusual/abnormal dreams (p = 0.010). Donepezil improved memory in MS patients with initial cognitive impairment in a single center clinical trial. A larger multicenter investigation of donepezil in MS is warranted in order to more definitively assess the efficacy of this intervention.

Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial.

PubMed

Banerjee, Rupa; Chaudhari, Hrushikesh; Shah, Nirish; Saravanan, Arjunan; Tandan, Manu; Reddy, D Nageshwar

2016-10-13

Adequate bowel preparation is an essential prerequisite for complete mucosal visualization during colonoscopy. Polyethylene glycol (PEG) solutions are commonly used. However the large volume of the solution is often poorly tolerated. Addition of Lubiprostone (LB) could improve the adequacy of standard PEG preparation & reduce requirement. The aims to assess adequacy of PEG preparation with addition of single dose LB (24mcg) vs placebo and efficacy of reduced dose PEG + LB compared with full dose PEG + LB. Single center prospective double blind randomized controlled trial. Part I: 442 patients for colonoscopy randomized to receive placebo (GrA) or single dose of LB (GrB) prior to PEG preparation. Quality of bowel preparation graded 0-9 according to Boston Bowel Preparation Scale (BBPS). BBPS-9: excellent and BBPS 0-4: repeat procedure. Part II: 146 patients randomized to receive LB + 1.5 L PEG (GrC; 75) or LB + 1 L PEG (GrD; 71). BBPS score compared with GrB (2 L PEG). Part I: 442 patients (221 GrA & 221 Gr B). LB resulted in significant improvement in total BBPS (7.44 + 0.14 vs. 6.36 + 0.16, p < 0.0001). 66.5 % Gr B vs 38 % Gr A had excellent prep; 42.5 % GrB vs 24 % GrA had adequate prep. Repeat procedure needed 9.5 % Gr B vs 16.7 % Gr A (P < 0.01). Part II: No difference in BBPS scores with lower doses (Gr C&D) compared to standard (GrB) (Mean BBPS 7.44 + 0.14 GrA,7.30 + 0.25 GrC;7.25 + 0.26 GrD;p >0.05). Single dose LB prior to PEG significantly enhanced bowel preparation compared to PEG alone. There was no significant difference in quality of preparation with lower doses of PEG when combined with LB. The study protocol was approved by institutional review board and the trial was registered on March 22, 2011 with clinicaltrials.gov ( NCT01324284 ).

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

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 becomes available for investigator-initiated trials and potentially for large multi-center trials.

Metallic VS2 Monolayer Polytypes as Potential Sodium-Ion Battery Anode via ab Initio Random Structure Searching.

PubMed

Putungan, Darwin Barayang; Lin, Shi-Hsin; Kuo, Jer-Lai

2016-07-27

We systematically investigated the potential of single-layer VS2 polytypes as Na-battery anode materials via density functional theory calculations. We found that sodiation tends to inhibit the 1H-to-1T structural phase transition, in contrast to lithiation-induced transition on monolayer MoS2. Thus, VS2 can have better structural stability in the cycles of charging and discharging. Diffussion of Na atom was found to be very fast on both polytypes, with very small diffusion barriers of 0.085 eV (1H) and 0.088 eV (1T). Ab initio random structure searching was performed in order to explore stable configurations of Na on VS2. Our search found that both the V top and the hexagonal center sites are preferred adsorption sites for Na, with the 1H phase showing a relatively stronger binding. Notably, our random structures search revealed that Na clusters can form as a stacked second layer at full Na concentration, which is not reported in earlier works wherein uniform, single-layer Na adsorption phases were assumed. With reasonably high specific energy capacity (232.91 and 116.45 mAh/g for 1H and 1T phases, respectively) and open-circuit voltage (1.30 and 1.42 V for 1H and 1T phases, respectively), VS2 is a promising alternative material for Na-ion battery anodes with great structural sturdiness. Finally, we have shown the capability of the ab initio random structure searching in the assessment of potential materials for energy storage applications.

A randomized controlled trial of electrocoagulation-enabled biopsy versus conventional biopsy in the diagnosis of endobronchial lesions.

PubMed

Khan, Ajmal; Aggarwal, Ashutosh N; Agarwal, Ritesh; Bal, Amanjit; Gupta, Dheeraj

2011-01-01

Although electrocoagulation at time of endobronchial biopsy can potentially reduce procedure-related bleeding during fiberoptic bronchoscopy (FOB), it can also impair quality of tissue specimen; credible data for either are lacking. To evaluate the impact of hot biopsy on the quality of tissue samples and to quantify the amount of procedure-related bleeding during endobronchial biopsy. In this single-center, prospective, single-blind, randomized controlled study we included adult patients referred for FOB and having endobronchial lesions. Patients were randomized to bronchial biopsy using an electrocoagulation-enabled biopsy forceps, with (EC+ group) or without (EC- group) application of electrocoagulation current (40 W for 10 s in a monopolar mode). Procedure-related bleeding was semi-quantified by observer description, as well as through a visual analogue scale. Overall quality of biopsy specimen and tissue damage were assessed and graded by a pulmonary pathologist blinded to FOB details. 160 patients were randomized to endobronchial biopsy with (n = 81) or without (n = 79) the application of electrocoagulation. There were no severe bleeding episodes in either group, and severity of bleeding in the EC+ and EC- groups was similar (median visual analogue scale scores of 14 and 16, respectively). Histopathological diagnosis was similar in the EC+ and EC- groups (77.8% and 82.3%, respectively). There was no significant difference in tissue quality between the two groups. Use of electrocoagulation-enabled endobronchial biopsy does not alter specimen quality and does not result in any significant reduction in procedure-related bleeding. Copyright © 2010 S. Karger AG, Basel.

Chemotaxis in densely populated tissue determines germinal center anatomy and cell motility: a new paradigm for the development of complex tissues.

PubMed

Hawkins, Jared B; Jones, Mark T; Plassmann, Paul E; Thorley-Lawson, David A

2011-01-01

Germinal centers (GCs) are complex dynamic structures that form within lymph nodes as an essential process in the humoral immune response. They represent a paradigm for studying the regulation of cell movement in the development of complex anatomical structures. We have developed a simulation of a modified cyclic re-entry model of GC dynamics which successfully employs chemotaxis to recapitulate the anatomy of the primary follicle and the development of a mature GC, including correctly structured mantle, dark and light zones. We then show that correct single cell movement dynamics (including persistent random walk and inter-zonal crossing) arise from this simulation as purely emergent properties. The major insight of our study is that chemotaxis can only achieve this when constrained by the known biological properties that cells are incompressible, exist in a densely packed environment, and must therefore compete for space. It is this interplay of chemotaxis and competition for limited space that generates all the complex and biologically accurate behaviors described here. Thus, from a single simple mechanism that is well documented in the biological literature, we can explain both higher level structure and single cell movement behaviors. To our knowledge this is the first GC model that is able to recapitulate both correctly detailed anatomy and single cell movement. This mechanism may have wide application for modeling other biological systems where cells undergo complex patterns of movement to produce defined anatomical structures with sharp tissue boundaries.

High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.

PubMed

Kudo, Taiki; Kawakami, Hiroshi; Hayashi, Tsuyoshi; Yasuda, Ichiro; Mukai, Tsuyoshi; Inoue, Hiroyuki; Katanuma, Akio; Kawakubo, Kazumichi; Ishiwatari, Hirotoshi; Doi, Shinpei; Yamada, Reiko; Maguchi, Hiroyuki; Isayama, Hiroyuki; Mitsuhashi, Tomoko; Sakamoto, Naoya

2014-12-01

EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. Prospective, single-blind, randomized, controlled crossover trial. Seven tertiary referral centers. Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. EUS-FNA by using NNP and HNP. The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. This was a single-blinded, crossover study. Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. ( UMIN000005939.). Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1): A Systematic Review.

PubMed

Pepper, Dominique J; Jaswal, Dharmvir; Sun, Junfeng; Welsh, Judith; Natanson, Charles; Eichacker, Peter Q

2018-04-17

This article has been corrected. To see what has changed, please read the Letter to the Editor and the authors' response. The original version (PDF) is appended to this article as a Supplement. The Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), the sepsis performance measure introduced in 2015 by the Centers for Medicare & Medicaid Services (CMS), requires the reporting of up to 5 hemodynamic interventions, as many as 141 tasks, and 3 hours to document for a single patient. To evaluate whether moderate- or high-level evidence shows that use of the 2015 SEP-1 or its hemodynamic interventions improves survival in adults with sepsis. PubMed, Embase, Scopus, Web of Science, and ClinicalTrials.gov from inception to 28 November 2017 with no language restrictions. Randomized and observational studies of death among adults with sepsis who received versus those who did not receive either the entire SEP-1 bundle or 1 or more SEP-1 hemodynamic interventions, including serial lactate measurements; a fluid infusion of 30 mL/kg of body weight; and assessment of volume status and tissue perfusion with a focused examination, bedside cardiovascular ultrasonography, or fluid responsiveness testing. Two investigators independently extracted study data and assessed each study's risk of bias; 4 authors rated level of evidence by consensus using CMS criteria published in 2013. High- or moderate-level evidence required studies to have no confounders and low risk of bias. Of 56 563 references, 20 studies (18 reports) met inclusion criteria. One single-center observational study reported lower in-hospital mortality after implementation of the SEP-1 bundle. Sixteen studies (2 randomized and 14 observational) reported increased survival with serial lactate measurements or 30-mL/kg fluid infusions. None of the 17 studies were free of confounders or at low risk of bias. In 3 randomized trials, fluid responsiveness testing did not alter survival. Few trials, poor-quality and confounded studies, and no studies (with survival outcomes) of the focused examination or bedside cardiovascular ultrasonography. Use of the 2015 version of SEP-1 and 2013 version of CMS evidence criteria, both of which were updated in 2017. No high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis. National Institutes of Health. (PROSPERO: CRD42016052716).

Indirect vs direct bonding of mandibular fixed retainers in orthodontic patients: a single-center randomized controlled trial comparing placement time and failure over a 6-month period.

PubMed

Bovali, Efstathia; Kiliaridis, Stavros; Cornelis, Marie A

2014-12-01

The objective of this 2-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure. Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure. Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines, and no active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4; the randomization sequence was generated using an online randomization service (www.randomization.com). Allocation concealment was secured by contacting the sequence generator for treatment assignment; blinding was possible for outcome assessment only. Bonding time was measured for each procedure. Unpaired t tests were used to assess differences in time. Patients were recalled at 1, 2, 4, and 6 months after bonding. Mandibular fixed retainers having at least 1 composite pad debonded were considered as failures. The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures. A test of proportion was applied to compare the failures at 6 months between the treatment groups. Sixty-four patients were randomized in a 1:1 ratio. One patient dropped out at baseline after the bonding procedure, and 3 patients did not attend the recalls at 4 and 6 months. Bonding time was significantly shorter for the indirect procedure (321 ± 31 seconds, mean ± SD) than for the direct procedure (401 ± 40 seconds) (per protocol analysis of 63 patients: mean difference = 80 seconds; 95% CI = 62.4-98.1; P <0.001). The 6-month numbers of failures were 10 of 31 (32%) with the indirect technique and 7 of 29 (24%) with the direct technique (log rank: P = 0.35; test of proportions: risk difference = 0.08; 95% CI = -0.15 to 0.31; P = 0.49). No serious harm was observed except for plaque accumulation. Indirect bonding was statistically significantly faster than direct bonding, with both techniques showing similar risks of failure. This trial was not registered. The protocol was not published before trial commencement. No funding or conflict of interest to be declared. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes.

PubMed

Reitsma, Angela; Chu, Rong; Thorpe, Julia; McDonald, Sarah; Thabane, Lehana; Hutton, Eileen

2014-09-26

Clustering of outcomes at centers involved in multicenter trials is a type of center effect. The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials (RCTs) should account for center effects in their analysis, however most do not. The Early External Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center at randomization, but did not account for center in the analyses, and due to the nature of the intervention and number of centers, may have been prone to center effects. Using data from the EECV trials, we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing (early or delayed) on the outcomes of cesarean section, preterm birth, and non-cephalic presentation at the time of birth. The data from the EECV pilot trial and the EECV2 trial were merged into one dataset. Fisher's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects. Seven statistical models that accounted for center effects were applied to the data. The models included: i) the Mantel-Haenszel test, ii) logistic regression with fixed center effect and fixed treatment effect, iii) center-size weighted and iv) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction, iv) logistic regression with random center effect and fixed treatment effect, v) logistic regression with random center effect and random treatment-by-center interaction, and vi) generalized estimating equations. For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial. The results were similar for the majority of the methods used to adjust for center, illustrating the robustness of the findings. Despite literature that suggests center effect can change the estimate of effect in multicenter trials, this empirical study does not show a difference in the outcomes of the EECV trials when accounting for center effect. The EECV2 trial was registered on 30 July 30 2005 with Current Controlled Trials: ISRCTN 56498577.

Pharmacokinetics and Bioequivalence Evaluation of 2 Loxoprofen Tablets in Healthy Egyptian Male Volunteers.

PubMed

Helmy, Sally A

2013-04-01

The objective of this study was to assess the in vitro dissolution and to evaluate the bioavailability of two brands of Loxoprofen sodium dihydrate tablets. Loxoprofen tablets (68.1 mg loxoprofen sodium dihydrate equivalent to 60 mg loxoprofen; test) relative to Roxonin tablets (68.1 mg loxoprofen sodium dihydrate equivalent to 60 mg loxoprofen; reference). In vitro study was adopted to determine and compare the dissolution behavior of both products. In vivo study was conducted according to a single-center, randomized, single-dose, and laboratory-blinded, 2-period, 2-sequence, crossover design with a washout period of 1 week. Under fasting conditions, 24 healthy Egyptian adult male volunteers were randomly allocated to receive a single dose of either test or reference product. Blood samples were collected at specified time intervals, and plasma was analyzed for loxoprofen concentrations using a validated high-performance liquid chromatography assay method. The pharmacokinetic parameters Cmax , AUC0-t , AUC0-∞ , tmax , and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio Cmax , AUC0-t , and AUCt-∞ of the test product over those of reference were within the acceptable range (0.8-1.25) for bioequivalence. On the basis of these results, the two-loxoprofen formulations are considered bioequivalent. © The Author(s) 2013.

Tecarfarin, a novel vitamin K reductase antagonist, is not affected by CYP2C9 and CYP3A4 inhibition following concomitant administration of fluconazole in healthy participants.

PubMed

Bavisotto, Linda M; Ellis, David J; Milner, Peter G; Combs, Daniel L; Irwin, Ian; Canafax, Daniel M

2011-04-01

Comparative pharmacokinetics of vitamin K epoxide reductase antagonists tecarfarin and warfarin were assessed before and after coadministration for 21 days of the CYP450 inhibitor fluconazole in a randomized, open-label, single-center drug interaction study. Twenty healthy adult participants were randomized 1:1 to receive approximately equipotent single oral doses of tecarfarin (50 mg) or warfarin (17.5 mg). Following 7 days of baseline serial blood level collections, each participant received oral fluconazole 400 mg daily for 21 days. A second identical single oral dose of tecarfarin or warfarin was given 14 days after starting fluconazole with serial pharmacokinetic sampling. Key pharmacokinetic parameters C(max), t(max), AUC(0-168), apparent clearance, and t(1/2) demonstrated no tecarfarin-fluconazole interaction but a strong warfarin-fluconazole interaction. The ratio of log-transformed mean AUC(0-168) with versus without fluconazole for tecarfarin was 91.2% (90% confidence interval [CI]: 83.3-99.8) and for racemic warfarin was 213% (90% CI: 202-226). The 90% CI was entirely within the standard 80% to 125% bioequivalence interval for tecarfarin but well outside the bioequivalence interval for warfarin, confirming a clinically significant pharmacokinetic interaction between warfarin and fluconazole. In contrast, tecarfarin pharmacokinetics were apparently unchanged by fluconazole.

Evolution of the concentration PDF in random environments modeled by global random walk

NASA Astrophysics Data System (ADS)

Suciu, Nicolae; Vamos, Calin; Attinger, Sabine; Knabner, Peter

2013-04-01

The evolution of the probability density function (PDF) of concentrations of chemical species transported in random environments is often modeled by ensembles of notional particles. The particles move in physical space along stochastic-Lagrangian trajectories governed by Ito equations, with drift coefficients given by the local values of the resolved velocity field and diffusion coefficients obtained by stochastic or space-filtering upscaling procedures. A general model for the sub-grid mixing also can be formulated as a system of Ito equations solving for trajectories in the composition space. The PDF is finally estimated by the number of particles in space-concentration control volumes. In spite of their efficiency, Lagrangian approaches suffer from two severe limitations. Since the particle trajectories are constructed sequentially, the demanded computing resources increase linearly with the number of particles. Moreover, the need to gather particles at the center of computational cells to perform the mixing step and to estimate statistical parameters, as well as the interpolation of various terms to particle positions, inevitably produce numerical diffusion in either particle-mesh or grid-free particle methods. To overcome these limitations, we introduce a global random walk method to solve the system of Ito equations in physical and composition spaces, which models the evolution of the random concentration's PDF. The algorithm consists of a superposition on a regular lattice of many weak Euler schemes for the set of Ito equations. Since all particles starting from a site of the space-concentration lattice are spread in a single numerical procedure, one obtains PDF estimates at the lattice sites at computational costs comparable with those for solving the system of Ito equations associated to a single particle. The new method avoids the limitations concerning the number of particles in Lagrangian approaches, completely removes the numerical diffusion, and speeds up the computation by orders of magnitude. The approach is illustrated for the transport of passive scalars in heterogeneous aquifers, with hydraulic conductivity modeled as a random field.

Physical constraints of cultural evolution of dialects in killer whales.

PubMed

Filatova, Olga A; Samarra, Filipa I P; Barrett-Lennard, Lance G; Miller, Patrick J O; Ford, John K B; Yurk, Harald; Matkin, Craig O; Hoyt, Erich

2016-11-01

Odontocete sounds are produced by two pairs of phonic lips situated in soft nares below the blowhole; the right pair is larger and is more likely to produce clicks, while the left pair is more likely to produce whistles. This has important implications for the cultural evolution of delphinid sounds: the greater the physical constraints, the greater the probability of random convergence. In this paper the authors examine the call structure of eight killer whale populations to identify structural constraints and to determine if they are consistent among all populations. Constraints were especially pronounced in two-voiced calls. In the calls of all eight populations, the lower component of two-voiced (biphonic) calls was typically centered below 4 kHz, while the upper component was typically above that value. The lower component of two-voiced calls had a narrower frequency range than single-voiced calls in all populations. This may be because some single-voiced calls are homologous to the lower component, while others are homologous to the higher component of two-voiced calls. Physical constraints on the call structure reduce the possible variation and increase the probability of random convergence, producing similar calls in different populations.

Density and energy relaxation in an open one-dimensional system

NASA Astrophysics Data System (ADS)

Jose, Prasanth P.; Bagchi, Biman

2004-05-01

A new master equation to mimic the dynamics of a collection of interacting random walkers in an open system is proposed and solved numerically. In this model, the random walkers interact through excluded volume interaction (single-file system); and the total number of walkers in the lattice can fluctuate because of exchange with a bath. In addition, the movement of the random walkers is biased by an external perturbation. Two models for the latter are considered: (1) an inverse potential (V∝1/r), where r is the distance between the center of the perturbation and the random walker and (2) an inverse of sixth power potential (V∝1/r6). The calculated density of the walkers and the total energy show interesting dynamics. When the size of the system is comparable to the range of the perturbing field, the energy relaxation is found to be highly nonexponential. In this range, the system can show stretched exponential (e-(t/τs)β) and even logarithmic time dependence of energy relaxation over a limited range of time. Introduction of density exchange in the lattice markedly weakens this nonexponentiality of the relaxation function, irrespective of the nature of perturbation.

Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial.

PubMed

Ott, O J; Hertel, S; Gaipl, U S; Frey, B; Schmidt, M; Fietkau, R

2012-10-01

The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 ± 20.2 and 55.7 ± 18.0 (p = 0.463), 32.1 ± 24.5 and 34.4 ± 22.5 (p = 0.256), and 27.0 ± 27.7 and 23.5 ± 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 ± 2.9 and 8.1 ± 3.1 (p = 0.207), 4.5 ± 3.2 and 5.0 ± 3.4 (p = 0.507), 3.9 ± 3.6 and 2.8 ± 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy.

Developing and executing quality improvement projects (concept, methods, and evaluation).

PubMed

Likosky, Donald S

2014-03-01

Continuous quality improvement, quality assurance, cycles of change--these words of often used to express the process of using data to inform and improve clinical care. Although many of us have been exposed to theories and practice of experimental work (e.g., randomized trial), few of us have been similarly exposed to the science underlying quality improvement. Through the lens of a single-center quality improvement study, this article exposes the reader to methodology for conducting such studies. The reader will gain an understanding of these methods required to embark on such a study.

Photoelectron circular dichroism in the multiphoton ionization by short laser pulses. II. Three- and four-photon ionization of fenchone and camphor.

PubMed

Müller, Anne D; Artemyev, Anton N; Demekhin, Philipp V

2018-06-07

Angle-resolved multiphoton ionization of fenchone and camphor by short intense laser pulses is computed by the time-dependent single center method. Thereby, the photoelectron circular dichroism (PECD) in the three-photon resonance enhanced ionization and four-photon above-threshold ionization of these molecules is investigated in detail. The computational results are in satisfactory agreement with the available experimental data, measured for randomly oriented fenchone and camphor molecules at different wavelengths of the exciting pulses. We predict a significant enhancement of the multiphoton PECD for uniaxially oriented fenchone and camphor.

Photoelectron circular dichroism in the multiphoton ionization by short laser pulses. II. Three- and four-photon ionization of fenchone and camphor

NASA Astrophysics Data System (ADS)

Müller, Anne D.; Artemyev, Anton N.; Demekhin, Philipp V.

2018-06-01

Angle-resolved multiphoton ionization of fenchone and camphor by short intense laser pulses is computed by the time-dependent single center method. Thereby, the photoelectron circular dichroism (PECD) in the three-photon resonance enhanced ionization and four-photon above-threshold ionization of these molecules is investigated in detail. The computational results are in satisfactory agreement with the available experimental data, measured for randomly oriented fenchone and camphor molecules at different wavelengths of the exciting pulses. We predict a significant enhancement of the multiphoton PECD for uniaxially oriented fenchone and camphor.

Safety and Pharmacokinetics of Multiple 750-Milligram Doses of Intravenous Levofloxacin in Healthy Volunteers

PubMed Central

Chow, Andrew T.; Fowler, Cynthia; Williams, R. Rex; Morgan, Nancy; Kaminski, Susan; Natarajan, Jaya

2001-01-01

The safety and pharmacokinetics of a once-daily high intravenous dose of levofloxacin (750 mg) in 18 healthy volunteers were studied in a double-blind, randomized, placebo-controlled, single-center parallel group study. Levofloxacin was well tolerated, and higher maximum concentration of drug in serum and area under the concentration-time curve values were achieved. For difficult-to-treat infections, high daily doses of levofloxacin may be beneficial, and intravenous administration may be preferred in certain clinical settings, such as when treating patients in intensive care units, warranting further evaluation. PMID:11408234

Safety and pharmacokinetics of multiple 750-milligram doses of intravenous levofloxacin in healthy volunteers.

PubMed

Chow, A T; Fowler, C; Williams, R R; Morgan, N; Kaminski, S; Natarajan, J

2001-07-01

The safety and pharmacokinetics of a once-daily high intravenous dose of levofloxacin (750 mg) in 18 healthy volunteers were studied in a double-blind, randomized, placebo-controlled, single-center parallel group study. Levofloxacin was well tolerated, and higher maximum concentration of drug in serum and area under the concentration-time curve values were achieved. For difficult-to-treat infections, high daily doses of levofloxacin may be beneficial, and intravenous administration may be preferred in certain clinical settings, such as when treating patients in intensive care units, warranting further evaluation.

The Effect of Spironolactone on the Incidence of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Catheterization: Study Design and Rationale.

PubMed

Mujtaba, Alhasan; Taher, Mohammed A; Hazza, Mazin A; Al-Rubaye, Hassan M; Kata, Asaad H; AbdulWahab, Hamid; AbdulBari, AbdulAmeer; AlRubay, Hayder K

2018-05-21

Patients undergoing coronary catheterization are at high risk of developing contrast-induced nephropathy (CIN) acute kidney injury (AKI). Several approaches have been supposed to limit such an effect but with mixed results or non-practical methods. Spironolactone is supposed to be effective as a nephroprotective agent in animal studies. This study will try to measure the effect of spironolactone on the incidence of CIN-AKI in patients undergoing coronary catheterization (angiography angioplasty). This study is a single-center, investigator-driven, double-blinded randomized controlled study in Iraq-Basra. More than 400 patients admitted for coronary angio unit in our center will be allocated in a 1:1 ratio to receive either spironolactone 200 mg single dose or placebo in addition to their usual premedication. Primary end point will be CIN defined as more than 25% or 0.3 mg/dl elevation in serum creatinine (S.Cr.) from baseline during the first 2-3 days after the procedure. We hope to identify or answer an important question regarding CIN in such high-risk patients. ClinicalTrials.gov Identifier, NCT03329443.

Staggering the dose of sugammadex lowers risks for severe emergence cough: a randomized control trial.

PubMed

P S, Loh; Miskan, M M; Y Z, Chin; Zaki, R A

2017-10-11

Cough on emergence has been reported as a common adverse reaction with sugammadex reversal. We investigated if staggering the dose of sugammadex will reduce emergence cough in a single-center, randomized, double-blinded study. A hundred and twenty ASA 1-3 adults were randomly reversed with 1 mg/kg sugammadex prior to extubation followed by another 1 mg/kg immediately after extubation (staggered group), single dose of 2 mg/kg sugammadex (single bolus group) or neostigmine 0.02 mg/kg with glycopyrrolate (neostigmine group). We found 70% of patients (n = 28) reversed with single boluses of sugammadex had Grade 3 emergence cough compared to 12.5% (n = 5) in the staggered sugammadex group and 17.5% (n = 7) in the neostigmine group (p < 0.001). Besides cough, emergence agitation also appeared highest in the single bolus sugammadex group (n = 14, 35%, p = 0.005). On the other hand, staggering sugammadex lowered risks of developing severe cough (RR 0.2, p < 0.001) and agitation (RR 0.43, p = 0.010) on emergence in addition to cough (RR 0.25, p = 0.039) and early sore throat (RR 0.70, p = 0.036) in the post-anesthetic care unit. The risks for severe emergence cough (RR 0.86, p = 0.762), severe cough in the post-anesthetic care unit (RR 1.0, p = 1.000) and sore throat (RR 1.17, p = 0.502) were also not different between the staggered sugammadex group and control given neostigmine. In terms of timing, there was no delay in time taken from discontinuing anesthetic agents to reversal and extubation if sugammadex was staggered (emergence time 6.0 ± 3.2 s, p = 0.625 and reversal time 6.5 ± 3.5, p = 0.809). Staggering the dose of sugammadex for reversal will effectively decrease common emergence and early postoperative complications. ANZCTR Number ACTRN12616000116426 . Retrospectively registered on 2nd February 2016.

The Effect of Eye Patching on Clear Corneal Incision Architecture in Phacoemulsification: A Randomized Controlled Trial.

PubMed

Ho, Fui Li; Salowi, Mohamad Aziz; Bastion, Mae-Lynn Catherine

2017-01-01

To investigate the effects of postoperative eye patching on clear corneal incision architecture in phacoemulsification. A single-center, randomized controlled trial. A total of 132 patients with uncomplicated phacoemulsification were randomly allocated to the intervention or control group. The intervention group received postoperative eye patching for approximately 18 hours, whereas the control group received eye shield. The clear corneal incision architecture was examined postoperatively at 2 hours, 1 day, and 7 days after surgery using optical coherence tomography. Epithelial gaping was significantly reduced on postoperative day 1 in the intervention group (52.4%) compared with control (74.2%) (P = 0.01). No differences were found for other architectural defects. Descemet membrane detachment was associated with lower intraocular pressure on postoperative day 7 (P = 0.02). Presence of underlying diabetes mellitus did not seem to influence architectural defects. Postoperative eye patching facilitated epithelial healing and reduced the occurrence of epithelial gaping on postoperative day 1. It may play a role in protecting and improving corneal wounds during the critical immediate postoperative period. Copyright 2017 Asia-Pacific Academy of Ophthalmology.

Development Testing and Subsequent Failure Investigation of a Spring Strut Mechanism

NASA Technical Reports Server (NTRS)

Dervan, Jared; Robertson, Brandon; Staab, Lucas; Culberson, Michael

2014-01-01

Commodities are transferred between the Multi-Purpose Crew Vehicle (MPCV) crew module (CM) and service module (SM) via an external umbilical that is driven apart with spring-loaded struts after the structural connection is severed. The spring struts must operate correctly for the modules to separate safely. There was no vibration testing of strut development units scoped in the MPCV Program Plan; therefore, any design problems discovered as a result of vibration testing would not have been found until the component qualification. The NASA Engineering and Safety Center (NESC) and Lockheed Martin (LM) performed random vibration testing on a single spring strut development unit to assess its ability to withstand qualification level random vibration environments. Failure of the strut while exposed to random vibration resulted in a follow-on failure investigation, design changes, and additional development tests. This paper focuses on the results of the failure investigations including identified lessons learned and best practices to aid in future design iterations of the spring strut and to help other mechanism developers avoid similar pitfalls.

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

PubMed

Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

2018-06-01

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

Safety and Efficacy of Rice Bran Supercritical CO2 Extract for Hair Growth in Androgenic Alopecia: A 16-Week Double-Blind Randomized Controlled Trial.

PubMed

Choi, Jae-Suk; Park, Jae Beom; Moon, Woi-Sook; Moon, Jin-Nam; Son, Sang Wook; Kim, Mi-Ryung

2015-01-01

We conducted a 16-week double-blind randomized controlled single-center trial to evaluate the safety and efficacy of dermal rice bran supercritical CO2 extract (RB-SCE) in the treatment of androgenic alopecia. Fifty alopecia patients were randomly assigned to the experimental and placebo groups. The experimental group received a dermal application of 0.5% RB-SCE (8 mL/d) to the head skin for 16 weeks while the control group received a dermal application of placebo. Changes in hair count, diameter, and density were evaluated with a Folliscope(®). Patient satisfaction was evaluated via questionnaire and clinical photographs were rated by dermatologists. The results showed that RB-SCE significantly increased hair density and hair diameter in male subjects. Patient satisfaction and the evaluation of photographs by dermatologists also confirmed the effectiveness of RB-SCE in the treatment of alopecia. No adverse reactions related to RB-SCE were reported. Therefore, RB-SCE shows promise for use in functional cosmetics and pharmaceuticals.

Representation of limb kinematics in Purkinje cell simple spike discharge is conserved across multiple tasks.

PubMed

Hewitt, Angela L; Popa, Laurentiu S; Pasalar, Siavash; Hendrix, Claudia M; Ebner, Timothy J

2011-11-01

Encoding of movement kinematics in Purkinje cell simple spike discharge has important implications for hypotheses of cerebellar cortical function. Several outstanding questions remain regarding representation of these kinematic signals. It is uncertain whether kinematic encoding occurs in unpredictable, feedback-dependent tasks or kinematic signals are conserved across tasks. Additionally, there is a need to understand the signals encoded in the instantaneous discharge of single cells without averaging across trials or time. To address these questions, this study recorded Purkinje cell firing in monkeys trained to perform a manual random tracking task in addition to circular tracking and center-out reach. Random tracking provides for extensive coverage of kinematic workspaces. Direction and speed errors are significantly greater during random than circular tracking. Cross-correlation analyses comparing hand and target velocity profiles show that hand velocity lags target velocity during random tracking. Correlations between simple spike firing from 120 Purkinje cells and hand position, velocity, and speed were evaluated with linear regression models including a time constant, τ, as a measure of the firing lead/lag relative to the kinematic parameters. Across the population, velocity accounts for the majority of simple spike firing variability (63 ± 30% of R(adj)(2)), followed by position (28 ± 24% of R(adj)(2)) and speed (11 ± 19% of R(adj)(2)). Simple spike firing often leads hand kinematics. Comparison of regression models based on averaged vs. nonaveraged firing and kinematics reveals lower R(adj)(2) values for nonaveraged data; however, regression coefficients and τ values are highly similar. Finally, for most cells, model coefficients generated from random tracking accurately estimate simple spike firing in either circular tracking or center-out reach. These findings imply that the cerebellum controls movement kinematics, consistent with a forward internal model that predicts upcoming limb kinematics.

Contribution of Transcranial Direct Current Stimulation on Inhibitory Control to Assess the Neurobiological Aspects of Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial

PubMed Central

Baptista, Abrahão Fontes; de Sena, Eduardo Pondé

2015-01-01

Background The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. Objective The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. Methods A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. Results The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. Conclusions The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Trial Registration Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD). PMID:25986784

Contribution of transcranial direct current stimulation on inhibitory control to assess the neurobiological aspects of attention deficit hyperactivity disorder: randomized controlled trial.

PubMed

Cosmo, Camila; Baptista, Abrahão Fontes; de Sena, Eduardo Pondé

2015-05-18

The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD).

The Efficacy of Plasma Rich in Growth Factors for the Treatment of Alveolar Osteitis: A Randomized Controlled Trial.

PubMed

King, Elizabeth M; Cerajewska, Tanya L; Locke, Matthew; Claydon, Nicholas C A; Davies, Maria; West, Nicola X

2018-06-01

To investigate the efficacy of plasma rich in growth factors (PRGF; BTI Biotechnology Institute, San Antonio, Spain) for the treatment of alveolar osteitis compared with a positive control (Alvogyl; Septodont, Maidstone, Kent, UK). This single-center, single-blinded, randomized, 2-treatment, parallel study was conducted in a UK dental hospital. All healthy adults who presented with alveolar osteitis after tooth extraction over a 3-month period were invited to participate. Each socket was randomized and treated with 1 of 2 treatment modalities, a test treatment (PRGF) or a positive control (Alvogyl). After treatment, patients were reviewed at 3 and 7 days by a second clinician blinded to the treatment given. Outcome measures included pain, exposed bone, inflammation, halitosis, dysgeusia, and quality-of-life assessment. Thirty-eight patients with data from 44 sockets (22 in the PRGF group and 22 in the Alvogyl group) were analyzed. The PRGF group showed significantly faster bone coverage and significantly decreased inflammation and halitosis (P < .05) compared with the control group receiving Alvogyl. There was no significant difference for pain, quality-of-life measures, or dysgeusia between groups. PRGF predictably treated alveolar osteitis after tooth extraction compared with the conventional standard treatment of Alvogyl, which has been used for many years. PRGF could be considered an alternative treatment for alveolar osteitis and indeed appears to have considerable advantages over Alvogyl. Copyright © 2018 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Study design for the fostering eating after stroke with transcranial direct current stimulation trial: a randomized controlled intervention for improving Dysphagia after acute ischemic stroke.

PubMed

Marchina, Sarah; Schlaug, Gottfried; Kumar, Sandeep

2015-03-01

Dysphagia is a major stroke complication but lacks effective therapy that can promote recovery. Noninvasive brain stimulation with and without peripheral sensorimotor activities may be an attractive treatment option for swallowing recovery but has not been systematically investigated in the stroke population. This article describes the study design of the first prospective, single-center, double-blinded trial of anodal versus sham transcranial direct current stimulation (tDCS) used in combination with swallowing exercises in patients with dysphagia from an acute ischemic stroke. The aim of this study is to gather safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiologic and clinically relevant swallowing parameters, and examine possible dose effects. Ninety-nine consecutive patients with dysphagia from an acute unilateral hemispheric infarction with a Penetration and Aspiration Scale (PAS) score of 4 or more and without other confounding reasons for dysphagia will be enrolled at a single tertiary care center. Subjects will be randomized to either a high or low dose tDCS or a sham group and will undergo 10 sessions over 5 consecutive days concomitantly with effortful swallowing maneuvers. The main efficacy measures are a change in the PAS score before and after treatment; the main safety measures are mortality, seizures, neurologic, motor, and swallowing deterioration. The knowledge gained from this study will help plan a larger confirmatory trial for treating stroke-related dysphagia and advance our understanding of important covariates influencing swallowing recovery and response to the proposed intervention. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A Single-Center, Open-Label, 3-Way Crossover Trial to Determine the Pharmacokinetic and Pharmacodynamic Interaction Between Nebivolol and Valsartan in Healthy Volunteers at Steady State

PubMed Central

Chen, Chun Lin; Desai-Krieger, Daksha; Ortiz, Stephan; Kerolous, Majid; Wright, Harold M.; Ghahramani, Parviz

2015-01-01

Combining different classes of antihypertensives is more effective for reducing blood pressure (BP) than increasing the dose of monotherapies. The aims of this phase I study were to investigate pharmacokinetic and pharmacodynamic interactions between nebivolol, a vasodilatory β1-selective blocker, and valsartan, an angiotensin II receptor blocker, and to assess safety and tolerability of the combination. This was a single-center, randomized, open-label, multiple-dose, 3-way crossover trial in 30 healthy adults aged 18–45 years. Participants were randomized into 1 of 6 treatment sequences (1:1:1:1:1:1) consisting of three 7-day treatment periods followed by a 7-day washout. Once-daily oral treatments comprised nebivolol (20 mg), valsartan (320 mg), and nebivolol–valsartan combination (20/320 mg). Outcomes included AUC0-τ,ss, Cmax,ss, Tmax,ss, changes in BP, pulse rate, plasma angiotensin II, plasma renin activity, 24-hour urinary aldosterone, and adverse events. Steady-state pharmacokinetic interactions were observed but deemed not clinically significant. Systolic and diastolic BP reduction was significantly greater with nebivolol–valsartan combination than with either monotherapy. The mean pulse rate associated with nebivolol and nebivolol–valsartan treatments was consistently lower than that associated with valsartan monotherapy. A sharp increase in mean day 7 plasma renin activity and plasma angiotensin II that occurred in valsartan-treated participants was significantly attenuated with concomitant nebivolol administration. Mean 24-hour urine aldosterone at day 7 was substantially decreased after combined treatment, as compared with either monotherapy. All treatments were safe and well tolerated. In conclusion, nebivolol and valsartan coadministration led to greater reductions in BP compared with either monotherapy; nebivolol and valsartan lower BP through complementary mechanisms. PMID:25853236

A Single-Center, Open-Label, 3-Way Crossover Trial to Determine the Pharmacokinetic and Pharmacodynamic Interaction Between Nebivolol and Valsartan in Healthy Volunteers at Steady State.

PubMed

Chen, Chun Lin; Desai-Krieger, Daksha; Ortiz, Stephan; Kerolous, Majid; Wright, Harold M; Ghahramani, Parviz

2015-01-01

Combining different classes of antihypertensives is more effective for reducing blood pressure (BP) than increasing the dose of monotherapies. The aims of this phase I study were to investigate pharmacokinetic and pharmacodynamic interactions between nebivolol, a vasodilatory β1-selective blocker, and valsartan, an angiotensin II receptor blocker, and to assess safety and tolerability of the combination. This was a single-center, randomized, open-label, multiple-dose, 3-way crossover trial in 30 healthy adults aged 18-45 years. Participants were randomized into 1 of 6 treatment sequences (1:1:1:1:1:1) consisting of three 7-day treatment periods followed by a 7-day washout. Once-daily oral treatments comprised nebivolol (20 mg), valsartan (320 mg), and nebivolol-valsartan combination (20/320 mg). Outcomes included AUC0-τ,ss, Cmax,ss, Tmax,ss, changes in BP, pulse rate, plasma angiotensin II, plasma renin activity, 24-hour urinary aldosterone, and adverse events. Steady-state pharmacokinetic interactions were observed but deemed not clinically significant. Systolic and diastolic BP reduction was significantly greater with nebivolol-valsartan combination than with either monotherapy. The mean pulse rate associated with nebivolol and nebivolol-valsartan treatments was consistently lower than that associated with valsartan monotherapy. A sharp increase in mean day 7 plasma renin activity and plasma angiotensin II that occurred in valsartan-treated participants was significantly attenuated with concomitant nebivolol administration. Mean 24-hour urine aldosterone at day 7 was substantially decreased after combined treatment, as compared with either monotherapy. All treatments were safe and well tolerated. In conclusion, nebivolol and valsartan coadministration led to greater reductions in BP compared with either monotherapy; nebivolol and valsartan lower BP through complementary mechanisms.

Design Features of the Diabetes and Periodontal Therapy Trial (DPTT): A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects with Type 2 Diabetes and Chronic Periodontitis

PubMed Central

2013-01-01

Background Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment results in a modest reduction in glycosylated hemoglobin (Hb) A1c. Purpose The purpose of the Diabetes and Periodontal Therapy Trial (DPTT) was to determine if periodontal treatment reduces HbA1c in patients with T2DM and periodontitis. Methods DPTT was a phase-III, single-masked, multi-center, randomized trial with a planned enrollment of 600 participants. Participants were randomly assigned to receive periodontal treatment immediately (Treatment Group) or after 6 months (Control Group). HbA1c values and clinical periodontal measures were determined at baseline and 3 and 6 months following randomization. Medication usage and dosing were assessed at each visit. Periodontal treatment consisted of scaling and root planing for a minimum of two 90-minute sessions, plus the use of an antibacterial mouth rinse for at least 32 days afterwards. The primary outcome was change in HbA1c from baseline to 6 months and the trial was powered to detect a between-group difference of 0.6%. Secondary outcomes included changes in periodontal clinical measures, fasting plasma glucose, the Homeostasis Model Assessment (HOMA2) and the need for rescue diabetes or periodontal therapy. Conclusion Dental and medical researchers collaborated to recruit, treat and monitor participants with two chronic diseases to determine if treatment of one condition affects the status of the other. PMID:24080100

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

PubMed

Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

2016-11-16

The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial

PubMed Central

Bronchud, Miguel; Mair, Stuart; Challand, Rodeina

2010-01-01

Recombinant human granulocyte colony-stimulating factor (filgrastim) has multiple hematologic and oncologic indications as Neupogen® (Amgen filgrastim). Hospira has developed a biosimilar filgrastim (Nivestim™). Here, results are reported from a phase I trial, primarily designed to compare the pharmacokinetic profiles of Hospira filgrastim and Amgen filgrastim. A phase I, single-center, open-label, randomized trial was undertaken to demonstrate equivalence of the pharmacokinetic characteristics of Hospira filgrastim and Amgen filgrastim. Forty-eight healthy volunteers were randomized to receive intravenous (i.v.) or subcutaneous (s.c.) dosing and then further randomized to order of treatment. Volunteers in each of the two dosing groups received a single 10µg/kg dose of Hospira filgrastim or Amgen filgrastim, with subsequent crossover. Bioequivalence was evaluated by analysis of variance; if the estimated 90% confidence intervals (CIs) for the ratio of ‘test’ to ‘reference’ treatment means were within the conventional equivalence limits of 0.80–1.25, then bioequivalence was concluded. Forty-six volunteers completed the study. Geometric mean area under the curve from time 0 to the last time point (primary endpoint) was similar in volunteers given Hospira filgrastim or Amgen filgrastim following i.v. (ratio of means: 0.96; 90% CI: 0.90–1.02) or s.c. (ratio of means: 1.02; 90% CI: 0.95–1.09) dosing; 90% CIs were within the predefined range necessary to demonstrate bioequivalence. Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim. Hospira filgrastim is bioequivalent with Amgen filgrastim in terms of its pharmacokinetic properties and may provide a clinically effective alternative. PMID:20428872

Thermal properties of the mixed spin-1 and spin-3/2 Ising ferrimagnetic system with two different random single-ion anisotropies

NASA Astrophysics Data System (ADS)

Pereira, J. R. V.; Tunes, T. M.; de Arruda, A. S.; Godoy, M.

2018-06-01

In this work, we have performed Monte Carlo simulations to study a mixed spin-1 and spin-3/2 Ising ferrimagnetic system on a square lattice with two different random single-ion anisotropies. This lattice is divided in two interpenetrating sublattices with spins SA = 1 in the sublattice A and SB = 3 / 2 in the sublattice B. The exchange interaction between the spins on the sublattices is antiferromagnetic (J < 0). We used two random single-ion anisotropies, DiA and DjB , on the sublattices A and B, respectively. We have determined the phase diagram of the model in the critical temperature Tc versus strength of the random single-ion anisotropy D plane and we shown that it exhibits only second-order phase transition lines. We also shown that this system displays compensation temperatures for some cases of the random single-ion distribution.

Oral sumatriptan for migraine in children and adolescents: a randomized, multicenter, placebo-controlled, parallel group study.

PubMed

Fujita, Mitsue; Sato, Katsuaki; Nishioka, Hiroshi; Sakai, Fumihiko

2014-04-01

The objective of this article is to evaluate the efficacy and tolerability of two doses of oral sumatriptan vs placebo in the acute treatment of migraine in children and adolescents. Currently, there is no approved prescription medication in Japan for the treatment of migraine in children and adolescents. This was a multicenter, outpatient, single-attack, double-blind, randomized, placebo-controlled, parallel-group study. Eligible patients were children and adolescents aged 10 to 17 years diagnosed with migraine with or without aura (ICHD-II criteria 1.1 or 1.2) from 17 centers. They were randomized to receive sumatriptan 25 mg, 50 mg or placebo (1:1:2). The primary efficacy endpoint was headache relief by two grades on a five-grade scale at two hours post-dose. A total of 178 patients from 17 centers in Japan were enrolled and randomized to an investigational product in double-blind fashion. Of these, 144 patients self-treated a single migraine attack, and all provided a post-dose efficacy assessment and completed the study. The percentage of patients in the full analysis set (FAS) population who report pain relief at two hours post-treatment for the primary endpoint was higher in the placebo group than in the pooled sumatriptan group (38.6% vs 31.1%, 95% CI: -23.02 to 8.04, P  = 0.345). The percentage of patients in the FAS population who reported pain relief at four hours post-dose was higher in the pooled sumatriptan group (63.5%) than in the placebo group (51.4%) but failed to achieve statistical significance ( P  = 0.142). At four hours post-dose, percentages of patients who were pain free or had complete relief of photophobia or phonophobia were numerically higher in the sumatriptan pooled group compared to placebo. Both doses of oral sumatriptan were well tolerated. No adverse events (AEs) were serious or led to study withdrawal. The most common AEs were somnolence in 6% (two patients) in the sumatriptan 25 mg treatment group and chest discomfort in 7% (three patients) in the sumatriptan 50 mg treatment group. There was no statistically significant improvement between the sumatriptan pooled group and the placebo group for pain relief at two hours. Oral sumatriptan was well tolerated.

Effects of the Caregiver Interaction Profile Training on Caregiver-Child Interactions in Dutch Child Care Centers: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Helmerhorst, Katrien O.; Riksen-Walraven, J. Marianne; Fukkink, Ruben G.; Tavecchio, Louis W. C.; Gevers Deynoot-Schaub, Mirjam J. J. M.

2017-01-01

Background: Previous studies underscore the need to improve caregiver-child interactions in early child care centers. Objective: In this study we used a randomized controlled trial to examine whether a 5-week video feedback training can improve six key interactive skills of caregivers in early child care centers: Sensitive responsiveness, respect…

The Palliative Care in Heart Failure (PAL-HF) Trial: Rationale and Design

PubMed Central

Mentz, Robert J.; Tulsky, James A.; Granger, Bradi B.; Anstrom, Kevin J.; Adams, Patricia A.; Dodson, Gwen C.; Fiuzat, Mona; Johnson, Kimberly S.; Patel, Chetan B.; Steinhauser, Karen E.; Taylor, Donald H.; O’Connor, Christopher M.; Rogers, Joseph G.

2014-01-01

Background The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. Methods The Palliative Care in Heart Failure trial (PAL-HF) is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or re-hospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns and advanced care planning. The primary endpoint is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary endpoints include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization and quality of life. Conclusions PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost-effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic endpoints. PMID:25440791

The palliative care in heart failure trial: rationale and design.

PubMed

Mentz, Robert J; Tulsky, James A; Granger, Bradi B; Anstrom, Kevin J; Adams, Patricia A; Dodson, Gwen C; Fiuzat, Mona; Johnson, Kimberly S; Patel, Chetan B; Steinhauser, Karen E; Taylor, Donald H; O'Connor, Christopher M; Rogers, Joseph G

2014-11-01

The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. PAL-HF is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns, and advanced care planning. The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary end points include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization, and quality of life. PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points. Copyright © 2014 Elsevier Inc. All rights reserved.

The effects of pulmonary rehabilitation in the national emphysema treatment trial.

PubMed

Ries, Andrew L; Make, Barry J; Lee, Shing M; Krasna, Mark J; Bartels, Matthew; Crouch, Rebecca; Fishman, Alfred P

2005-12-01

Pulmonary rehabilitation is an established treatment in patients with chronic lung disease but is not widely utilized. Most trials have been conducted in single centers. The National Emphysema Treatment Trial (NETT) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States. Prospective observational study of cohort prior to randomization in a multicenter clinical trial. University-based clinical centers and community-based satellite pulmonary rehabilitation programs. A total of 1,218 patients with severe emphysema underwent pulmonary rehabilitation before and after randomization to lung volume reduction surgery (LVRS) or continued medical management. Rehabilitation was conducted at 17 NETT centers supplemented by 539 satellite centers. Lung function, exercise tolerance, dyspnea, and quality of life were evaluated at regular intervals. Significant (p < 0.001) improvements were observed consistently in exercise (cycle ergometry, 3.1 W; 6-min walk test distance, 76 feet), dyspnea (University of California, San Diego Shortness of Breath Questionnaire score, -3.2; Borg breathlessness score: breathing cycle, -0.8; 6-min walk, -0.5) and quality of life (St. George Respiratory Questionnaire score, -3.5; Quality of Well-Being Scale score, +0.035; Medical Outcomes Study 36-item short form score: physical health summary, +1.3; mental health summary, + 2.0). Patients who had not undergone prior rehabilitation improved more than those who had. In multivariate models, only prior rehabilitation status predicted changes after rehabilitation. In 20% of patients, exercise level changed sufficiently after rehabilitation to alter the NETT subgroup predictive of outcome. Overall, changes after rehabilitation did not predict differential mortality or improvement in exercise (primary outcomes) by treatment group. The NETT experience demonstrates the effectiveness of pulmonary rehabilitation in patients with severe emphysema who were treated in a national cross-section of programs. Pulmonary rehabilitation plays an important role in preparing and selecting patients for surgical interventions such as LVRS.

SMART DOCS: A New Patient-Centered Outcomes and Coordinated-Care Management Approach for the Future Practice of Sleep Medicine

PubMed Central

Kushida, Clete A.; Nichols, Deborah A.; Holmes, Tyson H.; Miller, Ric; Griffin, Kara; Cardell, Chia-Yu; Hyde, Pamela R.; Cohen, Elyse; Manber, Rachel; Walsh, James K.

2015-01-01

The practice of medicine is currently undergoing a transformation to become more efficient, cost-effective, and patient centered in its delivery of care. The aim of this article is to stimulate discussion within the sleep medicine community in addressing these needs by our approach as well as other approaches to sleep medicine care. The primary goals of the Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) are: (1) to introduce a new Patient-Centered Outcomes and Coordinated-Care Management (PCCM) approach for the future practice of sleep medicine, and (2) to test the PCCM approach against a Conventional Diagnostic and Treatment Outpatient Medical Care (CONV) approach in a randomized, two-arm, single-center, long-term, comparative effectiveness trial. The PCCM approach is integrated into a novel outpatient care delivery model for patients with sleep disorders that includes the latest technology, allowing providers to obtain more accurate and rapid diagnoses and to make evidence-based treatment recommendations, while simultaneously enabling patients to have access to personalized medical information and reports regarding their diagnosis and treatment so that they can make more informed health care decisions. Additionally, the PCCM approach facilitates better communication between patients, referring primary care physicians, sleep specialists, and allied health professionals so that providers can better assist patients in achieving their preferred outcomes. A total of 1,506 patients 18 y or older will be randomized to either the PCCM or CONV approach and will be followed for at least 1 y with endpoints of improved health care performance, better health, and cost control. Clinical Trials Registration: ClinicalTrials.gov Identifier: NCT02037438. Citation: Kushida CA, Nichols DA, Holmes TH, Miller R, Griffin K, Cardell CY, Hyde PR, Cohen E, Manber R, Walsh JK. SMART DOCS: a new patient-centered outcomes and coordinated-care management approach for the future practice of sleep medicine. SLEEP 2015;38(2):315–326. PMID:25409112

High-flavanol and high-theobromine versus low-flavanol and low-theobromine chocolate to improve uterine artery pulsatility index: a double blind randomized clinical trial.

PubMed

Bujold, Emmanuel; Leblanc, Vicky; Lavoie-Lebel, Élise; Babar, Asma; Girard, Mario; Poungui, Lionel; Blanchet, Claudine; Marc, Isabelle; Lemieux, Simone; Belkacem, Abdous; Sidi, Elhadji Laouan; Dodin, Sylvie

2017-09-01

To evaluate the impact of high-flavanol and high-theobromine (HFHT) chocolate in women at risk of preeclampsia (PE). We conducted a single-center randomized controlled trial including women with singleton pregnancy between 11 and 14 weeks gestation who had bilateral abnormal uterine artery (UtA) waveforms (notching) and elevated pulsatility index (PI). Participants were randomized to either HFHT or low-flavanol and low-theobromine (LFLT) chocolate (30 grams daily for a total of 12 weeks). UtA PI, reported as multiple of medians (MoM) adjusted for gestational age, was assessed at baseline and 12 weeks after randomization. One hundred thirty-one women were randomized with mean gestational age of 12.4 ± 0.6 weeks and a mean UtA PI of 1.39 ± 0.31 MoM. UtA PI adjusted for gestational age significantly decreased from baseline to the second visit (12 weeks later) in the two groups (p < 0.0001) but no significant difference was observed between the groups (p = 0.16). Compared with LFLT chocolate, daily intake of HFHT chocolate was not associated with significant changes of UtA PI. Nevertheless, the improvement observed in both groups suggests that chocolate could improve placental function independently of flavanol and/or theobromine content.

Single-dose pharmacokinetic study comparing the pharmacokinetics of recombinant human chorionic gonadotropin in healthy Japanese and Caucasian women and recombinant human chorionic gonadotropin and urinary human chorionic gonadotropin in healthy Japanese women.

PubMed

Bagchus, Wilhelmina; Wolna, Peter; Uhl, Wolfgang

2018-01-01

Recombinant hCG (r-hCG) was approved in Japan in 2016. As a prerequisite for a Phase III study in Japan related to this approval, the pharmacokinetic (PK) profile of r-hCG was investigated. An open-label, partly randomized, single-center, single-dose, group-comparison, Phase I PK-bridging study was done that compared a single 250 μg dose of r-hCG with a single 5000 IU dose of urinary hCG (u-hCG) in healthy Japanese women, as well as comparing a single 250 μg dose of r-hCG in Japanese and Caucasian women. The Japanese participants were randomized 1:1 to receive either r-hCG or u-hCG, while the Caucasian participants were weight-matched to the Japanese participants who were receiving r-hCG in a 1:1 fashion. The primary PK parameters were the area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC 0-∞ ) and the maximum serum concentration (C max ). The mean serum hCG concentration-time profiles of r-hCG in the Japanese and Caucasian participants were a similar shape, but the level of overall exposure was ~20% lower in the Japanese participants. For the Japanese participants, r-hCG resulted in an 11% lower C max but a 19% higher AUC 0-∞ compared with u-hCG. No new safety signal was identified. This study cannot exclude a potential difference in the PK profile of r-hCG between Japanese and Caucasian participants. However, this study does not indicate that there are clinically relevant differences in the serum PK of r-hCG and u-hCG in the Japanese participants.

SOP: parallel surrogate global optimization with Pareto center selection for computationally expensive single objective problems

DOE PAGES

Krityakierne, Tipaluck; Akhtar, Taimoor; Shoemaker, Christine A.

2016-02-02

This paper presents a parallel surrogate-based global optimization method for computationally expensive objective functions that is more effective for larger numbers of processors. To reach this goal, we integrated concepts from multi-objective optimization and tabu search into, single objective, surrogate optimization. Our proposed derivative-free algorithm, called SOP, uses non-dominated sorting of points for which the expensive function has been previously evaluated. The two objectives are the expensive function value of the point and the minimum distance of the point to previously evaluated points. Based on the results of non-dominated sorting, P points from the sorted fronts are selected as centersmore » from which many candidate points are generated by random perturbations. Based on surrogate approximation, the best candidate point is subsequently selected for expensive evaluation for each of the P centers, with simultaneous computation on P processors. Centers that previously did not generate good solutions are tabu with a given tenure. We show almost sure convergence of this algorithm under some conditions. The performance of SOP is compared with two RBF based methods. The test results show that SOP is an efficient method that can reduce time required to find a good near optimal solution. In a number of cases the efficiency of SOP is so good that SOP with 8 processors found an accurate answer in less wall-clock time than the other algorithms did with 32 processors.« less

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

PubMed

Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H

2014-09-08

Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. ClinicalTrials.gov identifier: NCT01258985.

