Probability, random variables, and random processes theory and signal processing applications

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Shynk, John J

2012-01-01

Probability, Random Variables, and Random Processes is a comprehensive textbook on probability theory for engineers that provides a more rigorous mathematical framework than is usually encountered in undergraduate courses. It is intended for first-year graduate students who have some familiarity with probability and random variables, though not necessarily of random processes and systems that operate on random signals. It is also appropriate for advanced undergraduate students who have a strong mathematical background. The book has the following features: Several app

Development of rigor mortis is not affected by muscle volume.

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Kobayashi, M; Ikegaya, H; Takase, I; Hatanaka, K; Sakurada, K; Iwase, H

2001-04-01

There is a hypothesis suggesting that rigor mortis progresses more rapidly in small muscles than in large muscles. We measured rigor mortis as tension determined isometrically in rat musculus erector spinae that had been cut into muscle bundles of various volumes. The muscle volume did not influence either the progress or the resolution of rigor mortis, which contradicts the hypothesis. Differences in pre-rigor load on the muscles influenced the onset and resolution of rigor mortis in a few pairs of samples, but did not influence the time taken for rigor mortis to reach its full extent after death. Moreover, the progress of rigor mortis in this muscle was biphasic; this may reflect the early rigor of red muscle fibres and the late rigor of white muscle fibres.

Rain dance: the role of randomization in clinical trials

Directory of Open Access Journals (Sweden)

Diniz JB

2016-07-01

Full Text Available Juliana Belo Diniz,1 Victor Fossaluza,2 Carlos Alberto de Bragança Pereira,1,2 Sergio Wechsler2 1Institute of Psychiatry, Clinics Hospital University of São Paulo Medical School, 2Department of Statistics, Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil Abstract: Randomized clinical trials are the gold standard for testing efficacy of treatment interventions. However, although randomization protects against deliberately biased samples, it does not guarantee random imbalances will not occur. Methods of intentional allocation that can overcome such deficiency of randomization have been developed, but are less frequently applied than randomization. Initially, we introduce a fictitious case example to revise and discuss the reasons of researchers' resistance to intentionally allocate instead of simply randomizing. We then introduce a real case example to evaluate the performance of an intentional protocol for allocation based on compositional data balance. A real case of allocation of 50 patients in two arms was compared with an optimal allocation of global instead of sequential arrivals. Performance was measured by a weighted average of Aitchison distances, between arms, of prognostic factors. To compare the intentional allocation with simple random allocation, 50,000 arrival orderings of 50 patients were simulated. To each one of the orders, both kinds of allocations into two arms were considered. Intentional allocation performed as well as optimal allocation in the case considered. In addition, out of the 50,000 simulated orders, 61% of them performed better with intentional allocation than random allocation. Hence, we conclude that intentional allocation should be encouraged in the design of future interventional clinical trials as a way to prevent unbalanced samples. Our sequential method is a viable alternative to overcome technical difficulties for study designs that require sequential inclusion of

Estimation of the time since death--reconsidering the re-establishment of rigor mortis.

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Anders, Sven; Kunz, Michaela; Gehl, Axel; Sehner, Susanne; Raupach, Tobias; Beck-Bornholdt, Hans-Peter

2013-01-01

In forensic medicine, there is an undefined data background for the phenomenon of re-establishment of rigor mortis after mechanical loosening, a method used in establishing time since death in forensic casework that is thought to occur up to 8 h post-mortem. Nevertheless, the method is widely described in textbooks on forensic medicine. We examined 314 joints (elbow and knee) of 79 deceased at defined time points up to 21 h post-mortem (hpm). Data were analysed using a random intercept model. Here, we show that re-establishment occurred in 38.5% of joints at 7.5 to 19 hpm. Therefore, the maximum time span for the re-establishment of rigor mortis appears to be 2.5-fold longer than thought so far. These findings have major impact on the estimation of time since death in forensic casework.

Fundamentals of randomized clinical trials in wound care

DEFF Research Database (Denmark)

Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

2012-01-01

randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

Long persistence of rigor mortis at constant low temperature.

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Varetto, Lorenzo; Curto, Ombretta

2005-01-06

We studied the persistence of rigor mortis by using physical manipulation. We tested the mobility of the knee on 146 corpses kept under refrigeration at Torino's city mortuary at a constant temperature of +4 degrees C. We found a persistence of complete rigor lasting for 10 days in all the cadavers we kept under observation; and in one case, rigor lasted for 16 days. Between the 11th and the 17th days, a progressively increasing number of corpses showed a change from complete into partial rigor (characterized by partial bending of the articulation). After the 17th day, all the remaining corpses showed partial rigor and in the two cadavers that were kept under observation "à outrance" we found the absolute resolution of rigor mortis occurred on the 28th day. Our results prove that it is possible to find a persistence of rigor mortis that is much longer than the expected when environmental conditions resemble average outdoor winter temperatures in temperate zones. Therefore, this datum must be considered when a corpse is found in those environmental conditions so that when estimating the time of death, we are not misled by the long persistence of rigor mortis.

Randomized clinical trials in pediatric critical care: Rarely done but desperately needed.

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Randolph, Adrienne G.; Lacroix, Jacques

2002-04-01

OBJECTIVE: To review the benefits and challenges of using the randomized, controlled trial (RCT) study design to evaluate preventive and therapeutic interventions in pediatric critical care medicine. CONCLUSIONS: The RCT design is able to control for many sources of potential bias that other types of study designs cannot. The findings of RCTs often contradict the findings of less rigorous study designs. Before performing an RCT, there must exist a state of clinical equipoise, a sufficient number of eligible patients must be available, and the epidemiology of the disorder in question must be well studied. There are many challenges to performing high-quality RCTs. Studying multiple element support strategies in the critically ill patient population is more complex than studying a single drug therapy. High patient and practice variability and hazy diagnostic definitions can dilute the signal-to-noise ratio. Most interventions in critical care are expected to have a modest or small effect. This markedly increases the requisite sample size. There is a paucity of accepted clinically important measurements of the outcome of critical care, making mortality a common outcome to evaluate with a not-so-common incidence. Developmental issues, the inability to give informed consent, and the failure to perform the appropriate pharmacokinetic and safety studies are additional challenges facing pediatric investigators. Despite these limitations, a good RCT remains the best way to prove that an intervention is working or not. Indeed, RCTs are and will remain the "gold standard" method to estimate the efficacy of a therapeutic or prophylactic intervention.

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

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Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

2016-08-02

Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

When to base clinical policies on observational versus randomized trial data.

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Hornberger, J; Wrone, E

1997-10-15

Physicians must decide when the evidence is sufficient to adopt a new clinical policy. Analysis of large clinical and administrative databases is becoming an important source of evidence for changing clinical policies. Because such analysis cannot control for the effects of all potential confounding variables, physicians risk drawing the wrong conclusion about the cause-and-effect relation between a change in clinical policy and outcomes. Randomized studies offer protection against drawing a conclusion that would lead to adoption of an inferior policy. However, a randomized study may be difficult to justify because of the extra costs of collecting data for a randomized study and concerns that a study will not directly benefit the patients enrolled in the study. This article reviews the advantages and disadvantages of basing clinical policy on analysis of large databases compared with conducting a randomized study. A technique is described and illustrated for accessing the potential costs and benefits of conducting such a study. This type of analysis formed the basis for a physician-managed health care organization deciding to sponsor a randomized study among patients with end-stage renal disease as part of a quality-improvement initiative.

A case of instantaneous rigor?

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Pirch, J; Schulz, Y; Klintschar, M

2013-09-01

The question of whether instantaneous rigor mortis (IR), the hypothetic sudden occurrence of stiffening of the muscles upon death, actually exists has been controversially debated over the last 150 years. While modern German forensic literature rejects this concept, the contemporary British literature is more willing to embrace it. We present the case of a young woman who suffered from diabetes and who was found dead in an upright standing position with back and shoulders leaned against a punchbag and a cupboard. Rigor mortis was fully established, livor mortis was strong and according to the position the body was found in. After autopsy and toxicological analysis, it was stated that death most probably occurred due to a ketoacidotic coma with markedly increased values of glucose and lactate in the cerebrospinal fluid as well as acetone in blood and urine. Whereas the position of the body is most unusual, a detailed analysis revealed that it is a stable position even without rigor mortis. Therefore, this case does not further support the controversial concept of IR.

Quality of nuchal translucency measurements correlates with broader aspects of program rigor and culture of excellence.

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Evans, Mark I; Krantz, David A; Hallahan, Terrence; Sherwin, John; Britt, David W

2013-01-01

To determine if nuchal translucency (NT) quality correlates with the extent to which clinics vary in rigor and quality control. We correlated NT performance quality (bias and precision) of 246,000 patients with two alternative measures of clinic culture - % of cases for whom nasal bone (NB) measurements were performed and % of requisitions correctly filled for race-ethnicity and weight. When requisition errors occurred in 5% (33%), the curve lowered to 0.93 MoM (p 90%, MoM was 0.99 compared to those quality exists independent of individual variation in NT quality, and two divergent indices of program rigor are associated with NT quality. Quality control must be program wide, and to effect continued improvement in the quality of NT results across time, the cultures of clinics must become a target for intervention. Copyright © 2013 S. Karger AG, Basel.

Mathematical Rigor in Introductory Physics

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Vandyke, Michael; Bassichis, William

2011-10-01

Calculus-based introductory physics courses intended for future engineers and physicists are often designed and taught in the same fashion as those intended for students of other disciplines. A more mathematically rigorous curriculum should be more appropriate and, ultimately, more beneficial for the student in his or her future coursework. This work investigates the effects of mathematical rigor on student understanding of introductory mechanics. Using a series of diagnostic tools in conjunction with individual student course performance, a statistical analysis will be performed to examine student learning of introductory mechanics and its relation to student understanding of the underlying calculus.

A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics.

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Bhavnani, Sanjeev P; Sola, Srikanth; Adams, David; Venkateshvaran, Ashwin; Dash, P K; Sengupta, Partho P

2018-04-01

This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD). Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated. A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year. An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

"Rigor mortis" in a live patient.

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Chakravarthy, Murali

2010-03-01

Rigor mortis is conventionally a postmortem change. Its occurrence suggests that death has occurred at least a few hours ago. The authors report a case of "Rigor Mortis" in a live patient after cardiac surgery. The likely factors that may have predisposed such premortem muscle stiffening in the reported patient are, intense low cardiac output status, use of unusually high dose of inotropic and vasopressor agents and likely sepsis. Such an event may be of importance while determining the time of death in individuals such as described in the report. It may also suggest requirement of careful examination of patients with muscle stiffening prior to declaration of death. This report is being published to point out the likely controversies that might arise out of muscle stiffening, which should not always be termed rigor mortis and/ or postmortem.

Classroom Talk for Rigorous Reading Comprehension Instruction

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Wolf, Mikyung Kim; Crosson, Amy C.; Resnick, Lauren B.

2004-01-01

This study examined the quality of classroom talk and its relation to academic rigor in reading-comprehension lessons. Additionally, the study aimed to characterize effective questions to support rigorous reading comprehension lessons. The data for this study included 21 reading-comprehension lessons in several elementary and middle schools from…

The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

Directory of Open Access Journals (Sweden)

Scardino Peter T

2009-03-01

Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

Theory of Randomized Search Heuristics in Combinatorial Optimization

DEFF Research Database (Denmark)

The rigorous mathematical analysis of randomized search heuristics(RSHs) with respect to their expected runtime is a growing research area where many results have been obtained in recent years. This class of heuristics includes well-known approaches such as Randomized Local Search (RLS), the Metr......The rigorous mathematical analysis of randomized search heuristics(RSHs) with respect to their expected runtime is a growing research area where many results have been obtained in recent years. This class of heuristics includes well-known approaches such as Randomized Local Search (RLS...... analysis of randomized algorithms to RSHs. Mostly, the expected runtime of RSHs on selected problems is analzyed. Thereby, we understand why and when RSHs are efficient optimizers and, conversely, when they cannot be efficient. The tutorial will give an overview on the analysis of RSHs for solving...

Blinding in randomized clinical trials: imposed impartiality

DEFF Research Database (Denmark)

Hróbjartsson, A; Boutron, I

2011-01-01

Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

Experimental evaluation of rigor mortis. III. Comparative study of the evolution of rigor mortis in different sized muscle groups in rats.

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Krompecher, T; Fryc, O

1978-01-01

The use of new methods and an appropriate apparatus has allowed us to make successive measurements of rigor mortis and a study of its evolution in the rat. By a comparative examination on the front and hind limbs, we have determined the following: (1) The muscular mass of the hind limbs is 2.89 times greater than that of the front limbs. (2) In the initial phase rigor mortis is more pronounced in the front limbs. (3) The front and hind limbs reach maximum rigor mortis at the same time and this state is maintained for 2 hours. (4) Resolution of rigor mortis is accelerated in the front limbs during the initial phase, but both front and hind limbs reach complete resolution at the same time.

[Experimental study of restiffening of the rigor mortis].

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Wang, X; Li, M; Liao, Z G; Yi, X F; Peng, X M

2001-11-01

To observe changes of the length of sarcomere of rat when restiffening. We measured the length of sarcomere of quadriceps in 40 rats in different condition by scanning electron microscope. The length of sarcomere of rigor mortis without destroy is obviously shorter than that of restiffening. The length of sarcomere is negatively correlative to the intensity of rigor mortis. Measuring the length of sarcomere can determine the intensity of rigor mortis and provide evidence for estimation of time since death.

[Rigor mortis -- a definite sign of death?].

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Heller, A R; Müller, M P; Frank, M D; Dressler, J

2005-04-01

In the past years an ongoing controversial debate exists in Germany, regarding quality of the coroner's inquest and declaration of death by physicians. We report the case of a 90-year old female, who was found after an unknown time following a suicide attempt with benzodiazepine. The examination of the patient showed livores (mortis?) on the left forearm and left lower leg. Moreover, rigor (mortis?) of the left arm was apparent which prevented arm flexion and extension. The hypothermic patient with insufficient respiration was intubated and mechanically ventilated. Chest compressions were not performed, because central pulses were (hardly) palpable and a sinus bradycardia 45/min (AV-block 2 degrees and sole premature ventricular complexes) was present. After placement of an intravenous line (17 G, external jugular vein) the hemodynamic situation was stabilized with intermittent boli of epinephrine and with sodium bicarbonate. With improved circulation livores and rigor disappeared. In the present case a minimal central circulation was noted, which could be stabilized, despite the presence of certain signs of death ( livores and rigor mortis). Considering the finding of an abrogated peripheral perfusion (livores), we postulate a centripetal collapse of glycogen and ATP supply in the patients left arm (rigor), which was restored after resuscitation and reperfusion. Thus, it appears that livores and rigor are not sensitive enough to exclude a vita minima, in particular in hypothermic patients with intoxications. Consequently a careful ABC-check should be performed even in the presence of apparently certain signs of death, to avoid underdiagnosing a vita minima. Additional ECG- monitoring is required to reduce the rate of false positive declarations of death. To what extent basic life support by paramedics should commence when rigor and livores are present until physician DNR order, deserves further discussion.

Monitoring muscle optical scattering properties during rigor mortis

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Xia, J.; Ranasinghesagara, J.; Ku, C. W.; Yao, G.

2007-09-01

Sarcomere is the fundamental functional unit in skeletal muscle for force generation. In addition, sarcomere structure is also an important factor that affects the eating quality of muscle food, the meat. The sarcomere structure is altered significantly during rigor mortis, which is the critical stage involved in transforming muscle to meat. In this paper, we investigated optical scattering changes during the rigor process in Sternomandibularis muscles. The measured optical scattering parameters were analyzed along with the simultaneously measured passive tension, pH value, and histology analysis. We found that the temporal changes of optical scattering, passive tension, pH value and fiber microstructures were closely correlated during the rigor process. These results suggested that sarcomere structure changes during rigor mortis can be monitored and characterized by optical scattering, which may find practical applications in predicting meat quality.

Random geometry and Yang-Mills theory

International Nuclear Information System (INIS)

Froehlich, J.

1981-01-01

The author states various problems and discusses a very few preliminary rigorous results in a branch of mathematics and mathematical physics which one might call random (or stochastic) geometry. Furthermore, he points out why random geometry is important in the quantization of Yang-Mills theory. (Auth.)

Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

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Saunders, Gabrielle H; Biswas, Kousick; Serpi, Tracey; McGovern, Stephanie; Groer, Shirley; Stock, Eileen M; Magruder, Kathryn M; Storzbach, Daniel; Skelton, Kelly; Abrams, Thad; McCranie, Mark; Richerson, Joan; Dorn, Patricia A; Huang, Grant D; Fallon, Michael T

2017-11-01

Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD. Published by Elsevier Inc.

Evaluating Rigor in Qualitative Methodology and Research Dissemination

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Trainor, Audrey A.; Graue, Elizabeth

2014-01-01

Despite previous and successful attempts to outline general criteria for rigor, researchers in special education have debated the application of rigor criteria, the significance or importance of small n research, the purpose of interpretivist approaches, and the generalizability of qualitative empirical results. Adding to these complications, the…

Pólya number and first return of bursty random walk: Rigorous solutions

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Wan, J.; Xu, X. P.

2012-03-01

The recurrence properties of random walks can be characterized by Pólya number, i.e., the probability that the walker has returned to the origin at least once. In this paper, we investigate Pólya number and first return for bursty random walk on a line, in which the walk has different step size and moving probabilities. Using the concept of the Catalan number, we obtain exact results for first return probability, the average first return time and Pólya number for the first time. We show that Pólya number displays two different functional behavior when the walk deviates from the recurrent point. By utilizing the Lagrange inversion formula, we interpret our findings by transferring Pólya number to the closed-form solutions of an inverse function. We also calculate Pólya number using another approach, which corroborates our results and conclusions. Finally, we consider the recurrence properties and Pólya number of two variations of the bursty random walk model.

An ultramicroscopic study on rigor mortis.

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Suzuki, T

1976-01-01

Gastrocnemius muscles taken from decapitated mice at various intervals after death and from mice killed by 2,4-dinitrophenol or mono-iodoacetic acid injection to induce rigor mortis soon after death, were observed by electron microscopy. The prominent appearance of many fine cross striations in the myofibrils (occurring about every 400 A) was considered to be characteristic of rigor mortis. These striations were caused by minute granules studded along the surfaces of both thick and thin filaments and appeared to be the bridges connecting the 2 kinds of filaments and accounted for the hardness and rigidity of the muscle.

Tenderness of pre- and post rigor lamb longissimus muscle.

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Geesink, Geert; Sujang, Sadi; Koohmaraie, Mohammad

2011-08-01

Lamb longissimus muscle (n=6) sections were cooked at different times post mortem (prerigor, at rigor, 1dayp.m., and 7 days p.m.) using two cooking methods. Using a boiling waterbath, samples were either cooked to a core temperature of 70 °C or boiled for 3h. The latter method was meant to reflect the traditional cooking method employed in countries where preparation of prerigor meat is practiced. The time postmortem at which the meat was prepared had a large effect on the tenderness (shear force) of the meat (PCooking prerigor and at rigor meat to 70 °C resulted in higher shear force values than their post rigor counterparts at 1 and 7 days p.m. (9.4 and 9.6 vs. 7.2 and 3.7 kg, respectively). The differences in tenderness between the treatment groups could be largely explained by a difference in contraction status of the meat after cooking and the effect of ageing on tenderness. Cooking pre and at rigor meat resulted in severe muscle contraction as evidenced by the differences in sarcomere length of the cooked samples. Mean sarcomere lengths in the pre and at rigor samples ranged from 1.05 to 1.20 μm. The mean sarcomere length in the post rigor samples was 1.44 μm. Cooking for 3 h at 100 °C did improve the tenderness of pre and at rigor prepared meat as compared to cooking to 70 °C, but not to the extent that ageing did. It is concluded that additional intervention methods are needed to improve the tenderness of prerigor cooked meat. Copyright © 2011 Elsevier B.V. All rights reserved.

A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

African Journals Online (AJOL)

2015-12-16

Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

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Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2016-01-01

Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

Randomized clinical trial of laparoscopic versus open appendicectomy

DEFF Research Database (Denmark)

Pedersen, A G; Petersen, O B; Wara, P

2001-01-01

BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

Scientific rigor through videogames.

Science.gov (United States)

Treuille, Adrien; Das, Rhiju

2014-11-01

Hypothesis-driven experimentation - the scientific method - can be subverted by fraud, irreproducibility, and lack of rigorous predictive tests. A robust solution to these problems may be the 'massive open laboratory' model, recently embodied in the internet-scale videogame EteRNA. Deploying similar platforms throughout biology could enforce the scientific method more broadly. Copyright © 2014 Elsevier Ltd. All rights reserved.

Emergency cricothyrotomy for trismus caused by instantaneous rigor in cardiac arrest patients.

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Lee, Jae Hee; Jung, Koo Young

2012-07-01

Instantaneous rigor as muscle stiffening occurring in the moment of death (or cardiac arrest) can be confused with rigor mortis. If trismus is caused by instantaneous rigor, orotracheal intubation is impossible and a surgical airway should be secured. Here, we report 2 patients who had emergency cricothyrotomy for trismus caused by instantaneous rigor. This case report aims to help physicians understand instantaneous rigor and to emphasize the importance of securing a surgical airway quickly on the occurrence of trismus. Copyright © 2012 Elsevier Inc. All rights reserved.

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

NARCIS (Netherlands)

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

IMPORTANCE To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. OBJECTIVE To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential

Rigor or mortis: best practices for preclinical research in neuroscience.

Science.gov (United States)

Steward, Oswald; Balice-Gordon, Rita

2014-11-05

Numerous recent reports document a lack of reproducibility of preclinical studies, raising concerns about potential lack of rigor. Examples of lack of rigor have been extensively documented and proposals for practices to improve rigor are appearing. Here, we discuss some of the details and implications of previously proposed best practices and consider some new ones, focusing on preclinical studies relevant to human neurological and psychiatric disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

Financial management of a large multisite randomized clinical trial.

Science.gov (United States)

Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

2014-08-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

Science.gov (United States)

Baumrind, S

1998-11-01

A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

Evaluating the Flipped Classroom: A Randomized Controlled Trial

Science.gov (United States)

Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

Medicine, methodology, and values: trade-offs in clinical science and practice.

Science.gov (United States)

Ho, Vincent K Y

2011-01-01

The current guidelines of evidence-based medicine (EBM) presuppose that clinical research and clinical practice should advance from rigorous scientific tests as they generate reliable, value-free knowledge. Under this presupposition, hypotheses postulated by doctors and patients in the process of their decision making are preferably tested in randomized clinical trials (RCTs), and in systematic reviews and meta-analyses summarizing outcomes from multiple RCTs. Since testing under this scheme is predominantly focused on the criteria of generality and precision achieved through methodological rigor, at the cost of the criterion of realism, translating test results to clinical practice is often problematic. Choices concerning which methodological criteria should have priority are inevitable, however, as clinical trials, and scientific research in general, cannot meet all relevant criteria at the same time. Since these choices may be informed by considerations external to science, we must acknowledge that science cannot be value-free in a strict sense, and this invites a more prominent role for value-laden considerations in evaluating clinical research. The urgency for this becomes even more apparent when we consider the important yet implicit role of scientific theories in EBM, which may also be subjected to methodological evaluation and for which selectiveness in methodological focus is likewise inevitable.

A prospective, randomized, double-blind clinical trial of one nano ...

African Journals Online (AJOL)

Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

Statistical mechanics rigorous results

CERN Document Server

Ruelle, David

1999-01-01

This classic book marks the beginning of an era of vigorous mathematical progress in equilibrium statistical mechanics. Its treatment of the infinite system limit has not been superseded, and the discussion of thermodynamic functions and states remains basic for more recent work. The conceptual foundation provided by the Rigorous Results remains invaluable for the study of the spectacular developments of statistical mechanics in the second half of the 20th century.

High and low rigor temperature effects on sheep meat tenderness and ageing.

Science.gov (United States)

Devine, Carrick E; Payne, Steven R; Peachey, Bridget M; Lowe, Timothy E; Ingram, John R; Cook, Christian J

2002-02-01

Immediately after electrical stimulation, the paired m. longissimus thoracis et lumborum (LT) of 40 sheep were boned out and wrapped tightly with a polyethylene cling film. One of the paired LT's was chilled in 15°C air to reach a rigor mortis (rigor) temperature of 18°C and the other side was placed in a water bath at 35°C and achieved rigor at this temperature. Wrapping reduced rigor shortening and mimicked meat left on the carcass. After rigor, the meat was aged at 15°C for 0, 8, 26 and 72 h and then frozen. The frozen meat was cooked to 75°C in an 85°C water bath and shear force values obtained from a 1×1 cm cross-section. The shear force values of meat for 18 and 35°C rigor were similar at zero ageing, but as ageing progressed, the 18 rigor meat aged faster and became more tender than meat that went into rigor at 35°C (Prigor at each ageing time were significantly different (Prigor were still significantly greater. Thus the toughness of 35°C meat was not a consequence of muscle shortening and appears to be due to both a faster rate of tenderisation and the meat tenderising to a greater extent at the lower temperature. The cook loss at 35°C rigor (30.5%) was greater than that at 18°C rigor (28.4%) (P<0.01) and the colour Hunter L values were higher at 35°C (P<0.01) compared with 18°C, but there were no significant differences in a or b values.

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

African Journals Online (AJOL)

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

Physiological studies of muscle rigor mortis in the fowl

International Nuclear Information System (INIS)

Nakahira, S.; Kaneko, K.; Tanaka, K.

1990-01-01

A simple system was developed for continuous measurement of muscle contraction during nor mortis. Longitudinal muscle strips dissected from the Peroneus Longus were suspended in a plastic tube containing liquid paraffin. Mechanical activity was transmitted to a strain-gauge transducer which is connected to a potentiometric pen-recorder. At the onset of measurement 1.2g was loaded on the muscle strip. This model was used to study the muscle response to various treatments during nor mortis. All measurements were carried out under the anaerobic condition at 17°C, except otherwise stated. 1. The present system was found to be quite useful for continuous measurement of muscle rigor course. 2. Muscle contraction under the anaerobic condition at 17°C reached a peak about 2 hours after the onset of measurement and thereafter it relaxed at a slow rate. In contrast, the aerobic condition under a high humidity resulted in a strong rigor, about three times stronger than that in the anaerobic condition. 3. Ultrasonic treatment (37, 000-47, 000Hz) at 25°C for 10 minutes resulted in a moderate muscle rigor. 4. Treatment of muscle strip with 2mM EGTA at 30°C for 30 minutes led to a relaxation of the muscle. 5. The muscle from the birds killed during anesthesia with pentobarbital sodium resulted in a slow rate of rigor, whereas the birds killed one day after hypophysectomy led to a quick muscle rigor as seen in intact controls. 6. A slight muscle rigor was observed when muscle strip was placed in a refrigerator at 0°C for 18.5 hours and thereafter temperature was kept at 17°C. (author)

Estimation of the breaking of rigor mortis by myotonometry.

Science.gov (United States)

Vain, A; Kauppila, R; Vuori, E

1996-05-31

Myotonometry was used to detect breaking of rigor mortis. The myotonometer is a new instrument which measures the decaying oscillations of a muscle after a brief mechanical impact. The method gives two numerical parameters for rigor mortis, namely the period and decrement of the oscillations, both of which depend on the time period elapsed after death. In the case of breaking the rigor mortis by muscle lengthening, both the oscillation period and decrement decreased, whereas, shortening the muscle caused the opposite changes. Fourteen h after breaking the stiffness characteristics of the right and left m. biceps brachii, or oscillation periods, were assimilated. However, the values for decrement of the muscle, reflecting the dissipation of mechanical energy, maintained their differences.

Rigorous simulation: a tool to enhance decision making

Energy Technology Data Exchange (ETDEWEB)

Neiva, Raquel; Larson, Mel; Baks, Arjan [KBC Advanced Technologies plc, Surrey (United Kingdom)

2012-07-01

The world refining industries continue to be challenged by population growth (increased demand), regional market changes and the pressure of regulatory requirements to operate a 'green' refinery. Environmental regulations are reducing the value and use of heavy fuel oils, and leading to convert more of the heavier products or even heavier crude into lighter products while meeting increasingly stringent transportation fuel specifications. As a result actions are required for establishing a sustainable advantage for future success. Rigorous simulation provides a key advantage improving the time and efficient use of capital investment and maximizing profitability. Sustainably maximizing profit through rigorous modeling is achieved through enhanced performance monitoring and improved Linear Programme (LP) model accuracy. This paper contains examples on these two items. The combination of both increases overall rates of return. As refiners consider optimizing existing assets and expanding projects, the process agreed to achieve these goals is key for a successful profit improvement. The benefit of rigorous kinetic simulation with detailed fractionation allows for optimizing existing asset utilization while focusing the capital investment in the new unit(s), and therefore optimizing the overall strategic plan and return on investment. Individual process unit's monitoring works as a mechanism for validating and optimizing the plant performance. Unit monitoring is important to rectify poor performance and increase profitability. The key to a good LP relies upon the accuracy of the data used to generate the LP sub-model data. The value of rigorous unit monitoring are that the results are heat and mass balanced consistently, and are unique for a refiners unit / refinery. With the improved match of the refinery operation, the rigorous simulation models will allow capturing more accurately the non linearity of those process units and therefore provide correct

Rigorous solution to Bargmann-Wigner equation for integer spin

CERN Document Server

Huang Shi Zhong; Wu Ning; Zheng Zhi Peng

2002-01-01

A rigorous method is developed to solve the Bargamann-Wigner equation for arbitrary integer spin in coordinate representation in a step by step way. The Bargmann-Wigner equation is first transformed to a form easier to solve, the new equations are then solved rigorously in coordinate representation, and the wave functions in a closed form are thus derived

RIGOR MORTIS AND THE INFLUENCE OF CALCIUM AND MAGNESIUM SALTS UPON ITS DEVELOPMENT.

Science.gov (United States)

Meltzer, S J; Auer, J

1908-01-01

Calcium salts hasten and magnesium salts retard the development of rigor mortis, that is, when these salts are administered subcutaneously or intravenously. When injected intra-arterially, concentrated solutions of both kinds of salts cause nearly an immediate onset of a strong stiffness of the muscles which is apparently a contraction, brought on by a stimulation caused by these salts and due to osmosis. This contraction, if strong, passes over without a relaxation into a real rigor. This form of rigor may be classed as work-rigor (Arbeitsstarre). In animals, at least in frogs, with intact cords, the early contraction and the following rigor are stronger than in animals with destroyed cord. If M/8 solutions-nearly equimolecular to "physiological" solutions of sodium chloride-are used, even when injected intra-arterially, calcium salts hasten and magnesium salts retard the onset of rigor. The hastening and retardation in this case as well as in the cases of subcutaneous and intravenous injections, are ion effects and essentially due to the cations, calcium and magnesium. In the rigor hastened by calcium the effects of the extensor muscles mostly prevail; in the rigor following magnesium injection, on the other hand, either the flexor muscles prevail or the muscles become stiff in the original position of the animal at death. There seems to be no difference in the degree of stiffness in the final rigor, only the onset and development of the rigor is hastened in the case of the one salt and retarded in the other. Calcium hastens also the development of heat rigor. No positive facts were obtained with regard to the effect of magnesium upon heat vigor. Calcium also hastens and magnesium retards the onset of rigor in the left ventricle of the heart. No definite data were gathered with regard to the effects of these salts upon the right ventricle.

Bringing scientific rigor to community-developed programs in Hong Kong

Directory of Open Access Journals (Sweden)

Fabrizio Cecilia S

2012-12-01

Full Text Available Abstract Background This paper describes efforts to generate evidence for community-developed programs to enhance family relationships in the Chinese culture of Hong Kong, within the framework of community-based participatory research (CBPR. Methods The CBPR framework was applied to help maximize the development of the intervention and the public health impact of the studies, while enhancing the capabilities of the social service sector partners. Results Four academic-community research teams explored the process of designing and implementing randomized controlled trials in the community. In addition to the expected cultural barriers between teams of academics and community practitioners, with their different outlooks, concerns and languages, the team navigated issues in utilizing the principles of CBPR unique to this Chinese culture. Eventually the team developed tools for adaptation, such as an emphasis on building the relationship while respecting role delineation and an iterative process of defining the non-negotiable parameters of research design while maintaining scientific rigor. Lessons learned include the risk of underemphasizing the size of the operational and skills shift between usual agency practices and research studies, the importance of minimizing non-negotiable parameters in implementing rigorous research designs in the community, and the need to view community capacity enhancement as a long term process. Conclusions The four pilot studies under the FAMILY Project demonstrated that nuanced design adaptations, such as wait list controls and shorter assessments, better served the needs of the community and led to the successful development and vigorous evaluation of a series of preventive, family-oriented interventions in the Chinese culture of Hong Kong.

Bringing scientific rigor to community-developed programs in Hong Kong.

Science.gov (United States)

Fabrizio, Cecilia S; Hirschmann, Malia R; Lam, Tai Hing; Cheung, Teresa; Pang, Irene; Chan, Sophia; Stewart, Sunita M

2012-12-31

This paper describes efforts to generate evidence for community-developed programs to enhance family relationships in the Chinese culture of Hong Kong, within the framework of community-based participatory research (CBPR). The CBPR framework was applied to help maximize the development of the intervention and the public health impact of the studies, while enhancing the capabilities of the social service sector partners. Four academic-community research teams explored the process of designing and implementing randomized controlled trials in the community. In addition to the expected cultural barriers between teams of academics and community practitioners, with their different outlooks, concerns and languages, the team navigated issues in utilizing the principles of CBPR unique to this Chinese culture. Eventually the team developed tools for adaptation, such as an emphasis on building the relationship while respecting role delineation and an iterative process of defining the non-negotiable parameters of research design while maintaining scientific rigor. Lessons learned include the risk of underemphasizing the size of the operational and skills shift between usual agency practices and research studies, the importance of minimizing non-negotiable parameters in implementing rigorous research designs in the community, and the need to view community capacity enhancement as a long term process. The four pilot studies under the FAMILY Project demonstrated that nuanced design adaptations, such as wait list controls and shorter assessments, better served the needs of the community and led to the successful development and vigorous evaluation of a series of preventive, family-oriented interventions in the Chinese culture of Hong Kong.

On stability of Random Riccati equations

Institute of Scientific and Technical Information of China (English)

王远; 郭雷

1999-01-01

Random Riccati equations (RRE) arise frequently in filtering, estimation and control, but their stability properties are rarely rigorously explored in the literature. First a suitable stochastic observability (or excitation) condition is introduced to guarantee both the L_r-and exponential stability of RRE. Then the stability of Kalman filter is analyzed with random coefficients, and the L_r boundedness of filtering errors is established.

Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

DEFF Research Database (Denmark)

Bisgaard, T; Kristiansen, V B; Hjortsø, N C

2004-01-01

BACKGROUND: Preoperative oral carbohydrate can attenuate postoperative insulin resistance and catabolism, and may have the potential to improve postoperative recovery. There are no data from randomized studies on postoperative clinical outcome after specific surgical procedures. This study...... evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials.

Science.gov (United States)

Herman, Amir; Botser, Itamar Busheri; Tenenbaum, Shay; Chechick, Ahron

2009-09-01

The intention-to-treat principle implies that all patients who are randomized in a clinical trial should be analyzed according to their original allocation. This means that patients crossing over to another treatment group and patients lost to follow-up should be included in the analysis as a part of their original group. This principle is important for preserving the randomization scheme, which is the basis for correct inference in any randomized trial. In this study, we examined the use of the intention-to-treat principle in recently published orthopaedic clinical trials. We surveyed eight leading orthopaedic journals for randomized clinical trials published between January 2005 and August 2008. We determined whether the intention-to-treat principle was implemented and, if so, how it was used in each trial. Specifically, we ascertained which methods were used to account for missing data. Our search yielded 274 randomized clinical trials, and the intention-to-treat principle was used in ninety-six (35%) of them. There were significant differences among the journals with regard to the use of the intention-to-treat principle. The relative number of trials in which the principle was used increased each year. The authors adhered to the strict definition of the intention-to-treat principle in forty-five of the ninety-six studies in which it was claimed that this principle had been used. In forty-four randomized trials, patients who had been lost to follow-up were excluded from the final analysis; this practice was most notable in studies of surgical interventions. The most popular method of adjusting for missing data was the "last observation carried forward" technique. In most of the randomized clinical trials published in the orthopaedic literature, the investigators did not adhere to the stringent use of the intention-to-treat principle, with the most conspicuous problem being a lack of accounting for patients lost to follow-up. This omission might introduce bias to

Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

NARCIS (Netherlands)

Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

2015-01-01

Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the

Financial Management of a Large Multi-site Randomized Clinical Trial

Science.gov (United States)

Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

2014-01-01

Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

Sensitivity analysis for missing dichotomous outcome data in multi-visit randomized clinical trial with randomization-based covariance adjustment.

Science.gov (United States)

Li, Siying; Koch, Gary G; Preisser, John S; Lam, Diana; Sanchez-Kam, Matilde

2017-01-01

Dichotomous endpoints in clinical trials have only two possible outcomes, either directly or via categorization of an ordinal or continuous observation. It is common to have missing data for one or more visits during a multi-visit study. This paper presents a closed form method for sensitivity analysis of a randomized multi-visit clinical trial that possibly has missing not at random (MNAR) dichotomous data. Counts of missing data are redistributed to the favorable and unfavorable outcomes mathematically to address possibly informative missing data. Adjusted proportion estimates and their closed form covariance matrix estimates are provided. Treatment comparisons over time are addressed with Mantel-Haenszel adjustment for a stratification factor and/or randomization-based adjustment for baseline covariables. The application of such sensitivity analyses is illustrated with an example. An appendix outlines an extension of the methodology to ordinal endpoints.

Random Schroedinger operators and the theory of disordered systems: some rigorous results

International Nuclear Information System (INIS)

Kunz, H.; Souillard, B.

1981-01-01

The authors report results on a class of finite difference Schroedinger operators with stochastic potentials. The Hamiltonian is then H(V)=-Δ+V; where Δ is the discretized Laplacian and the potential V acts as a multiplication operator. The potential V is random. (Auth.)

A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

DEFF Research Database (Denmark)

Kruse, A Y; Kjaergard, L L; Krogsgaard, K

2000-01-01

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased...

Randomized Clinical Trial of Interceptive and Comprehensive Orthodontics

Science.gov (United States)

King, G.J.; Spiekerman, C.F.; Greenlee, G.M.; Huang, G.J.

2012-01-01

Focusing public insurance programs on interceptive orthodontics (IO) may increase access for low-income children. This report presents outcomes from a randomized clinical trial (RCT) comparing IO with comprehensive orthodontics (CO) in Medicaid patients. One hundred seventy pre-adolescents with Medicaid-eligible malocclusions were randomized to IO (n = 86) followed by observation (OBS) or OBS followed by CO (n = 84). One hundred thirty-four completed the trial. Models at pre-treatment (baseline) and following ≤ 2 years of intervention and 2 years of OBS (48 mos) were scored by calibrated examiners using the Peer Assessment Rating (PAR) and Index of Complexity, Outcome and Need (ICON). Overall outcomes and clinically meaningful categorical ICON data on need/acceptability, complexity, and improvement were compared. At baseline, groups were balanced by age, gender, ethnicity, and PAR/ICON scores. Most were minorities. Most (77%) were rated as difficult-to-very difficult. Scores improved significantly for both groups, but CO more than IO (PAR, 18.6 [95%CI 15.1, 22.1] vs.10.1 [95%CI 6.7, 13.4]; ICON, 44.8 [95% CI 39.7, 49.9] vs. 35.2 [95%CI 29.7, 40.6], respectively). On average, IO is effective at reducing malocclusions in Medicaid patients, but less than CO. (ClinicalTrials.gov number CT00067379) PMID:22699670

Rigorous bounds on the free energy of electron-phonon models

NARCIS (Netherlands)

Raedt, Hans De; Michielsen, Kristel

1997-01-01

We present a collection of rigorous upper and lower bounds to the free energy of electron-phonon models with linear electron-phonon interaction. These bounds are used to compare different variational approaches. It is shown rigorously that the ground states corresponding to the sharpest bounds do

Rigorous theory of molecular orientational nonlinear optics

International Nuclear Information System (INIS)

Kwak, Chong Hoon; Kim, Gun Yeup

2015-01-01

Classical statistical mechanics of the molecular optics theory proposed by Buckingham [A. D. Buckingham and J. A. Pople, Proc. Phys. Soc. A 68, 905 (1955)] has been extended to describe the field induced molecular orientational polarization effects on nonlinear optics. In this paper, we present the generalized molecular orientational nonlinear optical processes (MONLO) through the calculation of the classical orientational averaging using the Boltzmann type time-averaged orientational interaction energy in the randomly oriented molecular system under the influence of applied electric fields. The focal points of the calculation are (1) the derivation of rigorous tensorial components of the effective molecular hyperpolarizabilities, (2) the molecular orientational polarizations and the electronic polarizations including the well-known third-order dc polarization, dc electric field induced Kerr effect (dc Kerr effect), optical Kerr effect (OKE), dc electric field induced second harmonic generation (EFISH), degenerate four wave mixing (DFWM) and third harmonic generation (THG). We also present some of the new predictive MONLO processes. For second-order MONLO, second-order optical rectification (SOR), Pockels effect and difference frequency generation (DFG) are described in terms of the anisotropic coefficients of first hyperpolarizability. And, for third-order MONLO, third-order optical rectification (TOR), dc electric field induced difference frequency generation (EFIDFG) and pump-probe transmission are presented

Accelerating Biomedical Discoveries through Rigor and Transparency.