Randomized, Placebo-controlled Trial of Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis: The ACROSS Trial

PubMed Central

Janz, David R; Bastarache, Julie A; Rice, Todd W; Bernard, Gordon R; Warren, Melissa A; Wickersham, Nancy; Sills, Gillian; Oates, John A; Roberts, L Jackson; Ware, Lorraine B

2014-01-01

Objective This trial evaluated the efficacy of acetaminophen in reducing oxidative injury, as measured by plasma F2-Isoprostanes, in adult patients with severe sepsis and detectable plasma cell-free hemoglobin. Design Single center, randomized, double-blind, placebo controlled phase II trial. Setting Medical ICU in a tertiary, academic medical center. Patients Critically ill patients ≥18 years old with severe sepsis and detectable plasma cell-free hemoglobin. Interventions Patients were randomized 1:1 to enteral acetaminophen 1 gram every 6 hours for three days (n = 18) or placebo (n = 22) with the same dosing schedule and duration. Measurements and Main Results F2-Isoprostanes on study day 3, the primary outcome, did not differ between acetaminophen (30 pg/mL, IQR 24–41) and placebo (36 pg/mL, IQR 25–80, p = 0.35). However, F2-Isoprostanes were significantly reduced on study day 2 in the acetaminophen group (24 pg/mL, IQR 19 – 36) compared with placebo (36 pg/mL, IQR 23–55, p = 0.047). Creatinine on study day 3, a secondary outcome, was significantly lower in the acetaminophen group (1.0 mg/dL, IQR 0.6–1.4) compared with placebo (1.3 mg/dL, IQR 0.83 – 2.0, p = 0.039). There was no statistically significant difference in hospital mortality (acetaminophen 5.6% vs. placebo 18.2%, p = 0.355) or adverse events (AST or ALT >400)(acetaminophen 9.5% vs. placebo 4.3%, p = 0.599). Conclusions In adults with severe sepsis and detectable plasma cell-free hemoglobin, treatment with acetaminophen within 24 hours of ICU admission may reduce oxidative injury and improve renal function. Further study is needed to confirm these findings and determine the effect of acetaminophen on patient-centered outcomes. PMID:25474535

A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

PubMed

Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

2015-11-30

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS. ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

Dynamics of Single-Photon Emission from Electrically Pumped Color Centers

NASA Astrophysics Data System (ADS)

Khramtsov, Igor A.; Agio, Mario; Fedyanin, Dmitry Yu.

2017-08-01

Low-power, high-speed, and bright electrically driven true single-photon sources, which are able to operate at room temperature, are vital for the practical realization of quantum-communication networks and optical quantum computations. Color centers in semiconductors are currently the best candidates; however, in spite of their intensive study in the past decade, the behavior of color centers in electrically controlled systems is poorly understood. Here we present a physical model and establish a theoretical approach to address single-photon emission dynamics of electrically pumped color centers, which interprets experimental results. We support our analysis with self-consistent numerical simulations of a single-photon emitting diode based on a single nitrogen-vacancy center in diamond and predict the second-order autocorrelation function and other emission characteristics. Our theoretical findings demonstrate remarkable agreement with the experimental results and pave the way to the understanding of single-electron and single-photon processes in semiconductors.

A novel approach to quality improvement in a safety-net practice: concurrent peer review visits.

PubMed

Fiscella, Kevin; Volpe, Ellen; Winters, Paul; Brown, Melissa; Idris, Amna; Harren, Tricia

2010-12-01

Concurrent peer review visits are structured office visits conducted by clinician peers of the primary care clinician that are specifically designed to reduce competing demands, clinical inertia, and bias. We assessed whether a single concurrent peer review visit reduced clinical inertia and improved control of hypertension, hyperlipidemia, and diabetes control among underserved patients. We conducted a randomized encouragement trial to evaluate concurrent peer review visits with a community health center. Seven hundred twenty-seven patients with hypertension, hyperlipidemia, and/or diabetes who were not at goal for systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and/or glycated hemoglobin (A1c) were randomly assigned to an invitation to participate in a concurrent peer review visit or to usual care. We compared change in these measures using mixed models and rates of therapeutic intensification during concurrent peer review visits with control visits. One hundred seventy-one patients completed a concurrent peer review visit. SBP improved significantly (p < .01) more among those completing concurrent peer review visits than among those who failed to respond to a concurrent peer review invitation or those randomized to usual care. There were no differences seen for changes in LDL-C or A1c. Concurrent peer review visits were associated with statistically significant greater clinician intensification of blood pressure (p < .001), lipid (p < .001), and diabetes (p < .005) treatment than either for control visits for patients in either the nonresponse group or usual care group. Concurrent peer review visits represent a promising strategy for improving blood pressure control and improving therapeutic intensification in community health centers.

The effectiveness of an intensive care quick reference checklist manual--a randomized simulation-based trial.

PubMed

Just, Katja S; Hubrich, Svenja; Schmidtke, Daniel; Scheifes, Andrea; Gerbershagen, Mark U; Wappler, Frank; Grensemann, Joern

2015-04-01

We aimed to test the effectiveness of checklists for emergency procedures on medical staff performance in intensive care crises. This is a prospective single-center randomized trial in a high-fidelity simulation center modeling an intensive care unit (ICU) in a tertiary care hospital in Germany. Teams consisted of 1 ICU resident and 2 ICU nurses (in total, n = 48). All completed 4 crisis scenarios, in which they were randomized to use checklists or to perform without any aid. In 2 of the scenarios, checklists could be used immediately (type 1 scenarios); and for the remaining, some further steps, for example, confirming diagnosis, were required first (type 2 scenarios). Outcome measurements were number of predefined items and time to completion of more than 50% and more than 75% of steps, respectively. When using checklists, participants initiated items faster and more completely according to appropriate treatment guidelines (9 vs 7 items with and without checklists, P < .05). Benefit of checklists was better in type 2 scenarios than in type 1 scenarios (2 vs 1 additional item, P < .05). In type 2 scenarios, time to complete 50% and 75% of items was faster with the use of checklists (P < .005). Use of checklists in ICU crises has a benefit on the completion of critical treatment steps. Within the type 2 scenarios, items were fulfilled faster with checklists. The implementation of checklists for intensive care crises is a promising approach that may improve patients' care. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Yusof, Barakatun-Nisak Mohd

2016-02-27

Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT02322268.

Accuracy of VarioGuide Frameless Stereotactic System Against Frame-Based Stereotaxy: Prospective, Randomized, Single-Center Study.

PubMed

Bradac, Ondrej; Steklacova, Anna; Nebrenska, Katerina; Vrana, Jiri; de Lacy, Patricia; Benes, Vladimir

2017-08-01

Frameless stereotactic brain biopsy systems are widely used today. VarioGuide (VG) is a relatively novel frameless system. Its accuracy was studied in a laboratory setting but has not yet been studied in the clinical setting. The purpose of this study was to determine its accuracy and diagnostic yield and to compare this with frame-based (FB) stereotaxy. Overall, 53 patients (33 males and 20 females, 60 ± 15 years old) were enrolled into this prospective, randomized, single-center study. Twenty-six patients were randomized into the FB group and 27 patients into the VG group. Real trajectory was pointed on intraoperative magnetic resonance. The distance of the targets and angle deviation between the planned and real trajectories were computed. The overall discomfort of the patient was subjectively assessed by the visual analog scale score. The median lesion volume was 5 mL (interquartile range [IQR]: 2-16 mL) (FB) and 16 mL (IQR: 2-27 mL) (VG), P = 0.133. The mean distance of the targets was 2.7 ± 1.1 mm (FB) and 2.9 ± 1.3 mm (VG), P = 0.456. Mean angle deviation was 2.6 ± 1.3 deg (FB) and 3.5 ± 2.1 deg (VG), P = 0.074. Diagnostic yield was 93% (25/27) in VG and 96% (25/26) in FB, P = 1.000. Mean operating time was 47 ± 26 minutes (FB) and 59 ± 31 minutes (VG), P = 0.140. One minor bleeding was encountered in the VG group. Overall patient discomfort was significantly higher in the FB group (visual analog scale score 2.5 ± 2.1 vs. 1.2 ± 0.6, P = 0,004). The VG system proved to be comparable in terms of the trajectory accuracy, rate of complications and diagnostic yield compared with the "gold standard" represented by the traditional FB stereotaxy for patients undergoing brain biopsy. VG is also better accepted by patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Speak fast, use jargon, and don't repeat yourself: a randomized trial assessing the effectiveness of online videos to supplement emergency department discharge instructions.

PubMed

Atzema, Clare L; Austin, Peter C; Wu, Libo; Brzozowski, Michael; Feldman, Michael J; McDonnell, Michael; Mazurik, Laurie

2013-01-01

Emergency department discharge instructions are variably understood by patients, and in the setting of emergency department crowding, innovations are needed to counteract shortened interaction times with the physician. We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions. In this prospective, single-center, randomized controlled trial conducted between November 2011 and January 2012, we randomized emergency department patients who were discharged with one of 38 diagnoses to either view (after they left the emergency department) a vetted online video of diagnosis-specific discharge instructions, or to usual care. Patients were subsequently contacted by telephone and asked three standardized questions about their discharge instructions; one point was awarded for each correct answer. Using an intention-to-treat analysis, differences between groups were assessed using univariate testing, and with logistic regression that accounted for clustering on managing physician. A secondary outcome measure was patient satisfaction with the videos, on a 10-point scale. Among 133 patients enrolled, mean age was 46.1 (s.d.D. 21.5) and 55% were female. Patients in the video group had 19% higher mean scores (2.5, s.d. 0.7) than patients in the control group (2.1, s.d. 0.8) (p=0.002). After adjustment for patient age, sex, first language, triage acuity score, and clustering, the odds of achieving a fully correct score (3 out of 3) were 3.5 (95% CI, 1.7 to 7.2) times higher in the video group, compared to the control group. Among those who viewed the videos, median rating of the videos was 10 (IQR 8 to 10). In this single-center trial, patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care. Those who viewed the videos found them to be a helpful addition to standard care. ClinicalTrials.gov NCT01361932 http://clinicaltrials.gov/ct2/show/NCT01361932?term=nct01361932&rank=1.

Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial.

PubMed

van Doorn, Eva; Pleguezuelos, Olga; Liu, Heng; Fernandez, Ana; Bannister, Robin; Stoloff, Gregory; Oftung, Fredrik; Norley, Stephen; Huckriede, Anke; Frijlink, Henderik W; Hak, Eelko

2017-04-04

Current influenza vaccines, based on antibodies against surface antigens, are unable to provide protection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be re-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum of influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of four synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated immunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses. In a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers aged 18-60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 μg FLU-v in saline (arm 1), one dose of emulsified 500 μg FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose (arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline dose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI, evaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary outcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include clinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity. Broadly protective influenza vaccines able to provide protection against multiple strains of influenza are urgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The dosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both cellular and humoral immune responses will be evaluated. EudraCT number 2015-001932-38 ; retrospectively registered clinicaltrials.gov NCT02962908 (November 7th 2016).

Current status of evidence-based sports medicine.

PubMed

Harris, Joshua D; Cvetanovich, Gregory; Erickson, Brandon J; Abrams, Geoffrey D; Chahal, Jaskarndip; Gupta, Anil K; McCormick, Frank M; Bach, Bernard R

2014-03-01

The purpose of this investigation is to determine the proportion of sports medicine studies that are labeled as Level I Evidence in 5 journals and compare the quality of surgical and nonsurgical studies using simple quality assessment tools (Consolidated Standards of Reporting Trials [CONSORT] and Jadad). By use of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines over the prior 2 years in the top 5 (citation and impact factor based) sports medicine journals, only Level I Evidence studies were eligible for inclusion and were analyzed. All study types (therapeutic, prognostic, diagnostic, and economic) were analyzed. Study quality was assessed with the level of evidence, Jadad score, and CONSORT 2010 guidelines. Study demographic data were compared among journals and between surgical and nonsurgical studies by use of χ(2), 1-way analysis of variance, and 2-sample Z tests. We analyzed 190 Level I Evidence studies (10% of eligible studies) (119 randomized controlled trials [RCTs]). Therapeutic, nonsurgical, single-center studies from the United States were the most common studies published. Sixty-two percent of studies reported a financial conflict of interest. The knee was the most common body part studied, and track-and-field/endurance sports were the most common sports analyzed. Significant differences (P < .05) were shown in Jadad and CONSORT scores among the journals reviewed. Overall, the Jadad and CONSORT scores were 2.71 and 77%, respectively. No differences (P > .05) were shown among journals based on the proportion of Level I studies or appropriate randomization. Significant strengths and limitations of RCTs were identified. This study showed that Level I Evidence and RCTs comprise 10% and 6% of contemporary sports medicine literature, respectively. Therapeutic, nonsurgical, single-center studies are the most common publications with Level I Evidence. Significant differences across sports medicine journals were found in study quality. Surgical studies appropriately described randomization, blinding, and patient enrollment significantly more than nonsurgical studies. Level I, systematic review of Level I studies. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

The evolution of machining-induced surface of single-crystal FCC copper via nanoindentation

NASA Astrophysics Data System (ADS)

Zhang, Lin; Huang, Hu; Zhao, Hongwei; Ma, Zhichao; Yang, Yihan; Hu, Xiaoli

2013-05-01

The physical properties of the machining-induced new surface depend on the performance of the initial defect surface and deformed layer in the subsurface of the bulk material. In this paper, three-dimensional molecular dynamics simulations of nanoindentation are preformed on the single-point diamond turning surface of single-crystal copper comparing with that of pristine single-crystal face-centered cubic copper. The simulation results indicate that the nucleation of dislocations in the nanoindentation test on the machining-induced surface and pristine single-crystal copper is different. The dislocation embryos are gradually developed from the sites of homogeneous random nucleation around the indenter in the pristine single-crystal specimen, while the dislocation embryos derived from the vacancy-related defects are distributed in the damage layer of the subsurface beneath the machining-induced surface. The results show that the hardness of the machining-induced surface is softer than that of pristine single-crystal copper. Then, the nanocutting simulations are performed along different crystal orientations on the same crystal surface. It is shown that the crystal orientation directly influences the dislocation formation and distribution of the machining-induced surface. The crystal orientation of nanocutting is further verified to affect both residual defect generations and their propagation directions which are important in assessing the change of mechanical properties, such as hardness and Young's modulus, after nanocutting process.

Protocol for disseminating an evidence-based fall prevention program in community senior centers: evaluation of translatability and public health impact via a single group pre-post study.

PubMed

Li, Fuzhong; Harmer, Peter

2014-05-26

Falls are the leading cause of injury death in older adults and present a significant public health problem and a major burden to healthcare. Although there is sufficient evidence from randomized controlled trials to indicate that exercise can prevent falls in older people, few effective, evidence-based fall prevention programs exist in community practice. Thus, there is a pressing need to translate and disseminate evidence-based exercise programs to community providers that serve older adults at increased risk of falling. The current study addresses this public health need by disseminating the evidence-based Tai Ji Quan: Moving for Better Balance (TJQMBB) program through community senior centers. The study uses a single-group design in which the TJQMBB program is being delivered to community-dwelling older adults through collaboration with senior centers in selected counties in Oregon, USA, for 48 weeks, followed by a 24-week post-intervention follow-up. Study process and outcome measures will be evaluated in accordance with the components of the RE-AIM framework that focus on Reach, Effectiveness, Adoption, Implementation and Maintenance. This study will determine whether the evidence-based TJQMBB fall prevention program can be disseminated through a broad spectrum of community-based senior centers that often cater to low-income, underserved community-dwelling older adults at risk of falling. If shown to be both practically implementable and sustainable, the TJQMBB program will provide an effective, potentially low-cost, easy-to-implement intervention that could be used by public health practitioners and community-based organizations to address the problem of falls among older adults. ClinicalTrials.gov Identifier: NCT01854931.

Soluble intercellular adhesion molecule-1 and clinical outcomes in patients with acute lung injury

PubMed Central

Eisner, Mark D.; Parsons, Polly E.; Thompson, B. Taylor; Conner, Edward R.; Matthay, Michael A.; Ware, Lorraine B.

2009-01-01

Objective To determine if levels of soluble intercellular adhesion molecule-1 (sICAM-1), a marker of alveolar epithelial and endothelial injury, differ in patients with hydrostatic pulmonary edema and acute lung injury (ALI) and are associated with clinical outcomes in patients with ALI. Design, setting, and participants Measurement of sICAM-1 levels in (1) plasma and edema fluid from 67 patients with either hydrostatic pulmonary edema or ALI enrolled in an observational, prospective single center study, and (2) in plasma from 778 patients with ALI enrolled in a large multi-center randomized controlled trial of ventilator strategy. Results In the single-center study, levels of sICAM-1 were significantly higher in both edema fluid and plasma (median 938 and 545 ng/ml, respectively) from ALI patients compared to hydrostatic edema patients (median 384 and 177 ng/ml, P < 0.03 for both comparisons). In the multi-center study, higher plasma sICAM-1 levels were associated with poor clinical outcomes in both unadjusted and multivariable models. Subjects with ALI whose plasma sICAM-1 levels increased over the first 3 days of the study had a higher risk of death, after adjusting for other important predictors of outcome (odds ratio 1.48; 95% CI 1.03–2.12, P = 0.03). Conclusions Both plasma and edema fluid levels of sICAM-1 are higher in patients with ALI than in patients with hydrostatic pulmonary edema. Higher plasma sICAM-1 levels and increasing sICAM-1 levels over time are associated with poor clinical outcomes in ALI. Measurement of sICAM-1 levels may be useful for identifying patients at highest risk of poor outcomes from ALI. PMID:18670758

Pharmacokinetic properties and safety profile of histamine dihydrochloride injection in Chinese healthy volunteers: a phase I, single-center, open-label, randomized study.

PubMed

Li, Jiapeng; Huang, Xiaojun; Wang, Qian; Jing, Shan; Jiang, Hao; Wei, Zhongna; Zang, Yannan; Liu, Yang; Zhao, Libo; Fang, Yi; Feng, Wanyu

2015-10-01

Histamine dihydrochloride (HDC) injection has been approved in Europe for the treatment of adults with acute myeloid leukemia, used in combination therapy with the T-cell-derived cytokine interleukin-2. Despite years of clinical applications of HDC in Europe, no data are available on its tolerability and pharmacokinetic properties in Chinese patients. The objective of this study was to determine the safety profile and pharmacokinetic properties of HDC in Chinese healthy volunteers (HVs). In this Phase I, single-center, open-label, randomized study, 20 Chinese HVs were randomized to receive a single dose of 0.5 or 1.0 mg HDC via a 10-minute subcutaneous injection. Whole-blood and urine samples were collected at designated time points after dosing. Plasma and urine concentrations of histamine and metabolite N-methyl histamine were measured using a validated HPLC-MS/MS method. Pharmacokinetic parameters were estimated through noncompartmental procedures based on concentration-time data. Adverse events and evaluation of clinical laboratory tests were used to assess the safety profile. The pharmacokinetic profile for a single-dose of 1.0 mg HDC in Chinese HVs was compared with that in Western HVs. No severe adverse events occurred in this study, and the severity of all adverse events was grade I according to the Common Terminology Criteria for Adverse Events, version 4.0. For the pharmacokinetic parameters of histamine at the 0.5-mg and 1.0-mg dose levels, t½ was 0.50 and 1.02 hours; Tmax was 0.15 and 0.14 hours; mean Cmax was 26.59 and 71.01 nmol/L; AUC0-t was 8.35 and 20.43 nmol/h/L; AUC0-∞ was 9.61 and 22.69 nmol/h/L; accumulated amount excreted in urine within 24 hours was 125.93 and 145.52 nmol; and maximum urine excretion rates were 21.85 and 38.94 nmol/h, respectively. For N-methyl histamine at the 0.5-mg and 1.0-mg dose levels, t½ was 0.58 and 0.66 hours; Tmax was 0.28 and 0.26 hours; mean Cmax was 17.01 and 23.54 nmol/L; AUC0-t was 7.72 and 17.08 nmol/h/L; AUC0-∞ was 9.01 and 19.62 nmol/h/L; accumulated amount excreted in urine within 24 hours was 331.7 and 583.21 nmol; and maximum urine excretion rates were 53.29 and 133.53 nmol/h, respectively. Both single-dose 0.5 mg and 1.0 mg HDC were well tolerated in Chinese HVs, and the pharmacokinetic profile of HDC in Chinese HVs was characterized in this study. A single dose of 1.0 mg HDC had a more rapid but similar extent of absorption, a wider distribution, and a little more rapid elimination in Chinese HVs compared with Western HVs. Findings from this study support additional clinical trials for HDC using in Chinese patients. Chinese Clinical Trial Registry identifier: ChiCTR-ONC-13003954. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Distributed Detection with Collisions in a Random, Single-Hop Wireless Sensor Network

DTIC Science & Technology

2013-05-26

public release; distribution is unlimited. Distributed detection with collisions in a random, single-hop wireless sensor network The views, opinions...1274 2 ABSTRACT Distributed detection with collisions in a random, single-hop wireless sensor network Report Title We consider the problem of... WIRELESS SENSOR NETWORK Gene T. Whipps?† Emre Ertin† Randolph L. Moses† ?U.S. Army Research Laboratory, Adelphi, MD 20783 †The Ohio State University

Balance training and center-of-pressure location in participants with chronic ankle instability.

PubMed

Mettler, Abby; Chinn, Lisa; Saliba, Susan A; McKeon, Patrick O; Hertel, Jay

2015-04-01

Chronic ankle instability (CAI) occurs in some people after a lateral ankle sprain and often results in residual feelings of instability and episodes of the ankle's giving way. Compared with healthy people, patients with CAI demonstrated poor postural control and used a more anteriorly and laterally positioned center of pressure (COP) during a single-limb static-balance task on a force plate. Balance training is an effective means of altering traditional COP measures; however, whether the overall location of the COP distribution under the foot also changes is unknown. To determine if the spatial locations of COP data points in participants with CAI change after a 4-week balance-training program. Randomized controlled trial. Laboratory. Thirty-one persons with self-reported CAI. Participants were randomly assigned to a 4-week balance-training program or no balance training. We collected a total of 500 COP data points while participants balanced using a single limb on a force plate during a 10-second trial. The location of each COP data point relative to the geometric center of the foot was determined, and the frequency count in 4 sections (anteromedial, anterolateral, posteromedial, posterolateral) was analyzed for differences between groups. Overall, COP position in the balance-training group shifted from being more anterior to less anterior in both eyes-open trials (before trial = 319.1 ± 165.4, after trial = 160.5 ± 149.5; P = .006) and eyes-closed trials (before trial = 387.9 ± 123.8, after trial = 189.4 ± 102.9; P < .001). The COP for the group that did not perform balance training remained the same in the eyes-open trials (before trial = 214.1 ± 193.3, after trial = 230.0 ± 176.3; P = .54) and eyes-closed trials (before trial = 326.9 ± 134.3, after trial = 338.2 ± 126.1; P = .69). In participants with CAI, the balance-training program shifted the COP location from anterolateral to posterolateral. The program may have repaired some of the damaged sensorimotor system pathways, resulting in a more optimally functioning and less constrained system.

MO-FG-CAMPUS-JeP3-01: A Statistical Model for Analyzing the Rotational Error of Single Iso-Center Technique

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

Chang, J; Dept of Radiation Oncology, New York Weill Cornell Medical Ctr, New York, NY

Purpose: To develop a generalized statistical model that incorporates the treatment uncertainty from the rotational error of single iso-center technique, and calculate the additional PTV (planning target volume) margin required to compensate for this error. Methods: The random vectors for setup and additional rotation errors in the three-dimensional (3D) patient coordinate system were assumed to follow the 3D independent normal distribution with zero mean, and standard deviations σx, σy, σz, for setup error and a uniform σR for rotational error. Both random vectors were summed, normalized and transformed to the spherical coordinates to derive the chi distribution with 3 degreesmore » of freedom for the radical distance ρ. PTV margin was determined using the critical value of this distribution for 0.05 significant level so that 95% of the time the treatment target would be covered by ρ. The additional PTV margin required to compensate for the rotational error was calculated as a function of σx, σy, σz and σR. Results: The effect of the rotational error is more pronounced for treatments that requires high accuracy/precision like stereotactic radiosurgery (SRS) or stereotactic body radiotherapy (SBRT). With a uniform 2mm PTV margin (or σx =σy=σz=0.7mm), a σR=0.32mm will decrease the PTV coverage from 95% to 90% of the time, or an additional 0.2mm PTV margin is needed to prevent this loss of coverage. If we choose 0.2 mm as the threshold, any σR>0.3mm will lead to an additional PTV margin that cannot be ignored, and the maximal σR that can be ignored is 0.0064 rad (or 0.37°) for iso-to-target distance=5cm, or 0.0032 rad (or 0.18°) for iso-to-target distance=10cm. Conclusions: The rotational error cannot be ignored for high-accuracy/-precision treatments like SRS/SBRT, particularly when the distance between the iso-center and target is large.« less

Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination.

PubMed

Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Damle, B

2015-03-01

RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis. This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore. To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination. This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference products under fasting conditions in a crossover fashion, with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (Cmax) and the area under plasma concentration-time curve (AUC). Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study. The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses.

Effects of pre-transplant azithromycin administration on kidney graft function: study protocol for a double-blind randomized clinical trial.

PubMed

Mokhtari, Gholamreza; Teimoori, Mojtaba

2018-06-28

Kidney transplantation is the best strategy for the management of end-stage renal disease; however, the outcomes need to improve further. Macrolides show antimicrobial and anti-inflammatory properties in chronic diseases and intraoperatively, and can accumulate in tissues for extended periods. Therefore, theoretically, when administered to a donor and because of accumulation in the donor kidney, macrolides can cause graft immunomodulation and improve kidney transplantation outcomes. This study is a single-center, randomized clinical trial. A total of 60 kidney donors will be randomly allocated to the azithromycin or placebo group and treated with a single dose (1 g) of azithromycin or placebo, respectively, 1 day before surgery. Recruitment commenced in September 2016 and is expected to be completed by March 2018. The primary outcome is kidney graft function. The secondary outcomes include rejection rate, urinary tract infections in graft recipients, pain and systemic inflammatory response syndrome in live donors, and complications in both donors and recipients. Outcomes will be evaluated at baseline and every day in the first week after transplantation, as well as at 1 and 3 months post transplantation. Adverse reactions will be documented. If the efficacy of azithromycin in reducing adverse outcomes is confirmed, it would serve as an easy to use, economic intervention able to lower post-transplantation risks. Short and mid-term analyses of blood and urine samples as well as immunological assays will facilitate a more in-depth analysis of the effects of azithromycin on transplantation outcomes. Iranian Clinical Trial Registry, IRCT201606141853N11 , registered on September 5, 2016.

Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers.

PubMed

Schück, Stéphane; Bentué-Ferrer, Danièle; Kleinermans, Diane; Reymann, Jean-Michel; Polard, Elisabeth; Gandon, Jean-Marc; Allain, Hervé

2002-02-01

Piribedil is a dopamine agonist acting on D2 and D3 central nervous system dopamine receptors. This drug has been administered to 12 young healthy male volunteers (age 22 +/- 2 years) according to a single center randomized, double-blind, two ways cross-over, placebo controlled trial, including a washout period of one week. Placebo and piribedil were administered by a single intravenous infusion over 2 h (3 mg). Psychomotor performance and cognitive functions were assessed through a standardized and computerized psychometric tests battery and a continuous electroencephalogram (EEG) mapping. Piribedil improved simple reaction time (P=0.02), immediate (P=0.045 and 0.004), and delayed free recall (P=0.05), dual coding test (P=0.02) and increased theta and fast beta waves on the EEG (P < 0.05 and 0.001, respectively). No deleterious effect was observed on the tests exploring attention and concentration via the other procedures. It is concluded that a single intravenous perfusion of piribedil 3 mg improves alertness and the information processing speed within the central nervous system, in healthy volunteers.

Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.

PubMed

Masata, Jaromir; Svabik, Kamil; Zvara, Karel; Drahoradova, Petra; El Haddad, Rachid; Hubka, Petr; Martan, Alois

2012-10-01

The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI). This single-center 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 the evaluation of ICIQ-UI SH (when patients ticked "Never"/"Urine does not leak" in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented. One hundred ninety-seven women with proven SUI were randomized into three groups--TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02). Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.

Single-electron random-number generator (RNG) for highly secure ubiquitous computing applications

NASA Astrophysics Data System (ADS)

Uchida, Ken; Tanamoto, Tetsufumi; Fujita, Shinobu

2007-11-01

Since the security of all modern cryptographic techniques relies on unpredictable and irreproducible digital keys generated by random-number generators (RNGs), the realization of high-quality RNG is essential for secure communications. In this report, a new RNG, which utilizes single-electron phenomena, is proposed. A room-temperature operating silicon single-electron transistor (SET) having nearby an electron pocket is used as a high-quality, ultra-small RNG. In the proposed RNG, stochastic single-electron capture/emission processes to/from the electron pocket are detected with high sensitivity by the SET, and result in giant random telegraphic signals (GRTS) on the SET current. It is experimentally demonstrated that the single-electron RNG generates extremely high-quality random digital sequences at room temperature, in spite of its simple configuration. Because of its small-size and low-power properties, the single-electron RNG is promising as a key nanoelectronic device for future ubiquitous computing systems with highly secure mobile communication capabilities.

Are mammographic changes in the tumor bed more pronounced after intraoperative radiotherapy for breast cancer? Subgroup analysis from a randomized trial (TARGIT-A).

PubMed

Engel, Dorothee; Schnitzer, Andreas; Brade, Joachim; Blank, Elena; Wenz, Frederik; Suetterlin, Marc; Schoenberg, Stefan; Wasser, Klaus

2013-01-01

Intraoperative radiotherapy (IORT) with low-energy x-rays is increasingly used in breast-conserving therapy (BCT). Previous non-randomized studies have observed mammographic changes in the tumor bed to be more pronounced after IORT. The purpose of this study was to reassess the postoperative changes in a randomized single-center subgroup of patients from a multicenter trial (TARGIT-A). In this subgroup (n = 48) 27 patients received BCT with IORT, 21 patients had BCT with standard whole-breast radiotherapy serving as controls. Overall 258 postoperative mammograms (median follow-up 4.3 years, range 3-8) were retrospectively evaluated by two radiologists in consensus focusing on changes in the tumor bed. Fat necroses showed to be significantly more frequent (56% versus 24%) and larger (8.7 versus 1.6 sq cm, median) after IORT than those in controls. Scar calcifications were also significantly more frequent after IORT (63% versus 19%). The high incidence of large fat necroses in our study confirms previous study findings. However, the overall higher incidence of calcifications in the tumor bed after IORT represents a new finding, requiring further attention. © 2012 Wiley Periodicals, Inc.

Efficacy and tolerability assessment of a topical formulation containing copper sulfate and hypericum perforatum on patients with herpes skin lesions: a comparative, randomized controlled trial.

PubMed

Clewell, Amy; Barnes, Matt; Endres, John R; Ahmed, Mansoor; Ghambeer, Daljit K S

2012-02-01

Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV. The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use. A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14. Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group. The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.

A randomized placebo-controlled trial of miglustat in cystic fibrosis based on nasal potential difference.

PubMed

Leonard, Anissa; Lebecque, Patrick; Dingemanse, Jasper; Leal, Teresinha

2012-05-01

Preclinical data suggest that miglustat could restore the function of the cystic fibrosis transmembrane conductance regulator gene in cystic fibrosis cells. Single-center, randomized, double-blind, placebo-controlled, crossover Phase II study in 11 patients (mean±SD age, 26.3±7.7 years) homozygous for the F508del mutation received oral miglustat 200 mgt.i.d. or placebo for two 8-day cycles separated by a 14-day washout period. The primary endpoint was the change in total chloride secretion (TCS) assessed by nasal potential difference. No statistically significant changes in TCS, sweat chloride values or FEV(1) were detected. Pharmacokinetic and safety were similar to those observed in patients with other diseases exposed to miglustat. There was no evidence of a treatment effect on any nasal potential difference variable. Further studies with miglustat need to adequately address criteria for assessment of nasal potential difference. Copyright © 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

The role of kinesiotaping combined with botulinum toxin to reduce plantar flexors spasticity after stroke.

PubMed

Karadag-Saygi, Evrim; Cubukcu-Aydoseli, Koza; Kablan, Nilufer; Ofluoglu, Demet

2010-01-01

To evaluate the effect of kinesiotaping as an adjuvant therapy to botulinum toxin A (BTX-A) injection in lower extremity spasticity. This is a single-center, randomized, and double-blind study. Twenty hemiplegic patients with spastic equinus foot were enrolled into the study and randomized into 2 groups. The first group (n=10) received BTX-A injection and kinesiotaping, and the second group (n=10) received BTX-A injection and sham-taping. Clinical assessment was done before injection and at 2 weeks and 1, 3, and 6 months. Outcome measures were modified Ashworth scale (MAS), passive ankle dorsiflexion, gait velocity, and step length. Improvement was recorded in both kinesiotaping and sham groups for all outcome variables. No significant difference was found between groups other than passive range of motion (ROM), which was found to have increased more in the kinesiotaping group at 2 weeks. There is no clear benefit in adjuvant kinesiotaping application with botulinum toxin for correction of spastic equinus in stroke.

Optimal configuration of microstructure in ferroelectric materials by stochastic optimization

NASA Astrophysics Data System (ADS)

Jayachandran, K. P.; Guedes, J. M.; Rodrigues, H. C.

2010-07-01

An optimization procedure determining the ideal configuration at the microstructural level of ferroelectric (FE) materials is applied to maximize piezoelectricity. Piezoelectricity in ceramic FEs differs significantly from that of single crystals because of the presence of crystallites (grains) possessing crystallographic axes aligned imperfectly. The piezoelectric properties of a polycrystalline (ceramic) FE is inextricably related to the grain orientation distribution (texture). The set of combination of variables, known as solution space, which dictates the texture of a ceramic is unlimited and hence the choice of the optimal solution which maximizes the piezoelectricity is complicated. Thus, a stochastic global optimization combined with homogenization is employed for the identification of the optimal granular configuration of the FE ceramic microstructure with optimum piezoelectric properties. The macroscopic equilibrium piezoelectric properties of polycrystalline FE is calculated using mathematical homogenization at each iteration step. The configuration of grains characterized by its orientations at each iteration is generated using a randomly selected set of orientation distribution parameters. The optimization procedure applied to the single crystalline phase compares well with the experimental data. Apparent enhancement of piezoelectric coefficient d33 is observed in an optimally oriented BaTiO3 single crystal. Based on the good agreement of results with the published data in single crystals, we proceed to apply the methodology in polycrystals. A configuration of crystallites, simultaneously constraining the orientation distribution of the c-axis (polar axis) while incorporating ab-plane randomness, which would multiply the overall piezoelectricity in ceramic BaTiO3 is also identified. The orientation distribution of the c-axes is found to be a narrow Gaussian distribution centered around 45°. The piezoelectric coefficient in such a ceramic is found to be nearly three times as that of the single crystal. Our optimization model provide designs for materials with enhanced piezoelectric performance, which would stimulate further studies involving materials possessing higher spontaneous polarization.

Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial.

PubMed

Bergamin, Fabricio S; Almeida, Juliano P; Landoni, Giovanni; Galas, Filomena R B G; Fukushima, Julia T; Fominskiy, Evgeny; Park, Clarice H L; Osawa, Eduardo A; Diz, Maria P E; Oliveira, Gisele Q; Franco, Rafael A; Nakamura, Rosana E; Almeida, Elisangela M; Abdala, Edson; Freire, Maristela P; Filho, Roberto K; Auler, Jose Otavio C; Hajjar, Ludhmila A

2017-05-01

To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Single center, randomized, double-blind controlled trial. Teaching hospital. Adult cancer patients with septic shock in the first 6 hours of ICU admission. Patients were randomized to the liberal (hemoglobin threshold, < 9 g/dL) or to the restrictive strategy (hemoglobin threshold, < 7 g/dL) of RBC transfusion during ICU stay. Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.

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

PubMed

Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2013-07-06

The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. NCT01857882.

The Efficacy of Incentives to Motivate Continued Fitness-Center Attendance in College First-Year Students: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Pope, Lizzy; Harvey, Jean

2014-01-01

Objective: To determine whether fitness-center attendance established with the provision of weekly monetary incentives persisted after the discontinuation, or decreased frequency, of incentives. Participants: One hundred seventeen first-year college students participated during the 2011-2012 academic year. Methods: A randomized controlled trial…

Teachers' Attitude towards Implementation of Learner-Centered Methodology in Science Education in Kenya

ERIC Educational Resources Information Center

Ndirangu, Caroline

2017-01-01

This study aims to evaluate teachers' attitude towards implementation of learner-centered methodology in science education in Kenya. The study used a survey design methodology, adopting the purposive, stratified random and simple random sampling procedures and hypothesised that there was no significant relationship between the head teachers'…

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

PubMed

Orozco-Beltran, Domingo; Ruescas-Escolano, Esther; Navarro-Palazón, Ana Isabel; Cordero, Alberto; Gaubert-Tortosa, María; Navarro-Perez, Jorge; Carratalá-Munuera, Concepción; Pertusa-Martínez, Salvador; Soler-Bahilo, Enrique; Brotons-Muntó, Francisco; Bort-Cubero, Jose; Nuñez-Martinez, Miguel Angel; Bertomeu-Martinez, Vicente; Gil-Guillen, Vicente Francisco

2013-08-02

To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Experimental study. Randomized clinical trial. Follow-up period: one year. primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. NCT01826929.

Matter distribution and spin-orbit force in spherical nuclei

NASA Astrophysics Data System (ADS)

Co', G.; Anguiano, M.; De Donno, V.; Lallena, A. M.

2018-03-01

We investigate the possibility that some nuclei show density distributions with a depletion in the center, a semibubble structure, by using a Hartree-Fock plus Bardeen-Cooper-Schrieffer approach. We separately study the proton, neutron, and matter distributions in 37 spherical nuclei mainly in the s -d shell region. We found a relation between the semibubble structure and the energy splitting of spin-orbit partner single particle levels. The presence of semibubble structure reduces this splitting, and we study its consequences on the excitation spectrum of the nuclei under investigation by using a quasiparticle random-phase-approximation approach. The excitation energies of the low-lying 4+ states can be related to the presence of semibubble structure in nuclei.

Dynamic speckle - Interferometry of micro-displacements

NASA Astrophysics Data System (ADS)

Vladimirov, A. P.

2012-06-01

The problem of the dynamics of speckles in the image plane of the object, caused by random movements of scattering centers is solved. We consider three cases: 1) during the observation the points move at random, but constant speeds, and 2) the relative displacement of any pair of points is a continuous random process, and 3) the motion of the centers is the sum of a deterministic movement and random displacement. For the cases 1) and 2) the characteristics of temporal and spectral autocorrelation function of the radiation intensity can be used for determining of individually and the average relative displacement of the centers, their dispersion and the relaxation time. For the case 3) is showed that under certain conditions, the optical signal contains a periodic component, the number of periods is proportional to the derivations of the deterministic displacements. The results of experiments conducted to test and application of theory are given.

Cumulative recruitment experience in two large single-center randomized, controlled clinical trials.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela; Forkner, Emma; Peters, Jay I

2008-05-01

Trial recruitment is challenging for researchers, who frequently overestimate the pool of qualified, willing participants. Little has been written about recruitment and the comparative success of recruitment strategies. We describe one center's experience with recruitment in two regional single-center clinical trials with a combined total of 1971 participants. The heart failure trial was conducted between 1999 and 2003. The asthma trial was performed between 2003 and 2006. Trial databases were queried for referral source of each individual. Data were analyzed for effectiveness of referral source using three measures: percentage of enrollment due to that source, subject commitment to the trial (retention rate), and economics (cost per enrollee). 47.8% of CHF enrollees came from computer-generated lists or from healthcare provider referrals. Average marketing cost for enrollees and completers was $29.20 and $41.96 respectively. The most economical marketing strategy was self-referral in response to flyers. Most asthma participants (53.5%) were referred from healthcare providers, mailings to lists from local healthcare institutions, or self-referred in response to flyers. Average marketing cost for enrollees and completers was $20.44 and $38.10 respectively. The most economical marketing strategy was patient mailings. Retention rates were not markedly different among referral sources in either trial. In order to be considered effective, a recruitment strategy must demonstrate a balance between response to recruitment, retention rates, and economics. Despite the differences between these two clinical trials, the most effective recruitment strategies in both trials were mailings to locally-generated, targeted lists, and referrals from healthcare providers.

Transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures: A randomized controlled study with patient-reported outcome.

PubMed

Galal, Sherif; Safwat, Wael

2017-01-01

The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.

Electromagnetic-guided placement of nasoduodenal feeding tubes versus endoscopic placement: a randomized, multicenter trial.

PubMed

Kappelle, Wouter F W; Walter, Daisy; Stadhouders, Paul H; Jebbink, Hendrik J A; Vleggaar, Frank P; van der Schaar, Peter J; Kappelle, Jan Willem; van der Tweel, Ingeborg; Van den Broek, Medard F M; Wessels, Frank J; Siersema, Peter D; Monkelbaan, Jan F

2018-01-01

Electromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and EGDP in outpatients, ward patients, and critically ill patients with normal upper GI anatomy. In 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle. In total, 160 patients were randomized to EGDP (N = 76) or EMP (N = 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; P = .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis N = 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP: $519.09 versus $622.49, respectively (P = .04). Success rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.). Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Effects of calcium supplementation on body weight and adiposity in overweight and obese adults: a randomized trial.

PubMed

Yanovski, Jack A; Parikh, Shamik J; Yanoff, Lisa B; Denkinger, Blakeley I; Calis, Karim A; Reynolds, James C; Sebring, Nancy G; McHugh, Teresa

2009-06-16

Some data suggest that increasing calcium intake may help prevent weight gain. To test the hypothesis that calcium supplementation can prevent weight gain in persons who are overweight or obese. Randomized, placebo-controlled trial. Randomization was computer-generated, and allocation was assigned by pharmacy personnel who prepared intervention and placebo capsules. Participants, providers, and those who assessed outcomes were blinded to study group assignment. Single research center. 340 overweight (body mass index [BMI], 25 to <30 kg/m(2)) and obese (BMI > or =30 kg/m(2)) adults (mean age, 38.8 years [SD, 10.5]). Calcium carbonate (elemental calcium, 1500 mg/d) (n = 170) or placebo (n = 170) with meals for 2 years. Changes in body weight and fat mass (primary outcomes). Seventy-five percent of participants completed the trial (78% received calcium; 73% received placebo). There were no statistically or clinically significant differences between the calcium and placebo groups in change in body weight (difference, 0.02 kg [95% CI, -1.64 to 1.69 kg]; P = 0.98), BMI (difference, 0.32 kg/m(2) [CI, -0.41 to 1.02 kg/m(2)]; P = 0.39), or body fat mass (difference, 0.39 kg [CI, -1.04 to 1.92 kg]; P = 0.55). Parathyroid hormone concentrations decreased in the calcium group compared with the placebo group (difference, -0.71 pmol/L [CI, -1.28 to -0.13 pmol/L]). The study took place at a research center, and its sample was mostly women. Dietary supplementation with elemental calcium, 1500 mg/d, for 2 years had no statistically or clinically significant effects on weight in overweight and obese adults. Calcium supplementation is unlikely to have clinically significant efficacy as a preventive measure against weight gain in such patients.

Analytical application of femtosecond laser-induced breakdown spectroscopy

NASA Astrophysics Data System (ADS)

Melikechi, Noureddine; Markushin, Yuri

2015-05-01

We report on significant advantages provided by femtosecond laser-induced breakdown spectroscopy (LIBS) for analytical applications in fields as diverse as protein characterization and material science. We compare the results of a femto- and nanosecond-laser-induced breakdown spectroscopy analysis of dual-elemental pellets in terms of the shot-to-shot variations of the neutral/ionic emission line intensities. This study is complemented by a numerical model based on two-dimensional random close packing of disks in an enclosed geometry. In addition, we show that LIBS can be used to obtain quantitative identification of the hydrogen composition of bio-macromolecules in a heavy water solution. Finally, we show that simultaneous multi-elemental particle assay analysis combined with LIBS can significantly improve macromolecule detectability up to near single molecule per particle efficiency. Research was supported by grants from the National Science Foundation Centers of Research Excellence in Science and Technology (0630388), National Aeronautics and Space Administration (NX09AU90A). Our gratitude to Dr. D. Connolly, Fox Chase Cancer Center.

Microstructure and Mechanical Properties of Fe-18Mn-18Cr-0.5N Austenitic Nonmagnetic Stainless Steel in Asymmetric Hot Rolling

NASA Astrophysics Data System (ADS)

Song, Y. L.; Li, C. S.; Ma, B.; Han, Y. H.

2017-05-01

Asymmetric hot rolling (ASHR) with a mismatch speed ratio of 1.15 in a single pass was applied to Fe-18Mn-18Cr-0.5N steel and was compared with symmetric hot rolling (SHR). The results indicated that a through-thickness microstructure gradient was formed in the plate due to the shear strain (0.36) introduced by ASHR. A fine-grained layer with the average size of 3 μm was achieved at the top surface of ASHR plate, while numerous elongated grains with a few recrystallized grains were presented at the center layer. The texture was distributed randomly at the top surface of ASHR plate, and a weaker intensity of typical hot-rolled texture in austenitic steel was obtained at the center layer of ASHR plate compared to SHR plate. An excellent combination of microhardness, strength and ductility was obtained in the ASHR plate, which was attributed to gradient microstructure induced by ASHR.

Role of corticosteroid as a prophylactic measure in fat embolism syndrome: a literature review.

PubMed

Sen, Ramesh K; Tripathy, Sujit K; Krishnan, Vibhu

2012-06-01

Despite a number of studies on steroid therapy as a prophylactic measure in fat embolism syndrome (FES), there is no universal agreement about its role in this critical situation. The present article attempts to search the available literature, and provides a more lucid picture to the readers on this issue. Seven articles (total 483 patients) were reviewed and analyzed. Total of 223 patients received steroid (methyl prednisolone sodium succinate), while the remaining 260 patients formed the control population. Among these subjects, 9 patients in steroid-receiving group and 60 patients in the control group developed FES (P < 0.05). The lack of uniformities in these studies, variable dose and single-center trial are the principal limitations and confuses the surgeons to have definite conclusion. Large-scale, more uniformly designed, multi-centered, randomized, prospective trials are needed to determine the correct situations and dosage in which steroids provide the maximum benefit (with the least possible risk).

Predicting the Crystal Structure and Phase Transitions in High-Entropy Alloys

NASA Astrophysics Data System (ADS)

King, D. M.; Middleburgh, S. C.; Edwards, L.; Lumpkin, G. R.; Cortie, M.

2015-06-01

High-entropy alloys (HEAs) have advantageous properties compared with other systems as a result of their chemistry and crystal structure. The transition between a face-centered cubic (FCC) and body-centered cubic (BCC) structure in the Al x CoCrFeNi high-entropy alloy system has been investigated on the atomic scale in this work. The Al x CoCrFeNi system, as well as being a useful system itself, can also be considered a model HEA material. Ordering in the FCC structure was investigated, and an order-disorder transition was predicted at ~600 K. It was found that, at low temperatures, an ordered lattice is favored over a truly random lattice. The fully disordered BCC structure was found to be unstable. When partial ordering was imposed (lowering the symmetry), with Al and Ni limited specific sites of the BCC system, the BCC packing was stabilized. Decomposition of the ordered BCC single phase into a dual phase (Al-Ni rich and Fe-Cr rich) is also considered.

A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions.

PubMed

Cotton, Bryan A; Podbielski, Jeanette; Camp, Elizabeth; Welch, Timothy; del Junco, Deborah; Bai, Yu; Hobbs, Rhonda; Scroggins, Jamie; Hartwell, Beth; Kozar, Rosemary A; Wade, Charles E; Holcomb, John B

2013-10-01

To determine whether resuscitation of severely injured patients with modified whole blood (mWB) resulted in fewer overall transfusions compared with component (COMP) therapy. For decades, whole blood (WB) was the primary product for resuscitating patients in hemorrhagic shock. After dramatic advances in blood banking in the 1970s, blood donor centers began supplying hospitals with individual components [red blood cell (RBC), plasma, platelets] and removed WB as an available product. However, no studies of efficacy or hemostatic potential in trauma patients were performed before doing so. Single-center, randomized trial of severely injured patients predicted to large transfusion volume. Pregnant patients, prisoners, those younger than 18 years or with more than 20% total body surface area burns (TBSA) burns were excluded. Patients were randomized to mWB (1 U mWB) or COMP therapy (1 U RBC+ 1 U plasma) immediately on arrival. Each group also received 1 U platelets (apheresis or prepooled random donor) for every 6 U of mWB or 6 U of RBC + 6 U plasma. The study was performed under the Exception From Informed Consent (Food and Drug Administration 21 code of federal regulations [CFR] 50.24). Primary outcome was 24-hour transfusion volumes. A total of 107 patients were randomized (55 mWB, 52 COMP therapy) over 14 months. There were no differences in demographics, arrival vitals or laboratory values, injury severity, or mechanism. Transfusions were similar between groups (intent-to-treat analysis). However, when excluding patients with severe brain injury (sensitivity analysis), WB group received less 24-hour RBC (median 3 vs 6, P = 0.02), plasma (4 vs 6, P = 0.02), platelets (0 vs 3, P = 0.09), and total products (11 vs 16, P = 0.02). Compared with COMP therapy, WB did not reduce transfusion volumes in severely injured patients predicted to receive massive transfusion. However, in the sensitivity analysis (patients without severe brain injuries), use of mWB significantly reduced transfusion volumes, achieving the prespecified endpoint of this initial pilot study.

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible effects of creative music therapy on short- and long-term brain development in preterm infants. This project lies at the interface of music therapy, neuroscience, and medical imaging. New insights into the potential role and impact of music on brain function and development may be elucidated. If such a low-cost, low-risk intervention is demonstrated in a future multi-center trial to be effective in supporting brain development in preterm neonates, findings could have broad clinical implications for this vulnerable patient population. ClinicalTrials.gov, NCT02434224.

Air bubble migration is a random event post embryo transfer.

PubMed

Confino, E; Zhang, J; Risquez, F

2007-06-01

Air bubble location following embryo transfer (ET) is the presumable placement spot of embryos. The purpose of this study was to document endometrial air bubble position and migration following embryo transfer. Multicenter prospective case study. Eighty-eight embryo transfers were performed under abdominal ultrasound guidance in two countries by two authors. A single or double air bubble was loaded with the embryos using a soft, coaxial, end opened catheters. The embryos were slowly injected 10-20 mm from the fundus. Air bubble position was recorded immediately, 30 minutes later and when the patient stood up. Bubble marker location analysis revealed a random distribution without visible gravity effect when the patients stood up. The bubble markers demonstrated splitting, moving in all directions and dispersion. Air bubbles move and split frequently post ET with the patient in the horizontal position, suggestive of active uterine contractions. Bubble migration analysis supports a rather random movement of the bubbles and possibly the embryos. Standing up changed somewhat bubble configuration and distribution in the uterine cavity. Gravity related bubble motion was uncommon, suggesting that horizontal rest post ET may not be necessary. This report challenges the common belief that a very accurate ultrasound guided embryo placement is mandatory. The very random bubble movement observed in this two-center study suggests that a large "window" of embryo placement maybe present.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

A randomized and placebo-controlled study to compare the skin-lightening efficacy and safety of lignin peroxidase cream vs. 2% hydroquinone cream.

PubMed

Mauricio, Tess; Karmon, Yoram; Khaiat, Alain

2011-12-01

  Historically, the most effective treatments for skin lightening have contained hydroquinone. However, there is a need for an effective alternative.   The purpose of this study was to evaluate the skin-lightening efficacy and safety of lignin peroxidase (LIP) creams using a regimen of both day and night products compared with twice-daily application of 2% hydroquinone cream and placebo in Asian women.   This was a randomized, double-blind, placebo-controlled, split-face, single-center study of 51 patients. Patients were randomized to receive day and night LIP cream on one randomly selected side of their face and either 2% hydroquinone cream or placebo on the other.   A statistically significant change from baseline in the melanin index was observed in LIP-treated skin, with a mean reduction of 7.6% (P < 0.001) on Day 31. Conversely, hydroquinone and placebo did not provide a statistically significant lightening effect when instrumentally measured. Dermatologist scoring demonstrated a significant improvement in overall fairness as early as 8 days after treatment initiation in the LIP-treated group, which was not observed in the other groups. Overall, patients preferred the LIP creams.   The application of day/night LIP cream provided a significantly more rapid and observable skin-lightening effect than hydroquinone 2% cream or placebo. © 2011 Wiley Periodicals, Inc.

Characteristics and trends of clinical trials funded by the National Institutes of Health between 2005 and 2015.

PubMed

Gresham, Gillian K; Ehrhardt, Stephan; Meinert, Jill L; Appel, Lawrence J; Meinert, Curtis L

2018-02-01

Background The National Institutes of Health is one of the largest biomedical research agencies in the world. Clinical trials are an important component of National Institutes of Health research efforts. Given the recent updates in National Institutes of Health trial reporting requirements, more information regarding the current state of National Institutes of Health-funded clinical trials is warranted. The objective of this analysis was to describe characteristics and trends of clinical trials funded by the National Institutes of Health over time and by Institutes and Centers of the National Institutes of Health. Methods Interventional studies funded by the National Institutes of Health and registered in ClinicalTrials.gov between 2005 and 2015 were included in the analysis. Trials were identified from the 27 March 2016 Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database. A descriptive analysis of trials by year and National Institutes of Health Institute/Center was performed. Results There were 12,987 National Institutes of Health-funded clinical trials registered between 2005 and 2015. There were 1,580, 1,116, and 930 trials registered in 2005, 2010, and 2015, respectively. The majority were early-development trials (phases 0, 1, or 2; 53%), randomized (61%), and single-center (63%). Trial demographics have remained unchanged over time. Median trial sample size was 64 (interquartile range 29-192) with 10% of trials enrolling ≥500 participants. Most trials were completed within 5 years of enrollment start (69%). Trial characteristics varied considerably across National Institutes of Health Institutes and Centers. Results were reported under the assumptions that most National Institutes of Health-funded trials are registered in ClinicalTrials.gov and that trials are being registered completely and accurately. Conclusion In conclusion, there has been a decline in the number of trials being funded over time, explained in part by a relatively constant budget, increases in trial costs, or other factors that cannot be quantified. National Institutes of Health-funded trials are relatively small and tend to be single-centered. There are substantial differences in the number and types of trials done by Institutes and Centers within the National Institutes of Health.

No Randomization? No Problem: Experimental Control and Random Assignment in Single Case Research

ERIC Educational Resources Information Center

Ledford, Jennifer R.

2018-01-01

Randomization of large number of participants to different treatment groups is often not a feasible or preferable way to answer questions of immediate interest to professional practice. Single case designs (SCDs) are a class of research designs that are experimental in nature but require only a few participants, all of whom receive the…

Public School Center vs. Family Home Day Care: Single Parents' Reasons for Selection.

ERIC Educational Resources Information Center

Rothschild, Maria Stupp

This study investigates the reasons single parents in San Diego had for choosing either a public day care center or a licensed day care home for their children. A sample of 30 single parents with children in school district administered children's centers was drawn and matched by a similarly geographically distributed sample of 23 parents with…

Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

PubMed Central

Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

2012-01-01

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Citation: Epstein DR; Sidani S; Bootzin RR; Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. SLEEP 2012;35(6):797-805. PMID:22654199

Renal function following xenon anesthesia for partial nephrectomy-An explorative analysis of a randomized controlled study.

PubMed

Stevanovic, Ana; Schaefer, Patrick; Coburn, Mark; Rossaint, Rolf; Stoppe, Christian; Boor, Peter; Pfister, David; Heidenreich, Axel; Christ, Hildegard; Hellmich, Martin; Fahlenkamp, Astrid V

2017-01-01

Perioperative preservation of renal function has a significant impact on morbidity and mortality in kidney surgery. Nephroprotective effects of the anesthetic xenon on ischemia-reperfusion injury were found in several experimental studies. We aimed to explore whether xenon anesthesia can reduce renal damage in humans undergoing partial nephrectomy and to gather pilot data of possible nephroprotection in these patients. A prospective randomized, single-blinded, controlled study. Single-center, University Hospital of Aachen, Germany between July 2013-October 2015. Forty-six patients with regular renal function undergoing partial nephrectomy. Patients were randomly assigned to receive xenon- (n = 23) or isoflurane (n = 23) anesthesia. Primary outcome was the maximum postoperative glomerular filtration rate (GFR) decline within seven days after surgery. Secondary outcomes included intraoperative and tumor-related data, assessment of further kidney injury markers, adverse events and optional determination of renal function after 3-6 months. Unexpected radical nephrectomy was performed in 5 patients, thus they were excluded from the per-protocol analysis, but included in the intention-to-treat analysis. The maximum postoperative GFR decline was attenuated by 45% in the xenon-group (10.9 ml min-1 1.73 cm-2 versus 19.7 ml min-1 1.73 cm-2 in the isoflurane group), but without significance (P = 0.084). Occurrence of adverse events was reduced (P = 0.003) in the xenon group. Renal function was similar among the groups after 3-6 months. Xenon anesthesia was feasible and safe in patients undergoing partial nephrectomy with regard to postoperative renal function. We found no significant effect on early renal function but less adverse events in the xenon group. Larger randomized controlled studies in more heterogeneous collectives are required, to confirm or refute the possible clinical benefit on renal function by xenon. ClinicalTrials.gov NCT01839084 and EudraCT 2012-005698-30.

Dobutamine-induced high cardiac index did not prevent vasospasm in subarachnoid hemorrhage patients: a randomized controlled pilot study.

PubMed

Rondeau, Nelly; Cinotti, Raphaël; Rozec, Bertrand; Roquilly, Antoine; Floch, Hervé; Groleau, Nicolas; Michel, Patrick; Asehnoune, Karim; Blanloeil, Yvonnick

2012-10-01

Prevention of vasospasm is a challenging issue in subarachnoid hemorrhage (SAH) patients and the objective is to compare high dobutamine-induced cardiac index (CI) and high norepinephrine-induced hypertension for the prevention of vasospasm in SAH patients. Single center, single blind, controlled randomized study. Patients hospitalized in intensive care unit (ICU) for a moderate to severe SAH (WFNS grade ≥2) were randomized to receive dobutamine to reach a 25 % increase in cardiac index or norepinephrine to reach a mean arterial pressure ≥100 mmHg. Norepinephrine could be used in the dobutamine group to maintain a cerebral pressure perfusion ≥60 mmHg. Primary endpoint was the incidence of angiographic vasospasm in the first 14 days in the ICU setting, which was upheld by a cerebral arteriography. Secondary endpoints were the incidence of delayed ischemic deficits, duration of mechanical ventilation, and ICU length of stay (LOS). During the 3-year study, 41 patients were randomized. Six patients were excluded--3 because of consent withdrawal and 3 who did not receive the assigned treatment. Respectively, 17 and 18 patients in the dobutamine and the norepinephrine group were kept in analysis. Five (28 %) patients in the dobutamine group and 5 (27 %) patients in the norepinephrine group developed vasospasm in ICU (p = 1). Seven (41 %) patients presented a delayed ischemic deficit in the dobutamine group and 9 (50 %) in the norepinephrine group (p = 0.24). Duration of mechanical ventilation was 8 [0.5-11.5] days in the dobutamine group and 19 [2.7-23] days in the norepinephrine group (p = 0.01). ICU LOS was 11 [6-15] days in the dobutamine group and 21 [9-28] days in the norepinephrine group (p = 0.01). As compared to norepinephrine-induced hypertension, dobutamine-induced high CI did not reduce the rate of vasospasm in SAH patients. Dobutamine may reduce durations of mechanical ventilation and ICU LOS.