Science.gov (United States)

Hewitt, Judith A; Brown, Liliana L; Murphy, Stephanie J; Grieder, Franziska; Silberberg, Shai D

2017-07-01

Difficulties in reproducing published research findings have garnered a lot of press in recent years. As a funder of biomedical research, the National Institutes of Health (NIH) has taken measures to address underlying causes of low reproducibility. Extensive deliberations resulted in a policy, released in 2015, to enhance reproducibility through rigor and transparency. We briefly explain what led to the policy, describe its elements, provide examples and resources for the biomedical research community, and discuss the potential impact of the policy on translatability with a focus on research using animal models. Importantly, while increased attention to rigor and transparency may lead to an increase in the number of laboratory animals used in the near term, it will lead to more efficient and productive use of such resources in the long run. The translational value of animal studies will be improved through more rigorous assessment of experimental variables and data, leading to better assessments of the translational potential of animal models, for the benefit of the research community and society. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Recent Development in Rigorous Computational Methods in Dynamical Systems

OpenAIRE

Arai, Zin; Kokubu, Hiroshi; Pilarczyk, Paweł

2009-01-01

We highlight selected results of recent development in the area of rigorous computations which use interval arithmetic to analyse dynamical systems. We describe general ideas and selected details of different ways of approach and we provide specific sample applications to illustrate the effectiveness of these methods. The emphasis is put on a topological approach, which combined with rigorous calculations provides a broad range of new methods that yield mathematically rel...

A randomized clinical trial on the sealing of occlusal carious lesions

DEFF Research Database (Denmark)

Alves, Luana Severo; Giongo, Fernanda Cristina Mendes de Santa; Mua, Bruna

2017-01-01

This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8-43 years (median: 19 years). The inclusion criteria comprised the presence...... of a cavity with no access allowing biofilm control. The maximum depth of the lesion was the middle third of the dentin thickness, as assessed by bitewing radiography. The teeth were randomly assigned to sealant treatment (n = 28) or restorative treatment (n = 26). Clinical and radiographic examinations were...... performed after 1 year and after 3-4 years. The outcomes depended on the clinical performance of the sealant/restoration and the control of caries progression observed radiographically. Survival analysis was performed to assess success rates. Over the 3-4 years of monitoring, 2 sealants were totally lost, 1...

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

Science.gov (United States)

Anisimov, Vladimir V

2011-01-01

This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

Trends: Rigor Mortis in the Arts.

Science.gov (United States)

Blodget, Alden S.

1991-01-01

Outlines how past art education provided a refuge for students from the rigors of other academic subjects. Observes that in recent years art education has become "discipline based." Argues that art educators need to reaffirm their commitment to a humanistic way of knowing. (KM)

Using grounded theory as a method for rigorously reviewing literature

NARCIS (Netherlands)

Wolfswinkel, J.; Furtmueller-Ettinger, Elfriede; Wilderom, Celeste P.M.

2013-01-01

This paper offers guidance to conducting a rigorous literature review. We present this in the form of a five-stage process in which we use Grounded Theory as a method. We first probe the guidelines explicated by Webster and Watson, and then we show the added value of Grounded Theory for rigorously

Prospective randomized clinical studies involving reirradiation. Lessons learned

International Nuclear Information System (INIS)

Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

2016-01-01

Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

A random walk model for evaluating clinical trials involving serial observations.

Science.gov (United States)

Hopper, J L; Young, G P

1988-05-01

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

Rigor, vigor, and the study of health disparities.

Science.gov (United States)

Adler, Nancy; Bush, Nicole R; Pantell, Matthew S

2012-10-16

Health disparities research spans multiple fields and methods and documents strong links between social disadvantage and poor health. Associations between socioeconomic status (SES) and health are often taken as evidence for the causal impact of SES on health, but alternative explanations, including the impact of health on SES, are plausible. Studies showing the influence of parents' SES on their children's health provide evidence for a causal pathway from SES to health, but have limitations. Health disparities researchers face tradeoffs between "rigor" and "vigor" in designing studies that demonstrate how social disadvantage becomes biologically embedded and results in poorer health. Rigorous designs aim to maximize precision in the measurement of SES and health outcomes through methods that provide the greatest control over temporal ordering and causal direction. To achieve precision, many studies use a single SES predictor and single disease. However, doing so oversimplifies the multifaceted, entwined nature of social disadvantage and may overestimate the impact of that one variable and underestimate the true impact of social disadvantage on health. In addition, SES effects on overall health and functioning are likely to be greater than effects on any one disease. Vigorous designs aim to capture this complexity and maximize ecological validity through more complete assessment of social disadvantage and health status, but may provide less-compelling evidence of causality. Newer approaches to both measurement and analysis may enable enhanced vigor as well as rigor. Incorporating both rigor and vigor into studies will provide a fuller understanding of the causes of health disparities.

Random walks, random fields, and disordered systems

CERN Document Server

Černý, Jiří; Kotecký, Roman

2015-01-01

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

Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

Directory of Open Access Journals (Sweden)

Vickers Andrew J

2012-02-01

Full Text Available Abstract Background Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. Although small differences would be worthwhile, an appropriately powered randomized trial would need to be very large, and thus of doubtful feasibility given the expense, complexity and regulatory burden of contemporary clinical trials. We have proposed a novel methodology, the clinically-integrated randomized trial, which dramatically streamlines trial procedures in order to reduce the marginal cost of an additional patient towards zero. We aimed to determine the feasibility of implementing such a trial for radical prostatectomy. Methods Patients undergoing radical prostatectomy as initial treatment for prostate cancer were randomized in a factorial design to involvement of the fascia during placement of the anastomotic sutures, urethral irrigation, both or neither. Endpoint data were obtained from routine clinical documentation. Accrual and compliance rates were monitored to determine the feasibility of the trial. Results From a total of 260 eligible patients, 154 (59% consented; 56 patients declined to participate, 20 were not approached on recommendation of the treating surgeon, and 30 were not approached for logistical reasons. Although recording by surgeons of the procedure used was incomplete (~80%, compliance with randomization was excellent when it was recorded, with only 6% of procedures inconsistent with allocation. Outcomes data was received from 71% of patients at one year. This improved to 83% as the trial progressed. Conclusions A clinically-integrated randomized trial was conducted at low cost, with excellent accrual, and acceptable compliance with treatment allocation and outcomes reporting. This demonstrates the feasibility of the methodology. Improved methods to ensure documentation of surgical procedures would be required before wider implementation

Randomized Controlled Trials: The Most Powerful Tool In Modern ...

African Journals Online (AJOL)

Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...

Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial.

Science.gov (United States)

Coric, Vladimir; Salloway, Stephen; van Dyck, Christopher H; Dubois, Bruno; Andreasen, Niels; Brody, Mark; Curtis, Craig; Soininen, Hilkka; Thein, Stephen; Shiovitz, Thomas; Pilcher, Gary; Ferris, Steven; Colby, Susan; Kerselaers, Wendy; Dockens, Randy; Soares, Holly; Kaplita, Stephen; Luo, Feng; Pachai, Chahin; Bracoud, Luc; Mintun, Mark; Grill, Joshua D; Marek, Ken; Seibyl, John; Cedarbaum, Jesse M; Albright, Charles; Feldman, Howard H; Berman, Robert M

2015-11-01

Early identification of Alzheimer disease (AD) is important for clinical management and affords the opportunity to assess potential disease-modifying agents in clinical trials. To our knowledge, this is the first report of a randomized trial to prospectively enrich a study population with prodromal AD (PDAD) defined by cerebrospinal fluid (CSF) biomarker criteria and mild cognitive impairment (MCI) symptoms. To assess the safety of the γ-secretase inhibitor avagacestat in PDAD and to determine whether CSF biomarkers can identify this patient population prior to clinical diagnosis of dementia. A randomized, placebo-controlled phase 2 clinical trial with a parallel, untreated, nonrandomized observational cohort of CSF biomarker-negative participants was conducted May 26, 2009, to July 9, 2013, in a multicenter global population. Of 1358 outpatients screened, 263 met MCI and CSF biomarker criteria for randomization into the treatment phase. One hundred two observational cohort participants who met MCI criteria but were CSF biomarker-negative were observed during the same study period to evaluate biomarker assay sensitivity. Oral avagacestat or placebo daily. Safety and tolerability of avagacestat. Of the 263 participants in the treatment phase, 132 were randomized to avagacestat and 131 to placebo; an additional 102 participants were observed in an untreated observational cohort. Avagacestat was relatively well tolerated with low discontinuation rates (19.6%) at a dose of 50 mg/d, whereas the dose of 125 mg/d had higher discontinuation rates (43%), primarily attributable to gastrointestinal tract adverse events. Increases in nonmelanoma skin cancer and nonprogressive, reversible renal tubule effects were observed with avagacestat. Serious adverse event rates were higher with avagacestat (49 participants [37.1%]) vs placebo (31 [23.7%]), attributable to the higher incidence of nonmelanoma skin cancer. At 2 years, progression to dementia was more frequent in the PDAD

A Review on asymptotic normality of sums of associated random ...

African Journals Online (AJOL)

Association between random variables is a generalization of independence of these random variables. This concept is more and more commonly used in current trends in any research elds in Statistics. In this paper, we proceed to a simple, clear and rigorous introduction to it. We will present the fundamental asymptotic ...

How Individual Scholars Can Reduce the Rigor-Relevance Gap in Management Research

OpenAIRE

Wolf, Joachim; Rosenberg, Timo

2012-01-01

This paper discusses a number of avenues management scholars could follow to reduce the existing gap between scientific rigor and practical relevance without relativizing the importance of the first goal dimension. Such changes are necessary because many management studies do not fully exploit the possibilities to increase their practical relevance while maintaining scientific rigor. We argue that this rigor-relevance gap is not only the consequence of the currently prevailing institutional c...

Onset of rigor mortis is earlier in red muscle than in white muscle.

Science.gov (United States)

Kobayashi, M; Takatori, T; Nakajima, M; Sakurada, K; Hatanaka, K; Ikegaya, H; Matsuda, Y; Iwase, H

2000-01-01

Rigor mortis is thought to be related to falling ATP levels in muscles postmortem. We measured rigor mortis as tension determined isometrically in three rat leg muscles in liquid paraffin kept at 37 degrees C or 25 degrees C--two red muscles, red gastrocnemius (RG) and soleus (SO) and one white muscle, white gastrocnemius (WG). Onset, half and full rigor mortis occurred earlier in RG and SO than in WG both at 37 degrees C and at 25 degrees C even though RG and WG were portions of the same muscle. This suggests that rigor mortis directly reflects the postmortem intramuscular ATP level, which decreases more rapidly in red muscle than in white muscle after death. Rigor mortis was more retarded at 25 degrees C than at 37 degrees C in each type of muscle.

Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial.

Science.gov (United States)

Meeker, Daniella; Knight, Tara K; Friedberg, Mark W; Linder, Jeffrey A; Goldstein, Noah J; Fox, Craig R; Rothfeld, Alan; Diaz, Guillermo; Doctor, Jason N

2014-03-01

"Nudges" that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications, but there have been few experiments to improve clinical practice. To investigate the use of a behavioral "nudge" based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections (ARIs). Randomized clinical trial in 5 outpatient primary care clinics. A total of 954 adults had ARI visits during the study timeframe: 449 patients were treated by clinicians randomized to the posted commitment letter (335 in the baseline period, 114 in the intervention period); 505 patients were treated by clinicians randomized to standard practice control (384 baseline, 121 intervention). The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks. These letters, featuring clinician photographs and signatures, stated their commitment to avoid inappropriate antibiotic prescribing for ARIs. Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods, adjusted for patient age, sex, and insurance status. Baseline rates were 43.5% and 42.8% for control and poster, respectively. During the intervention period, inappropriate prescribing rates increased to 52.7% for controls but decreased to 33.7% in the posted commitment letter condition. Controlling for baseline prescribing rates, we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control (P = .02). There was no evidence of diagnostic coding shift, and rates of appropriate antibiotic prescriptions did not diminish over time. Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs. The effect of this simple, low-cost intervention is comparable in magnitude to costlier, more

Exergaming and older adult cognition: a cluster randomized clinical trial.

Science.gov (United States)

Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

2012-02-01

Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

Photoconductivity of amorphous silicon-rigorous modelling

International Nuclear Information System (INIS)

Brada, P.; Schauer, F.

1991-01-01

It is our great pleasure to express our gratitude to Prof. Grigorovici, the pioneer of the exciting field of amorphous state by our modest contribution to this area. In this paper are presented the outline of the rigorous modelling program of the steady-state photoconductivity in amorphous silicon and related materials. (Author)

Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

Science.gov (United States)

Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

2014-06-01

To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

Reframing Rigor: A Modern Look at Challenge and Support in Higher Education

Science.gov (United States)

Campbell, Corbin M.; Dortch, Deniece; Burt, Brian A.

2018-01-01

This chapter describes the limitations of the traditional notions of academic rigor in higher education, and brings forth a new form of rigor that has the potential to support student success and equity.

Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

Science.gov (United States)

Mousavi, Maryam; Hayatshahi, Alireza; Sarayani, Amir; Hadjibabaie, Molouk; Javadi, Mohammadreza; Torkamandi, Hassan; Gholami, Kheirollah; Ghavamzadeh, Ardeshir

2013-12-01

Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

Rigorously testing multialternative decision field theory against random utility models.

Science.gov (United States)

Berkowitsch, Nicolas A J; Scheibehenne, Benjamin; Rieskamp, Jörg

2014-06-01

Cognitive models of decision making aim to explain the process underlying observed choices. Here, we test a sequential sampling model of decision making, multialternative decision field theory (MDFT; Roe, Busemeyer, & Townsend, 2001), on empirical grounds and compare it against 2 established random utility models of choice: the probit and the logit model. Using a within-subject experimental design, participants in 2 studies repeatedly choose among sets of options (consumer products) described on several attributes. The results of Study 1 showed that all models predicted participants' choices equally well. In Study 2, in which the choice sets were explicitly designed to distinguish the models, MDFT had an advantage in predicting the observed choices. Study 2 further revealed the occurrence of multiple context effects within single participants, indicating an interdependent evaluation of choice options and correlations between different context effects. In sum, the results indicate that sequential sampling models can provide relevant insights into the cognitive process underlying preferential choices and thus can lead to better choice predictions. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

Science.gov (United States)

Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

2013-04-01

To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

Rigorous approach to the comparison between experiment and theory in Casimir force measurements

International Nuclear Information System (INIS)

Klimchitskaya, G L; Chen, F; Decca, R S; Fischbach, E; Krause, D E; Lopez, D; Mohideen, U; Mostepanenko, V M

2006-01-01

In most experiments on the Casimir force the comparison between measurement data and theory was done using the concept of the root-mean-square deviation, a procedure that has been criticized in the literature. Here we propose a special statistical analysis which should be performed separately for the experimental data and for the results of the theoretical computations. In so doing, the random, systematic and total experimental errors are found as functions of separation, taking into account the distribution laws for each error at 95% confidence. Independently, all theoretical errors are combined to obtain the total theoretical error at the same confidence. Finally, the confidence interval for the differences between theoretical and experimental values is obtained as a function of separation. This rigorous approach is applied to two recent experiments on the Casimir effect

Single-case synthesis tools I: Comparing tools to evaluate SCD quality and rigor.

Science.gov (United States)

Zimmerman, Kathleen N; Ledford, Jennifer R; Severini, Katherine E; Pustejovsky, James E; Barton, Erin E; Lloyd, Blair P

2018-03-03

Tools for evaluating the quality and rigor of single case research designs (SCD) are often used when conducting SCD syntheses. Preferred components include evaluations of design features related to the internal validity of SCD to obtain quality and/or rigor ratings. Three tools for evaluating the quality and rigor of SCD (Council for Exceptional Children, What Works Clearinghouse, and Single-Case Analysis and Design Framework) were compared to determine if conclusions regarding the effectiveness of antecedent sensory-based interventions for young children changed based on choice of quality evaluation tool. Evaluation of SCD quality differed across tools, suggesting selection of quality evaluation tools impacts evaluation findings. Suggestions for selecting an appropriate quality and rigor assessment tool are provided and across-tool conclusions are drawn regarding the quality and rigor of studies. Finally, authors provide guidance for using quality evaluations in conjunction with outcome analyses when conducting syntheses of interventions evaluated in the context of SCD. Copyright © 2018 Elsevier Ltd. All rights reserved.

The rigorous stochastic matrix multiplication scheme for the calculations of reduced equilibrium density matrices of open multilevel quantum systems

International Nuclear Information System (INIS)

Chen, Xin

2014-01-01

Understanding the roles of the temporary and spatial structures of quantum functional noise in open multilevel quantum molecular systems attracts a lot of theoretical interests. I want to establish a rigorous and general framework for functional quantum noises from the constructive and computational perspectives, i.e., how to generate the random trajectories to reproduce the kernel and path ordering of the influence functional with effective Monte Carlo methods for arbitrary spectral densities. This construction approach aims to unify the existing stochastic models to rigorously describe the temporary and spatial structure of Gaussian quantum noises. In this paper, I review the Euclidean imaginary time influence functional and propose the stochastic matrix multiplication scheme to calculate reduced equilibrium density matrices (REDM). In addition, I review and discuss the Feynman-Vernon influence functional according to the Gaussian quadratic integral, particularly its imaginary part which is critical to the rigorous description of the quantum detailed balance. As a result, I establish the conditions under which the influence functional can be interpreted as the average of exponential functional operator over real-valued Gaussian processes for open multilevel quantum systems. I also show the difference between the local and nonlocal phonons within this framework. With the stochastic matrix multiplication scheme, I compare the normalized REDM with the Boltzmann equilibrium distribution for open multilevel quantum systems

Studies on the estimation of the postmortem interval. 3. Rigor mortis (author's transl).

Science.gov (United States)

Suzutani, T; Ishibashi, H; Takatori, T

1978-11-01

The authors have devised a method for classifying rigor mortis into 10 types based on its appearance and strength in various parts of a cadaver. By applying the method to the findings of 436 cadavers which were subjected to medico-legal autopsies in our laboratory during the last 10 years, it has been demonstrated that the classifying method is effective for analyzing the phenomenon of onset, persistence and disappearance of rigor mortis statistically. The investigation of the relationship between each type of rigor mortis and the postmortem interval has demonstrated that rigor mortis may be utilized as a basis for estimating the postmortem interval but the values have greater deviation than those described in current textbooks.

Rigor mortis in an unusual position: Forensic considerations.

Science.gov (United States)

D'Souza, Deepak H; Harish, S; Rajesh, M; Kiran, J

2011-07-01

We report a case in which the dead body was found with rigor mortis in an unusual position. The dead body was lying on its back with limbs raised, defying gravity. Direction of the salivary stains on the face was also defying the gravity. We opined that the scene of occurrence of crime is unlikely to be the final place where the dead body was found. The clues were revealing a homicidal offence and an attempt to destroy the evidence. The forensic use of 'rigor mortis in an unusual position' is in furthering the investigations, and the scientific confirmation of two facts - the scene of death (occurrence) is different from the scene of disposal of dead body, and time gap between the two places.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

Science.gov (United States)

Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

2016-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

Effect of Pre-rigor Salting Levels on Physicochemical and Textural Properties of Chicken Breast Muscles

Science.gov (United States)

Choi, Yun-Sang

2015-01-01

This study was conducted to evaluate the effect of pre-rigor salting level (0-4% NaCl concentration) on physicochemical and textural properties of pre-rigor chicken breast muscles. The pre-rigor chicken breast muscles were de-boned 10 min post-mortem and salted within 25 min post-mortem. An increase in pre-rigor salting level led to the formation of high ultimate pH of chicken breast muscles at post-mortem 24 h. The addition of minimum of 2% NaCl significantly improved water holding capacity, cooking loss, protein solubility, and hardness when compared to the non-salting chicken breast muscle (psalting level caused the inhibition of myofibrillar protein degradation and the acceleration of lipid oxidation. However, the difference in NaCl concentration between 3% and 4% had no great differences in the results of physicochemical and textural properties due to pre-rigor salting effects (p>0.05). Therefore, our study certified the pre-rigor salting effect of chicken breast muscle salted with 2% NaCl when compared to post-rigor muscle salted with equal NaCl concentration, and suggests that the 2% NaCl concentration is minimally required to ensure the definite pre-rigor salting effect on chicken breast muscle. PMID:26761884

Effect of Pre-rigor Salting Levels on Physicochemical and Textural Properties of Chicken Breast Muscles.

Science.gov (United States)

Kim, Hyun-Wook; Hwang, Ko-Eun; Song, Dong-Heon; Kim, Yong-Jae; Ham, Youn-Kyung; Yeo, Eui-Joo; Jeong, Tae-Jun; Choi, Yun-Sang; Kim, Cheon-Jei

2015-01-01

This study was conducted to evaluate the effect of pre-rigor salting level (0-4% NaCl concentration) on physicochemical and textural properties of pre-rigor chicken breast muscles. The pre-rigor chicken breast muscles were de-boned 10 min post-mortem and salted within 25 min post-mortem. An increase in pre-rigor salting level led to the formation of high ultimate pH of chicken breast muscles at post-mortem 24 h. The addition of minimum of 2% NaCl significantly improved water holding capacity, cooking loss, protein solubility, and hardness when compared to the non-salting chicken breast muscle (prigor salting level caused the inhibition of myofibrillar protein degradation and the acceleration of lipid oxidation. However, the difference in NaCl concentration between 3% and 4% had no great differences in the results of physicochemical and textural properties due to pre-rigor salting effects (p>0.05). Therefore, our study certified the pre-rigor salting effect of chicken breast muscle salted with 2% NaCl when compared to post-rigor muscle salted with equal NaCl concentration, and suggests that the 2% NaCl concentration is minimally required to ensure the definite pre-rigor salting effect on chicken breast muscle.

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

Directory of Open Access Journals (Sweden)

Humam Saltaji

Full Text Available To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.Sequence generation was assessed to be inadequate (at unclear or high risk of bias in 68% (n = 367 of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%. Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154 and 40.5% (n = 219 of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427 of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95 of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%, while the method of blinding was appropriate in 53% (n = 286 of the trials. We identified a significant decrease over time (1955-2013 in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05 in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

Moving beyond Data Transcription: Rigor as Issue in Representation of Digital Literacies

Science.gov (United States)

Hagood, Margaret Carmody; Skinner, Emily Neil

2015-01-01

Rigor in qualitative research has been based upon criteria of credibility, dependability, confirmability, and transferability. Drawing upon articles published during our editorship of the "Journal of Adolescent & Adult Literacy," we illustrate how the use of digital data in research study reporting may enhance these areas of rigor,…

The recolonization hypothesis in a full-mouth or multiple-session treatment protocol : a blinded, randomized clinical trial

NARCIS (Netherlands)

Zijnge, Vincent; Meijer, Henriette F.; Lie, Mady-Ann; Tromp, Jan A. H.; Degener, John E.; Harmsen, Hermie J. M.; Abbas, Frank

P>Aim To test recolonization of periodontal lesions after full-mouth scaling and root planing (FM-SRP) or multiple session-SRP (MS-SRP) in a randomized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes. Materials and Methods Thirty-nine subjects were randomly

Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial

NARCIS (Netherlands)

Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.

2009-01-01

OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10

Increased scientific rigor will improve reliability of research and effectiveness of management

Science.gov (United States)

Sells, Sarah N.; Bassing, Sarah B.; Barker, Kristin J.; Forshee, Shannon C.; Keever, Allison; Goerz, James W.; Mitchell, Michael S.

2018-01-01

Rigorous science that produces reliable knowledge is critical to wildlife management because it increases accurate understanding of the natural world and informs management decisions effectively. Application of a rigorous scientific method based on hypothesis testing minimizes unreliable knowledge produced by research. To evaluate the prevalence of scientific rigor in wildlife research, we examined 24 issues of the Journal of Wildlife Management from August 2013 through July 2016. We found 43.9% of studies did not state or imply a priori hypotheses, which are necessary to produce reliable knowledge. We posit that this is due, at least in part, to a lack of common understanding of what rigorous science entails, how it produces more reliable knowledge than other forms of interpreting observations, and how research should be designed to maximize inferential strength and usefulness of application. Current primary literature does not provide succinct explanations of the logic behind a rigorous scientific method or readily applicable guidance for employing it, particularly in wildlife biology; we therefore synthesized an overview of the history, philosophy, and logic that define scientific rigor for biological studies. A rigorous scientific method includes 1) generating a research question from theory and prior observations, 2) developing hypotheses (i.e., plausible biological answers to the question), 3) formulating predictions (i.e., facts that must be true if the hypothesis is true), 4) designing and implementing research to collect data potentially consistent with predictions, 5) evaluating whether predictions are consistent with collected data, and 6) drawing inferences based on the evaluation. Explicitly testing a priori hypotheses reduces overall uncertainty by reducing the number of plausible biological explanations to only those that are logically well supported. Such research also draws inferences that are robust to idiosyncratic observations and

Trends in Methodological Rigor in Intervention Research Published in School Psychology Journals

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Burns, Matthew K.; Klingbeil, David A.; Ysseldyke, James E.; Petersen-Brown, Shawna

2012-01-01

Methodological rigor in intervention research is important for documenting evidence-based practices and has been a recent focus in legislation, including the No Child Left Behind Act. The current study examined the methodological rigor of intervention research in four school psychology journals since the 1960s. Intervention research has increased…

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Directory of Open Access Journals (Sweden)

Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

Simulation can contribute a part of cardiorespiratory physiotherapy clinical education: two randomized trials.

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Blackstock, Felicity C; Watson, Kathryn M; Morris, Norman R; Jones, Anne; Wright, Anthony; McMeeken, Joan M; Rivett, Darren A; O'Connor, Vivienne; Peterson, Raymond F; Haines, Terry P; Watson, Geoffrey; Jull, Gwendolen Anne

2013-02-01

Simulated learning environments (SLEs) are used worldwide in health professional education, including physiotherapy, to train certain attributes and skills. To date, no randomized controlled trial (RCT) has evaluated whether education in SLEs can partly replace time in the clinical environment for physiotherapy cardiorespiratory practice. Two independent single-blind multi-institutional RCTs were conducted in parallel using a noninferiority design. Participants were volunteer physiotherapy students (RCT 1, n = 176; RCT 2, n = 173) entering acute care cardiorespiratory physiotherapy clinical placements. Two SLE models were investigated as follows: RCT 1, 1 week in SLE before 3 weeks of clinical immersion; RCT 2, 2 weeks of interspersed SLE/clinical immersion (equivalent to 1 SLE week) within the 4-week clinical placement. Students in each RCT were stratified on academic grade and randomly allocated to an SLE plus clinical immersion or clinical immersion control group. The primary outcome was competency to practice measured in 2 clinical examinations using the Assessment of Physiotherapy Practice. Secondary outcomes were student perception of experience and clinical educator and patient rating of student performance. There were no significant differences in student competency between the SLE and control groups in either RCT, although students in the interspersed group (RCT 2) achieved a higher score in 5 of 7 Assessment of Physiotherapy Practice standards (all P Students rated the SLE experience positively. Clinical educators and patients reported comparability between groups. An SLE can replace clinical time in cardiorespiratory physiotherapy practice. Part education in the SLE satisfied clinical competency requirements, and all stakeholders were satisfied.

Digital versus analogue preoperative planning of total hip arthroplasties - A randomized clinical trial of 210 total hip arthroplasties

NARCIS (Netherlands)

The, Bertram; Verdonschot, Nico; van Horn, Jim R.; van Ooijen, Peter M. A.; Diercks, Ron L.

The objective of this randomized clinical trial was to compare the clinical and technical results of digital preoperative planning for primary total hip arthroplasties with analogue planning. Two hundred and ten total hip arthroplasties were randomized. All plans were constructed on standardized

A comprehensive comparison of random forests and support vector machines for microarray-based cancer classification

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Wang Lily

2008-07-01

Full Text Available Abstract Background Cancer diagnosis and clinical outcome prediction are among the most important emerging applications of gene expression microarray technology with several molecular signatures on their way toward clinical deployment. Use of the most accurate classification algorithms available for microarray gene expression data is a critical ingredient in order to develop the best possible molecular signatures for patient care. As suggested by a large body of literature to date, support vector machines can be considered "best of class" algorithms for classification of such data. Recent work, however, suggests that random forest classifiers may outperform support vector machines in this domain. Results In the present paper we identify methodological biases of prior work comparing random forests and support vector machines and conduct a new rigorous evaluation of the two algorithms that corrects these limitations. Our experiments use 22 diagnostic and prognostic datasets and show that support vector machines outperform random forests, often by a large margin. Our data also underlines the importance of sound research design in benchmarking and comparison of bioinformatics algorithms. Conclusion We found that both on average and in the majority of microarray datasets, random forests are outperformed by support vector machines both in the settings when no gene selection is performed and when several popular gene selection methods are used.

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

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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 PLC group had superior technical and communication skills and global performance in the simulated setting (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.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

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Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

International Nuclear Information System (INIS)

Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

1996-01-01

Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse

DEFF Research Database (Denmark)

Nyström, P-O; Qvist, N; Raahave, D

2010-01-01

BACKGROUND: : This multicentre randomized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of haemorrhoids. METHODS: : The study involved 18 hospitals in Sweden, Denmark and the UK. Some 207 patients were randomized to either anopexy or Milligan-Morg...

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

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Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Celiac Patients: A Randomized, Controlled Clinical Study

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Giuseppe Mazzarella

2012-01-01

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

Why so many "rigorous" evaluations fail to identify unintended consequences of development programs: How mixed methods can contribute.

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Bamberger, Michael; Tarsilla, Michele; Hesse-Biber, Sharlene

2016-04-01

Many widely-used impact evaluation designs, including randomized control trials (RCTs) and quasi-experimental designs (QEDs), frequently fail to detect what are often quite serious unintended consequences of development programs. This seems surprising as experienced planners and evaluators are well aware that unintended consequences frequently occur. Most evaluation designs are intended to determine whether there is credible evidence (statistical, theory-based or narrative) that programs have achieved their intended objectives and the logic of many evaluation designs, even those that are considered the most "rigorous," does not permit the identification of outcomes that were not specified in the program design. We take the example of RCTs as they are considered by many to be the most rigorous evaluation designs. We present a numbers of cases to illustrate how infusing RCTs with a mixed-methods approach (sometimes called an "RCT+" design) can strengthen the credibility of these designs and can also capture important unintended consequences. We provide a Mixed Methods Evaluation Framework that identifies 9 ways in which UCs can occur, and we apply this framework to two of the case studies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of rigor status during high-pressure processing on the physical qualities of farm-raised abalone (Haliotis rufescens).

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Hughes, Brianna H; Greenberg, Neil J; Yang, Tom C; Skonberg, Denise I

2015-01-01

High-pressure processing (HPP) is used to increase meat safety and shelf-life, with conflicting quality effects depending on rigor status during HPP. In the seafood industry, HPP is used to shuck and pasteurize oysters, but its use on abalones has only been minimally evaluated and the effect of rigor status during HPP on abalone quality has not been reported. Farm-raised abalones (Haliotis rufescens) were divided into 12 HPP treatments and 1 unprocessed control treatment. Treatments were processed pre-rigor or post-rigor at 2 pressures (100 and 300 MPa) and 3 processing times (1, 3, and 5 min). The control was analyzed post-rigor. Uniform plugs were cut from adductor and foot meat for texture profile analysis, shear force, and color analysis. Subsamples were used for scanning electron microscopy of muscle ultrastructure. Texture profile analysis revealed that post-rigor processed abalone was significantly (P abalone meat was more tender than pre-rigor processed meat, and post-rigor processed foot meat was lighter in color than pre-rigor processed foot meat, suggesting that waiting for rigor to resolve prior to processing abalones may improve consumer perceptions of quality and market value. © 2014 Institute of Food Technologists®

Rigor or Reliability and Validity in Qualitative Research: Perspectives, Strategies, Reconceptualization, and Recommendations.

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Cypress, Brigitte S

Issues are still raised even now in the 21st century by the persistent concern with achieving rigor in qualitative research. There is also a continuing debate about the analogous terms reliability and validity in naturalistic inquiries as opposed to quantitative investigations. This article presents the concept of rigor in qualitative research using a phenomenological study as an exemplar to further illustrate the process. Elaborating on epistemological and theoretical conceptualizations by Lincoln and Guba, strategies congruent with qualitative perspective for ensuring validity to establish the credibility of the study are described. A synthesis of the historical development of validity criteria evident in the literature during the years is explored. Recommendations are made for use of the term rigor instead of trustworthiness and the reconceptualization and renewed use of the concept of reliability and validity in qualitative research, that strategies for ensuring rigor must be built into the qualitative research process rather than evaluated only after the inquiry, and that qualitative researchers and students alike must be proactive and take responsibility in ensuring the rigor of a research study. The insights garnered here will move novice researchers and doctoral students to a better conceptual grasp of the complexity of reliability and validity and its ramifications for qualitative inquiry.

Um exercício rigoroso de investigação clínica A rigorous exercise on clinical investigation

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Angélica Bastos

2007-12-01

Full Text Available O artigo visa extrair da produção psicanalítica de Juan Carlos Cosentino as coordenadas de sua investigação. Com base no procedimento segundo o qual Freud concebeu a elaboração do saber em psicanálise, busca-se delimitar suas questões clínicas. Nas fobias, na angústia e nos sonhos, o psicanalista distingue duas ordens de laço na experiência analítica: por um lado, a fantasia e a neurose de transferência, e, por outro, a estrutura. Procura-se demonstrar o quanto sua releitura de Freud é movida por problemáticas originais, configurando uma pesquisa rigorosa impulsionada pela direção do tratamento e ditada pela função do desejo do analista.The article aims at drawing out the coordinates of investigation from the psychoanalytical production of Juan Carlos Cosentino. Based on the proceedings which Freud conceived knowledge elaboration in psychoanalysis, the clinical questions are delimited in his investigation. The psychoanalyst distinguishes two bond types in the analytical experience in relation to phobias, angst and dreams: on one hand, fantasy and transfer neurosis and on the other hand, the structure. We try to demonstrate how much his reading on Freud is powered by original problems, thus outlining a rigorous research triggered by the treatment course and ruled by the function of the therapist's desire.

Acupuncture for Children with Autism Spectrum Disorders: A Systematic Review of Randomized Clinical Trials

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Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard

2012-01-01

This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…

Does clinical equipoise apply to cluster randomized trials in health research?

Science.gov (United States)

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

Some rigorous results concerning spectral theory for ideal MHD

International Nuclear Information System (INIS)

Laurence, P.

1986-01-01

Spectral theory for linear ideal MHD is laid on a firm foundation by defining appropriate function spaces for the operators associated with both the first- and second-order (in time and space) partial differential operators. Thus, it is rigorously established that a self-adjoint extension of F(xi) exists. It is shown that the operator L associated with the first-order formulation satisfies the conditions of the Hille--Yosida theorem. A foundation is laid thereby within which the domains associated with the first- and second-order formulations can be compared. This allows future work in a rigorous setting that will clarify the differences (in the two formulations) between the structure of the generalized eigenspaces corresponding to the marginal point of the spectrum ω = 0

Some rigorous results concerning spectral theory for ideal MHD

International Nuclear Information System (INIS)

Laurence, P.

1985-05-01

Spectral theory for linear ideal MHD is laid on a firm foundation by defining appropriate function spaces for the operators associated with both the first and second order (in time and space) partial differential operators. Thus, it is rigorously established that a self-adjoint extension of F(xi) exists. It is shown that the operator L associated with the first order formulation satisfies the conditions of the Hille-Yosida theorem. A foundation is laid thereby within which the domains associated with the first and second order formulations can be compared. This allows future work in a rigorous setting that will clarify the differences (in the two formulations) between the structure of the generalized eigenspaces corresponding to the marginal point of the spectrum ω = 0

A randomized controlled pilot trial comparing the impact of access to clinical endocrinology video demonstrations with access to usual revision resources on medical student performance of clinical endocrinology skills.

Science.gov (United States)

Hibbert, Emily J; Lambert, Tim; Carter, John N; Learoyd, Diana L; Twigg, Stephen; Clarke, Stephen

2013-10-03

Demonstrating competence in clinical skills is key to course completion for medical students. Methods of providing clinical instruction that foster immediate learning and potentially serve as longer-term repositories for on-demand revision, such as online videos demonstrating competent performance of clinical skills, are increasingly being used. However, their impact on learning has been little studied. The aim of this study was to determine the value of adjunctive on-demand video-based training for clinical skills acquisition by medical students in endocrinology. Following an endocrinology clinical tutorial program, 2nd year medical students in the pre-assessment revision period were recruited and randomized to either a set of bespoke on-line clinical skills training videos (TV), or to revision as usual (RAU). The skills demonstrated on video were history taking in diabetes mellitus (DMH), examination for diabetes lower limb complications (LLE), and examination for signs of thyroid disease (TE). Students were assessed on these clinical skills in an observed structured clinical examination two weeks after randomization. Assessors were blinded to student randomization status. For both diabetes related clinical skills assessment tasks, students in the TV group performed significantly better than those in the RAU group. There were no between group differences in thyroid examination performance. For the LLE, 91.7% (n = 11/12) of students randomized to the video were rated globally as competent at the skill compared with 40% (n = 4/10) of students not randomized to the video (p = 0.024). For the DMH, 83.3% (n = 10/12) of students randomized to the video were rated globally as competent at the skill compared with 20% (n = 2/10) of students not randomized to the video (p = 0.007). Exposure to high quality videos demonstrating clinical skills can significantly improve medical student skill performance in an observed structured clinical examination of these skills, when

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

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

2011-01-01

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

Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial.

Science.gov (United States)

Sunay, Didem; Sunay, Melih; Aydoğmuş, Yasin; Bağbancı, Sahin; Arslan, Hüseyin; Karabulut, Ayhan; Emir, Levent

2011-05-01

Acupuncture therapy has been used by many researchers in both male and female sexual dysfunction studies. To determine whether acupuncture is effective as a premature ejaculation (PE) treatment compared with paroxetine and placebo. The study was conducted with methodologic rigor based on Consolidated Standards of Reporting Trials (CONSORT) criteria. Ninety patients referred to the urology clinic at a tertiary training and research hospital with PE were included in this randomized controlled trial and randomly assigned into paroxetine, acupuncture, and placebo groups. Heterosexual, sexually active men aged between 28 and 50 yr were included. Men with other sexual disorders, including erectile dysfunction; with chronic psychiatric or systemic diseases; with alcohol or substance abuse; or who used any medications were excluded. The medicated group received paroxetine 20 mg/d; the acupuncture or sham-acupuncture (placebo) groups were treated twice a week for 4 wk. Intravaginal ejaculation latency times (IELTs) and the Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE. IELTs were calculated by using a partner-held stopwatch. Data were analyzed statistically. Median PEDT scores of paroxetine, acupuncture, and placebo groups were 17.0, 16.0, and 15.5 before treatment, and 10.5, 11.0, and 16.0 after treatment, respectively (p=0.001, p=0.001, and p=0.314, respectively). Subscores after treatment were significantly lower than subscores before treatment in the paroxetine and acupuncture groups but remained the same in the placebo group. Significant differences were found between mean-rank IELTs of the paroxetine and placebo groups (p=0.001) and the acupuncture and placebo groups (p=0.001) after treatment. Increases of IELTs with paroxetine, acupuncture, and placebo acupuncture were 82.7, 65.7, and 33.1 s, respectively. Extent of ejaculation delay induced by paroxetine was significantly higher than that of acupuncture (p=0.001). The most important limitation

Critical Analysis of Strategies for Determining Rigor in Qualitative Inquiry.

Science.gov (United States)

Morse, Janice M

2015-09-01

Criteria for determining the trustworthiness of qualitative research were introduced by Guba and Lincoln in the 1980s when they replaced terminology for achieving rigor, reliability, validity, and generalizability with dependability, credibility, and transferability. Strategies for achieving trustworthiness were also introduced. This landmark contribution to qualitative research remains in use today, with only minor modifications in format. Despite the significance of this contribution over the past four decades, the strategies recommended to achieve trustworthiness have not been critically examined. Recommendations for where, why, and how to use these strategies have not been developed, and how well they achieve their intended goal has not been examined. We do not know, for example, what impact these strategies have on the completed research. In this article, I critique these strategies. I recommend that qualitative researchers return to the terminology of social sciences, using rigor, reliability, validity, and generalizability. I then make recommendations for the appropriate use of the strategies recommended to achieve rigor: prolonged engagement, persistent observation, and thick, rich description; inter-rater reliability, negative case analysis; peer review or debriefing; clarifying researcher bias; member checking; external audits; and triangulation. © The Author(s) 2015.

A random walk rule for phase I clinical trials.

Science.gov (United States)

Durham, S D; Flournoy, N; Rosenberger, W F

1997-06-01

We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose these probabilities in order to center dose level assignments unimodally around any target quantile of interest. Estimation of the quantile is discussed; the maximum likelihood estimator and its variance are derived under a two-parameter logistic distribution, and the maximum likelihood estimator is compared with other nonparametric estimators. Random walk rules have clear advantages: they are simple to implement, and finite and asymptotic distribution theory is completely worked out. For a specific random walk rule, we compute finite and asymptotic properties and give examples of its use in planning studies. Having the finite distribution theory available and tractable obviates the need for elaborate simulation studies to analyze the properties of the design. The small sample properties of our rule, as determined by exact theory, compare favorably to those of the continual reassessment method, determined by simulation.

RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

Science.gov (United States)

Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

2015-08-01

Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

Realization of a Quantum Random Generator Certified with the Kochen-Specker Theorem

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Kulikov, Anatoly; Jerger, Markus; Potočnik, Anton; Wallraff, Andreas; Fedorov, Arkady

2017-12-01

Random numbers are required for a variety of applications from secure communications to Monte Carlo simulation. Yet randomness is an asymptotic property, and no output string generated by a physical device can be strictly proven to be random. We report an experimental realization of a quantum random number generator (QRNG) with randomness certified by quantum contextuality and the Kochen-Specker theorem. The certification is not performed in a device-independent way but through a rigorous theoretical proof of each outcome being value indefinite even in the presence of experimental imperfections. The analysis of the generated data confirms the incomputable nature of our QRNG.