Transdermal Nitroglycerin Therapy May Not Prevent Early Postmenopausal Bone Loss

PubMed Central

Wimalawansa, Sunil J.; Grimes, Julia P.; Wilson, Alan C.; Hoover, Donald R.

2009-01-01

Context: Osteoporosis is common among postmenopausal women; animal studies and human pilot studies support the concept of nitric oxide (NO) donors reducing bone mineral density loss. Objective: The objective of the study was to evaluate whether NO donor, nitroglycerin, prevents postmenopausal bone loss. Design: This was a 3-yr randomized, double blinded, single-center, placebo-controlled clinical trial. Setting: The single-center study was conducted at the University of Medicine and Dentistry-Robert Wood Johnson Medical School (New Brunswick, NJ). Participants: Participants included 186 postmenopausal women aged 40–65 yr, with lumbar bone mineral density (BMD) T-scores of 0 to −2.5. Intervention: Women, stratified by lumbar T-score (<−1.50 and ≥−1.50) and years since menopause (≤5 and >5 yr), were randomized to receive nitroglycerin ointment (22.5 mg as Nitro-Bid) or placebo ointment received daily for 3 yr. Both groups took 630 mg daily calcium plus 400 IU vitamin D supplements. Measurements: BMD was measured at 6 months and annually by dual-energy x-ray absorptiometry. Percent change in lumbar vertebrae BMD was the primary outcome. Hip BMD, total body bone mineral content, and height were secondary outcomes. Results: After 36 months of therapy, changes of −2.1% in the active group (n = 88) and −2.5% in the placebo group (n = 82) in lumbar spine BMD were seen (P = 0.59; 95% confidence interval −1.001, 1.975). Secondary outcomes also did not differ by intervention arm. The active group reported more headaches compared with the placebo group (57 vs. 14%, P < 0.001). Other adverse and serious adverse events were not different. Conclusions: BMD changes did not substantially differ between postmenopausal women who received the dose of nitroglycerin tested, in comparison with a placebo. Once-daily dosing with 22.5 mg of transdermal-administered nitroglycerin was not effective (compliance adjusted dose was only ∼16 mg/d); a sub-therapeutic dose. PMID:19549739

Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

PubMed

Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

2012-06-01

Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

Nicorandil Versus Nitroglycerin for Symptomatic Relief of Angina in Patients With Slow Coronary Flow Phenomenon: A Randomized Clinical Trial.

PubMed

Sani, Hashem Danesh; Eshraghi, Ali; Nezafati, Mohammad Hassan; Vojdanparast, Mohammad; Shahri, Bahram; Nezafati, Pouya

2015-07-01

Patients with the coronary slow flow phenomenon frequently experience angina episodes. The present study aimed to compare the efficacy of nicorandil versus nitroglycerin for alleviation of angina symptoms in slow flow patients. In a single-center, single-blind, parallel-design, comparator-controlled, randomized clinical trial (NCT02254252), 54 patients with slow flow and normal or near-normal coronary angiography who presented with frequent angina episodes were randomly assigned to 1-month treatment with nicorandil 10 mg, 2 times a day (n = 27) or sustained-release glyceryltrinitrate 6.4 mg 2 times a day (n =27). Frequency of angina episodes, pain intensity, and the Canadian Cardiovascular Society (CCS) grading of angina pectoris were assessed at baseline and after 1 month of treatment. In all, 25 patients in the nicorandil arm and 24 patients in the nitroglycerin arm were analyzed. After 1 month, patients treated with nicorandil had fewer angina episodes (adjusted mean number of episodes per week, nicorandil versus nitroglycerin; 1.68 ± 0.15 vs 2.29 ± 0.15, P = .007, effect size = 14.6%). Patients also reported greater reductions in pain intensity with nicorandil versus nitroglycerin (adjusted mean of self-reported pain score; 3.03 ± 0.29 vs 3.89 ± 0.30, P = .046, effect size = 8.4%). A significantly higher proportion of patients in the nicorandil arm were categorized in CCS class I (76% vs 33.3%, P = .004) or class II (16.0% vs 45.8%, P = .032). In slow flow patients, nicorandil provides better symptomatic relief of angina than nitroglycerin. © The Author(s) 2015.

Efficacy and safety of 1 % terbinafine film-forming solution in Chinese patients with tinea pedis: a randomized, double-blind, placebo-controlled, multicenter, parallel-group study.

PubMed

Li, Ruo Yu; Wang, A P; Xu, J H; Xi, L Y; Fu, M H; Zhu, M; Xu, M L; Li, X Q; Lai, W; Liu, W D; Lu, X Y; Gong, Z Q

2014-03-01

Superficial fungal skin infections are treated using topical antifungals. The aim of this study was to demonstrate the efficacy of a single application of 1 % terbinafine film-forming solution (FFS) versus placebo for the treatment of tinea pedis in the Chinese population. Six centers in China randomized 290 patients in a 1:1 ratio to receive either 1 % terbinafine FFS or FFS vehicle (placebo) once on the affected foot/feet. Efficacy assessments included microscopy and mycologic culture, and assessing clinical signs and symptoms at baseline, and at weeks 1 and 6 after the topical treatment. All adverse events were recorded. At week 6, 1 % terbinafine FFS was superior to placebo for effective treatment rate (63 vs. 8 %); clinical cure (30 vs. 6 %); mycological cure (86 vs. 12 %); negative microscopy (90 vs. 24 %); and negative mycological culture (90 vs. 27 %): all p ≤ 0.001 and clinically relevant. At week 6, 1 % terbinafine FFS was clinically superior to placebo for the absence of: erythema (69 vs. 29 %); desquamation (33 vs. 8 %); and pruritus (70 vs. 30 %): all p ≤ 0.001 and clinically relevant. At week 6, differences in the average total signs and symptoms scores were significantly lower for 1 % terbinafine FFS versus placebo (p ≤ 0.001). Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments. This double-blind, randomized, multicenter study demonstrated one single topical application of 1 % terbinafine FFS was safe and effective in the treatment of tinea pedis in the Chinese population.

Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment : A 12-month, single-center, randomized controlled clinical trial.

PubMed

Hammad, Shaza M; Knösel, Michael

2016-11-01

White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2-96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant. For this 2-arm parallel-group randomized trial, 50 subjects aged 12-18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ 2 test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status. Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant. In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.

Bioavailability of everolimus administered as a single 5 mg tablet versus five 1 mg tablets: a randomized, open-label, two-way crossover study of healthy volunteers.

PubMed

Thudium, Karen; Gallo, Jorge; Bouillaud, Emmanuel; Sachs, Carolin; Eddy, Simantini; Cheung, Wing

2015-01-01

The mammalian target of rapamycin (mTOR) inhibitor everolimus has a well-established pharmacokinetics profile. We conducted a randomized, single-center, open-label, two-sequence, two-period crossover study of healthy volunteers to assess the relative bioavailability of everolimus administered as one 5 mg tablet or five 1 mg tablets. Subjects were randomized 1:1 to receive everolimus dosed as one 5 mg tablet or as five 1 mg tablets on day 1, followed by a washout period on days 8-14 and then the opposite formulation on day 15. Blood sampling for pharmacokinetic evaluation was performed at prespecified time points, with 17 samples taken for each treatment period. Primary variables for evaluation of relative bioavailability were area under the concentration-time curve from time zero to infinity (AUCinf) and maximum blood concentration (Cmax). Safety was assessed by reporting the incidence of adverse events (AEs). Twenty-two participants received everolimus as one 5 mg tablet followed by five 1 mg tablets (n=11) or the opposite sequence (n=11). The Cmax of five 1 mg tablets was 48% higher than that of one 5 mg tablet (geometric mean ratio, 1.48; 90% confidence interval [CI], 1.35-1.62). AUCinf was similar (geometric mean ratio, 1.08; 90% CI, 1.02-1.16), as were the extent of absorption and the distribution and elimination kinetics. AEs, all grade 1 or 2, were observed in 54.5% of subjects. Although the extent of absorption was similar, the Cmax of five 1 mg tablets was higher than that of one 5 mg tablet, suggesting these formulations lead to different peak blood concentrations and are not interchangeable at the dose tested.

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

PubMed Central

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-01-01

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

PubMed

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-08-23

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

PubMed

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

Intrathecal Morphine for Laparoscopic Segmental Colonic Resection as Part of an Enhanced Recovery Protocol: A Randomized Controlled Trial.

PubMed

Koning, Mark V; Teunissen, Aart Jan W; van der Harst, Erwin; Ruijgrok, Elisabeth J; Stolker, Robert Jan

2018-02-01

Management of postoperative pain after laparoscopic segmental colonic resections remains controversial. We compared 2 methods of analgesia within an Enhanced Recovery After Surgery (ERAS) program. The goal of the study was to investigate whether administration of intrathecal bupivacaine/morphine would lead to an enhanced recovery. A single-center, randomized, double-blind controlled trial was performed (NL43488.101.13). Patients scheduled for laparoscopic segmental intestinal resections were considered. Exclusion criteria were patients in whom contraindications to spinal anesthesia were present, conversion to open surgery, and gastric and rectal surgery. The intervention group received single-shot intrathecal bupivacaine/morphine (12.5 mg/300 μg), with an altered dose for older patients. The control group received a sham procedure and a bolus of piritramide (0.1 mg/kg). Both groups received standardized general anesthesia and a patient-controlled intravenous analgesia pump as postoperative analgesia. All patients were treated according to an ERAS protocol. A decrease in days to "fit for discharge" was the primary outcome. Fifty-six patients were enrolled. Intervention group patients were fit for discharge earlier (median of 3 vs 4 days, P = 0.044). Furthermore, there was a significant decrease in opioid use and lower pain scores on the first postoperative day in the intervention group. There were no differences in adverse events (except for more pruritus), time to mobilization, fluid administration, or patient satisfaction. This randomized controlled trial shows that intrathecal morphine is a more effective method of postoperative analgesia in laparoscopic surgery than intravenous opioids within an ERAS program. Recovery is faster and less painful with intrathecal morphine. Other studies have confirmed these results, although data on faster recovery are new and require confirmation in future trials. This study was registered at ClinicalTrials.gov, identifier NCT02284282.

A Prospective Randomized Comparison Between Laparoscopic Ureterolithotomy and Semirigid Ureteroscopy for Upper Ureteral Stones >2 cm: A Single-Center Experience.

PubMed

Kumar, Anup; Vasudeva, Pawan; Nanda, Biswajit; Kumar, Niraj; Jha, Sanjeev Kumar; Singh, Harbinder

2015-11-01

The optimal management method of upper ureteral stones >2 cm is still a challenge. We performed a prospective randomized comparison between laparoscopic ureterolithotomy (LU) and ureteroscopic lithotripsy for upper ureteral calculus >2 cm to evaluate safety and efficacy of both procedures. Between January 2010 and May 2012, 110 patients with a single radiopaque upper ureteral calculus >2 cm were included in the present study. Randomization was done in two groups-group A: LU was performed and group B: Ureteroscopy (URS) was performed using a 6/7.5F semirigid ureteroscope (Richard Wolf) with holmium laser intracorporeal lithotripsy. Statistical analysis was performed regarding demographic profile, success, retreatment, auxiliary procedure rates, and also complications. Out of the total 110 patients, 54 patients were enrolled in group A and 56 patients were enrolled in group B. Mean stone size was 2.3±0.2 cm in group A versus 2.2±0.1 cm in group B (p=0.52). The overall 3-month stone-free rate was (50/50) 100% for group A versus (38/50) 76% for group B (p=0.02). The retreatment rate was significantly greater in group B than group A (8% vs. 0%, respectively; (p=0.01). Auxiliary procedure rate was higher in group B than in group A (26% vs. 0% respectively; p=0.001). The complication rate was 12% in group A versus 26% in group B (p=0.001). For upper ureteral stones of size greater than 2 cm, LU has a greater stone clearance rate, comparable operating time, lesser need for auxiliary procedure, and complication rate as compared to URS.

Evaluation of the alignment efficiency of nickel-titanium and copper-nickel-titanium archwires in patients undergoing orthodontic treatment over a 12-week period: A single-center, randomized controlled clinical trial.

PubMed

Aydın, Burcu; Şenışık, Neslihan Ebru; Koşkan, Özgür

2018-05-01

The aim of this trial was to compare the alignment efficiency and intermaxillary arch dimension changes of nickel-titanium (NiTi) or copper-nickel-titanium (CuNiTi) round archwires with increasing diameters applied sequentially to the mandibular arch. The initial alignment phase of fixed orthodontic treatment with NiTi or CuNiTi round archwires was studied in a randomly allocated sample of 66 patients. The NiTi group comprised 26 women, 10 men, and the CuNiTi (27℃) group comprised 20 women, 10 men. The eligibility criteria were as follows: anterior mandibular crowding of minimum 6 mm according to Little's Irregularity Index (LII), treatment requiring no extraction of premolars, 12 to 18 years of age, permanent dentition, skeletal and dental Class I malocclusion. The main outcome measure was the alignment of the mandibular anterior dentition; the secondary outcome measure was the change in mandibular dental arch dimensions during 12 weeks. Simple randomization (allocation ratio 1:1) was used in this single-blind study. LII and mandibular arch dimensions were measured on three-dimensional digital dental models at 2-week intervals. No statistically significant difference was observed between NiTi and CuNiTi according to LII ( p > 0.05). Intercanine and intermolar arch perimeters increased in the CuNiTi group ( p < 0.001). Inter-first premolar width showed a statistically significant interaction in week × diameter × application ( p < 0.05). The effects of NiTi and CuNiTi round archwires were similar in terms of their alignment efficiency. However, the intercanine and intermolar arch perimeters, and the inter-first premolar width changes differed between groups.

[Prevent postnatal urinary incontinence by prenatal pelvic floor exercise? Rationale and protocol of the multicenter randomized study PreNatal Pelvic floor Prevention (3PN)].

PubMed

Fritel, X; Fauconnier, A; de Tayrac, R; Amblard, J; Cotte, L; Fernandez, H

2008-09-01

Female urinary incontinence (UI) is a frequent affection that generates handicap and expenses. There is a link between UI and pregnancy; onset of UI during pregnancy is a risk factor for permanent UI. Postnatal pelvic floor exercise has shown efficacy to improve postnatal UI. However, it remains uncertain if benefits last more than few months. Publication of our rationale for prenatal pelvic floor exercise is an opportunity to expose our pre-specified hypotheses and help health professionals' awareness. The purpose of PreNatal Pelvic floor Prevention (3PN) is to compare the effects of prenatal pelvic floor exercise versus sole written instructions on UI one year after delivery. It is a multicenter, randomized, single blind study. Main inclusion criteria are first, single and non-complicated pregnancy over 18 years. Women randomized in pelvic floor exercise group will undergo eight sessions with a physiotherapist between six and eight months of pregnancy. Our principal criterion is UI score (International Consultation on Incontinence Questionnaire Short Form [ICIQ-SF]) one year after delivery. We plan to include 280 pregnant women in five centers over a 12-month screening period to show a one-point difference on UI score. ETHIC AND FINANCING: The study was approved by the IRB Comité de protection des personnes Sud-Ouest et Outre-Mer. It was registered by French Health Products Safety Agency (AFSSAPS) and Clinical Trials.gov. It is supported by the French Ministry of Health through the 2007 Hospital Plan for Clinical Research (PHRC). We plan to assess if prenatal pelvic floor exercise reduces postnatal medical consultations or physiotherapy sessions.

Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study.

PubMed

Pepin, Stephanie; Szymanski, Henryk; Rochín Kobashi, Ilya Angélica; Villagomez Martinez, Sandra; González Zamora, José Francisco; Brzostek, Jerzy; Huang, Li-Min; Chiu, Cheng-Hsun; Chen, Po-Yen; Ahonen, Anitta; Forstén, Aino; Seppä, Ilkka; Quiroz, René Farfán; Korhonen, Tiina; Rivas, Enrique; Monfredo, Celine; Hutagalung, Yanee; Menezes, Josemund; Vesikari, Timo

2016-12-01

A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomized, double-blind, active-controlled, multi-center study to examine the immunogenicity and safety of IIV4 in children 3-8 y of age (EudraCT no. 2011-005374-33). Participants were randomized 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received 2 doses of vaccine 28 d apart; all others received a single dose. 1242 children were included. For all 4 strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 d after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3-8 y who received one dose or 2 doses 28 d apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain.

A Prospective Randomized Trial of the Efficacy of Fibrin Glue, Triamcinolone Acetonide, and Quilting Sutures in Seroma Prevention after Latissimus Dorsi Breast Reconstruction.

PubMed

Hart, Alexandra M; Duggal, Clarie; Pinell-White, Ximena; Losken, Albert

2017-04-01

Donor-site seroma is the most common complication following latissimus dorsi flap breast reconstruction. Various agents and techniques have attempted to minimize seroma formation. The purpose of this study was to compare the efficacy of different products and quilting sutures at seroma prevention. This is a single-center, double-blinded, randomized, controlled trial of a consecutive series of breast cancer patients (n = 96) undergoing latissimus dorsi flap reconstruction performed by a single surgeon. Patients were randomized to receive (1) fibrin glue (Tisseel) (n = 23), (2) triamcinolone acetonide (n = 26), or (3) normal saline (control) (n = 27) sprayed into the donor site. The fourth arm included donor-site quilting sutures (n = 20). Outcomes included seroma, drain output, and days to last drain removal. Drain removal was standardized at less than 30 cc/day. All groups were matched evenly without differences in risk, procedures, or complications. The overall seroma rate was 31.3 percent (n = 30). The quilting group had significantly less drainage for weeks 1 (p = 0.006) and 2 (p = 0.050) postoperatively. Quilting statistically reduced the incidence of seromas to 5.0 percent (n = 1; p = 0.038) compared with other groups (control, 34.5 percent; fibrin, 27.6 percent; and triamcinolone, 37.6 percent). Drains were removed 10 days earlier with quilting (control, 35.5 days; fibrin, 39.5 days; triamcinolone, 37.4 days; and quilting, 25.8 days; p = 0.001). The incidence of all other complications was similar between groups. The use of quilting donor sites significantly decreases the incidence of donor-site seromas and leads to earlier drain removal following latissimus dorsi flap reconstruction and maintains a low complication profile. Therapeutic, II.

Comparison of the Effect of Sensory-Level and Conventional Motor-Level Neuromuscular Electrical Stimulations on Quadriceps Strength After Total Knee Arthroplasty: A Prospective Randomized Single-Blind Trial.

PubMed

Yoshida, Yosuke; Ikuno, Koki; Shomoto, Koji

2017-12-01

To compare sensory-level neuromuscular electrical stimulation (NMES) and conventional motor-level NMES in patients after total knee arthroplasty. Prospective randomized single-blind trial. Hospital total arthroplasty center: inpatients. Patients with osteoarthritis (N=66; mean age, 73.5±6.3y; 85% women) were randomized to receive either sensory-level NMES applied to the quadriceps (the sensory-level NMES group), motor-level NMES (the motor-level NMES group), or no stimulation (the control group) in addition to a standard rehabilitation program. Each type of NMES was applied in 45-minute sessions, 5d/wk, for 2 weeks. Data for the quadriceps maximum voluntary isometric contraction, the leg skeletal muscle mass determined using multiple-frequency bioelectrical impedance analysis, the timed Up and Go test, the 2-minute walk test, the visual analog scale, and the range of motion of the knee were measured preoperatively and at 2 and 4 weeks after total knee arthroplasty. The motor-level NMES (P=.001) and sensory-level NMES (P=.028) groups achieved better maximum voluntary isometric contraction results than did the control group. The motor-level NMES (P=.003) and sensory-level NMES (P=.046) groups achieved better 2-minute walk test results than did the control group. Some patients in the motor-level NMES group dropped out of the experiment because of discomfort. Motor-level NMES significantly improved muscle strength and functional performance more than did the standard program alone. Motor-level NMES was uncomfortable for some patients. Sensory-level NMES was comfortable and improved muscle strength and functional performance more than did the standard program alone. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Stark tuning and electrical charge state control of single divacancies in silicon carbide

NASA Astrophysics Data System (ADS)

de las Casas, Charles F.; Christle, David J.; Ul Hassan, Jawad; Ohshima, Takeshi; Son, Nguyen T.; Awschalom, David D.

2017-12-01

Neutrally charged divacancies in silicon carbide (SiC) are paramagnetic color centers whose long coherence times and near-telecom operating wavelengths make them promising for scalable quantum communication technologies compatible with existing fiber optic networks. However, local strain inhomogeneity can randomly perturb their optical transition frequencies, which degrades the indistinguishability of photons emitted from separate defects and hinders their coupling to optical cavities. Here, we show that electric fields can be used to tune the optical transition frequencies of single neutral divacancy defects in 4H-SiC over a range of several GHz via the DC Stark effect. The same technique can also control the charge state of the defect on microsecond timescales, which we use to stabilize unstable or non-neutral divacancies into their neutral charge state. Using fluorescence-based charge state detection, we show that both 975 nm and 1130 nm excitation can prepare their neutral charge state with near unity efficiency.

Efficacy of a high-resolution consultation system in gastroenterology at an Andalusian hospital center.

PubMed

Zambrana-García, José Luis; Montoro-Caba, María Isabel; Chicano-Gallardo, Maite; Monrobel-Lancho, Ana; Pérez-de-Luque, Daniel Jesús; Peña-Ojeda, José Antonio; Recio-Ramírez, José Manuel

2016-01-01

By high resolution consultation (HRC) we mean an ambulatory process of assistance fulfilled in a single day, by which treatment and diagnosis are established and recorded. To assess to which extent patients with digestive conditions may benefit from a single consultation system. A descriptive study of 179 first visit events, randomly selected as high-resolution consultations in gastroenterology. We discuss the percentage of patients who benefited from HRC and the complementary tests performed. Most common conditions included dyspepsia (16%), a family history of colon cancer (16%) and gastroesophageal reflux disease (GERD) (16%). Seventy-nine (44%) of all first visits became HRCs and 80 (45%) required a diagnostic test (100% abdominal ultrasound) that was reviewed on the same day. Performing a test on the same day significantly increased the percentage of HRCs (57% vs. 34%, p < 0.002). GERD, dyspepsia, cholelithiasis and chronic liver disease were the subjects most commonly leading to HRC. Gastroenterology consultations may largely benefit from an HRC system with only organizational changes and no additional costs.

A Comparison of Single Sample and Bootstrap Methods to Assess Mediation in Cluster Randomized Trials

ERIC Educational Resources Information Center

Pituch, Keenan A.; Stapleton, Laura M.; Kang, Joo Youn

2006-01-01

A Monte Carlo study examined the statistical performance of single sample and bootstrap methods that can be used to test and form confidence interval estimates of indirect effects in two cluster randomized experimental designs. The designs were similar in that they featured random assignment of clusters to one of two treatment conditions and…

A Randomized Controlled Trial of a Parent-Centered Intervention in Preventing Substance Use and HIV Risk Behaviors in Hispanic Adolescents

ERIC Educational Resources Information Center

Prado, Guillermo; Pantin, Hilda; Briones, Ervin; Schwartz, Seth J.; Feaster, Daniel; Huang, Shi; Sullivan, Summer; Tapia, Maria I.; Sabillon, Eduardo; Lopez, Barbara; Szapocznik, Jose

2007-01-01

The present study evaluated the efficacy of Familias Unidas + Parent-Preadolescent Training for HIV Prevention (PATH), a Hispanic-specific, parent-centered intervention, in preventing adolescent substance use and unsafe sexual behavior. Two hundred sixty-six 8th-grade Hispanic adolescents and their primary caregivers were randomly assigned to 1 of…

A Randomized Control Trial of Preoperative Oral Antibiotics as Adjunct Therapy to Systemic Antibiotics for Preventing Surgical Site Infection in Clean Contaminated, Contaminated, and Dirty Type of Colorectal Surgeries.

PubMed

Anjum, Nadeem; Ren, Jianan; Wang, Gefei; Li, Guanwei; Wu, Xiuwen; Dong, Hu; Wu, Qin; Li, Jieshou

2017-12-01

Preoperative bowel preparation with or without oral antibiotics is controversial in terms of postoperative surgical site infections. This study aimed to evaluate the efficacy of oral antibiotics as adjunct therapy to systemic antibiotics with mechanical bowel preparation for preventing surgical site infections in clean contaminated, contaminated, and dirty colorectal procedures. This was a single-center, prospective randomized study. This study was conducted at the General Surgery Department at Jinling Hospital, Nanjing University, China, from July 15, 2014 to January 20, 2016. Patients aged ≥18 years scheduled for abdominal surgery with clean-contaminated, contaminated, and dirty wounds were selected. Patients were randomly assigned to receive preoperative mechanical bowel preparation or mechanical bowel preparation with oral antibiotics. The primary outcome was the rate of surgical site infections. The secondary outcomes were extra-abdominal complications, duration of postoperative ileus, and readmission rate. Ninety-five patients were allocated to each group. Eight and 26 surgical site infections (8.42% vs 27.3 %, p = 0.004) occurred in the mechanical bowel preparation with oral antibiotics and mechanical bowel preparation groups. Thirteen extra-abdominal complications were reported: 6 in the mechanical bowel preparation with oral antibiotics group and 7 in the mechanical bowel preparation group (6.3% vs 7.3%, p = 0.77). Postoperative ileus duration did not differ between groups (p = 0.23). There were 4 readmissions in the mechanical bowel preparation group and none in the mechanical bowel preparation with oral antibiotics group (p = 0.04). On multivariable analysis, blood loss ≥500 mL (OR, 5.1; 95% CI, 1.27-20.4; p = 0.02), ASA score ≥3 (OR, 3.9; 95% CI, 1.2-12.5; p = 0.01), contaminated types (OR, 3.6; 95% CI, 1.5-8.6; p = 0.01), and administration of preoperative oral antibiotics (OR, 0.20; 95% CI, 0.06-0.60; p = 0.005) independently affected the incidence of surgical site infections. This was a single-center study. Preoperative oral antibiotics, as adjunct therapy to systemic antibiotics and mechanical bowel preparation, significantly reduced surgical site infections and minimized the readmission rates in clean contaminated, contaminated, and dirty types of colorectal surgery. See Video Abstract at http://links.lww.com/DCR/A437.

Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial.

PubMed

Chambers, Jaclyn E; Brooks, Adam C; Medvin, Rachel; Metzger, David S; Lauby, Jennifer; Carpenedo, Carolyn M; Favor, Kevin E; Kirby, Kimberly C

2016-04-18

Brief interventions such as Screening, a single session of Brief Intervention, and Referral to Treatment (SBIRT) have shown mixed effectiveness in primary care. However, there are indications that multi-session brief interventions may demonstrate more consistently positive outcomes, and perhaps a more intensive approach would be of benefit in addressing substance use in primary care. This study compared the effectiveness of SBIRT with a single BI session (BI/RT) to a multi-session brief-treatment intervention (BI/RT+) in primary care. We also developed easy-to-use, evidence-based materials to assist clinicians in delivering these interventions. This study was conducted in three Federally Qualified Healthcare Centers (FQHCs). A total of 10,935 patients were screened, and 600 individuals were recruited. The sample was primarily Black/African American (82 %) with a mean age of 40. Patients who attended a healthcare appointment were screened for substance use via the AUDIT and DAST. Patients were eligible for the study if they scored 8 or higher on the AUDIT, were using only marijuana and scored 2 or higher on the DAST, or were using other illicit drugs and scored 1 or higher on the DAST. Participants were randomly assigned to receive one-session BI/RT, or two to six sessions of brief intervention that incorporated elements of motivational enhancement therapy and cognitive-behavioral therapy (BI/RT+). Both interventions were delivered by behavioral health consultants at the FQHCs. Participants completed follow-up assessments every 3 months for 1 year. Primary outcome variables included substance use treatment sessions attended and days of substance use. Secondary outcomes included measures of health, employment, legal, and psychiatric functioning and HIV risk behaviors. Additionally, we will conduct an economic evaluation examining cost-effectiveness and will analyze outcomes from a process evaluation examining patient and provider experiences. The ability of brief interventions to impact substance use has great potential, but research findings have been mixed. By conducting a large-scale randomized controlled trial in real-world health centers, this study will answer important questions about the effectiveness of expanded BIs for patients who screen positive for risky substance use in primary care. Trial registration NCT01751672.

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

PubMed

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

2017-04-19

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

HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA): a randomized single-blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage.

PubMed

Gathier, C S; van den Bergh, W M; Slooter, A J C

2014-04-01

Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes the design of the HIMALAIA trial (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA), designed to assess the effectiveness of induced hypertension on neurological outcome in patients with DCI after SAH. To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH. The HIMALAIA trial is a multicenter, singe-blinded, randomized controlled trial in patients with DCI after a recent SAH. Eligible patients will be randomized to either induced hypertension (n = 120) or to no induced hypertension (n = 120). In selected centers, the efficacy of induced hypertension in augmenting cerebral blood flow will be measured by means of cerebral perfusion computerized tomography scanning. Follow-up assessments will be performed at 3 and 12 months after randomization by trial nurses who are blinded to the treatment allocation and management. We will include patients during five years. The primary outcome is the proportion of subarachnoid hemorrhage patients with delayed cerebral ischemia with poor outcome three-months after randomization, defined as a modified Rankin scale of more than 3. Secondary outcome measures are related to treatment failure, functional outcome, adverse events, and cerebral hemodynamics. The HIMALAIA trial is registered at clinicaltrials.gov under identifier NCT01613235. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

PubMed

Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

2015-02-01

Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

Effect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients: A Randomized Clinical Trial.

PubMed

Rocha Ferreira, Graziela Santos; de Almeida, Juliano Pinheiro; Landoni, Giovanni; Vincent, Jean Louis; Fominskiy, Evgeny; Gomes Galas, Filomena Regina Barbosa; Gaiotto, Fabio A; Dallan, Luís Oliveira; Franco, Rafael Alves; Lisboa, Luiz Augusto; Palma Dallan, Luis Roberto; Fukushima, Julia Tizue; Rizk, Stephanie Itala; Park, Clarice Lee; Strabelli, Tânia Mara; Gelas Lage, Silvia Helena; Camara, Ligia; Zeferino, Suely; Jardim, Jaquelline; Calvo Arita, Elisandra Cristina Trevisan; Caldas Ribeiro, Juliana; Ayub-Ferreira, Silvia Moreira; Costa Auler, Jose Otavio; Filho, Roberto Kalil; Jatene, Fabio Biscegli; Hajjar, Ludhmila Abrahao

2018-04-30

The aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients. A single-center randomized controlled trial and a meta-analysis of randomized controlled trials. Heart Institute of São Paulo University. High-risk patients undergoing elective coronary artery bypass surgery. Patients were randomized to receive preskin incision intra-aortic balloon pump insertion after anesthesia induction versus no intra-aortic balloon pump use. The primary outcome was a composite endpoint of 30-day mortality and major morbidity (cardiogenic shock, stroke, acute renal failure, mediastinitis, prolonged mechanical ventilation, and a need for reoperation). A total of 181 patients (mean [SD] age 65.4 [9.4] yr; 32% female) were randomized. The primary outcome was observed in 43 patients (47.8%) in the intra-aortic balloon pump group and 42 patients (46.2%) in the control group (p = 0.46). The median duration of inotrope use (51 hr [interquartile range, 32-94 hr] vs 39 hr [interquartile range, 25-66 hr]; p = 0.007) and the ICU length of stay (5 d [interquartile range, 3-8 d] vs 4 d [interquartile range, 3-6 d]; p = 0.035) were longer in the intra-aortic balloon pump group than in the control group. A meta-analysis of 11 randomized controlled trials confirmed a lack of survival improvement in high-risk cardiac surgery patients with perioperative intra-aortic balloon pump use. In high-risk patients undergoing cardiac surgery, the perioperative use of an intra-aortic balloon pump did not reduce the occurrence of a composite outcome of 30-day mortality and major complications compared with usual care alone.

A New Random Walk for Replica Detection in WSNs.

PubMed

Aalsalem, Mohammed Y; Khan, Wazir Zada; Saad, N M; Hossain, Md Shohrab; Atiquzzaman, Mohammed; Khan, Muhammad Khurram

2016-01-01

Wireless Sensor Networks (WSNs) are vulnerable to Node Replication attacks or Clone attacks. Among all the existing clone detection protocols in WSNs, RAWL shows the most promising results by employing Simple Random Walk (SRW). More recently, RAND outperforms RAWL by incorporating Network Division with SRW. Both RAND and RAWL have used SRW for random selection of witness nodes which is problematic because of frequently revisiting the previously passed nodes that leads to longer delays, high expenditures of energy with lower probability that witness nodes intersect. To circumvent this problem, we propose to employ a new kind of constrained random walk, namely Single Stage Memory Random Walk and present a distributed technique called SSRWND (Single Stage Memory Random Walk with Network Division). In SSRWND, single stage memory random walk is combined with network division aiming to decrease the communication and memory costs while keeping the detection probability higher. Through intensive simulations it is verified that SSRWND guarantees higher witness node security with moderate communication and memory overheads. SSRWND is expedient for security oriented application fields of WSNs like military and medical.

A New Random Walk for Replica Detection in WSNs

PubMed Central

Aalsalem, Mohammed Y.; Saad, N. M.; Hossain, Md. Shohrab; Atiquzzaman, Mohammed; Khan, Muhammad Khurram

2016-01-01

Wireless Sensor Networks (WSNs) are vulnerable to Node Replication attacks or Clone attacks. Among all the existing clone detection protocols in WSNs, RAWL shows the most promising results by employing Simple Random Walk (SRW). More recently, RAND outperforms RAWL by incorporating Network Division with SRW. Both RAND and RAWL have used SRW for random selection of witness nodes which is problematic because of frequently revisiting the previously passed nodes that leads to longer delays, high expenditures of energy with lower probability that witness nodes intersect. To circumvent this problem, we propose to employ a new kind of constrained random walk, namely Single Stage Memory Random Walk and present a distributed technique called SSRWND (Single Stage Memory Random Walk with Network Division). In SSRWND, single stage memory random walk is combined with network division aiming to decrease the communication and memory costs while keeping the detection probability higher. Through intensive simulations it is verified that SSRWND guarantees higher witness node security with moderate communication and memory overheads. SSRWND is expedient for security oriented application fields of WSNs like military and medical. PMID:27409082

Comparative electrophysiological study of response to botulinum toxin type B in Japanese and Caucasians.

PubMed

Arimura, Kimiyoshi; Arimura, Yumiko; Takata, Yoshiharu; Nakamura, Tomonori; Kaji, Ryuji

2008-01-30

Ethnic differences in the muscle-relaxing effect of botulinum toxin type B (BTX-B) were examined by means of electrophysiological measurements in Japanese and Caucasian volunteers. This was a randomized, single-blinded, single-center study of 24 Japanese and 24 Caucasian healthy adult male subjects in Japan. BTX-B (20 U, 100 U, or 500 U/0.2 mL) or placebo was administered to the extensor digitorum brevis (EDB) muscle in the left lower limb as a single dose (in each dose group, 6 subjects received the test drug and two received placebo). The inhibitory effect of BTX-B on the M wave amplitude of EDB muscle generated by stimulation of the deep peroneal nerve was measured frequently during 2 weeks after administration, and then at weeks 4 (day 28) and 12 (day 84). The inhibitory effect of BTX-B on the M wave amplitude of EDB muscle was dose-dependent in both Japanese and Caucasian subjects, and the dose-response curves were similar. These findings demonstrate that the muscle-relaxing effect of BTX-B in Japanese subjects is electrophysiologically similar to that in Caucasians. 2007 Movement Disorder Society

Accelerated 1 H MRSI using randomly undersampled spiral-based k-space trajectories.

PubMed

Chatnuntawech, Itthi; Gagoski, Borjan; Bilgic, Berkin; Cauley, Stephen F; Setsompop, Kawin; Adalsteinsson, Elfar

2014-07-30

To develop and evaluate the performance of an acquisition and reconstruction method for accelerated MR spectroscopic imaging (MRSI) through undersampling of spiral trajectories. A randomly undersampled spiral acquisition and sensitivity encoding (SENSE) with total variation (TV) regularization, random SENSE+TV, is developed and evaluated on single-slice numerical phantom, in vivo single-slice MRSI, and in vivo three-dimensional (3D)-MRSI at 3 Tesla. Random SENSE+TV was compared with five alternative methods for accelerated MRSI. For the in vivo single-slice MRSI, random SENSE+TV yields up to 2.7 and 2 times reduction in root-mean-square error (RMSE) of reconstructed N-acetyl aspartate (NAA), creatine, and choline maps, compared with the denoised fully sampled and uniformly undersampled SENSE+TV methods with the same acquisition time, respectively. For the in vivo 3D-MRSI, random SENSE+TV yields up to 1.6 times reduction in RMSE, compared with uniform SENSE+TV. Furthermore, by using random SENSE+TV, we have demonstrated on the in vivo single-slice and 3D-MRSI that acceleration factors of 4.5 and 4 are achievable with the same quality as the fully sampled data, as measured by RMSE of reconstructed NAA map, respectively. With the same scan time, random SENSE+TV yields lower RMSEs of metabolite maps than other methods evaluated. Random SENSE+TV achieves up to 4.5-fold acceleration with comparable data quality as the fully sampled acquisition. Magn Reson Med, 2014. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

PACS in an intensive care unit: results from a randomized controlled trial

NASA Astrophysics Data System (ADS)

Bryan, Stirling; Weatherburn, Gwyneth C.; Watkins, Jessamy; Walker, Samantha; Wright, Carl; Waters, Brian; Evans, Jeff; Buxton, Martin J.

1998-07-01

The objective of this research was to assess the costs and benefits associated with the introduction of a small PACS system into an intensive care unit (ICU) at a district general hospital in north Wales. The research design adopted for this study was a single center randomized controlled trial (RCT). Patients were randomly allocated either to a trial arm where their x-ray imaging was solely film-based or to a trial arm where their x-ray imaging was solely PACS based. Benefit measures included examination-based process measures, such as image turn-round time, radiation dose and image unavailability; and patient-related process measures, which included adverse events and length of stay. The measurement of costs focused on additional 'radiological' costs and the costs of patient management. The study recruited 600 patients. The key findings from this study were that the installation of PACS was associated with important benefits in terms of image availability, and important costs in both monetary and radiation dose terms. PACS-related improvements in terms of more timely 'clinical actions' were not found. However, the qualitative aspect of the research found that clinicians were advocates of the technology and believed that an important benefit of PACS related to improved image availability.

The Trail Making test: a study of its ability to predict falls in the acute neurological in-patient population.

PubMed

Mateen, Bilal Akhter; Bussas, Matthias; Doogan, Catherine; Waller, Denise; Saverino, Alessia; Király, Franz J; Playford, E Diane

2018-05-01

To determine whether tests of cognitive function and patient-reported outcome measures of motor function can be used to create a machine learning-based predictive tool for falls. Prospective cohort study. Tertiary neurological and neurosurgical center. In all, 337 in-patients receiving neurosurgical, neurological, or neurorehabilitation-based care. Binary (Y/N) for falling during the in-patient episode, the Trail Making Test (a measure of attention and executive function) and the Walk-12 (a patient-reported measure of physical function). The principal outcome was a fall during the in-patient stay ( n = 54). The Trail test was identified as the best predictor of falls. Moreover, addition of other variables, did not improve the prediction (Wilcoxon signed-rank P < 0.001). Classical linear statistical modeling methods were then compared with more recent machine learning based strategies, for example, random forests, neural networks, support vector machines. The random forest was the best modeling strategy when utilizing just the Trail Making Test data (Wilcoxon signed-rank P < 0.001) with 68% (± 7.7) sensitivity, and 90% (± 2.3) specificity. This study identifies a simple yet powerful machine learning (Random Forest) based predictive model for an in-patient neurological population, utilizing a single neuropsychological test of cognitive function, the Trail Making test.

Comparison of Verapamil versus Heparin as Adjunctive Treatment for Transradial Coronary Procedures: The VERMUT Study.

PubMed

Tebaldi, Matteo; Biscaglia, Simone; Tumscitz, Carlo; Del Franco, Annamaria; Gallo, Francesco; Spitaleri, Giosafat; Fileti, Luca; Serenelli, Matteo; Tonet, Elisabetta; Erriquez, Andrea; Campo, Gianluca; Ferrari, Roberto

2018-06-13

We sought to demonstrate that the combination of a local vasodilator (verapamil), modern materials, patent hemostasis, and intravenous anticoagulant only in the case of percutaneous coronary intervention, as compared to default heparin administration after sheath insertion, may optimize a combined endpoint, including radial artery oc-clusion (RAO), radial artery spasm (RAS), and access site complication. This is a prospective, single-center, double-blind randomized trial. Overall, 418 patients undergoing a transradial approach (TRA) for coronary procedures were randomized 1: 1 to receive intraradial verapamil (5 mg) or heparin (5,000 IU) after a 6-Fr sheath insertion. The primary outcome was the 24-h occurrence of RAO (ultrasound confirmation), access site complication, and RAS requiring the bailout administration of vasodilators. The combined primary outcome occurred in 127 (30%) patients. It was significantly lower in patients randomized to verapamil as compared to others (26 vs. 35%, p = 0.03). This was mainly due to a significant reduction in RAS (3 vs. 10%, p = 0.006). The 24-h and 30-day occurrence of RAO did not differ between the study groups. Local administration of verapamil versus heparin reduces RAS, without increasing RAO, which appears to be strictly related to radial artery diameter and hemostasis time. © 2018 S. Karger AG, Basel.

Combining Afferent Stimulation and Mirror Therapy for Improving Muscular, Sensorimotor, and Daily Functions After Chronic Stroke: A Randomized, Placebo-Controlled Study.

PubMed

Lee, Ya-yun; Lin, Keh-chung; Wu, Ching-yi; Liao, Ching-hua; Lin, Jui-chi; Chen, Chia-ling

2015-10-01

Mirror therapy (MT) combined with mesh glove (MG) afferent stimulation (MT + MG) has been suggested as an effective intervention for motor recovery in patients with stroke. This study aimed to further determine the treatment effects of the MT + MG approach on muscular properties, sensorimotor functions, and daily function. This was a single-blind, randomized, placebo-controlled study. Forty-eight participants with chronic stroke were recruited from medical centers and were randomly assigned to the MT, MT + MG, and MT with sham MG stimulation (MT + sham) groups. The intervention consisted of 1.5 hrs/day, 5 days/wk for 4 wks. Primary outcomes were the Fugl-Meyer Assessment and muscular properties (muscle tone and stiffness). Secondary outcomes included measures of sensorimotor and daily functions. Compared with the MT and MT + sham groups, the MT + MG group demonstrated improved muscular properties. The MT + MG and MT + sham groups showed greater improvement in manual dexterity and daily function than the MT group did. No beneficial effects on the Fugl-Meyer Assessment and other sensorimotor outcomes were found for the MT + MG group. Although no significant group differences were found in the Fugl-Meyer Assessment, MT + MG induced distinctive effects on muscular properties, manual dexterity, and daily function.

High coherence plane breaking packaging for superconducting qubits.

PubMed

Bronn, Nicholas T; Adiga, Vivekananda P; Olivadese, Salvatore B; Wu, Xian; Chow, Jerry M; Pappas, David P

2018-04-01

We demonstrate a pogo pin package for a superconducting quantum processor specifically designed with a nontrivial layout topology (e.g., a center qubit that cannot be accessed from the sides of the chip). Two experiments on two nominally identical superconducting quantum processors in pogo packages, which use commercially available parts and require modest machining tolerances, are performed at low temperature (10 mK) in a dilution refrigerator and both found to behave comparably to processors in standard planar packages with wirebonds where control and readout signals come in from the edges. Single- and two-qubit gate errors are also characterized via randomized benchmarking, exhibiting similar error rates as in standard packages, opening the possibility of integrating pogo pin packaging with extensible qubit architectures.

Building Networks for Global Clinical Research: The Basics.

PubMed

Shearer, David W; Volberding, Paul A; Schemitsch, Emil H; Cook, Gillian E; Slobogean, Gerard P; Morshed, Saam

2015-12-01

Over the last several decades, interest in global health across all fields of medicine, including orthopaedic surgery, has grown markedly. Cross-national collaborations are an effective means of conducting high-quality clinical research and offer many advantages over single-center investigations. Successful collaboration requires a well-designed research protocol, development of an effective team structure, and the funding to ensure the project is sustained to completion. Equally important, investigators must consider the social, linguistic, and cultural context in which the study is being undertaken. Although randomized clinical trials are the highest level of evidence, study designs may have to be adapted to accommodate available resources, expertise, and local contextual factors. With appropriate planning, these collaborative endeavors can generate changes in clinical practice and positively impact health policy.

High coherence plane breaking packaging for superconducting qubits

NASA Astrophysics Data System (ADS)

Bronn, Nicholas T.; Adiga, Vivekananda P.; Olivadese, Salvatore B.; Wu, Xian; Chow, Jerry M.; Pappas, David P.

2018-04-01

We demonstrate a pogo pin package for a superconducting quantum processor specifically designed with a nontrivial layout topology (e.g., a center qubit that cannot be accessed from the sides of the chip). Two experiments on two nominally identical superconducting quantum processors in pogo packages, which use commercially available parts and require modest machining tolerances, are performed at low temperature (10 mK) in a dilution refrigerator and both found to behave comparably to processors in standard planar packages with wirebonds where control and readout signals come in from the edges. Single- and two-qubit gate errors are also characterized via randomized benchmarking, exhibiting similar error rates as in standard packages, opening the possibility of integrating pogo pin packaging with extensible qubit architectures.

Single-center, single-dose, open-label, randomized, two-period crossover study on the bioavailability of methotrexate administered using a novel prefilled, needle-free delivery system.

PubMed

Bienvenu, Boris; Aouba, Achille; Gottenberg, Jacques-Eric; Verstuyft, Celine

2017-04-01

Zeneo 1 is a needle-free injection device. We performed a pharmacokinetic study to investigate the bioequivalence of methotrexate administered subcutaneously using either the needle-free injection device or a conventional needle and syringe. This was a single-dose, open-label, laboratory-blind, randomized crossover study performed in adult healthy volunteers. Each participant received two methotrexate injections (each 25 mg), one via needle-free injection device and one via conventional injection, with a 21-28 day wash-out interval between dosing. For each participant, the administration site for both injections was either the abdomen or the thigh. The primary pharmacokinetic outcome parameters were AUC (0- t ) and C max . Bioequivalence was assessed by standard criteria: whether 90% confidence intervals of geometric mean ratios for the two administration methods were within 80-125%. Fifty-two individuals completed the study. Bioequivalence criteria were met for AUC (0- t ) , for the overall analysis (both injection sites: 90% confidence interval: 99.4-103.1%), and for each injection site separately. Bioequivalence was similarly demonstrated with AUC (0-∞) . Bioequivalence criteria for C max were fulfilled for abdominal administration but not for the overall analysis. Injection via the needle-free injection device was well tolerated. Limitations include conducting the study in healthy volunteers and the relatively small subject number (albeit satisfactory for bioequivalence). This study shows that methotrexate injection via needle-free injection device is bioequivalent to a conventional needle and syringe in relation to AUC (0- t ) and AUC (0-∞) . Studies of needle-free injection device use in patients requiring methotrexate therapy are planned.

Clinical trials in dentistry in India: Analysis from trial registry.

PubMed

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published. The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

Effect of enhanced ultraviolet germicidal irradiation in the heating ventilation and air conditioning system on ventilator-associated pneumonia in a neonatal intensive care unit.

PubMed

Ryan, R M; Wilding, G E; Wynn, R J; Welliver, R C; Holm, B A; Leach, C L

2011-09-01

The objective of this study was to test the hypothesis that enhanced ultraviolet germicidal irradiation (eUVGI) installed in our neonatal intensive care unit (NICU) heating ventilation and air conditioning system (HVAC) would decrease HVAC and NICU environment microbes, tracheal colonization and ventilator-associated pneumonia (VAP). The study was designed as a prospective interventional pre- and post-single-center study. University-affiliated Regional Perinatal Center NICU. Intubated patients in the NICU were evaluated for colonization, and a high-risk sub-population of infants <30 weeks gestation ventilated for ≥ 14 days was studied for VAP. eUVGI was installed in the NICU's remote HVACs. The HVACs, NICU environment and intubated patients' tracheas were cultured pre- and post-eUVGI for 12 months. The high-risk patients were studied for VAP (positive bacterial tracheal culture, increased ventilator support, worsening chest radiograph and ≥ 7 days of antibiotics). Pseudomonas, Klebsiella, Serratia, Acinetobacter, Staphylococcus aureus and Coagulase-negative Staphylococcus species were cultured from all sites. eUVGI significantly decreased HVAC organisms (baseline 500,000 CFU cm(-2); P=0.015) and NICU environmental microbes (P<0.0001). Tracheal microbial loads decreased 45% (P=0.004), and fewer patients became colonized. VAP in the high-risk cohort fell from 74% (n=31) to 39% (n=18), P=0.04. VAP episodes per patient decreased (Control: 1.2 to eUVGI: 0.4; P=0.004), and antibiotic usage was 62% less (P=0.013). eUVGI decreased HVAC microbial colonization and was associated with reduced NICU environment and tracheal microbial colonization. Significant reductions in VAP and antibiotic use were also associated with eUVGI in this single-center study. Large randomized multicenter trials are needed.

Collective behavior of minus-ended motors in mitotic microtubule asters gliding toward DNA

NASA Astrophysics Data System (ADS)

Athale, Chaitanya A.; Dinarina, Ana; Nedelec, Francois; Karsenti, Eric

2014-02-01

Microtubules (MTs) nucleated by centrosomes form star-shaped structures referred to as asters. Aster motility and dynamics is vital for genome stability, cell division, polarization and differentiation. Asters move either toward the cell center or away from it. Here, we focus on the centering mechanism in a membrane independent system of Xenopus cytoplasmic egg extracts. Using live microscopy and single particle tracking, we find that asters move toward chromatinized DNA structures. The velocity and directionality profiles suggest a random-walk with drift directed toward DNA. We have developed a theoretical model that can explain this movement as a result of a gradient of MT length dynamics and MT gliding on immobilized dynein motors. In simulations, the antagonistic action of the motor species on the radial array of MTs leads to a tug-of-war purely due to geometric considerations and aster motility resembles a directed random-walk. Additionally, our model predicts that aster velocities do not change greatly with varying initial distance from DNA. The movement of asymmetric asters becomes increasingly super-diffusive with increasing motor density, but for symmetric asters it becomes less super-diffusive. The transition of symmetric asters from superdiffusive to diffusive mobility is the result of number fluctuations in bound motors in the tug-of-war. Overall, our model is in good agreement with experimental data in Xenopus cytoplasmic extracts and predicts novel features of the collective effects of motor-MT interactions.

Two Phase 1, Open-Label, Single-Dose, Randomized, Crossover Studies to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered Granules of Secnidazole (2 g) in Healthy Female Volunteers Under Different Administration Conditions.

PubMed

Pentikis, Helen S; Adetoro, Nikki

2017-11-10

Bacterial vaginosis (BV) is the most common vaginal infection in reproductive-age women and a significant risk factor for sexually transmitted diseases and pregnancy complications. Standard 5- to 7-day antimicrobial treatments for BV are associated with high rates of recurrence and adverse events. SYM-1219 is a novel granule formulation containing 2 g of secnidazole, developed as an oral, single-dose BV treatment. Two phase 1, open-label, single-center, randomized, crossover trials (studies 102 and 103) assessed the pharmacokinetics and safety of SYM-1219 single doses (≥7-day washout between doses) in healthy, nonpregnant women aged 18 to 65 years inclusive. Study 102 compared SYM-1219 in applesauce in fasted vs fed states. Study 103 compared SYM-1219 (fasted) in pudding and yogurt vs applesauce. Studies 102 and 103 each dosed 24 subjects (mean [standard deviation] ages, 36 [1.8] and 40 [11.6] years, respectively). In both studies the 90% confidence intervals for all treatment comparisons of maximum plasma concentration, area under the concentration-time curve from 0 to last measurable concentration and to infinity, geometric mean ratios were within 80% to 125%, demonstrating bioequivalence. In both studies median fasted time to maximum plasma concentration was 4 hours (6 hours fed in study 102), and mean half-life ranged from 17 to 19 hours. Treatment-emergent adverse events occurred in 70.8% and 83.3% subjects in studies 102 and 103, respectively, most commonly headache (41.7% and 50.0%) and gastrointestinal treatment-emergent adverse events. The pharmacokinetics of SYM-1219 were similar in fed and fasted states and when administered in different foods. © 2017 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

Multi-site randomized controlled trial of a child-centered physical activity program, a parent-centered dietary-modification program, or both in overweight children: the HIKCUPS study.

PubMed

Okely, Anthony D; Collins, Clare E; Morgan, Philip J; Jones, Rachel A; Warren, Janet M; Cliff, Dylan P; Burrows, Tracy L; Colyvas, Kim; Steele, Julie R; Baur, Louise A

2010-09-01

To evaluate whether a child-centered physical activity program, combined with a parent-centered dietary program, was more efficacious than each treatment alone, in preventing unhealthy weight-gain in overweight children. An assessor-blinded randomized controlled trial involving 165 overweight/obese 5.5- to 9.9- year-old children. Participants were randomly assigned to 1 of 3 interventions: a parent-centered dietary program (Diet); a child-centered physical activity program (Activity); or a combination of both (Diet+Activity). All groups received 10 weekly face-to-face sessions followed by 3 monthly relapse-prevention phone calls. Analysis was by intention-to-treat. The primary outcome was change in body mass index z-score at 6 and 12 months (n=114 and 106, respectively). Body mass index z-scores were reduced at 12-months in all groups, with the Diet (mean [95% confidence interval]) (-0.39 [-0.51 to 0.27]) and Diet + Activity (-0.32, [-0.36, -0.23]) groups showing a greater reduction than the Activity group (-0.17 [-0.28, -0.06]) (P=.02). Changes in other outcomes (waist circumference and metabolic profile) were not statistically significant among groups. Relative body weight decreased at 6 months and was sustained at 12 months through treatment with a child-centered physical activity program, a parent-centered dietary program, or both. The greatest effect was achieved when a parent-centered dietary component was included. Copyright (c) 2010 Mosby, Inc. All rights reserved.

Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes.

PubMed

Li, Baoyue; Lingsma, Hester F; Steyerberg, Ewout W; Lesaffre, Emmanuel

2011-05-23

Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC.Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain.

No difference in joint awareness after mobile- and fixed-bearing total knee arthroplasty: 3-year follow-up of a randomized controlled trial.

PubMed

Schotanus, M G M; Pilot, P; Vos, R; Kort, N P

2017-12-01

To compare the patients ability to forget the artificial knee joint in everyday life who were randomized to be operated for mobile- or fixed-bearing total knee arthroplasty (TKA). This single-center randomized controlled trial evaluated the 3-year follow-up of the cemented mobile- and fixed-bearing TKA from the same brand in a series of 41 patients. Clinical examination was during the pre-, 6-week, 6-month, 1-, 2- and 3-year follow-up containing multiple patient-reported outcome measures (PROMs) including the 12-item Forgotten Joint Score (FJS-12) at 3 years. Effect size was calculated for each PROM at 3-year follow-up to quantify the size of the difference between both bearings. At 3-year follow-up, general linear mixed model analysis showed that there were no significant or clinically relevant differences between the two groups for all outcome measures. Calculated effect sizes were small (<0.3) for all the PROMs except for the FJS-12; these were moderate (0.5). The results of this study demonstrate that joint awareness was slightly lower in patients operated with the MB TKA with comparable improved clinical outcome and PROMs at 3-year follow-up. Measuring joint awareness with the FJS-12 is useful and provides more stringent information at 3-year follow-up compared to other PROMs and should be the PROM of choice at each follow-up after TKA. Level I, randomized controlled trial.

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Central venous catheters play an important role in patient care. Real-time ultrasound-guided subclavian central venous (SCV) cannulation may reduce the incidence of complications and the time between skin penetration and the aspiration of venous blood into the syringe. Ultrasonic diagnosis of catheter misplacement and pneumothorax related to central venous catheterization is rapid and accurate. It is unclear, however, whether ultrasound real-time guidance and examination can reduce procedure times and complication rates when compared with landmark guidance and radiographic examination for SCV catheterization. Methods/Design The Subclavian Central Venous Catheters Guidance and Examination by UltraSound (SUBGEUS) study is an investigator-initiated single center, randomized, controlled two-arm trial. Three hundred patients undergoing SCV catheter placement will be randomized to ultrasound real-time guidance and examination or landmark guidance and radiographic examination. The primary outcome is the time between the beginning of the procedure and control of the catheter. Secondary outcomes include the times required for the six components of the total procedure, the occurrence of complications (pneumothorax, hemothorax, or misplacement), failure of the technique and occurrence of central venous catheter infections. Discussion The SUBGEUS trial is the first randomized controlled study to investigate whether ultrasound real-time guidance and examination for SCV catheter placement reduces all procedure times and the rate of complications. Trial registration ClinicalTrials.gov Identifier: NCT01888094 PMID:24885789

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

PubMed

Yang, Chiu-Ling; Chen, Chung-Hey

2018-01-01

Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery.

PubMed

Maged, Ahmed M; Helal, Omneya M; Elsherbini, Moutaz M; Eid, Marwa M; Elkomy, Rasha O; Dahab, Sherif; Elsissy, Maha H

2015-12-01

To study the efficacy and safety of preoperative intravenous tranexamic acid to reduce blood loss during and after elective lower-segment cesarean delivery. A single-blind, randomized placebo-controlled study was undertaken of women undergoing elective lower-segment cesarean delivery of a full-term singleton pregnancy at a center in Cairo, Egypt, between November 2013 and November 2014. Patients were randomly assigned (1:1) using computer-generated random numbers to receive either 1g tranexamic acid or 5% glucose 15 minutes before surgery. Preoperative and postoperative complete blood count, hematocrit values, and maternal weight were used to calculate the estimated blood loss (EBL) during cesarean, which was the primary outcome. Analyses included women who received their assigned treatment, whose surgery was 90 minutes or less, and who completed follow-up. Analyses included 100 women in each group. Mean EBL was significantly higher in the placebo group (700.3 ± 143.9 mL) than in the tranexamic acid group (459.4 ±7 5.4 mL; P<0.001). Only six women, all in the placebo group, experienced an EBL of more than 1000 mL. There were no reports of thromboembolic events up to 4 weeks postoperatively. Preoperative administration of tranexamic acid safely reduces blood loss during elective lower-segment cesarean delivery. Australian New Zealand Clinical Trials Registry:ACTRN12615000312549. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial

DTIC Science & Technology

2017-03-21

FINAL REPORT Project Title: Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial...Center ATTN: DTIC-OA 8725 John J. Kingman Rd Fort Belvoir, VA 22060-6218 Submitted by: Jill M. Clark, MBA/HCM, CCRP, CCRC Senior Research ...Associate/ Research Manager Clinical Investigation Program Mike O’Callaghan Federal Medical Center (MOFMC) 4700 Las Vegas Blvd North, Bldg 1300, Room

Online evolution reconstruction from a single measurement record with random time intervals for quantum communication

NASA Astrophysics Data System (ADS)

Zhou, Hua; Su, Yang; Wang, Rong; Zhu, Yong; Shen, Huiping; Pu, Tao; Wu, Chuanxin; Zhao, Jiyong; Zhang, Baofu; Xu, Zhiyong

2017-10-01

Online reconstruction of a time-variant quantum state from the encoding/decoding results of quantum communication is addressed by developing a method of evolution reconstruction from a single measurement record with random time intervals. A time-variant two-dimensional state is reconstructed on the basis of recovering its expectation value functions of three nonorthogonal projectors from a random single measurement record, which is composed from the discarded qubits of the six-state protocol. The simulated results prove that our method is robust to typical metro quantum channels. Our work extends the Fourier-based method of evolution reconstruction from the version for a regular single measurement record with equal time intervals to a unified one, which can be applied to arbitrary single measurement records. The proposed protocol of evolution reconstruction runs concurrently with the one of quantum communication, which can facilitate the online quantum tomography.

Predicting animal home-range structure and transitions using a multistate Ornstein-Uhlenbeck biased random walk

USGS Publications Warehouse

Breed, Greg A.; Golson, Emily A.; Tinker, M. Tim

2017-01-01

The home‐range concept is central in animal ecology and behavior, and numerous mechanistic models have been developed to understand home range formation and maintenance. These mechanistic models usually assume a single, contiguous home range. Here we describe and implement a simple home‐range model that can accommodate multiple home‐range centers, form complex shapes, allow discontinuities in use patterns, and infer how external and internal variables affect movement and use patterns. The model assumes individuals associate with two or more home‐range centers and move among them with some estimable probability. Movement in and around home‐range centers is governed by a two‐dimensional Ornstein‐Uhlenbeck process, while transitions between centers are modeled as a stochastic state‐switching process. We augmented this base model by introducing environmental and demographic covariates that modify transition probabilities between home‐range centers and can be estimated to provide insight into the movement process. We demonstrate the model using telemetry data from sea otters (Enhydra lutris) in California. The model was fit using a Bayesian Markov Chain Monte Carlo method, which estimated transition probabilities, as well as unique Ornstein‐Uhlenbeck diffusion and centralizing tendency parameters. Estimated parameters could then be used to simulate movement and space use that was virtually indistinguishable from real data. We used Deviance Information Criterion (DIC) scores to assess model fit and determined that both wind and reproductive status were predictive of transitions between home‐range centers. Females were less likely to move between home‐range centers on windy days, less likely to move between centers when tending pups, and much more likely to move between centers just after weaning a pup. These tendencies are predicted by theoretical movement rules but were not previously known and show that our model can extract meaningful behavioral insight from complex movement data.

Reduction of display artifacts by random sampling

NASA Technical Reports Server (NTRS)

Ahumada, A. J., Jr.; Nagel, D. C.; Watson, A. B.; Yellott, J. I., Jr.

1983-01-01

The application of random-sampling techniques to remove visible artifacts (such as flicker, moire patterns, and paradoxical motion) introduced in TV-type displays by discrete sequential scanning is discussed and demonstrated. Sequential-scanning artifacts are described; the window of visibility defined in spatiotemporal frequency space by Watson and Ahumada (1982 and 1983) and Watson et al. (1983) is explained; the basic principles of random sampling are reviewed and illustrated by the case of the human retina; and it is proposed that the sampling artifacts can be replaced by random noise, which can then be shifted to frequency-space regions outside the window of visibility. Vertical sequential, single-random-sequence, and continuously renewed random-sequence plotting displays generating 128 points at update rates up to 130 Hz are applied to images of stationary and moving lines, and best results are obtained with the single random sequence for the stationary lines and with the renewed random sequence for the moving lines.

Prediction of protein long-range contacts using an ensemble of genetic algorithm classifiers with sequence profile centers.

PubMed

Chen, Peng; Li, Jinyan

2010-05-17

Prediction of long-range inter-residue contacts is an important topic in bioinformatics research. It is helpful for determining protein structures, understanding protein foldings, and therefore advancing the annotation of protein functions. In this paper, we propose a novel ensemble of genetic algorithm classifiers (GaCs) to address the long-range contact prediction problem. Our method is based on the key idea called sequence profile centers (SPCs). Each SPC is the average sequence profiles of residue pairs belonging to the same contact class or non-contact class. GaCs train on multiple but different pairs of long-range contact data (positive data) and long-range non-contact data (negative data). The negative data sets, having roughly the same sizes as the positive ones, are constructed by random sampling over the original imbalanced negative data. As a result, about 21.5% long-range contacts are correctly predicted. We also found that the ensemble of GaCs indeed makes an accuracy improvement by around 5.6% over the single GaC. Classifiers with the use of sequence profile centers may advance the long-range contact prediction. In line with this approach, key structural features in proteins would be determined with high efficiency and accuracy.

The effect on problematic drinking behavior of a brief motivational interview shortly after a first arrest for driving under the influence of alcohol: a randomized trial.

PubMed

Utter, Garth H; Young, Jason B; Theard, Leslie A; Cropp, David M; Mohar, Craig J; Eisenberg, Daniel; Schermer, Carol R; Owens, Leon J

2014-03-01

In medical settings, motivational interviewing-based "brief intervention" (BI) counseling reduces alcohol-related risk-taking behavior and harm in high-risk populations. Individuals arrested for driving under the influence of alcohol (DUI) are another at-risk population. We sought to determine whether a BI administered shortly after a first DUI arrest might decrease problematic drinking behavior. We conducted a single-center, parallel-group, double-blinded superiority randomized trial (NCT01270217), enrolling first-time DUI arrestees at a county jail from December 2010 through April 2011. Before their release, we randomized participants by computer-generated sequence to either a single BI or no discussion. We assessed 90-day change in Alcohol Use Disorders Identification Test (AUDIT) scores (range 0-40, higher values indicating more problematic drinking) as the primary outcome. We enrolled 200 subjects (100 to each arm), and 181 (90.5%, 86 control and 95 BI) completed the 90-day follow-up. Mean (SD) age was 30 (10) years, and 50% were men. Mean (SD) blood alcohol concentration upon arrest was 0.14% (0.04%). Mean (SD) baseline AUDIT scores were 8.8 (5.8) among control subjects and 7.7 (6.3) among BI subjects. At 90 days, AUDIT scores decreased by a mean (SD) 4.7 (5.1) units among control subjects and 3.4 (5.0) among BI subjects (difference, -1.3; 95% confidence interval [CI], -2.8 to +0.1). The likelihood of subsequent binge drinking [relative risk (RR) 1.6; 95% CI, 0.8-3.0; BI vs. control], abstinence (RR, 0.9; 95% CI, 0.4-2.1), alcohol-related injury to self or others (RR, 0.4; 95% CI, 0.1-2.4), and seeking treatment (RR, 1.2; 95% CI, 0.8-1.7) did not differ. A single BI counseling session shortly after first-time DUI arrest does not reduce 90-day self-reported drinking behavior or increase seeking treatment for drinking beyond that which occurs without such a discussion. Therapeutic study, level III.

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.

PubMed

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 rapidly distributed, with a prolonged terminal elimination phase. These data support the development of BG00010 for the treatment of neuropathic pain. ClinicalTrials.gov NCT00961766.

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.

PubMed

Backes, Manouk; Dingemans, Siem A; Dijkgraaf, Marcel G W; van den Berg, H Rogier; van Dijkman, Bart; Hoogendoorn, Jochem M; Joosse, Pieter; Ritchie, Ewan D; Roerdink, W Herbert; Schots, Judith P M; Sosef, Nico L; Spijkerman, Ingrid J B; Twigt, Bas A; van der Veen, Alexander H; van Veen, Ruben N; Vermeulen, Jefrey; Vos, Dagmar I; Winkelhagen, Jasper; Goslings, J Carel; Schepers, Tim

2017-12-26

Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. clinicaltrials.gov Identifier: NCT02225821.

The conditional power of randomization tests for single-case effect sizes in designs with randomized treatment order: A Monte Carlo simulation study.

PubMed

Michiels, Bart; Heyvaert, Mieke; Onghena, Patrick

2018-04-01

The conditional power (CP) of the randomization test (RT) was investigated in a simulation study in which three different single-case effect size (ES) measures were used as the test statistics: the mean difference (MD), the percentage of nonoverlapping data (PND), and the nonoverlap of all pairs (NAP). Furthermore, we studied the effect of the experimental design on the RT's CP for three different single-case designs with rapid treatment alternation: the completely randomized design (CRD), the randomized block design (RBD), and the restricted randomized alternation design (RRAD). As a third goal, we evaluated the CP of the RT for three types of simulated data: data generated from a standard normal distribution, data generated from a uniform distribution, and data generated from a first-order autoregressive Gaussian process. The results showed that the MD and NAP perform very similarly in terms of CP, whereas the PND performs substantially worse. Furthermore, the RRAD yielded marginally higher power in the RT, followed by the CRD and then the RBD. Finally, the power of the RT was almost unaffected by the type of the simulated data. On the basis of the results of the simulation study, we recommend at least 20 measurement occasions for single-case designs with a randomized treatment order that are to be evaluated with an RT using a 5% significance level. Furthermore, we do not recommend use of the PND, because of its low power in the RT.

Erosion Remineralization Efficacy of Gel-to-Foam Fluoride Toothpastes in situ: A Randomized Clinical Trial.

PubMed

Nehme, Marc; Jeffery, Peter; Mason, Stephen; Lippert, Frank; Zero, Domenick T; Hara, Anderson T

2016-01-01

This single-center, randomized, placebo-controlled, four-treatment, four-period crossover study compared the enamel remineralization effects of low- and medium-abrasivity gel-to-foam toothpastes and a reference toothpaste (all 1,450 ppm fluoride as NaF) versus placebo toothpaste (0 ppm fluoride) using a short-term in situ erosion model. Subjects (n = 56) wearing a palatal appliance holding acid-softened bovine enamel specimens brushed their teeth with the test toothpastes. Thereafter, the specimens were removed for analysis of percent surface microhardness recovery (%SMHR) and percent relative erosion resistance (%RER) at 2, 4, and 8 h. Both low- and medium-abrasivity gel-to-foam fluoride toothpastes and the reference toothpaste provided significantly greater %SMHR than placebo at all assessment time points (all p < 0.05). No statistically significant difference of %SMHR was observed between the fluoride treatment groups at any time point. Similarly, all fluoride products provided significantly superior %RER versus placebo (all p < 0.0001), whereas no significant difference of this parameter was noted between the fluoride treatment groups. Increasing numerical improvements of %SMHR and %RER were observed in all four treatment groups over time (2, 4, and 8 h). The present in situ model is a sensitive tool to investigate intrinsic and fluoride-enhanced rehardening of eroded enamel. All three fluoride toothpastes were more efficacious than placebo, and there were no safety concerns following single dosing in this short-term in situ model. © 2016 The Author(s) Published by S. Karger AG, Basel.

A comparison of lower canine retraction and loss of anchorage between conventional and self-ligating brackets: a single-center randomized split-mouth controlled trial.

PubMed

da Costa Monini, André; Júnior, Luiz Gonzaga Gandini; Vianna, Alexandre Protásio; Martins, Renato Parsekian

2017-05-01

To evaluate the rate of lower canine retraction, anchorage loss, and changes on lower canines and first molars axial inclination using self-ligating and conventional brackets. Twenty-five adult patients with a treatment plan involving extractions of four first premolars were selected for this split-mouth trial and had either conventional or self-ligating brackets bonded to lower canines in a block randomization. Retraction was accomplished using 100-g nickel titanium closed-coil springs, which were reactivated each 4 weeks. Oblique radiographs were taken before and after total canine retraction and the cephalograms were superimposed on stable structures of the mandible. Cephalometric points were digitized twice by a single-blinded operator for error control and the average of the points were used to determine the following variables: canine cusp horizontal changes, molar cusp horizontal changes, and angulation changes in canines and molars. Paired t tests were used to analyze the blinded data for group differences. All patients reached final phase without bracket debonds. No differences were found between the two groups for all variables tested. No serious harm was observed. Both brackets showed the same rate of canine retraction and loss of anteroposterior anchorage of the molars. No changes were found between brackets regarding the inclination of canines and first molars. Using self-ligating brackets to retract lower canines will not increase the velocity of tooth movement, does not increase anchorage, and does not decrease tipping.

2005 Workforce Study: Ohio Early Childhood Centers. General Analysis

ERIC Educational Resources Information Center

Stoneburner, Chris

2006-01-01

The purpose of this study was to understand the characteristics of the current workforce in early childhood. This report highlights key characteristics of the 2005 early childhood center workforce in Ohio. Survey packets were sent to 3.600 randomly selected centers in April 2005, representing centers licensed by the Ohio Department of Job and…

Elucidating fluctuating diffusivity in center-of-mass motion of polymer models with time-averaged mean-square-displacement tensor

NASA Astrophysics Data System (ADS)

Miyaguchi, Tomoshige

2017-10-01

There have been increasing reports that the diffusion coefficient of macromolecules depends on time and fluctuates randomly. Here a method is developed to elucidate this fluctuating diffusivity from trajectory data. Time-averaged mean-square displacement (MSD), a common tool in single-particle-tracking (SPT) experiments, is generalized to a second-order tensor with which both magnitude and orientation fluctuations of the diffusivity can be clearly detected. This method is used to analyze the center-of-mass motion of four fundamental polymer models: the Rouse model, the Zimm model, a reptation model, and a rigid rodlike polymer. It is found that these models exhibit distinctly different types of magnitude and orientation fluctuations of diffusivity. This is an advantage of the present method over previous ones, such as the ergodicity-breaking parameter and a non-Gaussian parameter, because with either of these parameters it is difficult to distinguish the dynamics of the four polymer models. Also, the present method of a time-averaged MSD tensor could be used to analyze trajectory data obtained in SPT experiments.

Infarct size in primary angioplasty without on-site cardiac surgical backup versus transferal to a tertiary center: a single photon emission computed tomography study.

PubMed

Knaapen, Paul; de Mulder, Maarten; van der Zant, Friso M; Peels, Hans O; Twisk, Jos W R; van Rossum, Albert C; Cornel, Jan H; Umans, Victor A W M

2009-02-01

Primary percutaneous coronary intervention (PCI) performed in large community hospitals without cardiac surgery back-up facilities (off-site) reduces door-to-balloon time compared with emergency transferal to tertiary interventional centers (on-site). The present study was performed to explore whether off-site PCI for acute myocardial infarction results in reduced infarct size. One hundred twenty-eight patients with acute ST-segment elevation myocardial infarction were randomly assigned to undergo primary PCI at the off-site center (n = 68) or to transferal to an on-site center (n = 60). Three days after PCI, (99m)Tc-sestamibi SPECT was performed to estimate infarct size. Off-site PCI significantly reduced door-to-balloon time compared with on-site PCI (94 +/- 54 versus 125 +/- 59 min, respectively, p < 0.01), although symptoms-to-treatment time was only insignificantly reduced (257 +/- 211 versus 286 +/- 146 min, respectively, p = 0.39). Infarct size was comparable between treatment centers (16 +/- 15 versus 14 +/- 12%, respectively p = 0.35). Multivariate analysis revealed that TIMI 0/1 flow grade at initial coronary angiography (OR 3.125, 95% CI 1.17-8.33, p = 0.023), anterior wall localization of the myocardial infarction (OR 3.44, 95% CI 1.38-8.55, p < 0.01), and development of pathological Q-waves (OR 5.07, 95% CI 2.10-12.25, p < 0.01) were independent predictors of an infarct size > 12%. Off-site PCI reduces door-to-balloon time compared with transferal to a remote on-site interventional center but does not reduce infarct size. Instead, pre-PCI TIMI 0/1 flow, anterior wall infarct localization, and development of Q-waves are more important predictors of infarct size.

Safety of herpes zoster vaccine in the shingles prevention study: a randomized trial.

PubMed

Simberkoff, Michael S; Arbeit, Robert D; Johnson, Gary R; Oxman, Michael N; Boardman, Kathy D; Williams, Heather M; Levin, Myron J; Schmader, Kenneth E; Gelb, Lawrence D; Keay, Susan; Neuzil, Kathleen; Greenberg, Richard N; Griffin, Marie R; Davis, Larry E; Morrison, Vicki A; Annunziato, Paula W

2010-05-04

The herpes zoster vaccine is effective in preventing herpes zoster and postherpetic neuralgia in immunocompetent older adults. However, its safety has not been described in depth. To describe local adverse effects and short- and long-term safety profiles of herpes zoster vaccine in immunocompetent older adults. Randomized, placebo-controlled trial with enrollment from November 1998 to September 2001 and follow-up through April 2004 (mean, 3.4 years). A Veterans Affairs Coordinating Center generated the permutated block randomization scheme, which was stratified by site and age. Participants and follow-up study personnel were blinded to treatment assignments. (ClinicalTrials.gov registration number: NCT00007501) 22 U.S. academic centers. 38 546 immunocompetent adults 60 years or older, including 6616 who participated in an adverse events substudy. Single dose of herpes zoster vaccine or placebo. Serious adverse events and rashes in all participants and inoculation-site events in substudy participants during the first 42 days after inoculation. Thereafter, vaccination-related serious adverse events and deaths were monitored in all participants, and hospitalizations were monitored in substudy participants. After inoculation, 255 (1.4%) vaccine recipients and 254 (1.4%) placebo recipients reported serious adverse events. Local inoculation-site side effects were reported by 1604 (48%) vaccine recipients and 539 (16%) placebo recipients in the substudy. A total of 977 (56.6%) of the vaccine recipients reporting local side effects were aged 60 to 69 years, and 627 (39.2%) were older than 70 years. After inoculation, herpes zoster occurred in 7 vaccine recipients versus 24 placebo recipients. Long-term follow-up (mean, 3.39 years) showed that rates of hospitalization or death did not differ between vaccine and placebo recipients. Participants in the substudy were not randomly selected. Confirmation of reported serious adverse events with medical record data was not always obtained. Herpes zoster vaccine is well tolerated in older, immunocompetent adults. Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development; grants from Merck to the Veterans Affairs Cooperative Studies Program; and the James R. and Jesse V. Scott Fund for Shingles Research.

Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.

PubMed

Lee, Kevin; Murphy, Patrick B; Ingves, Matthew V; Duncan, Audra; DeRose, Guy; Dubois, Luc; Forbes, Thomas L; Power, Adam

2017-12-01

The surgical site infection (SSI) rate in vascular surgery after groin incision for lower extremity revascularization can lead to significant morbidity and mortality. This trial was designed to study the effect of negative pressure wound therapy (NPWT) on SSI in closed groin wounds after lower extremity revascularization in patients at high risk for SSI. A single-center, randomized, controlled trial was performed at an academic tertiary medical center. Patients with previous femoral artery surgical exposure, body mass index of >30 kg/m 2 or the presence of ischemic tissue loss were classified as a high-risk patient for SSI. All wounds were closed primarily and patients were randomized to either NPWT or standard dressing. The primary outcome of the trial was postoperative 30-day SSI in the groin wound. The secondary outcomes included 90-day SSI, hospital duration of stay, readmissions or reoperations for SSI, and mortality. A total of 102 patients were randomized between August 2014 and December 2015. Patients were classified as at high risk owing to the presence of previous femoral artery cut down (29%), body mass index of >30 kg/m 2 (39%) or presence of ischemic tissue loss (32%). Revascularization procedures performed included femoral to distal artery bypass (57%), femoral endarterectomy (18%), femoral to femoral artery crossover (17%), and other procedures (8%). The primary outcome of 30-day SSI was 11% in NPWT group versus 19% in standard dressing group (P = .24). There was a statistically significant shorter mean duration of hospital stay in the NPWT group (6.4 days) compared with the standard group (8.9 days; P = .01). There was no difference in readmission or reoperation for SSI or mortality between the two groups. This study demonstrated a nonsignificant lower rate of groin SSI in high-risk revascularization patients with NPWT compared with standard dressing. Owing to a lower than expected infection rate, the study was underpowered to detect a difference at the prespecified level. The NPWT group did show significantly shorter mean hospital duration of stay compared with the standard dressing group. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial of Aminophylline to Prevent Acute Kidney Injury in Children Following Congenital Heart Surgery With Cardiopulmonary Bypass.

PubMed

Axelrod, David M; Sutherland, Scott M; Anglemyer, Andrew; Grimm, Paul C; Roth, Stephen J

2016-02-01

Acute kidney injury occurs commonly in children following congenital cardiac surgery with cardiopulmonary bypass and has been associated with increased morbidity and mortality. Aminophylline, a methylxanthine nonselective adenosine receptor antagonist, has been effective in the management of acute kidney injury in certain populations. This study sought to determine whether postoperative administration of aminophylline attenuates acute kidney injury in children undergoing congenital cardiac surgery with cardiopulmonary bypass. Single-center, double-blinded, placebo-controlled, randomized clinical trial. Tertiary center, pediatric cardiovascular ICU. A total of 144 children after congenital heart surgery with cardiopulmonary bypass. Seventy-two patients were randomized to receive aminophylline and 72 patients received placebo. Study drug was administered every 6 hours for 72 hours. The primary outcome variable was the development of any acute kidney injury, defined by the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes. Secondary outcomes included the development of severe acute kidney injury, time between cardiovascular ICU admission and first successful extubation, percent fluid overload, total fluid balance, urine output, bioelectrical impedance, and serum neutrophil gelatinase-associated lipocalin. The unadjusted rate and severity of acute kidney injury were not different between groups; 43 of 72 (60%) of the treatment group and 36 of 72 (50%) of the placebo group developed acute kidney injury (p = 0.32). Stage 2/3 acute kidney injury occurred in 23 of 72 (32%) of the treatment group and 15 of 72 (21%) of the placebo group (p = 0.18). Secondary outcome measures also demonstrated no significant difference between treatment and placebo groups. Aminophylline administration was safe; no deaths occurred in either group, and rates of adverse events were similar (14% in the treatment group vs 18% in the placebo group; p = 0.30). In this placebo-controlled randomized clinical trial, we found no effect of aminophylline to prevent acute kidney injury in children recovering from cardiac surgery performed with cardiopulmonary bypass. Future study of preoperative aminophylline administration to prevent acute kidney injury may be warranted.

Predicting the random drift of MEMS gyroscope based on K-means clustering and OLS RBF Neural Network

NASA Astrophysics Data System (ADS)

Wang, Zhen-yu; Zhang, Li-jie

2017-10-01

Measure error of the sensor can be effectively compensated with prediction. Aiming at large random drift error of MEMS(Micro Electro Mechanical System))gyroscope, an improved learning algorithm of Radial Basis Function(RBF) Neural Network(NN) based on K-means clustering and Orthogonal Least-Squares (OLS) is proposed in this paper. The algorithm selects the typical samples as the initial cluster centers of RBF NN firstly, candidates centers with K-means algorithm secondly, and optimizes the candidate centers with OLS algorithm thirdly, which makes the network structure simpler and makes the prediction performance better. Experimental results show that the proposed K-means clustering OLS learning algorithm can predict the random drift of MEMS gyroscope effectively, the prediction error of which is 9.8019e-007°/s and the prediction time of which is 2.4169e-006s

Single-mode SOA-based 1kHz-linewidth dual-wavelength random fiber laser.

PubMed

Xu, Yanping; Zhang, Liang; Chen, Liang; Bao, Xiaoyi

2017-07-10

Narrow-linewidth multi-wavelength fiber lasers are of significant interests for fiber-optic sensors, spectroscopy, optical communications, and microwave generation. A novel narrow-linewidth dual-wavelength random fiber laser with single-mode operation, based on the semiconductor optical amplifier (SOA) gain, is achieved in this work for the first time, to the best of our knowledge. A simplified theoretical model is established to characterize such kind of random fiber laser. The inhomogeneous gain in SOA mitigates the mode competition significantly and alleviates the laser instability, which are frequently encountered in multi-wavelength fiber lasers with Erbium-doped fiber gain. The enhanced random distributed feedback from a 5km non-uniform fiber provides coherent feedback, acting as mode selection element to ensure single-mode operation with narrow linewidth of ~1kHz. The laser noises are also comprehensively investigated and studied, showing the improvements of the proposed random fiber laser with suppressed intensity and frequency noises.

Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.

PubMed

Zatzick, Douglas; Russo, Joan; Lord, Sarah Peregrine; Varley, Christopher; Wang, Jin; Berliner, Lucy; Jurkovich, Gregory; Whiteside, Lauren K; O'Connor, Stephen; Rivara, Frederick P

2014-06-01

Violence and injury risk behaviors, alcohol and drug use problems, and posttraumatic stress disorder (PTSD) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury. To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury. A pragmatic randomized clinical trial was conducted at a single US level I trauma center. Participants included 120 adolescents aged 12 to 18 years randomized to intervention (n = 59) and control (n = 61) conditions. Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms. Adolescents were assessed at baseline before randomization and 2, 5, and 12 months after injury hospitalization. Standardized instruments were used to assess violence risk behaviors, alcohol and drug use, and PTSD and depressive symptoms. The investigation attained more than 95% adolescent follow-up at each assessment point. At baseline, approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon. Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury (group × time effect, F3,344 = 3.0; P = .03). At 12 months after the injury, 4 (7.3%) intervention patients vs 13 (21.3%) control patients reported currently carrying a weapon (relative risk, 0.31; 95% CI, 0.11-0.90). The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury. Other treatment targets, including alcohol and drug use problems and high levels of PTSD and depressive symptoms, occurred less frequently in the cohort relative to weapon carrying and were not significantly affected by the intervention. Collaborative care intervention reduced the risk of adolescent weapon carrying during the year after the injury hospitalization. Future investigation should replicate this preliminary observation. If the finding is replicated, orchestrated investigative and policy efforts could systematically implement and evaluate screening and intervention procedures targeting youth violence prevention at US trauma centers. clinicaltrials.gov identifier: NCT00619255.

A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

PubMed

Wang, Chenchen; McAlindon, Timothy; Fielding, Roger A; Harvey, William F; Driban, Jeffrey B; Price, Lori Lyn; Kalish, Robert; Schmid, Anna; Scott, Tammy M; Schmid, Christopher H

2015-01-30

Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs. ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.

Emory Angioplasty Versus Surgery Trial (EAST): design, recruitment, and baseline description of patients.

PubMed

King, S B; Lembo, N J; Weintraub, W S; Kosinski, A S; Barnhart, H X; Kutner, M H

1995-03-23

In patients with multivessel coronary artery disease who require revascularization there is uncertainty as to the selection of the appropriate patients for percutaneous transluminal coronary angioplasty (PTCA) as opposed to coronary artery bypass grafting (CABG). To define the relative roles of PTCA and CABG for multivessel disease, 392 patients were randomly assigned to revascularization by PTCA or CABG and followed for 3 years. This is a single-center randomized study in which individual group assignment was known but grouped data remained blinded until a full 3 years of follow-up was complete on all patients. The patients were randomized in 4 strata: (1) 2-vessel disease with 1 lesion per vessel; (2) 2-vessel disease with multiple lesions in at least 1 vessel; (3) 3-vessel disease with 1 lesion per vessel; and (4) 3-vessel disease with multiple lesions in at least 1 vessel. All data were collected on study-specific forms and sent to an independent biostatistical coordinating center for entry into a computerized database. All data will be analyzed by intention-to-treat. The primary endpoint of the trial is the composite of death of any cause, Q-wave myocardial infarction within 3 years, or a large reversible thallium defect at 3 years. Multiple secondary endpoints will include each of the components of the primary endpoint, the need for additional procedures, angiographic status at 1 and 3 years measured by an independent quantitative coronary arteriography laboratory, and measures of quality of life. A total of 5,118 patients were screened, of whom 3,371 were excluded for angiographic reasons, 191 because the angioplasty operators or surgeons believed that the patients were anatomically unsuitable, and 714 for clinical exclusions, leaving 842 eligible patients, of whom 392 were randomized. Of these, 40% had triple-vessel disease and 60% had double-vessel disease. There was no baseline difference between the 2 treatment arms for any clinical or major angiographic variable. This randomized trial will permit an in-depth comparison of coronary angioplasty and coronary surgery in comparable patients suitable for either procedure. Clinical, angiographic, and quality-of-life comparisons will be made and should be helpful in medical decision making between the 2 procedures.

Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study

ERIC Educational Resources Information Center

Byun, Tara McAllister

2017-01-01

Purpose: This study documented the efficacy of visual-acoustic biofeedback intervention for residual rhotic errors, relative to a comparison condition involving traditional articulatory treatment. All participants received both treatments in a single-subject experimental design featuring alternating treatments with blocked randomization of…

Blood Pressure and Cognitive Performance After a Single Administration of a Camphor-Crataegus Combination in Adolescents with Low Blood Pressure.

PubMed

Schandry, Rainer; Lindauer, Daniela; Mauz, Matthias

2018-06-18

Low blood pressure is rather widespread among adolescents and frequently accompanied by complaints. Two single-center, double-blinded, randomized, and placebo-controlled trials were performed with adolescent participants in the age range of 14 - 17 y having a systolic blood pressure below 118 mmHg (boys) or 110 mmHg (girls). They received a single dose of 20 drops of a fixed combination of natural D-camphor and an ethanolic extract from fresh Crataegus berries (CCC) or of an ethanolic placebo. The efficacy of CCC (commercial name Korodin) has proven its efficacy in the treatment of low blood pressure in adults of all ages, although related placebo-controlled, double-blind studies for adolescents following European (EU) pediatric regulations are lacking. Blood pressure and heart rate were assessed during a rest period, prior to substance administration, 1 min thereafter, and after about 5 min. Additionally, performance was assessed by two cognitive tests. After administration of CCC, a significantly greater rise in blood pressure occurred compared to placebo. In the cognitive tasks, no significant differences were observed. No adverse events or subjective complaints were reported at the final examination; thus, the present study provides evidence for the safety and tolerability of CCC after a single administration. Georg Thieme Verlag KG Stuttgart · New York.

Effects of a randomized intervention to improve workplace social capital in community health centers in China.

PubMed

Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

2014-01-01

To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. This study was conducted in 20 community health centers of similar size in Jinan of China during 2012-2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings.

Effects of a Randomized Intervention to Improve Workplace Social Capital in Community Health Centers in China

PubMed Central

Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

2014-01-01

Objective To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. Methods This study was conducted in 20 community health centers of similar size in Jinan of China during 2012–2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. Results No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. Conclusions The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings. PMID:25503627

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

Predicting Employment Outcomes of Consumers of State-Operated Comprehensive Rehabilitation Centers

ERIC Educational Resources Information Center

Beach, David Thomas

2009-01-01

This study used records from a state-operated comprehensive rehabilitation center to investigate possible predictive factors related to completing comprehensive rehabilitation center programs and successful vocational rehabilitation (VR) case closure. An analysis of demographic data of randomly selected comprehensive rehabilitation center…

Effect of rater training on reliability and accuracy of mini-CEX scores: a randomized, controlled trial.

PubMed

Cook, David A; Dupras, Denise M; Beckman, Thomas J; Thomas, Kris G; Pankratz, V Shane

2009-01-01

Mini-CEX scores assess resident competence. Rater training might improve mini-CEX score interrater reliability, but evidence is lacking. Evaluate a rater training workshop using interrater reliability and accuracy. Randomized trial (immediate versus delayed workshop) and single-group pre/post study (randomized groups combined). Academic medical center. Fifty-two internal medicine clinic preceptors (31 randomized and 21 additional workshop attendees). The workshop included rater error training, performance dimension training, behavioral observation training, and frame of reference training using lecture, video, and facilitated discussion. Delayed group received no intervention until after posttest. Mini-CEX ratings at baseline (just before workshop for workshop group), and four weeks later using videotaped resident-patient encounters; mini-CEX ratings of live resident-patient encounters one year preceding and one year following the workshop; rater confidence using mini-CEX. Among 31 randomized participants, interrater reliabilities in the delayed group (baseline intraclass correlation coefficient [ICC] 0.43, follow-up 0.53) and workshop group (baseline 0.40, follow-up 0.43) were not significantly different (p = 0.19). Mean ratings were similar at baseline (delayed 4.9 [95% confidence interval 4.6-5.2], workshop 4.8 [4.5-5.1]) and follow-up (delayed 5.4 [5.0-5.7], workshop 5.3 [5.0-5.6]; p = 0.88 for interaction). For the entire cohort, rater confidence (1 = not confident, 6 = very confident) improved from mean (SD) 3.8 (1.4) to 4.4 (1.0), p = 0.018. Interrater reliability for ratings of live encounters (entire cohort) was higher after the workshop (ICC 0.34) than before (ICC 0.18) but the standard error of measurement was similar for both periods. Rater training did not improve interrater reliability or accuracy of mini-CEX scores. clinicaltrials.gov identifier NCT00667940

Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery.

PubMed

Newburger, Jane W; Jonas, Richard A; Soul, Janet; Kussman, Barry D; Bellinger, David C; Laussen, Peter C; Robertson, Richard; Mayer, John E; del Nido, Pedro J; Bacha, Emile A; Forbess, Joseph M; Pigula, Frank; Roth, Stephen J; Visconti, Karen J; du Plessis, Adre J; Farrell, David M; McGrath, Ellen; Rappaport, Leonard A; Wypij, David

2008-02-01

We previously reported that postoperative hemodynamics and developmental outcomes were better among infants randomized to a higher hematocrit value during hypothermic cardiopulmonary bypass. However, worse outcomes were concentrated in patients with hematocrit values of 20% or below, and the benefits of hematocrit values higher than 25% were uncertain. We compared perioperative hemodynamics and, at 1 year, developmental outcome and brain magnetic resonance imaging in a single-center, randomized trial of hemodilution to a hematocrit value of 25% versus 35% during hypothermic radiopulmonary bypass for reparative heart surgery in infants undergoing 2-ventricle repairs without aortic arch obstruction. Among 124 subjects, 56 were assigned to the lower-hematocrit strategy (24.8% +/- 3.1%, mean +/- SD) and 68 to the higher-hematocrit strategy (32.6% +/- 3.5%). Infants randomized to the 25% strategy, compared with the 35% strategy, had a more positive intraoperative fluid balance (P = .007) and lower regional cerebral oxygen saturation at 10 minutes after cooling (P = .04) and onset of low flow (P = .03). Infants with dextro-transposition of the great arteries in the 25% group had significantly longer hospital stay. Other postoperative outcomes, blood product usage, and adverse events were similar in the treatment groups. At age 1 year (n = 106), the treatment groups had similar scores on the Psychomotor and Mental Development Indexes of the Bayley Scales; both groups scored significantly worse than population norms. Hemodilution to hematocrit levels of 35% compared with those of 25% had no major benefits or risks overall among infants undergoing 2-ventricle repair. Developmental outcomes at age 1 year in both randomized groups were below those in the normative population.

The development of STS payload environmental engineering standards

NASA Technical Reports Server (NTRS)

Bangs, W. F.

1982-01-01

The presently reported effort to provide a single set of standards for the design, analysis and testing of Space Transportation System (STS) payloads throughout the NASA organization must be viewed as essentially experimental, since the concept of incorporating the diverse opinions and experiences of several separate field research centers may in retrospect be judged too ambitious or perhaps even naive. While each STS payload may have unique characteristics, and the project should formulate its own criteria for environmental design, testing and evaluation, a reference source document providing coordinated standards is expected to minimize the duplication of effort and limit random divergence of practices among the various NASA payload programs. These standards would provide useful information to all potential STS users, and offer a degree of standardization to STS users outside the NASA organization.

Dapoxetine has no pharmacokinetic or cognitive interactions with ethanol in healthy male volunteers.

PubMed

Modi, Nishit B; Dresser, Mark; Desai, Dhaval; Edgar, Christopher; Wesnes, Keith

2007-03-01

Dapoxetine is being investigated for the treatment of premature ejaculation. This study evaluated the potential pharmacokinetic and cognitive interactions of dapoxetine 60 mg with ethanol 0.5 g/kg in a single-center, double-blind, randomized, placebo-controlled crossover study in healthy adult male participants (n = 24). Dapoxetine was rapidly absorbed and eliminated; peak concentrations were noted 1.47 hours after administration and decreased with an alpha half-life of 1.33 hours and a terminal half-life of 15.6 hours. Pharmacokinetic parameters (C(max), AUC(infinity), t((1/2)), and t(max)) of dapoxetine were not altered with concurrent ethanol consumption. Furthermore, coadministration of dapoxetine did not affect the pharmacokinetics of ethanol or potentiate the cognitive and subjective effects of ethanol.

Duality in Power-Law Localization in Disordered One-Dimensional Systems

NASA Astrophysics Data System (ADS)

Deng, X.; Kravtsov, V. E.; Shlyapnikov, G. V.; Santos, L.

2018-03-01

The transport of excitations between pinned particles in many physical systems may be mapped to single-particle models with power-law hopping, 1 /ra . For randomly spaced particles, these models present an effective peculiar disorder that leads to surprising localization properties. We show that in one-dimensional systems almost all eigenstates (except for a few states close to the ground state) are power-law localized for any value of a >0 . Moreover, we show that our model is an example of a new universality class of models with power-law hopping, characterized by a duality between systems with long-range hops (a <1 ) and short-range hops (a >1 ), in which the wave function amplitude falls off algebraically with the same power γ from the localization center.

Interventional Therapy for Upper Extremity Deep Vein Thrombosis

PubMed Central

Carlon, Timothy A.; Sudheendra, Deepak

2017-01-01

Approximately 10% of all deep vein thromboses occur in the upper extremity, and that number is increasing due to the use of peripherally inserted central catheters. Sequelae of upper extremity deep vein thrombosis (UEDVT) are similar to those for lower extremity deep vein thrombosis (LEDVT) and include postthrombotic syndrome and pulmonary embolism. In addition to systemic anticoagulation, there are multiple interventional treatment options for UEDVT with the potential to reduce the incidence of these sequelae. To date, there have been no randomized trials to define the optimal management strategy for patients presenting with UEDVT, so many conclusions are drawn from smaller, single-center studies or from LEDVT research. In this article, the authors describe the evidence for the currently available treatment options and an approach to a patient with acute UEDVT. PMID:28265130

The Influence of Microgravity on Invasive Growth in Saccharomyces cerevisiae

NASA Astrophysics Data System (ADS)

Van Mulders, Sebastiaan E.; Stassen, Catherine; Daenen, Luk; Devreese, Bart; Siewers, Verena; van Eijsden, Rudy G. E.; Nielsen, Jens; Delvaux, Freddy R.; Willaert, Ronnie

2011-01-01

This study investigates the effects of microgravity on colony growth and the morphological transition from single cells to short invasive filaments in the model eukaryotic organism Saccharomyces cerevisiae. Two-dimensional spreading of the yeast colonies grown on semi-solid agar medium was reduced under microgravity in the Σ1278b laboratory strain but not in the CMBSESA1 industrial strain. This was supported by the Σ1278b proteome map under microgravity conditions, which revealed upregulation of proteins linked to anaerobic conditions. The Σ1278b strain showed a reduced invasive growth in the center of the yeast colony. Bud scar distribution was slightly affected, with a switch toward more random budding. Together, microgravity conditions disturb spatially programmed budding patterns and generate strain-dependent growth differences in yeast colonies on semi-solid medium.

CM-2 Environmental / Modal Testing of Spacehab Racks

NASA Technical Reports Server (NTRS)

McNelis, Mark E.; Goodnight, Thomas W.; Farkas, Michael A.

2001-01-01

Combined environmental/modal vibration testing has been implemented at the NASA Glenn Research Center's Structural Dynamics Laboratory. The benefits of combined vibration testing are that it facilitates test article modal characterization and vibration qualification testing. The Combustion Module-2 (CM-2) is a space experiment that launches on Shuttle mission STS 107 in the SPACEHAB Research Double Module. The CM-2 flight hardware is integrated into a SPACEHAB single and double rack. CM-2 rack level combined vibration testing was recently completed on a shaker table to characterize the structure's modal response and verify the random vibration response. Control accelerometers and limit force gauges, located between the fixture and rack interface, were used to verify the input excitation. Results of the testing were used to verify the loads and environments for flight on the Shuttle.

Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes

PubMed Central

2011-01-01

Background Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. Methods We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC. Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. Results The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. Conclusions On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain. PMID:21605357

Stochastic analysis of uncertain thermal parameters for random thermal regime of frozen soil around a single freezing pipe

NASA Astrophysics Data System (ADS)

Wang, Tao; Zhou, Guoqing; Wang, Jianzhou; Zhou, Lei

2018-03-01

The artificial ground freezing method (AGF) is widely used in civil and mining engineering, and the thermal regime of frozen soil around the freezing pipe affects the safety of design and construction. The thermal parameters can be truly random due to heterogeneity of the soil properties, which lead to the randomness of thermal regime of frozen soil around the freezing pipe. The purpose of this paper is to study the one-dimensional (1D) random thermal regime problem on the basis of a stochastic analysis model and the Monte Carlo (MC) method. Considering the uncertain thermal parameters of frozen soil as random variables, stochastic processes and random fields, the corresponding stochastic thermal regime of frozen soil around a single freezing pipe are obtained and analyzed. Taking the variability of each stochastic parameter into account individually, the influences of each stochastic thermal parameter on stochastic thermal regime are investigated. The results show that the mean temperatures of frozen soil around the single freezing pipe with three analogy method are the same while the standard deviations are different. The distributions of standard deviation have a great difference at different radial coordinate location and the larger standard deviations are mainly at the phase change area. The computed data with random variable method and stochastic process method have a great difference from the measured data while the computed data with random field method well agree with the measured data. Each uncertain thermal parameter has a different effect on the standard deviation of frozen soil temperature around the single freezing pipe. These results can provide a theoretical basis for the design and construction of AGF.

Family Support Center Village: A Unique Approach for Low-Income Single Women with Children

ERIC Educational Resources Information Center

Graber, Helen V.; Wolfe, Jayne L.

2004-01-01

The Family Support Center, recognizing the need for single women with children to maintain stability, has developed a program referred to as the Family Support Center Village, which incorporates a service enriched co-housing model. The "Village" will be the catalyst for these mothers' self-sufficiency and will provide opportunities to develop…

Radial Alignment of Ellipitcal Galaxies by the Tidal Force of a Cluster of Galaxies

NASA Astrophysics Data System (ADS)

Zhang, Shuang-Nan; Rong, Yu; Tu, Hong

2015-08-01

Unlike the random radial orientation distribution of field elliptical galaxies, galaxies in a cluster of galaxies are expected to point preferentially toward the center of the cluster, as a result of the cluster's tidal force on its member galaxies. In this work an analytic model is formulated to simulate this effect. The deformation time scale of a galaxy in a cluster is usually much shorter than the time scale of change of the tidal force; the dynamical process of the tidal interaction within the galaxy can thus be ignored. An equilibrium shape of a galaxy is then assumed to be the surface of equipotential, which is the sum of the self-gravitational potential of the galaxy and the tidal potential of the cluster at this location. We use a Monte-Carlo method to calculate the radial orientation distribution of these galaxies, by assuming the NFW mass profile of the cluster and the initial ellipticity of field galaxies. The radial angles show a single peak distribution centered at zero. The Monte-Carlo simulations also show that a shift of the reference center from the real cluster center weakens the anisotropy of the radial angle distribution. Therefore, the expected radial alignment cannot be revealed if the distribution of spatial position angle is used instead of that of radial angle. The observed radial orientations of elliptical galaxies in cluster Abell~2744 are consistent with the simulated distribution.

Radial Alignment of Elliptical Galaxies by the Tidal Force of a Cluster of Galaxies

NASA Astrophysics Data System (ADS)

Zhang, Shuang-Nan; Rong, Yu; Tu, Hong

2015-08-01

Unlike the random radial orientation distribution of field elliptical galaxies, galaxies in a cluster of galaxies are expected to point preferentially toward the center of the cluster, as a result of the cluster's tidal force on its member galaxies. In this work an analytic model is formulated to simulate this effect. The deformation time scale of a galaxy in a cluster is usually much shorter than the time scale of change of the tidal force; the dynamical process of the tidal interaction within the galaxy can thus be ignored. An equilibrium shape of a galaxy is then assumed to be the surface of equipotential, which is the sum of the self-gravitational potential of the galaxy and the tidal potential of the cluster at this location. We use a Monte-Carlo method to calculate the radial orientation distribution of these galaxies, by assuming the NFW mass profile of the cluster and the initial ellipticity of field galaxies. The radial angles show a single peak distribution centered at zero. The Monte-Carlo simulations also show that a shift of the reference center from the real cluster center weakens the anisotropy of the radial angle distribution. Therefore, the expected radial alignment cannot be revealed if the distribution of spatial position angle is used instead of that of radial angle. The observed radial orientations of elliptical galaxies in cluster Abell~2744 are consistent with the simulated distribution.

A multilevel model to estimate the within- and the between-center components of the exposure/disease association in the EPIC study.

PubMed

Sera, Francesco; Ferrari, Pietro

2015-01-01

In a multicenter study, the overall relationship between exposure and the risk of cancer can be broken down into a within-center component, which reflects the individual level association, and a between-center relationship, which captures the association at the aggregate level. A piecewise exponential proportional hazards model with random effects was used to evaluate the association between dietary fiber intake and colorectal cancer (CRC) risk in the EPIC study. During an average follow-up of 11.0 years, 4,517 CRC events occurred among study participants recruited in 28 centers from ten European countries. Models were adjusted by relevant confounding factors. Heterogeneity among centers was modelled with random effects. Linear regression calibration was used to account for errors in dietary questionnaire (DQ) measurements. Risk ratio estimates for a 10 g/day increment in dietary fiber were equal to 0.90 (95%CI: 0.85, 0.96) and 0.85 (0.64, 1.14), at the individual and aggregate levels, respectively, while calibrated estimates were 0.85 (0.76, 0.94), and 0.87 (0.65, 1.15), respectively. In multicenter studies, over a straightforward ecological analysis, random effects models allow information at the individual and ecologic levels to be captured, while controlling for confounding at both levels of evidence.

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India.

PubMed

Solomon, Sunil S; Lucas, Gregory M; Celentano, David D; McFall, Allison M; Ogburn, Elizabeth; Moulton, Lawrence H; Srikrishnan, Aylur K; Kumar, M Suresh; Anand, Santhanam; Solomon, Suniti; Mehta, Shruti H

2016-11-14

Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings. This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys. For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations. ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012.

A comparative study of grasping-type scissors forceps and insulated-tip knife for endoscopic submucosal dissection of early gastric cancer: a randomized controlled trial

PubMed Central

Nagai, Kengo; Uedo, Noriya; Yamashina, Takeshi; Matsui, Fumi; Matsuura, Noriko; Ito, Takashi; Yamamoto, Sachiko; Hanaoka, Noboru; Takeuchi, Yoji; Higashino, Koji; Ishihara, Ryu; Iishi, Hiroyasu

2016-01-01

Background and study aims: Endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is technically difficult for beginners. Few comparative studies of technical feasibility, efficacy, and safety using various devices have been reported. This study evaluated the feasibility, efficacy, and safety of ESD for EGC < 2 cm using grasping-type scissors forceps (GSF) or insulated-tip knife (IT2) for three resident endoscopists. Patients and methods: This was a randomized phase II study in a cancer referral center. A total of 108 patients with 120 EGCs were enrolled with the following characteristics: differentiated-type mucosal EGC, without ulcers or scars, < 2 cm (86 men, 22 women; median age 72 years). All lesions were stratified according to operator and tumor location (antrum or corpus), assigned randomly to two groups (GSF or IT2), and resected by ESD. Self-completion rate, complete resection rate, procedure time, and adverse events were evaluated as main outcome measures. Results: There was no difference in self-completion rate between the IT2 group (77 %, 47/61, P = 0.187) and the GSF group (66 %, 37/56). Also, there were no differences in en bloc resection rate (98 %, 60/61 vs. 93 %, 52/56, P = 0.195) and adverse events (3.3 %, 2/61 vs. 7.1 %, 4/56, P = 0.424). Median (min [range]) procedure time in the IT2 group (47 [33 – 67], P = 0.003) was shorter than that in the GSF group (66 [40 – 100]). Limitations of this study were the small sample size and single center design. Conclusions: ESD with GSF did not show a statistically significant advantage in improvement of self-completion rate over IT2. (Study registration: UMIN 000005048) PMID:27556074

Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy.

PubMed

Protic, Mladjan; Veljkovic, Radovan; Bilchik, Anton J; Popovic, Ana; Kresoja, Milana; Nissan, Aviram; Avital, Itzhak; Stojadinovic, Alexander

2017-02-01

Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC. Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site injection with 0.25 % bupivacaine significantly reduces pain after LC. This study was designed as single-blinded PRCT. This study was conducted in an academic medical center. Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to non-opioid/opioid analgesic combinations (Control Group, n = 32) and non-opioid/opioid analgesic combinations plus topical 0.25 % bupivacaine onto the cystic plate and local 0.25 % bupivacaine port-site injection, post-LC (Study Group, n = 31). Primary endpoint was patient-reported pain 1, 4, 6, 12, 24 h and 1 week post-LC using the Visual Analog Scale (VAS 0-10). Study groups were comparable clinicopathologically. There were no adverse events. A statistically significant reduction in mean pain score was apparent in Study Group patients in comparison with Control Group (mean VAS 4.83 ± 2.33 vs. 6.80 ± 1.87; p < 0.001) at all early (1-6 h) post-operative time points following LC. This PRCT shows significantly improved pain control with somatovisceral pain blockade over non-opioid/opioid analgesic combinations following LC for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for LC, this topical use of bupivacaine may improve patient comfort during recovery. This trial was registered on www.ClinicalTrials.gov NCT# 01972620.

A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial of Aminophylline to Prevent Acute Kidney Injury in Children following Congenital Heart Surgery with Cardiopulmonary Bypass

PubMed Central

Axelrod, David M.; Sutherland, Scott M.; Anglemyer, Andrew; Grimm, Paul C.; Roth, Stephen J.

2015-01-01

Objective Acute kidney injury (AKI) occurs commonly in children following congenital cardiac surgery with cardiopulmonary bypass (CPB) and has been associated with increased morbidity and mortality. Aminophylline, a methylxanthine nonselective adenosine receptor antagonist, has been effective in the management of AKI in certain populations. This study sought to determine if post-operative administration of aminophylline attenuates AKI in children undergoing congenital cardiac surgery with CPB. Design Single-center, double-blinded, placebo-controlled, randomized clinical trial (RCT). Setting Tertiary center, pediatric cardiovascular intensive care unit. Patients 144 children after congenital heart surgery with CPB. Interventions Seventy-two patients were randomized to receive aminophylline and 72 patients received placebo. Study drug was administered every six hours for 72 hours. Measurements and Main Results The primary outcome variable was development of any AKI, defined by the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes (KDIGO) criteria. Secondary outcomes included the development of severe AKI, time between CVICU admission and first successful extubation, percent fluid overload, total fluid balance, urine output, bioelectrical impedance, and serum neutrophil gelatinase-associated lipocalin (NGAL). The unadjusted rate and severity of AKI were not different between groups; 43/72 (60%) of the treatment group and 36/72 (50%) of the placebo group developed AKI (p=0.32). Stage 2/3 AKI occurred in 23/72 (32%) of the treatment group and 15/72 (21%) of the placebo group (p=0.18). Secondary outcome measures also demonstrated no significant difference between treatment and placebo groups. Aminophylline administration was safe; no deaths occurred in either group, and rates of adverse events were similar (14% in the treatment group versus 18% in the placebo group, p =0.30). Conclusions In this placebo-controlled RCT, we found no effect of aminophylline to prevent AKI in children recovering from cardiac surgery performed with CPB. Future study of pre-operative aminophylline administration to prevent AKI may be warranted. PMID:26669642

A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer.

PubMed

Park, K H; Lee, S; Park, J H; Kang, S Y; Kim, H Y; Park, I H; Park, Y H; Im, Y H; Lee, H J; Park, S; Lee, S I; Jung, K H; Kim, Y S; Seo, Jae Hong

2017-02-01

This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN). Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m 2 /day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle. The mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 ± 0.85 days for the filgrastim group and 2.28 ± 1.14 days for the DA-3031 group. The difference between groups was 0.2 ± 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm 3 and 161.75/mm 3 for the filgrastim and DA-3031 groups, respectively; P = 0.8414) or in time to ANC recovery (10.03 ± 0.75 and 9.83 ± 1.56 days in the filgrastim and DA-3031 groups, respectively; P = 0.0611) during cycle 1. Serious AEs occurred in six (15.8 %) patients receiving filgrastim and in ten (27.8 %) patients receiving DA-3031; however, none was determined to be related to the study drug. DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy.

Quantum logic readout and cooling of a single dark electron spin

NASA Astrophysics Data System (ADS)

Shi, Fazhan; Zhang, Qi; Naydenov, Boris; Jelezko, Fedor; Du, Jiangfeng; Reinhard, Friedemann; Wrachtrup, Jörg

2013-05-01

We study a single dark N2 electron spin defect in diamond, which is magnetically coupled to a nearby nitrogen-vacancy (NV) center. We perform pulsed electron spin resonance on this single spin by mapping its state to the NV center spin and optically reading out the latter. Moreover, we show that the NV center's spin polarization can be transferred to the electron spin by combined two decoupling control-NOT gates. These two results allow us to extend the NV center's two key properties—optical spin polarization and detection—to any electron spin in its vicinity. This enables dark electron spins to be used as local quantum registers and engineerable memories.

Single-shot stand-off chemical identification of powders using random Raman lasing

PubMed Central

Hokr, Brett H.; Bixler, Joel N.; Noojin, Gary D.; Thomas, Robert J.; Rockwell, Benjamin A.; Yakovlev, Vladislav V.; Scully, Marlan O.

2014-01-01

The task of identifying explosives, hazardous chemicals, and biological materials from a safe distance is the subject we consider. Much of the prior work on stand-off spectroscopy using light has been devoted to generating a backward-propagating beam of light that can be used drive further spectroscopic processes. The discovery of random lasing and, more recently, random Raman lasing provide a mechanism for remotely generating copious amounts of chemically specific Raman scattered light. The bright nature of random Raman lasing renders directionality unnecessary, allowing for the detection and identification of chemicals from large distances in real time. In this article, the single-shot remote identification of chemicals at kilometer-scale distances is experimentally demonstrated using random Raman lasing. PMID:25114231

Effectiveness of nurse-led patient-centered care behavioral risk modification on secondary prevention of coronary heart disease: A systematic review.

PubMed

Chiang, Chung-Yan; Choi, Kai-Chow; Ho, Ka-Ming; Yu, Sau-Fung

2018-04-22

Despite establishment of advocacies centered on using patient-centered care to improve disease-related behavioral changes and health outcomes, studies have seldom discussed incorporation of patient-centered care concept in the design of secondary cardiac prevention. This review aimed to identify, appraise, and examine existing evidence on the effectiveness of nurse-led patient-centered care for secondary cardiac prevention in patients with coronary heart disease. A systematic review of randomized controlled trials focusing on nurse-led patient-centered care for secondary cardiac prevention was conducted. Primary outcomes were behavioral risks (e.g. smoking, physical activity), secondary outcomes were clinically relevant physiological parameters (e.g. body weight, blood pressure, blood glucose, blood lipoproteins), health-related quality of life, mortality, and self efficacy. Twenty-three English and seven Chinese electronic databases were searched to identify the trials. The studies' eligibility and methodological quality were assessed by two reviewers independently according to the Joanna Briggs Institute guidelines. Statistical heterogeneities of the included studies were assessed by Higgins I2 and quantitative pooling was performed when studies showed sufficient comparability. 15 articles on 12 randomized controlled trials were included in this review. Methodological quality of the included studies was fair. Based on the Joanna Briggs Institute critical appraisal tool for experimental studies, the included studies had met a mean of six criteria out the ten in this appraisal tool. The meta-analyses of the included studies revealed that nurse-led patient-centered care had significantly improved patients' smoking habits, adherence toward physical activity advices, and total cholesterol level with medical regime optimization, in short- to medium-term. The intervention was also favorable in improving the patients' health-related quality of life in several domains of SF-36. Furthermore, from single-study results, the intervention was favorable in improving the patients' weight management and alcohol consumption. However, it did not show significant effects on improving the patient's dietary habits, certain cardiac physiological parameters, mortality and self-efficacy. Currently, no addition long-term benefit of the intervention on secondary cardiac prevention was identified. This review has systematically analyzed the effects of nurseledpatient-centered care on patients' behavioral risks, cardiacphysiological parameters, mortality, health-related quality of life and self-efficacy. Given limited quantity of existing evidence regarding certain outcomes and long-term follow-up period; cross-trial heterogeneity of the interventions, measurement methods and statistical results; high or unclear risk of bias in some quality dimensions, the effectiveness of the intervention on secondary cardiac prevention remains inconclusive and subject to additional trials and evidences. Copyright © 2018 Elsevier Ltd. All rights reserved.