Stock Versus CAD/CAM Customized Zirconia Implant Abutments - Clinical and Patient-Based Outcomes in a Randomized Controlled Clinical Trial

NARCIS (Netherlands)

Schepke, Ulf; Meijer, Henny J. A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco

BackgroundSingle-tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. PurposeThis randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant

A Rigorous Temperature-Dependent Stochastic Modelling and Testing for MEMS-Based Inertial Sensor Errors

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Spiros Pagiatakis

2009-10-01

Full Text Available In this paper, we examine the effect of changing the temperature points on MEMS-based inertial sensor random error. We collect static data under different temperature points using a MEMS-based inertial sensor mounted inside a thermal chamber. Rigorous stochastic models, namely Autoregressive-based Gauss-Markov (AR-based GM models are developed to describe the random error behaviour. The proposed AR-based GM model is initially applied to short stationary inertial data to develop the stochastic model parameters (correlation times. It is shown that the stochastic model parameters of a MEMS-based inertial unit, namely the ADIS16364, are temperature dependent. In addition, field kinematic test data collected at about 17 °C are used to test the performance of the stochastic models at different temperature points in the filtering stage using Unscented Kalman Filter (UKF. It is shown that the stochastic model developed at 20 °C provides a more accurate inertial navigation solution than the ones obtained from the stochastic models developed at −40 °C, −20 °C, 0 °C, +40 °C, and +60 °C. The temperature dependence of the stochastic model is significant and should be considered at all times to obtain optimal navigation solution for MEMS-based INS/GPS integration.

A Rigorous Temperature-Dependent Stochastic Modelling and Testing for MEMS-Based Inertial Sensor Errors.

Science.gov (United States)

El-Diasty, Mohammed; Pagiatakis, Spiros

2009-01-01

In this paper, we examine the effect of changing the temperature points on MEMS-based inertial sensor random error. We collect static data under different temperature points using a MEMS-based inertial sensor mounted inside a thermal chamber. Rigorous stochastic models, namely Autoregressive-based Gauss-Markov (AR-based GM) models are developed to describe the random error behaviour. The proposed AR-based GM model is initially applied to short stationary inertial data to develop the stochastic model parameters (correlation times). It is shown that the stochastic model parameters of a MEMS-based inertial unit, namely the ADIS16364, are temperature dependent. In addition, field kinematic test data collected at about 17 °C are used to test the performance of the stochastic models at different temperature points in the filtering stage using Unscented Kalman Filter (UKF). It is shown that the stochastic model developed at 20 °C provides a more accurate inertial navigation solution than the ones obtained from the stochastic models developed at -40 °C, -20 °C, 0 °C, +40 °C, and +60 °C. The temperature dependence of the stochastic model is significant and should be considered at all times to obtain optimal navigation solution for MEMS-based INS/GPS integration.

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials

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Ting-Hao Chen

2016-01-01

Full Text Available Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care group. Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [-0.23,0.24]. Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures.

The Relationship between Project-Based Learning and Rigor in STEM-Focused High Schools

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Edmunds, Julie; Arshavsky, Nina; Glennie, Elizabeth; Charles, Karen; Rice, Olivia

2016-01-01

Project-based learning (PjBL) is an approach often favored in STEM classrooms, yet some studies have shown that teachers struggle to implement it with academic rigor. This paper explores the relationship between PjBL and rigor in the classrooms of ten STEM-oriented high schools. Utilizing three different data sources reflecting three different…

Rigorous approximation of stationary measures and convergence to equilibrium for iterated function systems

International Nuclear Information System (INIS)

Galatolo, Stefano; Monge, Maurizio; Nisoli, Isaia

2016-01-01

We study the problem of the rigorous computation of the stationary measure and of the rate of convergence to equilibrium of an iterated function system described by a stochastic mixture of two or more dynamical systems that are either all uniformly expanding on the interval, either all contracting. In the expanding case, the associated transfer operators satisfy a Lasota–Yorke inequality, we show how to compute a rigorous approximations of the stationary measure in the L "1 norm and an estimate for the rate of convergence. The rigorous computation requires a computer-aided proof of the contraction of the transfer operators for the maps, and we show that this property propagates to the transfer operators of the IFS. In the contracting case we perform a rigorous approximation of the stationary measure in the Wasserstein–Kantorovich distance and rate of convergence, using the same functional analytic approach. We show that a finite computation can produce a realistic computation of all contraction rates for the whole parameter space. We conclude with a description of the implementation and numerical experiments. (paper)

Linking of uniform random polygons in confined spaces

International Nuclear Information System (INIS)

Arsuaga, J; Blackstone, T; Diao, Y; Karadayi, E; Saito, M

2007-01-01

In this paper, we study the topological entanglement of uniform random polygons in a confined space. We derive the formula for the mean squared linking number of such polygons. For a fixed simple closed curve in the confined space, we rigorously show that the linking probability between this curve and a uniform random polygon of n vertices is at least 1-O(1/√n). Our numerical study also indicates that the linking probability between two uniform random polygons (in a confined space), of m and n vertices respectively, is bounded below by 1-O(1/√(mn)). In particular, the linking probability between two uniform random polygons, both of n vertices, is bounded below by 1-O(1/n)

Percutaneous nephrolithotomy with and without retrograde pyelography: a randomized clinical trial

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Ali Tabibi

2007-02-01

Full Text Available OBJECTIVE: Since the introduction of percutaneous nephrolithotomy (PCNL, many changes have been added regarding the entrance to pyelocalyceal system such as insertion of the needle pointed to an opaque stone as a guided landmark. We aim at comparing the outcomes of managing renal calculi with and without retrograde pyelography. MATERIALS AND METHODS: In a randomized clinical trial, 55 cases with opaque renal calculi candidates for PCNL with stone in one calyce, in the pelvis or both in one calyce and the pelvis simultaneously were included in a nine-month study. They were randomized into 2 groups, noncatheterized (n = 28 and catheterized (n = 27, called intervention and control groups, respectively. RESULTS: The 2 groups had similar distributions regarding gender, age, duration of operation, length of hospital stay, past history of any surgical procedures on kidney, and stone size. Outcome (residual stone based on aforementioned management was evaluated with plain X-ray on the morning following the operation. Postoperative hemoglobin decrease was significantly higher in controls than in the intervention group (p < 0.001 (with no clinical significance. No difference in outcome, postoperative fever, duration of surgery, duration of hospital stay and radiation exposure was observed between the 2 groups. CONCLUSION: Our findings showed no differences in major clinical outcomes between the 2 groups (with and without catheter insertion for retrograde pyelography.

Do Implant Overdentures Improve Dietary Intake? A Randomized Clinical Trial

Science.gov (United States)

Hamdan, N.M.; Gray-Donald, K.; Awad, M.A.; Johnson-Down, L.; Wollin, S.; Feine, J.S.

2013-01-01

People wearing mandibular two-implant overdentures (IOD) chew food with less difficulty than those wearing conventional complete dentures (CD). However, there is still controversy over whether or not this results in better dietary intake. In this randomized clinical trials (RCT), the amounts of total dietary fiber (TDF), macronutrients, 9 micronutrients, and energy in diets consumed by persons with IOD and CD were compared. Male and female edentate patients ≥ 65 yrs (n = 255) were randomly divided into 2 groups and assigned to receive a maxillary CD and either a mandibular IOD or a CD. One year following prosthesis delivery, 217 participants (CD = 114, IOD = 103) reported the food and quantities they consumed to a registered dietician through a standard 24-hour dietary recall method. The mean and median values of TDF, macro- and micronutrients, and energy consumed by both groups were calculated and compared analytically. No significant between-group differences were found (ps > .05). Despite quality-of-life benefits from IODs, this adequately powered study reveals no evidence of nutritional advantages for independently living medically healthy edentate elders wearing two-implant mandibular overdentures over those wearing conventional complete dentures in their dietary intake at one year following prosthesis delivery (International Clinical Trials ISRCTN24273915). PMID:24158335

Acupoint Stimulation for Fibromyalgia: A Systematic Review of Randomized Controlled Trials

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Huijuan Cao

2013-01-01

Full Text Available Background. Acupoint stimulation is popular for treatment of fibromyalgia though there is lack of comprehensive evaluation of current clinical evidence for its effect and safety. Objective. To systematically review the beneficial effects and safety of acupoint stimulation for fibromyalgia. Methods. We searched six electronic databases for randomized trials on acupoint stimulation for treatment of fibromyalgia. Two authors extracted data and assessed the trial quality independently. RevMan 5.2 software was used for data analyses with effect estimate presented as (standard mean difference and a 95% confidence interval. We defined minimum, medium, and large SMD effect sizes as 0.3, 0.5, and 0.75. Results. 16 RCTs with 1081 participants were involved in this review. Only two trials were evaluated as low risk of bias. Meta-analysis showed that acupuncture alone or combined with cupping therapy was superior to conventional medications on reducing pain scores and/or the number of tender points. However, acupuncture showed no better than sham acupuncture on pain reduction. There was no serious adverse event reported to be related to acupoint stimulation. Conclusions. Acupoint stimulation appears to be effective in treating fibromyalgia compared with medications. However, further large, rigorously designed trials are warranted due to insufficient methodological rigor in the included trials.

Incorporating PROMIS Symptom Measures into Primary Care Practice-a Randomized Clinical Trial.

Science.gov (United States)

Kroenke, Kurt; Talib, Tasneem L; Stump, Timothy E; Kean, Jacob; Haggstrom, David A; DeChant, Paige; Lake, Kittie R; Stout, Madison; Monahan, Patrick O

2018-04-05

Symptoms account for more than 400 million clinic visits annually in the USA. The SPADE symptoms (sleep, pain, anxiety, depression, and low energy/fatigue) are particularly prevalent and undertreated. To assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes. Randomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system. Primary care patients who screened positive for at least one SPADE symptom. After completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomized to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians. The primary outcome was the 3-month change in composite SPADE score. Secondary outcomes were individual symptom scores, symptom documentation in the clinic note, symptom-specific clinician actions, and patient satisfaction. Most patients (84%) had multiple clinically significant (T-score ≥ 55) SPADE symptoms. Both groups demonstrated moderate symptom improvement with a non-significant trend favoring the feedback compared to control group (between-group difference in composite T-score improvement, 1.1; P = 0.17). Symptoms present at baseline resolved at 3-month follow-up only one third of the time, and patients frequently still desired treatment. Except for pain, clinically significant symptoms were documented less than half the time. Neither symptom documentation, symptom-specific clinician actions, nor patient satisfaction differed between treatment arms. Predictors of greater symptom improvement included female sex, black race, fewer medical conditions, and receiving care in a family medicine clinic. Simple feedback of symptom scores to primary care clinicians in the absence of

Low versus high volume of culture medium during embryo transfer: a randomized clinical trial.

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Sigalos, George Α; Michalopoulos, Yannis; Kastoras, Athanasios G; Triantafyllidou, Olga; Vlahos, Nikos F

2018-04-01

The aim of this prospective randomized control trial was to evaluate if the use of two different volumes (20-25 vs 40-45 μl) of media used for embryo transfer affects the clinical outcomes in fresh in vitro fertilization (IVF) cycles. In total, 236 patients were randomized in two groups, i.e., "low volume" group (n = 118) transferring the embryos with 20-25 μl of medium and "high volume" group (n = 118) transferring the embryos with 40-45 μl of medium. The clinical pregnancy, implantation, and ongoing pregnancy rates were compared between the two groups. No statistically significant differences were observed in clinical pregnancy (46.8 vs 54.3%, p = 0.27), implantation (23.7 vs 27.8%, p = 0.30), and ongoing pregnancy (33.3 vs 40.0%, p = 0.31) rates between low and high volume group, respectively. Higher volume of culture medium to load the embryo into the catheter during embryo transfer does not influence the clinical outcome in fresh IVF cycles. NCT03350646.

Study of the quality characteristics in cold-smoked salmon (Salmo salar) originating from pre- or post-rigor raw material.

Science.gov (United States)

Birkeland, S; Akse, L

2010-01-01

Improved slaughtering procedures in the salmon industry have caused a delayed onset of rigor mortis and, thus, a potential for pre-rigor secondary processing. The aim of this study was to investigate the effect of rigor status at time of processing on quality traits color, texture, sensory, microbiological, in injection salted, and cold-smoked Atlantic salmon (Salmo salar). Injection of pre-rigor fillets caused a significant (Prigor processed fillets; however, post-rigor (1477 ± 38 g) fillets had a significant (P>0.05) higher fracturability than pre-rigor fillets (1369 ± 71 g). Pre-rigor fillets were significantly (Prigor fillets (37.8 ± 0.8) and had significantly lower (Prigor processed fillets. This study showed that similar quality characteristics can be obtained in cold-smoked products processed either pre- or post-rigor when using suitable injection salting protocols and smoking techniques. © 2010 Institute of Food Technologists®

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

Science.gov (United States)

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

Experimental evaluation of rigor mortis. VIII. Estimation of time since death by repeated measurements of the intensity of rigor mortis on rats.

Science.gov (United States)

Krompecher, T

1994-10-21

The development of the intensity of rigor mortis was monitored in nine groups of rats. The measurements were initiated after 2, 4, 5, 6, 8, 12, 15, 24, and 48 h post mortem (p.m.) and lasted 5-9 h, which ideally should correspond to the usual procedure after the discovery of a corpse. The experiments were carried out at an ambient temperature of 24 degrees C. Measurements initiated early after death resulted in curves with a rising portion, a plateau, and a descending slope. Delaying the initial measurement translated into shorter rising portions, and curves initiated 8 h p.m. or later are comprised of a plateau and/or a downward slope only. Three different phases were observed suggesting simple rules that can help estimate the time since death: (1) if an increase in intensity was found, the initial measurements were conducted not later than 5 h p.m.; (2) if only a decrease in intensity was observed, the initial measurements were conducted not earlier than 7 h p.m.; and (3) at 24 h p.m., the resolution is complete, and no further changes in intensity should occur. Our results clearly demonstrate that repeated measurements of the intensity of rigor mortis allow a more accurate estimation of the time since death of the experimental animals than the single measurement method used earlier. A critical review of the literature on the estimation of time since death on the basis of objective measurements of the intensity of rigor mortis is also presented.

Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

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Villafranca Alex

2009-11-01

Full Text Available Abstract Background Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. Methods/Design BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60 or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration. Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation. The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium. Discussion This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091

The MIXED framework: A novel approach to evaluating mixed-methods rigor.

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Eckhardt, Ann L; DeVon, Holli A

2017-10-01

Evaluation of rigor in mixed-methods (MM) research is a persistent challenge due to the combination of inconsistent philosophical paradigms, the use of multiple research methods which require different skill sets, and the need to combine research at different points in the research process. Researchers have proposed a variety of ways to thoroughly evaluate MM research, but each method fails to provide a framework that is useful for the consumer of research. In contrast, the MIXED framework is meant to bridge the gap between an academic exercise and practical assessment of a published work. The MIXED framework (methods, inference, expertise, evaluation, and design) borrows from previously published frameworks to create a useful tool for the evaluation of a published study. The MIXED framework uses an experimental eight-item scale that allows for comprehensive integrated assessment of MM rigor in published manuscripts. Mixed methods are becoming increasingly prevalent in nursing and healthcare research requiring researchers and consumers to address issues unique to MM such as evaluation of rigor. © 2017 John Wiley & Sons Ltd.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

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Soon Judith A

2011-06-01

Full Text Available Abstract Background We describe the rationale and protocol for a randomized controlled trial (RCT to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention or four weeks (recommended care post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one

Rigorous Results for the Distribution of Money on Connected Graphs

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Lanchier, Nicolas; Reed, Stephanie

2018-05-01

This paper is concerned with general spatially explicit versions of three stochastic models for the dynamics of money that have been introduced and studied numerically by statistical physicists: the uniform reshuffling model, the immediate exchange model and the model with saving propensity. All three models consist of systems of economical agents that consecutively engage in pairwise monetary transactions. Computer simulations performed in the physics literature suggest that, when the number of agents and the average amount of money per agent are large, the limiting distribution of money as time goes to infinity approaches the exponential distribution for the first model, the gamma distribution with shape parameter two for the second model and a distribution similar but not exactly equal to a gamma distribution whose shape parameter depends on the saving propensity for the third model. The main objective of this paper is to give rigorous proofs of these conjectures and also extend these conjectures to generalizations of the first two models and a variant of the third model that include local rather than global interactions, i.e., instead of choosing the two interacting agents uniformly at random from the system, the agents are located on the vertex set of a general connected graph and can only interact with their neighbors.

Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding

DEFF Research Database (Denmark)

Hróbjartsson, A; Forfang, E; Haahr, M T

2007-01-01

Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

ATP, IMP, and glycogen in cod muscle at onset and during development of rigor mortis depend on the sampling location

DEFF Research Database (Denmark)

Cappeln, Gertrud; Jessen, Flemming

2002-01-01

Variation in glycogen, ATP, and IMP contents within individual cod muscles were studied in ice stored fish during the progress of rigor mortis. Rigor index was determined before muscle samples for chemical analyzes were taken at 16 different positions on the fish. During development of rigor......, the contents of glycogen and ATP decreased differently in relation to rigor index depending on sampling location. Although fish were considered to be in strong rigor according to the rigor index method, parts of the muscle were not in rigor as high ATP concentrations were found in dorsal and tall muscle....

Tai chi exercise in patients with chronic heart failure: a randomized clinical trial.

Science.gov (United States)

Yeh, Gloria Y; McCarthy, Ellen P; Wayne, Peter M; Stevenson, Lynne W; Wood, Malissa J; Forman, Daniel; Davis, Roger B; Phillips, Russell S

2011-04-25

Preliminary evidence suggests that meditative exercise may have benefits for patients with chronic systolic heart failure (HF); this has not been rigorously tested in a large clinical sample. We sought to investigate whether tai chi, as an adjunct to standard care, improves functional capacity and quality of life in patients with HF. A single-blind, multisite, parallel-group, randomized controlled trial evaluated 100 outpatients with systolic HF (New York Heart Association class I-III, left ventricular ejection fraction ≤40%) who were recruited between May 1, 2005, and September 30, 2008. A group-based 12-week tai chi exercise program (n = 50) or time-matched education (n = 50, control group) was conducted. Outcome measures included exercise capacity (6- minute walk test and peak oxygen uptake) and disease-specific quality of life (Minnesota Living With Heart Failure Questionnaire). Mean (SD) age of patients was 67 (11) years; baseline values were left ventricular ejection fraction, 29% (8%) and peak oxygen uptake, 13.5 mL/kg/min; the median New York Heart Association class of HF was class II. At completion of the study, there were no significant differences in change in 6-minute walk distance and peak oxygen uptake (median change [first quartile, third quartile], 35 [-2, 51] vs 2 [-7, 54] meters, P = .95; and 1.1 [-1.1, 1.5] vs -0.5 [-1.2, 1.8] mL/kg/min, P = .81) when comparing tai chi and control groups; however, patients in the tai chi group had greater improvements in quality of life (Minnesota Living With Heart Failure Questionnaire, -19 [-23, -3] vs 1 [-16, 3], P = .02). Improvements with tai chi were also seen in exercise self-efficacy (Cardiac Exercise Self-efficacy Instrument, 0.1 [0.1, 0.6] vs -0.3 [-0.5, 0.2], P mood (Profile of Mood States total mood disturbance, -6 [-17, 1] vs -1 [-13, 10], P = .01). Tai chi exercise may improve quality of life, mood, and exercise self-efficacy in patients with HF. Trial Registration clinicaltrials.gov Identifier

Blood Pressure Reduction and Secondary Stroke Prevention: A Systematic Review and Metaregression Analysis of Randomized Clinical Trials.

Science.gov (United States)

Katsanos, Aristeidis H; Filippatou, Angeliki; Manios, Efstathios; Deftereos, Spyridon; Parissis, John; Frogoudaki, Alexandra; Vrettou, Agathi-Rosa; Ikonomidis, Ignatios; Pikilidou, Maria; Kargiotis, Odysseas; Voumvourakis, Konstantinos; Alexandrov, Anne W; Alexandrov, Andrei V; Tsivgoulis, Georgios

2017-01-01

Current recommendations do not specifically address the optimal blood pressure (BP) reduction for secondary stroke prevention in patients with previous cerebrovascular events. We conducted a systematic review and metaregression analysis on the association of BP reduction with recurrent stroke and cardiovascular events using data from randomized controlled clinical trials of secondary stroke prevention. For all reported events during each eligible study period, we calculated the corresponding risk ratios to express the comparison of event occurrence risk between patients randomized to antihypertensive treatment and those randomized to placebo. On the basis of the reported BP values, we performed univariate metaregression analyses according to the achieved BP values under the random-effects model (Method of Moments) for those adverse events reported in ≥10 total subgroups of included randomized controlled clinical trials. In pairwise meta-analyses, antihypertensive treatment lowered the risk for recurrent stroke (risk ratio, 0.73; 95% confidence interval, 0.62-0.87; Psecondary stroke prevention. © 2016 American Heart Association, Inc.

On the entropy of random surfaces with arbitrary genus

International Nuclear Information System (INIS)

Kostov, I.K.; Krzywicki, A.

1987-01-01

We calculate the susceptibility critical exponent γ for Polyakov random surfaces with arbitrary genus, using the Liouville theory to one-loop order. Some rigorous results obtained for special dimensionalities in a discrete version of the model are also noted. In all cases γ grows linearly with the genus of the surface. (orig.)

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

Science.gov (United States)

Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

2018-01-26

Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

Permissive or Trophic Enteral Nutrition and Full Enteral Nutrition Had Similar Effects on Clinical Outcomes in Intensive Care: A Systematic Review of Randomized Clinical Trials.

Science.gov (United States)

Silva, Camila F A; de Vasconcelos, Simone G; da Silva, Thales A; Silva, Flávia M

2018-01-26

The aim of this study was to systematically review the effect of permissive underfeeding/trophic feeding on the clinical outcomes of critically ill patients. A systematic review of randomized clinical trials to evaluate the mortality, length of stay, and mechanical ventilation duration in patients randomized to either hypocaloric or full-energy enteral nutrition was performed. Data sources included PubMed and Scopus and the reference lists of the articles retrieved. Two independent reviewers participated in all phases of this systematic review as proposed by the Cochrane Handbook, and the review was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 7 randomized clinical trials that included a total of 1,717 patients were reviewed. Intensive care unit length of stay and mechanical ventilation duration were not statistically different between the intervention and control groups in all randomized clinical trials, and mortality rate was also not different between the groups. In conclusion, hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition. It is still necessary to determine the safety of this intervention in this group of patients, the optimal amount of energy provided, and the duration of this therapy. © 2018 American Society for Parenteral and Enteral Nutrition.

Control of anxiety through music in a head and neckoutpatient clinic: a randomized clinical trial

Directory of Open Access Journals (Sweden)

Mariana Alves Firmeza

Full Text Available Abstract OBJECTIVE Evaluating the effectiveness of a musical intervention in reducing anxiety and vital parameters in people suffering from head and neck cancer. METHOD A randomized controlled clinical trial, performed in a head and neck outpatient clinic with 40 participants, subdivided into two groups (intervention and control.The classicalmusic“Spring” from The Four Seasons by Vivaldi was used as an intervention.The State-Trait Anxiety Inventory (STAI was used as the data collectioninstrument,along with an inventory of socio-demographic and clinical data. Student'st-test was used to verify intragroup and intergroup statistical significance. RESULTS Participants presented a statistically significant reduction in levels of perceived anxiety (t= 12.68; p<0.001,as well as blood pressure levels (t = 4.56; p<0.001; pulse (t = 6.15; p<0.001 and respiratory rate (t = 5.10; p<0.001. CONCLUSION Music has proven to be an effective non-pharmacological therapeutic resource in managinganxiety in an outpatient setting for people with cancer, as well as in reducing blood pressure, pulse and respiratory rate. Brazilian Registry of Clinical Trials: RBR-7W4YJJ

Disciplining Bioethics: Towards a Standard of Methodological Rigor in Bioethics Research

Science.gov (United States)

Adler, Daniel; Shaul, Randi Zlotnik

2012-01-01

Contemporary bioethics research is often described as multi- or interdisciplinary. Disciplines are characterized, in part, by their methods. Thus, when bioethics research draws on a variety of methods, it crosses disciplinary boundaries. Yet each discipline has its own standard of rigor—so when multiple disciplinary perspectives are considered, what constitutes rigor? This question has received inadequate attention, as there is considerable disagreement regarding the disciplinary status of bioethics. This disagreement has presented five challenges to bioethics research. Addressing them requires consideration of the main types of cross-disciplinary research, and consideration of proposals aiming to ensure rigor in bioethics research. PMID:22686634

Randomized Clinical Trial: The Use of SpeechEasy® in Stuttering Treatment

Science.gov (United States)

Ritto, Ana Paula; Juste, Fabiola Staróbole; Stuart, Andrew; Kalinowski, Joseph; de Andrade, Claudia Regina Furquim

2016-01-01

Background: Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims: The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods &…

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

Science.gov (United States)

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Scattering analysis of point processes and random measures

International Nuclear Information System (INIS)

Hanisch, K.H.

1984-01-01

In the present paper scattering analysis of point processes and random measures is studied. Known formulae which connect the scattering intensity with the pair distribution function of the studied structures are proved in a rigorous manner with tools of the theory of point processes and random measures. For some special fibre processes the scattering intensity is computed. For a class of random measures, namely for 'grain-germ-models', a new formula is proved which yields the pair distribution function of the 'grain-germ-model' in terms of the pair distribution function of the underlying point process (the 'germs') and of the mean structure factor and the mean squared structure factor of the particles (the 'grains'). (author)

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.

Science.gov (United States)

Oyama, M A; Ellenberg, S S; Shaw, P A

2017-07-01

Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine.

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Vassy, Jason L; Lautenbach, Denise M; McLaughlin, Heather M; Kong, Sek Won; Christensen, Kurt D; Krier, Joel; Kohane, Isaac S; Feuerman, Lindsay Z; Blumenthal-Barby, Jennifer; Roberts, J Scott; Lehmann, Lisa Soleymani; Ho, Carolyn Y; Ubel, Peter A; MacRae, Calum A; Seidman, Christine E; Murray, Michael F; McGuire, Amy L; Rehm, Heidi L; Green, Robert C

2014-03-20

Whole genome sequencing (WGS) is already being used in certain clinical and research settings, but its impact on patient well-being, health-care utilization, and clinical decision-making remains largely unstudied. It is also unknown how best to communicate sequencing results to physicians and patients to improve health. We describe the design of the MedSeq Project: the first randomized trials of WGS in clinical care. This pair of randomized controlled trials compares WGS to standard of care in two clinical contexts: (a) disease-specific genomic medicine in a cardiomyopathy clinic and (b) general genomic medicine in primary care. We are recruiting 8 to 12 cardiologists, 8 to 12 primary care physicians, and approximately 200 of their patients. Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS. Our laboratory delivers a genome report to physician participants that balances the needs to enhance understandability of genomic information and to convey its complexity. We provide an educational curriculum for physician participants and offer them a hotline to genetics professionals for guidance in interpreting and managing their patients' genome reports. Using varied data sources, including surveys, semi-structured interviews, and review of clinical data, we measure the attitudes, behaviors and outcomes of physician and patient participants at multiple time points before and after the disclosure of these results. The impact of emerging sequencing technologies on patient care is unclear. We have designed a process of interpreting WGS results and delivering them to physicians in a way that anticipates how we envision genomic medicine will evolve in the near future. That is, our WGS report provides clinically relevant information while communicating the complexity and uncertainty of WGS results to physicians and, through physicians, to their patients. This project will not only

MASTERS OF ANALYTICAL TRADECRAFT: CERTIFYING THE STANDARDS AND ANALYTIC RIGOR OF INTELLIGENCE PRODUCTS

Science.gov (United States)

2016-04-01

AU/ACSC/2016 AIR COMMAND AND STAFF COLLEGE AIR UNIVERSITY MASTERS OF ANALYTICAL TRADECRAFT: CERTIFYING THE STANDARDS AND ANALYTIC RIGOR OF...establishing unit level certified Masters of Analytic Tradecraft (MAT) analysts to be trained and entrusted to evaluate and rate the standards and...cues) ideally should meet or exceed effective rigor (based on analytical process).4 To accomplish this, decision makers should not be left to their

Generating random networks and graphs

CERN Document Server

Coolen, Ton; Roberts, Ekaterina

2017-01-01

This book supports researchers who need to generate random networks, or who are interested in the theoretical study of random graphs. The coverage includes exponential random graphs (where the targeted probability of each network appearing in the ensemble is specified), growth algorithms (i.e. preferential attachment and the stub-joining configuration model), special constructions (e.g. geometric graphs and Watts Strogatz models) and graphs on structured spaces (e.g. multiplex networks). The presentation aims to be a complete starting point, including details of both theory and implementation, as well as discussions of the main strengths and weaknesses of each approach. It includes extensive references for readers wishing to go further. The material is carefully structured to be accessible to researchers from all disciplines while also containing rigorous mathematical analysis (largely based on the techniques of statistical mechanics) to support those wishing to further develop or implement the theory of rand...

Linking of uniform random polygons in confined spaces

Science.gov (United States)

Arsuaga, J.; Blackstone, T.; Diao, Y.; Karadayi, E.; Saito, M.

2007-03-01

In this paper, we study the topological entanglement of uniform random polygons in a confined space. We derive the formula for the mean squared linking number of such polygons. For a fixed simple closed curve in the confined space, we rigorously show that the linking probability between this curve and a uniform random polygon of n vertices is at least 1-O\\big(\\frac{1}{\\sqrt{n}}\\big) . Our numerical study also indicates that the linking probability between two uniform random polygons (in a confined space), of m and n vertices respectively, is bounded below by 1-O\\big(\\frac{1}{\\sqrt{mn}}\\big) . In particular, the linking probability between two uniform random polygons, both of n vertices, is bounded below by 1-O\\big(\\frac{1}{n}\\big) .

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder.

Science.gov (United States)

Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

2008-09-15

Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. NCT00572520.

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

Science.gov (United States)

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

The spectral dimension of random trees

International Nuclear Information System (INIS)

Destri, Claudio; Donetti, Luca

2002-01-01

We present a simple yet rigorous approach to the determination of the spectral dimension of random trees, based on the study of the massless limit of the Gaussian model on such trees. As a by-product, we obtain evidence in favour of a new scaling hypothesis for the Gaussian model on generic bounded graphs and in favour of a previously conjectured exact relation between spectral and connectivity dimensions on more general tree-like structures

Garlic for hypertension: A systematic review and meta-analysis of randomized controlled trials.

Science.gov (United States)

Xiong, X J; Wang, P Q; Li, S J; Li, X K; Zhang, Y Q; Wang, J

2015-03-15

In the past decade, garlic has become one of the most popular complementary therapies for blood pressure (BP) control used by hypertensive patients. Numerous clinical studies have focused on the BP-lowering effect of garlic, but results have been inconsistent. Overall, there is a dearth of information available to guide the clinical community on the efficacy of garlic in hypertensive patients. To systematically review the medical literature to investigate the current evidence of garlic for the treatment of hypertension. PubMed, the Cochrane Library and EMBASE were searched for appropriate articles from their respective inceptions until August 2014. Randomized, placebo-controlled trials comparing garlic vs. a placebo in patients with hypertension were considered. Papers were independently reviewed by two reviewers and were analyzed using Cochrane software Revman 5.2. A total of seven randomized, placebo-controlled trials were identified. Compared with the placebo, this meta-analysis revealed a significant lowering effect of garlic on both systolic BP (WMD: -6.71 mmHg; 95% CI: -12.44 to -0.99; P = 0.02) and diastolic BP (WMD: -4.79 mmHg; 95% CI: -6.60 to -2.99; P garlic is an effective and safe approach for hypertension. However, more rigorously designed randomized controlled trials focusing on primary endpoints with long-term follow-up are still warranted before garlic can be recommended to treat hypertensive patients. Copyright © 2015 Elsevier GmbH. All rights reserved.

Rééducation Posturale Globale in musculoskeletal diseases: scientific evidence and clinical practice

Directory of Open Access Journals (Sweden)

D. Tosarelli

2011-09-01

Full Text Available Several studies on the treatment of musculoskeletal diseases with physiotherapy and clinical experiences on the basis of a method called Rééducation Posturale Globale (RPG, have highlighted the usefulness of this treatment. Although such treatment technique is commonly used in physical therapy practice, only few studies support its therapeutic effectiveness. Objective: To search the literature for evidence of RPG effectiveness, in order to identify the most appropriate therapeutic contexts for its use. Methods: A review of the literature through the following databases: PubMed, Embase, Cinahl, Pedro, and Medscape. The keywords used for the search in the databases are: Rééducation Posturale Globale, Souchard, Posture, and Manual Therapy. The following clinical studies were selected: randomized controlled studies, non-randomized controlled studies, observation studies, and case reports, in English, Spanish, Portuguese, and Italian. Results: Out of 18 studies found, 9 were analyzed: 2 randomized controlled studies, 2 non-randomized controlled studies, 3 non-controlled studies, and 2 case reports. Conclusions: The RPG method has been shown to be an effective treatment technique for musculoskeletal diseases, in particular for ankylosing spondylitis, acute and chronic low back pain, and lumbar discherniation. Although the scarcity of rigorous experimental trials on a large scale does not allow the drawing of undisputable conclusions, the results gathered up to now are an encouragement to carry on research in the field of conservative treatment.

Vitamin E in aging persons with Down syndrome: A randomized, placebo-controlled clinical trial.

Science.gov (United States)

Sano, Mary; Aisen, Paul S; Andrews, Howard F; Tsai, Wei-Yann; Lai, Florence; Dalton, Arthur J

2016-05-31

To determine whether vitamin E would slow the progression of cognitive deterioration and dementia in aging persons with Down syndrome (DS). A randomized, double-blind controlled clinical trial was conducted at 21 clinical sites, and researchers trained in research procedures recruited adults with DS older than 50 years to participate. Participants were randomly assigned to receive 1,000 IU of vitamin E orally twice daily for 3 years or identical placebo. The primary outcome was change on the Brief Praxis Test (BPT). Secondary outcomes included incident dementia and measures of clinical global change, cognition, function, and behavior. A total of 337 individuals were randomized, 168 to vitamin E and 169 to placebo. Both groups demonstrated deterioration on the BPT with no difference between drug and placebo. At baseline, 26% were diagnosed with dementia and there was an overall rate of incident dementia of 11%/year with no difference between groups. There was no effect on the secondary outcome measures. Though numerically higher in the treatment group, there was no difference in the number of adverse events (p = 0.079) and deaths (p = 0.086) between groups. Vitamin E did not slow the progression of cognitive deterioration in older individuals with DS. This study provides Class II evidence that vitamin E does not significantly slow the progression of cognitive deterioration in aging persons with DS. © 2016 American Academy of Neurology.

Multi-platform mass spectrometry analysis of the CSF and plasma metabolomes of rigorously matched amyotrophic lateral sclerosis, Parkinson's disease and control subjects.

Science.gov (United States)

Wuolikainen, Anna; Jonsson, Pär; Ahnlund, Maria; Antti, Henrik; Marklund, Stefan L; Moritz, Thomas; Forsgren, Lars; Andersen, Peter M; Trupp, Miles

2016-04-01

Amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD) are protein-aggregation diseases that lack clear molecular etiologies. Biomarkers could aid in diagnosis, prognosis, planning of care, drug target identification and stratification of patients into clinical trials. We sought to characterize shared and unique metabolite perturbations between ALS and PD and matched controls selected from patients with other diagnoses, including differential diagnoses to ALS or PD that visited our clinic for a lumbar puncture. Cerebrospinal fluid (CSF) and plasma from rigorously age-, sex- and sampling-date matched patients were analyzed on multiple platforms using gas chromatography (GC) and liquid chromatography (LC)-mass spectrometry (MS). We applied constrained randomization of run orders and orthogonal partial least squares projection to latent structure-effect projections (OPLS-EP) to capitalize upon the study design. The combined platforms identified 144 CSF and 196 plasma metabolites with diverse molecular properties. Creatine was found to be increased and creatinine decreased in CSF of ALS patients compared to matched controls. Glucose was increased in CSF of ALS patients and α-hydroxybutyrate was increased in CSF and plasma of ALS patients compared to matched controls. Leucine, isoleucine and ketoleucine were increased in CSF of both ALS and PD. Together, these studies, in conjunction with earlier studies, suggest alterations in energy utilization pathways and have identified and further validated perturbed metabolites to be used in panels of biomarkers for the diagnosis of ALS and PD.

Random Generators and Normal Numbers

OpenAIRE

Bailey, David H.; Crandall, Richard E.

2002-01-01

Pursuant to the authors' previous chaotic-dynamical model for random digits of fundamental constants, we investigate a complementary, statistical picture in which pseudorandom number generators (PRNGs) are central. Some rigorous results are achieved: We establish b-normality for constants of the form $\\sum_i 1/(b^{m_i} c^{n_i})$ for certain sequences $(m_i), (n_i)$ of integers. This work unifies and extends previously known classes of explicit normals. We prove that for coprime $b,c>1$ the...

Electrocardiogram artifact caused by rigors mimicking narrow complex tachycardia: a case report.

Science.gov (United States)

Matthias, Anne Thushara; Indrakumar, Jegarajah

2014-02-04

The electrocardiogram (ECG) is useful in the diagnosis of cardiac and non-cardiac conditions. Rigors due to shivering can cause electrocardiogram artifacts mimicking various cardiac rhythm abnormalities. We describe an 80-year-old Sri Lankan man with an abnormal electrocardiogram mimicking narrow complex tachycardia during the immediate post-operative period. Electrocardiogram changes caused by muscle tremor during rigors could mimic a narrow complex tachycardia. Identification of muscle tremor as a cause of electrocardiogram artifact can avoid unnecessary pharmacological and non-pharmacological intervention to prevent arrhythmias.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

Science.gov (United States)

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Effects of Pre and Post-Rigor Marinade Injection on Some Quality Parameters of Longissimus Dorsi Muscles

Science.gov (United States)

Fadıloğlu, Eylem Ezgi; Serdaroğlu, Meltem

2018-01-01

Abstract This study was conducted to evaluate the effects of pre and post-rigor marinade injections on some quality parameters of Longissimus dorsi (LD) muscles. Three marinade formulations were prepared with 2% NaCl, 2% NaCl+0.5 M lactic acid and 2% NaCl+0.5 M sodium lactate. In this study marinade uptake, pH, free water, cooking loss, drip loss and color properties were analyzed. Injection time had significant effect on marinade uptake levels of samples. Regardless of marinate formulation, marinade uptake of pre-rigor samples injected with marinade solutions were higher than post rigor samples. Injection of sodium lactate increased pH values of samples whereas lactic acid injection decreased pH. Marinade treatment and storage period had significant effect on cooking loss. At each evaluation period interaction between marinade treatment and injection time showed different effect on free water content. Storage period and marinade application had significant effect on drip loss values. Drip loss in all samples increased during the storage. During all storage days, lowest CIE L* value was found in pre-rigor samples injected with sodium lactate. Lactic acid injection caused color fade in pre-rigor and post-rigor samples. Interaction between marinade treatment and storage period was found statistically significant (p<0.05). At day 0 and 3, the lowest CIE b* values obtained pre-rigor samples injected with sodium lactate and there were no differences were found in other samples. At day 6, no significant differences were found in CIE b* values of all samples. PMID:29805282

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

Science.gov (United States)

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

2013-02-01

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

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Use of the Rigor Mortis Process as a Tool for Better Understanding of Skeletal Muscle Physiology: Effect of the Ante-Mortem Stress on the Progression of Rigor Mortis in Brook Charr (Salvelinus fontinalis).

Science.gov (United States)

Diouf, Boucar; Rioux, Pierre

1999-01-01

Presents the rigor mortis process in brook charr (Salvelinus fontinalis) as a tool for better understanding skeletal muscle metabolism. Describes an activity that demonstrates how rigor mortis is related to the post-mortem decrease of muscular glycogen and ATP, how glycogen degradation produces lactic acid that lowers muscle pH, and how…

Measurements of the degree of development of rigor mortis as an indicator of stress in slaughtered pigs.

Science.gov (United States)

Warriss, P D; Brown, S N; Knowles, T G

2003-12-13

The degree of development of rigor mortis in the carcases of slaughter pigs was assessed subjectively on a three-point scale 35 minutes after they were exsanguinated, and related to the levels of cortisol, lactate and creatine kinase in blood collected at exsanguination. Earlier rigor development was associated with higher concentrations of these stress indicators in the blood. This relationship suggests that the mean rigor score, and the frequency distribution of carcases that had or had not entered rigor, could be used as an index of the degree of stress to which the pigs had been subjected.

Einstein's Theory A Rigorous Introduction for the Mathematically Untrained

CERN Document Server

Grøn, Øyvind

2011-01-01

This book provides an introduction to the theory of relativity and the mathematics used in its processes. Three elements of the book make it stand apart from previously published books on the theory of relativity. First, the book starts at a lower mathematical level than standard books with tensor calculus of sufficient maturity to make it possible to give detailed calculations of relativistic predictions of practical experiments. Self-contained introductions are given, for example vector calculus, differential calculus and integrations. Second, in-between calculations have been included, making it possible for the non-technical reader to follow step-by-step calculations. Thirdly, the conceptual development is gradual and rigorous in order to provide the inexperienced reader with a philosophically satisfying understanding of the theory.  Einstein's Theory: A Rigorous Introduction for the Mathematically Untrained aims to provide the reader with a sound conceptual understanding of both the special and genera...