True randomness from an incoherent source

NASA Astrophysics Data System (ADS)

Qi, Bing

2017-11-01

Quantum random number generators (QRNGs) harness the intrinsic randomness in measurement processes: the measurement outputs are truly random, given the input state is a superposition of the eigenstates of the measurement operators. In the case of trusted devices, true randomness could be generated from a mixed state ρ so long as the system entangled with ρ is well protected. We propose a random number generation scheme based on measuring the quadrature fluctuations of a single mode thermal state using an optical homodyne detector. By mixing the output of a broadband amplified spontaneous emission (ASE) source with a single mode local oscillator (LO) at a beam splitter and performing differential photo-detection, we can selectively detect the quadrature fluctuation of a single mode output of the ASE source, thanks to the filtering function of the LO. Experimentally, a quadrature variance about three orders of magnitude larger than the vacuum noise has been observed, suggesting this scheme can tolerate much higher detector noise in comparison with QRNGs based on measuring the vacuum noise. The high quality of this entropy source is evidenced by the small correlation coefficients of the acquired data. A Toeplitz-hashing extractor is applied to generate unbiased random bits from the Gaussian distributed raw data, achieving an efficiency of 5.12 bits per sample. The output of the Toeplitz extractor successfully passes all the NIST statistical tests for random numbers.

Single-Molecule Electrical Random Resequencing of DNA and RNA

NASA Astrophysics Data System (ADS)

Ohshiro, Takahito; Matsubara, Kazuki; Tsutsui, Makusu; Furuhashi, Masayuki; Taniguchi, Masateru; Kawai, Tomoji

2012-07-01

Two paradigm shifts in DNA sequencing technologies--from bulk to single molecules and from optical to electrical detection--are expected to realize label-free, low-cost DNA sequencing that does not require PCR amplification. It will lead to development of high-throughput third-generation sequencing technologies for personalized medicine. Although nanopore devices have been proposed as third-generation DNA-sequencing devices, a significant milestone in these technologies has been attained by demonstrating a novel technique for resequencing DNA using electrical signals. Here we report single-molecule electrical resequencing of DNA and RNA using a hybrid method of identifying single-base molecules via tunneling currents and random sequencing. Our method reads sequences of nine types of DNA oligomers. The complete sequence of 5'-UGAGGUA-3' from the let-7 microRNA family was also identified by creating a composite of overlapping fragment sequences, which was randomly determined using tunneling current conducted by single-base molecules as they passed between a pair of nanoelectrodes.

Insulin and oral agents for managing cystic fibrosis-related diabetes.

PubMed

Onady, Gary M; Stolfi, Adrienne

2016-04-18

The Cystic Fibrosis Foundation recommends both short-term and long-acting insulin therapy when cystic fibrosis-related diabetes has been diagnosed. Diagnosis is based on: an elevated fasting blood glucose level greater than 6.94 mmol/liter (125 mg/deciliter); or oral glucose tolerance tests greater than 11.11 mmol/liter (200 mg/deciliter) at two hours; or symptomatic diabetes for random glucose levels greater than 11.11 mmol/liter (200 mg/deciliter); or glycated hemoglobin levels of at least 6.5%. To establish the effectiveness of insulin and oral agents for managing diabetes in people with cystic fibrosis in relation to blood sugar levels, lung function and weight management. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also handsearched abstracts from pulmonary symposia and the North American Cystic Fibrosis Conferences.Date of the most recent search of the Group's Cystic Fibrosis Trials Register: 18 February 2016. Randomized controlled trials comparing all methods of diabetes therapy in people with diagnosed cystic fibrosis-related diabetes. Two authors independently extracted data and assessed the risk of bias in the included studies. The searches identified 22 trials (34 references). Four trials (200 participants) are included: one short-term single-center trial (n = 7) comparing insulin with oral repaglinide and no medication in people with cystic fibrosis-related diabetes and normal fasting glucose; one long-term multicenter trial (n = 100, 74 of whom had cystic fibrosis-related diabetes) comparing insulin with oral repaglinide and placebo; one long-term multicenter trial (n = 73) comparing insulin with oral repaglinide; and one 12-week single-center trial (n = 20) comparing the long-acting insulin glargine to short-term neutral protamine Hagedorn insulin.Two trials with data for the comparison of insulin to placebo did not report any significant differences between groups for the primary outcomes of blood glucose levels, lung function and nutritional status. This was also true for the single trial with data for the comparison of repaglinide to placebo. Two trials (one lasting one year and one lasting two years) contributed data for the comparison of insulin versus repaglinide. There were no significant differences for the primary outcomes at any time point, except at one year (in the two-year trial) when the insulin group had significant improvement in z score for body mass index compared to the repaglinide group. The single trial comparing glargine to neutral protamine Hagedorn insulin also did not report any significant differences in the review's primary outcomes. A few cases of hypoglycemia were seen in three out of the four trials (none in the longest trial), but these events resolved without further treatment.There was an unclear risk of bias from randomization and allocation concealment in two of the four included trials as the authors did not report any details; in the remaining two studies details for randomization led to a low risk of bias, but only one had sufficient details on allocation concealment to allow a low risk judgement, the second was unclear. There was a high risk from blinding for all trials (except for the comparison of oral repaglinide versus placebo) due to the nature of the interventions. Complete data for all outcomes were not available from any trial leading to a high risk of reporting bias. The amounts of insulin and repaglinide administered were not comparable and this may lead to bias in the results. None of the included trials were powered to show a significant improvement in lung function. This review has not found any significant conclusive evidence that long-acting insulins, short-acting insulins or oral hypoglycemic agents have a distinct advantage over one another in controlling hyperglycemia or clinical outcomes associated with cystic fibrosis-related diabetes. While some cystic fibrosis centers use oral medications to help control diabetes, the Cystic Fibrosis Foundation (USA) clinical practice guidelines support the use of insulin therapy and this remains the most widely-used treatment method. Randomized controlled trials specifically related to controlling diabetes with this impact on the course of pulmonary disease process in cystic fibrosis continue to be a high priority.There is no demonstrated advantage yet established for using oral hypoglycemic agents over insulin, and further trials need to be evaluated to establish whether there is clear benefit for using hypoglycemic agents. Agents that potentiate insulin action, especially agents with additional anti-inflammatory potential should be further investigated to see if there may be a clinical advantage to adding these medications to insulin as adjuvant therapy.

Protocol of randomized control trial for effectiveness of angiotensin receptor blockers on blood pressure control among euvolemic hypertensive hemodialysis patients

PubMed Central

Aftab, Raja Ahsan; Khan, Amer Hayat; Syed Sulaiman, Syed Azhar; Khan, Tahir Mehmood; Adnan, Azreen Syazril

2017-01-01

Abstract Introduction: Volume overload and the renin–aldosterone–angiotensin system (RAAS) are 2 major factors contributing to hypertension (HTN) among hemodialysis (HD) patients. Although volume-dependent components of HTN can be corrected by appropriate volume removal, a proportion of HD patients experience elevated blood pressure (BP) despite achieving euvolemic and ideal dry weight. Method and analysis: A single center, prospective, randomized, parallel design, single-blind trial will be conducted in the Malaysian state of Kelantan among postdialysis euvolemic hypertensive patients that are on regular dialysis at least 3 times a week. The primary outcome of the trial will be to note the effectiveness of losartan (RAAS inhibitor) in reducing systolic BP < 140 mm Hg compared to standard non-RAAS-inhibitor antihypertensive therapy. The secondary outcome will be to look at all causes of mortality. A body composition monitor (BCM) will be used to assess postdialysis volume and dry weight. Postdialysis euvolemic patients that have systolic BP > 140 mm Hg will be randomized using Covariate Adaptive Randomization to standard or treatment arm. Participants in the treatment arm will be given 50 mg of losartan once daily except on dialysis days, whereas the standard arm patients will be prescribed non-RAAS antihypertensive agents. The study participants will be followed for a period of 12 months. A Wilcoxon statistical test will be performed to note the difference in BP from baseline up to 12 months using Statistical Package for the Social Sciences (SPSS) 20. Ethical and trial registration: The study protocols are approved from the Ethical and Research Committee of the Universiti Sains Malaysia (USM/JEPeM/15050173). The trial is registered under the Australia New Zealand Clinical Trial Registry (ACTRN12615001322527). The trial was registered on 2/12/2015 and the 1st patient was enrolled on 10/12/2015. The trial was formally initiated on 16/02/2016. Conclusion: Management of HTN among HD patients requires understanding the primary cause of HTN and treating accordingly. The current trial is an attempt to reduce BP among postdialysis euvolemic but hypertensive patients. PMID:28383400

Maintaining Apical Patency Does Not Increase Postoperative Pain in Molars with Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

PubMed

Yaylali, Ibrahim Ethem; Kurnaz, Safa; Tunca, Yasar Meric

2018-03-01

This prospective, single-center, single-blind, randomized controlled trial aimed to evaluate whether maintaining apical patency (AP) during endodontic treatment increases postoperative pain in molar teeth with necrotic pulp and apical periodontitis. Three hundred twenty qualified patients between 21 and 45 years of age were randomized into 1 of 2 groups (the AP group and the nonapical patency [NAP] group) using a series of random numbers in a 1:1 ratio. Qualified patients were selected from patients who had necrotic pulp and apical periodontitis in the maxillary or mandibular molar teeth. The primary outcome was to assess postoperative pain severity, and the secondary outcome was to evaluate analgesic consumption during the 7-day follow-up period using the visual analog scale (VAS). The VAS consisted of a 100-mm line. Pain severity was evaluated as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The Student t test was used to identify statistically significant differences between the study groups (P < .05). The mean VAS scores were significantly lower in the AP group in the first 5 postoperative days (P < .05); after which, it was nonsignificant. In the NAP group, the postoperative pain increased between 12 and 24 hours, whereas the postoperative pain decreased in the AP group during that period. At 12 and 24 hours, the mean VAS scores for the AP group were 42.90 and 37.78 mm, respectively. The mean VAS scores for the NAP group were 64.46 and 65.74 mm, respectively. None of the patients had severe postoperative pain during the follow-up period. No significant difference was found in analgesic consumption (P > .05) between the groups. The maintenance of AP in molar teeth with necrotic pulp and apical periodontitis was associated with less postoperative pain when compared with NAP. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Tapered fiber coupling of single photons emitted by a deterministically positioned single nitrogen vacancy center

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

Liebermeister, Lars, E-mail: lars.liebermeister@physik.uni-muenchen.de; Petersen, Fabian; Münchow, Asmus v.

2014-01-20

A diamond nano-crystal hosting a single nitrogen vacancy (NV) center is optically selected with a confocal scanning microscope and positioned deterministically onto the subwavelength-diameter waist of a tapered optical fiber (TOF) with the help of an atomic force microscope. Based on this nano-manipulation technique, we experimentally demonstrate the evanescent coupling of single fluorescence photons emitted by a single NV-center to the guided mode of the TOF. By comparing photon count rates of the fiber-guided and the free-space modes and with the help of numerical finite-difference time domain simulations, we determine a lower and upper bound for the coupling efficiency ofmore » (9.5 ± 0.6)% and (10.4 ± 0.7)%, respectively. Our results are a promising starting point for future integration of single photon sources into photonic quantum networks and applications in quantum information science.« less

Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson’s disease: the DUALITY trial

PubMed Central

2014-01-01

Background Multiple tasking is an integral part of daily mobility. Patients with Parkinson’s disease have dual tasking difficulties due to their combined motor and cognitive deficits. Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties: either to discourage simultaneous execution of dual tasks (consecutive training); or to practice their concurrent use (integrated training). It is currently unclear which of these training methods should be adopted to achieve safe and consolidated dual task performance in daily life. Therefore, the proposed randomized controlled trial will compare the effects of integrated versus consecutive training of dual tasking (tested by combining walking with cognitive exercises). Methods and design Hundred and twenty patients with Parkinson’s disease will be recruited to participate in this multi-centered, single blind, randomized controlled trial. Patients in Hoehn & Yahr stage II-III, with or without freezing of gait, and who report dual task difficulties will be included. All patients will undergo a six-week control period without intervention after which they will be randomized to integrated or consecutive task practice. Training will consist of standardized walking and cognitive exercises delivered at home four times a week during six weeks. Treatment is guided by a physiotherapist twice a week and consists of two sessions of self-practice using an MP3 player. Blinded testers will assess patients before and after the control period, after the intervention period and after a 12-week follow-up period. The primary outcome measure is dual task gait velocity, i.e. walking combined with a novel untrained cognitive task to evaluate the consolidation of learning. Secondary outcomes include several single and dual task gait and cognitive measures, functional outcomes and a quality of life scale. Falling will be recorded as a possible adverse event using a weekly phone call for the entire study period. Discussion This randomized study will evaluate the effectiveness and safety of integrated versus consecutive task training in patients with Parkinson’s disease. The study will also highlight whether dual task gait training leads to robust motor learning effects, and whether these can be retained and carried-over to untrained dual tasks and functional mobility. Trial registration Clinicaltrials.gov NCT01375413. PMID:24674594

Singles correlation energy contributions in solids

NASA Astrophysics Data System (ADS)

Klimeš, Jiří; Kaltak, Merzuk; Maggio, Emanuele; Kresse, Georg

2015-09-01

The random phase approximation to the correlation energy often yields highly accurate results for condensed matter systems. However, ways how to improve its accuracy are being sought and here we explore the relevance of singles contributions for prototypical solid state systems. We set out with a derivation of the random phase approximation using the adiabatic connection and fluctuation dissipation theorem, but contrary to the most commonly used derivation, the density is allowed to vary along the coupling constant integral. This yields results closely paralleling standard perturbation theory. We re-derive the standard singles of Görling-Levy perturbation theory [A. Görling and M. Levy, Phys. Rev. A 50, 196 (1994)], highlight the analogy of our expression to the renormalized singles introduced by Ren and coworkers [Phys. Rev. Lett. 106, 153003 (2011)], and introduce a new approximation for the singles using the density matrix in the random phase approximation. We discuss the physical relevance and importance of singles alongside illustrative examples of simple weakly bonded systems, including rare gas solids (Ne, Ar, Xe), ice, adsorption of water on NaCl, and solid benzene. The effect of singles on covalently and metallically bonded systems is also discussed.

A framework for understanding cancer comparative effectiveness research data needs.

PubMed

Carpenter, William R; Meyer, Anne-Marie; Abernethy, Amy P; Stürmer, Til; Kosorok, Michael R

2012-11-01

Randomized controlled trials remain the gold standard for evaluating cancer intervention efficacy. Randomized trials are not always feasible, practical, or timely and often don't adequately reflect patient heterogeneity and real-world clinical practice. Comparative effectiveness research can leverage secondary data to help fill knowledge gaps randomized trials leave unaddressed; however, comparative effectiveness research also faces shortcomings. The goal of this project was to develop a new model and inform an evolving framework articulating cancer comparative effectiveness research data needs. We examined prevalent models and conducted semi-structured discussions with 76 clinicians and comparative effectiveness research researchers affiliated with the Agency for Healthcare Research and Quality's cancer comparative effectiveness research programs. A new model was iteratively developed and presents cancer comparative effectiveness research and important measures in a patient-centered, longitudinal chronic care model better reflecting contemporary cancer care in the context of the cancer care continuum, rather than a single-episode, acute-care perspective. Immediately relevant for federally funded comparative effectiveness research programs, the model informs an evolving framework articulating cancer comparative effectiveness research data needs, including evolutionary enhancements to registries and epidemiologic research data systems. We discuss elements of contemporary clinical practice, methodology improvements, and related needs affecting comparative effectiveness research's ability to yield findings clinicians, policy makers, and stakeholders can confidently act on. Copyright © 2012 Elsevier Inc. All rights reserved.

A framework for understanding cancer comparative effectiveness research data needs

PubMed Central

Carpenter, William R; Meyer, Anne-Marie; Abernethy, Amy P.; Stürmer, Til; Kosorok, Michael R.

2012-01-01

Objective Randomized controlled trials remain the gold standard for evaluating cancer intervention efficacy. Randomized trials are not always feasible, practical, or timely, and often don’t adequately reflect patient heterogeneity and real-world clinical practice. Comparative effectiveness research can leverage secondary data to help fill knowledge gaps randomized trials leave unaddressed; however, comparative effectiveness research also faces shortcomings. The goal of this project was to develop a new model and inform an evolving framework articulating cancer comparative effectiveness research data needs. Study Design and Setting We examined prevalent models and conducted semi-structured discussions with 76 clinicians and comparative effectiveness research researchers affiliated with the Agency for Healthcare Research and Quality’s cancer comparative effectiveness research programs. Results A new model was iteratively developed, and presents cancer comparative effectiveness research and important measures in a patient-centered, longitudinal chronic care model better-reflecting contemporary cancer care in the context of the cancer care continuum, rather than a single-episode, acute-care perspective. Conclusion Immediately relevant for federally-funded comparative effectiveness research programs, the model informs an evolving framework articulating cancer comparative effectiveness research data needs, including evolutionary enhancements to registries and epidemiologic research data systems. We discuss elements of contemporary clinical practice, methodology improvements, and related needs affecting comparative effectiveness research’s ability to yield findings clinicians, policymakers, and stakeholders can confidently act on. PMID:23017633

Sonographic evaluation of the fetal spine position and success rate of manual rotation of the fetus in occiput posterior position: A randomized controlled trial.

PubMed

Masturzo, Bianca; Farina, Antonio; Attamante, Lorenza; Piazzese, Annalisa; Rolfo, Alessandro; Gaglioti, Pietro; Todros, Tullia

2017-10-01

To evaluate whether sonographic (US) diagnosis of the fetal spine position could increase the success rate of manual rotation of the fetal occiput (MRFO) in second-stage arrest in persistent occiput posterior position (OPP). In this randomized controlled parallel single-center trial, 58 nulliparous in second-stage arrest of labor with fetus in cephalic presentation and OPP diagnosed by US were randomly assigned to group A where the fetal spine position was not known by the operator or to group B where the operator knew it. The main outcome was the success of MRFO in the two groups. Secondary outcomes were perineal injuries, blood loss, duration of expulsive period, and neonatal APGAR at 5 minutes. A priori knowledge of the spine position improves the success of the MRFO (41.4% group A versus 82.8% group B, p value < 0.001), the percentage of spontaneous deliveries (27.6% group A versus 69% group B, p value = 0.01), and maternal outcome (intact perineum and blood loss). No differences were detected on the neonatal side. MRFO is a safe and useful procedure that should be performed in second-stage arrest in OPP. A better performance was observed when supported by the US knowledge of the spine position. © 2017 Wiley Periodicals, Inc. J Clin Ultrasound 45:472-476, 2017. © 2017 Wiley Periodicals, Inc.

Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients.

PubMed

Pacheco, Larissa Sgaria; Garcia, Valter Duro; Prá, Ronivan Luis Dal; Cardoso, Bruna Doleys; Rodrigues, Mariana Ferras; Zanetti, Helen Kris; Meinerz, Gisele; Neumann, Jorge; Gnatta, Diego; Keitel, Elizete

2018-05-14

Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients. This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV-positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors. Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between group (p-value G=0.286). Group 1 showed a higher incidence of dyslipidemia (p=0.03) and proteinuria events (p=0.01), while no difference was observed in the incidence of anemia (p=0.17), new onset of post-transplant diabetes mellitus (p=1.00) or urinary tract infection (p=0.60). The mean eGFR was similar in both groups. Our study did not show viral load decrease after conversion to EVR with maintenance of antiproliferative therapy.

Nonstandard convergence to jamming in random sequential adsorption: The case of patterned one-dimensional substrates

NASA Astrophysics Data System (ADS)

Verma, Arjun; Privman, Vladimir

2018-02-01

We study approach to the large-time jammed state of the deposited particles in the model of random sequential adsorption. The convergence laws are usually derived from the argument of Pomeau which includes the assumption of the dominance, at large enough times, of small landing regions into each of which only a single particle can be deposited without overlapping earlier deposited particles and which, after a certain time are no longer created by depositions in larger gaps. The second assumption has been that the size distribution of gaps open for particle-center landing in this large-time small-gaps regime is finite in the limit of zero gap size. We report numerical Monte Carlo studies of a recently introduced model of random sequential adsorption on patterned one-dimensional substrates that suggest that the second assumption must be generalized. We argue that a region exists in the parameter space of the studied model in which the gap-size distribution in the Pomeau large-time regime actually linearly vanishes at zero gap sizes. In another region, the distribution develops a threshold property, i.e., there are no small gaps below a certain gap size. We discuss the implications of these findings for new asymptotic power-law and exponential-modified-by-a-power-law convergences to jamming in irreversible one-dimensional deposition.

Efficacy of two different dosages of levofloxacin in curing Helicobacter pylori infection: A Prospective, Single-Center, randomized clinical trial.

PubMed

Gan, Huo-Ye; Peng, Tie-Li; Huang, You-Ming; Su, Kai-Hua; Zhao, Lin-Li; Yao, Li-Ya; Yang, Rong-Jiao

2018-06-13

Bismuth + proton pump inhibitor (PPI) + amoxicillin + levofloxacin is one of the bismuth quadruple therapy regimens widely used for the eradication of H. pylori infection. The recommended dosage of levofloxacin is 500 mg once daily or 200 mg twice daily to eradicate H. pylori infection. The aim of the present open-label, randomized control trial was to compare the effectiveness, safety, and compliance of different dosages of levofloxacin used to cure Helicobacter pylori infection. Eligible patients were randomly assigned to receive esomeprazole, amoxicillin, colloidal bismuth pectin and levofloxacin 500 mg once/day (group A) or levofloxacin 200 mg twice/day (group B) for 14 days. The primary outcome was the eradication rates in the intention-to-treat (ITT) and per protocol (PP) analyses. Overall, 400 patients were enrolled. The eradication rates in group A and group B were 77.5% and 79.5% respectively, in the ITT analysis, and 82.9% and 86.4%, respectively, in the PP analysis. No significant differences were found between two groups in terms of eradication rate, adverse effects or compliance. Oral levofloxacin 200 mg twice daily was similar in efficacy for eradicating H. pylori infection to oral levofloxacin 500 mg once daily but with lower mean total costs.

Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial.

PubMed

Spieth, Peter M; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

2014-05-02

General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary function and reduces systemic inflammatory response. However, it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation. The PROtective VARiable ventilation trial ('PROVAR') is a single center, randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3 hours. PROVAR compares conventional (non-variable) lung protective ventilation (CV) with variable lung protective ventilation (VV) regarding pulmonary function and inflammatory response. The primary endpoint of the study is the forced vital capacity on the first postoperative day. Secondary endpoints include further lung function tests, plasma cytokine levels, spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications. We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3 hours. PROVAR is the first randomized controlled trial aiming at intra- and postoperative effects of VV on lung function. This study may help to define the role of VV during general anesthesia requiring mechanical ventilation. Clinicaltrials.gov NCT01683578 (registered on September 3 3012).

Tocolysis in women with advanced preterm labor: a secondary analysis of a randomized clinical trial.

PubMed

Klauser, Chad K; Briery, Christian M; Tucker, Ann R; Martin, Rick W; Magann, Everett F; Chauhan, Suneet P; Morrison, John C

2016-03-01

To compare the efficacy of tocolytic treatment with indomethacin (I), magnesium sulfate (M) and nifedipine (N) for acute tocolysis in women with advanced cervical dilation (4-6 cm). A single center, randomized trial was carried out involving patients in preterm labor (cervix 1-6 cm). Secondary analysis of women with advanced cervical dilation (cervix 4-6 cm) at 24-32 weeks' gestation who received intravenous M, oral N or I suppositories comprised this study population. Over 38 months, 92 women with advanced cervical dilation were randomized to one tocoloytic type. Days gained in utero (11.7) and percent remaining undelivered at 48 h (60.8%), 72 h (53.1%) and >7 days (38.3%) were similar regardless of tocolytic employed (p = 0.923, 0.968, 0.791, 0.802, respectively). Likewise, gestational age at delivery (30.7 ± 3.2) was similar between groups (p = 0.771). Finally, neonatal statistics were not different when stratified by tocolytic treatment. There were no statistical differences between tocolytics in treating women with advanced cervical dilation. All offered significant days gained in utero after therapy, a high percentage remaining undelivered after 48 or 72 h and after 7 days. It would appear from data that there may be advantages to tocolytic treatment even in women with advanced cervical dilation.

Multimodal Therapy Involving High-Intensity Interval Training Improves the Physical Fitness, Motor Skills, Social Behavior, and Quality of Life of Boys With ADHD: A Randomized Controlled Study.

PubMed

Meßler, Carolin Friederike; Holmberg, Hans-Christer; Sperlich, Billy

2018-06-01

To compare the effects of multimodal therapy including supervised high-intensity interval training (HIIT) with those of standard multimodal therapy (TRAD) concerning key variables of physical fitness (peak power and oxygen uptake), motor skills, social behavior, and quality of life in boys with ADHD. A single-center, two-arm randomized, controlled design was used, with 28 boys (8-13 years of age, IQ = 83-136) being randomly assigned to multimodal HIIT (three sessions/week, 4 × 4-min intervals at 95% of peak heart rate) or TRAD. The Movement Assessment Battery for Children II evaluated motor skills and the German version of the hyperkinetic disorder questionnaire for external evaluation by the guardians (FBB-HKS) or German version of the hyperkinetic disorder questionnaire for self-assessment by the children (SBB-HKS) and the KINDL-R questionnaires mental health and health-related quality of life. Both interventions enhanced peak power, and HIIT also reduced submaximal oxygen uptake. HIIT was more effective than TRAD in improving the total score for motor skills (including manual dexterity and ball skills; p < .05), self-esteem, friends, and competence ( p < .05) and, moreover, improved subjective ratings of attention. Three weeks of multimodal therapy including HIIT improved physical fitness, motor skills, certain aspects of quality of life, competence, and attention in boys with ADHD.

Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial.

PubMed

Li, Tian; Wu, Huangan; Soto-Aguliar, Franscisca; Huang, Li; Li, Wentao; Lao, Lixing; Xu, Shifen

2018-01-19

Vascular cognitive impairment with no dementia (VCIND), manifested mainly as mild impairment of concentration and executive function, is the early phase of vascular dementia (VD). Currently, there is no specific treatment for VCIND. We hypothesize that electrical acupuncture can improve the mental and motor functions of patients with VCIND. Thus, we designed this randomized controlled trial to test this hypothesis by comparing the therapeutic effect of electrical acupuncture versus sham acupuncture in patients with VCIND. In this single-center 3-year study, 120 eligible patients will be recruited and randomly assigned to receive electrical acupuncture treatment (n = 60) or sham acupuncture (n = 60) for 8 consecutive weeks (24 sessions in total), with the same acupoint prescription (DU20, EX-HN3, DU24, DU17, DU26, EX-HN1, HT7, PC6, GB20, SP6). The primary assessment is the Montreal Cognitive Assessment. The secondary assessments are the Modified Barthel Index and Event-Related Potential. All outcomes will be assessed at baseline, endpoint, and follow-up at 8 and 24 weeks after the end of treatment. If the outcome confirms the effectiveness and safety of electrical acupuncture in treating VCIND, this treatment is expected to be promoted in clinical practice to treat such patients. Chinese Clinical Trial Registry identifier: ChiCTR-IIR-17011513 ; Registered on 27 May 2017.

Follow-up of colorectal cancer patients after resection with curative intent-the GILDA trial.

PubMed

Grossmann, Erik M; Johnson, Frank E; Virgo, Katherine S; Longo, Walter E; Fossati, Rolando

2004-01-01

Surgery remains the primary treatment of colorectal cancer. Data are lacking to delineate the optimal surveillance strategy following resection. A large-scale multi-center European study is underway to address this issue (Gruppo Italiano di Lavoro per la Diagnosi Anticipata-GILDA). Following primary surgery with curative intent, stratification, and randomization at GILDA headquarters, colon cancer patients are then assigned to a more intensive or less intensive surveillance regimen. Rectal cancer patients undergoing curative resection are similarly randomized, with their follow-up regimens placing more emphasis on detection of local recurrence. Target recruitment for the study will be 1500 patients to achieve a statistical power of 80% (assuming an alpha of 0.05 and a hazard-rate reduction of >24%). Since the trial opened in 1998, 985 patients have been randomized from 41 centers as of February 2004. There were 496 patients randomized to the less intensive regimens, and 489 randomized to the more intensive regimens. The mean duration of follow-up is 14 months. 75 relapses (15%) and 32 deaths (7%) had been observed in the two more intensive follow-up arms, while 64 relapses (13%) and 24 deaths (5%) had been observed in the two less intensive arms as of February 2004. This trial should provide the first evidence based on an adequately powered randomized trial to determine the optimal follow-up strategy for colorectal cancer patients. This trial is open to US centers, and recruitment continues.

Methylphenidate bioavailability in adults when an extended-release multiparticulate formulation is administered sprinkled on food or as an intact capsule.

PubMed

Pentikis, Helen S; Simmons, Roy D; Benedict, Michael F; Hatch, Simon J

2002-04-01

To determine the single-dose bioavailability of 20-mg Metadate CD (methylphenidate HCI, USP) Extended-Release Capsules sprinkled onto 1 level tablespoon (15 mL) of applesauce relative to an intact capsule under fasted conditions in healthy adults. This was a single-center, open-label, single-dose, randomized, two-way crossover study with a 6-day washout period between doses, in healthy male and female subjects (N= 26), aged 21-40 years. Plasma concentration-time data for methylphenidate were used to calculate the pharmacokinetic parameters for each treatment. The pharmacokinetic profile for Metadate CD exhibited biphasic release characteristics with a sharp initial slope and a second rising portion. For Cmax (maximum observed concentration), AUC(0-infinity) (area under the plasma concentration curve from time 0 to infinity) and AUC(0-infinity) (area under the plasma concentration curve from time 0 to the last measurable time point), the geometric least squares mean ratios and 90% confidence intervals were within the 80% to 125% confidence interval for bioequivalence. Adverse events were similar to those reported for methylphenidate. The bioavailability of methylphenidate was not altered when Metadate CD capsules were administered by sprinkling their contents onto a small amount of applesauce.

Splitting livers: Trans-hilar or trans-umbilical division? Technical aspects and comparative outcomes.

PubMed

de Ville de Goyet, J; di Francesco, F; Sottani, V; Grimaldi, C; Tozzi, A E; Monti, L; Muiesan, P

2015-08-01

Controversy remains about the best line of division for liver splitting, through Segment IV or through the umbilical fissure. Both techniques are currently used, with the choice varying between surgical teams in the absence of an evidence-based choice. We conducted a single-center retrospective analysis of 47 left split liver grafts that were procured with two different division techniques: "classical" (N = 28, Group A) or through the umbilical fissure and plate (N = 19, Group B). The allocation of recipients to each group was at random; a single transplant team performed all transplantations. Demographics, characteristics, technical aspects, and outcomes were similar in both groups. The grafts in Group A, prepared with the classical technique, were procured more often with a single BD orifice compared with the grafts in Group B; however, this was not associated with a higher incidence of biliary problems in this series of transplants (96% actual graft survival rate [median ± s.d. 26 ± 20 months]). Both techniques provide good quality split grafts and an excellent outcome; surgical expertise with a given technique is more relevant than the technique itself. The classical technique, however, seems to be more flexible in various ways, and surgeons may find it to be preferable. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Phase I Trial of a CD8+ T-Cell Peptide Epitope-Based Vaccine for Infectious Mononucleosis▿

PubMed Central

Elliott, Suzanne L.; Suhrbier, Andreas; Miles, John J.; Lawrence, Greg; Pye, Stephanie J.; Le, Thuy T.; Rosenstengel, Andrew; Nguyen, Tam; Allworth, Anthony; Burrows, Scott R.; Cox, John; Pye, David; Moss, Denis J.; Bharadwaj, Mandvi

2008-01-01

A single blind, randomized, placebo-controlled, single-center phase I clinical trial of a CD8+ T-cell peptide epitope vaccine against infectious mononucleosis was conducted with 14 HLA B*0801-positive, Epstein-Barr virus (EBV)-seronegative adults. The vaccine comprised the HLA B*0801-restricted peptide epitope FLRGRAYGL and tetanus toxoid formulated in a water-in-oil adjuvant, Montanide ISA 720. FLRGRAYGL-specific responses were detected in 8/9 peptide-vaccine recipients and 0/4 placebo vaccine recipients by gamma interferon enzyme-linked immunospot assay and/or limiting-dilution analysis. The same T-cell receptor Vβ CDR3 sequence that is found in FLRGRAYGL-specific T cells from most EBV-seropositive individuals could also be detected in the peripheral blood of vaccine recipients. The vaccine was well tolerated, with the main side effect being mild to moderate injection site reactions. After a 2- to 12-year follow-up, 1/2 placebo vaccinees who acquired EBV developed infectious mononucleosis, whereas 4/4 vaccinees who acquired EBV after completing peptide vaccination seroconverted asymptomatically. Single-epitope vaccination did not predispose individuals to disease, nor did it significantly influence development of a normal repertoire of EBV-specific CD8+ T-cell responses following seroconversion. PMID:18032491

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

PubMed

Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

2016-03-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

Rationale and Design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

PubMed Central

Hedayati, S. Susan; Daniel, Divya M.; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M.; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L.; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H.; Unruh, Mark; Weisbord, Steven; Young, Bessie A.; Mehrotra, Rajnish

2015-01-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. PMID:26621218

Identifying inaccuracies on emergency medicine residency applications

PubMed Central

Katz, Eric D; Shockley, Lee; Kass, Lawrence; Howes, David; Tupesis, Janis P; Weaver, Christopher; Sayan, Osman R; Hogan, Victoria; Begue, Jason; Vrocher, Diamond; Frazer, Jackie; Evans, Timothy; Hern, Gene; Riviello, Ralph; Rivera, Antonio; Kinoshita, Keith; Ferguson, Edward

2005-01-01

Background Previous trials have showed a 10–30% rate of inaccuracies on applications to individual residency programs. No studies have attempted to corroborate this on a national level. Attempts by residency programs to diminish the frequency of inaccuracies on applications have not been reported. We seek to clarify the national incidence of inaccuracies on applications to emergency medicine residency programs. Methods This is a multi-center, single-blinded, randomized, cohort study of all applicants from LCME accredited schools to involved EM residency programs. Applications were randomly selected to investigate claims of AOA election, advanced degrees and publications. Errors were reported to applicants' deans and the NRMP. Results Nine residencies reviewed 493 applications (28.6% of all applicants who applied to any EM program). 56 applications (11.4%, 95%CI 8.6–14.2%) contained at least one error. Excluding "benign" errors, 9.8% (95% CI 7.2–12.4%), contained at least one error. 41% (95% CI 35.0–47.0%) of all publications contained an error. All AOA membership claims were verified, but 13.7% (95%CI 4.4–23.1%) of claimed advanced degrees were inaccurate. Inter-rater reliability of evaluations was good. Investigators were reluctant to notify applicants' dean's offices and the NRMP. Conclusion This is the largest study to date of accuracy on application for residency and the first such multi-centered trial. High rates of incorrect data were found on applications. This data will serve as a baseline for future years of the project, with emphasis on reporting inaccuracies and warning applicants of the project's goals. PMID:16105178

Enhancing the brightness of electrically driven single-photon sources using color centers in silicon carbide

NASA Astrophysics Data System (ADS)

Khramtsov, Igor A.; Vyshnevyy, Andrey A.; Fedyanin, Dmitry Yu.

2018-03-01

Practical applications of quantum information technologies exploiting the quantum nature of light require efficient and bright true single-photon sources which operate under ambient conditions. Currently, point defects in the crystal lattice of diamond known as color centers have taken the lead in the race for the most promising quantum system for practical non-classical light sources. This work is focused on a different quantum optoelectronic material, namely a color center in silicon carbide, and reveals the physics behind the process of single-photon emission from color centers in SiC under electrical pumping. We show that color centers in silicon carbide can be far superior to any other quantum light emitter under electrical control at room temperature. Using a comprehensive theoretical approach and rigorous numerical simulations, we demonstrate that at room temperature, the photon emission rate from a p-i-n silicon carbide single-photon emitting diode can exceed 5 Gcounts/s, which is higher than what can be achieved with electrically driven color centers in diamond or epitaxial quantum dots. These findings lay the foundation for the development of practical photonic quantum devices which can be produced in a well-developed CMOS compatible process flow.

Comparing point-of-care A1C and random plasma glucose for screening diabetes in migrant farm workers.

PubMed

Wensil, Ashley M; Smith, Jennifer D; Pound, Melanie W; Herring, Charles

2013-01-01

To compare point-of-care (POC) glycosylated hemoglobin (A1C) and random plasma glucose (RPG) as a POC screening tool for prediabetes and diabetes in migrant farm workers of eastern North Carolina. Prospective, observational, single-center study. Federally qualified community health center in eastern North Carolina, from August to October 2011. Migrant farm workers 18 years or older who resided in a migrant camp in eastern North Carolina. Diabetes screening using POC A1C and RPG via fingerstick followed by venipuncture A1C and basic metabolic panel in individuals with a positive screening. Positive predictive value (PPV) of POC A1C and RPG, incidence of positive screening, incidence of confirmed diagnosis, concordance rate of the screening tools, and correlation between POC A1C and laboratory A1C. 206 workers participated in the screenings; screening identified 39 individuals with a POC A1C greater than 5.7% and 1 individual with both an RPG of 200 mg/dL or more and a POC A1C greater than 5.7%. Of the 39 individuals found to have a positive screening, 24 presented to Carolina Family Health Centers, Inc., for follow-up venipuncture; however, 1 participant did not have a venipuncture A1C, leaving 23 individuals with complete data. Two participants were diagnosed with diabetes and 17 with prediabetes. POC A1C had a PPV of 82.6%; however, the PPV of RPG could not be calculated due to the number of participants lost to follow-up. POC A1C correlated well with laboratory A1C regardless of time to follow-up. POC A1C should be considered for diabetes screening in high-risk populations. If the screening had been performed with RPG alone, 38 individuals would have gone undetected. Early identification of individuals with elevated blood glucose will likely decrease the risk of long-term complications.

Multiplexing T- and B-Cell FLUOROSPOT Assays: Experimental Validation of the Multi-Color ImmunoSpot® Software Based on Center of Mass Distance Algorithm.

PubMed

Karulin, Alexey Y; Megyesi, Zoltán; Caspell, Richard; Hanson, Jodi; Lehmann, Paul V

2018-01-01

Over the past decade, ELISPOT has become a highly implemented mainstream assay in immunological research, immune monitoring, and vaccine development. Unique single cell resolution along with high throughput potential sets ELISPOT apart from flow cytometry, ELISA, microarray- and bead-based multiplex assays. The necessity to unambiguously identify individual T and B cells that do, or do not co-express certain analytes, including polyfunctional cytokine producing T cells has stimulated the development of multi-color ELISPOT assays. The success of these assays has also been driven by limited sample/cell availability and resource constraints with reagents and labor. There are few commercially available test kits and instruments available at present for multi-color FLUOROSPOT. Beyond commercial descriptions of competing systems, little is known about their accuracy in experimental settings detecting individual cells that secrete multiple analytes vs. random overlays of spots. Here, we present a theoretical and experimental validation study for three and four color T- and B-cell FLUOROSPOT data analysis. The ImmunoSpot ® Fluoro-X™ analysis system we used includes an automatic image acquisition unit that generates individual color images free of spectral overlaps and multi-color spot counting software based on the maximal allowed distance between centers of spots of different colors or Center of Mass Distance (COMD). Using four color B-cell FLUOROSPOT for IgM, IgA, IgG1, IgG3; and three/four color T-cell FLUOROSPOT for IL-2, IFN-γ, TNF-α, and GzB, in serial dilution experiments, we demonstrate the validity and accuracy of Fluoro-X™ multi-color spot counting algorithms. Statistical predictions based on the Poisson spatial distribution, coupled with scrambled image counting, permit objective correction of true multi-color spot counts to exclude randomly overlaid spots.

Confidence intervals for single-case effect size measures based on randomization test inversion.

PubMed

Michiels, Bart; Heyvaert, Mieke; Meulders, Ann; Onghena, Patrick

2017-02-01

In the current paper, we present a method to construct nonparametric confidence intervals (CIs) for single-case effect size measures in the context of various single-case designs. We use the relationship between a two-sided statistical hypothesis test at significance level α and a 100 (1 - α) % two-sided CI to construct CIs for any effect size measure θ that contain all point null hypothesis θ values that cannot be rejected by the hypothesis test at significance level α. This method of hypothesis test inversion (HTI) can be employed using a randomization test as the statistical hypothesis test in order to construct a nonparametric CI for θ. We will refer to this procedure as randomization test inversion (RTI). We illustrate RTI in a situation in which θ is the unstandardized and the standardized difference in means between two treatments in a completely randomized single-case design. Additionally, we demonstrate how RTI can be extended to other types of single-case designs. Finally, we discuss a few challenges for RTI as well as possibilities when using the method with other effect size measures, such as rank-based nonoverlap indices. Supplementary to this paper, we provide easy-to-use R code, which allows the user to construct nonparametric CIs according to the proposed method.

College Counselors' Perceptions and Practices regarding Anticipatory Guidance on Firearms

ERIC Educational Resources Information Center

Price, James; Mrdjenovich, Adam J.; Thompson, Amy; Dake, Joseph A.

2009-01-01

Objectives: This study assessed college counselors' anticipatory guidance on firearms for student clients. Participants: The membership of the Association for University and College Counseling Center Directors was used to identify a national random sample of counseling centers (n = 361). One counselor from each center was selected to survey.…

Trial of early noninvasive ventilation for ALS: A pilot placebo-controlled study.

PubMed

Jacobs, Teresa L; Brown, Devin L; Baek, Jonggyu; Migda, Erin M; Funckes, Timothy; Gruis, Kirsten L

2016-11-01

To evaluate the use and tolerability of noninvasive positive pressure ventilation (NIV) in patients with amyotrophic lateral sclerosis (ALS) early in their disease by comparing active NIV and sham NIV in patients not yet eligible for NIV use as recommended by practice guidelines. This was a single-center, prospective, double-blind, randomized, placebo (sham)-controlled pilot trial. Patients with ALS were randomized to receive either sham NIV or active NIV and underwent active surveillance approximately every 3 months until they reached a forced vital capacity (FVC) <50% or required NIV for clinical symptom management. In total, 54 participants were randomized. The mean NIV use was 2.0 hours (95% confidence interval [CI] 1.1-3.0) per day in the sham NIV treatment group and 3.3 hours (CI 2.0-4.6) per day in the active NIV group, which did not differ by treatment group (p = 0.347). The majority of sham NIV participants (88%) and active NIV participants (73%) reported only mild or no problem with NIV use. Difference of change in FVC through the treatment period by group (0.44 per month) favored active NIV (p = 0.049). Survival and changes in maximal inspiratory or expiratory pressure did not differ between treatment groups. The efficacy of early NIV in ALS should be tested in randomized, placebo-controlled trials. The trial is registered on clinicaltrials.gov (NCT00580593). This study provides Class II evidence that for patients with ALS, adherence with NIV and sham NIV are similar. © 2016 American Academy of Neurology.

Analysis of photogenerated random telegraph signal in single electron detector (photo-SET).

PubMed

Troudi, M; Sghaier, Na; Kalboussi, A; Souifi, A

2010-01-04

In this paper, we analyzed slow single traps, situated inside the tunnel oxide of small area single electron photo-detector (photo-SET or nanopixel). The relationship between excitation signal (photons) and random-telegraph-signal (RTS) was evidenced. We demonstrated that photoinduced RTS observed on a photo-detector is due to the interaction between single photogenerated charges that tunnel from dot to dot and current path. Based on RTS analysis for various temperatures, gate bias and optical power we determined the characteristics of these single photogenerated traps: the energy position within the silicon bandgap, capture cross section and the position within the Si/SiO(x = 1.5) interfaces.

Packet Randomized Experiments for Eliminating Classes of Confounders

PubMed Central

Pavela, Greg; Wiener, Howard; Fontaine, Kevin R.; Fields, David A.; Voss, Jameson D.; Allison, David B.

2014-01-01

Background Although randomization is considered essential for causal inference, it is often not possible to randomize in nutrition and obesity research. To address this, we develop a framework for an experimental design—packet randomized experiments (PREs), which improves causal inferences when randomization on a single treatment variable is not possible. This situation arises when subjects are randomly assigned to a condition (such as a new roommate) which varies in one characteristic of interest (such as weight), but also varies across many others. There has been no general discussion of this experimental design, including its strengths, limitations, and statistical properties. As such, researchers are left to develop and apply PREs on an ad hoc basis, limiting its potential to improve causal inferences among nutrition and obesity researchers. Methods We introduce PREs as an intermediary design between randomized controlled trials and observational studies. We review previous research that used the PRE design and describe its application in obesity-related research, including random roommate assignments, heterochronic parabiosis, and the quasi-random assignment of subjects to geographic areas. We then provide a statistical framework to control for potential packet-level confounders not accounted for by randomization. Results PREs have successfully been used to improve causal estimates of the effect of roommates, altitude, and breastfeeding on weight outcomes. When certain assumptions are met, PREs can asymptotically control for packet-level characteristics. This has the potential to statistically estimate the effect of a single treatment even when randomization to a single treatment did not occur. Conclusions Applying PREs to obesity-related research will improve decisions about clinical, public health, and policy actions insofar as it offers researchers new insight into cause and effect relationships among variables. PMID:25444088

Changes in Postural Control After a Ball-Kicking Balance Exercise in Individuals With Chronic Ankle Instability

PubMed Central

Conceição, Josilene Souza; Schaefer de Araújo, Felipe Gustavo; Santos, Gilmar Moraes; Keighley, John

2016-01-01

Context:  Rehabilitation programs for patients with chronic ankle instability (CAI) generally involve balance-perturbation training (BPT). Anticipatory postural adjustments (APAs) and compensatory postural adjustments (CPAs) are the primary strategies used to maintain equilibrium during body perturbations. Little is known, however, about how APAs and CPAs are modified to promote better postural control for individuals with CAI after BPT. Objective:  To investigate the effect of BPT that involves kicking a ball on postural-control strategies in individuals with CAI. Design:  Randomized controlled clinical trial. Setting:  Laboratory. Patients or Other Participants:  We randomly assigned 44 volunteers with CAI to either a training group (TG; 11 women, 11 men; age = 24 ± 4 years, height = 173.0 ± 9.8 cm, mass = 72.64 ± 11.98 kg) or control group (CG; 11 women, 11 men; age = 22 ± 3 years, height = 171.0 ± 9.7 cm, mass = 70.00 ± 11.03 kg). Intervention(s):  The TG performed a single 30-minute training session that involved kicking a ball while standing on 1 foot. The CG received no intervention. Main Outcome Measure(s):  The primary outcome was the sum of the integrated electromyographic activity (∑∫EMG) of the lower extremity muscles in the supporting limb that were calculated during typical intervals for APAs and CPAs. A secondary outcome was center-of-pressure displacement during similar intervals. Results:  In the TG after training, the ∑∫EMG decreased in both dorsal and ventral muscles during compensatory adjustment (ie, the time interval that followed lower limb movement). During this interval, muscle activity (∑∫EMG) was less in the TG than in the CG. Consequently, center-of-pressure displacement increased during the task after training. Conclusions:  A single session of ball-kicking BPT promoted changes in postural-control strategies in individuals with CAI. These results should stimulate new and more comprehensive studies to investigate the effect of this and other BPT techniques on postural control in patients with CAI. PMID:27295488

The phototoxic and photoallergy potential of clindamycin phosphate 1.2%/ tretinoin 0.025% gel for facial acne: results of two single-center, evaluator-blinded, randomized, vehicle-controlled phase 1 studies in healthy volunteers.

PubMed

Murray, John; Potts, Aaron

2014-01-01

A fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne. Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel. Study 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal. No subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation. Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

Implementing a low-cost web-based clinical trial management system for community studies: a case study.

PubMed

Geyer, John; Myers, Kathleen; Vander Stoep, Ann; McCarty, Carolyn; Palmer, Nancy; DeSalvo, Amy

2011-10-01

Clinical trials with multiple intervention locations and a single research coordinating center can be logistically difficult to implement. Increasingly, web-based systems are used to provide clinical trial support with many commercial, open source, and proprietary systems in use. New web-based tools are available which can be customized without programming expertise to deliver web-based clinical trial management and data collection functions. To demonstrate the feasibility of utilizing low-cost configurable applications to create a customized web-based data collection and study management system for a five intervention site randomized clinical trial establishing the efficacy of providing evidence-based treatment via teleconferencing to children with attention-deficit hyperactivity disorder. The sites are small communities that would not usually be included in traditional randomized trials. A major goal was to develop database that participants could access from computers in their home communities for direct data entry. Discussed is the selection process leading to the identification and utilization of a cost-effective and user-friendly set of tools capable of customization for data collection and study management tasks. An online assessment collection application, template-based web portal creation application, and web-accessible Access 2007 database were selected and customized to provide the following features: schedule appointments, administer and monitor online secure assessments, issue subject incentives, and securely transmit electronic documents between sites. Each tool was configured by users with limited programming expertise. As of June 2011, the system has successfully been used with 125 participants in 5 communities, who have completed 536 sets of assessment questionnaires, 8 community therapists, and 11 research staff at the research coordinating center. Total automation of processes is not possible with the current set of tools as each is loosely affiliated, creating some inefficiency. This system is best suited to investigations with a single data source e.g., psychosocial questionnaires. New web-based applications can be used by investigators with limited programming experience to implement user-friendly, efficient, and cost-effective tools for multi-site clinical trials with small distant communities. Such systems allow the inclusion in research of populations that are not usually involved in clinical trials.

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus.

PubMed

Petrak, Frank; Herpertz, Stephan; Albus, Christian; Hermanns, Norbert; Hiemke, Christoph; Hiller, Wolfgang; Kronfeld, Kai; Kruse, Johannes; Kulzer, Bernd; Ruckes, Christian; Müller, Matthias J

2013-08-06

Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50-200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. Current controlled trials ISRCTN89333241.

Use of the Randomization Test in Single-Case Research

ERIC Educational Resources Information Center

Grünke, Matthias; Boon, Richard T.; Burke, Mack D.

2015-01-01

The purpose of this study was to illustrate the use of the randomization test for single-case research designs (SCR; Kratochwill & Levin, 2010). To demonstrate the application of this approach, a systematic replication of Grünke, Wilbert, and Calder Stegemann (2013) was conducted to evaluate the effects of a story map to improve the reading…

Coupling a single nitrogen-vacancy center with a superconducting qubit via the electro-optic effect

NASA Astrophysics Data System (ADS)

Li, Chang-Hao; Li, Peng-Bo

2018-05-01

We propose an efficient scheme for transferring quantum states and generating entangled states between two qubits of different nature. The hybrid system consists of a single nitrogen-vacancy (NV) center and a superconducting (SC) qubit, which couple to an optical cavity and a microwave resonator, respectively. Meanwhile, the optical cavity and the microwave resonator are coupled via the electro-optic effect. By adjusting the relative parameters, we can achieve high-fidelity quantum state transfer as well as highly entangled states between the NV center and the SC qubit. This protocol is within the reach of currently available techniques, and may provide interesting applications in quantum communication and computation with single NV centers and SC qubits.

Causal Effects of Single-Sex Schools on College Entrance Exams and College Attendance: Random Assignment in Seoul High Schools

PubMed Central

Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung

2012-01-01

Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private. PMID:23073751

Causal effects of single-sex schools on college entrance exams and college attendance: random assignment in Seoul high schools.

PubMed

Park, Hyunjoon; Behrman, Jere R; Choi, Jaesung

2013-04-01

Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul-the random assignment of students into single-sex versus coeducational high schools-to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private.

Using Minitel Network and New Software Engineering Techniques for Randomized Clinical Trials Management

PubMed Central

Lepage, E.; Tavernier, H.; Bouhaddou, O.; Jais, JP.; Gisselbrecht, C.; Aurengo, A.; Boiron, M.

1989-01-01

The usual Randomized Clinical Trials (RCT) management using an anachronic procedure involving a flowsheet exchange between the remote centers and the coordinating center presents a number of inadequacies. Eligibility criteria are not always verified by the coordinating center before inclusion in the trial and randomization. Laboratory tests and therapeutic adjustments are frequently decided from memory by the clinician which often leads to data oversight and variability of therapeutic decisions. This results in protocol deviations and alteration of the efficiency of the RCT. HICREN is a medical consultation system designed to take into account the different difficulties encountered during RCT driving. The system integrates a clinical database with artificial intelligence technics to manage clinical trial data on non-expensive and widely available Minitel® terminals. Randomization is then possible, after eligibility criteria are satisfied, anytime and anywhere in France through the national telematic network. HICREN also includes an intuitive graphic interface to increase physician's compliance: a user friendly dialogue manager supports on line data entry with multi-windowing facilities and pull down menus. Interactive data validation is achieved through an interface to dedicated C programs. Patient follow up is achieved by an expert system that proposes appropriate dose of treatment according to the rules defined in the trial. At present, HICREN is implemented on the CISARC system for conducting three randomized clinical trials and one epidemiologic study.

Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study.

PubMed

Johnson, Casey; Hohenboken, Matthew; Poling, Terry; Jaehnig, Peter; Kanesa-Thasan, Niranjan

2015-07-01

A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important. In this phase I, randomized, observer-blind, dose-ranging study, 627 healthy subjects ≥ 3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 µg, 7.5 µg, or 15 µg hemagglutinin antigen of H3N2v with or without MF59 (registered trademark of Novartis AG) adjuvant (an oil-in-water emulsion). This paper reports Day 43 planned interim data. Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose; the Center for Biologics Evaluation Research and Review (CBER) licensure criteria were met for all groups. Subjects with prevaccination hemagglutination inhibition titers <10 and children 3-<9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine. Highest antibody titers were observed in the 7.5 µg + 0.25 mL MF59 groups in all age cohorts. MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events, predominately mild or moderate. A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines, especially for pediatric populations. ClinicalTrials.gov identifier NCT01855945 (http://clinicaltrials.gov/ct2/show/NCT01855945). © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial.

PubMed

Ferraz, Daniel Dominguez; Trippo, Karen Valadares; Duarte, Gabriel Pereira; Neto, Mansueto Gomes; Bernardes Santos, Kionna Oliveira; Filho, Jamary Oliveira

2018-05-01

To compare the effects of functional training, bicycle exercise, and exergaming on walking capacity of elderly with Parkinson disease (PD). A pilot randomized, controlled, single-blinded trial. A state reference health care center for elderly, a public reference outpatient clinic for the elderly. Elderly individuals (≥60 years of age; N=62) with idiopathic PD (stage 2 to 3 of modified Hoehn and Yahr staging scale) according to the London Brain Bank. The participants were randomly assigned to three groups. Group 1 (G1) participated in functional training (n=22); group 2 (G2) performed bicycle exercise (n=20), and group 3 (G3) trained with Kinect Adventures (Microsoft, Redmond, WA) exergames (n=20). The primary outcome measure was the 6-minute walk test (6MWT); secondary outcome measures were the 10-m walk test (10MWT), sitting-rising test (SRT), body mass index, Parkinson Disease Questionnaire-39, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and 15-item Geriatric Depression Scale. All groups showed significant improvements in 6MWT (G1 P=.008; G2 P=.001; G3 P=.005), SRT (G1 P<.001; G2 P=.001; G3 P=.003), and WHODAS 2.0 (G1 P=.018; G2 P=.019; G3 P=.041). Only G3 improved gait speed in 10MWT (P=.11). G1 (P=.014) and G3 (P=.004) improved quality of life. No difference was found between groups. Eight weeks of exergaming can improve the walking capacity of elderly patients with PD. Exergame training had similar outcomes compared with functional training and bicycle exercise. The three physical exercise modalities presented significant improvements on walking capacity, ability to stand up and sit, and functionality of the participants. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Alleviation of mandibular anterior crowding with copper-nickel-titanium vs nickel-titanium wires: a double-blind randomized control trial.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2009-08-01

The purpose of this study was to investigate the efficiency of copper-nickel-titanium (CuNiTi) vs nickel-titanium (NiTi) archwires in resolving crowding of the anterior mandibular dentition. Sixty patients were included in this single-center, single-operator, double-blind randomized trial. All patients were bonded with the In Ovation-R self-ligating bracket (GAC, Central Islip, NY) with a 0.022-in slot, and the amount of crowding of the mandibular anterior dentition was assessed by using the irregularity index. The patients were randomly allocated into 2 groups of 30 patients, each receiving a 0.016-in CuNiTi 35 degrees C (Ormco, Glendora, Calif) or a 0.016-in NiTi (ModernArch, Wyomissing, Pa) wire. The type of wire selected for each patient was not disclosed to the provider or the patient. The date that each patient received a wire was recorded, and all patients were followed monthly for a maximum of 6 months. Demographic and clinical characteristics between the 2 wire groups were compared with the t test or the chi-square test and the Fisher exact test. Time to resolve crowding was explored with statistical methods for survival analysis, and alignment rate ratios for wire type and crowding level were calculated with Cox proportional hazards multivariate modeling. The type of wire (CuNiTi vs NiTi) had no significant effect on crowding alleviation (129.4 vs 121.4 days; hazard ratio, 1.3; P >0.05). Severe crowding (>5 on the irregularity index) showed a significantly higher probability of crowding alleviation duration relative to dental arches with a score of <5 (138.5 vs 113.1 days; hazard ratio, 2.2; P=0.02). The difference of the loading pattern of wires in laboratory and clinical conditions might effectively eliminate the laboratory-derived advantage of CuNiTi wires.

Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial

PubMed Central

2013-01-01

Background Chinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome. Methods We performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi decoction or placebo in a 2:1 ratio. Herbal or placebo granules were dissolved in 300 ml of boiled water cooled to 70°C. Patients in both groups were administered 150 ml (50°C) twice daily. The trial included a 4-week treatment period and a 4-week follow-up period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment. Results Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05). Conclusions CHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome. Trial registration Chinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074 PMID:23453018

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces

PubMed Central

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

Purpose To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Setting Assil Eye Institute, Beverly Hills, CA, USA. Design Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients and methods Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Results Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. Conclusion The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient. PMID:26345628

The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial.