Sonoelasticity to monitor mechanical changes during rigor and ageing.

Science.gov (United States)

Ayadi, A; Culioli, J; Abouelkaram, S

2007-06-01

We propose the use of sonoelasticity as a non-destructive method to monitor changes in the resistance of muscle fibres, unaffected by connective tissue. Vibrations were applied at low frequency to induce oscillations in soft tissues and an ultrasound transducer was used to detect the motions. The experiments were carried out on the M. biceps femoris muscles of three beef cattle. In addition to the sonoelasticity measurements, the changes in meat during rigor and ageing were followed by measurements of both the mechanical resistance of myofibres and pH. The variations of mechanical resistance and pH were compared to those of the sonoelastic variables (velocity and attenuation) at two frequencies. The relationships between pH and velocity or attenuation and between the velocity or attenuation and the stress at 20% deformation were highly correlated. We concluded that sonoelasticity is a non-destructive method that can be used to monitor mechanical changes in muscle fibers during rigor-mortis and ageing.

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

Directory of Open Access Journals (Sweden)

Wong Samuel YS

2011-11-01

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

Lidocaine for systemic sclerosis: a double-blind randomized clinical trial

Directory of Open Access Journals (Sweden)

Trevisani Virgínia FM

2011-02-01

Full Text Available Abstract Background Systemic sclerosis (scleroderma; SSc is an orphan disease with the highest case-specific mortality of any connective-tissue disease. Excessive collagen deposit in affected tissues is a key for the disease's pathogenesis and comprises most of the clinical manifestations. Lidocaine seems to be an alternative treatment for scleroderma considering that: a the patient's having excessive collagen deposits in tissues affected by scleroderma; b the patient's demonstrating increased activity of the enzyme prolyl hydroxylase, an essential enzyme for the biosynthesis of collagen; and c lidocaine's reducing the activity of prolyl hydroxylase. The aim of this study was to evaluate the efficacy and safety of lidocaine in treating scleroderma. Methods A randomized double-blind clinical trial included 24 patients with scleroderma randomized to receive lidocaine or placebo intravenously in three cycles of ten days each, with a one-month interval between them. Outcomes: cutaneous (modified Rodnan skin score, oesophageal (manometry and microvascular improvement (nailfold capillaroscopy; improvement in subjective self-assessment and in quality of life (HAQ. Results There was no statistically significant difference between the groups for any outcome after the treatment and after 6-months follow-up. Improvement in modified Rodnan skin score occurred in 66.7% and 50% of placebo and lidocaine group, respectively (p = 0.408. Both groups showed an improvement in subjective self-assessment, with no difference between them. Conclusions Despite the findings of a previous cohort study favouring the use of lidocaine, this study demonstrated that lidocaine at this dosage and means of administration showed a lack of efficacy for treating scleroderma despite the absence of significant adverse effects. However, further similar clinical trials are needed to evaluate the efficacy of lidocaine when administered in different dosages and by other means.

OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

DEFF Research Database (Denmark)

Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.

2008-01-01

human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity......, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy. CONCLUSIONS: The OPPORTUNITY Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers...

A rigorous proof for the Landauer-Büttiker formula

DEFF Research Database (Denmark)

Cornean, Horia Decebal; Jensen, Arne; Moldoveanu, V.

Recently, Avron et al. shed new light on the question of quantum transport in mesoscopic samples coupled to particle reservoirs by semi-infinite leads. They rigorously treat the case when the sample undergoes an adiabatic evolution thus generating a current through th leads, and prove the so call...

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

Directory of Open Access Journals (Sweden)

Crawford Sybil

2008-09-01

Full Text Available Abstract Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174 will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520

Inference of median difference based on the Box-Cox model in randomized clinical trials.

Science.gov (United States)

Maruo, K; Isogawa, N; Gosho, M

2015-05-10

In randomized clinical trials, many medical and biological measurements are not normally distributed and are often skewed. The Box-Cox transformation is a powerful procedure for comparing two treatment groups for skewed continuous variables in terms of a statistical test. However, it is difficult to directly estimate and interpret the location difference between the two groups on the original scale of the measurement. We propose a helpful method that infers the difference of the treatment effect on the original scale in a more easily interpretable form. We also provide statistical analysis packages that consistently include an estimate of the treatment effect, covariance adjustments, standard errors, and statistical hypothesis tests. The simulation study that focuses on randomized parallel group clinical trials with two treatment groups indicates that the performance of the proposed method is equivalent to or better than that of the existing non-parametric approaches in terms of the type-I error rate and power. We illustrate our method with cluster of differentiation 4 data in an acquired immune deficiency syndrome clinical trial. Copyright © 2015 John Wiley & Sons, Ltd.

A randomized, controlled, split-face clinical trial of 1320-nm Nd:YAG laser therapy in the treatment of acne vulgaris.

Science.gov (United States)

Orringer, Jeffrey S; Kang, Sewon; Maier, Lisa; Johnson, Timothy M; Sachs, Dana L; Karimipour, Darius J; Helfrich, Yolanda R; Hamilton, Ted; Voorhees, John J

2007-03-01

There is a need for additional effective treatments for acne vulgaris. Laser therapy has been explored as a therapeutic option for acne, but rigorously designed studies in this area have been limited. We sought to examine the efficacy of an infrared laser in the treatment of acne. We conducted a randomized, controlled, single-blind, split-face clinical trial of 46 patients with facial acne. Patients received a series of 3 nonablative laser treatments using a novel neodymium:yttrium-aluminum-garnet (Nd:YAG) laser to half of the face. Serial blinded lesion counts and global acne severity rating of standardized bilateral patient photographs were performed. Sebum production was measured, and patient self-assessment surveys were administered. A transient but statistically significant improvement in lesion counts of open comedones was demonstrated in treated skin as compared with untreated skin. There were no significant differences between treated and control sides of the face in terms of changes in mean papule or pustule counts. Grading of serial photographs revealed no significant differences between treated and untreated skin. Patient surveys indicated that the majority of patients found the treatments to be at least mildly effective for both acne and oiliness. The current study only addresses the efficacy of a single laser system employing a specific treatment regimen. Infrared laser therapy may improve comedonal acne. Additional work is needed to better define the degree and duration of the effect. Patients appear to positively view such therapy for both acne and oily skin.

Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

NARCIS (Netherlands)

Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

2004-01-01

OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

Ultrafast quantum random number generation based on quantum phase fluctuations.

Science.gov (United States)

Xu, Feihu; Qi, Bing; Ma, Xiongfeng; Xu, He; Zheng, Haoxuan; Lo, Hoi-Kwong

2012-05-21

A quantum random number generator (QRNG) can generate true randomness by exploiting the fundamental indeterminism of quantum mechanics. Most approaches to QRNG employ single-photon detection technologies and are limited in speed. Here, we experimentally demonstrate an ultrafast QRNG at a rate over 6 Gbits/s based on the quantum phase fluctuations of a laser operating near threshold. Moreover, we consider a potential adversary who has partial knowledge on the raw data and discuss how one can rigorously remove such partial knowledge with postprocessing. We quantify the quantum randomness through min-entropy by modeling our system and employ two randomness extractors--Trevisan's extractor and Toeplitz-hashing--to distill the randomness, which is information-theoretically provable. The simplicity and high-speed of our experimental setup show the feasibility of a robust, low-cost, high-speed QRNG.

Characterization of rigor mortis of longissimus dorsi and triceps ...

African Journals Online (AJOL)

24 h) of the longissimus dorsi (LD) and triceps brachii (TB) muscles as well as the shear force (meat tenderness) and colour were evaluated, aiming at characterizing the rigor mortis in the meat during industrial processing. Data statistic treatment demonstrated that carcass temperature and pH decreased gradually during ...

A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia.

Science.gov (United States)

Gomar, Jesús J; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J; Ovejero, María R; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J

2015-11-01

The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Software metrics a rigorous and practical approach

CERN Document Server

Fenton, Norman

2014-01-01

A Framework for Managing, Measuring, and Predicting Attributes of Software Development Products and ProcessesReflecting the immense progress in the development and use of software metrics in the past decades, Software Metrics: A Rigorous and Practical Approach, Third Edition provides an up-to-date, accessible, and comprehensive introduction to software metrics. Like its popular predecessors, this third edition discusses important issues, explains essential concepts, and offers new approaches for tackling long-standing problems.New to the Third EditionThis edition contains new material relevant

Setting up a randomized clinical trial in the UK: approvals and process.

Science.gov (United States)

Greene, Louise Eleanor; Bearn, David R

2013-06-01

Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.

[A new formula for the measurement of rigor mortis: the determination of the FRR-index (author's transl)].

Science.gov (United States)

Forster, B; Ropohl, D; Raule, P

1977-07-05

The manual examination of rigor mortis as currently used and its often subjective evaluation frequently produced highly incorrect deductions. It is therefore desirable that such inaccuracies should be replaced by the objective measuring of rigor mortis at the extremities. To that purpose a method is described which can also be applied in on-the-spot investigations and a new formula for the determination of rigor mortis--indices (FRR) is introduced.

Stochastic Geometry and Quantum Gravity: Some Rigorous Results

Science.gov (United States)

Zessin, H.

The aim of these lectures is a short introduction into some recent developments in stochastic geometry which have one of its origins in simplicial gravity theory (see Regge Nuovo Cimento 19: 558-571, 1961). The aim is to define and construct rigorously point processes on spaces of Euclidean simplices in such a way that the configurations of these simplices are simplicial complexes. The main interest then is concentrated on their curvature properties. We illustrate certain basic ideas from a mathematical point of view. An excellent representation of this area can be found in Schneider and Weil (Stochastic and Integral Geometry, Springer, Berlin, 2008. German edition: Stochastische Geometrie, Teubner, 2000). In Ambjørn et al. (Quantum Geometry Cambridge University Press, Cambridge, 1997) you find a beautiful account from the physical point of view. More recent developments in this direction can be found in Ambjørn et al. ("Quantum gravity as sum over spacetimes", Lect. Notes Phys. 807. Springer, Heidelberg, 2010). After an informal axiomatic introduction into the conceptual foundations of Regge's approach the first lecture recalls the concepts and notations used. It presents the fundamental zero-infinity law of stochastic geometry and the construction of cluster processes based on it. The second lecture presents the main mathematical object, i.e. Poisson-Delaunay surfaces possessing an intrinsic random metric structure. The third and fourth lectures discuss their ergodic behaviour and present the two-dimensional Regge model of pure simplicial quantum gravity. We terminate with the formulation of basic open problems. Proofs are given in detail only in a few cases. In general the main ideas are developed. Sufficiently complete references are given.

Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

Science.gov (United States)

Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

2017-12-01

Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

Reconciling the Rigor-Relevance Dilemma in Intellectual Capital Research

Science.gov (United States)

Andriessen, Daniel

2004-01-01

This paper raises the issue of research methodology for intellectual capital and other types of management research by focusing on the dilemma of rigour versus relevance. The more traditional explanatory approach to research often leads to rigorous results that are not of much help to solve practical problems. This paper describes an alternative…

Stakeholder-Driven Quality Improvement: A Compelling Force for Clinical Practice Guidelines.

Science.gov (United States)

Rosenfeld, Richard M; Wyer, Peter C

2018-01-01

Clinical practice guideline development should be driven by rigorous methodology, but what is less clear is where quality improvement enters the process: should it be a priority-guiding force, or should it enter only after recommendations are formulated? We argue for a stakeholder-driven approach to guideline development, with an overriding goal of quality improvement based on stakeholder perceptions of needs, uncertainties, and knowledge gaps. In contrast, the widely used topic-driven approach, which often makes recommendations based only on randomized controlled trials, is driven by epidemiologic purity and evidence rigor, with quality improvement a downstream consideration. The advantages of a stakeholder-driven versus a topic-driven approach are highlighted by comparisons of guidelines for otitis media with effusion, thyroid nodules, sepsis, and acute bacterial rhinosinusitis. These comparisons show that stakeholder-driven guidelines are more likely to address the quality improvement needs and pressing concerns of clinicians and patients, including understudied populations and patients with multiple chronic conditions. Conversely, a topic-driven approach often addresses "typical" patients, based on research that may not reflect the needs of high-risk groups excluded from studies because of ethical issues or a desire for purity of research design.

Efficacy of auriculotherapy for constipation in adults: a systematic review and meta-analysis of randomized controlled trials.

Science.gov (United States)

Yang, Li-Hua; Duan, Pei-Bei; Du, Shi-Zheng; Sun, Jin-Fang; Mei, Si-Juan; Wang, Xiao-Qing; Zhang, Yuan-Yuan

2014-08-01

To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52- 2.79; pcultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial

Directory of Open Access Journals (Sweden)

Catley Delwyn

2012-06-01

Full Text Available Abstract Background Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. Methods/Design A sample of adult community resident smokers (N = 255 who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and

Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill.

Science.gov (United States)

Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

2017-01-01

Physicians encounter various symptom-based complaints each day. While physicians strive to support patients with chronic illnesses, evidence indicates that patients who are actively involved in their health care have better health outcomes and sometimes lowers costs. This article is to analyze how patient engagement is described when complex interventions such as Tai Chi were delivered in Randomized Controlled clinical Trials (RCTs). It reviews the dynamic patient- physician relationship in chronic illness management and to illustrate the patient engagement process, using Tai Chi as an example intervention. RCTs are considered the gold standard in clinical research. This study is a qualitative analysis of RCTs using Tai Chi as an intervention. A systematic literature search was performed to identify quality randomized controlled clinical trials that investigated the effects of Tai Chi. Selected clinical trials were classified according to research design, intervention style, patient engagement, and outcomes. Patient engagement was classified based on levels of patient participation, compliance, and selfmanagement. The chronic health conditions included in this paper are Parkinson's disease, polyneuropathy, hypertension, stroke, chronic insomnia, chronic heart failure, fibromyalgia, osteoarthritis, central obesity, depression, deconditioning in the elderly, or being pre-clinically disabled. We found that patient engagement, as a concept, was not well defined in literature. It covers a wide range of related terms, such as patient involvement, participation, shared decision- making, patient activation, adherence, compliance, and self-management. Tai Chi, as a very complex practice system, is to balance all aspects of a patient's life; however, the level of patient engagement is difficult to describe using conventional clinical trial design. To accurately illustrate the effect of a complex intervention, novel research design must explore ways to measure patient

Weak limits for quantum random walks

International Nuclear Information System (INIS)

Grimmett, Geoffrey; Janson, Svante; Scudo, Petra F.

2004-01-01

We formulate and prove a general weak limit theorem for quantum random walks in one and more dimensions. With X n denoting position at time n, we show that X n /n converges weakly as n→∞ to a certain distribution which is absolutely continuous and of bounded support. The proof is rigorous and makes use of Fourier transform methods. This approach simplifies and extends certain preceding derivations valid in one dimension that make use of combinatorial and path integral methods

Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

Science.gov (United States)

Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

2017-09-01

There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

Science.gov (United States)

Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

2013-01-01

The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

Zhen gan xi feng decoction, a traditional chinese herbal formula, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

Science.gov (United States)

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use.

Stock Versus CAD/CAM Customized Zirconia Implant Abutments – Clinical and Patient‐Based Outcomes in a Randomized Controlled Clinical Trial

Science.gov (United States)

Meijer, Henny J.A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco

2016-01-01

Abstract Background Single‐tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. Purpose This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient‐based outcome measures. Material and Methods Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri‐implant bone level (primary outcome), Plaque‐index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. Results No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. Conclusion The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. PMID:27476829

Quality properties of pre- and post-rigor beef muscle after interventions with high frequency ultrasound.

Science.gov (United States)

Sikes, Anita L; Mawson, Raymond; Stark, Janet; Warner, Robyn

2014-11-01

The delivery of a consistent quality product to the consumer is vitally important for the food industry. The aim of this study was to investigate the potential for using high frequency ultrasound applied to pre- and post-rigor beef muscle on the metabolism and subsequent quality. High frequency ultrasound (600kHz at 48kPa and 65kPa acoustic pressure) applied to post-rigor beef striploin steaks resulted in no significant effect on the texture (peak force value) of cooked steaks as measured by a Tenderometer. There was no added benefit of ultrasound treatment above that of the normal ageing process after ageing of the steaks for 7days at 4°C. Ultrasound treatment of post-rigor beef steaks resulted in a darkening of fresh steaks but after ageing for 7days at 4°C, the ultrasound-treated steaks were similar in colour to that of the aged, untreated steaks. High frequency ultrasound (2MHz at 48kPa acoustic pressure) applied to pre-rigor beef neck muscle had no effect on the pH, but the calculated exhaustion factor suggested that there was some effect on metabolism and actin-myosin interaction. However, the resultant texture of cooked, ultrasound-treated muscle was lower in tenderness compared to the control sample. After ageing for 3weeks at 0°C, the ultrasound-treated samples had the same peak force value as the control. High frequency ultrasound had no significant effect on the colour parameters of pre-rigor beef neck muscle. This proof-of-concept study showed no effect of ultrasound on quality but did indicate that the application of high frequency ultrasound to pre-rigor beef muscle shows potential for modifying ATP turnover and further investigation is warranted. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

Rigorous derivation from Landau-de Gennes theory to Ericksen-Leslie theory

OpenAIRE

Wang, Wei; Zhang, Pingwen; Zhang, Zhifei

2013-01-01

Starting from Beris-Edwards system for the liquid crystal, we present a rigorous derivation of Ericksen-Leslie system with general Ericksen stress and Leslie stress by using the Hilbert expansion method.

The Researchers' View of Scientific Rigor-Survey on the Conduct and Reporting of In Vivo Research.

Science.gov (United States)

Reichlin, Thomas S; Vogt, Lucile; Würbel, Hanno

2016-01-01

Reproducibility in animal research is alarmingly low, and a lack of scientific rigor has been proposed as a major cause. Systematic reviews found low reporting rates of measures against risks of bias (e.g., randomization, blinding), and a correlation between low reporting rates and overstated treatment effects. Reporting rates of measures against bias are thus used as a proxy measure for scientific rigor, and reporting guidelines (e.g., ARRIVE) have become a major weapon in the fight against risks of bias in animal research. Surprisingly, animal scientists have never been asked about their use of measures against risks of bias and how they report these in publications. Whether poor reporting reflects poor use of such measures, and whether reporting guidelines may effectively reduce risks of bias has therefore remained elusive. To address these questions, we asked in vivo researchers about their use and reporting of measures against risks of bias and examined how self-reports relate to reporting rates obtained through systematic reviews. An online survey was sent out to all registered in vivo researchers in Switzerland (N = 1891) and was complemented by personal interviews with five representative in vivo researchers to facilitate interpretation of the survey results. Return rate was 28% (N = 530), of which 302 participants (16%) returned fully completed questionnaires that were used for further analysis. According to the researchers' self-report, they use measures against risks of bias to a much greater extent than suggested by reporting rates obtained through systematic reviews. However, the researchers' self-reports are likely biased to some extent. Thus, although they claimed to be reporting measures against risks of bias at much lower rates than they claimed to be using these measures, the self-reported reporting rates were considerably higher than reporting rates found by systematic reviews. Furthermore, participants performed rather poorly when asked to

Concomitant Anticonvulsants With Bitemporal Electroconvulsive Therapy: A Randomized Controlled Trial With Clinical and Neurobiological Application.

Science.gov (United States)

Rakesh, Gopalkumar; Thirthalli, Jagadisha; Kumar, Channaveerachari Naveen; Muralidharan, Kesavan; Phutane, Vivek H; Gangadhar, Bangalore N

2017-03-01

Electroconvulsive therapy (ECT) is an effective treatment for major affective disorders. The combined use of ECT and anticonvulsant mood stabilizers is a common clinical scenario. There is dearth of systematic studies on the use of this combination with regard to clinical or cognitive outcomes. We aimed to compare clinical improvement and cognitive adverse effects between patients who received only ECT versus those who received ECT and anticonvulsants. We hypothesized that improvement would be fastest in patients who received only ECT. We conducted a randomized controlled trial in which patients prescribed ECT while being treated with anticonvulsants were randomized into 3 groups: full-dose (FD), half-dose (HD), and stop anticonvulsant. A blind rater assessed clinical improvement in patients using rating scales [Young's Mania Rating Scale (YMRS) and Clinical Global Impression] for clinical improvement and cognitive adverse effects (Postgraduate Institute memory scale). Analysis was done using mixed-effects modeling to delineate differences in clinical and cognitive outcomes across the 3 arms of the study over the course of ECT. Of the 54 patients recruited, 36 patients went into treatment allocation arms per the initial randomization plan. The main anticonvulsants prescribed were sodium valproate and carbamazepine. Patients in the 3 groups were comparable on clinical features. The most common diagnosis was bipolar affective disorder-with current episode of mania. Overall, there was no difference across the 3 groups in final clinical outcome scores (YMRS and Clinical Global Impression) when analyzed as intention to treat (ITT) or "as treated." In both analyses, group × time interaction was significant when comparing trend of YMRS scores between the FD anticonvulsant group and the HD group from baseline to last ECT (P = 0.0435 in ITT and P = 0.0055 in as treated). Patients in the FD group improved faster than those in the HD group. There were no differences across

Randomized Clinical Trial of Intraosseous Methylprednisolone Injection for Acute Pulpitis Pain.

Science.gov (United States)

Bane, Khaly; Charpentier, Emmanuel; Bronnec, François; Descroix, Vianney; Gaye-N'diaye, Fatou; Kane, Abdoul Wahabe; Toledo, Rafael; Machtou, Pierre; Azérad, Jean

2016-01-01

The present study reports the results of a randomized clinical trial comparing local intraosseous methylprednisolone injection and emergency pulpotomy in the management of acute pulpitis on efficacy, safety, and efficiency end points. After providing prior informed written consent, 94 patients consulting for acute irreversible pulpitis pain at university-affiliated teaching hospital dental clinics in Dakar, Senegal were randomly assigned to either the methylprednisolone treatment group (n = 47) or the pulpotomy treatment group (n = 47). Patients were followed up at 1 week and assessed 6 months later to evaluate the therapeutic outcome of their treatment. At day 7 the patients in the methylprednisolone group reported less intense spontaneous and percussion pain in the day 0-day 7 period than the patients in the pulpotomy group. Methylprednisolone treatment took approximately 7 minutes (4.6-9.3) less to accomplish than pulpotomy (or about half the time). No difference in the therapeutic outcome was found between the 2 treatment groups at 6 months (all credible intervals span 0). This study establishes that methylprednisolone injection for acute pulpitis is relieved by a minimally invasive pharmacologic approach more effectively than by the reference pulpotomy and conserves scarce dental resources (ie, endodontic equipment and supplies, dental surgeon's time). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Striation Patterns of Ox Muscle in Rigor Mortis

Science.gov (United States)

Locker, Ronald H.

1959-01-01

Ox muscle in rigor mortis offers a selection of myofibrils fixed at varying degrees of contraction from sarcomere lengths of 3.7 to 0.7 µ. A study of this material by phase contrast and electron microscopy has revealed four distinct successive patterns of contraction, including besides the familiar relaxed and contracture patterns, two intermediate types (2.4 to 1.9 µ, 1.8 to 1.5 µ) not previously well described. PMID:14417790

Philosophers assess randomized clinical trials: the need for dialogue.

Science.gov (United States)

Miké, V

1989-09-01

In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.

Assessing quality of reports on randomized clinical trials in nursing journals.

Science.gov (United States)

Parent, Nicole; Hanley, James A

2009-01-01

Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

Science.gov (United States)

McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

2008-01-01

Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

Science.gov (United States)

Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

2017-04-01

Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p < 0.05) in clinical results regarding the number (two or four) of mini dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference in

Mathematical framework for fast and rigorous track fit for the ZEUS detector

Energy Technology Data Exchange (ETDEWEB)

Spiridonov, Alexander

2008-12-15

In this note we present a mathematical framework for a rigorous approach to a common track fit for trackers located in the inner region of the ZEUS detector. The approach makes use of the Kalman filter and offers a rigorous treatment of magnetic field inhomogeneity, multiple scattering and energy loss. We describe mathematical details of the implementation of the Kalman filter technique with a reduced amount of computations for a cylindrical drift chamber, barrel and forward silicon strip detectors and a forward straw drift chamber. Options with homogeneous and inhomogeneous field are discussed. The fitting of tracks in one ZEUS event takes about of 20ms on standard PC. (orig.)

The role of radiation therapy in pediatric oncology as assessed by cooperative clinical trials

International Nuclear Information System (INIS)

D'Angio, G.J.

1985-01-01

Major advances have been made in pediatric oncology, and many are due to the advent of the cooperative clinical trial. This important research tool was originally developed for the testing of various therapeutic strategies for the management of children with acute leukemia. Such trials were eminently successful, as the consistently better long-term survival rates for children with this hitherto uniformly lethal disease can attest. The method soon found favor for the investigation of patients with so-called solid tumors. These trails were originally concerned with the elucidation of the value of various chemotherapeutic agents. Radiation therapists soon became involved, however, and this discipline became more heavily represented in study design and data analyses. Much radiation therapy information has been gained, some through prospective, randomized clinical investigations and some through retrospective reviews of roentgen therapy as it was employed in protocols accenting other aspects of care. Voluminous, important radiation therapy data have been deduced through the latter retrospective kinds of analyses, but this review will be confined largely to the published results of prospective, randomized cooperative clinical trials where radiation therapy was a governing variable. Certain investigations of historical interest will also be cited together with other results that established important principles even though not so rigorous in design

Learning from Science and Sport - How we, Safety, "Engage with Rigor"

Science.gov (United States)

Herd, A.

2012-01-01

As the world of spaceflight safety is relatively small and potentially inward-looking, we need to be aware of the "outside world". We should then try to remind ourselves to be open to the possibility that data, knowledge or experience from outside of the spaceflight community may provide some constructive alternate perspectives. This paper will assess aspects from two seemingly tangential fields, science and sport, and align these with the world of safety. In doing so some useful insights will be given to the challenges we face and may provide solutions relevant in our everyday (of safety engineering). Sport, particularly a contact sport such as rugby union, requires direct interaction between members of two (opposing) teams. Professional, accurately timed and positioned interaction for a desired outcome. These interactions, whilst an essential part of the game, are however not without their constraints. The rugby scrum has constraints as to the formation and engagement of the two teams. The controlled engagement provides for an interaction between the two teams in a safe manner. The constraints arising from the reality that an incorrect engagement could cause serious injury to members of either team. In academia, scientific rigor is applied to assure that the arguments provided and the conclusions drawn in academic papers presented for publication are valid, legitimate and credible. The scientific goal of the need for rigor may be expressed in the example of achieving a statistically relevant sample size, n, in order to assure analysis validity of the data pool. A failure to apply rigor could then place the entire study at risk of failing to have the respective paper published. This paper will consider the merits of these two different aspects, scientific rigor and sports engagement, and offer a reflective look at how this may provide a "modus operandi" for safety engineers at any level whether at their desks (creating or reviewing safety assessments) or in a

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all.

Science.gov (United States)

Papageorgiou, Spyridon N; Antonoglou, Georgios N; Sándor, George K; Eliades, Theodore

2017-01-01

A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

Differential rigor development in red and white muscle revealed by simultaneous measurement of tension and stiffness.

Science.gov (United States)

Kobayashi, Masahiko; Takemori, Shigeru; Yamaguchi, Maki

2004-02-10

Based on the molecular mechanism of rigor mortis, we have proposed that stiffness (elastic modulus evaluated with tension response against minute length perturbations) can be a suitable index of post-mortem rigidity in skeletal muscle. To trace the developmental process of rigor mortis, we measured stiffness and tension in both red and white rat skeletal muscle kept in liquid paraffin at 37 and 25 degrees C. White muscle (in which type IIB fibres predominate) developed stiffness and tension significantly more slowly than red muscle, except for soleus red muscle at 25 degrees C, which showed disproportionately slow rigor development. In each of the examined muscles, stiffness and tension developed more slowly at 25 degrees C than at 37 degrees C. In each specimen, tension always reached its maximum level earlier than stiffness, and then decreased more rapidly and markedly than stiffness. These phenomena may account for the sequential progress of rigor mortis in human cadavers.

Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial

OpenAIRE

Gerami, Hooshang; Saberi, Alia; Nemati, Shadman; Kazemnejad, Ehsan; Aghajanpour, Mohammad

2012-01-01

Background: It is still a challenge to find an effective treatment for tinnitus. The aim of this study was the evaluation of carbamazepine and oxcarbazepine effects on tinnitus.Methods: In a randomized double–blind clinical trial, 57 patients who were visited in a university hospital due to chronic non-pulsatile tinnitus, were randomized in three groups and treated with carbamazepine (300-600 mg/day), oxcarbazepine (450-900 mg/day) and placebo for 12 weeks. Visual analogue scale (VAS) and tin...

Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

Directory of Open Access Journals (Sweden)

Chuan Zhang

Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

Evaluation of physical dimension changes as nondestructive measurements for monitoring rigor mortis development in broiler muscles.

Science.gov (United States)

Cavitt, L C; Sams, A R

2003-07-01

Studies were conducted to develop a non-destructive method for monitoring the rate of rigor mortis development in poultry and to evaluate the effectiveness of electrical stimulation (ES). In the first study, 36 male broilers in each of two trials were processed at 7 wk of age. After being bled, half of the birds received electrical stimulation (400 to 450 V, 400 to 450 mA, for seven pulses of 2 s on and 1 s off), and the other half were designated as controls. At 0.25 and 1.5 h postmortem (PM), carcasses were evaluated for the angles of the shoulder, elbow, and wing tip and the distance between the elbows. Breast fillets were harvested at 1.5 h PM (after chilling) from all carcasses. Fillet samples were excised and frozen for later measurement of pH and R-value, and the remainder of each fillet was held on ice until 24 h postmortem. Shear value and pH means were significantly lower, but R-value means were higher (P rigor mortis by ES. The physical dimensions of the shoulder and elbow changed (P rigor mortis development and with ES. These results indicate that physical measurements of the wings maybe useful as a nondestructive indicator of rigor development and for monitoring the effectiveness of ES. In the second study, 60 male broilers in each of two trials were processed at 7 wk of age. At 0.25, 1.5, 3.0, and 6.0 h PM, carcasses were evaluated for the distance between the elbows. At each time point, breast fillets were harvested from each carcass. Fillet samples were excised and frozen for later measurement of pH and sacromere length, whereas the remainder of each fillet was held on ice until 24 h PM. Shear value and pH means (P rigor mortis development. Elbow distance decreased (P rigor development and was correlated (P rigor mortis development in broiler carcasses.

A Framework for Rigorously Identifying Research Gaps in Qualitative Literature Reviews

DEFF Research Database (Denmark)

Müller-Bloch, Christoph; Kranz, Johann

2015-01-01

Identifying research gaps is a fundamental goal of literature reviewing. While it is widely acknowledged that literature reviews should identify research gaps, there are no methodological guidelines for how to identify research gaps in qualitative literature reviews ensuring rigor and replicability....... Our study addresses this gap and proposes a framework that should help scholars in this endeavor without stifling creativity. To develop the framework we thoroughly analyze the state-of-the-art procedure of identifying research gaps in 40 recent literature reviews using a grounded theory approach....... Based on the data, we subsequently derive a framework for identifying research gaps in qualitative literature reviews and demonstrate its application with an example. Our results provide a modus operandi for identifying research gaps, thus enabling scholars to conduct literature reviews more rigorously...

Generalizing Evidence From Randomized Clinical Trials to Target Populations

Science.gov (United States)

Cole, Stephen R.; Stuart, Elizabeth A.

2010-01-01

Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

[Adequate application of quantitative and qualitative statistic analytic methods in acupuncture clinical trials].

Science.gov (United States)

Tan, Ming T; Liu, Jian-ping; Lao, Lixing

2012-08-01

Recently, proper use of the statistical methods in traditional Chinese medicine (TCM) randomized controlled trials (RCTs) has received increased attention. Statistical inference based on hypothesis testing is the foundation of clinical trials and evidence-based medicine. In this article, the authors described the methodological differences between literature published in Chinese and Western journals in the design and analysis of acupuncture RCTs and the application of basic statistical principles. In China, qualitative analysis method has been widely used in acupuncture and TCM clinical trials, while the between-group quantitative analysis methods on clinical symptom scores are commonly used in the West. The evidence for and against these analytical differences were discussed based on the data of RCTs assessing acupuncture for pain relief. The authors concluded that although both methods have their unique advantages, quantitative analysis should be used as the primary analysis while qualitative analysis can be a secondary criterion for analysis. The purpose of this paper is to inspire further discussion of such special issues in clinical research design and thus contribute to the increased scientific rigor of TCM research.

Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

Science.gov (United States)

Andersson, M; Kolodziej, B; Andersson, R E

2017-10-01

The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

A rigorous test for a new conceptual model for collisions

International Nuclear Information System (INIS)

Peixoto, E.M.A.; Mu-Tao, L.

1979-01-01

A rigorous theoretical foundation for the previously proposed model is formulated and applied to electron scattering by H 2 in the gas phase. An rigorous treatment of the interaction potential between the incident electron and the Hydrogen molecule is carried out to calculate Differential Cross Sections for 1 KeV electrons, using Glauber's approximation Wang's molecular wave function for the ground electronic state of H 2 . Moreover, it is shown for the first time that, when adequately done, the omission of two center terms does not adversely influence the results of molecular calculations. It is shown that the new model is far superior to the Independent Atom Model (or Independent Particle Model). The accuracy and simplicity of the new model suggest that it may be fruitfully applied to the description of other collision phenomena (e.g., in molecular beam experiments and nuclear physics). A new techniques is presented for calculations involving two center integrals within the frame work of the Glauber's approximation for scattering. (Author) [pt

Rigorous Analysis of a Randomised Number Field Sieve

OpenAIRE

Lee, Jonathan; Venkatesan, Ramarathnam

2018-01-01

Factorisation of integers $n$ is of number theoretic and cryptographic significance. The Number Field Sieve (NFS) introduced circa 1990, is still the state of the art algorithm, but no rigorous proof that it halts or generates relationships is known. We propose and analyse an explicitly randomised variant. For each $n$, we show that these randomised variants of the NFS and Coppersmith's multiple polynomial sieve find congruences of squares in expected times matching the best-known heuristic e...

A rigorous pole representation of multilevel cross sections and its practical applications

International Nuclear Information System (INIS)

Hwang, R.N.

1987-01-01

In this article a rigorous method for representing the multilevel cross sections and its practical applications are described. It is a generalization of the rationale suggested by de Saussure and Perez for the s-wave resonances. A computer code WHOPPER has been developed to convert the Reich-Moore parameters into the pole and residue parameters in momentum space. Sample calculations have been carried out to illustrate that the proposed method preserves the rigor of the Reich-Moore cross sections exactly. An analytical method has been developed to evaluate the pertinent Doppler-broadened line shape functions. A discussion is presented on how to minimize the number of pole parameters so that the existing reactor codes can be best utilized

Prospective randomized clinical studies involving reirradiation. Lessons learned

Energy Technology Data Exchange (ETDEWEB)

Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

2016-10-15

Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

Greedy Local Search and Vertex Cover in Sparse Random Graphs

DEFF Research Database (Denmark)

Witt, Carsten

2009-01-01

. This work starts with a rigorous explanation for this claim based on the refined analysis of the Karp-Sipser algorithm by Aronson et al. Subsequently, theoretical supplements are given to experimental studies of search heuristics on random graphs. For c 1, a greedy and randomized local-search heuristic...... finds an optimal cover in polynomial time with a probability arbitrarily close to 1. This behavior relies on the absence of a giant component. As an additional insight into the randomized search, it is shown that the heuristic fails badly also on graphs consisting of a single tree component of maximum......Recently, various randomized search heuristics have been studied for the solution of the minimum vertex cover problem, in particular for sparse random instances according to the G(n, c/n) model, where c > 0 is a constant. Methods from statistical physics suggest that the problem is easy if c

Effect of pre-rigor stretch and various constant temperatures on the rate of post-mortem pH fall, rigor mortis and some quality traits of excised porcine biceps femoris muscle strips.

Science.gov (United States)

Vada-Kovács, M

1996-01-01

Porcine biceps femoris strips of 10 cm original length were stretched by 50% and fixed within 1 hr post mortem then subjected to temperatures of 4 °, 15 ° or 36 °C until they attained their ultimate pH. Unrestrained control muscle strips, which were left to shorten freely, were similarly treated. Post-mortem metabolism (pH, R-value) and shortening were recorded; thereafter ultimate meat quality traits (pH, lightness, extraction and swelling of myofibrils) were determined. The rate of pH fall at 36 °C, as well as ATP breakdown at 36 and 4 °C, were significantly reduced by pre-rigor stretch. The relationship between R-value and pH indicated cold shortening at 4 °C. Myofibrils isolated from pre-rigor stretched muscle strips kept at 36 °C showed the most severe reduction of hydration capacity, while paleness remained below extreme values. However, pre-rigor stretched myofibrils - when stored at 4 °C - proved to be superior to shortened ones in their extractability and swelling.

Experimental evaluation of rigor mortis IX. The influence of the breaking (mechanical solution) on the development of rigor mortis.

Science.gov (United States)

Krompecher, Thomas; Gilles, André; Brandt-Casadevall, Conception; Mangin, Patrice

2008-04-07

Objective measurements were carried out to study the possible re-establishment of rigor mortis on rats after "breaking" (mechanical solution). Our experiments showed that: *Cadaveric rigidity can re-establish after breaking. *A significant rigidity can reappear if the breaking occurs before the process is complete. *Rigidity will be considerably weaker after the breaking. *The time course of the intensity does not change in comparison to the controls: --the re-establishment begins immediately after the breaking; --maximal values are reached at the same time as in the controls; --the course of the resolution is the same as in the controls.

Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).

Science.gov (United States)

Ferris, Maria; Norwood, Victoria; Radeva, Milena; Gassman, Jennifer J; Al-Uzri, Amira; Askenazi, David; Matoo, Tej; Pinsk, Maury; Sharma, Amita; Smoyer, William; Stults, Jenna; Vyas, Shefali; Weiss, Robert; Gipson, Debbie; Kaskel, Frederick; Friedman, Aaron; Moxey-Mims, Marva; Trachtman, Howard

2013-02-01

We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. © 2013 Wiley Periodicals, Inc.

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

Science.gov (United States)

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

Effects of music therapy on intravitreal injections: a randomized clinical trial.

Science.gov (United States)

Chen, Xuejing; Seth, Rajeev K; Rao, Veena S; Huang, John J; Adelman, Ron A

2012-08-01

To investigate the effects of music therapy on anxiety, perceived pain, and satisfaction in patients undergoing intravitreal injections in the outpatient setting. This is a randomized clinical trial. Seventy-three patients were recruited from the retina clinic at 1 institution and randomized into a music therapy (n=37) or control (n=36) group. Prior to injection, patients completed the state portion of the Spielberger State Trait Anxiety Inventory (STAI-S). The music therapy group listened to classical music through computer speakers while waiting for and during the injection. The control group underwent the injection in the same setting without music. Afterward, all patients completed another STAI-S and a satisfaction and pain questionnaire. The main outcome measures were objective anxiety derived from STAI-S scores and subjective pain and anxiety from the post procedure questionnaire. The music therapy group had a greater decrease in anxiety than the control group (P=0.0480). Overall, 73% of all patients requested music for future injections (P=0.0001). The music therapy group (84%) requested music in future injections more frequently than the control group (61%) (P=0.0377). Both groups reported similar levels of pain (P=0.5879). Classical music before and during intravitreal injections decreases anxiety in patients without decreasing pain. Most patients desire to have music during future injections. Music therapy is a low-cost, easy, safe intervention that reduces anxiety during intravitreal injections in the outpatient setting.

Clinical decision making-a functional medicine perspective.

Science.gov (United States)

Pizzorno, Joseph E

2012-09-01

As 21st century health care moves from a disease-based approach to a more patient-centric system that can address biochemical individuality to improve health and function, clinical decision making becomes more complex. Accentuating the problem is the lack of a clear standard for this more complex functional medicine approach. While there is relatively broad agreement in Western medicine for what constitutes competent assessment of disease and identification of related treatment approaches, the complex functional medicine model posits multiple and individualized diagnostic and therapeutic approaches, most or many of which have reasonable underlying science and principles, but which have not been rigorously tested in a research or clinical setting. This has led to non-rigorous thinking and sometimes to uncritical acceptance of both poorly documented diagnostic procedures and ineffective therapies, resulting in less than optimal clinical care.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

Science.gov (United States)

Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

2013-05-22

The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process

Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

Directory of Open Access Journals (Sweden)

Sudha Prathikanti

Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

Science.gov (United States)

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Parent Stress in a Randomized Clinical Trial of Atomoxetine and Parent Training for Children with Autism Spectrum Disorder

Science.gov (United States)

Lecavalier, Luc; Pan, Xueliang; Smith, Tristram; Handen, Benjamin L.; Arnold, L. Eugene; Silverman, Laura; Tumuluru, Rameshwari V.; Hollway, Jill; Aman, Michael G.

2018-01-01

We previously reported a 2 × 2 randomized clinical trial of atomoxetine (ATX) and parent training (PT) for attention deficit hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 children with autism spectrum disorder, ages 5-14 years. Children were randomized to one of four conditions: ATX alone, placebo alone, ATX + PT, or…

The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

NARCIS (Netherlands)

Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

1992-01-01

Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

Effects of post mortem temperature on rigor tension, shortening and ...

African Journals Online (AJOL)

Fully developed rigor mortis in muscle is characterised by maximum loss of extensibility. The course of post mortem changes in ostrich muscle was studied by following isometric tension, shortening and change in pH during the first 24 h post mortem within muscle strips from the muscularis gastrocnemius, pars interna at ...

The effects of additional care by a pulmonary nurse for asthma and COPD patients at a respiratory outpatient clinic: results from a double blind, randomized clinical trial

NARCIS (Netherlands)

Rootmensen, Geert N.; van Keimpema, Anton R. J.; Looysen, Elske E.; van der Schaaf, Letty; de Haan, Rob J.; Jansen, Henk M.

2008-01-01

OBJECTIVE: To assess the effects of additional information based nursing care program in the treatment of asthma and COPD patients at a pulmonary outpatient clinic. METHODS: In a double blind, randomized clinical trial, 191 patients were allocated to an additional care group or control group.

Pre-rigor temperature and the relationship between lamb tenderisation, free water production, bound water and dry matter.

Science.gov (United States)

Devine, Carrick; Wells, Robyn; Lowe, Tim; Waller, John

2014-01-01

The M. longissimus from lambs electrically stimulated at 15 min post-mortem were removed after grading, wrapped in polythene film and held at 4 (n=6), 7 (n=6), 15 (n=6, n=8) and 35°C (n=6), until rigor mortis then aged at 15°C for 0, 4, 24 and 72 h post-rigor. Centrifuged free water increased exponentially, and bound water, dry matter and shear force decreased exponentially over time. Decreases in shear force and increases in free water were closely related (r(2)=0.52) and were unaffected by pre-rigor temperatures. © 2013.

New rigorous asymptotic theorems for inverse scattering amplitudes

International Nuclear Information System (INIS)

Lomsadze, Sh.Yu.; Lomsadze, Yu.M.

1984-01-01

The rigorous asymptotic theorems both of integral and local types obtained earlier and establishing logarithmic and in some cases even power correlations aetdeen the real and imaginary parts of scattering amplitudes Fsub(+-) are extended to the inverse amplitudes 1/Fsub(+-). One also succeeds in establishing power correlations of a new type between the real and imaginary parts, both for the amplitudes themselves and for the inverse ones. All the obtained assertions are convenient to be tested in high energy experiments when the amplitudes show asymptotic behaviour

Sampling large random knots in a confined space

International Nuclear Information System (INIS)

Arsuaga, J; Blackstone, T; Diao, Y; Hinson, K; Karadayi, E; Saito, M

2007-01-01

DNA knots formed under extreme conditions of condensation, as in bacteriophage P4, are difficult to analyze experimentally and theoretically. In this paper, we propose to use the uniform random polygon model as a supplementary method to the existing methods for generating random knots in confinement. The uniform random polygon model allows us to sample knots with large crossing numbers and also to generate large diagrammatically prime knot diagrams. We show numerically that uniform random polygons sample knots with large minimum crossing numbers and certain complicated knot invariants (as those observed experimentally). We do this in terms of the knot determinants or colorings. Our numerical results suggest that the average determinant of a uniform random polygon of n vertices grows faster than O(e n 2 )). We also investigate the complexity of prime knot diagrams. We show rigorously that the probability that a randomly selected 2D uniform random polygon of n vertices is almost diagrammatically prime goes to 1 as n goes to infinity. Furthermore, the average number of crossings in such a diagram is at the order of O(n 2 ). Therefore, the two-dimensional uniform random polygons offer an effective way in sampling large (prime) knots, which can be useful in various applications

Sampling large random knots in a confined space

Science.gov (United States)

Arsuaga, J.; Blackstone, T.; Diao, Y.; Hinson, K.; Karadayi, E.; Saito, M.

2007-09-01

DNA knots formed under extreme conditions of condensation, as in bacteriophage P4, are difficult to analyze experimentally and theoretically. In this paper, we propose to use the uniform random polygon model as a supplementary method to the existing methods for generating random knots in confinement. The uniform random polygon model allows us to sample knots with large crossing numbers and also to generate large diagrammatically prime knot diagrams. We show numerically that uniform random polygons sample knots with large minimum crossing numbers and certain complicated knot invariants (as those observed experimentally). We do this in terms of the knot determinants or colorings. Our numerical results suggest that the average determinant of a uniform random polygon of n vertices grows faster than O(e^{n^2}) . We also investigate the complexity of prime knot diagrams. We show rigorously that the probability that a randomly selected 2D uniform random polygon of n vertices is almost diagrammatically prime goes to 1 as n goes to infinity. Furthermore, the average number of crossings in such a diagram is at the order of O(n2). Therefore, the two-dimensional uniform random polygons offer an effective way in sampling large (prime) knots, which can be useful in various applications.

Sampling large random knots in a confined space

Energy Technology Data Exchange (ETDEWEB)

Arsuaga, J [Department of Mathematics, San Francisco State University, 1600 Holloway Ave, San Francisco, CA 94132 (United States); Blackstone, T [Department of Computer Science, San Francisco State University, 1600 Holloway Ave., San Francisco, CA 94132 (United States); Diao, Y [Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, NC 28223 (United States); Hinson, K [Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, NC 28223 (United States); Karadayi, E [Department of Mathematics, University of South Florida, 4202 E Fowler Avenue, Tampa, FL 33620 (United States); Saito, M [Department of Mathematics, University of South Florida, 4202 E Fowler Avenue, Tampa, FL 33620 (United States)

2007-09-28

DNA knots formed under extreme conditions of condensation, as in bacteriophage P4, are difficult to analyze experimentally and theoretically. In this paper, we propose to use the uniform random polygon model as a supplementary method to the existing methods for generating random knots in confinement. The uniform random polygon model allows us to sample knots with large crossing numbers and also to generate large diagrammatically prime knot diagrams. We show numerically that uniform random polygons sample knots with large minimum crossing numbers and certain complicated knot invariants (as those observed experimentally). We do this in terms of the knot determinants or colorings. Our numerical results suggest that the average determinant of a uniform random polygon of n vertices grows faster than O(e{sup n{sup 2}}). We also investigate the complexity of prime knot diagrams. We show rigorously that the probability that a randomly selected 2D uniform random polygon of n vertices is almost diagrammatically prime goes to 1 as n goes to infinity. Furthermore, the average number of crossings in such a diagram is at the order of O(n{sup 2}). Therefore, the two-dimensional uniform random polygons offer an effective way in sampling large (prime) knots, which can be useful in various applications.

Localization of a random copolymer at an interface

International Nuclear Information System (INIS)

Madras, N; Whittington, S G

2003-01-01

We investigate the nature of the phase diagram for a self-avoiding walk model of a random copolymer at an interface between two immiscible solvents, when one monomer prefers to be in one solvent, the other monomer prefers to be in the other solvent, and both types of monomer have an attractive or repulsive interaction with the interface. Our results are all rigorous, and extend previous work of Maritan et al (1999) and Martin et al (2000)

Double phosphorylation of the myosin regulatory light chain during rigor mortis of bovine Longissimus muscle.

Science.gov (United States)

Muroya, Susumu; Ohnishi-Kameyama, Mayumi; Oe, Mika; Nakajima, Ikuyo; Shibata, Masahiro; Chikuni, Koichi

2007-05-16

To investigate changes in myosin light chains (MyLCs) during postmortem aging of the bovine longissimus muscle, we performed two-dimensional gel electrophoresis followed by identification with matrix-assisted laser desorption ionization time-of-flight mass spectrometry. The results of fluorescent differential gel electrophoresis showed that two spots of the myosin regulatory light chain (MyLC2) at pI values of 4.6 and 4.7 shifted toward those at pI values of 4.5 and 4.6, respectively, by 24 h postmortem when rigor mortis was completed. Meanwhile, the MyLC1 and MyLC3 spots did not change during the 14 days postmortem. Phosphoprotein-specific staining of the gels demonstrated that the MyLC2 proteins at pI values of 4.5 and 4.6 were phosphorylated. Furthermore, possible N-terminal region peptides containing one and two phosphoserine residues were detected in each mass spectrum of the MyLC2 spots at pI values of 4.5 and 4.6, respectively. These results demonstrated that MyLC2 became doubly phosphorylated during rigor formation of the bovine longissimus, suggesting involvement of the MyLC2 phosphorylation in the progress of beef rigor mortis. Bovine; myosin regulatory light chain (RLC, MyLC2); phosphorylation; rigor mortis; skeletal muscle.

Towards an operational definition of pharmacy clinical competency

Science.gov (United States)

Douglas, Charles Allen

an expert panel. Pharmacy preceptors assessed the performances with the new performance criteria. Estimates of reliability and accuracy from preceptors' assessments can be used to establish benchmarks for future comparisons. Findings from the first phase suggested preceptors held a unique perspective, where APPE assessments are based in relevance to clinical activities. The second phase analyzed assessment results from pharmacy preceptors who watched the video simulations. Reliability results were higher for non-randomized compared to randomized video simulations. Accuracy results showed preceptors more readily identified high and low student performances compared to average students. These results indicated the need for pharmacy preceptor training in performance assessment. The study illustrated a rigorous method to evaluate the validity and reliability of APPE assessment instruments.

A Rigorous Methodology for Analyzing and Designing Plug-Ins

DEFF Research Database (Denmark)

Fasie, Marieta V.; Haxthausen, Anne Elisabeth; Kiniry, Joseph

2013-01-01

. This paper addresses these problems by describing a rigorous methodology for analyzing and designing plug-ins. The methodology is grounded in the Extended Business Object Notation (EBON) and covers informal analysis and design of features, GUI, actions, and scenarios, formal architecture design, including...... behavioral semantics, and validation. The methodology is illustrated via a case study whose focus is an Eclipse environment for the RAISE formal method's tool suite....

A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

Science.gov (United States)

McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

2001-05-01

Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

Directory of Open Access Journals (Sweden)

Callahan Christopher M

2012-06-01

Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

Search for a perfect generator of random numbers

International Nuclear Information System (INIS)

Musyck, E.

1977-01-01

Theoretical tests have been carried out by COVEYOU and MAC PHERSON to verify the applications of the LEHMER algorithm. In a similar way, a theoretical method is proposed to evaluate in a rigorous way the random character of numbers generated by a shift register. This theory introduces the concept of ''degree of randomness'' of the elements, taken in a definite order, of a shift register. It permits making the judicious choice of the elements of the shift register which will produce the bits of the random numbers. On the other hand, a calculation method is developed in order to verify the primitive character of any shift register of high complexity. A new test, called ''slice test'', of empirical and theoretical use is also described; it constitutes a significant contribution to the understanding of certain properties of pseudo-random sequences. As a practical example, a random number generator structure formed with 32 bits, built out of a shift register with 61 elements and 60 modulo-2 adder circuits was made. The author is convinced that this generator can be considered to be practically perfect for all empirical applications of random numbers, particularly for the solution of Monte-Carlo problems. (author)

Randomized controlled clinical trial of long-term chemo-mechanical caries removal using PapacarieTM gel

Directory of Open Access Journals (Sweden)

Lara Jansiski MOTTA

2014-07-01

Full Text Available Objectives: Compare the effectiveness of PapacarieTM gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings. Material and Methods: A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with PapacarieTM and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations. Results: No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment. Conclusion: PapacarieTM is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission a randomized clinical trial

DEFF Research Database (Denmark)

Ravn-Nielsen, Lene Vestergaard; Duckert, Marie Louise; Lund, Mia Lolk

2018-01-01

IMPORTANCE Hospital readmissions are common among patients receiving multiple medications, with considerable costs to the patients and society. OBJECTIVE To determine whether a multifaceted pharmacist intervention based on medication review, patient interview, and follow-up can reduce the number...... of readmissions and emergency department (ED) visits. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical multicenter study (Odense Pharmacist Trial Investigating Medication Interventions at Sector Transfer [OPTIMIST]) enrolled patients from September 1, 2013, through April 23, 2015, with a follow-up of 6...... days (HR, 0.80; 95% CI, 0.59-1.08) after inclusion and in deaths (HR, 0.83; 95% CI, 0.22-3.11). The number needed to treat to achieve the primary composite outcome for the extended intervention (vs usual care) was 12. CONCLUSIONS AND RELEVANCE A multifaceted clinical pharmacist intervention may reduce...

10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

DEFF Research Database (Denmark)

Galløe, Anders M; Kelbæk, Henning; Thuesen, Leif

2017-01-01

of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention. METHODS: A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES...... for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT...

Therapeutic effects of flurbiprofen axetil on mesenteric traction syndrome: randomized clinical trial.

Science.gov (United States)

Takahashi, Hidemasa; Shida, Dai; Tagawa, Kyoko; Iwamoto, Ryo; Arita, Makoto; Arai, Hiroyuki; Suzuki, Takeo

2017-08-11

This study aimed to reveal the appropriate timing for the intravenous administration of flurbiprofen axetil for preventing mesenteric traction syndrome (MTS), caused by prostacyclin release. In this prospective, randomized, clinical study, forty-five patients who were undergoing elective surgery for colorectal cancer via laparotomy were enrolled. Patients were randomly divided into 3 groups: a preoperative group (n = 16) receiving flurbiprofen axetil directly before surgery; a post-MTS group (n = 14) receiving following MTS onset; and a control group (n = 15) who were not administered flurbiprofen axetil. 6-keto-PGF1α, a stable metabolite of prostacyclin, levels were measured and mean blood pressures were recorded. In the preoperative group, 6-keto-PGF1α levels did not increase, blood pressure levels did not decrease, and no facial flushing was observed. In both the post-MTS and control groups, 6-keto-PGF1α levels increased markedly after mesenteric traction and blood pressure decreased significantly. The post-MTS group exhibited a faster decreasing trend in 6-keto-PGF1α levels and quick restore of the mean blood pressure, and the use of vasopressors and phenylephrine were lower than that in the control group. Even therapeutic administration of flurbiprofen axetil after the onset of MTS has also effects on MTS by suppressing prostacyclin production. Clinical trial number: UMIN000009111 . (Registered 14 October 2012).

Introduction to random matrices theory and practice

CERN Document Server

Livan, Giacomo; Vivo, Pierpaolo

2018-01-01

Modern developments of Random Matrix Theory as well as pedagogical approaches to the standard core of the discipline are surprisingly hard to find in a well-organized, readable and user-friendly fashion. This slim and agile book, written in a pedagogical and hands-on style, without sacrificing formal rigor fills this gap. It brings Ph.D. students in Physics, as well as more senior practitioners, through the standard tools and results on random matrices, with an eye on most recent developments that are not usually covered in introductory texts. The focus is mainly on random matrices with real spectrum. The main guiding threads throughout the book are the Gaussian Ensembles. In particular, Wigner’s semicircle law is derived multiple times to illustrate several techniques  (e.g., Coulomb gas approach, replica theory). Most chapters are accompanied by Matlab codes (stored in an online repository) to guide readers through the numerical check of most analytical results.

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

Science.gov (United States)

Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

2014-01-01

Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

The effect of temperature on the mechanical aspects of rigor mortis in a liquid paraffin model.

Science.gov (United States)

Ozawa, Masayoshi; Iwadate, Kimiharu; Matsumoto, Sari; Asakura, Kumiko; Ochiai, Eriko; Maebashi, Kyoko

2013-11-01

Rigor mortis is an important phenomenon to estimate the postmortem interval in forensic medicine. Rigor mortis is affected by temperature. We measured stiffness of rat muscles using a liquid paraffin model to monitor the mechanical aspects of rigor mortis at five temperatures (37, 25, 10, 5 and 0°C). At 37, 25 and 10°C, the progression of stiffness was slower in cooler conditions. At 5 and 0°C, the muscle stiffness increased immediately after the muscles were soaked in cooled liquid paraffin and then muscles gradually became rigid without going through a relaxed state. This phenomenon suggests that it is important to be careful when estimating the postmortem interval in cold seasons. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A rigorous treatment of uncertainty quantification for Silicon damage metrics

International Nuclear Information System (INIS)

Griffin, P.

2016-01-01

These report summaries the contributions made by Sandia National Laboratories in support of the International Atomic Energy Agency (IAEA) Nuclear Data Section (NDS) Technical Meeting (TM) on Nuclear Reaction Data and Uncertainties for Radiation Damage. This work focused on a rigorous treatment of the uncertainties affecting the characterization of the displacement damage seen in silicon semiconductors. (author)

Paper 3: Content and Rigor of Algebra Credit Recovery Courses

Science.gov (United States)

Walters, Kirk; Stachel, Suzanne

2014-01-01

This paper describes the content, organization and rigor of the f2f and online summer algebra courses that were delivered in summers 2011 and 2012. Examining the content of both types of courses is important because research suggests that algebra courses with certain features may be better than others in promoting success for struggling students.…

Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.

Science.gov (United States)

Smith, Stephen R; Murray, David; Pockney, Peter G; Bendinelli, Cino; Draganic, Brian D; Carroll, Rosemary

2018-01-01

Lower GI hemorrhage is a common source of morbidity and mortality. Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss in a variety of clinical conditions. Information regarding the use of tranexamic acid in treating lower GI hemorrhage is lacking. The aim of this trial was to determine the clinical efficacy of tranexamic acid when used for lower GI hemorrhage. This was a prospective, double-blind, placebo-controlled, randomized clinical trial. The study was conducted at a tertiary referral university hospital in Australia. Consecutive patients aged >18 years with lower GI hemorrhage requiring hospital admission from November 2011 to January 2014 were screened for trial eligibility (N = 265). A total of 100 patients were recruited after exclusions and were randomly assigned 1:1 to either tranexamic acid or placebo. The primary outcome was blood loss as determined by reduction in hemoglobin levels. The secondary outcomes were transfusion rates, transfusion volume, intervention rates for bleeding, length of hospital stay, readmission, and complication rates. There was no difference between groups with respect to hemoglobin drop (11 g/L of tranexamic acid vs 13 g/L of placebo; p = 0.9445). There was no difference with respect to transfusion rates (14/49 tranexamic acid vs 16/47 placebo; p = 0.661), mean transfusion volume (1.27 vs 1.93 units; p = 0.355), intervention rates (7/49 vs 13/47; p = 0.134), length of hospital stay (4.67 vs 4.74 d; p = 0.934), readmission, or complication rates. No complications occurred as a direct result of tranexamic acid use. A larger multicenter trial may be required to determine whether there are more subtle advantages with tranexamic acid use in some of the secondary outcomes. Tranexamic acid does not appear to decrease blood loss or improve clinical outcomes in patients presenting with lower GI hemorrhage in the context of this trial. see Video Abstract at http://links.lww.com/DCR/A453.

Randomized, Controlled Clinical Trial of Bilayer Ceramic and Metal-Ceramic Crown Performance

Science.gov (United States)

Esquivel-Upshaw, Josephine; Rose, William; Oliveira, Erica; Yang, Mark; Clark, Arthur E.; Anusavice, Kenneth

2013-01-01

Purpose Analyzing the clinical performance of restorative materials is important, as there is an expectation that these materials and procedures will restore teeth and do no harm. The objective of this research study was to characterize the clinical performance of metal-ceramic crowns, core ceramic crowns, and core ceramic/veneer ceramic crowns based on 11 clinical criteria. Materials and Methods An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study. The following three types of full crowns were fabricated: (1) metal-ceramic crown (MC) made from a Pd-Au-Ag-Sn-In alloy (Argedent 62) and a glass-ceramic veneer (IPS d.SIGN veneer); (2) non-veneered (glazed) lithium disilicate glass-ceramic crown (LDC) (IPS e.max Press core and e.max Ceram Glaze); and (3) veneered lithia disilicate glass-ceramic crown (LDC/V) with glass-ceramic veneer (IPS Empress 2 core and IPS Eris). Single-unit crowns were randomly assigned. Patients were recalled for each of 3 years and were evaluated by two calibrated clinicians. Thirty-six crowns were placed in 31 patients. A total of 12 crowns of each of the three crown types were studied. Eleven criteria were evaluated: tissue health, marginal integrity, secondary caries, proximal contact, anatomic contour, occlusion, surface texture, cracks/chips (fractures), color match, tooth sensitivity, and wear (of crowns and opposing enamel). Numerical rankings ranged from 1 to 4, with 4 being excellent, and 1 indicating a need for immediate replacement. Statistical analysis of the numerical rankings was performed using a Fisher’s exact test. Results There was no statistically significant difference between performance of the core ceramic crowns and the two veneered crowns at year 1 and year 2 (p > 0.05). All crowns were rated either as excellent or good for each of the clinical criteria; however, between years 2 and 3, gradual roughening of the occlusal surface occurred in some of the ceramic-ceramic crowns

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial.

Science.gov (United States)

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs.

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

Directory of Open Access Journals (Sweden)

Guallar Eliseo

2010-12-01

of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness. Trial Registration Clinical Trials.gov NCT00902694

Re-establishment of rigor mortis: evidence for a considerably longer post-mortem time span.

Science.gov (United States)

Crostack, Chiara; Sehner, Susanne; Raupach, Tobias; Anders, Sven

2017-07-01

Re-establishment of rigor mortis following mechanical loosening is used as part of the complex method for the forensic estimation of the time since death in human bodies and has formerly been reported to occur up to 8-12 h post-mortem (hpm). We recently described our observation of the phenomenon in up to 19 hpm in cases with in-hospital death. Due to the case selection (preceding illness, immobilisation), transfer of these results to forensic cases might be limited. We therefore examined 67 out-of-hospital cases of sudden death with known time points of death. Re-establishment of rigor mortis was positive in 52.2% of cases and was observed up to 20 hpm. In contrast to the current doctrine that a recurrence of rigor mortis is always of a lesser degree than its first manifestation in a given patient, muscular rigidity at re-establishment equalled or even exceeded the degree observed before dissolving in 21 joints. Furthermore, this is the first study to describe that the phenomenon appears to be independent of body or ambient temperature.

Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.

LENUS (Irish Health Repository)

Ridgway, P F

2009-11-01

Despite the high prevalence of hospitalization for left iliac fossa tenderness, there is a striking lack of randomized data available to guide therapy. The authors hypothesize that an oral antibiotic and fluids are not inferior to intravenous (IV) antibiotics and \\'bowel rest\\' in clinically diagnosed acute uncomplicated diverticulitis.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

Science.gov (United States)

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each

Differential algebras with remainder and rigorous proofs of long-term stability

International Nuclear Information System (INIS)

Berz, Martin

1997-01-01

It is shown how in addition to determining Taylor maps of general optical systems, it is possible to obtain rigorous interval bounds for the remainder term of the n-th order Taylor expansion. To this end, the three elementary operations of addition, multiplication, and differentiation in the Differential Algebraic approach are augmented by suitable interval operations in such a way that a remainder bound of the sum, product, and derivative is obtained from the Taylor polynomial and remainder bound of the operands. The method can be used to obtain bounds for the accuracy with which a Taylor map represents the true map of the particle optical system. In a more general sense, it is also useful for a variety of other numerical problems, including rigorous global optimization of highly complex functions. Combined with methods to obtain pseudo-invariants of repetitive motion and extensions of the Lyapunov- and Nekhoroshev stability theory, the latter can be used to guarantee stability for storage rings and other weakly nonlinear systems

Continuous-time random walks with reset events. Historical background and new perspectives

Science.gov (United States)

Montero, Miquel; Masó-Puigdellosas, Axel; Villarroel, Javier

2017-09-01

In this paper, we consider a stochastic process that may experience random reset events which relocate the system to its starting position. We focus our attention on a one-dimensional, monotonic continuous-time random walk with a constant drift: the process moves in a fixed direction between the reset events, either by the effect of the random jumps, or by the action of a deterministic bias. However, the orientation of its motion is randomly determined after each restart. As a result of these alternating dynamics, interesting properties do emerge. General formulas for the propagator as well as for two extreme statistics, the survival probability and the mean first-passage time, are also derived. The rigor of these analytical results is verified by numerical estimations, for particular but illuminating examples.

Therapeutic assessment promotes treatment readiness but does not affect symptom change in patients with personality disorders: Findings from a randomized clinical trial

NARCIS (Netherlands)

de Saeger, H.; Kamphuis, J.H.; Finn, S.E.; Smith, J.D.; Verheul, R.; van Busschbach, J.J.; Feenstra, D.J.; Dine, J.; Horn, E.K.

2014-01-01

The field of clinical personality assessment is lacking in published empirical evidence regarding its treatment and clinical utility. This article reports on a randomized controlled clinical trial (N = 74) allocating patients awaiting treatment in a specialized clinic for personality disorders to

Clinical benefit of steroid use in patients undergoing cardiopulmonary bypass: a meta-analysis of randomized trials

DEFF Research Database (Denmark)

Whitlock, R.P.; Chan, S.; Devereaux, P.J.

2008-01-01

We sought to establish the efficacy and safety of prophylactic steroids in adult patients undergoing cardiopulmonary bypass (CPB). We performed a meta-analysis of randomized trials reporting the effects of prophylactic steroids on clinical outcomes after CPB. Outcomes examined were mortality...

Rigorous high-precision enclosures of fixed points and their invariant manifolds

Science.gov (United States)

Wittig, Alexander N.

The well established concept of Taylor Models is introduced, which offer highly accurate C0 enclosures of functional dependencies, combining high-order polynomial approximation of functions and rigorous estimates of the truncation error, performed using verified arithmetic. The focus of this work is on the application of Taylor Models in algorithms for strongly non-linear dynamical systems. A method is proposed to extend the existing implementation of Taylor Models in COSY INFINITY from double precision coefficients to arbitrary precision coefficients. Great care is taken to maintain the highest efficiency possible by adaptively adjusting the precision of higher order coefficients in the polynomial expansion. High precision operations are based on clever combinations of elementary floating point operations yielding exact values for round-off errors. An experimental high precision interval data type is developed and implemented. Algorithms for the verified computation of intrinsic functions based on the High Precision Interval datatype are developed and described in detail. The application of these operations in the implementation of High Precision Taylor Models is discussed. An application of Taylor Model methods to the verification of fixed points is presented by verifying the existence of a period 15 fixed point in a near standard Henon map. Verification is performed using different verified methods such as double precision Taylor Models, High Precision intervals and High Precision Taylor Models. Results and performance of each method are compared. An automated rigorous fixed point finder is implemented, allowing the fully automated search for all fixed points of a function within a given domain. It returns a list of verified enclosures of each fixed point, optionally verifying uniqueness within these enclosures. An application of the fixed point finder to the rigorous analysis of beam transfer maps in accelerator physics is presented. Previous work done by

A Draft Conceptual Framework of Relevant Theories to Inform Future Rigorous Research on Student Service-Learning Outcomes

Science.gov (United States)

Whitley, Meredith A.

2014-01-01

While the quality and quantity of research on service-learning has increased considerably over the past 20 years, researchers as well as governmental and funding agencies have called for more rigor in service-learning research. One key variable in improving rigor is using relevant existing theories to improve the research. The purpose of this…

Building an Evidence Base to Inform Interventions for Pregnant and Parenting Adolescents: A Call for Rigorous Evaluation

Science.gov (United States)

Burrus, Barri B.; Scott, Alicia Richmond

2012-01-01

Adolescent parents and their children are at increased risk for adverse short- and long-term health and social outcomes. Effective interventions are needed to support these young families. We studied the evidence base and found a dearth of rigorously evaluated programs. Strategies from successful interventions are needed to inform both intervention design and policies affecting these adolescents. The lack of rigorous evaluations may be attributable to inadequate emphasis on and sufficient funding for evaluation, as well as to challenges encountered by program evaluators working with this population. More rigorous program evaluations are urgently needed to provide scientifically sound guidance for programming and policy decisions. Evaluation lessons learned have implications for other vulnerable populations. PMID:22897541

Randomized clinical trials as reflexive-interpretative process in patients with rheumatoid arthritis: a qualitative study.

Science.gov (United States)

de Jorge, Mercedes; Parra, Sonia; de la Torre-Aboki, Jenny; Herrero-Beaumont, Gabriel

2015-08-01

Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semi-structured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category "Interactional Empowerment" emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: "weight of systematisation", "working together", and the significance of the experience: "the duties". Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive-interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY: a pilot cluster randomized trial

Directory of Open Access Journals (Sweden)

Pai Menaka

2013-01-01

Full Text Available Abstract Background Venous thromboembolism (VTE is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. Methods We conducted a 16-week pilot cluster randomized controlled trial (RCT to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians’ orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place. Blinding was not used. Results A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022, and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE

Blocked Randomization with Randomly Selected Block Sizes

Directory of Open Access Journals (Sweden)

Jimmy Efird

2010-12-01

Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

Solution-Processed Carbon Nanotube True Random Number Generator.

Science.gov (United States)

Gaviria Rojas, William A; McMorrow, Julian J; Geier, Michael L; Tang, Qianying; Kim, Chris H; Marks, Tobin J; Hersam, Mark C

2017-08-09

With the growing adoption of interconnected electronic devices in consumer and industrial applications, there is an increasing demand for robust security protocols when transmitting and receiving sensitive data. Toward this end, hardware true random number generators (TRNGs), commonly used to create encryption keys, offer significant advantages over software pseudorandom number generators. However, the vast network of devices and sensors envisioned for the "Internet of Things" will require small, low-cost, and mechanically flexible TRNGs with low computational complexity. These rigorous constraints position solution-processed semiconducting single-walled carbon nanotubes (SWCNTs) as leading candidates for next-generation security devices. Here, we demonstrate the first TRNG using static random access memory (SRAM) cells based on solution-processed SWCNTs that digitize thermal noise to generate random bits. This bit generation strategy can be readily implemented in hardware with minimal transistor and computational overhead, resulting in an output stream that passes standardized statistical tests for randomness. By using solution-processed semiconducting SWCNTs in a low-power, complementary architecture to achieve TRNG, we demonstrate a promising approach for improving the security of printable and flexible electronics.

Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy: A Randomized Clinical Trial.

Science.gov (United States)

Silva, Marly Conceição; Magalhães, Tiago Augusto; Meira, Zilda Maria Alves; Rassi, Carlos Henrique Reis Esselin; Andrade, Amanda Cristina de Souza; Gutierrez, Paulo Sampaio; Azevedo, Clerio Francisco; Gurgel-Giannetti, Juliana; Vainzof, Mariz; Zatz, Mayana; Kalil-Filho, Roberto; Rochitte, Carlos Eduardo

2017-02-01

In Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD), interventions reducing the progression of myocardial disease could affect survival. To assess the effect of early angiotensin-converting enzyme (ACE) inhibitor therapy in patients with normal left ventricular function on the progression of myocardial fibrosis (MF) identified on cardiovascular magnetic resonance (CMR). A randomized clinical trial conducted in 2 centers included 76 male patients with DMD or BMD undergoing 2 CMR studies with a 2-year interval for ventricular function and MF assessment. In a non-intent-to-treat trial, 42 patients with MF and normal left ventricular ejection fraction (LVEF) were randomized (1:1) to receive or not receive ACE inhibitor therapy. The study was conducted from June 26, 2009, to June 30, 2012. Data analysis was performed from June 30, 2013, to October 3, 2016. Randomization (1:1) to receive or not receive ACE inhibitor therapy. Primary outcome was MF progression from baseline to the 2-year CMR study. Of the 76 male patients included in the study, 70 had DMD (92%) and 6 had BMD (8%); mean (SD) age at baseline was 13.1 (4.4) years. Myocardial fibrosis was present in 55 patients (72%) and LV systolic dysfunction was identified in 13 patients (24%). Myocardial fibrosis at baseline was an independent indicator of lower LVEF at follow-up (coefficient [SE], -0.16 [0.07]; P = .03). Among patients with MF and preserved LVEF (42 [55%]), those randomized (21 patients in each arm) to receive ACE inhibitors demonstrated slower MF progression compared with the untreated group (mean [SD] increase of 3.1% [7.4%] vs 10.0% [6.2%] as a percentage of LV mass; P = .001). In multivariate analysis, ACE inhibitor therapy was an independent indicator of decreased MF progression (coefficient [SE], -4.51 [2.11]; P = .04). Patients with MF noted on CMR had a higher probability of cardiovascular events (event rate, 10 of 55 [18.2%] vs 0 of 21 [0%]; log-rank P = .04

Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields

Directory of Open Access Journals (Sweden)

Hong-Jie Dai

2015-01-01

Full Text Available Electronic health record (EHR is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents.

Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: A randomized clinical trial

OpenAIRE

Martinez, Esteban; Gonzalez-Cordon, Ana; Ferrer, Elena; Domingo, Pere; Negredo, Eugenia; Gutierrez, Felix; Portilla, Joaquin; Curran, Adrià; Podzamczer, Daniel; Ribera, Esteban; Murillas, Javier; Bernardino, Jose I.; Santos, Ignacio; Carton, Jose A.; Peraire, Joaquim

2015-01-01

This article has been accepted for publication in Clinical Infectious Diseases ©2014 The Authors .Published by Oxford University Press on Clinical Infectious Disease 60.5. DOI: 10.1093/cid/ciu898 Background. It is unclear whether metabolic or body composition effects may differ between protease inhibitor-based regimens recommended for initial treatment of HIV infection. Methods. ATADAR is a phase IV, open-label, multicenter randomized clinical trial. Stable antiretroviral-naive HIV-in...

Placental cord drainage in the third stage of labor: Randomized clinical trial.

Science.gov (United States)

Vasconcelos, Fernanda Barros; Katz, Leila; Coutinho, Isabela; Lins, Vanessa Laranjeiras; de Amorim, Melania Maria

2018-01-01

An open randomized clinical trial was developed at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) in Recife and at Petronila Campos Municipal Hospital in São Lourenço da Mata, both in Pernambuco, northeastern Brazil, including 226 low-risk pregnant women bearing a single, full-term, live fetus after delayed cord clamping, 113 randomized to placental cord drainage and 113 to a control group not submitted to this procedure. Women incapable of understanding the study objectives and those who went on to have an instrumental or cesarean delivery were excluded. Duration of the third stage of labor did not differ between the two groups (14.2±12.9 versus 13.7±12.1 minutes (mean ± SD), p = 0.66). Likewise, there was no significant difference in mean blood loss (248±254 versus 208±187ml, p = 0.39) or in postpartum hematocrit levels (32.3±4.06 versus 32.8±4.25mg/dl, p = 0.21). Furthermore, no differences were found between the groups for any of the secondary outcomes (postpartum hemorrhage >500 or >1000ml, therapeutic use of oxytocin, third stage >30 or 60 minutes, digital evacuation of the uterus or curettage, symptoms of postpartum anemia and maternal satisfaction). Placental cord drainage had no effect in reducing duration or blood loss during the third stage of labor. ClinicalTrials.gov: www.clinicaltrial.gov, NCT01655576.

Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

Science.gov (United States)

Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

2014-01-01

For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

The conflict between randomized clinical trials and the therapeutic obligation.

Science.gov (United States)

Gifford, F

1986-11-01

The central dilemma concerning randomized clinical trials (RCTs) arises out of some simple facts about causal methodology (RCTs are the best way to generate the reliable causal knowledge necessary for optimally-informed action) and a prima facie plausible principle concerning how physicians should treat their patients (always do what it is most reasonable to believe will be best for the patient). A number of arguments related to this in the literature are considered. Attempts to avoid the dilemma fail. Appeals to informed consent and mechanisms for minimizing the resulting harm are important for policy, but informed consent is problematic and mechanisms for minimization of harm do not address the dilemma. Appeals to some sort of contract model of justification are promising and illuminating.

Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials.

Science.gov (United States)

Hilbrich, Lutz; Sleight, Peter

2006-09-01

Randomized clinical trials (RCTs) are the definitive contributors to evidence-based medicine. RCTs assessing serious outcomes in cardiovascular disease have grown, with 'megatrials' becoming more common with the realization that wrong conclusions resulted from random error in inadequately sized trials. Simple design and a heterogeneous patient population were early features, but multinational trials have increased in scientific, logistical, bureaucratic, regulatory, and legal complexity. These studies now exceed the financial means of academia or medical charities. Governments have left the bill with the pharmaceutical industry, encouraging a symbiosis with academics, who contribute medical and scientific expertise, and access to patients. Industry provides pharmacological, pharmaceutical, technical and regulatory know-how, good clinical practice expertise, and legal assistance during the trial. Study supervision is then in the hands of an independent steering committee and associated subcommittees, until appropriate dissemination of results. Prospectively defined interaction with the sponsor facilitates unbiased design and conduct, but arrangements need careful implementation to avoid conflicts of interest. The patient is protected by a strong data safety monitoring board that is wholly independent. Megatrials are under threat from over-regulation, increasing costs, and difficulties in execution. These issues merit urgent public and political education and debate.

Sutures coated with antiseptic pomade to prevent bacterial colonization: a randomized clinical trial.

Science.gov (United States)

Cruz, Fernando; Leite, Fabiola; Cruz, Gustavo; Cruz, Silvia; Reis, Juarez; Pierce, Matthew; Cruz, Mauro

2013-08-01

The aim of this study was to assess if an antiseptic pomade could reduce the bacterial colonization on multifilament sutures. A randomized clinical trial was conducted with 40 volunteer patients of both sexes aged 18-70, randomly separated into experimental (n = 20) and control (n = 20) groups. The experimental group received pomade-coated sutures (iodoform + calendula) and the control group uncoated sutures. Two millimeters of the suture was harvested from each patient from the 1st to the 15th postoperative day. The bacteria that had adhered to them were cultured. The number of colony-forming units per milliliter (CFU/mL) was determined and the groups were compared using the Mann-Whitney statistical test (P antiseptic pomade was effective in reducing bacterial colonization on silk braided sutures. Copyright © 2013 Elsevier Inc. All rights reserved.

Randomized Clinical Trial of Lansoprazole for Poorly Controlled Asthma in Children

Science.gov (United States)

Holbrook, Janet T.; Wise, Robert A.; Gold, Benjamin D.; Blake, Kathryn; Brown, Ellen D.; Castro, Mario; Dozor, Allen J.; Lima, John; Mastronarde, John G.; Sockrider, Marianna; Teague, W. Gerald

2013-01-01

Context Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. It is not known whether treatment of GER with a proton-pump inhibitor (PPI) improves asthma control. Objective To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. Design, Setting, and Patients A multicenter, randomized, masked, placebo controlled, parallel clinical trial comparing lansoprazole to placebo in children with poor asthma control on inhaled corticosteroid treatment conducted at 18 academic clinical centers. Participants were followed for 24 weeks. A subgroup had an esophageal pH study before randomization. Intervention Children received either lansoprazole (15 mg daily lansoprazole and placebo groups, respectively (P=0.12). There were no detectable treatment differences in secondary outcomes (mean (95% CI) for FEV1(0.00 (−0.08, 0.08)), asthma quality of life (−0.1 (−0.4, 0.1) or episodes of poor asthma control, hazard ratio of 1.18 (95% CI 0.91, 1.53). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole versus placebo was observed for any asthma outcome. Children treated with lansoprazole reported more upper respiratory infections (63% vs 49%, P=0.02), sore throats (52% vs 39%, P=0.02), and bronchitis (7% vs 2%, P=0.05). Conclusion Among children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, as compared to placebo, did not improve symptoms nor lung function but was associated with increased adverse events. PMID:22274684

Blastocyst culture using single versus sequential media in clinical IVF: a systematic review and meta-analysis of randomized controlled trials.

Science.gov (United States)

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

Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial

Science.gov (United States)

Tolsgaard, M G; Ringsted, C; Dreisler, E; Nørgaard, L N; Petersen, J H; Madsen, M E; Freiesleben, N L C; Sørensen, J L; Tabor, A

2015-01-01

Objective To study the effect of initial simulation-based transvaginal sonography (TVS) training compared with clinical training only, on the clinical performance of residents in obstetrics and gynecology (Ob-Gyn), assessed 2 months into their residency. Methods In a randomized study, new Ob-Gyn residents (n = 33) with no prior ultrasound experience were recruited from three teaching hospitals. Participants were allocated to either simulation-based training followed by clinical training (intervention group; n = 18) or clinical training only (control group; n = 15). The simulation-based training was performed using a virtual-reality TVS simulator until an expert performance level was attained, and was followed by training on a pelvic mannequin. After 2 months of clinical training, one TVS examination was recorded for assessment of each resident's clinical performance (n = 26). Two ultrasound experts blinded to group allocation rated the scans using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. Results During the 2 months of clinical training, participants in the intervention and control groups completed an average ± SD of 58 ± 41 and 63 ± 47 scans, respectively (P = 0.67). In the subsequent clinical performance test, the intervention group achieved higher OSAUS scores than did the control group (mean score, 59.1% vs 37.6%, respectively; P training leads to substantial improvement in clinical performance that is sustained after 2 months of clinical training. © 2015 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. PMID:25580809

Feedback for relatedness and competence : Can feedback in blended learning contribute to optimal rigor, basic needs, and motivation?

NARCIS (Netherlands)

Bombaerts, G.; Nickel, P.J.

2017-01-01

We inquire how peer and tutor feedback influences students' optimal rigor, basic needs and motivation. We analyze questionnaires from two courses in two subsequent years. We conclude that feedback in blended learning can contribute to rigor and basic needs, but it is not clear from our data what

Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites

NARCIS (Netherlands)

Gresnigt, Marco M. M.; Kalk, Warner; Ozcan, M.; Ozcan, Mutlu

Objectives: This randomized, split-mouth clinical study evaluated the survival rate of direct laminate veneers made of two resin-composite materials. Methods: A total of 23 patients (mean age: 52.4 years old) received 96 direct composite laminate veneers using two micro-hybrid composites in

Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

NARCIS (Netherlands)

Versyck, B.; Geffen, G.J. van; Houwe, P. Van

2017-01-01

STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

Science.gov (United States)

Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

2012-01-01

Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

Randomized Clinical Trial of Indirect Resin Composite and Ceramic Veneers : Up to 3-year Follow-up

NARCIS (Netherlands)

Gresnigt, Marco M. M.; Kalk, Warner; Ozcan, Mutlu

2013-01-01

Purpose: This randomized controlled split-mouth clinical trial evaluated the short-term survival rate of indirect resin composite and ceramic laminate veneers. Materials and Methods: A total of 10 patients (mean age: 48.6 years) received 46 indirect resin composite (Estenia; n = 23) and ceramic

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico.