PubMed

Kimhy, David; Vakhrusheva, Julia; Bartels, Matthew N; Armstrong, Hilary F; Ballon, Jacob S; Khan, Samira; Chang, Rachel W; Hansen, Marie C; Ayanruoh, Lindsey; Lister, Amanda; Castrén, Eero; Smith, Edward E; Sloan, Richard P

2015-07-01

Individuals with schizophrenia display substantial neurocognitive deficits for which available treatments offer only limited benefits. Yet, findings from studies of animals, clinical and nonclinical populations have linked neurocognitive improvements to increases in aerobic fitness (AF) via aerobic exercise training (AE). Such improvements have been attributed to up-regulation of brain-derived neurotrophic factor (BDNF). However, the impact of AE on neurocognition, and the putative role of BDNF, have not been investigated in schizophrenia. Employing a proof-of-concept, single-blind, randomized clinical trial design, 33 individuals with schizophrenia were randomized to receive standard psychiatric treatment (n = 17; "treatment as usual"; TAU) or attend a 12-week AE program (n = 16) utilizing active-play video games (Xbox 360 Kinect) and traditional AE equipment. Participants completed assessments of AF (indexed by VO2 peak ml/kg/min), neurocognition (MATRICS Consensus Cognitive Battery), and serum-BDNF before and after and 12-week period. Twenty-six participants (79%) completed the study. At follow-up, the AE participants improved their AF by 18.0% vs a -0.5% decline in the TAU group (P = .002) and improved their neurocognition by 15.1% vs -2.0% decline in the TAU group (P = .031). Hierarchical multiple regression analyses indicated that enhancement in AF and increases in BDNF predicted 25.4% and 14.6% of the neurocognitive improvement variance, respectively. The results indicate AE is effective in enhancing neurocognitive functioning in people with schizophrenia and provide preliminary support for the impact of AE-related BDNF up-regulation on neurocognition in this population. Poor AF represents a modifiable risk factor for neurocognitive dysfunction in schizophrenia for which AE training offer a safe, nonstigmatizing, and side-effect-free intervention. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Traditional Chinese medicine versus western medicine as used in China in the management of rheumatoid arthritis: a randomized, single-blind, 24-week study.

PubMed

He, Yi-Ting; Ou, Ai-Hua; Yang, Xiao-Bo; Chen, Wei; Fu, Li-Yuan; Lu, Ai-Ping; Yan, Xiao-Ping; Feng, Xing-Hua; Su, Li; Song, Yue-Jin; Zeng, Sheng-Ping; Liu, Wei; Qian, Xian; Zhu, Wan-Hua; Lao, Ying-Rong; Xu, Wei-Hua; Wen, Ze-Huai; He, Xiao-Hong; Wang, Bao-Juan; Chen, Geng-Xin; Xue, Su-Qin

2014-12-01

This study is designed to compare the efficacy and safety of traditional Chinese medicine (TCM) with western medicine (WM) in the management of rheumatoid arthritis (RA). This is a 24-week, randomized, multicenter, single-blind study comparing TCM with WM (as used in China) carried out between June 2002 and December 2004 in nine research centers in China, involving 489 patients. Patients were randomized to receive TCM (n = 247), MTX and SSZ (n = 242). MTX was started at a dose of 5 mg to a final dose of 7.5-15 mg weekly. The maintenance dose was 2.5-7.5 mg weekly. The starting dose of SSZ was 0.25 g bid, increasing by 0.25 g a day once a week to a final dose of 0.5-1 g qid. The maintenance dose was 0.5 g tid to qid. Primary end point was the proportion of patients with response according to the American College of Rheumatology 20 % improvement criteria (ACR20) at weeks 24. At 24 weeks, ACR20 responses were 53.0 % in TCM group and 66.5 % in WM group, (P < 0.001) at 24 weeks. ACR 50 responses were 31.6 % of TCM group and 42.6 % in WM group, (P = 0.01). ACR70 responses were 12.6 % in TCM group and 17.4 % in WM group, (P = 0.14). Side effects were observed more frequently in WM group. In this study, ACR20, ACR50 responses at 24 weeks were significantly better in the WM treated group, by intention to treat (ITT) and per protocol analysis. The ACR 70 response showed no significant difference between the two groups. TCM, while effective in treating RA, appears to be less effective than WM in controlling symptoms, but TCM is associated with fewer side effects.

Planning Paths Through Singularities in the Center of Mass Space

NASA Technical Reports Server (NTRS)

Doggett, William R.; Messner, William C.; Juang, Jer-Nan

1998-01-01

The center of mass space is a convenient space for planning motions that minimize reaction forces at the robot's base or optimize the stability of a mechanism. A unique problem associated with path planning in the center of mass space is the potential existence of multiple center of mass images for a single Cartesian obstacle, since a single center of mass location can correspond to multiple robot joint configurations. The existence of multiple images results in a need to either maintain multiple center of mass obstacle maps or to update obstacle locations when the robot passes through a singularity, such as when it moves from an elbow-up to an elbow-down configuration. To illustrate the concepts presented in this paper, a path is planned for an example task requiring motion through multiple center of mass space maps. The object of the path planning algorithm is to locate the bang- bang acceleration profile that minimizes the robot's base reactions in the presence of a single Cartesian obstacle. To simplify the presentation, only non-redundant robots are considered and joint non-linearities are neglected.

An efficient fluorescent single-particle position tracking system for long-term pulsed measurements of nitrogen-vacancy centers in diamond

NASA Astrophysics Data System (ADS)

Kim, Kiho; Yun, Jiwon; Lee, Donghyuck; Kim, Dohun

2018-02-01

A simple and convenient design enables real-time three-dimensional position tracking of nitrogen-vacancy (NV) centers in diamond. The system consists entirely of commercially available components (a single-photon counter, a high-speed digital-to-analog converter, a phase-sensitive detector-based feedback device, and a piezo stage), eliminating the need for custom programming or rigorous optimization processes. With a large input range of counters and trackers combined with high sensitivity of single-photon counting, high-speed position tracking (upper bound recovery time of 0.9 s upon 250 nm of step-like positional shift) not only of bright ensembles, but also of low-photon-collection-efficiency single to few NV centers (down to 103 s-1) is possible. The tracking requires position modulation of only 10 nm, which allows simultaneous position tracking and pulsed measurements in the long term. Therefore, this tracking system enables measuring a single-spin magnetic resonance and Rabi oscillations at a very high resolution even without photon collection optimization. The system is widely applicable to various fields related to NV center quantum manipulation research such as NV optical trapping, NV tracking in fluid dynamics, and biological sensing using NV centers inside a biological cell.

Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial.

PubMed

Ward, Dianne S; Vaughn, Amber E; Hales, Derek; Viera, Anthony J; Gizlice, Ziya; Bateman, Lori A; Grummon, Anna H; Arandia, Gabriela; Linnan, Laura A

2018-05-01

Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 (±14.2) minutes/day of MVPA and consume 1.3 (±1.4) and 1.3 (±0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 (±1.4) hours/night of sleep; and 34.9% are high risk for depression. Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial

PubMed Central

Ward, Dianne S.; Vaughn, Amber E.; Hales, Derek; Viera, Anthony J.; Gizlice, Ziya; Bateman, Lori A.; Grummon, Anna H.; Arandia, Gabriela; Linnan, Laura A.

2018-01-01

Background Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Methods Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. Results In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 ( ± 14.2) minutes/day of MVPA and consume 1.3 ( ± 1.4) and 1.3 ( ± 0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 ( ± 1.4) hours/night of sleep; and 34.9% are high risk for depression. Conclusions Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. PMID:29501740

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Sequential multiple-assignment randomized trial design of neurobehavioral treatment for patients with metastatic malignant melanoma undergoing high-dose interferon-alpha therapy.

PubMed

Auyeung, S Freda; Long, Qi; Royster, Erica Bruce; Murthy, Smitha; McNutt, Marcia D; Lawson, David; Miller, Andrew; Manatunga, Amita; Musselman, Dominique L

2009-10-01

Interferon-alpha therapy, which is used to treat metastatic malignant melanoma, can cause patients to develop two distinct neurobehavioral symptom complexes: a mood syndrome and a neurovegetative syndrome. Interferon-alpha effects on serotonin metabolism appear to contribute to the mood and anxiety syndrome, while the neurovegetative syndrome appears to be related to interferon-alpha effects on dopamine. Our goal is to propose a design for utilizing a sequential, multiple assignment, randomized trial design for patients with malignant melanoma to test the relative efficacy of drugs that target serotonin versus dopamine metabolism during 4 weeks of intravenous, then 8 weeks of subcutaneous, interferon-alpha therapy. Patients will be offered participation in a double-blinded, randomized, controlled, 14-week trial involving two treatment phases. During the first month of intravenous interferon-alpha therapy, we will test the hypotheses that escitalopram will be more effective in reducing depressed mood, anxiety, and irritability, whereas methylphenidate will be more effective in diminishing interferon-alpha-induced neurovegetative symptoms, such as fatigue and psychomotor slowing. During the next 8 weeks of subcutaneous interferon therapy, participants whose symptoms do not improve significantly will be randomized to the alternate agent alone versus escitalopram and methylphenidate together. We present a prototype for a single-center, sequential, multiple assignment, randomized trial, which seeks to determine the efficacy of sequenced and targeted treatment for the two distinct symptom complexes suffered by patients treated with interferon-alpha. Because we cannot completely control for external factors, a relevant question is whether or not 'short-term' neuropsychiatric interventions can increase the number of interferon-alpha doses tolerated and improve long-term survival. This sequential, multiple assignment, randomized trial proposes a framework for developing optimal treatment strategies; however, additional studies are needed to determine the best strategy for treating or preventing neurobehavioral symptoms induced by the immunotherapy interferon-alpha.

Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone

PubMed Central

Do, Richard K.; Gonen, Mithat; Covey, Anne M.; Getrajdman, George I.; Sofocleous, Constantinos T.; Jarnagin, William R.; D’Angelica, Michael I.; Allen, Peter J.; Erinjeri, Joseph P.; Brody, Lynn A.; O’Neill, Gerald P.; Johnson, Kristian N.; Garcia, Alessandra R.; Beattie, Christopher; Zhao, Binsheng; Solomon, Stephen B.; Schwartz, Lawrence H.; DeMatteo, Ronald; Abou-Alfa, Ghassan K.

2016-01-01

Purpose Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. Materials and Methods At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Results Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, −0.1%; 95% CI, −9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. Conclusion There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC. PMID:26834067

A Comparison of the Preventive Health Care Provided by Women's Health Centers and General Internal Medicine Practices

PubMed Central

Harpole, Linda H; Mort, Elizabeth A; Freund, Karen M; Orav, John; Brennan, Troyen A

2000-01-01

OBJECTIVE To evaluate women's health centers as alternatives to traditional internal medicine practices. DESIGN Cross-sectional mailed survey. SETTING A women's health center and an internal medicine practice at each of three university-affiliated teaching hospitals. PATIENTS There were 3,035 female patients randomly selected to receive a mailed survey after their office visits. MEASUREMENTS AND MAIN RESULTS The survey asked for patient characteristics, patient satisfaction, and rates of gender-specific preventive health services. The survey response rate was 64% (1,942/3,035). Patients at women's health centers were younger, more educated, had higher physical functioning but lower mental health functioning, and more of them were single and employed. Patient satisfaction was similar at the two types of practices, although patients at women's health centers were more satisfied with certain aspects of the patient-provider interaction. After adjusting for measured differences in patient characteristics and site, patients at women's health centers were more likely to receive discussions on hormone replacement therapy (odds ratio [OR] 1.6; 95% confidence interval [CI] 1.1, 2.2) and dietary calcium (OR 1.3; 95% CI 1.1, 1.6). They were also more likely to receive their gender-specific preventive health services from their primary care provider: breast examination (OR 2.0; 95% CI 1.5, 2.6), Pap smear (OR 2.4; 95% CI 1.9, 3.1), hormone replacement therapy discussion (OR 2.2; 95% CI 1.5, 3.3), and dietary calcium discussion (OR 2.6; 95% CI 1.7, 3.9). These findings remained when the analyses were limited to patients of female providers only. CONCLUSIONS In this study, patients at women's health centers were more likely to receive gender-specific health prevention counseling than patients at internal medicine practices. Moreover, patients were more likely to receive their gender-specific preventive health services from their primary care providers. PMID:10632827

Random-access technique for modular bathymetry data storage in a continental shelf wave refraction program

NASA Technical Reports Server (NTRS)

Poole, L. R.

1974-01-01

A study was conducted of an alternate method for storage and use of bathymetry data in the Langley Research Center and Virginia Institute of Marine Science mid-Atlantic continental-shelf wave-refraction computer program. The regional bathymetry array was divided into 105 indexed modules which can be read individually into memory in a nonsequential manner from a peripheral file using special random-access subroutines. In running a sample refraction case, a 75-percent decrease in program field length was achieved by using the random-access storage method in comparison with the conventional method of total regional array storage. This field-length decrease was accompanied by a comparative 5-percent increase in central processing time and a 477-percent increase in the number of operating-system calls. A comparative Langley Research Center computer system cost savings of 68 percent was achieved by using the random-access storage method.

Variable- and Person-Centered Approaches to the Analysis of Early Adolescent Substance Use: Linking Peer, Family, and Intervention Effects with Developmental Trajectories

ERIC Educational Resources Information Center

Connell, Arin M.; Dishion, Thomas J.; Deater-Deckard, Kirby

2006-01-01

This 4-year study of 698 young adolescents examined the covariates of early onset substance use from Grade 6 through Grade 9. The youth were randomly assigned to a family-centered Adolescent Transitions Program (ATP) condition. Variable-centered (zero-inflated Poisson growth model) and person-centered (latent growth mixture model) approaches were…

Variation in perioperative care across centers for infants undergoing the Norwood procedure.

PubMed

Pasquali, Sara K; Ohye, Richard G; Lu, Minmin; Kaltman, Jonathan; Caldarone, Christopher A; Pizarro, Christian; Dunbar-Masterson, Carolyn; Gaynor, J William; Jacobs, Jeffrey P; Kaza, Aditya K; Newburger, Jane; Rhodes, John F; Scheurer, Mark; Silver, Eric; Sleeper, Lynn A; Tabbutt, Sarah; Tweddell, James; Uzark, Karen; Wells, Winfield; Mahle, William T; Pearson, Gail D

2012-10-01

In the Single Ventricle Reconstruction trial, infants undergoing the Norwood procedure were randomly allocated to undergo a right ventricle-to-pulmonary artery shunt or a modified Blalock-Taussig shunt. Apart from shunt type, subjects received the local standard of care. We evaluated variation in perioperative care during the Norwood hospitalization across 14 trial sites. Data on preoperative, operative, and postoperative variables for 546 enrolled subjects who underwent the Norwood procedure were collected prospectively on standardized case report forms, and variation across the centers was described. Gestational age, birth weight, and proportion with hypoplastic left heart syndrome were similar across sites. In contrast, all recorded variables related to preoperative care varied across centers, including fetal diagnosis (range, 55%-85%), preoperative intubation (range, 29%-91%), and enteral feeding. Perioperative and operative factors were also variable across sites, including median total support time (range, 74-189 minutes) and other perfusion variables, arch reconstruction technique, intraoperative medication use, and use of modified ultrafiltration (range, 48%-100%). Additional variation across centers was seen in variables related to postoperative care, including proportion with an open sternum (range, 35%-100%), median intensive care unit stay (range, 9-44 days), type of feeding at discharge, and enrollment in a home monitoring program (range, 1%-100%; 5 sites did not have a program). Overall, in-hospital death or transplant occurred in 18% (range across sites, 7%-39%). Perioperative care during the Norwood hospitalization varies across centers. Further analysis evaluating the underlying causes and relationship of this variation to outcome is needed to inform future studies and quality improvement efforts. Copyright © 2012 The American Association for Thoracic Surgery. All rights reserved.

Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

ERIC Educational Resources Information Center

Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

2017-01-01

Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

Phase geometries of two-dimensional excitable waves govern self-organized morphodynamics of amoeboid cells

PubMed Central

Taniguchi, Daisuke; Ishihara, Shuji; Oonuki, Takehiko; Honda-Kitahara, Mai; Kaneko, Kunihiko; Sawai, Satoshi

2013-01-01

In both randomly moving Dictyostelium and mammalian cells, phosphatidylinositol (3,4,5)-trisphosphate and F-actin are known to propagate as waves at the membrane and act to push out the protruding edge. To date, however, the relationship between the wave geometry and the patterns of amoeboid shape change remains elusive. Here, by using phase map analysis, we show that morphology dynamics of randomly moving Dictyostelium discoideum cells can be characterized by the number, topology, and position of spatial phase singularities, i.e., points that represent organizing centers of rotating waves. A single isolated singularity near the cellular edge induced a rotational protrusion, whereas a pair of singularities supported a symmetric extension. These singularities appeared by strong phase resetting due to de novo nucleation at the back of preexisting waves. Analysis of a theoretical model indicated excitability of the system that is governed by positive feedback from phosphatidylinositol (3,4,5)-trisphosphate to PI3-kinase activation, and we showed experimentally that this requires F-actin. Furthermore, by incorporating membrane deformation into the model, we demonstrated that geometries of competing waves explain most of the observed semiperiodic changes in amoeboid morphology. PMID:23479620

Effect of 4% chlorhexidine gluconate predisinfection skin scrub prior to hepatectomy: a double-blinded, randomized control study.

PubMed

Hsieh, Ching-Shui; Cheng, Hsiu-Chi; Lin, Jen-Shiou; Kuo, Shou-Jen; Chen, Yao-Li

2014-01-01

This trial was designed to compare the efficacy of 4% chlorhexidine gluconate (CHG) with normal saline (NS) as a predisinfection skin-scrub solution prior to standard presurgical skin preparation. Data was collected at a single transplantation center where patients electing resection of hepatic tumors were recruited between October 2011 and September 2012. In total, 100 patients were consecutively enrolled for random assignment to either 4% CHG or NS as a predisinfection skin-scrub solution prior to surgery. Our aim was to assess the comparative antiseptic efficacy of CHG in this setting, focusing on cutaneous microbial colonization (at baseline, preoperatively, and postoperatively) and postsurgical site infections as primary outcome measures. Positivity rates of baseline, preoperative, and postoperative cultures were similar for both groups, showing significant declines (relative to baseline) after skin preparation and no significant postsurgical rebound. Rates of surgical site infection were also similar in both groups (CHG, 6.0%; NS, 4.1%; P = 1.0). For patients with hepatic tumors undergoing hepatectomy, the effect of 4% CHG as a predisinfection scrub solution was similar to that of NS in terms of skin decontamination and surgical site infections.

Tolerability of clindamycin/tretinoin gel vs. tretinoin microsphere gel and adapalene gel.

PubMed

Leyden, James; Wortzman, Mitchell; Baldwin, Edward K

2009-04-01

Newer agents and formulations seek to improve the tolerability of topical retinoid therapy. Recently, a gel containing crystalline clindamycin 1.2% and tretinoin 0.025% (CLIN/RA) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of treating mild-to-moderate acne. This single-center, randomized, evaluator-blind phase 1 study compared the tolerability of CLIN/RA to 0.1% tretinoin gel or 0.1% adapalene gel. Forty-five patients applied CLIN/RA once daily to one side of their face every day for 21 days. Patients were randomized to either tretinoin 0.1% (n = 23) or adapalene 0.1% (n = 22) on the contralateral side. A clinical evaluator assessed degree of erythema and scaling; patients provided subjective evaluations of burning, stinging, and itching. CLIN/RA was significantly better tolerated than was 0.1% tretinoin gel, as evidenced by significantly reduced erythema (P < 0.04), scaling (P < 0.03), itching (P < 0.02), burning (P < 0.03) and stinging (P < 0.04). A trend for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel compared to CLIN/RA was also evident.

Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study.

PubMed

Hexsel, Doris; Soirefmann, Mariana; Porto, Manoela D; Schilling-Souza, Juliana; Siega, Carolina; Dal'Forno, Taciana

2014-05-01

Striae distensae (SD) is a common skin condition, with a prevalence ranging from 40% to 90%, depending on the population studied. To evaluate the efficacy of superficial dermabrasion and compare it with that of topical tretinoin cream in the treatment of narrow and early SD. Prospective, single-center, randomized, open-label study. Thirty-two women presenting with early, untreated SD (striae rubra) were included in this study. One group received 16 weekly sessions of superficial and localized dermabrasion, and the other used 0.05% tretinoin cream daily. Striae width and length were measured and compared between groups and over time. Global Aesthetic Improvement Scale scores and subject satisfaction were also assessed. Biopsies were performed for subjects who agreed to undergo this procedure, followed by histologic analyses of the skin samples. Both treatments were efficacious, with significant improvement in early SD from baseline, but there was no significant difference between the two treatments. Histologic assessment showed improvement in epidermal and dermal layers for the dermabrasion treatment group. Both treatments had similar efficacy, but superficial dermabrasion had a lower frequency of side effects and better adherence of the patients. © 2014 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

The effects of eyeball exercise on balance ability and falls efficacy of the elderly who have experienced a fall: A single-blind, randomized controlled trial.

PubMed

Park, Jin-Hyuck

The purpose of this study was to investigate the effects of eyeball exercise on balance and fall efficacy of the elderly who have experienced a fall. Subjects were randomly assigned to the eyeball exercise group (n=30) or functional exercise group (n=31). All subjects received 30 sessions for 10 weeks. To identify the effects on balance, static and dynamic balance were measured using the center of pressure (CoP) measurement equipment and Timed Up and Go Test (TUGT) respectively. Fall efficacy was evaluated using the modified efficacy scale (MFES). The outcome measurements were performed before and after the 10 weeks training period. After 10 weeks, static balance, dynamic balance, and fall efficacy were significantly improved in both groups. Also, there were significant differences in the outcome measures between both groups (p<0.05). These results indicate that eyeball exercise is beneficial to improve the fall efficacy as well as the balance of the elderly compared with functional exercise. Eyeball exercise would be useful to improve balance and fall efficacy of the elderly who have experienced a fall. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Comparison of visual evoked potential monitoring during spine surgeries under total intravenous anesthesia versus balanced general anesthesia.

PubMed

Uribe, Alberto A; Mendel, Ehud; Peters, Zoe A; Shneker, Bassel F; Abdel-Rasoul, Mahmoud; Bergese, Sergio D

2017-10-01

To determine the comparison of its clinical utility and safety profile for visual evoked potential (VEP) monitoring during prone spine surgeries under total intravenous anesthesia (TIVA) versus balanced general anesthesia using the SightSaver™ visual stimulator. The protocol was designed asa pilot, single center, prospective, randomized, and double-arm study. Subjects were randomized to receive either TIVA or balanced general anesthesia. Following induction and intubation, 8 electrodes were placed subcutaneously to collect VEP recordings. The SightSaver™ visual stimulator was placed on the subject's scalp before prone positioning. VEP waveforms were recorded every 30min and assessed by a neurophysiologist throughout the length of surgery. A total of 19 subjects were evaluated and VEP waveforms were successfully collected. TIVA group showed higher amplitude and lower latency than balanced anesthesia. Our data suggested that TIVA is associated with higher VEP amplitude and shorter latencies than balanced general anesthesia; therefore, TIVA could be the most efficient anesthesia regimen for VEP monitoring. The findings help to better understand the effect of different anesthesia regimens on intra-operative VEP monitoring. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Influence of gravity and light on the developmental polarity of Ceratopteris richardii fern spores

NASA Technical Reports Server (NTRS)

Edwards, E. S.; Roux, S. J.

1998-01-01

The polarity of germinating single-celled spores of the fern Ceratopteris richardii Brogn. is influenced by gravity during a time period prior to the first cellular division designated a "polarity-determination window". After this window closes, control of polarity is seen in the downward (with respect to gravity) migration of the nucleus along the proximal face of the spore and the subsequent downward growth of the primary rhizoid. When spores are germinated on a clinostat the direction of nuclear migration and subsequent primary rhizoid growth is random. However, in each case the direction of nuclear migration predicts the direction of rhizoid elongation. Although it is the most obvious movement, the downward migration is not the first movement of the nucleus. During the polarity-determination window, the nucleus moves randomly within a region centered behind the trilete marking. While the polarity of many fern spores has been reported to be controlled by light, spores of C. richardii are the first documented to have their polarity influenced by gravity. Directional white light also affects the polarity of these spores, but this influence is slight and is secondary to that of gravity.

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Hochwald, Ori; Mainzer, Gur; Borenstein-Levin, Liron; Jubran, Huda; Dinur, Gil; Zucker, Meirav; Mor, Malka; Khoury, Asaad; Kugelman, Amir

2018-05-21

 The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 31 6/7 weeks postmenstrual age.  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12).  There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p  = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.  Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Shiatsu as an adjuvant therapy for depression in patients with Alzheimer's disease: A pilot study.

PubMed

Lanza, Giuseppe; Centonze, Stella Silvia; Destro, Gera; Vella, Veronica; Bellomo, Maria; Pennisi, Manuela; Bella, Rita; Ciavardelli, Domenico

2018-06-01

Among the complementary and alternative medicine, Shiatsu might represent a feasible option for depression in Alzheimer's disease (AD). We evaluated Shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Single-blind randomized controlled study. Dedicated Community Center for patients with AD. AD patients with depression were randomly assigned to the "active group" (Shiatsu + physical activity) or the "control group" (physical activity alone). Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination - MMSE), depressive symptoms (Geriatric Depression Scale - GDS), and functional status (Activity of Daily Living - ADL, Instrumental ADL - IADL) were assessed before and after the intervention. We found a within-group improvement of MMSE, ADL, and GDS in the active group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the active group. The combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation. Copyright © 2018 Elsevier Ltd. All rights reserved.

The Effect of Pistacia atlantica Var. mutica Mouthwash on Dental Plaque Bacteria and Subgingival Microorganisms: a Randomized and Controlled Triple-blind Study.

PubMed

Arami, S; Mojaddadi, M A; Pourabbas, R; Chitsaz, M T; Delazar, A; Mobayen, H

2015-09-01

Dental plaque is a well-documented etiologic factor for periodontal diseases. While chlorhexidine (CHX) is the gold-standard agent for treating dental plaques, undesirable side effects are often found after continuous use of the mouthwash. Therefore, this single-center, randomized, triple-blinded and clinical trial was undertaken to evaluate the efficacy of Pistacia atlantica Var. mutica extract mouthwash on de novo dental plaque bacteria and subgingival microorganisms compared to CHX on a total of 28 patients. The mean aerobic plaque bacterial count of patients at baseline was 2.17 × 10(6). After 4 days of treatment, there were statistically significant decreases in the mean aerobic bacteria in the patients who received P. atlantica and/or CHX (7.25 × 10(4), p = 0.006) and (9.91 × 10(3), p = 0.002), respectively, compared to the patients who received the placebo (6.26 × 10(5)). This study showed that P. atlantica mouthwash is effective against gingival microorganisms. Because of its reduced side effects, P. atlantica mouthwash may be a good alternative choice for patients. © Georg Thieme Verlag KG Stuttgart · New York.

[Use of topical non-steroidal anti-inflammatory agents in an urban health center. Comparison with the current evidence].

PubMed

Yagüe-Sebastián, M M; Coscollar-Escartín, I; Muñoz-Albadalejo, P; López-Canales, M C; Villaverde-Royo, M V; Gutiérrez-Moreno, F

2013-09-01

To describe the prescribing of topical non-steroidal anti-inflammatory drugs (NSAIDs) in an urban health center (Zaragoza, Spain). A cross-sectional descriptive study was conducted on subjects who belonged to an urban center and were studied during the year 2010. The sample size with a confidence level of 95%, was calculated, a total of 843 prescriptions were analyzed. The sample was single random, and 150 cases were selected. The prevalence and confidence intervals were calculated. The statistical package STATA 9.1 was used for the calculations. The most used drug was diclofenac, in 27.33% (95% CI: 20.65-34.88). NSAIDs were most used in females. In 18% of the cases the area of application was the knee, followed by the 15% in the lower back area (95% CI: 10,22-21,78). There were no adverse reactions. Frequent use is made of topical NSAIDs in a basic health area. Current recommendations support the use in the knee and in the hand, but not in the back, where its use is common. The use of topical NSAIDs decreases side effects and drug interactions, therefore their use is recommended in patients on multiple drug therapy and in the elderly. Copyright © 2012 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

Lagrangian statistics in weakly forced two-dimensional turbulence.

PubMed

Rivera, Michael K; Ecke, Robert E

2016-01-01

Measurements of Lagrangian single-point and multiple-point statistics in a quasi-two-dimensional stratified layer system are reported. The system consists of a layer of salt water over an immiscible layer of Fluorinert and is forced electromagnetically so that mean-squared vorticity is injected at a well-defined spatial scale ri. Simultaneous cascades develop in which enstrophy flows predominately to small scales whereas energy cascades, on average, to larger scales. Lagrangian correlations and one- and two-point displacements are measured for random initial conditions and for initial positions within topological centers and saddles. Some of the behavior of these quantities can be understood in terms of the trapping characteristics of long-lived centers, the slow motion near strong saddles, and the rapid fluctuations outside of either centers or saddles. We also present statistics of Lagrangian velocity fluctuations using energy spectra in frequency space and structure functions in real space. We compare with complementary Eulerian velocity statistics. We find that simultaneous inverse energy and enstrophy ranges present in spectra are not directly echoed in real-space moments of velocity difference. Nevertheless, the spectral ranges line up well with features of moment ratios, indicating that although the moments are not exhibiting unambiguous scaling, the behavior of the probability distribution functions is changing over short ranges of length scales. Implications for understanding weakly forced 2D turbulence with simultaneous inverse and direct cascades are discussed.

Utilizing PowerPoint Presentation to Promote Fall Prevention among Older Adults

ERIC Educational Resources Information Center

McCrary-Quarles, Audrey R.

2008-01-01

This study evaluated a PowerPoint home safety (PPHS) presentation in enhancing awareness, knowledge and behavior change among senior center attendees in southern Illinois. Twelve centers were utilized as data collection sites in a pretest-posttest control group design. Through stratified randomization, centers were placed into categories (high,…

A Market Study for the Center for the Performing Arts.

ERIC Educational Resources Information Center

Rae, John; And Others

In fall 1983, a telephone survey was conducted by Macomb Community College (MCC) to assess community perceptions of the college's Center for the Performing Arts (CPA) and to aid in developing marketing strategies for the Center. Interviews were conducted with 500 randomly selected Macomb County (Michigan) residents to determine if they had…

Effectiveness of aquatic versus land physiotherapy in the treatment of peripheral neuropathies: a randomized controlled trial.

PubMed

Zivi, Ilaria; Maffia, Sara; Ferrari, Vanessa; Zarucchi, Alessio; Molatore, Katia; Maestri, Roberto; Frazzitta, Giuseppe

2018-05-01

To compare the effects on gait and balance of aquatic physiotherapy versus on-land training, in the context of an inpatient rehabilitation treatment tailored for peripheral neuropathies. Parallel-group, single-center, single-blind randomized controlled trial. Consecutive patients affected by peripheral neuropathy admitted in our Neuro-Rehabilitation Unit. Patients received a four-week rehabilitation program composed by daily sessions of conventional physiotherapy and three sessions/week of specific treatment (aquatic vs. on-land). Primary outcome measures were Berg Balance Scale and Dynamic Gait Index. Secondary outcome measures were Neuropathic Pain Scale, Overall Neuropathy Limitations Scale, Functional Independence Measure, Functional Ambulation Classification, Conley Scale and Medical Research Council Scale score for the strength of hip and ankle flexor and extensor muscles. For each scale, we calculated the difference between the scores at discharge and admission and compared it between the two groups. Forty patients were enrolled: 21 in the water-based rehabilitation group and 19 in the land-based one. Patients were similar between groups. When comparing the groups, we found that "in-water" patients had a significant better improvement in the Dynamic Gait Index score (6.00 (4.00, 7.25) vs. 4.00 (1.25, 6.00), P = 0.0433). On the opposite, the "on-land" group showed a better improvement of the Functional Ambulation Classification score (1.0 (0.75, 1.0) vs. 1.0 (1.0, 2.0), P = 0.0386). Aquatic physiotherapy showed an effect comparable to the land-based rehabilitation on gait and balance dysfunctions of neuropathic patients.

Impact of one-to-one tutoring on fundamentals of laparoscopic surgery (FLS) passing rate in a single center experience outside the United States: a randomized controlled trial.

PubMed

Gheza, Federico; Raimondi, Paolo; Solaini, Leonardo; Coccolini, Federico; Baiocchi, Gian Luca; Portolani, Nazario; Tiberio, Guido Alberto Massimo

2018-04-11

Outside the US, FLS certification is not required and its teaching methods are not well standardized. Even if the FLS was designed as "stand alone" training system, most of Academic Institution offer support to residents during training. We present the first systematic application of FLS in Italy. Our aim was to evaluate the role of mentoring/coaching on FLS training in terms of the passing rate and global performance in the search for resource optimization. Sixty residents in general surgery, obstetrics & gynecology, and urology were selected to be enrolled in a randomized controlled trial, practicing FLS with the goal of passing a simulated final exam. The control group practiced exclusively with video material from SAGES, whereas the interventional group was supported by a mentor. Forty-six subjects met the requirements and completed the trial. For the other 14 subjects no results are available for comparison. One subject for each group failed the exam, resulting in a passing rate of 95.7%, with no obvious differences between groups. Subgroup analysis did not reveal any difference between the groups for FLS tasks. We confirm that methods other than video instruction and deliberate FLS practice are not essential to pass the final exam. Based on these results, we suggest the introduction of the FLS system even where a trained tutor is not available. This trial is the first single institution application of the FLS in Italy and one of the few experiences outside the US. Trial Number: NCT02486575 ( https://www.clinicaltrials.gov ).

A liberal preoperative fasting regimen improves patient comfort and satisfaction with anesthesia care in day-stay minor surgery.

PubMed

Bopp, C; Hofer, S; Klein, A; Weigand, M A; Martin, E; Gust, R

2011-07-01

The aim of this study was to evaluate whether a single preoperative limited oral intake of a carbohydrate drink could improve perioperative patient comfort and satisfaction with anesthesia care in elective day-stay ophthalmologic surgery. A single-center, prospective, randomized clinical trial was conducted in a university hospital. The study included ASA I-III patients undergoing ophthalmologic surgery. Patients undergoing both general anesthesia and local anesthesia were included in the study. The control group fasted in accordance to nil per os after midnight, while patients in the experimental group received 200 mL of a carbohydrate drink 2 h before the operation. Both groups were allowed to drink and eat until midnight ad libitum. Patient characteristics, subjective perceptions, taste of the drink, and satisfaction with anesthesia care were ascertained using a questionnaire administered three times: after the anesthesiologist's visit, before surgery and before discharge from the ward to assess patient comfort. An analysis of variance and the Mann-Whitney U-test were used for statistical analysis. A total of 123 patients were included and 109 patients were randomly assigned to one of two preoperative fasting regimens. Patients drinking 200 mL 2 h before surgery were not as hungry (P<0.05), not as thirsty preoperatively (P<0.001) and not as thirsty after surgery (P<0.05), resulting in increased postoperative satisfaction with anesthesia care (P<0.05). Standardized limited oral preoperative fluid intake increases patient comfort and satisfaction with anesthesia care and should be a part of modern day-stay ophthalmologic surgery.

Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

PubMed

Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

2015-06-01

At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease.

PubMed

Marazzi, Giuseppe; Pelliccia, Francesco; Campolongo, Giuseppe; Quattrino, Silvia; Cacciotti, Luca; Volterrani, Maurizio; Gaudio, Carlo; Rosano, Giuseppe

2015-12-15

Statins are extensively used to treat dyslipidemia, but, because of their low tolerability profile, they are discontinued in a significant proportion of patients. Ezetimibe and nutraceuticals have been introduced as alternative therapies and have proved to be effective and well tolerated. A single-blind, single-center, randomized, prospective, and parallel group trial comparing a combination of nutraceuticals (red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin), called Armolipid Plus, and ezetimibe for 3 months in terms of efficacy and tolerability. Patients who did not achieve their therapeutic target (low-density lipoprotein cholesterol <100 mg/dl) could add the alternative treatment on top of randomized treatment for another 12 months: 100 patients who are dyslipidemic with ischemic heart disease treated with percutaneous coronary intervention were enrolled (ezetimibe n = 50, nutraceutical n = 50). Efficacy (lipid profile) and tolerability (adverse events, transaminases, and creatine kinase) were assessed after 3 and 12 months. After 3 months, 14 patients in the nutraceutical group achieved their therapeutic target, whereas none of the patients in the ezetimibe group did. At 1-year follow-up, 58 patients (72.5%) of the combined therapy group (n = 86) and 14 (100%) of the nutraceutical group reached the therapeutic goal. No patients experienced important undesirable effects. In conclusion, nutraceuticals alone or in combination with ezetimibe are well tolerated and improve the lipid profile in statin-intolerant patients with coronary heart disease. Further studies are needed to assess long-term effects of nutraceuticals on mortality. Copyright © 2015 Elsevier Inc. All rights reserved.

A Multilevel Model to Estimate the Within- and the Between-Center Components of the Exposure/Disease Association in the EPIC Study

PubMed Central

2015-01-01

In a multicenter study, the overall relationship between exposure and the risk of cancer can be broken down into a within-center component, which reflects the individual level association, and a between-center relationship, which captures the association at the aggregate level. A piecewise exponential proportional hazards model with random effects was used to evaluate the association between dietary fiber intake and colorectal cancer (CRC) risk in the EPIC study. During an average follow-up of 11.0 years, 4,517 CRC events occurred among study participants recruited in 28 centers from ten European countries. Models were adjusted by relevant confounding factors. Heterogeneity among centers was modelled with random effects. Linear regression calibration was used to account for errors in dietary questionnaire (DQ) measurements. Risk ratio estimates for a 10 g/day increment in dietary fiber were equal to 0.90 (95%CI: 0.85, 0.96) and 0.85 (0.64, 1.14), at the individual and aggregate levels, respectively, while calibrated estimates were 0.85 (0.76, 0.94), and 0.87 (0.65, 1.15), respectively. In multicenter studies, over a straightforward ecological analysis, random effects models allow information at the individual and ecologic levels to be captured, while controlling for confounding at both levels of evidence. PMID:25785729

Random breakup of microdroplets for single-cell encapsulation

NASA Astrophysics Data System (ADS)

Um, Eujin; Lee, Seung-Goo; Park, Je-Kyun

2010-10-01

Microfluidic droplet-based technology enables encapsulation of cells in the isolated aqueous chambers surrounded by immiscible fluid but single-cell encapsulation efficiency is usually less than 30%. In this letter, we introduce a simple microgroove structure to break droplets into random sizes which further allows collecting of single-cell [Escherichia coli (E. coli)] containing droplets by their size differences. Pinched-flow separation method is integrated to sort out droplets of certain sizes which have high probability of containing one cell. Consequently, we were able to obtain more than 50% of droplets having single E. coli inside, keeping the proportion of multiple-cell containing droplets less than 16%.

Cause, timing, and location of death in the Single Ventricle Reconstruction trial.

PubMed

Ohye, Richard G; Schonbeck, Julie V; Eghtesady, Pirooz; Laussen, Peter C; Pizarro, Christian; Shrader, Peter; Frank, Deborah U; Graham, Eric M; Hill, Kevin D; Jacobs, Jeffrey P; Kanter, Kirk R; Kirsh, Joel A; Lambert, Linda M; Lewis, Alan B; Ravishankar, Chitra; Tweddell, James S; Williams, Ismee A; Pearson, Gail D

2012-10-01

The Single Ventricle Reconstruction trial randomized 555 subjects with a single right ventricle undergoing the Norwood procedure at 15 North American centers to receive either a modified Blalock-Taussig shunt or right ventricle-to-pulmonary artery shunt. Results demonstrated a rate of death or cardiac transplantation by 12 months postrandomization of 36% for the modified Blalock-Taussig shunt and 26% for the right ventricle-to-pulmonary artery shunt, consistent with other publications. Despite this high mortality rate, little is known about the circumstances surrounding these deaths. There were 164 deaths within 12 months postrandomization. A committee adjudicated all deaths for cause and recorded the timing, location, and other factors for each event. The most common cause of death was cardiovascular (42%), followed by unknown cause (24%) and multisystem organ failure (7%). The median age at death for subjects dying during the 12 months was 1.6 months (interquartile range, 0.6 to 3.7 months), with the highest number of deaths occurring during hospitalization related to the Norwood procedure. The most common location of death was at a Single Ventricle Reconstruction trial hospital (74%), followed by home (13%). There were 29 sudden, unexpected deaths (18%), although in retrospect, 12 were preceded by a prodrome. In infants with a single right ventricle undergoing staged repair, the majority of deaths within 12 months of the procedure are due to cardiovascular causes, occur in a hospital, and within the first few months of life. Increased understanding of the circumstances surrounding the deaths of these single ventricle patients may reduce the high mortality rate. Copyright © 2012 The American Association for Thoracic Surgery. All rights reserved.

Kernel-Correlated Levy Field Driven Forward Rate and Application to Derivative Pricing

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

Bo Lijun; Wang Yongjin; Yang Xuewei, E-mail: xwyangnk@yahoo.com.cn

2013-08-01

We propose a term structure of forward rates driven by a kernel-correlated Levy random field under the HJM framework. The kernel-correlated Levy random field is composed of a kernel-correlated Gaussian random field and a centered Poisson random measure. We shall give a criterion to preclude arbitrage under the risk-neutral pricing measure. As applications, an interest rate derivative with general payoff functional is priced under this pricing measure.

Graphene based widely-tunable and singly-polarized pulse generation with random fiber lasers

PubMed Central

Yao, B. C.; Rao, Y. J.; Wang, Z. N.; Wu, Y.; Zhou, J. H.; Wu, H.; Fan, M. Q.; Cao, X. L.; Zhang, W. L.; Chen, Y. F.; Li, Y. R.; Churkin, D.; Turitsyn, S.; Wong, C. W.

2015-01-01

Pulse generation often requires a stabilized cavity and its corresponding mode structure for initial phase-locking. Contrastingly, modeless cavity-free random lasers provide new possibilities for high quantum efficiency lasing that could potentially be widely tunable spectrally and temporally. Pulse generation in random lasers, however, has remained elusive since the discovery of modeless gain lasing. Here we report coherent pulse generation with modeless random lasers based on the unique polarization selectivity and broadband saturable absorption of monolayer graphene. Simultaneous temporal compression of cavity-free pulses are observed with such a polarization modulation, along with a broadly-tunable pulsewidth across two orders of magnitude down to 900 ps, a broadly-tunable repetition rate across three orders of magnitude up to 3 MHz, and a singly-polarized pulse train at 41 dB extinction ratio, about an order of magnitude larger than conventional pulsed fiber lasers. Moreover, our graphene-based pulse formation also demonstrates robust pulse-to-pulse stability and wide-wavelength operation due to the cavity-less feature. Such a graphene-based architecture not only provides a tunable pulsed random laser for fiber-optic sensing, speckle-free imaging, and laser-material processing, but also a new way for the non-random CW fiber lasers to generate widely tunable and singly-polarized pulses. PMID:26687730

Graphene based widely-tunable and singly-polarized pulse generation with random fiber lasers.

PubMed

Yao, B C; Rao, Y J; Wang, Z N; Wu, Y; Zhou, J H; Wu, H; Fan, M Q; Cao, X L; Zhang, W L; Chen, Y F; Li, Y R; Churkin, D; Turitsyn, S; Wong, C W

2015-12-21

Pulse generation often requires a stabilized cavity and its corresponding mode structure for initial phase-locking. Contrastingly, modeless cavity-free random lasers provide new possibilities for high quantum efficiency lasing that could potentially be widely tunable spectrally and temporally. Pulse generation in random lasers, however, has remained elusive since the discovery of modeless gain lasing. Here we report coherent pulse generation with modeless random lasers based on the unique polarization selectivity and broadband saturable absorption of monolayer graphene. Simultaneous temporal compression of cavity-free pulses are observed with such a polarization modulation, along with a broadly-tunable pulsewidth across two orders of magnitude down to 900 ps, a broadly-tunable repetition rate across three orders of magnitude up to 3 MHz, and a singly-polarized pulse train at 41 dB extinction ratio, about an order of magnitude larger than conventional pulsed fiber lasers. Moreover, our graphene-based pulse formation also demonstrates robust pulse-to-pulse stability and wide-wavelength operation due to the cavity-less feature. Such a graphene-based architecture not only provides a tunable pulsed random laser for fiber-optic sensing, speckle-free imaging, and laser-material processing, but also a new way for the non-random CW fiber lasers to generate widely tunable and singly-polarized pulses.

Tales told by tails: watching DNA driven through a random medium

NASA Astrophysics Data System (ADS)

Guan, Juan; Wang, Bo; Bae, Sung Chul; Granick, Steve

2013-03-01

DNA ligation is used to label separately the ends and centers of monodisperse DNA 16 μm in contour length, and 2-color fluorescence microscopy is used to follow with nm resolution how chains migrate through agarose networks driven by electric fields, at both whole chain and segment level. We observe that the leading segment is always a physical chain end which stretches and pulls out slack in the still-quiescent remainder of the chain until the other end is taken up. Heads and tails behave strikingly differently: the leading end of migrating chains migrates more smoothly, whereas motion of the trailing end shows intermittent pauses and jerky recoil. None of the mechanisms imagined classically for this situation - chain reptation, hooking or entropic trapping, appears to fully describe these data obtained from single-molecule visualization.

The effect of long-range order on the elastic properties of Cu3Au

NASA Astrophysics Data System (ADS)

Wang, Gui-Sheng; Krisztina Delczeg-Czirjak, Erna; Hu, Qing-Miao; Kokko, Kalevi; Johansson, Börje; Vitos, Levente

2013-02-01

Ab initio calculations, based on the exact muffin-tin orbitals method are used to determine the elastic properties of Cu-Au alloys with Au/Cu ratio 1/3. The compositional disorder is treated within the coherent potential approximation. The lattice parameters and single-crystal elastic constants are calculated for different partially ordered structures ranging from the fully ordered L12 to the random face centered cubic lattice. It is shown that the theoretical elastic constants follow a clear trend with the degree of chemical order: namely, C11 and C12 decrease, whereas C44 remains nearly constant with increasing disorder. The present results are in line with the experimental findings that the impact of the chemical ordering on the fundamental elastic parameters is close to the resolution of the available experimental and theoretical tools.

CM-2 Environmental/Modal Testing of SPACEHAB Racks

NASA Technical Reports Server (NTRS)

McNelis, Mark E.; Goodnight, Thomas W.

2001-01-01

Combined environmental/modal vibration testing has been implemented at the NASA Glenn Research Center's Structural Dynamics Laboratory. The benefits of combined vibration testing are that it facilitates test article modal characterization and vibration qualification testing. The Combustion Module-2 (CM-2) is a space experiment that will launch on shuttle mission STS-107 in the SPACEHAB Research Double Module. The CM-2 flight hardware is integrated into a SPACEHAB single and double rack. CM-2 rack-level combined vibration testing was recently completed on a shaker table to characterize the structure's modal response and verify the random vibration response. Control accelerometers and limit force gauges, located between the fixture and rack interface, were used to verify the input excitation. Results of the testing were used to verify the loads and environments for flight on the shuttles.

Immunotherapy for cow's milk allergy

PubMed Central

Takahashi, Masaya; Soejima, Kazukiko; Hatano, Yasuko; Minami, Hirotaka

2017-01-01

ABSTRACT Oral immunotherapy (OIT) is used regularly for young children with cow's milk (CM) allergy and has been shown to be effective in several studies. However, adverse events occur frequently during OIT. Furthermore, there are only 5 randomized controlled trial studies of CM-OIT and these are low-powered single center trials. Therefore, evidence levels are also low and sometimes frequent and severe allergic events occur during the OIT. Furthermore, there are no standardized protocols in pediatric allergy guidelines from several countries and studies with long-term follow-up observations and clinical tolerance defined as sustained unresponsiveness are rare. Additionally, clinical tolerance by OIT is generally not well defined and obscure. Thus, several problems remain to be resolved, however we hope OIT in combination with omalizumab and less allergenic heated CM products will resolve these problems in the future. PMID:28825866

Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial.

PubMed

Grochola, Lukasz Filip; Soll, Christopher; Zehnder, Adrian; Wyss, Roland; Herzog, Pascal; Breitenstein, Stefan

2017-02-09

Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon's stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date. This study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon's stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon's physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1 st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon's comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10-15%) resulted in a number of 30 randomized patients per arm. The study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to conventional laparoscopic approaches in cholecystectomy, one of the most frequently performed operations in general surgery. This trial is registered at clinicaltrials.gov (trial number: NCT02485392 ). Registered February 19, 2015.

The effects of noise due to random undetected tilts and paleosecular variation on regional paleomagnetic directions

USGS Publications Warehouse

Calderone, G.J.; Butler, R.F.

1991-01-01

Random tilting of a single paleomagnetic vector produces a distribution of vectors which is not rotationally symmetric about the original vector and therefore not Fisherian. Monte Carlo simulations were performed on two types of vector distributions: 1) distributions of vectors formed by perturbing a single original vector with a Fisher distribution of bedding poles (each defining a tilt correction) and 2) standard Fisher distributions. These simulations demonstrate that inclinations of vectors drawn from both distributions are biased toward shallow inclinations. The Fisher mean direction of the distribution of vectors formed by perturbing a single vector with random undetected tilts is biased toward shallow inclinations, but this bias is insignificant for angular dispersions of bedding poles less than 20??. -from Authors

Orally Formulated Artemisinin in Healthy Fasting Vietnamese Male Subjects: A Randomized, Four-Sequence, Open-Label, Pharmacokinetic Crossover Study

PubMed Central

Hien, Tran Tinh; Hanpithakpong, Warunee; Truong, Nguyen Thanh; Dung, Nguyen Thi; Toi, Pham Van; Farrar, Jeremy; Lindegardh, Niklas; Tarning, Joel; Ashton, Michael

2011-01-01

Background Artemisinin derivatives are used in antimalarial drug combination therapy. Artemisinin and piperaquine have recently been proven to be prospective candidates for combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Objective The goal of this study was to evaluate the relative bioavailability and to characterize the pharmacokinetic properties of a new micronized powder formulation of artemisinin against the previous standard Vietnamese formulation when administered as a single oral dose or in combination with piperaquine. Methods This was a single-center, randomized, 4-sequence, open-label, crossover study conducted in 15 healthy male Vietnamese volunteers under fasting conditions with a washout period of 3 weeks between study visits. A single oral dose of 160 or 500 mg of artemisinin was administered alone or in combination with piperaquine. Potential adverse events were monitored daily by the clinician and by using laboratory test results. Frequent blood samples were drawn for 12 hours after dose. Artemisinin was quantified in plasma using LC-MS/MS. Pharmacokinetic parameters were computed from the plasma concentration–time profiles using a noncompartmental analysis method. Results Pharmacokinetic parameters Tmax, Cmax, AUC0-∞, Vd/F, CL/F, and t1/2 (mean [SD]) for the new formulation of artemisinin were 1.83 (0.88) hours, 178 (97) ng/mL, 504 (210) h × ng/mL, 1270 (780) L, 401 (260) L/h, and 2.21 (0.29) hours, respectively. The mean percentage of the test/reference formulation ratio for the logarithmically transformed values of Cmax, AUC0–last, and AUC0–∞ were 121% (90% CI, 92.5–158), 122% (90% CI, 101–148), and 120% (90% CI, 98.0–146), respectively. Conclusions This single-dose study found that the dose-normalized Cmax, AUC0–last, and AUC0–∞ mean geometric differences between the test and reference formulations were relatively small (<40%) and will probably not have a clinical impact in the treatment of malaria infections. PMID:21665048

Encapsulation of single cells on a microfluidic device integrating droplet generation with fluorescence-activated droplet sorting.

PubMed

Wu, Liang; Chen, Pu; Dong, Yingsong; Feng, Xiaojun; Liu, Bi-Feng

2013-06-01

Encapsulation of single cells is a challenging task in droplet microfluidics due to the random compartmentalization of cells dictated by Poisson statistics. In this paper, a microfluidic device was developed to improve the single-cell encapsulation rate by integrating droplet generation with fluorescence-activated droplet sorting. After cells were loaded into aqueous droplets by hydrodynamic focusing, an on-flight fluorescence-activated sorting process was conducted to isolate droplets containing one cell. Encapsulation of fluorescent polystyrene beads was investigated to evaluate the developed method. A single-bead encapsulation rate of more than 98 % was achieved under the optimized conditions. Application to encapsulate single HeLa cells was further demonstrated with a single-cell encapsulation rate of 94.1 %, which is about 200 % higher than those obtained by random compartmentalization. We expect this new method to provide a useful platform for encapsulating single cells, facilitating the development of high-throughput cell-based assays.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Likelihood of Entanglement when Materials are Dropped Vertically onto a Rotating PTO Knuckle.

PubMed

Schwab, Charles V; Rempe, Isaac J

2017-11-20

Power take-off (PTO) is a common method of transferring power from a tractor to a towed piece of machinery. The PTO is also a well-documented cause of severe and often permanent disabling injuries to farm operators. The physical conditions that cause entanglements are not well established. Several studies have explored the parameters of PTO entanglements as materials have been drawn across a rotating PTO knuckle to test for entanglement probability. The objective of this study was to determine probability of entanglement when materials are dropped vertically onto a PTO knuckle spinning at 540 rpm. A total of 360 randomized trials were conducted with ten replications for each of the six positions (center of yoke, edge of yoke rotating downward, edge of yoke rotating upward, center of cross, edge of cross rotating downward, and edge of cross rotating upward) and six different materials (woven cotton athletic shoe lace, cotton workboot lace, leather workboot lace, cotton twine, denim strip, and Tyvek strip). Not a single entanglement was recorded. Dramatic high-speed video imagery authenticated the material's motion and path as it interacted with the rotating PTO knuckle. Copyright© by the American Society of Agricultural Engineers.

A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women

DTIC Science & Technology

2004-10-01

This study is a randomized clinical trial comparing two types of individual psychotherapy for treating PTSD in 384 female veterans and active duty...Exposure therapy will be more effective than Present Centered Therapy for the treatment of PTSD in female veterans and active duty personnel. The study has entered the randomized phase. There are no conclusions to date.

Distinct Molecular Phenotypes of Direct vs Indirect ARDS in Single-Center and Multicenter Studies

PubMed Central

Janz, David R.; Bernard, Gordon R.; May, Addison K.; Kangelaris, Kirsten N.; Matthay, Michael A.; Ware, Lorraine B.

2015-01-01

BACKGROUND: ARDS is a heterogeneous syndrome that encompasses lung injury from both direct and indirect sources. Direct ARDS (pneumonia, aspiration) has been hypothesized to cause more severe lung epithelial injury than indirect ARDS (eg, nonpulmonary sepsis); however, this hypothesis has not been well studied in humans. METHODS: We measured plasma biomarkers of lung epithelial and endothelial injury and inflammation in a single-center study of 100 patients with ARDS and severe sepsis and in a secondary analysis of 853 patients with ARDS drawn from a multicenter randomized controlled trial. Biomarker levels in patients with direct vs indirect ARDS were compared in both cohorts. RESULTS: In both studies, patients with direct ARDS had significantly higher levels of a biomarker of lung epithelial injury (surfactant protein D) and significantly lower levels of a biomarker of endothelial injury (angiopoietin-2) than those with indirect ARDS. These associations were robust to adjustment for severity of illness and ARDS severity. In the multicenter study, patients with direct ARDS also had lower levels of von Willebrand factor antigen and IL-6 and IL-8, markers of endothelial injury and inflammation, respectively. The prognostic value of the biomarkers was similar in direct and indirect ARDS. CONCLUSIONS: Direct lung injury in humans is characterized by a molecular phenotype consistent with more severe lung epithelial injury and less severe endothelial injury. The opposite pattern was identified in indirect lung injury. Clinical trials of novel therapies targeted specifically at the lung epithelium or endothelium may benefit from preferentially enrolling patients with direct and indirect ARDS, respectively. PMID:26033126

Impact of New Quick Gold Nanoparticle-Based Cortisol Assay During Adrenal Vein Sampling for Primary Aldosteronism.

PubMed

Yoneda, Takashi; Karashima, Shigehiro; Kometani, Mitsuhiro; Usukura, Mikiya; Demura, Masashi; Sanada, Junichirou; Minami, Tetsuya; Koda, Wataru; Gabata, Toshifumi; Matsui, Osamu; Idegami, Koutarou; Takamura, Yuzuru; Tamiya, Eiichi; Oe, Masashi; Nakai, Masuo; Mori, Shunsuke; Terayama, Noboru; Matsuda, Yuichi; Kamemura, Kouhei; Fujii, Sumie; Seta, Takashi; Sawamura, Toshitaka; Okuda, Rika; Takeda, Yoshimichi; Hayashi, Kenshi; Yamagishi, Masakazu; Takeda, Yoshiyu

2016-06-01

Adrenal vein sampling (AVS) is essential for identifying a surgically curable form of primary aldosteronism (PA), but accurate placement of the sampling catheter is technically challenging. Intraprocedural cortisol measurement can confirm the catheter's position, thereby increasing the AVS success rate. We developed a quick cortisol assay (QCA) that uses immunochromatography and gold nanoparticles and can be performed either semiquantitatively or quantitatively. The assay was evaluated in two studies. In a single-center study, PA patients were assigned to undergo AVS incorporating the semiquantitative QCA (n = 30), the quantitative QCA (n = 30), or without the QCA (n = 30), and the rates of successful AVS were determined. In a prospective multicenter randomized, controlled study, the success rates of AVS performed with (n = 148) or without (n = 145) the semiquantitative QCA were determined. Cortisol concentrations were measured during AVS in 6 minutes or less in the radiology suite, without additional technical assistance, and significantly correlated with a conventional reference assay (R(2) = 0.994; P < .001). In the single-center study, the differences in the AVS success rates associated with semiquantitative and quantitative QCAs were not significant (both 93%); however, the success rates were significantly higher than the rate of successful AVS performed without using the QCA (63%; P < .001). The success rate of AVS performed in the multicenter study was 94% for the semiquantitative QCA, which was significantly higher than the rate for the patients without QCA (60%; P < .001). Our novel QCA was rapidly and easily performed at the point of care and improved the rate of successful AVS.