Science.gov (United States)

Horigian, Viviana E; Marín-Navarrete, Rodrigo A; Verdeja, Rosa E; Alonso, Elizabeth; Perez, María A; Fernández-Mondragón, José; Berlanga, Carlos; Medina-Mora, María Elena; Szapocznik, José

2015-09-01

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Reciprocity relations in transmission electron microscopy: A rigorous derivation.

Science.gov (United States)

Krause, Florian F; Rosenauer, Andreas

2017-01-01

A concise derivation of the principle of reciprocity applied to realistic transmission electron microscopy setups is presented making use of the multislice formalism. The equivalence of images acquired in conventional and scanning mode is thereby rigorously shown. The conditions for the applicability of the found reciprocity relations is discussed. Furthermore the positions of apertures in relation to the corresponding lenses are considered, a subject which scarcely has been addressed in previous publications. Copyright © 2016 Elsevier Ltd. All rights reserved.

The effect of rigor mortis on the passage of erythrocytes and fluid through the myocardium of isolated dog hearts.

Science.gov (United States)

Nevalainen, T J; Gavin, J B; Seelye, R N; Whitehouse, S; Donnell, M

1978-07-01

The effect of normal and artificially induced rigor mortis on the vascular passage of erythrocytes and fluid through isolated dog hearts was studied. Increased rigidity of 6-mm thick transmural sections through the centre of the posterior papillary muscle was used as an indication of rigor. The perfusibility of the myocardium was tested by injecting 10 ml of 1% sodium fluorescein in Hanks solution into the circumflex branch of the left coronary artery. In prerigor hearts (20 minute incubation) fluorescein perfused the myocardium evenly whether or not it was preceded by an injection of 10 ml of heparinized dog blood. Rigor mortis developed in all hearts after 90 minutes incubation or within 20 minutes of perfusing the heart with 50 ml of 5 mM iodoacetate in Hanks solution. Fluorescein injected into hearts in rigor did not enter the posterior papillary muscle and adjacent subendocardium whether or not it was preceded by heparinized blood. Thus the vascular occlusion caused by rigor in the dog heart appears to be so effective that it prevents flow into the subendocardium of small soluble ions such as fluorescein.

Statistics for mathematicians a rigorous first course

CERN Document Server

Panaretos, Victor M

2016-01-01

This textbook provides a coherent introduction to the main concepts and methods of one-parameter statistical inference. Intended for students of Mathematics taking their first course in Statistics, the focus is on Statistics for Mathematicians rather than on Mathematical Statistics. The goal is not to focus on the mathematical/theoretical aspects of the subject, but rather to provide an introduction to the subject tailored to the mindset and tastes of Mathematics students, who are sometimes turned off by the informal nature of Statistics courses. This book can be used as the basis for an elementary semester-long first course on Statistics with a firm sense of direction that does not sacrifice rigor. The deeper goal of the text is to attract the attention of promising Mathematics students.

A Randomized Clinical Trial of a Brief, Problem-Focused Couple Therapy for Depression

OpenAIRE

Cohen, Shiri; O’Leary, K. Daniel; Foran, Heather

2010-01-01

The aim of this study was to evaluate a brief couple therapy for depression targeted for mildly discordant or nondiscordant couples struggling with the negative impact of depression. Subjects included women with major depression or dysthymia who had husbands without clinical depression. Thirty-five couples were randomly assigned to the 5-week intervention (n = 18) or a waitlist control group (n = 17), and followed up 1 and 3 months later. Results showed a significant effect of treatment in re...

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

Directory of Open Access Journals (Sweden)

Birtwhistle Richard

2003-12-01

Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

Directory of Open Access Journals (Sweden)

Aleksandra E. Zgierska

2017-01-01

Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

Atlantic salmon skin and fillet color changes effected by perimortem handling stress, rigor mortis, and ice storage.

Science.gov (United States)

Erikson, U; Misimi, E

2008-03-01

The changes in skin and fillet color of anesthetized and exhausted Atlantic salmon were determined immediately after killing, during rigor mortis, and after ice storage for 7 d. Skin color (CIE L*, a*, b*, and related values) was determined by a Minolta Chroma Meter. Roche SalmoFan Lineal and Roche Color Card values were determined by a computer vision method and a sensory panel. Before color assessment, the stress levels of the 2 fish groups were characterized in terms of white muscle parameters (pH, rigor mortis, and core temperature). The results showed that perimortem handling stress initially significantly affected several color parameters of skin and fillets. Significant transient fillet color changes also occurred in the prerigor phase and during the development of rigor mortis. Our results suggested that fillet color was affected by postmortem glycolysis (pH drop, particularly in anesthetized fillets), then by onset and development of rigor mortis. The color change patterns during storage were different for the 2 groups of fish. The computer vision method was considered suitable for automated (online) quality control and grading of salmonid fillets according to color.

Structured triglyceride for parenteral nutrition: meta-analysis of randomized controlled trials.

Science.gov (United States)

Zhou, Yong; Wu, Xiao-Ting; Li, Ni; Zhuang, Wen; Liu, Guanjian; Wu, Taixiang; Wei, Mao-Ling

2006-01-01

This study assessed the safety and efficacy of structured triglyceride (ST) for parenteral nutrition. A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Clinical trials were identified from the following electronic databases: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database. The search was undertaken in March 2005. Language was restricted to Chinese and English. Literature references were checked at the same time. Only RCTs were extracted and evaluated by two reviewers independently of each other. The statistical analysis was performed by RevMan4.2 software which was provided by the Cochrane Collaboration. A P value of triglyceride (LCT), and the combined results showed that the ST had significant effect on resting energy expenditure (weighted mean difference [WMD] =1.54, 95%CI [ 1.26, 1.82], ptriglycerides (WMD = -0.10, 95%CI [-0.30, 0.10], P=0.32). Only two RCTs compared ST with the physical mixture of medium- and long-chain triglyceride (MCT/LCT), data from trials were not combined due to clinical differences between trials, and conclusions can not be drew from the present data. ST appeared to be safe and well tolerated. Further trials are required, especially compared with the MCT/LCT, with sufficient size and rigorous design.

Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

NARCIS (Netherlands)

Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

Science.gov (United States)

Kerson, Cynthia

2013-01-01

Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial.

Science.gov (United States)

Moran, Gregory J; Krishnadasan, Anusha; Mower, William R; Abrahamian, Fredrick M; LoVecchio, Frank; Steele, Mark T; Rothman, Richard E; Karras, David J; Hoagland, Rebecca; Pettibone, Stephanie; Talan, David A

2017-05-23

Emergency department visits for skin infections in the United States have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). For cellulitis without purulent drainage, β-hemolytic streptococci are presumed to be the predominant pathogens. It is unknown if antimicrobial regimens possessing in vitro MRSA activity provide improved outcomes compared with treatments lacking MRSA activity. To determine whether cephalexin plus trimethoprim-sulfamethoxazole yields a higher clinical cure rate of uncomplicated cellulitis than cephalexin alone. Multicenter, double-blind, randomized superiority trial in 5 US emergency departments among outpatients older than 12 years with cellulitis and no wound, purulent drainage, or abscess enrolled from April 2009 through June 2012. All participants had soft tissue ultrasound performed at the time of enrollment to exclude abscess. Final follow-up was August 2012. Cephalexin, 500 mg 4 times daily, plus trimethoprim-sulfamethoxazole, 320 mg/1600 mg twice daily, for 7 days (n = 248 participants) or cephalexin plus placebo for 7 days (n = 248 participants). The primary outcome determined a priori in the per-protocol group was clinical cure, defined as absence of these clinical failure criteria at follow-up visits: fever; increase in erythema (>25%), swelling, or tenderness (days 3-4); no decrease in erythema, swelling, or tenderness (days 8-10); and more than minimal erythema, swelling, or tenderness (days 14-21). A clinically significant difference was defined as greater than 10%. Among 500 randomized participants, 496 (99%) were included in the modified intention-to-treat analysis and 411 (82.2%) in the per-protocol analysis (median age, 40 years [range, 15-78 years]; 58.4% male; 10.9% had diabetes). Median length and width of erythema were 13.0 cm and 10.0 cm. In the per-protocol population, clinical cure occurred in 182 (83.5%) of 218 participants in the cephalexin plus trimethoprim

Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

NARCIS (Netherlands)

Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

Biomedical text mining for research rigor and integrity: tasks, challenges, directions.

Science.gov (United States)

Kilicoglu, Halil

2017-06-13

An estimated quarter of a trillion US dollars is invested in the biomedical research enterprise annually. There is growing alarm that a significant portion of this investment is wasted because of problems in reproducibility of research findings and in the rigor and integrity of research conduct and reporting. Recent years have seen a flurry of activities focusing on standardization and guideline development to enhance the reproducibility and rigor of biomedical research. Research activity is primarily communicated via textual artifacts, ranging from grant applications to journal publications. These artifacts can be both the source and the manifestation of practices leading to research waste. For example, an article may describe a poorly designed experiment, or the authors may reach conclusions not supported by the evidence presented. In this article, we pose the question of whether biomedical text mining techniques can assist the stakeholders in the biomedical research enterprise in doing their part toward enhancing research integrity and rigor. In particular, we identify four key areas in which text mining techniques can make a significant contribution: plagiarism/fraud detection, ensuring adherence to reporting guidelines, managing information overload and accurate citation/enhanced bibliometrics. We review the existing methods and tools for specific tasks, if they exist, or discuss relevant research that can provide guidance for future work. With the exponential increase in biomedical research output and the ability of text mining approaches to perform automatic tasks at large scale, we propose that such approaches can support tools that promote responsible research practices, providing significant benefits for the biomedical research enterprise. Published by Oxford University Press 2017. This work is written by a US Government employee and is in the public domain in the US.

Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

Science.gov (United States)

Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

2016-05-01

Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies

Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

Science.gov (United States)

Xu, Tian-Min; Zhang, Xiaoyun; Oh, Hee Soo; Boyd, Robert L; Korn, Edward L; Baumrind, Sheldon

2010-11-01

The objective of this pilot randomized clinical trial was to investigate the relative effectiveness of anchorage conservation of en-masse and 2-step retraction techniques during maximum anchorage treatment in patients with Angle Class I and Class II malocclusions. Sixty-four growing subjects (25 boys, 39 girls; 10.2-15.9 years old) who required maximum anchorage were randomized to 2 treatment techniques: en-masse retraction (n = 32) and 2-step retraction (n = 32); the groups were stratified by sex and starting age. Each patient was treated by a full-time clinic instructor experienced in the use of both retraction techniques at the orthodontic clinic of Peking University School of Stomatology in China. All patients used headgear, and most had transpalatal appliances. Lateral cephalograms taken before treatment and at the end of treatment were used to evaluate treatment-associated changes. Differences in maxillary molar mesial displacement and maxillary incisor retraction were measured with the before and after treatment tracings superimposed on the anatomic best fit of the palatal structures. Differences in mesial displacement of the maxillary first molar were compared between the 2 treatment techniques, between sexes, and between different starting-age groups. Average mesial displacement of the maxillary first molar was slightly less in the en-masse group than in the 2-step group (mean, -0.36 mm; 95% CI, -1.42 to 0.71 mm). The average mesial displacement of the maxillary first molar for both treatment groups pooled (n = 63, because 1 patient was lost to follow-up) was 4.3 ± 2.1 mm (mean ± standard deviation). Boys had significantly more mesial displacement than girls (mean difference, 1.3 mm; P <0.03). Younger adolescents had significantly more mesial displacement than older adolescents (mean difference, 1.3 mm; P <0.02). Average mesial displacement of the maxillary first molar with 2-step retraction was slightly greater than that for en-masse retraction, but the

Rigorous results on measuring the quark charge below color threshold

International Nuclear Information System (INIS)

Lipkin, H.J.

1979-01-01

Rigorous theorems are presented showing that contributions from a color nonsinglet component of the current to matrix elements of a second order electromagnetic transition are suppressed by factors inversely proportional to the energy of the color threshold. Parton models which obtain matrix elements proportional to the color average of the square of the quark charge are shown to neglect terms of the same order of magnitude as terms kept. (author)

Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

Science.gov (United States)

Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

2015-11-01

Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

Control group design: enhancing rigor in research of mind-body therapies for depression.

Science.gov (United States)

Kinser, Patricia Anne; Robins, Jo Lynne

2013-01-01

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research.

Rigor mortis development in turkey breast muscle and the effect of electrical stunning.

Science.gov (United States)

Alvarado, C Z; Sams, A R

2000-11-01

Rigor mortis development in turkey breast muscle and the effect of electrical stunning on this process are not well characterized. Some electrical stunning procedures have been known to inhibit postmortem (PM) biochemical reactions, thereby delaying the onset of rigor mortis in broilers. Therefore, this study was designed to characterize rigor mortis development in stunned and unstunned turkeys. A total of 154 turkey toms in two trials were conventionally processed at 20 to 22 wk of age. Turkeys were either stunned with a pulsed direct current (500 Hz, 50% duty cycle) at 35 mA (40 V) in a saline bath for 12 seconds or left unstunned as controls. At 15 min and 1, 2, 4, 8, 12, and 24 h PM, pectoralis samples were collected to determine pH, R-value, L* value, sarcomere length, and shear value. In Trial 1, the samples obtained for pH, R-value, and sarcomere length were divided into surface and interior samples. There were no significant differences between the surface and interior samples among any parameters measured. Muscle pH significantly decreased over time in stunned and unstunned birds through 2 h PM. The R-values increased to 8 h PM in unstunned birds and 24 h PM in stunned birds. The L* values increased over time, with no significant differences after 1 h PM for the controls and 2 h PM for the stunned birds. Sarcomere length increased through 2 h PM in the controls and 12 h PM in the stunned fillets. Cooked meat shear values decreased through the 1 h PM deboning time in the control fillets and 2 h PM in the stunned fillets. These results suggest that stunning delayed the development of rigor mortis through 2 h PM, but had no significant effect on the measured parameters at later time points, and that deboning turkey breasts at 2 h PM or later will not significantly impair meat tenderness.

Rigorous Integration of Non-Linear Ordinary Differential Equations in Chebyshev Basis

Czech Academy of Sciences Publication Activity Database

Dzetkulič, Tomáš

2015-01-01

Roč. 69, č. 1 (2015), s. 183-205 ISSN 1017-1398 R&D Projects: GA MŠk OC10048; GA ČR GD201/09/H057 Institutional research plan: CEZ:AV0Z10300504 Keywords : Initial value problem * Rigorous integration * Taylor model * Chebyshev basis Subject RIV: IN - Informatics, Computer Science Impact factor: 1.366, year: 2015

Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

OpenAIRE

AMMARI, Michelle Mikhael; MOLITERNO, Luiz Flávio Martins; HIRATA JÚNIOR, Raphael; SÉLLOS, Mariana Canano; SOVIERO, Vera Mendes; COUTINHO FILHO, Wagner Pereira

2014-01-01

The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie®) versus the manual method (excavators) in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old) having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into thr...

Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

DEFF Research Database (Denmark)

Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

2008-01-01

cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

Acupoints Stimulation for Anxiety and Depression in Cancer Patients: A Quantitative Synthesis of Randomized Controlled Trials

Directory of Open Access Journals (Sweden)

Tao Wang

2016-01-01

Full Text Available This study aims at concluding the current evidence on the therapeutic effects of acupoints stimulation for cancer patients with anxiety and depression. Randomized controlled trials using acupoints stimulation for relieving anxiety and/or depression in cancer patients were searched, and 11 studies were finally included, of which eight trials compared acupoints stimulation with standard methods of treatment/care, and acupoints stimulation showed significantly better effects in improving depression than using standard methods of treatment/care. Four studies compared true acupoints stimulation with sham methods, and no significant differences can be found between groups for either depression or anxiety, although the pooled effects still favored true intervention. For the five studies that evaluated sleep quality, the results were conflicting, with three supporting the superiority of acupoints stimulation in improving sleep quality and two demonstrating no differences across groups. Acupoints stimulation seems to be an effective approach in relieving depression and anxiety in cancer patients, and placebo effects may partially contribute to the benefits. However, the evidence is not conclusive due to the limited number of included studies and the clinical heterogeneity identified among trials. More rigorous designed randomized, sham-controlled studies are necessary in future research.

Rigorous quantum limits on monitoring free masses and harmonic oscillators

Science.gov (United States)

Roy, S. M.

2018-03-01

There are heuristic arguments proposing that the accuracy of monitoring position of a free mass m is limited by the standard quantum limit (SQL): σ2( X (t ) ) ≥σ2( X (0 ) ) +(t2/m2) σ2( P (0 ) ) ≥ℏ t /m , where σ2( X (t ) ) and σ2( P (t ) ) denote variances of the Heisenberg representation position and momentum operators. Yuen [Phys. Rev. Lett. 51, 719 (1983), 10.1103/PhysRevLett.51.719] discovered that there are contractive states for which this result is incorrect. Here I prove universally valid rigorous quantum limits (RQL), viz. rigorous upper and lower bounds on σ2( X (t ) ) in terms of σ2( X (0 ) ) and σ2( P (0 ) ) , given by Eq. (12) for a free mass and by Eq. (36) for an oscillator. I also obtain the maximally contractive and maximally expanding states which saturate the RQL, and use the contractive states to set up an Ozawa-type measurement theory with accuracies respecting the RQL but beating the standard quantum limit. The contractive states for oscillators improve on the Schrödinger coherent states of constant variance and may be useful for gravitational wave detection and optical communication.

Parent Management Training-Oregon Model: Adapting Intervention with Rigorous Research.

Science.gov (United States)

Forgatch, Marion S; Kjøbli, John

2016-09-01

Parent Management Training-Oregon Model (PMTO(®) ) is a set of theory-based parenting programs with status as evidence-based treatments. PMTO has been rigorously tested in efficacy and effectiveness trials in different contexts, cultures, and formats. Parents, the presumed agents of change, learn core parenting practices, specifically skill encouragement, limit setting, monitoring/supervision, interpersonal problem solving, and positive involvement. The intervention effectively prevents and ameliorates children's behavior problems by replacing coercive interactions with positive parenting practices. Delivery format includes sessions with individual families in agencies or families' homes, parent groups, and web-based and telehealth communication. Mediational models have tested parenting practices as mechanisms of change for children's behavior and found support for the theory underlying PMTO programs. Moderating effects include children's age, maternal depression, and social disadvantage. The Norwegian PMTO implementation is presented as an example of how PMTO has been tailored to reach diverse populations as delivered by multiple systems of care throughout the nation. An implementation and research center in Oslo provides infrastructure and promotes collaboration between practitioners and researchers to conduct rigorous intervention research. Although evidence-based and tested within a wide array of contexts and populations, PMTO must continue to adapt to an ever-changing world. © 2016 Family Process Institute.

Rigor force responses of permeabilized fibres from fast and slow skeletal muscles of aged rats.

Science.gov (United States)

Plant, D R; Lynch, G S

2001-09-01

1. Ageing is generally associated with a decline in skeletal muscle mass and strength and a slowing of muscle contraction, factors that impact upon the quality of life for the elderly. The mechanisms underlying this age-related muscle weakness have not been fully resolved. The purpose of the present study was to determine whether the decrease in muscle force as a consequence of age could be attributed partly to a decrease in the number of cross-bridges participating during contraction. 2. Given that the rigor force is proportional to the approximate total number of interacting sites between the actin and myosin filaments, we tested the null hypothesis that the rigor force of permeabilized muscle fibres from young and old rats would not be different. 3. Permeabilized fibres from the extensor digitorum longus (fast-twitch; EDL) and soleus (predominantly slow-twitch) muscles of young (6 months of age) and old (27 months of age) male F344 rats were activated in Ca2+-buffered solutions to determine force-pCa characteristics (where pCa = -log(10)[Ca2+]) and then in solutions lacking ATP and Ca2+ to determine rigor force levels. 4. The rigor forces for EDL and soleus muscle fibres were not different between young and old rats, indicating that the approximate total number of cross-bridges that can be formed between filaments did not decline with age. We conclude that the age-related decrease in force output is more likely attributed to a decrease in the force per cross-bridge and/or decreases in the efficiency of excitation-contraction coupling.

Angioplasty Guided by Intravascular Ultrasound: Meta-Analysis of Randomized Clinical Trials

Energy Technology Data Exchange (ETDEWEB)

Figueiredo, José Albuquerque Neto de, E-mail: jafneto@cardiol.br; Nogueira, Iara Antonia Lustosa [Universidade Federal do Maranhão, São Luiz, MA (Brazil); Figueiro, Mabel Fernandes; Buehler, Anna Maria; Berwanger, Otavio [Instituto de Ensino e Pesquisa do Hospital do Coração, São Paulo, SP (Brazil)

2013-08-15

The impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results. Systematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution. A search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases. It included randomized clinical trials (RCTs) that evaluated the implantation of stents guided by IVUS, compared with those using angiography alone (ANGIO). The minimum follow-up duration was six months and the following outcomes were assessed: thrombosis, mortality, myocardial infarction, percutaneous and surgical revascularization, major adverse cardiovascular events (MACE) and restenosis. The binary outcomes were presented considering the number of events in each group; the estimates were generated by a random effects model, considering Mantel-Haenszel statistics as weighting agent and magnitude of effect for the relative risk (RR) with its respective 95% confidence interval (95%CI). Higgins I{sup 2} test was used to quantify the consistency between the results of each study. A total of 2,689 articles were evaluated, including 8 RCTs. There was a 27% reduction in angiographic restenosis (RR: 0.73, 95% CI: 0.54-0.97, I{sup 2} = 51%) and statistically significant reduction in the rates of percutaneous revascularization and overall (RR: 0.88; 95% CI: 0.51 to 1.53, I{sup 2} = 61%, RR: 0.73, 95% CI: 0.54 to 0.99, I{sup 2} = 55%), with no statistical difference in surgical revascularization (RR: 0.95, 95% CI: 0.52-1.74, I{sup 2} = 0%) in favor of IVUS vs. ANGIO. There were no differences regarding the other outcomes in the comparison between the two strategies. Angioplasty with stenting guided by IVUS decreases the rates of restenosis and revascularization, with no impact on MACE, acute myocardial infarction, mortality or thrombosis outcomes.

Dexamethasone for Parapneumonic Pleural Effusion: A Randomized, Double-Blind, Clinical Trial.

Science.gov (United States)

Tagarro, Alfredo; Otheo, Enrique; Baquero-Artigao, Fernando; Navarro, María-Luisa; Velasco, Rosa; Ruiz, Marta; Penín, María; Moreno, David; Rojo, Pablo; Madero, Rosario

2017-06-01

To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion. This was a multicenter, randomized, double blind, parallel-group, placebo-controlled clinical trial of 60 children, ranging in age from 1 month to 14 years, with community-acquired pneumonia (CAP) and pleural effusion. Patients received either intravenous DXM (0.25?mg/kg/dose) or placebo every 6 hours over a period of 48 hours, along with antibiotics. The primary endpoint was the time to recovery in hours, defined objectively. We also evaluated complications and adverse events. Among the 60 randomized patients (mean age, 4.7 years; 58% female), 57 (95%) completed the study. Compared with placebo recipients, the patients receiving DXM had a shorter time to recovery, after adjustment by severity group and stratification by center (hazard ratio, 1.95; 95% CI, 1.10-3.45; P?=?.021). The median time to recovery for patients receiving DXM was 68 hours (2.8 days) shorter than patients receiving placebo (109 hours vs 177 hours; P?=?.037). In exploratory subgroup analysis, the median time to recovery for patients with simple effusion receiving DXM was 76 hours (3.1 days) shorter than for patients with simple effusion receiving placebo (P?=?.017). The median time to recovery for patients with complicated effusion receiving DXM was 14 hours (0.5 days) shorter than for patients with complicated effusion receiving placebo (P?=?.66). The difference in the effect of DXM in the 2 severity groups was not statistically significant (P?=?.138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycemia. In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion. ClinicalTrials.gov: NCT01261546. Copyright © 2017 Elsevier Inc. All rights reserved.

Indirect vs Direct Voice Therapy for Children With Vocal Nodules: A Randomized Clinical Trial.

Science.gov (United States)

Hartnick, Christopher; Ballif, Catherine; De Guzman, Vanessa; Sataloff, Robert; Campisi, Paolo; Kerschner, Joseph; Shembel, Adrianna; Reda, Domenic; Shi, Helen; Sheryka Zacny, Elinore; Bunting, Glenn

2018-02-01

Benign vocal fold nodules affect 12% to 22% of the pediatric population, and 95% of otolaryngologists recommend voice therapy as treatment. However, no randomized clinical trials that we are aware of have shown its benefits. To determine the impact of voice therapy in children with vocal fold nodules according to pretherapy and posttherapy scores on the Pediatric Voice-Related Quality of Life (PVRQOL) survey; secondary objectives included changes in phonatory parameters. For this multicenter randomized clinical trial, 114 children ages 6 to 10 years with vocal fold nodules, PVRQOL scores less than 87.5, and dysphonia for longer than 12 weeks were recruited from outpatient voice and speech clinics. This age range was identified because these patients have not experienced pubertal changes of the larynx, tolerate stroboscopy, and cooperate with voice therapy. Participants were blinded to treatment arm. Participants received either indirect or direct therapy for 8 to 12 weeks. Indirect therapy focused on education and discussion of voice principles, while direct treatment used the stimulus, response, antecedent paradigm. The primary outcome measure was PVRQOL score change before and after treatment. Secondary phonatory measures were also compared. Overall, 114 children were recruited for study (mean [SD] age, 8 [1.4] years; 83 males [73%]); with 57 randomized to receive either indirect or direct therapy. Both direct and indirect therapy approaches showed significant differences in PVRQOL scores pretherapy to posttherapy. The mean increase in PVRQOL score for direct therapy was 19.2, and 14.7 for indirect therapy (difference, 4.5; 95.3% CI, -10.8 to 19.8). Of 44 participants in the direct therapy group, 27 (61%) achieved a clinically meaningful PVRQOL improvement, compared with 26 of 49 (53%) for indirect therapy (difference, 8%; 95% CI, -12 to 28). Post hoc stratification showed robust effects in the direct therapy group for older children (Cohen d = 0.50) and the

Video- or text-based e-learning when teaching clinical procedures? A randomized controlled trial.

Science.gov (United States)

Buch, Steen Vigh; Treschow, Frederik Philip; Svendsen, Jesper Brink; Worm, Bjarne Skjødt

2014-01-01

This study investigated the effectiveness of two different levels of e-learning when teaching clinical skills to medical students. Sixty medical students were included and randomized into two comparable groups. The groups were given either a video- or text/picture-based e-learning module and subsequently underwent both theoretical and practical examination. A follow-up test was performed 1 month later. The students in the video group performed better than the illustrated text-based group in the practical examination, both in the primary test (Pvideo group performed better on the follow-up test (P=0.04). Video-based e-learning is superior to illustrated text-based e-learning when teaching certain practical clinical skills.

Rigorous simulations of a helical core fiber by the use of transformation optics formalism.

Science.gov (United States)

Napiorkowski, Maciej; Urbanczyk, Waclaw

2014-09-22

We report for the first time on rigorous numerical simulations of a helical-core fiber by using a full vectorial method based on the transformation optics formalism. We modeled the dependence of circular birefringence of the fundamental mode on the helix pitch and analyzed the effect of a birefringence increase caused by the mode displacement induced by a core twist. Furthermore, we analyzed the complex field evolution versus the helix pitch in the first order modes, including polarization and intensity distribution. Finally, we show that the use of the rigorous vectorial method allows to better predict the confinement loss of the guided modes compared to approximate methods based on equivalent in-plane bending models.

Cognitive-Behavioral Therapy for Anxiety Disordered Youth: A Randomized Clinical Trial Evaluating Child and Family Modalities

Science.gov (United States)

Kendall, Philip C.; Hudson, Jennifer L.; Gosch, Elizabeth; Flannery-Schroeder, Ellen; Suveg, Cynthia

2008-01-01

This randomized clinical trial compared the relative efficacy of individual (child) cognitive-behavioral therapy (ICBT), family cognitive-behavioral therapy (FCBT), and a family-based education/support/attention (FESA) active control for treating anxiety disordered youth ages 7-14 years (M = 10.27). Youth (N = 161; 44% female; 85% Caucasian, 9%…

Discussion of a Well-Designed Clinical Trial Which Did Not Demonstrate Effectiveness: UIC Center for Botanical Dietary Supplements Research Study of Black Cohosh and Red Clover

Science.gov (United States)

Shulman, Lee P.; Banuvar, Suzanne; Fong, Harry H. S.; Farnsworth, Norman R.

2016-01-01

The performance of a clinical trial for pharmaceutical agents is usually undertaken only after there is likely benefit demonstrated from the use of the putative agent. The consideration of botanical products as pharmaceutical agents must similarly go through a rigorous evaluation process. The present work reviews the recently published Phase II study evaluating the effectiveness of black cohosh and red clover in a randomized trial with conjugated equine estradiol/medroxyprogesterone acetate and placebo for the treatment of menopausal symptoms. We analyze the possible reasons why this study failed to show benefit for either botanical product in reducing menopause-related vasomotor symptoms. PMID:21034798

Clinical and neurobiological effects of aerobic exercise in dental phobia: A randomized controlled trial.

Science.gov (United States)

Lindenberger, Brigitt L; Plag, Jens; Schumacher, Sarah; Gaudlitz, Katharina; Bischoff, Sophie; Bobbert, Thomas; Dimeo, Fernando; Petzold, Moritz B; Kirschbaum, Clemens; Dudás, Zsuzsa; Ströhle, Andreas

2017-11-01

Physical activity has shown to be effective in anxiety disorders. For specific phobia, no studies are available that systematically examined the effects of an aerobic exercise intervention on phobic fear within a randomized-controlled design. Therefore, we investigated the acute effect of a standardized aerobic training on clinical symptoms of dental phobia as well as on stress-related neurobiological markers. Within a crossover design, 30 patients with dental phobia (mean age: 34.1 years; mean score of the Dental Anxiety Scale: 18.8) underwent two minor dental interventions separated by 7 days. Dental treatment was performed after 30 min of physical activity at either 20% VO 2 max (control) or 70% VO 2 max (intervention), respectively. To control for habituation, patients were randomly assigned to one of the two conditions prior to the first intervention. Moreover, saliva samples were collected at five times in order to determine changes in salivary cortisol (sC) and alpha-amylase (sAA) due to treatment. In comparison to baseline, aerobic exercise within 70% VO 2 max significantly reduced clinical anxiety and sC concentrations before, during, and after the dental treatment. In contrast, the control condition led to decreased sAA levels at different time points of measurement. Habituation occurred at the second study day, independent of the order. Our study provides evidence for an effect of moderate-intense exercise on clinical symptoms and sC in patients with dental phobia. Therefore, acute aerobic exercise might be a simple and low-cost intervention to reduce disorder-specific phobic fear. © 2017 Wiley Periodicals, Inc.

Dropout from individual psychotherapy for major depression: A meta-analysis of randomized clinical trials.

Science.gov (United States)

Cooper, Andrew A; Conklin, Laren R

2015-08-01

Dropout from mental health treatment poses a substantial problem, but rates vary substantially across studies and diagnoses. Focused reviews are needed to provide more detailed estimates for specific areas of research. Randomized clinical trials involving individual psychotherapy for unipolar depression are ubiquitous and important, but empirical data on average dropout rates from these studies is lacking. We conducted a random-effects meta-analysis of 54 such studies (N=5852) including 80 psychotherapy conditions, and evaluated a number of predictors of treatment- and study-level dropout rates. Our overall weighted dropout estimates were 19.9% at the study level, and 17.5% for psychotherapy conditions specifically. Therapy orientation did not significantly account for variance in dropout estimates, but estimates were significantly higher in psychotherapy conditions with more patients of minority racial status or with comorbid personality disorders. Treatment duration was also positively associated with dropout rates at trend level. Studies with an inactive control comparison had higher dropout rates than those without such a condition. Limitations include the inability to test certain potential predictors (e.g., socioeconomic status) due to infrequent reporting. Overall, our findings suggest the need to consider how specific patient and study characteristics may influence dropout rates in clinical research on individual therapy for depression. Copyright © 2015 Elsevier Ltd. All rights reserved.

Objective and subjective measures of simultaneous vs sequential bilateral cochlear implants in adults : A randomized clinical trial

NARCIS (Netherlands)

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

2017-01-01

IMPORTANCE: To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed.  OBJECTIVE: To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential

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

NARCIS (Netherlands)

Kraaijenga, V.J.; Ramakers, G.G.; Smulders, Y.E.; Zon, A. van; Stegeman, I.; Smit, A.L.; Stokroos, R.J.; Hendrice, N.; Free, R.H.; Maat, B.; Frijns, J.H.; Briaire, J.J.; Mylanus, E.A.M.; Huinck, W.J.; Zanten, G.A.; Grolman, W.

2017-01-01

Importance: To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. Objective: To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential

A quantum-like model of homeopathy clinical trials: importance of in situ randomization and unblinding.

Science.gov (United States)

Beauvais, Francis

2013-04-01

The randomized controlled trial (RCT) is the 'gold standard' of modern clinical pharmacology. However, for many practitioners of homeopathy, blind RCTs are an inadequate research tool for testing complex therapies such as homeopathy. Classical probabilities used in biological sciences and in medicine are only a special case of the generalized theory of probability used in quantum physics. I describe homeopathy trials using a quantum-like statistical model, a model inspired by quantum physics and taking into consideration superposition of states, non-commuting observables, probability interferences, contextuality, etc. The negative effect of blinding on success of homeopathy trials and the 'smearing effect' ('specific' effects of homeopathy medicine occurring in the placebo group) are described by quantum-like probabilities without supplementary ad hoc hypotheses. The difference of positive outcome rates between placebo and homeopathy groups frequently vanish in centralized blind trials. The model proposed here suggests a way to circumvent such problems in masked homeopathy trials by incorporating in situ randomization/unblinding. In this quantum-like model of homeopathy clinical trials, success in open-label setting and failure with centralized blind RCTs emerge logically from the formalism. This model suggests that significant differences between placebo and homeopathy in blind RCTs would be found more frequently if in situ randomization/unblinding was used. Copyright © 2013. Published by Elsevier Ltd.

Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

Science.gov (United States)

McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

2018-03-08

We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

Science.gov (United States)

Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

2017-06-01

Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms. Copyright © 2017 American Dairy Science Association. Published by

A rigorous proof of the Landau-Peierls formula and much more

DEFF Research Database (Denmark)

Briet, Philippe; Cornean, Horia; Savoie, Baptiste

2012-01-01

We present a rigorous mathematical treatment of the zero-field orbital magnetic susceptibility of a non-interacting Bloch electron gas, at fixed temperature and density, for both metals and semiconductors/insulators. In particular, we obtain the Landau-Peierls formula in the low temperature and d...... and density limit as conjectured by Kjeldaas and Kohn (Phys Rev 105:806–813, 1957)....

Asymptotic Modeling of Coherent Scattering from Random Rough Layers: Application to Road Survey by GPR at Nadir

Directory of Open Access Journals (Sweden)

Nicolas Pinel

2012-01-01

Full Text Available This paper studies the coherent scattering from random rough layers made up of two uncorrelated random rough surfaces, by considering 2D problems. The results from a rigorous electromagnetic method called PILE (propagation-inside-layer expansion are used as a reference. Also, two asymptotic analytical approaches are presented and compared to the numerical model for comparison. The cases of surfaces with both Gaussian and exponential correlations are studied. This approach is applied to road survey by GPR at nadir.

Effects of Continuous Positive Airway Pressure on Cognitive Deficits in Middle-aged Patients with Obstructive Sleep Apnea Syndrome: A Meta-analysis of Randomized Controlled Trials

Directory of Open Access Journals (Sweden)

Yue-Ying Pan

2015-01-01

Conclusions: Cognition partially improved in patients with OSAS after CPAP treatment. The only domain with significant improvement was vigilance. Rigorous randomized controlled trials need to be performed to obtain clear results.

The recolonization hypothesis in a full-mouth or multiple-session treatment protocol: a blinded, randomized clinical trial.

Science.gov (United States)

Zijnge, Vincent; Meijer, Henriette F; Lie, Mady-Ann; Tromp, Jan A H; Degener, John E; Harmsen, Hermie J M; Abbas, Frank

2010-06-01

To test recolonization of periodontal lesions after full-mouth scaling and root planing (FM-SRP) or multiple session-SRP (MS-SRP) in a randomized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes. Thirty-nine subjects were randomly assigned to FM-SRP or MS-SRP groups. At baseline and after 3 months, probing pocket depth (PPD), plaque index (PlI) and bleeding on probing (BoP) were recorded. At baseline, immediately after treatment, after 1, 2, 7, 14 and 90 days, paper point samples from a single site from the maxillary right quadrant were collected for microbiological analysis of five putative pathogens by polymerase chain reaction. FM-SRP and MS-SRP resulted in significant reductions in PPD, BoP and PlI and the overall detection frequencies of the five species after 3 months without significant differences between treatments. Compared with MS-SRP, FM-SRP resulted in less recolonization of the five species, significantly for Treponema denticola, in the tested sites. FM-SRP and MS-SRP result in overall clinically and microbiologically comparable outcomes where recolonization of periodontal lesions may be better prevented by FM-SRP.

Generated effect modifiers (GEM's) in randomized clinical trials.

Science.gov (United States)

Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R Todd

2017-01-01

In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an "effect modifier". Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

Science.gov (United States)

Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

2015-01-01

Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

Science.gov (United States)

Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-09-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

Science.gov (United States)

Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

2016-08-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

Group psychotherapy for eating disorders: A randomized clinical trial and a pre-treatment moderator and mediator analyses

DEFF Research Database (Denmark)

Davidsen, Annika Helgadóttir

disorders in group therapy. We conducted a randomized clinical trial and included 159 adult participants, 156 females and 3 males, diagnosed with bulimia nervosa, binge eating disorder, or eating disorder not otherwise specified according to DSM-IV. Eighty participants were allocated to the experimental...

Comparison between conventional and piezoelectric surgical tools for maxillary sinus floor elevation : a randomized controlled clinical trial

NARCIS (Netherlands)

Rickert, Daniela; Vissink, Arjan; Huddleston Slater, James; Meijer, Henny J. A.; Raghoebar, Gerry M.

Aim: The aim of this study was to assess the performance of conventional rotative instruments and a piezoelectric device for maxillary sinus floor elevation surgery, and to assess whether application of a resorbable membrane reduces resorption of an augmented site in a randomized clinical trial.

Universality for 1d Random Band Matrices: Sigma-Model Approximation

Science.gov (United States)

Shcherbina, Mariya; Shcherbina, Tatyana

2018-02-01

The paper continues the development of the rigorous supersymmetric transfer matrix approach to the random band matrices started in (J Stat Phys 164:1233-1260, 2016; Commun Math Phys 351:1009-1044, 2017). We consider random Hermitian block band matrices consisting of W× W random Gaussian blocks (parametrized by j,k \\in Λ =[1,n]^d\\cap Z^d ) with a fixed entry's variance J_{jk}=δ _{j,k}W^{-1}+β Δ _{j,k}W^{-2} , β >0 in each block. Taking the limit W→ ∞ with fixed n and β , we derive the sigma-model approximation of the second correlation function similar to Efetov's one. Then, considering the limit β , n→ ∞, we prove that in the dimension d=1 the behaviour of the sigma-model approximation in the bulk of the spectrum, as β ≫ n , is determined by the classical Wigner-Dyson statistics.

Effectiveness and cost effectiveness of cognitive behavioral therapy (CBT) in clinically depressed adolescents: individual CBT versus treatment as usual (TAU).

Science.gov (United States)

Stikkelbroek, Yvonne; Bodden, Denise Hm; Deković, Maja; van Baar, Anneloes L

2013-11-21

Depressive disorders occur in 2 to 5% of the adolescents and are associated with a high burden of disease, a high risk of recurrence and a heightened risk for development of other problems, like suicide attempts. The effectiveness of cognitive behaviour therapy (CBT), cost-effectiveness of this treatment and the costs of illness of clinical depression in adolescents are still unclear. Although several Randomized Controlled Trials (RCT) have been conducted to establish the efficacy of CBT, the effectiveness has not been established yet. Aim of this study is to conduct a RCT to test the effectiveness of CBT and to establish the cost-effectiveness of CBT under rigorous conditions within routine care provided by professionals already working in mental health institutions. CBT is investigated with a multi-site, RCT using block randomisation. The targeted population is 140 clinically referred depressed adolescents aged 12 to 21 years old. Adolescents are randomly assigned to the experimental (N = 70, CBT) or control condition (N = 70, TAU). Four assessments (pre, post, follow up at 6 and 12 months) and two mediator assessments during treatment are conducted. Primary outcome measure is depression diagnosis based on a semi-structured interview namely the K-SADS-PL. Secondary outcome measures include depressive symptoms, severity and improvement of the depression, global functioning, quality of life, suicide risk, comorbidity, alcohol and drug use, parental depression and psychopathology, parenting and conflicts. Costs and treatment characteristics will also be assessed. Furthermore, moderator and mediator analyses will be conducted. This trial will be the first to compare CBT with TAU under rigorous conditions within routine care and with a complex sample. Furthermore, cost-effectiveness of treatment and cost-of-illness of clinical depression are established which will provide new insights on depression as a disorder and its treatment. Dutch Trial register number

Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clinical trial

NARCIS (Netherlands)

Azaripour, Adriano; Kissinger, Maren; Farina, Vittorio Siro Leone; van Noorden, Cornelis J. F.; Gerhold-Ay, Aslihan; Willershausen, Brita; Cortellini, Pierpaolo

2016-01-01

Aim: The aim of this randomized clinical trial was to compare the coronally advanced flap (CAF) with the modified microsurgical tunnel technique (MMTT) for treatment of Miller class I and II recessions. Material and Methods: Forty patients with 71 gingival recessions were recruited and randomly

Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial.

Science.gov (United States)

Hudson, James I; McElroy, Susan L; Ferreira-Cornwell, M Celeste; Radewonuk, Jana; Gasior, Maria

2017-09-01

The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions-Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Lisdexamfetamine administration. The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over

Which orthodontic appliance is best for oral hygiene? A randomized clinical trial.

Science.gov (United States)

Chhibber, Aditya; Agarwal, Sachin; Yadav, Sumit; Kuo, Chia-Ling; Upadhyay, Madhur

2018-02-01

Clear aligners and to a lesser extent self-ligated brackets are considered to facilitate better oral hygiene than traditional fixed orthodontic appliances. This 3-arm parallel-group prospective randomized clinical trial compared the long-term and short-term effects of clear aligners, self-ligated brackets, and conventional (elastomeric-ligated) brackets on patients' oral hygiene during active orthodontic treatment. Seventy-one participants (41 boys, 30 girls; mean age, 15.6 years) undergoing orthodontic treatment were randomly allocated through a computer-generated randomization schedule to one of the groups based on the choice of intervention: Clear Aligners (CLA) (Align Technology, San Jose, Calif) (n = 27), preadjusted edgewise fixed appliance with self-ligated brackets (SLB) (Carriere, Carlsbad, Calif (n = 22), or preadjusted edgewise fixed appliance with elastomeric ligated brackets (ELB) (Ortho Organizers Inc., Carlsbad, CA) (n = 22). For each participant, the primary outcome, plaque index (PI), and secondary outcomes, gingival Index (GI) and periodontal bleeding index (PBI), were measured at baseline (T0), after 9 months of treatment (T1), and after 18 months of treatment (T2). Blinding of the clinicians and the patients to the intervention was impossible. It was only done for outcome assessment and for the statistician. Ten participants did not receive the allocated intervention for various reasons. The means and standard deviations of PI at T0 (CLA, 0.50 ± 0.51; SLB, 0.65 ± 0.49; ELB, 0.70 ± 0.73), T1 (CLA, 0.83 ± 0.48; SLB, 1.38 ± 0.72; ELB, 1.32 ± 0.67), and T2 (CLA, 0.92 ± 0.58; SLB, 1.07 ± 0.59; ELB, 1.32 ± 0.67) were similar. The odds ratio (OR) for plaque index (0 or ≥1) comparing SLB or CLA to ELB was not significant. OR for SLB vs ELB = 1.54 at T0 (95% CI, 0.39-6.27), 0.88 at T1 (95% CI, 0.03-24.69), and 0.83 at T2 (95% CI, 0.02-27.70); OR for CLA vs ELB = 1.07 at T0 (95% CI, 0.30-3.88), 0.24 at T1 (95% CI

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

Science.gov (United States)

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Two-year Randomized Clinical Trial of Self-etching Adhesives and Selective Enamel Etching.

Science.gov (United States)

Pena, C E; Rodrigues, J A; Ely, C; Giannini, M; Reis, A F

2016-01-01

The aim of this randomized, controlled prospective clinical trial was to evaluate the clinical effectiveness of restoring noncarious cervical lesions with two self-etching adhesive systems applied with or without selective enamel etching. A one-step self-etching adhesive (Xeno V(+)) and a two-step self-etching system (Clearfil SE Bond) were used. The effectiveness of phosphoric acid selective etching of enamel margins was also evaluated. Fifty-six cavities were restored with each adhesive system and divided into two subgroups (n=28; etch and non-etch). All 112 cavities were restored with the nanohybrid composite Esthet.X HD. The clinical effectiveness of restorations was recorded in terms of retention, marginal integrity, marginal staining, caries recurrence, and postoperative sensitivity after 3, 6, 12, 18, and 24 months (modified United States Public Health Service). The Friedman test detected significant differences only after 18 months for marginal staining in the groups Clearfil SE non-etch (p=0.009) and Xeno V(+) etch (p=0.004). One restoration was lost during the trial (Xeno V(+) etch; p>0.05). Although an increase in marginal staining was recorded for groups Clearfil SE non-etch and Xeno V(+) etch, the clinical effectiveness of restorations was considered acceptable for the single-step and two-step self-etching systems with or without selective enamel etching in this 24-month clinical trial.

College Readiness in California: A Look at Rigorous High School Course-Taking

Science.gov (United States)

Gao, Niu

2016-01-01

Recognizing the educational and economic benefits of a college degree, education policymakers at the federal, state, and local levels have made college preparation a priority. There are many ways to measure college readiness, but one key component is rigorous high school coursework. California has not yet adopted a statewide college readiness…

Rigor in Qualitative Supply Chain Management Research

DEFF Research Database (Denmark)

Goffin, Keith; Raja, Jawwad; Claes, Björn

2012-01-01

, reliability, and theoretical saturation. Originality/value – It is the authors' contention that the addition of the repertory grid technique to the toolset of methods used by logistics and supply chain management researchers can only enhance insights and the building of robust theories. Qualitative studies......Purpose – The purpose of this paper is to share the authors' experiences of using the repertory grid technique in two supply chain management studies. The paper aims to demonstrate how the two studies provided insights into how qualitative techniques such as the repertory grid can be made more...... rigorous than in the past, and how results can be generated that are inaccessible using quantitative methods. Design/methodology/approach – This paper presents two studies undertaken using the repertory grid technique to illustrate its application in supply chain management research. Findings – The paper...

How to Map Theory: Reliable Methods Are Fruitless Without Rigorous Theory.

Science.gov (United States)

Gray, Kurt

2017-09-01

Good science requires both reliable methods and rigorous theory. Theory allows us to build a unified structure of knowledge, to connect the dots of individual studies and reveal the bigger picture. Some have criticized the proliferation of pet "Theories," but generic "theory" is essential to healthy science, because questions of theory are ultimately those of validity. Although reliable methods and rigorous theory are synergistic, Action Identification suggests psychological tension between them: The more we focus on methodological details, the less we notice the broader connections. Therefore, psychology needs to supplement training in methods (how to design studies and analyze data) with training in theory (how to connect studies and synthesize ideas). This article provides a technique for visually outlining theory: theory mapping. Theory mapping contains five elements, which are illustrated with moral judgment and with cars. Also included are 15 additional theory maps provided by experts in emotion, culture, priming, power, stress, ideology, morality, marketing, decision-making, and more (see all at theorymaps.org ). Theory mapping provides both precision and synthesis, which helps to resolve arguments, prevent redundancies, assess the theoretical contribution of papers, and evaluate the likelihood of surprising effects.

Outcomes of Vogt-Koyanagi-Harada disease: a subanalysis from a randomized clinical trial of antimetabolite therapies

Science.gov (United States)

Shen, Elizabeth; Rathinam, Sivakumar R.; Babu, Manohar; Kanakath, Anuradha; Thundikandy, Radhika; Lee, Salena M.; Browne, Erica N.; Porco, Travis C.; Acharya, Nisha R.

2016-01-01

Purpose To report outcomes of Vogt-Koyanagi-Harada (VKH) disease from a clinical trial of antimetabolite therapies. Design Subanalysis from an observer-masked randomized clinical trial for non-infectious intermediate, posterior, and pan- uveitis. Methods Setting clinical practice at Aravind Eye Hospitals, India Patient Population Forty-three of 80 patients enrolled (54%) diagnosed with VKH. Intervention Patients were randomized to either 25mg oral methotrexate weekly or 1g mycophenolate mofetil twice daily, with a corticosteroid taper. Main outcome measures Primary outcome was corticosteroid-sparing control of inflammation at 5 and 6 months. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Patients were categorized as acute (diagnosis ≤3 months prior to enrollment) or chronic (diagnosis >3 months prior to enrollment). Results Twenty-seven patients were randomized to methotrexate and 16 to mycophenolate mofetil; 30 had acute VKH. The odds of achieving corticosteroid-sparing control of inflammation with methotrexate were 2.5 times (95% CI: 0.6, 9.8; P=0.20) the odds with mycophenolate mofetil, a difference which was not statistically significant. The average improvement in visual acuity was 12.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. On average, visual acuity for patients with acute VKH improved by 14 more ETDRS letters than those with chronic VKH (P<0.001), but there was no difference in corticosteroid-sparing control of inflammation (P=0.99). All 26 eyes with a serous retinal detachment at baseline resolved, and 88% achieved corticosteroid-sparing control of inflammation. Conclusions The majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months. Although patients with acute VKH gained more visual improvement than those with chronic VKH, this did not correspond with a higher rate of controlled inflammation. PMID

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: a 3-year randomized clinical trial.

Science.gov (United States)

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele

2012-02-01

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.

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

Science.gov (United States)

Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

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

Science.gov (United States)

Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

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

Mental skills training with basic combat training soldiers: A group-randomized trial.

Science.gov (United States)

Adler, Amy B; Bliese, Paul D; Pickering, Michael A; Hammermeister, Jon; Williams, Jason; Harada, Coreen; Csoka, Louis; Holliday, Bernie; Ohlson, Carl

2015-11-01

Cognitive skills training has been linked to greater skills, self-efficacy, and performance. Although research in a variety of organizational settings has demonstrated training efficacy, few studies have assessed cognitive skills training using rigorous, longitudinal, randomized trials with active controls. The present study examined cognitive skills training in a high-risk occupation by randomizing 48 platoons (N = 2,432 soldiers) in basic combat training to either (a) mental skills training or (b) an active comparison condition (military history). Surveys were conducted at baseline and 3 times across the 10-week course. Multilevel mixed-effects models revealed that soldiers in the mental skills training condition reported greater use of a range of cognitive skills and increased confidence relative to those in the control condition. Soldiers in the mental skills training condition also performed better on obstacle course events, rappelling, physical fitness, and initial weapons qualification scores, although effects were generally moderated by gender and previous experience. Overall, effects were small; however, given the rigor of the design, the findings clearly contribute to the broader literature by providing supporting evidence that cognitive training skills can enhance performance in occupational and sports settings. Future research should address gender and experience to determine the need for targeting such training appropriately. (c) 2015 APA, all rights reserved).

Sunlight exposure or vitamin D supplementation for vitamin D-deficient non-western immigrants: a randomized clinical trial

NARCIS (Netherlands)

Wicherts, I.S.; Boeke, A.J.P.; van der Meer, I.M.; van Schoor, N.M.; Knol, D.L.; Lips, P.T.A.M.

2011-01-01

Summary: Vitamin D deficiency is very common in non-western immigrants. In this randomized clinical trial, vitamin D 800 IU/day or 100,000 IU/3 months were compared with advised sunlight exposure. Vitamin D supplementation was more effective than advised sunlight exposure in improving vitamin D

Optimal correction and design parameter search by modern methods of rigorous global optimization

International Nuclear Information System (INIS)

Makino, K.; Berz, M.

2011-01-01

Frequently the design of schemes for correction of aberrations or the determination of possible operating ranges for beamlines and cells in synchrotrons exhibit multitudes of possibilities for their correction, usually appearing in disconnected regions of parameter space which cannot be directly qualified by analytical means. In such cases, frequently an abundance of optimization runs are carried out, each of which determines a local minimum depending on the specific chosen initial conditions. Practical solutions are then obtained through an often extended interplay of experienced manual adjustment of certain suitable parameters and local searches by varying other parameters. However, in a formal sense this problem can be viewed as a global optimization problem, i.e. the determination of all solutions within a certain range of parameters that lead to a specific optimum. For example, it may be of interest to find all possible settings of multiple quadrupoles that can achieve imaging; or to find ahead of time all possible settings that achieve a particular tune; or to find all possible manners to adjust nonlinear parameters to achieve correction of high order aberrations. These tasks can easily be phrased in terms of such an optimization problem; but while mathematically this formulation is often straightforward, it has been common belief that it is of limited practical value since the resulting optimization problem cannot usually be solved. However, recent significant advances in modern methods of rigorous global optimization make these methods feasible for optics design for the first time. The key ideas of the method lie in an interplay of rigorous local underestimators of the objective functions, and by using the underestimators to rigorously iteratively eliminate regions that lie above already known upper bounds of the minima, in what is commonly known as a branch-and-bound approach. Recent enhancements of the Differential Algebraic methods used in particle

Surgical-site infections and postoperative complications: agreement between the Danish Gynecological Cancer Database and a randomized clinical trial

DEFF Research Database (Denmark)

Antonsen, Sofie L; Meyhoff, Christian Sylvest; Lundvall, Lene

2011-01-01

between November 2006 and October 2008 and data from the DGCD. METHODS: Outcomes within 30 days from the trial and the database were compared and levels of agreements were calculated with kappa-statistics. MAIN OUTCOME MEASURES: Primary outcome was surgical-site infection. Other outcomes included re-operation...... registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia). CONCLUSIONS: The randomized trial reported significantly more surgical-site infections......OBJECTIVE: Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits. DESIGN...

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

Science.gov (United States)

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison.

Science.gov (United States)

Gordon, Michael S; Kinlock, Timothy W; Couvillion, Kathryn A; Schwartz, Robert P; O'Grady, Kevin

2012-05-01

The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly assigned to one of three treatment conditions: counseling only (counseling in prison; n= 70); counseling plus transfer (counseling in prison with transfer to methadone maintenance treatment upon release; n= 70); and counseling plus methadone (methadone maintenance in prison, continued in a community-based methadone maintenance program upon release; n= 71). Entered prison treatment (p prison treatment (pprison sentences may have better outcomes than younger individuals with shorter sentences, meaning they are more likely to enter and complete prison-based treatment. Furthermore, implications for the treatment of prisoners with prior heroin dependence and for conducting clinical trials may indicate the importance of examining individual characteristics and the possibility of the examination of patient preference.

Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial.

Science.gov (United States)

McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-06-01

Exercise using virtual reality (VR) has improved balance in adults with traumatic brain injury and community-dwelling older adults. Rigorous randomized studies regarding its efficacy, safety, and applicability with individuals after stroke are lacking. The purpose of this study was to determine whether an adjunct VR therapy improves balance, mobility, and gait in stroke rehabilitation inpatients. A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed. The treatment group (n=30) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance (eg, soccer goaltending, snowboarding) performed while standing. The control group (n=29) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance (performed in sitting). VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period. Objective outcome measures of balance and mobility were assessed before, immediately after, and 1 month after training. Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test, with both groups meeting minimal clinical important differences after training. More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain (P=0.04) immediately after training. This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes. Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR. http://www.ANZCTR.org.au/. Unique identifier: ACTRN12613000710729. © 2014 American Heart Association, Inc.

Volume Holograms in Photopolymers: Comparison between Analytical and Rigorous Theories

Directory of Open Access Journals (Sweden)

Augusto Beléndez

2012-08-01

Full Text Available There is no doubt that the concept of volume holography has led to an incredibly great amount of scientific research and technological applications. One of these applications is the use of volume holograms as optical memories, and in particular, the use of a photosensitive medium like a photopolymeric material to record information in all its volume. In this work we analyze the applicability of Kogelnik’s Coupled Wave theory to the study of volume holograms recorded in photopolymers. Some of the theoretical models in the literature describing the mechanism of hologram formation in photopolymer materials use Kogelnik’s theory to analyze the gratings recorded in photopolymeric materials. If Kogelnik’s theory cannot be applied is necessary to use a more general Coupled Wave theory (CW or the Rigorous Coupled Wave theory (RCW. The RCW does not incorporate any approximation and thus, since it is rigorous, permits judging the accurateness of the approximations included in Kogelnik’s and CW theories. In this article, a comparison between the predictions of the three theories for phase transmission diffraction gratings is carried out. We have demonstrated the agreement in the prediction of CW and RCW and the validity of Kogelnik’s theory only for gratings with spatial frequencies higher than 500 lines/mm for the usual values of the refractive index modulations obtained in photopolymers.

Volume Holograms in Photopolymers: Comparison between Analytical and Rigorous Theories

Science.gov (United States)

Gallego, Sergi; Neipp, Cristian; Estepa, Luis A.; Ortuño, Manuel; Márquez, Andrés; Francés, Jorge; Pascual, Inmaculada; Beléndez, Augusto

2012-01-01

There is no doubt that the concept of volume holography has led to an incredibly great amount of scientific research and technological applications. One of these applications is the use of volume holograms as optical memories, and in particular, the use of a photosensitive medium like a photopolymeric material to record information in all its volume. In this work we analyze the applicability of Kogelnik’s Coupled Wave theory to the study of volume holograms recorded in photopolymers. Some of the theoretical models in the literature describing the mechanism of hologram formation in photopolymer materials use Kogelnik’s theory to analyze the gratings recorded in photopolymeric materials. If Kogelnik’s theory cannot be applied is necessary to use a more general Coupled Wave theory (CW) or the Rigorous Coupled Wave theory (RCW). The RCW does not incorporate any approximation and thus, since it is rigorous, permits judging the accurateness of the approximations included in Kogelnik’s and CW theories. In this article, a comparison between the predictions of the three theories for phase transmission diffraction gratings is carried out. We have demonstrated the agreement in the prediction of CW and RCW and the validity of Kogelnik’s theory only for gratings with spatial frequencies higher than 500 lines/mm for the usual values of the refractive index modulations obtained in photopolymers.

A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study).

Science.gov (United States)

Gringeri, A; Lundin, B; von Mackensen, S; Mantovani, L; Mannucci, P M

2011-04-01

Prevention of arthropathy is a major goal of hemophilia treatment. While studies in adults have demonstrated an impact of prophylaxis on the incidence of joint bleeds and patients' well-being in terms of improved quality of life (QoL), it is unclear whether or not prophylaxis influences the outcome and perception of well- of children with hemophilia. This randomized controlled study compared the efficacy of prophylaxis with episodic therapy in preventing hemarthroses and image-proven joint damage in children with severe hemophilia A (factor VIII <1%) over a 10-year time period. Forty-five children with severe hemophilia A, aged 1-7 years (median 4), with negative clinical-radiologic joint score at entry and at least one bleed during the previous 6 months, were consecutively randomized to prophylaxis with recombinant factor VIII (25 IU kg(-1) 3 × week) or episodic therapy with ≥25 IU kg(-1) every 12-24 h until complete clinical bleeding resolution. Safety, feasibility, direct costs and QoL were also evaluated. Twenty-one children were assigned to prophylaxis, 19 to episodic treatment. Children on prophylaxis had fewer hemarthroses than children on episodic therapy: 0.20 vs. 0.52 events per patient per month (P < 0.02). Plain-film radiology showed signs of arthropathy in six patients on prophylaxis (29%) vs. 14 on episodic treatment (74%) (P < 0.05). Prophylaxis was more effective when started early (≤36 months), with patients having fewer joint bleeds (0.12 joint bleeds per patient per month) and no radiologic signs of arthropathy. This randomized trial confirms the efficacy of prophylaxis in preventing bleeds and arthropathy in children with hemophilia, particularly when it is initiated early in life. © 2011 International Society on Thrombosis and Haemostasis.

The rigorous bound on the transmission probability for massless scalar field of non-negative-angular-momentum mode emitted from a Myers-Perry black hole

Energy Technology Data Exchange (ETDEWEB)

Ngampitipan, Tritos, E-mail: tritos.ngampitipan@gmail.com [Faculty of Science, Chandrakasem Rajabhat University, Ratchadaphisek Road, Chatuchak, Bangkok 10900 (Thailand); Particle Physics Research Laboratory, Department of Physics, Faculty of Science, Chulalongkorn University, Phayathai Road, Patumwan, Bangkok 10330 (Thailand); Boonserm, Petarpa, E-mail: petarpa.boonserm@gmail.com [Department of Mathematics and Computer Science, Faculty of Science, Chulalongkorn University, Phayathai Road, Patumwan, Bangkok 10330 (Thailand); Chatrabhuti, Auttakit, E-mail: dma3ac2@gmail.com [Particle Physics Research Laboratory, Department of Physics, Faculty of Science, Chulalongkorn University, Phayathai Road, Patumwan, Bangkok 10330 (Thailand); Visser, Matt, E-mail: matt.visser@msor.vuw.ac.nz [School of Mathematics, Statistics, and Operations Research, Victoria University of Wellington, PO Box 600, Wellington 6140 (New Zealand)

2016-06-02

Hawking radiation is the evidence for the existence of black hole. What an observer can measure through Hawking radiation is the transmission probability. In the laboratory, miniature black holes can successfully be generated. The generated black holes are, most commonly, Myers-Perry black holes. In this paper, we will derive the rigorous bounds on the transmission probabilities for massless scalar fields of non-negative-angular-momentum modes emitted from a generated Myers-Perry black hole in six, seven, and eight dimensions. The results show that for low energy, the rigorous bounds increase with the increase in the energy of emitted particles. However, for high energy, the rigorous bounds decrease with the increase in the energy of emitted particles. When the black holes spin faster, the rigorous bounds decrease. For dimension dependence, the rigorous bounds also decrease with the increase in the number of extra dimensions. Furthermore, as comparison to the approximate transmission probability, the rigorous bound is proven to be useful.

The rigorous bound on the transmission probability for massless scalar field of non-negative-angular-momentum mode emitted from a Myers-Perry black hole

International Nuclear Information System (INIS)

Ngampitipan, Tritos; Boonserm, Petarpa; Chatrabhuti, Auttakit; Visser, Matt

2016-01-01

Hawking radiation is the evidence for the existence of black hole. What an observer can measure through Hawking radiation is the transmission probability. In the laboratory, miniature black holes can successfully be generated. The generated black holes are, most commonly, Myers-Perry black holes. In this paper, we will derive the rigorous bounds on the transmission probabilities for massless scalar fields of non-negative-angular-momentum modes emitted from a generated Myers-Perry black hole in six, seven, and eight dimensions. The results show that for low energy, the rigorous bounds increase with the increase in the energy of emitted particles. However, for high energy, the rigorous bounds decrease with the increase in the energy of emitted particles. When the black holes spin faster, the rigorous bounds decrease. For dimension dependence, the rigorous bounds also decrease with the increase in the number of extra dimensions. Furthermore, as comparison to the approximate transmission probability, the rigorous bound is proven to be useful.

Some comments on rigorous quantum field path integrals in the analytical regularization scheme

Energy Technology Data Exchange (ETDEWEB)

Botelho, Luiz C.L. [Universidade Federal Fluminense (UFF), Niteroi, RJ (Brazil). Dept. de Matematica Aplicada]. E-mail: botelho.luiz@superig.com.br

2008-07-01

Through the systematic use of the Minlos theorem on the support of cylindrical measures on R{sup {infinity}}, we produce several mathematically rigorous path integrals in interacting euclidean quantum fields with Gaussian free measures defined by generalized powers of the Laplacian operator. (author)

Some comments on rigorous quantum field path integrals in the analytical regularization scheme

International Nuclear Information System (INIS)

Botelho, Luiz C.L.

2008-01-01

Through the systematic use of the Minlos theorem on the support of cylindrical measures on R ∞ , we produce several mathematically rigorous path integrals in interacting euclidean quantum fields with Gaussian free measures defined by generalized powers of the Laplacian operator. (author)

A plea for rigorous conceptual analysis as central method in transnational law design

NARCIS (Netherlands)

Rijgersberg, R.; van der Kaaij, H.

2013-01-01

Although shared problems are generally easily identified in transnational law design, it is considerably more difficult to design frameworks that transcend the peculiarities of local law in a univocal fashion. The following exposition is a plea for giving more prominence to rigorous conceptual

Orthodontic treatment simultaneous to or after periodontal cause-related treatment in periodontitis susceptible patients. Part I: Clinical outcome. A randomized clinical trial.

Science.gov (United States)

Zasčiurinskienė, Eglė; Basevičienė, Nomeda; Lindsten, Rune; Slotte, Christer; Jansson, Henrik; Bjerklin, Krister

2018-02-01

To compare two treatment strategies regarding the effect of orthodontic treatment on periodontal status in patients with plaque-induced periodontitis. This was a randomized clinical trial. Fifty periodontal patients were randomly assigned to the test or control groups according to periodontal treatment timing. All patients received supra- and subgingival debridement following baseline examination. Control group patients received cause-related periodontal treatment before the start of orthodontic treatment and which was performed simultaneous to orthodontic treatment for the test group patients. No difference between the test and control groups was found regarding change of clinical attachment level (CAL) after periodontal-orthodontic treatment. Fewer sites with initial pocket depth (PD) of 4-6 mm healed after periodontal-orthodontic treatment in the test group (20.5%, IQR = 11.9%) in comparison with controls (30.4%, IQR = 27.1%) (p = .03). Anterior teeth [OR 2.5] and teeth in male patients [OR 1.6] had a greater chance for PD improvement ≥2 mm. Total periodontal-orthodontic treatment duration was significantly longer for the control group (p Orthodontic treatment, simultaneously to the periodontal treatment, could be used in the routine treatment of patients with plaque-induced periodontitis. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

Science.gov (United States)

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

Science.gov (United States)

Graham, Amanda L; Burke, Michael V; Jacobs, Megan A; Cha, Sarah; Croghan, Ivana T; Schroeder, Darrell R; Moriarty, James P; Borah, Bijan J; Rasmussen, Donna F; Brookover, M Jody; Suesse, Dale B; Midthun, David E; Hays, J Taylor

2017-11-28

Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask-Advise-Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS). The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital

Clinical Trials

Medline Plus

Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

Laparoscopic Anterior Versus Posterior Fundoplication for Gastroesophageal Reflux Disease Systematic Review and Meta-Analysis of Randomized Clinical Trials

NARCIS (Netherlands)

Broeders, Joris A.; Roks, David J.; Ahmed Ali, Usama; Draaisma, Werner A.; Smout, André J.; Hazebroek, Eric J.

2011-01-01

Objective: To compare short- and long-term outcome after laparoscopic anterior fundoplication (LAF) versus posterior fundoplication (LPF) through a systematic review and meta-analysis of randomized clinical trials (RCTs). Summary of Background Data: LPF is currently considered the surgical therapy

Therapeutic Effect of Virtual Reality on Post-Stroke Patients: Randomized Clinical Trial.

Science.gov (United States)

Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz

2017-01-01

The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P < .05. We selected 30 patients, but there were three segment losses, resulting in a total of 13 patients in the control group and 14 in the treatment group. There was an improvement in gait balance and reduced occurrence of falls in both groups. After intervention, the differences in gait balance in the control group (P = .047) and the reduction in the occurrence of falls in the treatment group (P = .049) were significant. However, in intergroup analysis, there was no difference in the two outcomes. Therapy with games was a useful tool for gait balance rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831).

Science.gov (United States)

Kean, James D; Kaufman, Jordy; Lomas, Justine; Goh, Antionette; White, David; Simpson, David; Scholey, Andrew; Singh, Hemant; Sarris, Jerome; Zangara, Andrea; Stough, Con

2015-12-02

Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6-14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners' Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831.

Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

DEFF Research Database (Denmark)

Nordentoft, Merete; Thorup, Anne; Petersen, Lone

2006-01-01

Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care.

Science.gov (United States)

Francis, Nick A; Ridd, Matthew J; Thomas-Jones, Emma; Butler, Christopher C; Hood, Kerenza; Shepherd, Victoria; Marwick, Charis A; Huang, Chao; Longo, Mirella; Wootton, Mandy; Sullivan, Frank

2017-03-01

Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema. We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Children with clinical, non-severely infected eczema were randomized to receive oral and topical placebos (control), oral antibiotic (flucloxacillin) and topical placebo, or topical antibiotic (fusidic acid) and oral placebo, for 1 week. We compared Patient Oriented Eczema Measure (POEM) scores at 2 weeks using analysis of covariance (ANCOVA). We randomized 113 children (40 to control, 36 to oral antibiotic, and 37 to topical antibiotic). Mean (SD) baseline Patient Oriented Eczema Measure scores were 13.4 (5.1) for the control group, 14.6 (5.3) for the oral antibiotic group, and 16.9 (5.5) for the topical antibiotic group. At baseline, 104 children (93%) had 1 or more of the following findings: weeping, crusting, pustules, or painful skin. Mean (SD) POEM scores at 2 weeks were 6.2 (6.0) for control, 8.3 (7.3) for the oral antibiotic group, and 9.3 (6.2) for the topical antibiotic group. Controlling for baseline POEM score, neither oral nor topical antibiotics produced a significant difference in mean (95% CI) POEM scores (1.5 [-1.4 to 4.4] and 1.5 [-1.6 to 4.5] respectively). There were no significant differences in adverse effects and no serious adverse events. We found rapid resolution in response to topical steroid and emollient treatment and ruled out a clinically meaningful benefit from the addition of either oral or topical antibiotics. Children seen in ambulatory care with mild clinically infected eczema do not need treatment with antibiotics. © 2017 Annals of Family Medicine, Inc.

Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

Science.gov (United States)

Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

2017-08-01

Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial

Science.gov (United States)

Dromerick, Alexander W.; Edwardson, Matthew A.; Edwards, Dorothy F.; Giannetti, Margot L.; Barth, Jessica; Brady, Kathaleen P.; Chan, Evan; Tan, Ming T.; Tamboli, Irfan; Chia, Ruth; Orquiza, Michael; Padilla, Robert M.; Cheema, Amrita K.; Mapstone, Mark E.; Fiandaca, Massimo S.; Federoff, Howard J.; Newport, Elissa L.

2015-01-01

Introduction: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2–3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial. PMID

Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial

Directory of Open Access Journals (Sweden)

Alexander W Dromerick

2015-04-01

Full Text Available Introduction: 795,000 Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 hours of upper extremity therapy either immediately upon rehab admission, 2-3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test at one year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial.

The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

Science.gov (United States)

Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

2017-12-01

The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

Generated effect modifiers (GEM’s) in randomized clinical trials

Science.gov (United States)

Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R. Todd

2017-01-01

In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an “effect modifier”. Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. PMID:27465235

The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

Science.gov (United States)

Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

2016-06-01

Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p dysmenorrhea and vit D deficiency could improve pain intensity.

An Exponential Tilt Mixture Model for Time-to-Event Data to Evaluate Treatment Effect Heterogeneity in Randomized Clinical Trials.

Science.gov (United States)

Wang, Chi; Tan, Zhiqiang; Louis, Thomas A

2014-01-01

Evaluating the effect of a treatment on a time-to-event outcome is the focus of many randomized clinical trials. It is often observed that the treatment effect is heterogeneous, where only a subgroup of the patients may respond to the treatment due to some unknown mechanism such as genetic polymorphism. In this paper, we propose a semiparametric exponential tilt mixture model to estimate the proportion of patients who respond to the treatment and to assess the treatment effect. Our model is a natural extension of parametric mixture models to a semiparametric setting with a time-to-event outcome. We propose a nonparametric maximum likelihood estimation approach for inference and establish related asymptotic properties. Our method is illustrated by a randomized clinical trial on biodegradable polymer-delivered chemotherapy for malignant gliomas patients.

MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial.

Science.gov (United States)

Hanser, Thomas; Doliveux, Romain

The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible. Using a randomized protocol, bone blocks were harvested with the MicroSaw and Piezosurgery either from the right or the left side. Clinical outcome parameters were the comparison of osteotomy time; volume of block graft; and clinical determination of intraoperative complications such as hemorrhage, nerve injury, pain, swelling, and healing of the donor site. The mean osteotomy time for harvesting including luxating a bone block was 5.63 (± 1.37) minutes using the MicroSaw and 16.47 (± 2.74) minutes using Piezosurgery (P .05). Swelling did not appear significantly different either (P > .05), and none of the donor sites showed primary healing complications. The data described in this randomized prospective split-mouth clinical trial indicate that the MicroSaw and Piezosurgery allowed efficient and safe bone block harvesting from the external oblique ridge. Clinically, concerning harvesting time and volume of the grafts, the MicroSaw performed significantly better, whereas pain, swelling, and healing did not appear to be considerably different. Given the improved visibility, precise cut geometries, and the margin of safety afforded by the MicroSaw and Piezosurgery, they are both instruments of choice when harvesting bone from the retromolar area.

A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function.

Science.gov (United States)

Jovancevic, Jelena; Rosano, Caterina; Perera, Subashan; Erickson, Kirk I; Studenski, Stephanie

2012-06-06

Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span.The study is IRB approved and the number is: PRO08080012ClinicalTrials.gov Identifier: NCT01443455.

Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Sanatinia Rahil

2012-08-01

Full Text Available Abstract Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention or control treatment (a leaflet on healthy living. Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic

Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial.

Science.gov (United States)

Botkin, Jeffrey R; Rothwell, Erin; Anderson, Rebecca A; Rose, Nancy C; Dolan, Siobhan M; Kuppermann, Miriam; Stark, Louisa A; Goldenberg, Aaron; Wong, Bob

2016-06-01

Research clearly indicates that current approaches to newborn blood spot screening (NBS) education are ineffective. Incorporating NBS education into prenatal care is broadly supported by lay and professional opinion. To determine the efficacy and effect of prenatal education about newborn screening and use of residual dried blood spots (DBS) in research on parental knowledge, attitudes, and behaviors. A randomized clinical trial of prenatal educational interventions, with outcomes measured by survey at 2 to 4 weeks postpartum. Participants were recruited from obstetric clinics in Salt Lake City, Utah; San Francisco, California; and the Bronx, New York. Eligible women were English- or Spanish-speaking adults and did not have a high-risk pregnancy. A total of 901 women were enrolled. Participants who completed the follow-up survey included 212 women in the usual care group (70% retention), 231 in the NBS group (77% retention), and 221 women in the NBS + DBS group (75% retention). Those who completed the survey were similar across the 3 groups with respect to age, ethnicity, race, education, marital status, income, obstetric history, and language. Participants were randomized into 1 of 3 groups: usual care (n = 305), those viewing an NBS movie and brochure (n = 300), and those viewing both the NBS and DBS movies and brochures (n = 296). Two to four weeks postpartum, women completed a 91-item survey by telephone, addressing knowledge, attitudes, and behavior with respect to opting out of NBS or DBS for their child. A total of 901 women (mean age, 31 years) were randomized and 664 completed the follow-up survey. The total correct responses on the knowledge instrument in regard to NBS were 69% in the usual care group, 79% in the NBS group, and 75% in the NBS + DBS group, a significant between-group difference (P Educational interventions can be implemented in the prenatal clinic, using multimedia tools and electronic platforms. Prenatal education is

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

Science.gov (United States)

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

2015-06-01

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

Application of the rigorous method to x-ray and neutron beam scattering on rough surfaces

International Nuclear Information System (INIS)

Goray, Leonid I.

2010-01-01

The paper presents a comprehensive numerical analysis of x-ray and neutron scattering from finite-conducting rough surfaces which is performed in the frame of the boundary integral equation method in a rigorous formulation for high ratios of characteristic dimension to wavelength. The single integral equation obtained involves boundary integrals of the single and double layer potentials. A more general treatment of the energy conservation law applicable to absorption gratings and rough mirrors is considered. In order to compute the scattering intensity of rough surfaces using the forward electromagnetic solver, Monte Carlo simulation is employed to average the deterministic diffraction grating efficiency due to individual surfaces over an ensemble of realizations. Some rules appropriate for numerical implementation of the theory at small wavelength-to-period ratios are presented. The difference between the rigorous approach and approximations can be clearly seen in specular reflectances of Au mirrors with different roughness parameters at wavelengths where grazing incidence occurs at close to or larger than the critical angle. This difference may give rise to wrong estimates of rms roughness and correlation length if they are obtained by comparing experimental data with calculations. Besides, the rigorous approach permits taking into account any known roughness statistics and allows exact computation of diffuse scattering.

A randomized comparison of care provided by a clinical nurse specialist, an inpatient team, and a day patient team in rheumatoid arthritis

NARCIS (Netherlands)

Tijhuis, Gerhardus J.; Zwinderman, Aeilko H.; Hazes, Johanna M. W.; van den Hout, Wilbert B.; Breedveld, Ferdinand C.; Vliet Vlieland, Theodora P. M.

2002-01-01

OBJECTIVES: To compare in a randomized, controlled trial the clinical effectiveness of care delivered by a clinical nurse specialist, inpatient team care, and day patient team care in patients with rheumatoid arthritis (RA) who have increasing functional limitations. METHODS: Between December 1996

A randomized clinical trial of alpha(1)-antitrypsin augmentation therapy.

Science.gov (United States)

Dirksen, A; Dijkman, J H; Madsen, F; Stoel, B; Hutchison, D C; Ulrik, C S; Skovgaard, L T; Kok-Jensen, A; Rudolphus, A; Seersholm, N; Vrooman, H A; Reiber, J H; Hansen, N C; Heckscher, T; Viskum, K; Stolk, J

1999-11-01

We have investigated whether restoration of the balance between neutrophil elastase and its inhibitor, alpha(1)-antitrypsin, can prevent the progression of pulmonary emphysema in patients with alpha(1)-antitrypsin deficiency. Twenty-six Danish and 30 Dutch ex-smokers with alpha(1)-antitrypsin deficiency of PI*ZZ phenotype and moderate emphysema (FEV(1) between 30% and 80% of predicted) participated in a double-blind trial of alpha(1)-antitrypsin augmentation therapy. The patients were randomized to either alpha(1)-antitrypsin (250 mg/kg) or albumin (625 mg/kg) infusions at 4-wk intervals for at least 3 yr. Self-administered spirometry performed every morning and evening at home showed no significant difference in decline of FEV(1) between treatment and placebo. Each year, the degree of emphysema was quantified by the 15th percentile point of the lung density histogram derived from computed tomography (CT). The loss of lung tissue measured by CT (mean +/- SEM) was 2.6 +/- 0.41 g/L/yr for placebo as compared with 1.5 +/- 0.41 g/L/yr for alpha(1)-antitrypsin infusion (p = 0.07). Power analysis showed that this protective effect would be significant in a similar trial with 130 patients. This is in contrast to calculations based on annual decline of FEV(1) showing that 550 patients would be needed to show a 50% reduction of annual decline. We conclude that lung density measurements by CT may facilitate future randomized clinical trials of investigational drugs for a disease in which little progress in therapy has been made in the past 30 yr.

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

Directory of Open Access Journals (Sweden)

Marina de Matos MADRUGA

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

Efficiency versus speed in quantum heat engines: Rigorous constraint from Lieb-Robinson bound

Science.gov (United States)

Shiraishi, Naoto; Tajima, Hiroyasu

2017-08-01

A long-standing open problem whether a heat engine with finite power achieves the Carnot efficiency is investgated. We rigorously prove a general trade-off inequality on thermodynamic efficiency and time interval of a cyclic process with quantum heat engines. In a first step, employing the Lieb-Robinson bound we establish an inequality on the change in a local observable caused by an operation far from support of the local observable. This inequality provides a rigorous characterization of the following intuitive picture that most of the energy emitted from the engine to the cold bath remains near the engine when the cyclic process is finished. Using this description, we prove an upper bound on efficiency with the aid of quantum information geometry. Our result generally excludes the possibility of a process with finite speed at the Carnot efficiency in quantum heat engines. In particular, the obtained constraint covers engines evolving with non-Markovian dynamics, which almost all previous studies on this topic fail to address.

Rigorous Screening Technology for Identifying Suitable CO2 Storage Sites II

Energy Technology Data Exchange (ETDEWEB)

George J. Koperna Jr.; Vello A. Kuuskraa; David E. Riestenberg; Aiysha Sultana; Tyler Van Leeuwen

2009-06-01

This report serves as the final technical report and users manual for the 'Rigorous Screening Technology for Identifying Suitable CO2 Storage Sites II SBIR project. Advanced Resources International has developed a screening tool by which users can technically screen, assess the storage capacity and quantify the costs of CO2 storage in four types of CO2 storage reservoirs. These include CO2-enhanced oil recovery reservoirs, depleted oil and gas fields (non-enhanced oil recovery candidates), deep coal seems that are amenable to CO2-enhanced methane recovery, and saline reservoirs. The screening function assessed whether the reservoir could likely serve as a safe, long-term CO2 storage reservoir. The storage capacity assessment uses rigorous reservoir simulation models to determine the timing, ultimate storage capacity, and potential for enhanced hydrocarbon recovery. Finally, the economic assessment function determines both the field-level and pipeline (transportation) costs for CO2 sequestration in a given reservoir. The screening tool has been peer reviewed at an Electrical Power Research Institute (EPRI) technical meeting in March 2009. A number of useful observations and recommendations emerged from the Workshop on the costs of CO2 transport and storage that could be readily incorporated into a commercial version of the Screening Tool in a Phase III SBIR.

Clinical and microbiological effects of levofloxacin in the treatment of chronic periodontitis: a randomized, placebo-controlled clinical trial.

Science.gov (United States)

Pradeep, Avani R; Singh, Sonender P; Martande, Santosh S; Naik, Savitha B; N, Priyanka; Kalra, Nitish; Suke, Deepak K

2015-08-01

The aim of the present study was to evaluate the clinical and microbiological effect of systemic levofloxacin (LFX) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis (CP). Sixty-five patients with CP were randomly divided into a test (n = 33, SRP and LFX 500 mg, once daily [o.d.]) and a control group (n = 32, SRP and placebo, o.d.). Plaque index (PI), gingival index (GI), percentage of sites with bleeding on probing (%BoP), probing depth (PD), and clinical attachment level (CAL) were recorded at baseline, 10 days, and 1-, 3-, and 6-month intervals. The percentage of sites positive for Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Porphyromonas gingivalis, and Tannerella forsythia were recorded at baseline and at 3 and 6 months. Patients receiving LFX showed statistically-significant improvements in mean PD and CAL. The intergroup difference in PI, GI, and%BoP was not significant at any interval. There was a reduction in the percentage of sites positive for periodontopathic bacteria over the duration of the study in both groups, and a statistically-significant reduction in the number of sites positive for A. actinomycetemcomitans in the LFX group (P < 0.001). Levofloxacin was found to significantly improve the clinical and microbiological parameters in CP individuals. © 2014 Wiley Publishing Asia Pty Ltd.