Distinct molecular phenotypes of direct vs indirect ARDS in single-center and multicenter studies.

PubMed

Calfee, Carolyn S; Janz, David R; Bernard, Gordon R; May, Addison K; Kangelaris, Kirsten N; Matthay, Michael A; Ware, Lorraine B

2015-06-01

ARDS is a heterogeneous syndrome that encompasses lung injury from both direct and indirect sources. Direct ARDS (pneumonia, aspiration) has been hypothesized to cause more severe lung epithelial injury than indirect ARDS (eg, nonpulmonary sepsis); however, this hypothesis has not been well studied in humans. We measured plasma biomarkers of lung epithelial and endothelial injury and inflammation in a single-center study of 100 patients with ARDS and severe sepsis and in a secondary analysis of 853 patients with ARDS drawn from a multicenter randomized controlled trial. Biomarker levels in patients with direct vs indirect ARDS were compared in both cohorts. In both studies, patients with direct ARDS had significantly higher levels of a biomarker of lung epithelial injury (surfactant protein D) and significantly lower levels of a biomarker of endothelial injury (angiopoietin-2) than those with indirect ARDS. These associations were robust to adjustment for severity of illness and ARDS severity. In the multicenter study, patients with direct ARDS also had lower levels of von Willebrand factor antigen and IL-6 and IL-8, markers of endothelial injury and inflammation, respectively. The prognostic value of the biomarkers was similar in direct and indirect ARDS. Direct lung injury in humans is characterized by a molecular phenotype consistent with more severe lung epithelial injury and less severe endothelial injury. The opposite pattern was identified in indirect lung injury. Clinical trials of novel therapies targeted specifically at the lung epithelium or endothelium may benefit from preferentially enrolling patients with direct and indirect ARDS, respectively.

Absolute Effect of Prostate Cancer Screening: Balance of benefits and harms by center within the European Randomized Study of Prostate Cancer Screening

PubMed Central

Auvinen, Anssi; Moss, Sue M; Tammela, Teuvo L J; Taari, Kimmo; Roobol, Monique J; Schröder, Fritz H; Bangma, Chris H; Carlsson, Sigrid; Aus, Gunnar; Zappa, Marco; Puliti, Donella; Denis, Louis J; Nelen, Vera; Kwiatkowski, Maciej; Randazzo, Marco; Paez, Alvaro; Lujan, Marcos; Hugosson, Jonas

2016-01-01

Purpose The balance of benefits and harms in prostate cancer screening has not been sufficiently characterized. We related indicators of mortality reduction and overdetection by center within the European Randomized Study of Prostate Cancer Screening. Experimental Design We analyzed the absolute mortality reduction expressed as number needed to invite (NNI=1/absolute risk reduction; indicating how many men had to be randomized to screening arm to avert a prostate cancer death) for screening and the absolute excess of prostate cancer detection as number needed for overdetection (NNO=1/absolute excess incidence; indicating the number of men invited per additional prostate cancer case), and compared their relationship across the seven ERSPC centers. Results Both absolute mortality reduction (NNI) and absolute overdetection (NNO) varied widely between the centers: NNI 200-7000 and NNO 16-69. Extent of overdiagnosis and mortality reduction were closely associated (correlation coefficient r=0.76, weighted linear regression coefficient β=33, 95% 5-62, R2=0.72). For an averted prostate cancer death at 13 years of follow-up, 12-36 excess cases had to be detected in various centers. Conclusions The differences between the ERSPC centers likely reflect variations in prostate cancer incidence and mortality, as well as in screening protocol and performance. The strong interrelation between the benefits and harms suggests that efforts to maximize the mortality effect are bound to increase overdiagnosis, and might be improved by focusing on high-risk populations. The optimal balance between screening intensity and risk of overdiagnosis remains unclear. PMID:26289069

Comparison of single-use and reusable metal laryngoscope blades for orotracheal intubation during rapid sequence induction of anesthesia: a multicenter cluster randomized study.

PubMed

Amour, Julien; Le Manach, Yannick Le; Borel, Marie; Lenfant, François; Nicolas-Robin, Armelle; Carillion, Aude; Ripart, Jacques; Riou, Bruno; Langeron, Olivier

2010-02-01

Single-use metal laryngoscope blades are cheaper and carry a lower risk of infection than reusable metal blades. The authors compared single-use and reusable metal blades during rapid sequence induction of anesthesia in a multicenter cluster randomized trial. One thousand seventy-two adult patients undergoing general anesthesia under emergency conditions and requiring rapid sequence induction were randomly assigned on a weekly basis to either single-use or reusable metal blades (cluster randomization). After induction, a 60-s period was allowed to complete intubation. In the case of failed intubation, a second attempt was performed using the opposite type of blade. The primary endpoint was the rate of failed intubation, and the secondary endpoints were the incidence of complications (oxygen desaturation, lung aspiration, and/or oropharynx trauma) and the Cormack and Lehane score. Both groups were similar in their main characteristics, including the risk factors for difficult intubation. The rate of failed intubation was significantly decreased with single-use metal blades at the first attempt compared with reusable blades (2.8 vs. 5.4%, P < 0.05). In addition, the proportion of grades III and IV in Cormack and Lehane score were also significantly decreased with single-use metal blades (6 vs. 10%, P < 0.05). The global complication rate did not reach statistical significance, although the same trend was noted (6.8% vs. 11.5%, P = not significant). An investigator survey and a measure of illumination pointed that illumination might have been responsible for this result. The single-use metal blade was more efficient than a reusable metal blade in rapid sequence induction of anesthesia.

One Year Primary Patency of Infrapopliteal Angioplasty Using Drug- Eluting Balloons: Single Center Experience at King Hussein Medical Center

PubMed Central

Haddad, Sizeph Edward; Shishani, Jan Mohammad; Qtaish, Izzeddin; Rawashdeh, Mohammad Abdelmajeed; Qtaishat, Belal Saleh

2017-01-01

Objective: Conventional percutaneous transluminal angioplasty (PTA) for long lesions in the below-the-knee (BTK) arteries in patients presenting with critical limb ischemia (CLI) has high restenosis rates at 1 year. Our goal is to evaluate whether paclitaxel drug-eluting balloons (DEB) have higher 1 year primary patency rates compared to conventional PTA. Methods: This is a single-center, prospective, randomized trial that was conducted from June 2013 to December 2015. The aim of the study was to compare 1 year primary patency rates of DEB and PTA in BTK arteries in CLI patients. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), stenosis or occlusion ≥30 mm of at least one tibial artery, and agreement to 12-month evaluation. Exclusion criteria were life expectancy <1 year, allergy to paclitaxel, and contraindication to combined antiplatelet treatment. Follow-up was performed by clinical assessment, ankle brachial pressure index, Doppler ultrasound imaging, and conventional angiogram if indicated. Primary end point was 1 year primary patency, and secondary end points were target lesion revascularization (TLR) and major amputation. Statistical analysis was performed using Fischer's exact test. Results: Ninety-three patients with 106 lesions in the BTK arteries were enrolled in this study. One year primary patency was achieved in 26 (65%) and seven (17%) in the DEB and PTA groups (P = 0.006), respectively. TLR was performed in nine lesions (23%) and 29 lesions (71%) in DEB and PTA groups (P = 0.009), respectively. Major amputations occurred in one limb (2%) and two limbs (4%) in DEB and PTA groups (P = 0.6), respectively. Conclusion: Paclitaxel DEB has significantly higher 1 year primary patency rate associated with significantly less TLR than conventional PTA, following endovascular recanalization of BTK arteries in patients presenting with CLI. PMID:28852581

The advantages and disadvantages of centralized control of air power at operational level

NASA Astrophysics Data System (ADS)

Arisoy, Uǧur

2014-05-01

People do not want to see and hear a war. In today's world, if war is inevitable, the use of air power is seen as the preferable means of conducting operations instead of financially burdensome land battles which are more likely to cause heavy loss of life. The use of Air Power has gained importance in NATO operations in the Post-Cold War era. For example, air power has undertaken a decisive role from the beginning to the end of the operation in Libya. From this point of view, the most important issue to consider is how to direct air power more effectively at operational level. NATO's Core JFAC (Joint Force Air Command) was established in 2012 to control joint air power at operational level from a single center. US had experienced JFAC aproach in the Operation Desert Storm in 1991. UK, France, Germany, Italy and Spain are also directing their air power from their JFAC structures. Joint air power can be directed from a single center at operational level by means of JFAC. JFAC aproach provides complex planning progress of Air Power to be controled faster in a single center. An Air Power with a large number of aircrafts, long range missiles of cutting-edge technology may have difficulties in achieving results unless directed effectively. In this article, directing air power more effectively at operational level has been studied in the framework of directing air power from a single center carried out by SWOT analysis technique. "Directing Air Power at operational level from a single center similar to JFAC-like structure" is compared with "Directing Air Power at operational level from two centers similar to AC (Air Command) + CAOC (Combined Air Operations Center) structure" As a result of this study, it is assessed that directing air power at operational level from a single center would bring effectiveness to the air campaign. The study examines directing air power at operational level. Developments at political, strategic and tactical levels have been ignored.

Effect of Task-Centered Instructional Programs on Hypertensives' Ability to Achieve and Maintain Reduced Dietary Sodium Intake.

ERIC Educational Resources Information Center

Mann, Karen V.; Sullivan, Patricia L.

This study sought to determine the effectiveness of systematically designed instructional programs in helping adult hypertensives to achieve and maintain dietary sodium intake. Sixty-six subjects were randomly allocated to one of three groups: task-centered instruction; task-centered instruction plus goal-setting and self-monitoring; or control.…

Radiation Effects of Commercial Resistive Random Access Memories

NASA Technical Reports Server (NTRS)

Chen, Dakai; LaBel, Kenneth A.; Berg, Melanie; Wilcox, Edward; Kim, Hak; Phan, Anthony; Figueiredo, Marco; Buchner, Stephen; Khachatrian, Ani; Roche, Nicolas

2014-01-01

We present results for the single-event effect response of commercial production-level resistive random access memories. We found that the resistive memory arrays are immune to heavy ion-induced upsets. However, the devices were susceptible to single-event functional interrupts, due to upsets from the control circuits. The intrinsic radiation tolerant nature of resistive memory makes the technology an attractive consideration for future space applications.

A Randomized Trial of Cognitive Behaviour Therapy and Cognitive Therapy for Children with Posttraumatic Stress Disorder following Single-Incident Trauma

ERIC Educational Resources Information Center

Nixon, Reginald David Vandervord; Sterk, Jisca; Pearce, Amanda

2012-01-01

The present study compared the efficacy of trauma-focused cognitive behavior therapy (CBT) with trauma-focused cognitive therapy (without exposure; CT) for children and youth with posttraumatic stress disorder (PTSD). Children and youth who had experienced single-incident trauma (N = 33; 7-17 years old) were randomly assigned to receive 9 weeks of…

Clustering Single-Cell Expression Data Using Random Forest Graphs.

PubMed

Pouyan, Maziyar Baran; Nourani, Mehrdad

2017-07-01

Complex tissues such as brain and bone marrow are made up of multiple cell types. As the study of biological tissue structure progresses, the role of cell-type-specific research becomes increasingly important. Novel sequencing technology such as single-cell cytometry provides researchers access to valuable biological data. Applying machine-learning techniques to these high-throughput datasets provides deep insights into the cellular landscape of the tissue where those cells are a part of. In this paper, we propose the use of random-forest-based single-cell profiling, a new machine-learning-based technique, to profile different cell types of intricate tissues using single-cell cytometry data. Our technique utilizes random forests to capture cell marker dependences and model the cellular populations using the cell network concept. This cellular network helps us discover what cell types are in the tissue. Our experimental results on public-domain datasets indicate promising performance and accuracy of our technique in extracting cell populations of complex tissues.

Compartmentalization Technologies via Self-Assembly and Cross-Linking of Amphiphilic Random Block Copolymers in Water.

PubMed

Matsumoto, Mayuko; Terashima, Takaya; Matsumoto, Kazuma; Takenaka, Mikihito; Sawamoto, Mitsuo

2017-05-31

Orthogonal self-assembly and intramolecular cross-linking of amphiphilic random block copolymers in water afforded an approach to tailor-make well-defined compartments and domains in single polymer chains and nanoaggregates. For a double compartment single-chain polymer, an amphiphilic random block copolymer bearing hydrophilic poly(ethylene glycol) (PEG) and hydrophobic dodecyl, benzyl, and olefin pendants was synthesized by living radical polymerization (LRP) and postfunctionalization; the dodecyl and benzyl units were incorporated into the different block segments, whereas PEG pendants were statistically attached along a chain. The copolymer self-folded via the orthogonal self-assembly of hydrophobic dodecyl and benzyl pendants in water, followed by intramolecular cross-linking, to form a single-chain polymer carrying double yet distinct hydrophobic nanocompartments. A single-chain cross-linked polymer with a chlorine terminal served as a globular macroinitiator for LRP to provide an amphiphilic tadpole macromolecule comprising a hydrophilic nanoparticle and a hydrophobic polymer tail; the tadpole thus self-assembled into multicompartment aggregates in water.

Optical characterization of single-crystal diamond grown by DC arc plasma jet CVD

NASA Astrophysics Data System (ADS)

Hei, Li-fu; Zhao, Yun; Wei, Jun-jun; Liu, Jin-long; Li, Cheng-ming; Lü, Fan-xiu

2017-12-01

Optical centers of single-crystal diamond grown by DC arc plasma jet chemical vapor deposition (CVD) were examined using a low-temperature photoluminescence (PL) technique. The results show that most of the nitrogen-vacancy (NV) complexes are present as NV- centers, although some H2 and H3 centers and B-aggregates are also present in the single-crystal diamond because of nitrogen aggregation resulting from high N2 incorporation and the high mobility of vacancies under growth temperatures of 950-1000°C. Furthermore, emissions of radiation-induced defects were also detected at 389, 467.5, 550, and 588.6 nm in the PL spectra. The reason for the formation of these radiation-induced defects is not clear. Although a Ni-based alloy was used during the diamond growth, Ni-related emissions were not detected in the PL spectra. In addition, the silicon-vacancy (Si-V)-related emission line at 737 nm, which has been observed in the spectra of many previously reported microwave plasma chemical vapor deposition (MPCVD) synthetic diamonds, was absent in the PL spectra of the single-crystal diamond prepared in this work. The high density of NV- centers, along with the absence of Ni-related defects and Si-V centers, makes the single-crystal diamond grown by DC arc plasma jet CVD a promising material for applications in quantum computing.

Blastocyst culture using single versus sequential media in clinical IVF: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Sfontouris, Ioannis A; Martins, Wellington P; Nastri, Carolina O; Viana, Iara G R; Navarro, Paula A; Raine-Fenning, Nick; van der Poel, Sheryl; Rienzi, Laura; Racowsky, Catherine

2016-10-01

The purpose of this study was to undertake a review of the available evidence comparing the use of a single medium versus sequential media for embryo culture to the blastocyst stage in clinical IVF. We searched the Cochrane Central, PubMed, Scopus, ClinicalTrials.gov, Current Controlled Trials and WHO International Clinical Trials Registry Platform to identify randomized controlled trials comparing single versus sequential media for blastocyst culture and ongoing pregnancy rate. Included studies randomized either oocytes/zygotes or women. Eligible oocyte/zygote studies were analyzed to assess the risk difference (RD) and 95 % confidence intervals (CI) between the two media systems; eligible woman-based studies were analyzed to assess the risk ratio (RR) and 95 % CI for clinical pregnancy rate. No differences were observed between single and sequential media for either ongoing pregnancy per randomized woman (relative risk (RR) = 0.9, 95 % CI = 0.7 to 1.3, two studies including 246 women, I 2  = 0 %) or clinical pregnancy per randomized woman (RR = 1.0, 95 % CI = 0.7 to 1.4, one study including 100 women); or miscarriage per clinical pregnancy: RR = 1.3, 95 % CI = 0.4 to 4.3, two studies including 246 participants, I 2  = 0 %). Single media use was associated with an increase blastocyst formation per randomized oocyte/zygote (relative distribution (RD) = +0.06, 95 % CI = +0.01 to +0.12, ten studies including 7455 oocytes/zygotes, I 2  = 83 %) but not top/high blastocyst formation (RD = +0.05, 95 % CI = -0.01 to +0.11, five studies including 3879 oocytes/zygotes, I 2  = 93 %). The overall quality of the evidence was very low for all these four outcomes. Although using a single medium for extended culture has some practical advantages and blastocyst formation rates appear to be higher, there is insufficient evidence to recommend either sequential or single-step media as being superior for the culture of embryos to days 5/6. Future studies comparing these two media systems in well-designed trials should be performed.

Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial.

PubMed

Nyberg, Andrè; Saey, Didier; Martin, Mickaël; Maltais, François

2015-04-27

Low-load, high-repetitive single-limb resistance training may increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while minimizing the occurrence of limiting exertional symptoms. Whether high-repetitive single-limb resistance training would perform better than high-repetitive two-limb resistance training is unknown. In addition, the mechanisms underlying possible benefits of high-repetitive resistance training has not been investigated. The aims of this study are to compare single versus two-limb high-repetitive resistance training in patients with COPD and to investigate mechanisms of action of these training modalities. This trial is a prospective, assessor-blind, randomized controlled trial. The participants are patients with stable severe to very severe COPD who are older than 40 years of age and healthy controls. The intervention is single-limb, high-repetitive, resistance training with elastic bands, three times/week for 8 weeks. The control is two-limb high-repetitive resistance training with elastic bands, three times/week for 8 weeks. The primary outcomes is change in the 6-min walking distance after 8 weeks of single-limb or two-limb high-repetitive resistance training. The secondary outcomes are changes in limb muscle strength and endurance capacity, key protein involved in quadriceps anabolic/catabolic signalization, fiber-type distribution and capillarization, subjective dyspnea and muscle fatigue, muscle oxygenation, cardiorespiratory demand and health-related quality-of-life after 8 weeks of single-limb or two-limb high-repetitive resistance training. The acute effects of single-limb versus two-limb high-repetitive resistance training on contractile fatigue, exercise stimulus (the product of number of repetition and load), subjective dyspnea and muscle fatigue, muscle oxygenation, and cardiorespiratory demand during upper and lower limb exercises will also be investigated in patients with COPD and healthy controls. Randomization will be performed using a random number generator by a person independent of the recruitment process, using 1:1 allocation to the intervention and the control group using random block sizes. All outcome assessors will be blinded to group assignment. The results of this project will provide important information to help developing and implementing customized exercise training programs for patients with COPD. ClinicalTrials.gov Identifier NCT02283580 Registration date: 4 November 2014. First participant randomized: 10 November 2014.

EPR study of free radical in gamma-irradiated bis(cyclopentadienyl)zirconium dichloride single crystal

NASA Astrophysics Data System (ADS)

Caliskan, Betul; Caliskan, Ali Cengiz

2017-06-01

Bis(cyclopentadienyl)zirconium dichloride (BCZD; zirconocene dichloride) single crystals were exposed to 60Co-γ irradiation at room temperature. The irradiated single crystals were investigated between 125 and 470 K by electron paramagnetic resonance spectroscopy. The spectra of the crystals were found to be temperature independent. The paramagnetic center was attributed to the cyclopentadienyl radical. The g values of the radiation damage center observed in BCZD single crystal and the hyperfine structure constants of the free electron with nearby protons were obtained.

Complete coherent control of silicon vacancies in diamond nanopillars containing single defect centers

DOE PAGES

Zhang, Jingyuan Linda; Lagoudakis, Konstantinos G.; Tzeng, Yan -Kai; ...

2017-10-23

Arrays of identical and individually addressable qubits lay the foundation for the creation of scalable quantum hardware such as quantum processors and repeaters. Silicon-vacancy (SiV) centers in diamond offer excellent physical properties such as low inhomogeneous broadening, fast photon emission, and a large Debye–Waller factor. The possibility for all-optical ultrafast manipulation and techniques to extend the spin coherence times makes them promising candidates for qubits. Here, we have developed arrays of nanopillars containing single (SiV) centers with high yield, and we demonstrate ultrafast all-optical complete coherent control of the excited state population of a single SiV center at the opticalmore » transition frequency. The high quality of the chemical vapor deposition (CVD) grown SiV centers provides excellent spectral stability, which allows us to coherently manipulate and quasi-resonantly read out the excited state population of individual SiV centers on picosecond timescales using ultrafast optical pulses. Furthermore, this work opens new opportunities to create a scalable on-chip diamond platform for quantum information processing and scalable nanophotonics applications.« less

Complete coherent control of silicon vacancies in diamond nanopillars containing single defect centers

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

Zhang, Jingyuan Linda; Lagoudakis, Konstantinos G.; Tzeng, Yan -Kai

Arrays of identical and individually addressable qubits lay the foundation for the creation of scalable quantum hardware such as quantum processors and repeaters. Silicon-vacancy (SiV) centers in diamond offer excellent physical properties such as low inhomogeneous broadening, fast photon emission, and a large Debye–Waller factor. The possibility for all-optical ultrafast manipulation and techniques to extend the spin coherence times makes them promising candidates for qubits. Here, we have developed arrays of nanopillars containing single (SiV) centers with high yield, and we demonstrate ultrafast all-optical complete coherent control of the excited state population of a single SiV center at the opticalmore » transition frequency. The high quality of the chemical vapor deposition (CVD) grown SiV centers provides excellent spectral stability, which allows us to coherently manipulate and quasi-resonantly read out the excited state population of individual SiV centers on picosecond timescales using ultrafast optical pulses. Furthermore, this work opens new opportunities to create a scalable on-chip diamond platform for quantum information processing and scalable nanophotonics applications.« less

Single-photon continuous-variable quantum key distribution based on the energy-time uncertainty relation.

PubMed

Qi, Bing

2006-09-15

We propose a new quantum key distribution protocol in which information is encoded on continuous variables of a single photon. In this protocol, Alice randomly encodes her information on either the central frequency of a narrowband single-photon pulse or the time delay of a broadband single-photon pulse, while Bob randomly chooses to do either frequency measurement or time measurement. The security of this protocol rests on the energy-time uncertainty relation, which prevents Eve from simultaneously determining both frequency and time information with arbitrarily high resolution. Since no interferometer is employed in this scheme, it is more robust against various channel noises, such as polarization and phase fluctuations.

ADHD Symptom Reduction in Elementary Students: A Single-Case Effectiveness Design

ERIC Educational Resources Information Center

Schottelkorb, April A.; Ray, Dee C.

2009-01-01

The authors used a single-case design to examine the effectiveness of child-centered play therapy (CCPT) and person-centered teacher consultation (PCTC) for four elementary students identified with attention deficit hyperactivity disorder (ADHD) symptoms. Two students participated in CCPT and their teachers participated in PCTC. Two students…

NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research.

PubMed

Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D; Cui, Licong

2015-11-10

A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f1, f2, ..., fk. The input for each function fi has 3 components: a random number r, an integer n, and input data m. The result, fi(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f1(r1, n1, m1), f2(r2, n2, m2), ..., fk(rk, nk, mk). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result of the encryption, concatenated with the random number r, is the final NHash study identifier. We performed experiments using a large synthesized dataset comparing NHash with random strings, and demonstrated neglegible probability for collision. We implemented NHash for the Center for SUDEP Research (CSR), a National Institute for Neurological Disorders and Stroke-funded Center Without Walls for Collaborative Research in the Epilepsies. This multicenter collaboration involves 14 institutions across the United States and Europe, bringing together extensive and diverse expertise to understand sudden unexpected death in epilepsy patients (SUDEP). The CSR Data Repository has successfully used NHash to link deidentified multimodal clinical data collected in participating CSR institutions, meeting all desired objectives of NHash.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A.

PubMed

Welzel, Grit; Boch, Angela; Sperk, Elena; Hofmann, Frank; Kraus-Tiefenbacher, Uta; Gerhardt, Axel; Suetterlin, Marc; Wenz, Frederik

2013-01-07

Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQ-BR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.

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

PubMed Central

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 center. The primary outcomes are FMD differences baseline, 24 hours and 3 months after treatment. The secondary outcomes are differences in C-reactive protein (hs-CRP), glucose serum levels, blood lipid profile, and HOMA index. Discussion This RCT is expected to provide more evidence on the effects of different periodontal treatment modalities on FMD values, as well as to correlate such findings with different surrogate markers of systemic inflammation with cardiovascular effects. Trial registration number ClinicalTrials.gov Identifier: NCT00681564. PMID:21324167

Massage Therapy Restores Peripheral Vascular Function following Exertion

PubMed Central

Franklin, Nina C.; Ali, Mohamed M.; Robinson, Austin T.; Norkeviciute, Edita; Phillips, Shane A.

2014-01-01

Objective To determine if lower extremity exercise-induced muscle injury (EMI) reduces vascular endothelial function of the upper extremity and if massage therapy (MT) improves peripheral vascular function after EMI. Design Randomized, blinded trial with evaluations at 90 minutes, 24 hours, 48 hours, and 72 hours. Setting Clinical research center at an academic medical center and laboratory Participants Thirty-six sedentary young adults were randomly assigned to one of three groups: 1) EMI + MT (n=15; mean age ± standard error (SE): 26.6±0.3), 2) EMI only (n=10; mean age ± SE: 23.6±0.4), and 3) MT only (n=11; mean age ± SE: 25.5 ± 0.4). Intervention Participants were assigned to either EMI only (a single bout of bilateral, eccentric leg-press exercise), MT only (30-minute lower extremity massage using Swedish technique), or EMI + MT. Main outcome measures Brachial artery flow-mediated dilation (FMD) was determined by ultrasound at each time point. Nitroglycerin-induced dilation was also assessed (NTG; 0.4 mg). Results Brachial FMD increased from baseline in the EMI + MT group and the MT only group (7.38±0.18 to 9.02±0.28%, p<0.05 and 7.77±0.25 to 10.20±0.22%, p < 0.05, respectively) at 90 minutes remaining elevated until 72 hrs. In the EMI only group FMD was reduced from baseline at 24 and 48 hrs (7.78±0.14 to 6.75±0.11%, p<0.05 and 6.53±0.11, p<0.05, respectively) returning to baseline after 72 hrs. Dilations to NTG were similar over time. Conclusions Our results suggest that MT attenuates impairment of upper extremity endothelial function resulting from lower extremity EMI in sedentary young adults. PMID:24583315

Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

PubMed Central

2011-01-01

Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

Better Respiratory Education and Treatment Help Empower (BREATHE) study: Methodology and baseline characteristics of a randomized controlled trial testing a transitional care program to improve patient-centered care delivery among chronic obstructive pulmonary disease patients.

PubMed

Aboumatar, H; Naqibuddin, M; Chung, S; Adebowale, H; Bone, L; Brown, T; Cooper, L A; Gurses, A P; Knowlton, A; Kurtz, D; Piet, L; Putcha, N; Rand, C; Roter, D; Shattuck, E; Sylvester, C; Urteaga-Fuentes, A; Wise, R; Wolff, J L; Yang, T; Hibbard, J; Howell, E; Myers, M; Shea, K; Sullivan, J; Syron, L; Wang, Nae-Yuh; Pronovost, P

2017-11-01

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of hospitalizations. Interventional studies focusing on the hospital-to-home transition for COPD patients are few. In the BREATHE (Better Respiratory Education and Treatment Help Empower) study, we developed and tested a patient and family-centered transitional care program that helps prepare hospitalized COPD patients and their family caregivers to manage COPD at home. In the study's initial phase, we co-developed the BREATHE transitional care program with COPD patients, family-caregivers, and stakeholders. The program offers tailored services to address individual patients' needs and priorities at the hospital and for 3months post discharge. We tested the program in a single-blinded RCT with 240 COPD patients who were randomized to receive the program or 'usual care'. Program participants were offered the opportunity to invite a family caregiver, if available, to enroll with them into the study. The primary outcomes were the combined number of COPD-related hospitalizations and Emergency Department (ED) visits per participant at 6months post discharge, and the change in health-related quality of life over the 6months study period. Other measures include 'all cause' hospitalizations and ED visits; patient activation; self-efficacy; and, self-care behaviors. Unlike 1month transitional care programs that focus on patients' post-acute care needs, the BREATHE program helps hospitalized COPD patients manage the post discharge period as well as prepare them for long term self-management of COPD. If proven effective, this program may offer a timely solution for hospitals in their attempts to reduce COPD rehospitalizations. Copyright © 2017 Elsevier Inc. All rights reserved.

Identifying patients with severe sepsis using administrative claims: patient-level validation of the angus implementation of the international consensus conference definition of severe sepsis.

PubMed

Iwashyna, Theodore J; Odden, Andrew; Rohde, Jeffrey; Bonham, Catherine; Kuhn, Latoya; Malani, Preeti; Chen, Lena; Flanders, Scott

2014-06-01

Severe sepsis is a common and costly problem. Although consistently defined clinically by consensus conference since 1991, there have been several different implementations of the severe sepsis definition using ICD-9-CM codes for research. We conducted a single center, patient-level validation of 1 common implementation of the severe sepsis definition, the so-called "Angus" implementation. Administrative claims for all hospitalizations for patients initially admitted to general medical services from an academic medical center in 2009-2010 were reviewed. On the basis of ICD-9-CM codes, hospitalizations were sampled for review by 3 internal medicine-trained hospitalists. Chart reviews were conducted with a structured instrument, and the gold standard was the hospitalists' summary clinical judgment on whether the patient had severe sepsis. Three thousand one hundred forty-six (13.5%) hospitalizations met ICD-9-CM criteria for severe sepsis by the Angus implementation (Angus-positive) and 20,142 (86.5%) were Angus-negative. Chart reviews were performed for 92 randomly selected Angus-positive and 19 randomly-selected Angus-negative hospitalizations. Reviewers had a κ of 0.70. The Angus implementation's positive predictive value was 70.7% [95% confidence interval (CI): 51.2%, 90.5%]. The negative predictive value was 91.5% (95% CI: 79.0%, 100%). The sensitivity was 50.4% (95% CI: 14.8%, 85.7%). Specificity was 96.3% (95% CI: 92.4%, 100%). Two alternative ICD-9-CM implementations had high positive predictive values but sensitivities of <20%. The Angus implementation of the international consensus conference definition of severe sepsis offers a reasonable but imperfect approach to identifying patients with severe sepsis when compared with a gold standard of structured review of the medical chart by trained hospitalists.

Pediatric advance care planning (pACP) for teens with cancer and their families: Design of a dyadic, longitudinal RCCT.

PubMed

Curtin, Katherine B; Watson, Anne E; Wang, Jichuan; Okonkwo, Obianuju C; Lyon, Maureen E

2017-11-01

Cancer is the leading cause of disease-related death for adolescents and young adults (AYAs) in the United States. Parents of AYAs with life-threatening illnesses have expressed the desire to talk to their children about end of life (EOL) care, yet, like caregivers of adult patients, struggle to initiate this conversation. Building Evidence for Effective Palliative/End of Life Care for Teens with Cancer is a longitudinal, randomized, controlled, single-blinded clinical trial aimed at evaluating the efficacy of FAmily CEntered disease-specific advance care planning (ACP) for teens with cancer (FACE-TC). A total of 130 dyads (260 subjects) composed of AYAs 14-20years old with cancer and their family decision maker (≥18years old) will be recruited from pediatric oncology programs at Akron Children's Hospital and St. Jude Children's Research Hospital. Dyads will be randomized to either the FACE-TC intervention or Treatment as Usual (TAU) control. FACE-TC intervention dyads will complete three 60-minute ACP sessions held at weekly intervals. Follow-up data will be collected at 3, 6, 12, and 18months post-intervention by a blinded research assistant (RA). The effects of FACE-TC on patient-family congruence in treatment preferences, quality of life (QOL), and advance directive completion will be analyzed. FACE-TC is an evidenced-based and patient-centered intervention that considers QOL and EOL care according to the AYA's representation of illness. The family is involved in the ACP process to facilitate shared decision making, increase understanding of the AYA's preferences, and make a commitment to honor the AYA's wishes. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of Proactive Nurse Participation in ICU Family Conferences: A Mixed-Method Study.

PubMed

Garrouste-Orgeas, Maité; Max, Adeline; Lerin, Talia; Grégoire, Charles; Ruckly, Stéphane; Kloeckner, Martin; Brochon, Sandie; Pichot, Emmanuelle; Simons, Clara; El-Mhadri, Myriame; Bruel, Cédric; Philippart, François; Fournier, Julien; Tiercelet, Kelly; Timsit, Jean-François; Misset, Benoit

2016-06-01

To investigate family perceptions of having a nurse participating in family conferences and to assess the psychologic well being of the same families after ICU discharge. Mixed-method design with a qualitative study embedded in a single-center randomized study. Twelve-bed medical-surgical ICU in a 460-bed tertiary hospital. One family member for each consecutive patient who received more than 48 hours of mechanical ventilation in the ICU. Planned proactive participation of a nurse in family conferences led by a physician. In the control group, conferences were led by a physician without a nurse. Of the 172 eligible family members, 100 (60.2%) were randomized; among them, 88 underwent semistructured interviews at ICU discharge and 86 completed the Peritraumatic Dissociative Experiences Questionnaire at ICU discharge and then the Hospital Anxiety Depression Questionnaire and the Impact of Event Scale (for posttraumatic stress-related symptoms) 3 months later. The intervention and control groups were not significantly different regarding the prevalence of posttraumatic stress-related symptoms (52.3 vs 50%, respectively; p = 0.83). Anxiety and depression subscale scores were significantly lower in the intervention group. The qualitative data indicated that the families valued the principle of the conference itself. Perceptions of nurse participation clustered into four main themes: trust that ICU teamwork was effective (50/88; 56.8%), trust that care was centered on the patient (33/88; 37.5%), trust in effective dissemination of information (15/88; 17%), and trust that every effort was made to relieve anxiety in family members (12/88; 13.6%). Families valued the conferences themselves and valued the proactive participation of a nurse. These positive perceptions were associated with significant anxiety or depression subscale scores but not with changes in posttraumatic stress-related symptoms.

Electrostatic orientation of the electron-transfer complex between plastocyanin and cytochrome c.

PubMed

Roberts, V A; Freeman, H C; Olson, A J; Tainer, J A; Getzoff, E D

1991-07-15

To understand the specificity and efficiency of protein-protein interactions promoting electron transfer, we evaluated the role of electrostatic forces in precollision orientation by the development of two new methods, computer graphics alignment of protein electrostatic fields and a systematic orientational search of intermolecular electrostatic energies for two proteins at present separation distances. We applied these methods to the plastocyanin/cytochrome c interaction, which is faster than random collision, but too slow for study by molecular dynamics techniques. Significant electrostatic potentials were concentrated on one-fourth (969 A2) of the plastocyanin surface, with the greatest negative potential centered on the Tyr-83 hydroxyl within the acidic patch, and on one-eighth (632 A2) of the cytochrome c surface, with the greatest positive potential centered near the exposed heme edge. Coherent electrostatic fields occurred only over these regions, suggesting that local, rather than global, charge complementarity controls productive recognition. The three energetically favored families of pre-collision orientations all directed the positive region surrounding the heme edge of cytochrome c toward the acidic patch of plastocyanin but differed in heme plane orientation. Analysis of electrostatic fields, electrostatic energies of precollision orientations with 12 and 6 A separation distances, and surface topographies suggested that the favored orientations should converge to productive complexes promoting a single electron-transfer pathway from the cytochrome c heme edge to Tyr-83 of plastocyanin. Direct interactions of the exposed Cu ligand in plastocyanin with the cytochrome c heme edge are not unfavorable sterically or electrostatically but should occur no faster than randomly, indicating that this is not the primary pathway for electron transfer.

Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

PubMed

van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

2016-07-26

Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

Lasting effect of an oral hygiene care program for patients with stroke during in-hospital rehabilitation: a randomized single-center clinical trial.

PubMed

Kim, Eun-Kyong; Park, Eun Young; Sa Gong, Jung-Whan; Jang, Sung-Ho; Choi, Youn-Hee; Lee, Hee-Kyung

2017-11-01

Because the oral hygiene is poorly prioritized in the immediate post-stroke period, we implemented an oral hygiene care program (OHCP) for stroke in-patients and evaluated its persistence after discharge. In all, 62 patients with stroke who were admitted to the rehabilitation ward were randomly assigned to two groups: 33 patients to the intervention group and 29 to the control group. The OHCP, including tooth brushing education and professional tooth cleaning, was administered to the intervention group twice a week six times during in-hospital rehabilitation. Oral health status was examined both at baseline and three months after discharge from the hospital. Oral hygiene status was examined at three- to four-day intervals five times during the hospitalization period. After OHCP, oral hygiene status including the plaque index, calculus index, and O'Leary plaque index improved significantly in the intervention group, compared to the control group (p < 0.05). In the intervention group, after administration of the OHCP for the fourth time, the O'Leary index improved significantly, and remained high when checked three months after discharge (p < 0.001). An OHCP conducted during in-hospital rehabilitation was effective in improving oral health and plaque control performance among patients with stroke, with effects still seen three months after discharge from the hospital. Implications for Rehabilitation Initial oral hygiene status and plaque control performance were poor in stroke patients who were in rehabilitation center. An oral hygiene care program during in-hospital rehabilitation was effective in improving oral hygiene status and plaque control performance among stroke patients at three months after discharge. Repeated tooth brushing education and professional tooth cleaning were necessary to improve plaque control performance of stroke patients.

Within-day variability on short and long walking tests in persons with multiple sclerosis.

PubMed

Feys, Peter; Bibby, Bo; Romberg, Anders; Santoyo, Carme; Gebara, Benoit; de Noordhout, Benoit Maertens; Knuts, Kathy; Bethoux, Francois; Skjerbæk, Anders; Jensen, Ellen; Baert, Ilse; Vaney, Claude; de Groot, Vincent; Dalgas, Ulrik

2014-03-15

To compare within-day variability of short (10 m walking test at usual and fastest speed; 10MWT) and long (2 and 6-minute walking test; 2MWT/6MWT) tests in persons with multiple sclerosis. Observational study. MS rehabilitation and research centers in Europe and US within RIMS (European network for best practice and research in MS rehabilitation). Ambulatory persons with MS (Expanded Disability Status Scale 0-6.5). Subjects of different centers performed walking tests at 3 time points during a single day. 10MWT, 2MWT and 6MWT at fastest speed and 10MWT at usual speed. Ninety-five percent limits of agreement were computed using a random effects model with individual pwMS as random effect. Following this model, retest scores are with 95% certainty within these limits of baseline scores. In 102 subjects, within-day variability was constant in absolute units for the 10MWT, 2MWT and 6MWT at fastest speed (+/-0.26, 0.16 and 0.15m/s respectively, corresponding to +/-19.2m and +/-54 m for the 2MWT and 6MWT) independent on the severity of ambulatory dysfunction. This implies a greater relative variability with increasing disability level, often above 20% depending on the applied test. The relative within-day variability of the 10MWT at usual speed was +/-31% independent of ambulatory function. Absolute values of within-day variability on walking tests at fastest speed were independent of disability level and greater with short compared to long walking tests. Relative within-day variability remained overall constant when measured at usual speed. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

PubMed Central

Fu, Juanjuan; Ding, Hong; Yang, Haimiao; Huang, Yuhong

2017-01-01

Background Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. Methods/Design This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson's scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson's scale and TCM symptom scale. Ethics and Trial Registration This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349). PMID:29430253

Comparison of Intravenous and Oral Hydration in the Prevention of Contrast-Induced Acute Kidney Injury in Low-Risk Patients: A Randomized Trial.

PubMed

Martin-Moreno, Paloma L; Varo, Nerea; Martínez-Ansó, Eduardo; Martin-Calvo, Nerea; Sayón-Orea, Carmen; Bilbao, Jose I; Garcia-Fernandez, Nuria

2015-01-01

Contrast-induced acute kidney injury (CI-AKI) is a common cause of renal failure. We evaluated the effectiveness of oral sodium citrate versus intravenous (IV) sodium bicarbonate for CI-AKI prophylaxis as well as their influence on kidney injury biomarkers. A randomized, controlled, single-center study including 130 hospitalized patients (62.3% men), who were randomized to receive sodium bicarbonate (1/6 men, 3 ml/kg/h for 1 h; n = 43), oral sodium citrate (75 ml/10 kg divided into 4 doses; n = 43) or nonspecific hydration (n = 44) before contrast administration, was conducted. Serum creatinine and kidney injury biomarkers (cystatin C, neutrophil gelatinase-associated lipocalin, interleukin-8, F2-isoprostanes and cardiotrophin-1 [CT-1]) were assessed. Incidence of CI-AKI was 9.2% with no differences found between hydration groups: 7.0% in sodium bicarbonate group, 11.6% in oral sodium citrate group and 9.1% in the nonspecific hydration group. Urinary creatinine and urinary CT-1/creatinine ratio decreased 4 h after contrast infusion (p < 0.001), but none of the biomarkers assessed were affected by the treatments. There were no differences in hydration with oral sodium citrate and IV sodium bicarbonate for the prophylaxis of CI-AKI. Therefore, oral hydration represents a safe, inexpensive and practical method for preventing CI-AKI in low-risk patients. No effect on biomarkers for kidney injury could be demonstrated. © 2015 S. Karger AG, Basel.

Comparison of two different dosage of GnRH agonist as ovulation trigger in oocyte donors: a randomized controled trial.

PubMed

Zarcos, Sonia Morales; Mejía, Pamela Valdivieso; Stefani, Carla Donado; Martin, Pascual Sánchez; Martin, Fernando Sánchez

2017-09-01

To compare the results obtained with two different GnRH agonist dosages: 0.3mg versus 0.4mg to trigger ovulation in oocyte donor cycles. Experimental controlled randomized trial including 40 patients from a private practice center. The patients were randomized into two groups. Group A received a single dose of Triptorelin 0.3mg (Decapeptyl®) 36hours before pick-up. Group B patients received Triptorelin 0.4mg (Decapeptyl®) before pick-up to final oocyte maturation. We evaluated the total number of oocytes collected, the number of mature oocytes and total days of ovarian stimulation. The average of total collected oocytes were 16 (Group A) versus 15 (Group B), and the mean number of mature oocytes were 13 versus 12 respectively. The only variable showing a difference was the percentage of mature oocytes, which was greater in Group A, resulting in 84.6%, in contrast with those treated with 0.4mg of Triptorelin (78.6%), although these differences were not statistical significant (p=0.35). Days of stimulation did not differ between groups. No cases of empty follicle syndrome were reported. We found that an increase from 0.3 to 0.4mg of triptorelin in an oocyte donation program might not improve outcomes. Nevertheless, more studies might be necessary, not only in oocyte donors but in sterile women as well, to evaluate how GnRH agonist dosage could affect the results among other factors.

A randomized 3-month clinical comparison of a power toothbrush to a manual toothbrush in the reduction of gingivitis.

PubMed

Li, Zhen; He, Tao; Li, Chun; Sun, Lily; Chang, Jinlan; He, Yanyan; Zhao, Jizhi; Ji, Ning

2016-08-01

To compare the anti-gingivitis effect of a power toothbrush relative to a manual toothbrush control. This was a 3-month, randomized and controlled, single-center, parallel group, examiner-blinded clinical study. 123 Chinese adults in good general health and with at least 15 gingival bleeding sites, as measured by the Gingival Bleeding Index, were enrolled into the study. At baseline, pre-treatment gingivitis levels were assessed using the Mazza Bleeding Index. Subjects were then randomly assigned to receive either an oscillating-rotating power toothbrush [Oral-B Professional Care 7000 (D17u/EB17)] or a flat-trim manual toothbrush with tapered filaments (Lion Dentor Systema). Subjects brushed at home twice-daily with their assigned toothbrush and a marketed sodium fluoride dentifrice (Crest Cavity Protection dentifrice), and were reevaluated at Months 1, 2, and 3. 113 evaluable subjects completed the study. Both groups showed significant reductions in gingivitis from baseline for all time points measured (P< 0.001). At Months 1, 2 and 3, the power toothbrush demonstrated significantly greater gingivitis reductions of 7.11%, 9.20% and 8.47%, respectively, than the manual toothbrush (P< 0.01), and significantly fewer bleeding sites (17.3%, 23.9% and 24.3%, respectively, P< 0.05). No adverse events were reported or observed for either brush during the study. The power brush provided statistically significantly greater reductions in gingivitis compared with a manual toothbrush at Months 1, 2 and 3.

A Randomized, Double-Blind Study Assessing Changes in Cognitive Function in Indian School Children Receiving a Combination of Bacopa monnieri and Micronutrient Supplementation vs. Placebo

PubMed Central

Mitra-Ganguli, Tora; Kalita, Soumik; Bhushan, Sakshi; Stough, Con; Kean, James; Wang, Nan; Sethi, Vidhu; Khadilkar, Anuradha

2017-01-01

Several studies have indicated a chronic cognitive enhancing effect of Bacopa monnieri across different ages and cognitive impairment associated with vitamin and mineral deficiencies in children. Therefore, we investigated the effects of 4-month supplementation with a combination of B. monnieri extract and multiple micronutrients on cognitive functions in Indian school children aged 7–12 years. This was a randomized, double-blind, parallel design, single-center study in which 300 children were randomized to receive a beverage either fortified with B. monnieri and multiple micronutrients (“fortified”) or a non-fortified isocaloric equivalent (“control”) twice-daily for 4 months. Cognitive function was assessed by the Cambridge Neuropsychological Automated Test Battery (CANTAB) administered at baseline, Day 60 and Day 121. The primary endpoint was change in short-term memory (working memory) from baseline in subjects receiving “fortified” vs. “control” beverages after 4 months. Secondary endpoints included sustained attention, episodic memory, and executive function. The “fortified” beverage did not significantly improve short-term memory or any of the secondary outcomes tested relative to the “control” beverage. However, the spatial working memory “strategy” score showed significant improvement on Day 60 (difference between groups in change from baseline: −0.55; p < 0.05), but not on Day 121 due to the active intervention. Study products were well-tolerated. Reasons for these unexpected findings are discussed. PMID:29204115

Effects of aromatherapy massage on face-down posture-related pain after vitrectomy: a randomized controlled trial.

PubMed

Adachi, Naho; Munesada, Minako; Yamada, Noriko; Suzuki, Haruka; Futohashi, Ayano; Shigeeda, Takashi; Kato, Satoshi; Nishigaki, Masakazu

2014-06-01

Postoperative face-down posturing (FDP) is recommended to optimize the effects of intraocular gas tamponade after vitrectomy. However, patients undergoing FDP usually experience physical and psychological burdens. This 3-armed, randomized, single-center trial investigated the effects of aromatherapy on FDP-related physical pain. Sixty-three patients under FDP were randomly allocated to one of three treatment groups: aromatherapy massage with essential oil (AT), oil massage without essential oil (OT), and a control group. The AT and OT groups received 10 minutes of massage by ward nurses trained by an aromatherapist, while the control group received usual care. Outcomes were assessed as short-term (pre- to post-intervention) and long-term (first to third postoperative day) changes in physical pain in five body regions using face-scale. The AT and OT groups both revealed similar short-term pain reductions after intervention, compared with the control group. Regarding long-term effects, neither group experienced significant effects until the second day. Significantly more pain reduction compared with usual care occurred on the third day, mainly in the AT group, though there were few significant differences between the AT and OT groups. In conclusion, this study suggests that simple oil massage is an effective strategy for immediate pain reduction in patients undergoing FDP, while aromatherapy may have a long-term effect on pain reduction. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Randomized trial of the effect of contact lens wear on self-perception in children.

PubMed

Walline, Jeffrey J; Jones, Lisa A; Sinnott, Loraine; Chitkara, Monica; Coffey, Bradley; Jackson, John Mark; Manny, Ruth E; Rah, Marjorie J; Prinstein, Mitchell J

2009-03-01

To determine whether contact lens wear affects children's self-perceptions. The Adolescent and Child Health Initiative to Encourage Vision Empowerment Study was a randomized, single-masked trial conducted at five clinical centers in the United States. Subjects were 8- to 11-year-old myopic children randomly assigned to wear spectacles (n = 237) or soft contact lenses (n = 247) for 3 years. The primary endpoint was the Self-Perception Profile for Children Global Self-Worth scale. Secondary outcomes included the Physical Appearance, Athletic Competence, Scholastic Competence, Behavioral Conduct, and Social Acceptance Self-Perception Profile for Children scales. Global self-worth was not affected by contact lens wear [analysis of variance (ANOVA), difference = 0.06; 95% CI, -0.004 to 0.117]. Physical appearance (ANOVA, difference = 0.15; 95% CI, 0.07 to 0.22), athletic competence (ANOVA, difference = 0.08; 95% CI, 0.01 to 0.15), and social acceptance (ANOVA, difference = 0.10; 95% CI, 0.03 to 0.17) were all greater for contact lens wearers. Although contact lens wear does not affect global self-perceptions of 8- to 11-year-old myopic children their physical appearance, athletic competence, and social acceptance self-perceptions are likely to improve with contact lens wear. Eye care practitioners should consider the social and visual benefits of contact lens wear when choosing the most appropriate vision correction modality for children as young as 8 years of age.

Intraoperative tight glucose control using hyperinsulinemic normoglycemia increases delirium after cardiac surgery.

PubMed

Saager, Leif; Duncan, Andra E; Yared, Jean-Pierre; Hesler, Brian D; You, Jing; Deogaonkar, Anupa; Sessler, Daniel I; Kurz, Andrea

2015-06-01

Postoperative delirium is common in patients recovering from cardiac surgery. Tight glucose control has been shown to reduce mortality and morbidity. Therefore, the authors sought to determine the effect of tight intraoperative glucose control using a hyperinsulinemic-normoglycemic clamp approach on postoperative delirium in patients undergoing cardiac surgery. The authors enrolled 198 adult patients having cardiac surgery in this randomized, double-blind, single-center trial. Patients were randomly assigned to either tight intraoperative glucose control with a hyperinsulinemic-normoglycemic clamp (target blood glucose, 80 to 110 mg/dl) or standard therapy (conventional insulin administration with blood glucose target, <150 mg/dl). Delirium was assessed using a comprehensive delirium battery. The authors considered patients to have experienced postoperative delirium when Confusion Assessment Method testing was positive at any assessment. A positive Confusion Assessment Method was defined by the presence of features 1 (acute onset and fluctuating course) and 2 (inattention) and either 3 (disorganized thinking) or 4 (altered consciousness). Patients randomized to tight glucose control were more likely to be diagnosed as being delirious than those assigned to routine glucose control (26 of 93 vs. 15 of 105; relative risk, 1.89; 95% CI, 1.06 to 3.37; P = 0.03), after adjusting for preoperative usage of calcium channel blocker and American Society of Anesthesiologist physical status. Delirium severity, among patients with delirium, was comparable with each glucose management strategy. Intraoperative hyperinsulinemic-normoglycemia augments the risk of delirium after cardiac surgery, but not its severity.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4–5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition. Methods/design Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH = day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality. Discussion This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002917 PMID:23957458

Effect of randomness on multi-frequency aeroelastic responses resolved by Unsteady Adaptive Stochastic Finite Elements

NASA Astrophysics Data System (ADS)

Witteveen, Jeroen A. S.; Bijl, Hester

2009-10-01

The Unsteady Adaptive Stochastic Finite Elements (UASFE) method resolves the effect of randomness in numerical simulations of single-mode aeroelastic responses with a constant accuracy in time for a constant number of samples. In this paper, the UASFE framework is extended to multi-frequency responses and continuous structures by employing a wavelet decomposition pre-processing step to decompose the sampled multi-frequency signals into single-frequency components. The effect of the randomness on the multi-frequency response is then obtained by summing the results of the UASFE interpolation at constant phase for the different frequency components. Results for multi-frequency responses and continuous structures show a three orders of magnitude reduction of computational costs compared to crude Monte Carlo simulations in a harmonically forced oscillator, a flutter panel problem, and the three-dimensional transonic AGARD 445.6 wing aeroelastic benchmark subject to random fields and random parameters with various probability distributions.

Task Allocation for Single Pilot Operations: A Role for the Ground

NASA Technical Reports Server (NTRS)

Johnson, Walter; Lachter, Joel; Feary, Mike; Comerford, Doreen; Battiste, Vernol; Mogford, Richard

2012-01-01

Researchers at NASA Ames Research Center and NASA Langley Research Center are jointly investigating issues associated with potential configurations for an environment in which a single pilot, or reduced crew, might operate. The research summarized in this document represents several of the efforts being put forth at NASA Ames Research Center. Specifically, researchers at NASA Ames Research Center coordinated and hosted a technical interchange meeting in order to gain insight from members of the aviation community. A description of this meeting and the findings are presented first. Thereafter, plans for ensuing research are presented.

A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention).

PubMed

Bandak, Mikkel; Jørgensen, Niels; Juul, Anders; Lauritsen, Jakob; Kreiberg, Michael; Oturai, Peter Sandor; Helge, Jørn Wulff; Daugaard, Gedske

2017-07-03

Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone (mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number of studies have shown that low serum levels of testosterone is associated with low grade inflammation and increased risk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improves metabolic dysfunction in TC survivors with mild Leydig cell insufficiency. This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluate the effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period begins in which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment will be made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone in the intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weeks post-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64). This study is the first to investigate the effect of testosterone substitution in testicular cancer survivors with mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors with borderline low levels of testosterone. ClinicalTrials.gov : NCT02991209 (November 25, 2016).

Building better bones in childhood: a randomized controlled study to test the efficacy of a dietary intervention program to increase calcium intake.

PubMed

Weber, D R; Stark, L J; Ittenbach, R F; Stallings, V A; Zemel, B S

2017-06-01

Many children do not consume the recommended daily allowance of calcium. Inadequate calcium intake in childhood may limit bone accrual. The objective of this study was to determine if a behavioral modification and nutritional education (BM-NE) intervention improved dietary calcium intake and bone accrual in children. 139 (86 female) healthy children, 7-10 years of age, were enrolled in this randomized controlled trial conducted over 36 months. Participants randomized to the BM-NE intervention attended five sessions over a 6-week period designed to increase calcium intake to 1500 mg/day. Participants randomized to the usual care (UC) group received a single nutritional counseling session. The Calcium Counts Food Frequency Questionnaire was used to assess calcium intake; dual energy X-ray absorptiometry was used to assess areal bone mineral density (aBMD) and bone mineral content (BMC). Longitudinal mixed effects models were used to assess for an effect of the intervention on calcium intake, BMC and aBMD. BM-NE participants had greater increases in calcium intake that persisted for 12 months following the intervention compared with UC. The intervention had no effect on BMC or aBMD accrual. Secondary analyses found a negative association between calcium intake and adiposity such that greater calcium intake was associated with lesser gains in body mass index and fat mass index. A family-centered BM-NE intervention program in healthy children was successful in increasing calcium intake for up to 12 months but had no effect on bone accrual. A beneficial relationship between calcium intake and adiposity was observed and warrants future study.

Randomized comparison of power Doppler ultrasonography-guided core-needle biopsy with open surgical biopsy for the characterization of lymphadenopathies in patients with suspected lymphoma.

PubMed

Pugliese, Novella; Di Perna, M; Cozzolino, I; Ciancia, G; Pettinato, G; Zeppa, P; Varone, V; Masone, S; Cerchione, C; Della Pepa, R; Simeone, L; Giordano, C; Martinelli, V; Salvatore, C; Pane, F; Picardi, M

2017-04-01

The sensitivity of lymph node core-needle biopsy under imaging guidance requires validation. We employed power Doppler ultrasonography (PDUS) to select the lymph node most suspected of malignancy and to histologically characterize it through the use of large cutting needle. Institutional review board approval and informed consent were obtained for this randomized clinical trial. In a single center between 1 January 2009 and 31 December 2015, patients with lymph node enlargement suspected for lymphoma were randomly assigned (1:1) to biopsy with either standard surgery or PDUS-guided 16-gauge modified Menghini needle. The primary endpoint was the superiority of sensitivity for the diagnosis of malignancy for core-needle cutting biopsy (CNCB). Secondary endpoints were times to biopsy, complications, and costs. A total of 376 patients were randomized into the two arms and received allocated biopsy. However, four patients undergoing CNCB were excluded for inadequate samples; thus, 372 patients were analyzed. Sensitivity for the detection of malignancy was significantly better for PDUS-guided CNCB [98.8%; 95% confidence interval (CI), 95.9-99.9] than standard biopsy (88.7%; 95% CI, 82.9-93; P < 0.001). For all secondary endpoints, the comparison was significantly disadvantageous for conventional approach. In particular, estimated cost per biopsy performed with standard surgery was 24-fold higher compared with that performed with CNCB. The presence of satellite enlarged reactive and/or necrotic lymph nodes may impair the success of an open surgical biopsy (OSB). PDUS and CNCB with adequate gauge are diagnostic tools that enable effective, safe, fast, and low-cost routine biopsy for patients with suspected lymphoma, avoiding psychological and physical pain of an unnecessary surgical intervention.

TVT-Exact and midurethral sling (SLING-IUFT) operative procedures: a randomized study

PubMed Central

Aniulis, Povilas; Skaudickas, Darijus

2015-01-01

Objectives The aim of the study is to compare results, effectiveness and complications of TVT exact and midurethral sling (SLING-IUFT) operations in the treatment of female stress urinary incontinence (SUI). Methods A single center nonblind, randomized study of women with SUI who were randomized to TVT-Exact and SLING-IUFT was performed by one surgeon from April 2009 to April 2011. SUI was diagnosed on coughing and Valsalva test and urodynamics (cystometry and uroflowmetry) were assessed before operation and 1 year after surgery. This was a prospective randomized study. The follow up period was 12 months. 76 patients were operated using the TVT-Exact operation and 78 patients – using the SLING-IUFT operation. There was no statistically significant differences between groups for BMI, parity, menopausal status and prolapsed stage (no patients had cystocele greater than stage II). Results Mean operative time was significantly shorter in the SLING-IUFT group (19 ± 5.6 min.) compared with the TVT-Exact group (27 ± 7.1 min.). There were statistically significant differences in the effectiveness of both procedures: TVT-Exact – at 94.5% and SLING-IUFT – at 61.2% after one year. Hospital stay was statistically significantly shorter in the SLING-IUFT group (1. 2 ± 0.5 days) compared with the TVT-Exact group (3.5 ± 1.5 days). Statistically significantly fewer complications occurred in the SLING-IUFT group. Conclusion the TVT-Exact and SLING-IUFT operations are both effective for surgical treatment of female stress urinary incontinence. The SLING-IUFT involved a shorter operation time and lower complications rate., the TVT-Exact procedure had statistically significantly more complications than the SLING-IUFT operation, but a higher effectiveness. PMID:28352711

TVT-Exact and midurethral sling (SLING-IUFT) operative procedures: a randomized study.

PubMed

Aniuliene, Rosita; Aniulis, Povilas; Skaudickas, Darijus

2015-01-01

The aim of the study is to compare results, effectiveness and complications of TVT exact and midurethral sling (SLING-IUFT) operations in the treatment of female stress urinary incontinence (SUI). A single center nonblind, randomized study of women with SUI who were randomized to TVT-Exact and SLING-IUFT was performed by one surgeon from April 2009 to April 2011. SUI was diagnosed on coughing and Valsalva test and urodynamics (cystometry and uroflowmetry) were assessed before operation and 1 year after surgery. This was a prospective randomized study. The follow up period was 12 months. 76 patients were operated using the TVT-Exact operation and 78 patients - using the SLING-IUFT operation. There was no statistically significant differences between groups for BMI, parity, menopausal status and prolapsed stage (no patients had cystocele greater than stage II). Mean operative time was significantly shorter in the SLING-IUFT group (19 ± 5.6 min.) compared with the TVT-Exact group (27 ± 7.1 min.). There were statistically significant differences in the effectiveness of both procedures: TVT-Exact - at 94.5% and SLING-IUFT - at 61.2% after one year. Hospital stay was statistically significantly shorter in the SLING-IUFT group (1. 2 ± 0.5 days) compared with the TVT-Exact group (3.5 ± 1.5 days). Statistically significantly fewer complications occurred in the SLING-IUFT group. the TVT-Exact and SLING-IUFT operations are both effective for surgical treatment of female stress urinary incontinence. The SLING-IUFT involved a shorter operation time and lower complications rate., the TVT-Exact procedure had statistically significantly more complications than the SLING-IUFT operation, but a higher effectiveness.

Design and Recruitment for a Randomized Controlled Trial of Problem-Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services.

PubMed

Albert, Steven M; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F

2016-01-01

Addressing subthreshold depression (indicated prevention) and vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative (Dep-ABC) is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing, senior centers) who meet criteria for subthreshold depression and disability. Therefore, the authors examine the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and the baseline status of participants. Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves six to eight sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect well-being and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem-solving therapy is acceptable to this population and can be added to current services. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial.

PubMed

Kessler, Thomas M; Mordasini, Livio; Weisstanner, Christian; Jüni, Peter; da Costa, Bruno R; Wiest, Roland; Thalmann, George N

2014-01-01

To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS. In a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) from baseline to 12 weeks. The 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was -3.1 points (95% CI -6.8 to 0.6, p = 0.11). In secondary comparisons of NIH-CPSI sub-scores, we found differences between groups most pronounced for the quality-of-life sub-score (difference at 12 weeks -1.6, 95% CI -2.8 to -0.4, p = 0.015). In stratified analyses, the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less (difference in NIH-CPSI total score -8.3, 95% CI -14.5 to 2.6) than in patients with a longer symptom duration (-0.8, 95% CI -4.6 to 3.1; p for interaction = 0.023). Sono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment. Subgroup analysis indicates, however, that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy, warranting larger randomized controlled trials in this subpopulation. ClinicalTrials.gov NCT00688506.

Design and Recruitment for a Randomized Controlled Trial of Problem Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services

PubMed Central

Albert, Steven M.; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F.

2015-01-01

Background Addressing subthreshold depression (indicated prevention) as well as vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing senior centers) who meet criteria for subthreshold depression and disability. Objective To examine (i) the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, (ii) the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and (iii) the baseline status of participants. Methods Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves 6–8 sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect wellbeing and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Results Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Conclusions Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem solving therapy is acceptable to this population and can be added to current services. PMID:26706911

The effect of individualized nutritional counseling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy: a randomized controlled trial protocol.

PubMed

van der Werf, Anne; Blauwhoff-Buskermolen, Susanne; Langius, Jacqueline A E; Berkhof, Johannes; Verheul, Henk M W; de van der Schueren, Marian A E

2015-03-05

A low muscle mass is prevalent in patients with metastatic colorectal cancer (mCRC) and has been associated with poor treatment outcome. Chemotherapeutic treatment has an additional unfavorable effect on muscle mass. Sufficient protein intake and physical activity are known to induce muscle protein anabolism in healthy individuals, however it is unclear whether optimal nutrition is effective to preserve muscle mass in patients with mCRC during first-line chemotherapy as well. We hypothesize that individual nutritional counseling by a trained dietitian during first-line chemotherapy is effective in preserving muscle mass and may improve clinical outcomes in patients with mCRC. In this multi-center single-blind randomized controlled trial, patients with mCRC scheduled for first-line combination chemotherapy consisting of oxaliplatin and fluoropyrimidine, with or without bevacizumab (n = 110), will be randomized to receive either individualized nutritional counseling by a trained dietitian to achieve a sufficient dietary intake and an adequate physical activity level, or usual care. Outcome measures will be assessed at baseline and after two and four months of treatment. The primary endpoint will be the change in skeletal muscle area (measured by CT-scan) at the first treatment evaluation. Secondary endpoints will be quality of life, physical functioning, treatment toxicity, treatment intensity and survival. Statistical analyses include one-sided t-tests for the primary endpoint and mixed models and the Kaplan-Meier method for secondary endpoints. This randomized controlled trial will provide evidence whether individualized nutritional counseling during chemotherapy is effective in preventing loss of muscle mass in patients with mCRC. ClinicalTrials.gov NCT01998152 ; Netherlands Trial Register NTR4223.

A Randomized Trial of Brief Versus Extended Seizure Prophylaxis After Aneurysmal Subarachnoid Hemorrhage.

PubMed

Human, Theresa; Diringer, Michael N; Allen, Michelle; Zipfel, Gregory J; Chicoine, Michael; Dacey, Ralph; Dhar, Rajat

2018-04-01

Seizures occur in 10-20% of patients with subarachnoid hemorrhage (SAH), predominantly in the acute phase. However, anticonvulsant prophylaxis remains controversial, with studies suggesting a brief course may be adequate and longer exposure may be associated with worse outcomes. Nonetheless, in the absence of controlled trials to inform practice, patients continue to receive variable chemoprophylaxis. The objective of this study was to compare brief versus extended seizure prophylaxis after aneurysmal SAH. We performed a prospective, single-center, randomized, open-label trial of a brief (3-day) course of levetiracetam (LEV) versus extended treatment (until hospital discharge). The primary outcome was in-hospital seizure. Secondary outcomes included drug discontinuation and functional outcome. Eighty-four SAH patients had been randomized when the trial was terminated due to slow enrollment. In-hospital seizures occurred in three (9%) of 35 in the brief LEV group versus one (2%) of 49 in the extended group (p = 0.2). Ten (20%) of the extended group discontinued LEV prematurely, primarily due to sedation. Four of five seizures (including one pre-randomization) occurred in patients with early brain injury (EBI) on computed tomography (CT) scans (adjusted OR 12.5, 95% CI 1.2-122, p = 0.03). Good functional outcome (mRS 0-2) was more likely in the brief LEV group (83 vs. 61%, p = 0.04). This study was underpowered to demonstrate superiority of extended LEV for seizure prophylaxis, although a trend to benefit was seen. Seizures primarily occurred in those with radiographic EBI, suggesting targeted prophylaxis may be preferable. Larger trials are required to evaluate optimal chemoprophylaxis in SAH, especially in light of worse outcomes in those receiving extended treatment.

Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial

PubMed Central

Ferrer, Assumpta; Formiga, Francesc; Sanz, Héctor; de Vries, Oscar J; Badia, Teresa; Pujol, Ramón

2014-01-01

Background The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. Methods A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Results Sixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94–1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03–2.09) and that functional impairment (HR 1.42, 95% CI 0.97–2.12), previous falls (HR 1.09, 95% CI 0.74–1.60), and cognitive impairment (HR 1.08, 95% CI 0.72–1.60) had no effect on the assessment. Conclusion This multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study. PMID:24596458

The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial.

PubMed

Kim, Eugene; Yang, Seong Mi; Yoon, So Jeong; Bahk, Jae-Hyon; Seo, Jeong-Hwa

2016-11-25

Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes. This is a prospective, double-blind, single-center, parallel-arm, noninferiority, randomized controlled trial to be conducted in participants aged 20-80 years who are undergoing elective surgery under general anesthesia with orotracheal intubation. Participants are randomly assigned into one of two groups depending on whether intubation is performed using a tracheal tube lubricated with water (n = 150) or without any pretreatment (n = 150). The primary outcome is the incidence of sore throat at 0, 2, 4, and 24 h after surgery, which is analyzed with a noninferiority test. The secondary outcomes are the incidence and severity of postoperative hoarseness, oropharyngeal injuries, and respiratory infections. Because we hypothesized that lubricating tracheal tubes using water has no advantage in reducing airway injuries associated with intubation, we will compare the incidence of sore throat, which is the most common complaint after intubation, in a noninferiority manner. This is the first randomized controlled trial to investigate the possibly beneficial or harmful effects of lubricating tracheal tubes using water before intubation. We expect that this trial will provide useful evidence to formulate a protocol for preparing tracheal tubes before intubation. This trial is registered at ClinicalTrials.gov on 1 July 2015 ( NCT02492646 ).

A randomized trial comparing didactics, demonstration, and simulation for teaching teamwork to medical residents.

PubMed

Semler, Matthew W; Keriwala, Raj D; Clune, Jennifer K; Rice, Todd W; Pugh, Meredith E; Wheeler, Arthur P; Miller, Alison N; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A

2015-04-01

Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel "Recognize, Respond, Reassess" score. Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs(2)] = 0.267, P < 0.001). Among incoming internal medicine interns, teamwork training by expert demonstration resulted in similar teamwork behavior to participation in high-fidelity simulation and was more effective than traditional didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities.

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

PubMed

Murphy, Patrick; Lee, Kevin; Dubois, Luc; DeRose, Guy; Forbes, Thomas; Power, Adam

2015-11-04

Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs. NCT02084017 , March 2014.

A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.

PubMed

Jin, Cai De; Kim, Moo Hyun; Bang, Junghee; Serebruany, Victor

The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017. © 2017 S. Karger AG, Basel.

Carotid artery stenting vs. carotid endarterectomy in the management of carotid artery stenosis: Lessons learned from randomized controlled trials

PubMed Central

Salem, Mohamed M.; Alturki, Abdulrahman Y.; Fusco, Matthew R.; Thomas, Ajith J.; Carter, Bob S.; Chen, Clark C.; Kasper, Ekkehard M.

2018-01-01

Background: Carotid artery stenosis, both symptomatic and asymptomatic, has been well studied with several multicenter randomized trials. The superiority of carotid endarterectomy (CEA) to medical therapy alone in both symptomatic and asymptomatic carotid artery stenosis has been well established in previous trials in the 1990s. The consequent era of endovascular carotid artery stenting (CAS) has offered another option for treating carotid artery stenosis. A series of randomized trials have now been conducted to compare CEA and CAS in the treatment of carotid artery disease. The large number of similar trials has created some confusion due to inconsistent results. Here, the authors review the trials that compare CEA and CAS in the management of carotid artery stenosis. Methods: The PubMed database was searched systematically for randomized controlled trials published in English that compared CEA and CAS. Only human studies on adult patients were assessed. The references of identified articles were reviewed for additional manuscripts to be included if inclusion criteria were met. The following terms were used during search: carotid stenosis, endarterectomy, stenting. Retrospective or single-center studies were excluded from the review. Results: Thirteen reports of seven large-scale prospective multicenter studies, comparing both interventions for symptomatic or asymptomatic extracranial carotid artery stenosis, were identified. Conclusions: While the superiority of intervention to medical management for symptomatic patients has been well established in the literatures, careful selection of asymptomatic patients for intervention should be undertaken and only be pursued after institution of appropriate medical therapy until further reports on trials comparing medical therapy to intervention in this patient group are available. PMID:29740506

Centering Single Cells in Microgels via Delayed Crosslinking Supports Long-Term 3D Culture by Preventing Cell Escape.

PubMed

Kamperman, Tom; Henke, Sieger; Visser, Claas Willem; Karperien, Marcel; Leijten, Jeroen

2017-06-01

Single-cell-laden microgels support physiological 3D culture conditions while enabling straightforward handling and high-resolution readouts of individual cells. However, their widespread adoption for long-term cultures is limited by cell escape. In this work, it is demonstrated that cell escape is predisposed to off-center encapsulated cells. High-speed microscopy reveals that cells are positioned at the microgel precursor droplets' oil/water interface within milliseconds after droplet formation. In conventional microencapsulation strategies, the droplets are typically gelled immediately after emulsification, which traps cells in this off-center position. By delaying crosslinking, driving cells toward the centers of microgels is succeeded. The centering of cells in enzymatically crosslinked microgels prevents their escape during at least 28 d. It thereby uniquely enables the long-term culture of individual cells within <5-µm-thick 3D uniform hydrogel coatings. Single cell analysis of mesenchymal stem cells in enzymatically crosslinked microgels reveals unprecedented high cell viability (>90%), maintained metabolic activity (>70%), and multilineage differentiation capacity (>60%) over a period of 28 d. The facile nature of this microfluidic cell-centering method enables its straightforward integration into many microencapsulation strategies and significantly enhances control, reproducibility, and reliability of 3D single cell cultures. © 2017 The Authors. Published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Randomized Dynamic Mode Decomposition

NASA Astrophysics Data System (ADS)

Erichson, N. Benjamin; Brunton, Steven L.; Kutz, J. Nathan

2017-11-01

The dynamic mode decomposition (DMD) is an equation-free, data-driven matrix decomposition that is capable of providing accurate reconstructions of spatio-temporal coherent structures arising in dynamical systems. We present randomized algorithms to compute the near-optimal low-rank dynamic mode decomposition for massive datasets. Randomized algorithms are simple, accurate and able to ease the computational challenges arising with `big data'. Moreover, randomized algorithms are amenable to modern parallel and distributed computing. The idea is to derive a smaller matrix from the high-dimensional input data matrix using randomness as a computational strategy. Then, the dynamic modes and eigenvalues are accurately learned from this smaller representation of the data, whereby the approximation quality can be controlled via oversampling and power iterations. Here, we present randomized DMD algorithms that are categorized by how many passes the algorithm takes through the data. Specifically, the single-pass randomized DMD does not require data to be stored for subsequent passes. Thus, it is possible to approximately decompose massive fluid flows (stored out of core memory, or not stored at all) using single-pass algorithms, which is infeasible with traditional DMD algorithms.

Relaxation Therapy and Anxiety, Self-Esteem, and Emotional Regulation among Adults with Intellectual Disabilities: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bouvet, Cyrille; Coulet, Aurélie

2016-01-01

This pilot study is a randomized controlled trial on the effects of relaxation on anxiety, self-esteem, and emotional regulation in adults with intellectual disabilities (ID) working in a center of supported employment in France. We studied 30 adults with mild or moderate ID who were split at random into a relaxation group (RG, 15 subjects), who…

Pharmacokinetics and Safety of Intravenous Murepavadin Infusion in Healthy Adult Subjects Administered Single and Multiple Ascending Doses.

PubMed

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.

First-in-man study with a novel PEGylated recombinant human insulin-like growth factor-I.

PubMed

Kletzl, H; Guenther, A; Höflich, A; Höflich, C; Frystyk, J; Staack, R F; Schick, E; Wandel, C; Bleich, N; Metzger, F

2017-04-01

This study is a first time assessment of safety and tolerability, pharmacokinetics, and pharmacodynamics of RO5046013 in human, in comparison with unmodified rhIGF-I. The study was conducted as a single-center, randomized, double-blinded, placebo-controlled, single ascending dose, parallel group study in a clinical research unit in France. A total of 62 healthy volunteers participated in this clinical trial. RO5046013 was given as single subcutaneous injection, or as intravenous infusion over 48h, at ascending dose levels. The active comparator rhIGF-I was administered at 50μg/kg subcutaneously twice daily for 4days. Safety and tolerability, pharmacokinetics, and pharmacodynamics of RO5046013 were evaluated. PEGylation resulted in long exposure to RO5046013 with a half-life of 140-200h. Exposure to RO5046013 increased approximately dose proportionally. RO5046013 was safe and well tolerated at all doses, injection site erythema after SC administration was the most frequent observed AE. No hypoglycemia occurred. Growth hormone (GH) secretion was almost completely suppressed with rhIGF-I administration, whereas RO5046013 caused only a modest decrease in GH at the highest dose given IV. PEGylation of IGF-I strongly enhances half-life, reduces the negative GH feedback and hypoglycemia potential, and therefore offers a valuable alternative to rhIGF-I in treatment of relevant diseases. Copyright © 2017 Elsevier Ltd. All rights reserved.

Polarization switching in undoped and La-doped TlInS2 ferroelectric-semiconductors

NASA Astrophysics Data System (ADS)

Seyidov, MirHasan Yu.; Mikailzade, Faik A.; Suleymanov, Rauf A.; Aliyeva, Vafa B.; Mammadov, Tofig G.; Sharifov, Galib M.

2017-12-01

Dielectric hysteresis loops of pure and lanthanum doped TlInS2 ferroelectric-semiconductors were studied at the frequency 50 Hz for different temperatures below the Curie temperature (Tc). It has been revealed that, without any poling procedure, pure TlInS2 exhibits normal single hysteresis loops at T < Tc. After electric field-cooled treatment of TlInS2 the shape of hysteresis loops was strongly affected by corresponding charged deep level defects which were previously activated during the poling process. As a result, an additional defect polarization state from space charges accumulated on the intrinsic deep level defects has been revealed in pure TlInS2 at the temperatures below Tc. Besides, unusual multiple hysteresis loops were observed in La doped TlInS2 at T < Tc after application of different external perturbations (electric field, exposition and memory effect) to the sample. Measurements of the hysteresis loops in TlInS2:La revealed the slim single, double and even triple polarization-electric field (P-E) hysteresis loops. This intriguing phenomenon is attributed to the domain pinning by photo- and electrically active La-impurity centers. The temperature variation of double-hysteresis loop was also investigated. Due to the heat elimination of the random local defect polar moments, the double-hysteresis loops were transformed into a normal single hysteresis loops on increasing the temperature.

Separating boys and girls and increasing weight? Assessing the impacts of single-sex schools through random assignment in Seoul

PubMed Central

Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R.

2015-01-01

A growing body of research reports associations of school contexts with adolescents’ weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents’ weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. PMID:25863424

Separating boys and girls and increasing weight? Assessing the impacts of single-sex schools through random assignment in Seoul.

PubMed

Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R

2015-06-01

A growing body of research reports associations of school contexts with adolescents' weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents' weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. Copyright © 2015 Elsevier Ltd. All rights reserved.

Center of mass perception and inertial frames of reference.

PubMed

Bingham, G P; Muchisky, M M

1993-11-01

Center of mass perception was investigated by varying the shape, size, and orientation of planar objects. Shape was manipulated to investigate symmetries as information. The number of reflective symmetry axes, the amount of rotational symmetry, and the presence of radial symmetry were varied. Orientation affected systematic errors. Judgments tended to undershoot the center of mass. Random errors increased with size and decreased with symmetry. Size had no effect on random errors for maximally symmetric objects, although orientation did. The spatial distributions of judgments were elliptical. Distribution axes were found to align with the principle moments of inertia. Major axes tended to align with gravity in maximally symmetric objects. A functional and physical account was given in terms of the repercussions of error. Overall, judgments were very accurate.

Reflection Effects in Multimode Fiber Systems Utilizing Laser Transmitters

NASA Technical Reports Server (NTRS)

Bates, Harry E.

1991-01-01

A number of optical communication lines are now in use at NASA-Kennedy for the transmission of voice, computer data, and video signals. Now, all of these channels use a single carrier wavelength centered near 1300 or 1550 nm. Engineering tests in the past have given indications of the growth of systematic and random noise in the RF spectrum of a fiber network as the number of connector pairs is increased. This noise seems to occur when a laser transmitter is used instead of a LED. It has been suggested that the noise is caused by back reflections created at connector fiber interfaces. Experiments were performed to explore the effect of reflection on the transmitting laser under conditions of reflective feedback. This effort included computer integration of some of the instrumentation in the fiber optic lab using the Lab View software recently acquired by the lab group. The main goal was to interface the Anritsu Optical and RF spectrum analyzers to the MacIntosh II computer so that laser spectra and network RF spectra could be simultaneously and rapidly acquired in a form convenient for analysis. Both single and multimode fiber is installed at Kennedy. Since most are multimode, this effort concentrated on multimode systems.

Scale-dependent cyclone-anticyclone asymmetry in a forced rotating turbulence experiment

NASA Astrophysics Data System (ADS)

Gallet, B.; Campagne, A.; Cortet, P.-P.; Moisy, F.

2014-03-01

We characterize the statistical and geometrical properties of the cyclone-anticyclone asymmetry in a statistically steady forced rotating turbulence experiment. Turbulence is generated by a set of vertical flaps which continuously inject velocity fluctuations towards the center of a tank mounted on a rotating platform. We first characterize the cyclone-anticyclone asymmetry from conventional single-point vorticity statistics. We propose a phenomenological model to explain the emergence of the asymmetry in the experiment, from which we predict scaling laws for the root-mean-square velocity in good agreement with the experimental data. We further quantify the cyclone-anticyclone asymmetry using a set of third-order two-point velocity correlations. We focus on the correlations which are nonzero only if the cyclone-anticyclone symmetry is broken. They offer two advantages over single-point vorticity statistics: first, they are defined from velocity measurements only, so an accurate resolution of the Kolmogorov scale is not required; second, they provide information on the scale-dependence of the cyclone-anticyclone asymmetry. We compute these correlation functions analytically for a random distribution of independent identical vortices. These model correlations describe well the experimental ones, indicating that the cyclone-anticyclone asymmetry is dominated by the large-scale long-lived cyclones.

Validation of Static and Dynamic Balance Assessment Using Microsoft Kinect for Young and Elderly Populations.

PubMed

Eltoukhy, Moataz A; Kuenze, Christopher; Oh, Jeonghoon; Signorile, Joseph F

2018-01-01

Reduction in balance is an indicator of fall risk, and therefore, an accurate and cost-effective balance assessment tool is essential for prescribing effective postural control strategies. This study established the validity of the Kinect v2 sensor in assessing center of mass (CoM) excursion and velocity during single-leg balance and voluntary ankle sway tasks among young and elderly subjects. We compared balance outcome measures (anteroposterior (AP) and mediolateral (ML) CoM excursion and velocity and average sway length) to a traditional three-dimensional motion analysis system. Twenty subjects (10 young: age = y, height cm, weight kg; 10 elderly: age y, height cm, weight kg), with no history of lower extremity injury, participated in this study. Subjects performed six randomized trials; four single-leg stand (SLS) and two ankle sway trials. SLS and voluntary ankle sway trials showed that consistency (ICC(2, k)) and agreement (ICC(3, k)) for all variables when all subjects were considered, as well as when the elderly and young groups were analyzed separately. Concordance between systems ranged from poor to nearly perfect depending on the group, task, and variable assessed.

Reflection effects in multimode fiber systems utilizing laser transmitters

NASA Astrophysics Data System (ADS)

Bates, Harry E.

1991-11-01

A number of optical communication lines are now in use at NASA-Kennedy for the transmission of voice, computer data, and video signals. Now, all of these channels use a single carrier wavelength centered near 1300 or 1550 nm. Engineering tests in the past have given indications of the growth of systematic and random noise in the RF spectrum of a fiber network as the number of connector pairs is increased. This noise seems to occur when a laser transmitter is used instead of a LED. It has been suggested that the noise is caused by back reflections created at connector fiber interfaces. Experiments were performed to explore the effect of reflection on the transmitting laser under conditions of reflective feedback. This effort included computer integration of some of the instrumentation in the fiber optic lab using the Lab View software recently acquired by the lab group. The main goal was to interface the Anritsu Optical and RF spectrum analyzers to the MacIntosh II computer so that laser spectra and network RF spectra could be simultaneously and rapidly acquired in a form convenient for analysis. Both single and multimode fiber is installed at Kennedy. Since most are multimode, this effort concentrated on multimode systems.

Dialysis Modality and Readmission Following Hospital Discharge: A Population-Based Cohort Study.

PubMed

Perl, Jeffrey; McArthur, Eric; Bell, Chaim; Garg, Amit X; Bargman, Joanne M; Chan, Christopher T; Harel, Shai; Li, Lihua; Jain, Arsh K; Nash, Danielle M; Harel, Ziv

2017-07-01

Readmissions following hospital discharge among maintenance dialysis patients are common, potentially modifiable, and costly. Compared with patients receiving in-center hemodialysis (HD), patients receiving peritoneal dialysis (PD) have fewer routine dialysis clinic encounters and as a result may be more susceptible to a hospital readmission following discharge. Population-based retrospective-cohort observational study. Patients treated with maintenance dialysis who were discharged following an acute-care hospitalization during January 1, 2003, to December 31, 2013, across 164 acute-care hospitals in Ontario, Canada. For those with multiple hospitalizations, we randomly selected a single hospitalization as the index hospitalization. Dialysis modality PD or in-center HD. Propensity scores were used to match each patient on PD therapy to 2 patients on in-center HD therapy to ensure that baseline indicators of health were similar between the 2 groups. All-cause 30-day readmission following the index hospital discharge. 28,026 dialysis patients were included in the study. 4,013 PD patients were matched to 8,026 in-center HD patients. Among the matched cohort, 30-day readmission rates were 7.1 (95% CI, 6.6-7.6) per 1,000 person-days for patients on PD therapy and 6.0 (95% CI, 5.7-6.3) per 1,000 person-days for patients on in-center HD therapy. The risk for a 30-day readmission among patients on PD therapy was higher compared with those on in-center HD therapy (adjusted HR, 1.19; 95% CI, 1.08-1.31). The primary results were consistent across several key prespecified subgroups. Lack of information for the frequency of nephrology physician encounters following discharge from the hospital in both the PD and in-center HD cohorts. Limited validation of International Classification of Diseases, Tenth Revision codes. The risk for 30-day readmission is higher for patients on home-based PD compared to in-center HD therapy. Interventions to improve transitions in care between the inpatient and outpatient settings are needed, particularly for patients on PD therapy. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Numerical study of slip system activity and crystal lattice rotation under wedge nanoindents in tungsten single crystals

NASA Astrophysics Data System (ADS)

Volz, T.; Schwaiger, R.; Wang, J.; Weygand, S. M.

2018-05-01

Tungsten is a promising material for plasma facing components in future nuclear fusion reactors. In the present work, we numerically investigate the deformation behavior of unirradiated tungsten (a body-centered cubic (bcc) single crystal) underneath nanoindents. A finite element (FE) model is presented to simulate wedge indentation. Crystal plasticity finite element (CPFE) simulations were performed for face-centered and body-centered single crystals accounting for the slip system family {110} <111> in the bcc crystal system and the {111} <110> slip family in the fcc system. The 90° wedge indenter was aligned parallel to the [1 ¯01 ]-direction and indented the crystal in the [0 1 ¯0 ]-direction up to a maximum indentation depth of 2 µm. In both, the fcc and bcc single crystals, the activity of slip systems was investigated and compared. Good agreement with the results from former investigations on fcc single crystals was observed. Furthermore, the in-plane lattice rotation in the material underneath an indent was determined and compared for the fcc and bcc single crystals.

Quantum Random Number Generation Using a Quanta Image Sensor

PubMed Central

Amri, Emna; Felk, Yacine; Stucki, Damien; Ma, Jiaju; Fossum, Eric R.

2016-01-01

A new quantum random number generation method is proposed. The method is based on the randomness of the photon emission process and the single photon counting capability of the Quanta Image Sensor (QIS). It has the potential to generate high-quality random numbers with remarkable data output rate. In this paper, the principle of photon statistics and theory of entropy are discussed. Sample data were collected with QIS jot device, and its randomness quality was analyzed. The randomness assessment method and results are discussed. PMID:27367698

The random walk of a drilling laser beam

NASA Technical Reports Server (NTRS)

Anthony, T. R.

1980-01-01

The disregistry of holes drilled with a pulse laser beam in 330-micron-thick single-crystal silicon-on-sapphire wafers is examined. The exit positions of the holes were displaced from the hole entrance positions on the opposing face of the wafer, and this random displacement increased with the number of laser pulses required. A model in which the bottom of the drill hole experiences small random displacements during each laser pulse is used to describe the experimental observations. It is shown that the average random displacement caused by each pulse is only a few percent of the hole diameter and can be reduced by using as few laser pulses as necessary while avoiding the cracking and spalling of the wafer that occur with a hole drilled with a single pulse.

Listening to the Noise: Random Fluctuations Reveal Gene Network Parameters

NASA Astrophysics Data System (ADS)

Munsky, Brian; Trinh, Brooke; Khammash, Mustafa

2010-03-01

The cellular environment is abuzz with noise originating from the inherent random motion of reacting molecules in the living cell. In this noisy environment, clonal cell populations exhibit cell-to-cell variability that can manifest significant prototypical differences. Noise induced stochastic fluctuations in cellular constituents can be measured and their statistics quantified using flow cytometry, single molecule fluorescence in situ hybridization, time lapse fluorescence microscopy and other single cell and single molecule measurement techniques. We show that these random fluctuations carry within them valuable information about the underlying genetic network. Far from being a nuisance, the ever-present cellular noise acts as a rich source of excitation that, when processed through a gene network, carries its distinctive fingerprint that encodes a wealth of information about that network. We demonstrate that in some cases the analysis of these random fluctuations enables the full identification of network parameters, including those that may otherwise be difficult to measure. We use theoretical investigations to establish experimental guidelines for the identification of gene regulatory networks, and we apply these guideline to experimentally identify predictive models for different regulatory mechanisms in bacteria and yeast.

Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial.

PubMed

Pomerantz, Hyemin; Hogan, Daniel; Eilers, David; Swetter, Susan M; Chen, Suephy C; Jacob, Sharon E; Warshaw, Erin M; Stricklin, George; Dellavalle, Robert P; Sidhu-Malik, Navjeet; Konnikov, Nellie; Werth, Victoria P; Keri, Jonette; Lew, Robert; Weinstock, Martin A

2015-09-01

Topical fluorouracil was demonstrated to be effective in reducing the number of actinic keratoses (AKs) for up to 6 months, but no randomized trials studied its long-term efficacy. To evaluate the long-term efficacy of a single course of fluorouracil cream, 5%, for AK treatment. The Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial was a randomized, double-blinded, placebo-controlled trial with patients from dermatology clinics at 12 VA medical centers recruited from 2009 to 2011 and followed up until 2013. Our study population comprised 932 veterans with 2 or more keratinocyte carcinomas in the 5 years prior to enrollment. The mean follow-up duration was 2.6 years in both treatment and control groups. Participants applied either topical fluorouracil cream, 5% (n = 468), or vehicle control cream (n = 464) to the face and ears twice daily for up to 4 weeks. This study reports on AK counts and treatments, which were secondary outcomes of the VAKCC trial. Actinic keratoses on the face and ears were counted by study dermatologists at enrollment and at study visits every 6 months. The number of spot treatments for AKs on the face and ears at semiannual study visits and in between study visits was recorded. The number of AKs on the face and ears per participant was not different between the fluorouracil and control groups at randomization (11.1 vs 10.6, P > .10). After randomization, the fluorouracil group had fewer AKs compared with the control group at 6 months (3.0 vs 8.1, P < .001) and for the overall study duration (P < .001). The fluorouracil group also had higher complete AK clearance rates (38% vs 17% at 6 months) and fewer spot treatments at 6-month intervals, at study visits, and in between study visits during the trial (P < .01 for all). The fluorouracil group took longer to require the first spot AK treatment (6.2 months) compared with the control group (6.0 months) (hazard ratio, 0.69; 95% CI, 0.60-0.79). The number of hypertrophic AKs was not different between the 2 groups overall (P = .60), although there were fewer hypertrophic AKs in the fluorouracil group at 6 months (0.23 vs 0.41) (P = .05). Our results indicate that a single course of fluorouracil cream, 5%, effectively reduces AK counts and the need for spot treatments for longer than 2 years. clinicaltrials.gov Identifier:NCT00847912.

Performance of the Dual BAK-12 Aircraft Arresting System with Modular Hardware with Deadloads and Aircraft

DTIC Science & Technology

1976-04-15

System, Dual-System, Single-Mode, and Dual-Mode configurations. Tests were conducted to determine the feasibility of incorporating modular hardware on a...and 11-1/2 feet OFF-CENTER with the BAK-12 configured in the Single and Dual Mode to determine the effect of engaging the aircraft arresting-hook...cable OFF-CENTER. 90,000- pound deadload arrestments were conducted ON-CENTER in the Dual Mode to determine system performance with high-energy

NASA's Single-Pilot Operations Technical Interchange Meeting: Proceedings and Findings

NASA Technical Reports Server (NTRS)

Comerford, Doreen; Brandt, Summer L.; Lachter, Joel B.; Wu, Shu-Chieh; Mogford, Richard H.; Battiste, Vernol; Johnson, Walter W.

2013-01-01

Researchers at the National Aeronautics and Space Administration (NASA) Ames Research Center and Langley Research Center are jointly investigating issues associated with potential concepts, or configurations, in which a single pilot might operate under conditions that are currently reserved for a minimum of two pilots. As part of early efforts, NASA Ames Research Center hosted a technical interchange meeting in order to gain insight from members of the aviation community regarding single-pilot operations (SPO). The meeting was held on April 10-12, 2012 at NASA Ames Research Center. Professionals in the aviation domain were invited because their areas of expertise were deemed to be directly related to an exploration of SPO. NASA, in selecting prospective participants, attempted to represent various relevant sectors within the aviation domain. Approximately 70 people representing government, academia, and industry attended. A primary focus of this gathering was to consider how tasks and responsibilities might be re-allocated to allow for SPO.

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

PubMed

Fukushima, Norihide; Tatsumi, Eisuke; Seguchi, Osamu; Takewa, Yoshiaki; Hamasaki, Toshimitsu; Onda, Kaori; Yamamoto, Haruko; Hayashi, Teruyuki; Fujita, Tomoyuki; Kobayashi, Junjiro

2018-06-08

The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device and the day of withdrawal of a trial device), and changes in left ventricular diastolic dimension (7 days after implantation of a trial device and the day of withdrawal of a trial device). We will disseminate the findings through regional, national, and international conferences and through peer-reviewed journals. UMIN Clinical Trials Registry (UMIN-CTR; R000033243) registered on 8 September 2017.

Nitrogen-vacancy centers in diamond: nanoscale sensors for physics and biology.

PubMed

Schirhagl, Romana; Chang, Kevin; Loretz, Michael; Degen, Christian L

2014-01-01

Crystal defects in diamond have emerged as unique objects for a variety of applications, both because they are very stable and because they have interesting optical properties. Embedded in nanocrystals, they can serve, for example, as robust single-photon sources or as fluorescent biomarkers of unlimited photostability and low cytotoxicity. The most fascinating aspect, however, is the ability of some crystal defects, most prominently the nitrogen-vacancy (NV) center, to locally detect and measure a number of physical quantities, such as magnetic and electric fields. This metrology capacity is based on the quantum mechanical interactions of the defect's spin state. In this review, we introduce the new and rapidly evolving field of nanoscale sensing based on single NV centers in diamond. We give a concise overview of the basic properties of diamond, from synthesis to electronic and magnetic properties of embedded NV centers. We describe in detail how single NV centers can be harnessed for nanoscale sensing, including the physical quantities that may be detected, expected sensitivities, and the most common measurement protocols. We conclude by highlighting a number of the diverse and exciting applications that may be enabled by these novel sensors, ranging from measurements of ion concentrations and membrane potentials to nanoscale thermometry and single-spin nuclear magnetic resonance.

The design concept of the 6-degree-of-freedom hydraulic shaker at ESTEC

NASA Technical Reports Server (NTRS)

Brinkman, P. W.; Kretz, D.

1992-01-01

The European Space Agency (ESA) has decided to extend its test facilities at the European Space and Technology Center (ESTEC) at Noordwijk, The Netherlands, by implementing a 6-degree-of-freedom hydraulic shaker. This shaker will permit vibration testing of large payloads in the frequency range from 0.1 Hz to 100 Hz. Conventional single axis sine and random vibration modes can be applied without the need for a configuration change of the test set-up for vertical and lateral excitations. Transients occurring during launch and/or landing of space vehicles can be accurately simulated in 6-degrees-of-freedom. The performance requirements of the shaker are outlined and the results of the various trade-offs, which are investigated during the initial phase of the design and engineering program are provided. Finally, the resulting baseline concept and the anticipated implementation plan of the new test facility are presented.

High-Intensity Radiated Field Fault-Injection Experiment for a Fault-Tolerant Distributed Communication System

NASA Technical Reports Server (NTRS)

Yates, Amy M.; Torres-Pomales, Wilfredo; Malekpour, Mahyar R.; Gonzalez, Oscar R.; Gray, W. Steven

2010-01-01

Safety-critical distributed flight control systems require robustness in the presence of faults. In general, these systems consist of a number of input/output (I/O) and computation nodes interacting through a fault-tolerant data communication system. The communication system transfers sensor data and control commands and can handle most faults under typical operating conditions. However, the performance of the closed-loop system can be adversely affected as a result of operating in harsh environments. In particular, High-Intensity Radiated Field (HIRF) environments have the potential to cause random fault manifestations in individual avionic components and to generate simultaneous system-wide communication faults that overwhelm existing fault management mechanisms. This paper presents the design of an experiment conducted at the NASA Langley Research Center's HIRF Laboratory to statistically characterize the faults that a HIRF environment can trigger on a single node of a distributed flight control system.

TVT-Secur (Hammock) Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

PubMed Central

Hota, Lekha S.; Hanaway, Katherine; Hacker, Michele R.; Disciullo, Anthony; Elkadry, Eman; Dramitinos, Patricia; Shapiro, Alexander; Ferzandi, Tanaz; Rosenblatt, Peter L.

2013-01-01

Objectives This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI). Methods This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year. Results Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3–16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5–128.0) at 12 weeks and 3.5 (95% CI, 1.1–11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36). Conclusions The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms. PMID:22453267

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures.

PubMed

Hota, Lekha S; Hanaway, Katherine; Hacker, Michele R; Disciullo, Anthony; Elkadry, Eman; Dramitinos, Patricia; Shapiro, Alexander; Ferzandi, Tanaz; Rosenblatt, Peter L

2012-01-01

This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI). This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year. Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3-16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5-128.0) at 12 weeks and 3.5 (95% CI, 1.1-11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36). The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

PubMed

Dalai, Shebani Sethi; Adler, Sarah; Najarian, Thomas; Safer, Debra Lynn

2018-01-01

Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. Copyright © 2017 Elsevier Inc. All rights reserved.

Sternotomy or drainage for a hemopericardium after penetrating trauma: a randomized controlled trial.

PubMed

Nicol, Andrew J; Navsaria, Pradeep H; Hommes, Martijn; Ball, Chad G; Edu, Sorin; Kahn, Delawir

2014-03-01

To determine if stable patients with a hemopericardium detected after penetrating chest trauma can be safely managed with pericardial drainage alone. The current international practice is to perform a sternotomy and cardiac repair if a hemopericardium is detected after penetrating chest trauma. The experience in Cape Town, South Africa, on performing a mandatory sternotomy in hemodynamically stable patients was that a sternotomy was unnecessary and the cardiac injury, if present, had sealed. A single-center parallel-group randomized controlled study was completed. All hemodynamically stable patients with a hemopericardium confirmed at subxiphoid pericardial window (SPW), and no active bleeding, were randomized. The primary outcome measure was survival to discharge from hospital. Secondary outcomes were complications and postoperative hospital stay. Fifty-five patients were randomized to sternotomy and 56 to pericardial drainage and wash-out only. Fifty-one of the 55 patients (93%) randomized to sternotomy had either no cardiac injury or a tangential injury. There were only 4 patients with penetrating wounds to the endocardium and all had sealed. There was 1 death postoperatively among the 111 patients (0.9%) and this was in the sternotomy group. The mean intensive care unit (ICU) stay for a sternotomy was 2.04 days (range, 0-25 days) compared with 0.25 days (range, 0-2) for the drainage (P < 0.001). The estimated mean difference highlighted a stay of 1.8 days shorter in the ICU for the drainage group (95% CI: 0.8-2.7). Total hospital stay was significantly shorter in the SPW group (P < 0.001; 95% CI: 1.4-3.3). SPW and drainage is effective and safe in the stable patient with a hemopericardium after penetrating chest trauma, with no increase in mortality and a shorter ICU and hospital stay. (ClinicalTrials.gov Identifier: NCT00823160).

Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.

PubMed

Zelen, Charles M; Poka, Attila; Andrews, James

2013-10-01

Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis. An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being. Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM. In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings. Level I, prospective randomized study.

Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial.

PubMed

Bakhshi, Sameer; Batra, Atul; Biswas, Bivas; Dhawan, Deepa; Paul, Reeja; Sreenivas, Vishnubhatla

2015-11-01

Aprepitant, a neurokinin-1 receptor antagonist, in combination with 5 HT-3 antagonist and dexamethasone is recommended in adults receiving moderately and highly emetogenic chemotherapy to reduce chemotherapy-induced vomiting (CIV). Data for use of aprepitant in children is limited and hence aprepitant is not recommended by Pediatric Oncology Group of Ontario guidelines for prevention of CIV in children <12 years. A randomized, double-blind, placebo-controlled trial was conducted at a single center in chemotherapy naïve children (5-18 years) receiving highly emetogenic chemotherapy. All patients received intravenous ondansetron (0.15 mg/kg) and dexamethasone (0.15 mg/kg) prior to chemotherapy followed by oral ondansetron and dexamethasone. Patients randomly assigned to aprepitant arm received oral aprepitant (15-40 kg = days 1-3, 80 mg; 41-65 kg = day 1, 125 mg and days 2-3, 80 mg) 1 h before chemotherapy. Control group received placebo as add-on therapy. Primary outcome measure was the incidence of acute moderate to severe vomiting, which was defined as more than two vomiting episodes within 24 h after the administration of the first chemotherapy dose until 24 h after the last chemotherapy dose in the block. Complete response (CR) was defined as absence of vomiting and retching during the specified phase. Of the 96 randomized patients, three were excluded from analysis; 93 patients were analyzed (50 in aprepitant arm and 43 in placebo arm). Acute moderate and severe vomiting was reported in 72 % patients receiving placebo and 38 % patients receiving aprepitant (p = 0.001). Complete response rates during acute phase were significantly higher in aprepitant arm (48 vs. 12 %, p < 0.001). No major adverse effects were reported by patients/guardians. This double-blind, randomized, placebo-controlled trial shows that aprepitant significantly decreases the incidence of CIV during acute phase when used as an add-on drug with ondansetron and dexamethasone in children receiving highly emetogenic chemotherapy.

Analysis of a Spatial Point Pattern: Examining the Damage to Pavement and Pipes in Santa Clara Valley Resulting from the Loma Prieta Earthquake

USGS Publications Warehouse

Phelps, G.A.

2008-01-01

This report describes some simple spatial statistical methods to explore the relationships of scattered points to geologic or other features, represented by points, lines, or areas. It also describes statistical methods to search for linear trends and clustered patterns within the scattered point data. Scattered points are often contained within irregularly shaped study areas, necessitating the use of methods largely unexplored in the point pattern literature. The methods take advantage of the power of modern GIS toolkits to numerically approximate the null hypothesis of randomly located data within an irregular study area. Observed distributions can then be compared with the null distribution of a set of randomly located points. The methods are non-parametric and are applicable to irregularly shaped study areas. Patterns within the point data are examined by comparing the distribution of the orientation of the set of vectors defined by each pair of points within the data with the equivalent distribution for a random set of points within the study area. A simple model is proposed to describe linear or clustered structure within scattered data. A scattered data set of damage to pavement and pipes, recorded after the 1989 Loma Prieta earthquake, is used as an example to demonstrate the analytical techniques. The damage is found to be preferentially located nearer a set of mapped lineaments than randomly scattered damage, suggesting range-front faulting along the base of the Santa Cruz Mountains is related to both the earthquake damage and the mapped lineaments. The damage also exhibit two non-random patterns: a single cluster of damage centered in the town of Los Gatos, California, and a linear alignment of damage along the range front of the Santa Cruz Mountains, California. The linear alignment of damage is strongest between 45? and 50? northwest. This agrees well with the mean trend of the mapped lineaments, measured as 49? northwest.

Casino physics in the classroom

NASA Astrophysics Data System (ADS)

Whitney, Charles A.

1986-12-01

This article describes a seminar on the elements of probability and random processes that is computer centered and focuses on Monte Carlo simulations of processes such as coin flips, random walks on a lattice, and the behavior of photons and atoms in a gas. Representative computer programs are also described.

Does the Well-Being of Individuals with Down Syndrome and Dementia Improve When Using Life Story Books and Rummage Boxes? A Randomized Single Case Series Experiment

ERIC Educational Resources Information Center

Crook, Nicola; Adams, Malcolm; Shorten, Nicola; Langdon, Peter E.

2016-01-01

Background: This study investigated whether a personalized life story book and rummage box enhanced well-being and led to changes in behaviour for people with Down syndrome (DS) who have dementia. Materials and Methods: A randomized single case series design was used with five participants who had DS and a diagnosis of dementia. Participants were…

Cryptotomography: reconstructing 3D Fourier intensities from randomly oriented single-shot diffraction patterns (CXIDB ID 9)

DOE Data Explorer

Loh, Ne-Te Duane

2011-08-01

These 2000 single-shot diffraction patterns include were either background-scattering only or hits (background-scattering plus diffraction signal from sub-micron ellipsoidal particles at random, undetermined orientations). Candidate hits were identified by eye, and the remainder were presumed as background. 54 usable, background-subtracted hits in this set (procedure in referenced article) were used to reconstruct the 3D diffraction intensities of the average ellipsoidal particle.

Comparative Analysis of Canal Centering Ability of Different Single File Systems Using Cone Beam Computed Tomography- An In-Vitro Study.

PubMed

Agarwal, Rolly S; Agarwal, Jatin; Jain, Pradeep; Chandra, Anil

2015-05-01

The ability of an endodontic instrument to remain centered in the root canal system is one of the most important characteristic influencing the clinical performance of a particular file system. Thus, it is important to assess the canal centering ability of newly introduced single file systems before they can be considered a viable replacement of full-sequence rotary file systems. The aim of the study was to compare the canal transportation, centering ability, and time taken for preparation of curved root canals after instrumentation with single file systems One Shape and Wave One, using cone-beam computed tomography (CBCT). Sixty mesiobuccal canals of mandibular molars with an angle of curvature ranging from 20(o) to 35(o) were divided into three groups of 20 samples each: ProTaper PT (group I) - full-sequence rotary control group, OneShape OS (group II)- single file continuous rotation, WaveOne WO - single file reciprocal motion (group III). Pre instrumentation and post instrumentation three-dimensional CBCT images were obtained from root cross-sections at 3mm, 6mm and 9mm from the apex. Scanned images were then accessed to determine canal transportation and centering ability. The data collected were evaluated using one-way analysis of variance (ANOVA) with Tukey's honestly significant difference test. It was observed that there were no differences in the magnitude of transportation between the rotary instruments (p >0.05) at both 3mm as well as 6mm from the apex. At 9 mm from the apex, Group I PT showed significantly higher mean canal transportation and lower centering ability (0.19±0.08 and 0.39±0.16), as compared to Group II OS (0.12±0.07 and 0.54±0.24) and Group III WO (0.13±0.06 and 0.55±0.18) while the differences between OS and WO were not statistically significant. It was concluded that there was minor difference between the tested groups. Single file systems demonstrated average canal transportation and centering ability comparable to full sequence Protaper system in curved root canals.

Coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone improves postprandial endothelial dysfunction in patients with borderline and stage 1 hypertension.

PubMed

Kajikawa, Masato; Maruhashi, Tatsuya; Hidaka, Takayuki; Nakano, Yukiko; Kurisu, Satoshi; Matsumoto, Takeshi; Iwamoto, Yumiko; Kishimoto, Shinji; Matsui, Shogo; Aibara, Yoshiki; Yusoff, Farina Mohamad; Kihara, Yasuki; Chayama, Kazuaki; Goto, Chikara; Noma, Kensuke; Nakashima, Ayumu; Watanabe, Takuya; Tone, Hiroshi; Hibi, Masanobu; Osaki, Noriko; Katsuragi, Yoshihisa; Higashi, Yukihito

2018-01-12

The purpose of this study was to evaluate acute effects of coffee with a high content of chlorogenic acids and different hydroxyhydroquinone contents on postprandial endothelial dysfunction. This was a single-blind, randomized, placebo-controlled, crossover-within-subject clinical trial. A total of 37 patients with borderline or stage 1 hypertension were randomized to two study groups. The participants consumed a test meal with a single intake of the test coffee. Subjects in the Study 1 group were randomized to single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone or coffee with a high content of chlorogenic acids and a high content of hydroxyhydroquinone with crossover. Subjects in the Study 2 group were randomized to single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone or placebo coffee with crossover. Endothelial function assessed by flow-mediated vasodilation and plasma concentration of 8-isoprostanes were measured at baseline and at 1 and 2 h after coffee intake. Compared with baseline values, single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone, but not coffee with a high content of chlorogenic acids and high content of hydroxyhydroquinone or placebo coffee, significantly improved postprandial flow-mediated vasodilation and decreased circulating 8-isoprostane levels. These findings suggest that a single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone is effective for improving postprandial endothelial dysfunction. URL for Clinical Trial: https://upload.umin.ac.jp ; Registration Number for Clinical Trial: UMIN000013283.

The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

PubMed

Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

2016-03-01

Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p < 0.01) and depression (odds ratio, 0.29; 95% CI, 0.11-0.77; p < 0.01) in female patients after dexamethasone administration. Health-related quality of life did not differ between groups and was not associated with psychopathology. Overall, our findings suggest that exogenous administration of the glucocorticoid receptor agonist dexamethasone-compared with placebo-during cardiac surgery does not positively or negatively affect the prevalence of posttraumatic stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

A novel bio-psycho-social approach for rehabilitation of traumatized victims of torture and war in the post-conflict context: a pilot randomized controlled trial in Kosovo.

PubMed

Wang, Shr-Jie; Bytyçi, Ardiana; Izeti, Selvi; Kallaba, Melita; Rushiti, Feride; Montgomery, Edith; Modvig, Jens

2016-01-01

Some evidence showed that multidisciplinary rehabilitation in Western countries is effective for treating war-related trauma, but it remains unclear whether this approach is applicable to civilians living in resource-poor countries affected by war. In 2012-14, Danish Institute against Torture (DIGNITY) conducted a randomized controlled trial (RCT), in partnership with Kosova Rehabilitation Centre for Torture Victims (KRCT), to examine the effects of multidisciplinary intervention among victims of torture and war in Kosovo. A single-center, randomized, parallel-arm, single-masked, waiting-list controlled trial was implemented in northern Kosovo. Thirty-four participants meeting the recruiting criteria were randomized to either intervention group, which received integrated treatments plus a once-daily multivitamin, or the waiting list group, which received multivitamin alone. The integrated treatments consisted of 10 weekly individual 60-min sessions of cognitive behavioral therapy (CBT), based on an adapted prolonged exposure therapy manual, an individual 20-min breathing exercise with an emWave biofeedback device, and 90-min group physiotherapy. The waiting list group also received the same treatment after the intervention group had completed their sessions. Outcome assessments were conducted at 3, 6 and 9 months after baseline assessment. Outcomes measures consisted of 4 subtypes: mental, emotional, physical health, functioning and social outcomes, i.e. PTSD, depression, anxiety, chronic pain, anger and hatred expression, body mass index, handgrip strength, standing balance, income, employment rate and disability score. Over 1/3 of PTSD cases were successfully treated. Inconsistent patterns with mental health and chronic pain outcomes were observed while there was a definite impact of intervention on functioning and social outcomes, i.e. the employment rate, which increased nearly 15 %, and the monthly wage, which rose 45-137 %. There was also a noticeable improvement in handgrip strength and disability score; the feelings of anger and hatred diminished. However, most of these changes did not reach statistical significance. The impact of bio-psycho-social intervention is likely sensitive to the context of post-war economy in Kosovo and the treatment goals. The potential for improving the emotional well-being and employment outcome in victims was demonstrated. A larger scale RCT in a similar setting is needed, with close monitoring of treatment integrity and data reliability. Clinicaltrials.gov (NCT01696578).

Critical appraisal of clinical trials in multiple system atrophy: Toward better quality.

PubMed

Castro Caldas, Ana; Levin, Johannes; Djaldetti, Ruth; Rascol, Olivier; Wenning, Gregor; Ferreira, Joaquim J

2017-10-01

Multiple system atrophy (MSA) is a rare neurodegenerative disease of undetermined cause. Although many clinical trials have been conducted, there is still no treatment that cures the disease or slows its progression. We sought to assess the clinical trials, methodology, and quality of reporting of clinical trails conducted in MSA patients. We conducted a systematic review of all trials with at least 1 MSA patient subject to any pharmacological/nonpharmacological interventions. Two independent reviewers evaluated the methodological characteristics and quality of reporting of trials. A total of 60 clinical trials were identified, including 1375 MSA patients. Of the trials, 51% (n = 31) were single-arm studies. A total of 28% (n = 17) had a parallel design, half of which (n = 13) were placebo controlled. Of the studies, 8 (13.3%) were conducted in a multicenter setting, 3 of which were responsible for 49.3% (n = 678) of the total included MSA patients. The description of primary outcomes was unclear in 60% (n = 40) of trials. Only 10 (16.7%) clinical trials clearly described the randomization process. Blinding of the participants, personnel, and outcome assessments were at high risk of bias in the majority of studies. The number of dropouts/withdrawals was high (n = 326, 23.4% among the included patients). Overall, the design and quality of reporting of the reviewed studies is unsatisfactory. The most frequent clinical trials were small and single centered. Inadequate reporting was related to the information on the randomization process, sequence generation, allocation concealment, blinding of participants, and sample size calculations. Although improved during the recent years, methodological quality and trial design need to be optimized to generate more informative results. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

Results of a Community-based, Randomized Study Comparing a Clear Liquid Diet With a Low-residue Diet Using a Magnesium Citrate Preparation for Screening and Surveillance Colonoscopies.

PubMed

Thukral, Chandrashekhar; Tewani, Sumeet K; Lake, Adam J; Shiels, Aaron J; Geissler, Kathy; Popejoy, Sara; Stafford, Megan; Vicari, Joseph J

2017-11-03

Current bowel preparations for colonoscopy include a clear liquid diet (CLD) along with consumption of a laxative. This dietary restriction along with large volume bowel preparations are barriers to compliance and willingness among patients in scheduling screening examinations. The aim of our study was to compare the efficacy and tolerability of a low-volume split dose magnesium citrate bowel preparation in patients on a low-residue diet (LRD) with those on a CLD. In this single center, single blinded, randomized controlled trial, patients scheduled for outpatient colonoscopies were assigned to either a CLD or a LRD 1 day before the examination. Both groups received a split dose magnesium citrate preparation. The quality of the preparation was rated using the Boston Bowel Preparation Scale (BBPS). Patient satisfaction and side effects were evaluated using a questionnaire. We were unable to detect a significant difference in the BBPS scores between the LRD and CLD groups (P=0.581). A significantly higher percentage of patients in the LRD group rated the diet as easy compared with the CLD group (P<0.001). Satisfaction scores were significantly higher in the LRD group, compared with the CLD group (P<0.001). The side effect profiles of both arms were similar. There was no significant difference between LRD and CLD in patients using a magnesium citrate bowel preparation for screening and surveillance colonoscopies. Patient satisfaction scores were higher with a LRD compared with a CLD. We believe the LRD should be the recommended diet in patients using a standard bowel preparation for screening and surveillance colonoscopy.

[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

PubMed

Lu, Quan

2010-03-01

To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

Perception of Muscular Effort During Dynamic Elbow Extension in Multiple Sclerosis.

PubMed

Heller, Mario; Retzl, Irene; Kiselka, Anita; Greisberger, Andrea

2016-02-01

To investigate the perception of muscular effort in individuals with multiple sclerosis (MS) and healthy controls during dynamic contractions. Case-control study. MS day care center. Individuals with MS (n=28) and controls (n=28) (N=56). Not applicable. Perceived muscular effort during dynamic elbow extensions was rated at 9 different weight intensities (10%-90% of 1-repetition maximum) in a single-blind, randomized order using the OMNI-Resistance Exercise Scale. Muscle activity of the triceps brachii muscle (lateral head) was measured via surface electromyography and normalized to maximal voluntary excitation. According to OMNI-level ratings, significant main effects were found for the diagnostic condition (F=27.33, P<.001, η(2)=.11), indicating 0.7 (95% confidence interval [CI], 0.3-1.1) lower mean OMNI-level ratings for MS, and for the intensity level (F=46.81, P<.001, η(2)=.46), showing increased OMNI-level ratings for increased intensity levels for both groups. Furthermore, significant main effects were found for the diagnostic condition (F=16.52, P<.001, η(2)=.07), indicating 7.1% (95% CI, -8.6 to 22.8) higher maximal voluntary excitation values for MS, and for the intensity level (F=33.09, P<.001, η(2)=.36), showing higher relative muscle activities for increasing intensity levels in both groups. Similar to controls, individuals with MS were able to differentiate between different intensities of weight during dynamic elbow extensions when provided in a single-blind, randomized order. Therefore, perceived muscular effort might be considered to control resistance training intensities in individuals with MS. However, training intensity for individuals with MS should be chosen at approximately 1 OMNI level lower than recommended, at least for dynamic elbow extension exercises. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.