Clinical effectiveness of diode laser therapy as an adjunct to non-surgical periodontal treatment: a randomized clinical study.

Science.gov (United States)

Dukić, Walter; Bago, Ivona; Aurer, Andrej; Roguljić, Marija

2013-08-01

The aim of this randomized clinical study is to evaluate the effect of a 980-nm diode laser as an adjunct to scaling and root planing (SRP) treatment. Thirty-five patients with chronic periodontitis were selected for the split-mouth clinical study. SRP was performed using a sonic device and hand instruments. Quadrants were equally divided between the right and left sides. Teeth were treated with SRP in two control quadrants (control groups [CG]), and the diode laser was used adjunctively with SRP in contralateral quadrants (laser groups [LG]). Diode laser therapy was applied to periodontal pockets on days 1, 3, and 7 after SRP. Baseline data, including approximal plaque index (API), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL), were recorded before the treatment and 6 and 18 weeks after treatment. Changes in PD and CAL were analyzed separately for initially moderate (4 to 6 mm) and deep (7 to 10 mm) pockets. The results were similar for both groups in terms of API, BOP, PD in deep pockets, and CAL. The laser group showed only significant PD gain in moderate pockets during the baseline to 18-week (P 0.05). The present study indicates that, compared to SRP alone, multiple adjunctive applications of a 980-nm diode laser with SRP showed PD improvements only in moderate periodontal pockets (4 to 6 mm).

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison

Science.gov (United States)

Gordon, Michael S.; Kinlock, Timothy W.; Couvillion, Kathryn A.; Schwartz, Robert P.; O'Grady, Kevin

2012-01-01

The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly…

The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.

NARCIS (Netherlands)

Baar, M.E. van; Dekker, J.; Oostendorp, R.A.B.; Bijl, D.; Voorn, T.B.; Lemmens, J.A.M.; Bijlsma, J.W.J.

1998-01-01

Objective: To determine the effectiveness of exercise therapy in patients with osteoarthritis (OA) of the hip or knee. Methods: A randomized single blind, clinical trial was conducted in a primary care setting. Patients with hip or knee OA by American College of Rheumatology criteria were

Post mortem rigor development in the Egyptian goose (Alopochen aegyptiacus) breast muscle (pectoralis): factors which may affect the tenderness.

Science.gov (United States)

Geldenhuys, Greta; Muller, Nina; Frylinck, Lorinda; Hoffman, Louwrens C

2016-01-15

Baseline research on the toughness of Egyptian goose meat is required. This study therefore investigates the post mortem pH and temperature decline (15 min-4 h 15 min post mortem) in the pectoralis muscle (breast portion) of this gamebird species. It also explores the enzyme activity of the Ca(2+)-dependent protease (calpain system) and the lysosomal cathepsins during the rigor mortis period. No differences were found for any of the variables between genders. The pH decline in the pectoralis muscle occurs quite rapidly (c = -0.806; ultimate pH ∼ 5.86) compared with other species and it is speculated that the high rigor temperature (>20 °C) may contribute to the increased toughness. No calpain I was found in Egyptian goose meat and the µ/m-calpain activity remained constant during the rigor period, while a decrease in calpastatin activity was observed. The cathepsin B, B & L and H activity increased over the rigor period. Further research into the connective tissue content and myofibrillar breakdown during aging is required in order to know if the proteolytic enzymes do in actual fact contribute to tenderisation. © 2015 Society of Chemical Industry.

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

Science.gov (United States)

Bradt, Joke

2012-01-01

Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial.

Science.gov (United States)

Wittneben, J G; Gavric, J; Belser, U C; Bornstein, M M; Joda, T; Chappuis, V; Sailer, I; Brägger, U

2017-02-01

Patients' esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure, resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean DIB (distance from the implant shoulder to the first bone-to-implant contact) of -0.15 mm (group A) and 0.12 mm (group B) at 1 y. There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla

A methodology for the rigorous verification of plasma simulation codes

Science.gov (United States)

Riva, Fabio

2016-10-01

The methodology used to assess the reliability of numerical simulation codes constitutes the Verification and Validation (V&V) procedure. V&V is composed by two separate tasks: the verification, which is a mathematical issue targeted to assess that the physical model is correctly solved, and the validation, which determines the consistency of the code results, and therefore of the physical model, with experimental data. In the present talk we focus our attention on the verification, which in turn is composed by the code verification, targeted to assess that a physical model is correctly implemented in a simulation code, and the solution verification, that quantifies the numerical error affecting a simulation. Bridging the gap between plasma physics and other scientific domains, we introduced for the first time in our domain a rigorous methodology for the code verification, based on the method of manufactured solutions, as well as a solution verification based on the Richardson extrapolation. This methodology was applied to GBS, a three-dimensional fluid code based on a finite difference scheme, used to investigate the plasma turbulence in basic plasma physics experiments and in the tokamak scrape-off layer. Overcoming the difficulty of dealing with a numerical method intrinsically affected by statistical noise, we have now generalized the rigorous verification methodology to simulation codes based on the particle-in-cell algorithm, which are employed to solve Vlasov equation in the investigation of a number of plasma physics phenomena.

Clinical and radiological results of patients treated with three treatment modalities for overdentures on implants of the ITI (R) Dental Implant System - A randomized controlled clinical trial

NARCIS (Netherlands)

Wismeijer, D; van Waas, MAJ; Mulder, J; Vermeeren, JIJF; Kalk, W

In a randomized controlled clinical trial carried out at the Ignatius teaching hospital in Breda, The Netherlands, 110 edentulous patients with severe mandibular bone loss were treated with implants of the ITI(R) Dental Implant System using 3 different treatment strategies: a mandibular overdenture

RIGOROUS PHOTOGRAMMETRIC PROCESSING OF CHANG'E-1 AND CHANG'E-2 STEREO IMAGERY FOR LUNAR TOPOGRAPHIC MAPPING

OpenAIRE

K. Di; Y. Liu; B. Liu; M. Peng

2012-01-01

Chang'E-1(CE-1) and Chang'E-2(CE-2) are the two lunar orbiters of China's lunar exploration program. Topographic mapping using CE-1 and CE-2 images is of great importance for scientific research as well as for preparation of landing and surface operation of Chang'E-3 lunar rover. In this research, we developed rigorous sensor models of CE-1 and CE-2 CCD cameras based on push-broom imaging principle with interior and exterior orientation parameters. Based on the rigorous sensor model, the 3D c...

Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

Science.gov (United States)

Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

2015-06-01

Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

Development of a Clinical Pharmacology Graduate Program at the University of Kentucky.

Science.gov (United States)

Blouin, Robert A.; And Others

1994-01-01

The structure, components, and anticipated outcomes of a University of Kentucky doctoral program in pharmacology are described. The program is designed to develop pharmacy-trained specialists who are interested in rigorous, intensive clinical experience, state-of-the-art coursework, and integrated laboratory-based and clinical dissertation…

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

Science.gov (United States)

Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

2015-01-21

In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials.

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Mahr, Alfred; Golmard, Clara; Pham, Emilie; Iordache, Laura; Deville, Laure; Faure, Pierre

2017-07-01

Scarce studies analyzing adverse event (AE) data from randomized placebo-controlled clinical trials (RPCCTs) of selected illnesses suggested that a substantial proportion of collected AEs are unrelated to the drug taken. This study analyzed the nonspecific AEs occurring with active-drug exposure in RPCCTs for a large range of medical conditions. Randomized placebo-controlled clinical trials published in five prominent medical journals during 2006-2012 were searched. Only trials that evaluated orally or parenterally administered active drugs versus placebo in a head-to-head setting were selected. For AEs reported from ≥10 RPCCTs, Pearson's correlation coefficients (r) were calculated to determine the relationship between AE rates in placebo and active-drug recipients. Random-effects meta-analyses were used to compute proportions of nonspecific AEs, which were truncated at a maximum of 100%, in active-drug recipients. We included 231 trials addressing various medical domains or healthy participants. For the 88 analyzed AE variables, AE rates for placebo and active-drug recipients were in general strongly correlated (r > 0.50) or very strongly correlated (r > 0.80). The pooled proportions of nonspecific AEs for the active-drug recipients were 96.8% (95%CI: 95.5-98.1) for any AEs, 100% (97.9-100) for serious AEs, and 77.7% (72.7-83.2) for drug-related AEs. Results were similar for individual medical domains and healthy participants. The pooled proportion of nonspecificity of 82 system organ class and individual AE types ranged from 38% to 100%. The large proportion of nonspecific AEs reported in active-drug recipients of RPCCTs, including serious and drug-related AEs, highlights the limitations of clinical trial data to determine the tolerability of drugs. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Treatment selection in a randomized clinical trial via covariate-specific treatment effect curves.

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Ma, Yunbei; Zhou, Xiao-Hua

2017-02-01

For time-to-event data in a randomized clinical trial, we proposed two new methods for selecting an optimal treatment for a patient based on the covariate-specific treatment effect curve, which is used to represent the clinical utility of a predictive biomarker. To select an optimal treatment for a patient with a specific biomarker value, we proposed pointwise confidence intervals for each covariate-specific treatment effect curve and the difference between covariate-specific treatment effect curves of two treatments. Furthermore, to select an optimal treatment for a future biomarker-defined subpopulation of patients, we proposed confidence bands for each covariate-specific treatment effect curve and the difference between each pair of covariate-specific treatment effect curve over a fixed interval of biomarker values. We constructed the confidence bands based on a resampling technique. We also conducted simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrated the application of the proposed method in a real-world data set.

Clinical Validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62): Further Evaluation and Clinical Applications

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McAleavey, Andrew A.; Nordberg, Samuel S.; Hayes, Jeffrey A.; Castonguay, Louis G.; Locke, Benjamin D.; Lockard, Allison J.

2012-01-01

Self-report instruments of psychological symptoms are increasingly used in counseling centers but rely on rigorous evaluation of their clinical validity. Three studies reported here (total N = 26,886) investigated the validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62; Locke et al., 2011) as an assessment and…

Patent Foramen Ovale Closure for Secondary Prevention of Cryptogenic Stroke: Updated Meta-Analysis of Randomized Clinical Trials.

Science.gov (United States)

Vaduganathan, Muthiah; Qamar, Arman; Gupta, Ankur; Bajaj, Navkaranbir; Golwala, Harsh B; Pandey, Ambarish; Bhatt, Deepak L

2018-05-01

Patent foramen ovale closure represents a potential secondary prevention strategy for cryptogenic stroke, but available trials have varied by size, device studied, and follow-up. We conducted a systematic search of published randomized clinical trials evaluating patent foramen ovale closure versus medical therapy in patients with recent stroke or transient ischemic attack using PubMED, EMBASE, and Cochrane through September 2017. Weighting was by random effects models. Of 480 studies screened, we included 5 randomized clinical trials in the meta-analysis in which 3440 patients were randomized to patent foramen ovale closure (n = 1829) or medical therapy (n = 1611) and followed for an average of 2.0 to 5.9 years. Index stroke/transient ischemic attack occurred within 6 to 9 months of randomization. The primary end point was composite stroke/transient ischemic attack and death (in 3 trials) or stroke alone (in 2 trials). Patent foramen ovale closure reduced the primary end point (0.70 vs 1.48 events per 100 patient-years; risk ratio [RR], 0.52 [0.29-0.91]; I 2  = 55.0%) and stroke/transient ischemic attack (1.04 vs 2.00 events per 100 patient-years; RR, 0.55 [0.37-0.82]; I 2  = 42.2%) with modest heterogeneity compared with medical therapy. Procedural bleeding was not different between study arms (1.8% vs 1.8%; RR, 0.94 [0.49-1.83]; I 2  = 29.2%), but new-onset atrial fibrillation/flutter was increased with patent foramen ovale closure (6.6% vs 0.7%; RR, 4.69 [2.17-10.12]; I 2  = 29.3%). In patients with recent cryptogenic stroke, patent foramen ovale closure reduces recurrent stroke/transient ischemic attack compared with medical therapy, but is associated with a higher risk of new-onset atrial fibrillation/flutter. Copyright © 2018 Elsevier Inc. All rights reserved.

The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial

NARCIS (Netherlands)

van Baar, M. E.; Dekker, J.; Oostendorp, R. A.; Bijl, D.; Voorn, T. B.; Lemmens, J. A.; Bijlsma, J. W.

1998-01-01

To determine the effectiveness of exercise therapy in patients with osteoarthritis (OA) of the hip or knee. A randomized single blind, clinical trial was conducted in a primary care setting. Patients with hip or knee OA by American College of Rheumatology criteria were selected. Two intervention

Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

Science.gov (United States)

Bueno, Letícia Rossi; Binda, Marcia; Monego, Heleusa; Scherer, Roberta Luísa; Rolim, Karen Machado; Bottini, Alessandra Leal; Fregnani, José H T G; dos Reis, Ricardo

2015-06-01

Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries. Randomized clinical trial. Hospital de Clínicas de Porto Alegre (HCPA). 102 patients that underwent cold knife conization. Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures. blood loss measured in grams. operative time and postoperative intervention. Only the participants were blinded to group assignment. From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082). Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Cardioprotective effects of cocoa: clinical evidence from randomized clinical intervention trials in humans.

Science.gov (United States)

Arranz, Sara; Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Urpi-Sarda, Mireia; Lamuela-Raventos, Rosa M; Estruch, Ramon

2013-06-01

Cocoa is an important source of polyphenols, which comprise 12-18% of its total dry weight. The major phenolic compounds in cocoa and cocoa products are mainly flavonoids such as epicatechin, catechin, and proanthocyanidins. These products contain higher amounts of flavonoids than other polyphenol-rich foods. However, the bioavailability of these compounds depends on other food constituents and their interactions with the food matrix. Many epidemiological and clinical intervention trials have concluded that the ingestion of flavonoids reduces the risk factors of developing cardiovascular disease. This review summarizes the new findings regarding the effects of cocoa and chocolate consumption on cardiovascular risk factors. The mechanisms involved in the cardioprotective effects of cocoa flavonoids include reduction of oxidative stress, inhibition of low-density lipoproteins oxidation and platelet aggregation, vasodilatation of blood vessels, inhibition of the adherence of monocytes to vascular endothelium, promotion of fibrinolysis, and immunomodulatory and anti-inflammatory activity. Scientific evidence supports a cause and effect relationship between consumption of cocoa flavonoids and the maintenance of normal endothelium-dependent vasodilation, which contributes to normal blood flow. However, larger randomized trials are required to definitively establish the impact of cocoa and cocoa products consumption on hard cardiovascular outcomes. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up.

Science.gov (United States)

Freitas, Maria Cristina Carvalho de Almendra; Fagundes, Ticiane Cestari; Modena, Karin Cristina da Silva; Cardia, Guilherme Saintive; Navarro, Maria Fidela de Lima

2018-01-18

This prospective, randomized, split-mouth clinical trial evaluated the clinical performance of conventional glass ionomer cement (GIC; Riva Self-Cure, SDI), supplied in capsules or in powder/liquid kits and placed in Class I cavities in permanent molars by the Atraumatic Restorative Treatment (ART) approach. A total of 80 restorations were randomly placed in 40 patients aged 11-15 years. Each patient received one restoration with each type of GIC. The restorations were evaluated after periods of 15 days (baseline), 6 months, and 1 year, according to ART criteria. Wilcoxon matched pairs, multivariate logistic regression, and Gehan-Wilcoxon tests were used for statistical analysis. Patients were evaluated after 15 days (n=40), 6 months (n=34), and 1 year (n=29). Encapsulated GICs showed significantly superior clinical performance compared with hand-mixed GICs at baseline (p=0.017), 6 months (p=0.001), and 1 year (p=0.026). For hand-mixed GIC, a statistically significant difference was only observed over the period of baseline to 1 year (p=0.001). Encapsulated GIC presented statistically significant differences for the following periods: 6 months to 1 year (p=0.028) and baseline to 1 year (p=0.002). Encapsulated GIC presented superior cumulative survival rate than hand-mixed GIC over one year. Importantly, both GICs exhibited decreased survival over time. Encapsulated GIC promoted better ART performance, with an annual failure rate of 24%; in contrast, hand-mixed GIC demonstrated a failure rate of 42%.

Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

Directory of Open Access Journals (Sweden)

Lona Roll

2013-01-01

Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

Kericho CLinic-based ART Diagnostic Evaluation (CLADE: design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya.

Directory of Open Access Journals (Sweden)

Fredrick K Sawe

Full Text Available Prospective clinical trial data regarding routine HIV-1 viral load (VL monitoring of antiretroviral therapy (ART in non-research clinics of Sub-Saharan Africa are needed for policy makers.CLinic-based ART Diagnostic Evaluation (CLADE is a randomized, controlled trial (RCT evaluating feasibility, superiority, and cost-effectiveness of routine VL vs. standard of care (clinical and immunological monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI+non-NRTI ART. Participants were randomized (1:1 at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics.Over 15 months, 820 adults enrolled at 7 sites with 86-152 enrolled per site. Monthly site enrollment ranged from 2-92 participants. Full (100% informed consent compliance was independently documented. Half (49.9% had HIV diagnosed through voluntary counseling and testing. Study arms were similar: mostly females (57.6% aged 37.6 (SD = 9.0 years with low CD4 (166 [SD = 106] cells/m3. Notable proportions had WHO Stage III or IV disease (28.7%, BMI <18.5 kg/m2 (23.1%, and a history of tuberculosis (5.6% or were receiving tuberculosis treatment (8.2% at ART initiation. In the routine VL arm, 407/409 (99.5% received baseline VL (234,577 SD = 151,055 copies/ml. All participants received lamivudine; 49.8% started zidovudine followed by 38.4% stavudine and 11.8% tenofovir; and, 64.4% received nevirapine as nNRTI (35.6% efavirenz.A RCT can be enrolled successfully in rural, non-research, resource limited, district-level clinics in western Kenya. Many adults presenting for ART have advanced HIV/AIDS, emphasizing the importance of universal HIV testing and linkage-to-care campaigns.ClinicalTrials.gov NCT01791556.

CIRM Alpha Stem Cell Clinics: Collaboratively Addressing Regenerative Medicine Challenges.

Science.gov (United States)

Jamieson, Catriona H M; Millan, Maria T; Creasey, Abla A; Lomax, Geoff; Donohoe, Mary E; Walters, Mark C; Abedi, Mehrdad; Bota, Daniela A; Zaia, John A; Adams, John S

2018-06-01

The California Institute for Regenerative Medicine (CIRM) Alpha Stem Cell Clinic (ASCC) Network was launched in 2015 to address a compelling unmet medical need for rigorous, FDA-regulated, stem cell-related clinical trials for patients with challenging, incurable diseases. Here, we describe our multi-center experiences addressing current and future challenges. Copyright © 2018 Elsevier Inc. All rights reserved.

75 FR 29732 - Career and Technical Education Program-Promoting Rigorous Career and Technical Education Programs...

Science.gov (United States)

2010-05-27

... rigorous knowledge and skills in English- language arts and mathematics that employers and colleges expect... specialists and to access the student outcome data needed to meet annual evaluation and reporting requirements...

Misuse of randomization

DEFF Research Database (Denmark)

Liu, Jianping; Kjaergard, Lise Lotte; Gluud, Christian

2002-01-01

The quality of randomization of Chinese randomized trials on herbal medicines for hepatitis B was assessed. Search strategy and inclusion criteria were based on the published protocol. One hundred and seventy-six randomized clinical trials (RCTs) involving 20,452 patients with chronic hepatitis B...... virus (HBV) infection were identified that tested Chinese medicinal herbs. They were published in 49 Chinese journals. Only 10% (18/176) of the studies reported the method by which they randomized patients. Only two reported allocation concealment and were considered as adequate. Twenty percent (30...

Rigorous Line-Based Transformation Model Using the Generalized Point Strategy for the Rectification of High Resolution Satellite Imagery

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Kun Hu

2016-09-01

Full Text Available High precision geometric rectification of High Resolution Satellite Imagery (HRSI is the basis of digital mapping and Three-Dimensional (3D modeling. Taking advantage of line features as basic geometric control conditions instead of control points, the Line-Based Transformation Model (LBTM provides a practical and efficient way of image rectification. It is competent to build the mathematical relationship between image space and the corresponding object space accurately, while it reduces the workloads of ground control and feature recognition dramatically. Based on generalization and the analysis of existing LBTMs, a novel rigorous LBTM is proposed in this paper, which can further eliminate the geometric deformation caused by sensor inclination and terrain variation. This improved nonlinear LBTM is constructed based on a generalized point strategy and resolved by least squares overall adjustment. Geo-positioning accuracy experiments with IKONOS, GeoEye-1 and ZiYuan-3 satellite imagery are performed to compare rigorous LBTM with other relevant line-based and point-based transformation models. Both theoretic analysis and experimental results demonstrate that the rigorous LBTM is more accurate and reliable without adding extra ground control. The geo-positioning accuracy of satellite imagery rectified by rigorous LBTM can reach about one pixel with eight control lines and can be further improved by optimizing the horizontal and vertical distribution of control lines.

Clinical effects of probiotics containing Bacillus species on gingivitis: a pilot randomized controlled trial.

Science.gov (United States)

Alkaya, B; Laleman, I; Keceli, S; Ozcelik, O; Cenk Haytac, M; Teughels, W

2017-06-01

Lactobacillus spp. and bifidobacteria are the most frequently used probiotics in oral health research. However, although probiotic effects have been suggested for other genera, such as bacilli, no trials are available to describe the effect of bacilli probiotics on gingivitis in humans. The aim of the present study was to evaluate the clinical effects of a bacilli-containing toothpaste, a mouthrinse and a toothbrush cleaner versus a placebo in patients with generalized gingivitis. In this double-blind placebo-controlled randomized clinical trial, nonsmoking, systemically healthy patients with generalized gingivitis were included. They used a placebo or an experimental probiotic Bacillus subtilis-, Bacillus megaterium- and Bacillus pumulus-containing toothpaste, mouthrinse and toothbrush cleaner for 8 wk. Primary outcome measures of interest were plaque and gingivitis index, and the secondary outcome measures were pocket probing depth and bleeding on probing. Twenty male and 20 female patients were randomized over the two groups. All participants could be included in the final analysis. Although plaque and gingivitis indices were significantly reduced after 8 wk, no intergroup differences could be found at any time point. Also, for the secondary outcome measure, intragroup but no intergroup differences could be detected. No harm or unintended effects were reported by the patients after using the study products. This study did not show any statistically significant differences between a placebo and a bacilli-containing toothpaste, mouthrinse and toothbrush cleaner on gingivitis parameters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Defining, evaluating, and removing bias induced by linear imputation in longitudinal clinical trials with MNAR missing data.

Science.gov (United States)

Helms, Ronald W; Reece, Laura Helms; Helms, Russell W; Helms, Mary W

2011-03-01

Missing not at random (MNAR) post-dropout missing data from a longitudinal clinical trial result in the collection of "biased data," which leads to biased estimators and tests of corrupted hypotheses. In a full rank linear model analysis the model equation, E[Y] = Xβ, leads to the definition of the primary parameter β = (X'X)(-1)X'E[Y], and the definition of linear secondary parameters of the form θ = Lβ = L(X'X)(-1)X'E[Y], including, for example, a parameter representing a "treatment effect." These parameters depend explicitly on E[Y], which raises the questions: What is E[Y] when some elements of the incomplete random vector Y are not observed and MNAR, or when such a Y is "completed" via imputation? We develop a rigorous, readily interpretable definition of E[Y] in this context that leads directly to definitions of β, Bias(β) = E[β] - β, Bias(θ) = E[θ] - Lβ, and the extent of hypothesis corruption. These definitions provide a basis for evaluating, comparing, and removing biases induced by various linear imputation methods for MNAR incomplete data from longitudinal clinical trials. Linear imputation methods use earlier data from a subject to impute values for post-dropout missing values and include "Last Observation Carried Forward" (LOCF) and "Baseline Observation Carried Forward" (BOCF), among others. We illustrate the methods of evaluating, comparing, and removing biases and the effects of testing corresponding corrupted hypotheses via a hypothetical but very realistic longitudinal analgesic clinical trial.

Overcoming recruitment challenges in palliative care clinical trials.

Science.gov (United States)

LeBlanc, Thomas W; Lodato, Jordan E; Currow, David C; Abernethy, Amy P

2013-11-01

Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.

Response of chronic gingivitis to hygiene therapy and experimental gingivitis. Clinical, microbiological and metabonomic changes.

Science.gov (United States)

Klukowska, Malgorzata; Goyal, C Ram; Khambe, Deepa; Cannon, Michael; Miner, Melanie; Gurich, Nataliya; Circello, Ben; Huggins, Tom; Barker, Matthew L; Furnish, Carrie; Conde, Erinn; Hoke, Phyllis; Haught, Chris; Xie, Sancai; White, Donald J

2015-10-01

To compare the clinical, microbiological and metabonomic profiles of subjects with high and low levels of chronic gingival bleeding during a controlled oral hygiene regimen intervention including sequential phases of rigorous therapeutic oral hygiene followed by experimental gingivitis (EG). Two cohorts of qualified study subjects with differences in gingival bleeding on probing levels at their baseline clinical examination were entered into the study. These two cohorts were followed through three separate study phases including a 1-week baseline phase, a 2-week phase of rigorous oral hygiene including dental prophylaxis, and a 3-week EG phase of no oral hygiene to encourage relapse of gingivitis. The 58 subjects were assessed during each phase of the study for clinical presentation of gingivitis and concurrently had plaque sampled for real-time polymerase chain reaction (RTPCR) microbiological characterization and salivary lavage samples for 'systems biology' metabonomics assessment by 1H-NMR. Subjects presenting with different levels of gingival bleeding on probing when they entered the study responded differently to rigorous oral hygiene and EG. Specifically, the high bleeding cohort responded sluggishly to rigorous oral hygiene and exhibited markedly greater relapse to gingivitis during EG. RTPCR analysis showed changes in bacterial populations that were associated with study phases, particularly the increases in putative periodontal pathogens during EG. However, the microbiological profiles of high- and low-susceptibility gingival bleeding patients were largely similar. Metabonomic analysis likewise revealed significant changes in metabolite composition during study phases associated with differences in plaque toxicity, especially the short chain carboxylic acids propionate and n-butyrate, which tracked clinical changes in gingivitis severity. Systems analysis of metabonomic changes suggested differences between cohorts, although analysis to date has not

Adjunctive Systemic Antimicrobial Therapy vs Asepsis in Conjunction with Guided Tissue Regeneration: A Randomized, Controlled Clinical Trial.

Science.gov (United States)

Abu-Ta'a, Mahmoud

2016-01-01

This randomized clinical trial compares the usefulness of adjunctive antibiotics, while strict asepsis was followed during periodontal surgery involving guided tissue regeneration. Two groups of 20 consecutive patients each with advanced periodontal disease were randomly assigned to treatment. They displayed one angular defect each with an intrabony component ≥3 mm, probing pocket depth and probing attachment level (PAL) ≥7 mm. Test group included 13 males, mean age 60 years, treated with enamel matrix derivative (EMD) and demineralized freeze-dried bone allograft with modified papilla preservation technique, received oral amoxicillin 1 gm, 1 hour preoperatively and 2 gm for 2 days postoperatively. Control group included 10 males, mean age 57 years, treated with EMD and demineralized freeze-dried bone allograft with modified papilla preservation technique, received no antibiotics. Outcome measures were clinical attachment level (CAL) gain, residual periodontal pocket depth (res. PD), gingival recession (GR), bleeding on probing (BOP), adverse events and postoperative complications. Patients were followed up to 12 months after periodontal surgery involving guided tissue regeneration. There were no significant differences between both groups for CAL gain, res. PD, GR, BOP nor other clinical parameters, though patients' subjective perception of postoperative discomfort was significantly smaller in the group receiving antibiotics. Antibiotics do not provide significant advantages concerning clinical periodontal parameters nor concerning postoperative infections in case of proper asepsis. It does, on the contrary, reduce postoperative discomfort. Regarding the results of this study, adjunc-tive systemic antibiotics in combination with guided tissue regeneration may be useful in reducing postoperative discomfort but may not be helpful for improving periodontal regeneration outcomes.

Effect of Genotype-Guided Warfarin Dosing on Clinical Events and Anticoagulation Control Among Patients Undergoing Hip or Knee Arthroplasty: The GIFT Randomized Clinical Trial.

Science.gov (United States)

Gage, Brian F; Bass, Anne R; Lin, Hannah; Woller, Scott C; Stevens, Scott M; Al-Hammadi, Noor; Li, Juan; Rodríguez, Tomás; Miller, J Philip; McMillin, Gwendolyn A; Pendleton, Robert C; Jaffer, Amir K; King, Cristi R; Whipple, Brandi DeVore; Porche-Sorbet, Rhonda; Napoli, Lynnae; Merritt, Kerri; Thompson, Anna M; Hyun, Gina; Anderson, Jeffrey L; Hollomon, Wesley; Barrack, Robert L; Nunley, Ryan M; Moskowitz, Gerard; Dávila-Román, Victor; Eby, Charles S

2017-09-26

Warfarin use accounts for more medication-related emergency department visits among older patients than any other drug. Whether genotype-guided warfarin dosing can prevent these adverse events is unknown. To determine whether genotype-guided dosing improves the safety of warfarin initiation. The randomized clinical Genetic Informatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis included patients aged 65 years or older initiating warfarin for elective hip or knee arthroplasty and was conducted at 6 US medical centers. Enrollment began in April 2011 and follow-up concluded in October 2016. Patients were genotyped for the following polymorphisms: VKORC1-1639G>A, CYP2C9*2, CYP2C9*3, and CYP4F2 V433M. In a 2 × 2 factorial design, patients were randomized to genotype-guided (n = 831) or clinically guided (n = 819) warfarin dosing on days 1 through 11 of therapy and to a target international normalized ratio (INR) of either 1.8 or 2.5. The recommended doses of warfarin were open label, but the patients and clinicians were blinded to study group assignment. The primary end point was the composite of major bleeding, INR of 4 or greater, venous thromboembolism, or death. Patients underwent a screening lower-extremity duplex ultrasound approximately 1 month after arthroplasty. Among 1650 randomized patients (mean age, 72.1 years [SD, 5.4 years]; 63.6% women; 91.0% white), 1597 (96.8%) received at least 1 dose of warfarin therapy and completed the trial (n = 808 in genotype-guided group vs n = 789 in clinically guided group). A total of 87 patients (10.8%) in the genotype-guided group vs 116 patients (14.7%) in the clinically guided warfarin dosing group met at least 1 of the end points (absolute difference, 3.9% [95% CI, 0.7%-7.2%], P = .02; relative rate [RR], 0.73 [95% CI, 0.56-0.95]). The numbers of individual events in the genotype-guided group vs the clinically guided group were 2 vs 8 for major bleeding (RR, 0.24; 95% CI, 0

A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491

Directory of Open Access Journals (Sweden)

Barbieri Antonella

2008-11-01

Full Text Available Abstract Background Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care. Methods Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway or to arm 2 (no intervention, usual care. The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated. Conclusion The management of patients affected by stroke involves the expertise of several professionals, which can

Control of Established Gingivitis and Dental Plaque Using a 1450 ppm Fluoride/Zinc-based Dentifrice: A Randomized Clinical Study.

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Zhong, Y; Li, X; Hu, D Y; Mateo, L R; Morrison, B M; Delgado, E; Zhang, Y P

2015-01-01

To investigate the clinical efficacy in controlling established gingivitis and dental plaque of a 1450 ppm fluoride as sodium monofluorophosphate (SMFP)/zinc-based dentifrice, as compared to a zinc-free dentifrice with 1450 ppm fluoride as SMFP after six months product use. A six-month clinical study, with eighty-six (86) subjects, was conducted in Chengdu, China, using a double-blind, randomized, parallel-group treatment design. After a baseline evaluation, study subjects were randomly assigned to one of the two study treatments: 1) 1450 ppm fluoride as SMFP/zinc-based dentifrice (Test) or 2) 1450 ppm fluoride as SMFP/zinc-free dentifrice (Negative Control). Subjects were provided with a soft bristle toothbrush and brushed their teeth twice daily (morning and evening) for one minute with their assigned dentifrice. After three months, and again after six months of product use, subjects returned to the testing facility for their followup gingivitis and plaque examinations. Statistical analyses were performed separately for the gingivitis assessments and dental plaque assessments using the appropriate statistical methods. All statistical tests of hypotheses were two-sided, and employed a level of significance of α = 0.05. After three and six months of product use, subjects assigned to the Test treatment exhibited statistically significant (p gingival index and plaque index scores as compared to subjects assigned to the Negative Control treatment. The results of this single-center, double-blind, parallel-group and randomized clinical study support the conclusion that a 1450 ppm fluoride as SMFP/zinc-based dentifrice provides clinically meaningful and statistically significant reductions in gingivitis (23.8%) and dental plaque (22.5%) as compared to a 1450 ppm fluoride as SMFP/zinc-free dentifrice over a six-month period of twice-daily product use.

A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

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Jovancevic Jelena

2012-06-01

Full Text Available Abstract Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. Methods/Design This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. Discussion This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span. The study is IRB approved and the number is: PRO08080012 ClinicalTrials.gov Identifier: NCT01443455

Rigorous patient-prosthesis matching of Perimount Magna aortic bioprosthesis.

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Nakamura, Hiromasa; Yamaguchi, Hiroki; Takagaki, Masami; Kadowaki, Tasuku; Nakao, Tatsuya; Amano, Atsushi

2015-03-01

Severe patient-prosthesis mismatch, defined as effective orifice area index ≤0.65 cm(2) m(-2), has demonstrated poor long-term survival after aortic valve replacement. Reported rates of severe mismatch involving the Perimount Magna aortic bioprosthesis range from 4% to 20% in patients with a small annulus. Between June 2008 and August 2011, 251 patients (mean age 70.5 ± 10.2 years; mean body surface area 1.55 ± 0.19 m(2)) underwent aortic valve replacement with a Perimount Magna bioprosthesis, with or without concomitant procedures. We performed our procedure with rigorous patient-prosthesis matching to implant a valve appropriately sized to each patient, and carried out annular enlargement when a 19-mm valve did not fit. The bioprosthetic performance was evaluated by transthoracic echocardiography predischarge and at 1 and 2 years after surgery. Overall hospital mortality was 1.6%. Only 5 (2.0%) patients required annular enlargement. The mean follow-up period was 19.1 ± 10.7 months with a 98.4% completion rate. Predischarge data showed a mean effective orifice area index of 1.21 ± 0.20 cm(2) m(-2). Moderate mismatch, defined as effective orifice area index ≤0.85 cm(2) m(-2), developed in 4 (1.6%) patients. None developed severe mismatch. Data at 1 and 2 years showed only two cases of moderate mismatch; neither was severe. Rigorous patient-prosthesis matching maximized the performance of the Perimount Magna, and no severe mismatch resulted in this Japanese population of aortic valve replacement patients. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Effect of Dextromethorphan-Quinidine on Agitation in Patients With Alzheimer Disease Dementia: A Randomized Clinical Trial.

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Cummings, Jeffrey L; Lyketsos, Constantine G; Peskind, Elaine R; Porsteinsson, Anton P; Mintzer, Jacobo E; Scharre, Douglas W; De La Gandara, Jose E; Agronin, Marc; Davis, Charles S; Nguyen, Uyen; Shin, Paul; Tariot, Pierre N; Siffert, João

Agitation is common among patients with Alzheimer disease; safe, effective treatments are lacking. To assess the efficacy, safety, and tolerability of dextromethorphan hydrobromide-quinidine sulfate for Alzheimer disease-related agitation. Phase 2 randomized, multicenter, double-blind, placebo-controlled trial using a sequential parallel comparison design with 2 consecutive 5-week treatment stages conducted August 2012-August 2014. Patients with probable Alzheimer disease, clinically significant agitation (Clinical Global Impressions-Severity agitation score ≥4), and a Mini-Mental State Examination score of 8 to 28 participated at 42 US study sites. Stable dosages of antidepressants, antipsychotics, hypnotics, and antidementia medications were allowed. In stage 1, 220 patients were randomized in a 3:4 ratio to receive dextromethorphan-quinidine (n = 93) or placebo (n = 127). In stage 2, patients receiving dextromethorphan-quinidine continued; those receiving placebo were stratified by response and rerandomized in a 1:1 ratio to dextromethorphan-quinidine (n = 59) or placebo (n = 60). The primary end point was change from baseline on the Neuropsychiatric Inventory (NPI) Agitation/Aggression domain (scale range, 0 [absence of symptoms] to 12 [symptoms occur daily and with marked severity]). A total of 194 patients (88.2%) completed the study. With the sequential parallel comparison design, 152 patients received dextromethorphan-quinidine and 127 received placebo during the study. Analysis combining stages 1 (all patients) and 2 (rerandomized placebo nonresponders) showed significantly reduced NPI Agitation/Aggression scores for dextromethorphan-quinidine vs placebo (ordinary least squares z statistic, -3.95; P dextromethorphan-quinidine and from 7.0 to 5.3 with placebo. Between-group treatment differences were significant in stage 1 (least squares mean, -1.5; 95% CI, -2.3 to -0.7; Pdextromethorphan-quinidine and from 6.7 to 5.8 with placebo

Matrix product approach for the asymmetric random average process

International Nuclear Information System (INIS)

Zielen, F; Schadschneider, A

2003-01-01

We consider the asymmetric random average process which is a one-dimensional stochastic lattice model with nearest-neighbour interaction but continuous and unbounded state variables. First, the explicit functional representations, so-called beta densities, of all local interactions leading to steady states of product measure form are rigorously derived. This also completes an outstanding proof given in a previous publication. Then we present an alternative solution for the processes with factorized stationary states by using a matrix product ansatz. Due to continuous state variables we obtain a matrix algebra in the form of a functional equation which can be solved exactly

Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease: A Randomized Clinical Trial.

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Clarke, Carl E; Patel, Smitaa; Ives, Natalie; Rick, Caroline E; Dowling, Francis; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F; Sackley, Catherine M

2016-03-01

It is unclear whether physiotherapy and occupational therapy are clinically effective and cost-effective in Parkinson disease (PD). To perform a large pragmatic randomized clinical trial to evaluate the clinical effectiveness of individualized physiotherapy and occupational therapy in PD. The PD REHAB Trial was a multicenter, open-label, parallel group, controlled efficacy trial. A total of 762 patients with mild to moderate PD were recruited from 38 sites across the United Kingdom. Recruitment took place between October 2009 and June 2012, with 15 months of follow-up. Participants with limitations in activities of daily living (ADL) were randomized to physiotherapy and occupational therapy or no therapy. The primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) Scale score at 3 months after randomization. Secondary outcomes were health-related quality of life (assessed by Parkinson Disease Questionnaire-39 and EuroQol-5D); adverse events; and caregiver quality of life. Outcomes were assessed before trial entry and then 3, 9, and 15 months after randomization. Of the 762 patients included in the study (mean [SD] age, 70 [9.1] years), 381 received physiotherapy and occupational therapy and 381 received no therapy. At 3 months, there was no difference between groups in NEADL total score (difference, 0.5 points; 95% CI, -0.7 to 1.7; P = .41) or Parkinson Disease Questionnaire-39 summary index (0.007 points; 95% CI, -1.5 to 1.5; P = .99). The EuroQol-5D quotient was of borderline significance in favor of therapy (-0.03; 95% CI, -0.07 to -0.002; P = .04). The median therapist contact time was 4 visits of 58 minutes over 8 weeks. Repeated-measures analysis showed no difference in NEADL total score, but Parkinson Disease Questionnaire-39 summary index (diverging 1.6 points per annum; 95% CI, 0.47 to 2.62; P = .005) and EuroQol-5D score (0.02; 95% CI, 0.00007 to 0.03; P = .04) showed small differences in favor of therapy. There was no difference in

Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition : a pragmatic randomized clinical trial

NARCIS (Netherlands)

Olegário, I.C.; Hesse, D.; Bönecker, M.; Pettorossi Imparato, J.C.; Minatel Braga, M.; Medeiros Mendes, F.; Prócida Raggio, D.

2016-01-01

Background: Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the

Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

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Jie Wang

2013-01-01

Full Text Available Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P=0.01. Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P<0.00001. Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P<0.0001. Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P=0.02. Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results.

Anethum graveolens and hyperlipidemia: A randomized clinical trial

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Mahmoud Mirhosseini

2014-01-01

Full Text Available Background: It has been established that hyperlipidemia increases the incidence and mortality associated with coronary heart disease. In this study, the effects of Dill (Anethum graveolens were evaluated on lipid profile of hypercholesterolemic patients. Materials and Methods: In this clinical study, 91 hyperlipidemic patients were randomly designated into two groups. One group received gemfibrozil (900 mg daily and the other group received Dill tablet (six tablets daily for 2 months. The blood lipids including total cholesterol, triglyceride and high density lipoprotein (HDL-cholesterol from each group were assessed at the beginning and end of the trial. Results: Use of gemfibrozil brought about increased HDL-cholesterol by 3.91% (P < 0.05 and reduced triglyceride and total cholesterol by 32.7% (P < 0.05 and 9.41% (P < 0.05, respectively. Applying Dill tablet for 2 months resulted in reduction of total cholesterol up to 18% (P < 0.05 and triglyceride by 7.38% (P < 0.05. However, circulating HDL-cholesterol was not affected by this treatment. In this study, gemfibrozil decreased triglyceride and increased HDL-cholesterol more than anethum (P < 0.05. Anethum decreased total cholesterol more than gemfibrozil (P < 0.05. Patients treated with anethum did not report any side effects. Conclusion: The results of this trial indicate that Dill might be beneficial for hypercholesterolemic and hypertriglycemic patients.

Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial

NARCIS (Netherlands)

Dijk, I. van; Lucassen, P.L.B.J.; Akkermans, R.P.; Engelen, B.G.M. van; Weel, C. van; Speckens, A.E.M.