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Statistical efficiency can be gained in clinical trials by using composites of time-to-event outcomes when the individual component outcomes have low event rates. However, the utility of continuous composite outcome measures is not as clear. Efficiency can be either gained or lost by using a continuous composite outcome measure depending on several factors, including the strength of correlation between the component outcomes and the size of the treatment effect on each component. In this article we review these concepts from the standpoint of planning a new trial. Statistical properties of composites formed from normally distributed continuous outcomes are discussed. An example dataset is used to demonstrate concepts and complete mathematical details are provided. Finally, a conceptual model for clinical trial design with continuous composites is proposed that could be used as a guide to evaluate the utility of a continuous composite outcome in a future trial based on existing knowledge in the therapeutic area.

Diabetes medications can substantially lower blood sugar, thereby improving health outcomes. Despite substantial efforts targeting this issue, diabetes medication adherence remains suboptimal. We present the development and implementation of an intervention emphasizing peer modeling and support as strategies to improve medication adherence.

Program adaptation, pretesting, and peer coach training were combined in an iterative process with community stakeholders. Peer coaches were community residents who had diabetes or took care of family members with diabetes. Study participants were community-dwelling adults taking diabetes oral medications who reported medication non-adherence or wanted help taking their medications.

The resulting intervention consisted of a six-month, 11-session telephone-delivered program. Nineteen peer coaches were trained and certified to deliver the intervention. The 473 study participants were mostly African-Americans (91%), women (79%), and low-income (70% reporting annual incorogram in their communities.The Australian clinical trials sector has grown steadily over the past decade, particularly with respect to early phase trials where Australia's research capacity, capability and quality of research is revered. With an increase in the number of internationally sponsored clinical research projects being conducted in Australia, particularly in the early phase setting, there has been a corresponding growth in the number of clinical research sites conducting early phase clinical trials. Australian researchers are guided by a multitude of research codes, guidance and statements which govern the conduct of clinical trials. Although international guidance regarding the conduct of early phase clinical trials exists, there is currently no single source outlining best practice recommendations for the conduct of early phase clinical trials in Australia. In recognition of this Clinical Trials Impact & Quality (CTIQ), a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector and particularly early phase research, to evaluate and collate broadly applicable and implementable guidance for the conduct of early phase clinical trials. Although the initial intent was to create guidance specific to early phase, we recognize the project outcomes are more broadly implementable irrespective of the research phase and are intended to support all clinical research sites to conduct high-quality clinical trials in Australia.Informed consent can be defined as a freely-given decision or agreement following disclosure of relevant information. This review explores how legislation surrounding informed consent has impacted upon clinical research practices, with a focus on clinical trials involving individuals with the capacity to give consent in the non-emergency setting. We also highlight the challenges which remain with the informed consent process, including those which exist in the era of data protection legislation and genetic research. Modern ethicists agree that informed consent encompasses three principal factors disclosure of information, capacity for decision making, and voluntariness. In the context of clinical research, informed consent is now required by regulatory and ethical frameworks as well as by law, and various guidelines govern the practice of informed consent, including the Declaration of Helsinki and the Good Clinical Practice Guidelines. Historically, however, researchers acted paternalistically and included participants in research without their knowledge or consent. Following societal and political revolution, an autonomy model of consent became prevalent, and individuals became free to make individual choices about whether to participate. Despite this, it is also recognized that an individual's community has a role in supporting their decision making, and this may be a strong influence, particularly within some societies. Research scandals and controversies and whistle-blowers which exposed unethical practices in the area of informed consent also contributed to changes in societal attitudes and legislation changed as a result. Medical journals also have an established, although indirect, role in strengthening good practices surrounding informed consent.Levomepromazine (LMP) is a phenothiazine neuroleptic drug with strong analgesic and sedative properties that is increasingly used off-label in pediatrics and is being discussed as an adjunct therapy in neonatal intensive care. Basic research points towards neuroprotective potential of phenothiazines, but LMP's effect on the developing brain is currently unknown. The aim of the present study was to assess LMP as a pharmacologic strategy in established neonatal in vitro and in vivo models of the healthy and injured developing mouse brain. In vitro, HT-22 cells kept exposure-naïve or injured by glutamate were pre-treated with vehicle or increasing doses of LMP and cell viability was determined. In vivo, LMP's effects were first assessed in 5-day-old healthy, uninjured CD-1 mouse pups receiving a single intraperitoneal injection of vehicle or different dosages of LMP. In a second step, mouse pups were subjected to excitotoxic brain injury and subsequently treated with vehicle or LMP. Endpoints included somatometric data as well as histological and immunohistochemical analyses. In vitro, cell viability in exposure-naïve cells was significantly reduced by high doses of LMP, but remained unaffected in glutamate-injured cells. In vivo, no specific toxic effects of LMP were observed neither in healthy mouse pups nor in experimental animals subjected to excitotoxic injury, but body weight gain was significantly lower following higher-dose LMP treatment. Also, LMP failed to produce a neuroprotective effect in the injured developing brain. Additional studies are required prior to a routine clinical use of LMP in neonatal intensive care units.High-fat diets (HFDs) adversely influence glutamate metabolism and neurotransmission. The precise role of the group II metabotropic glutamate receptors (mGluR2/3) antagonist on spatial memory deficit following consumption of HFD has not yet been clarified. Therefore, in this study, we examined the effects of post-training administration of mGluR2/3 antagonism; LY341495 on spatial memory in rats fed with HFD (for 10 weeks) by using Morris Water Maze (MWM) task. The training session for testing memory acquisition in MWM consisted of 4 trials per day for 4 consecutive days. Twenty-four hours after the last training session the spatial probe test (retention) was given. Intraperitoneal injection (i.p) injection of LY341495 was done 30 min before probe test. Our results showed that 10 weeks consumption of HFD had no significant effect on escape latency and swimming distance in memory acquisition. #link# Our finding showed that consumption of a HFD leads to reference memory impairment in the probe test. HFD animals spent less time in the target zone in compare with control animals. Also, LY341495 improved HFD-induced reference memory (retention) impairment. HFD animals treated with LY341495 spent more time in the target zone in compare with HFD animals. Escape latencies to find the visible platform during visual task were same in all experimental groups, indicating no visual impairment in the animals. link2 We propose that a HFD may act through mGluR2/3 within the brain to reduce synaptic plasticity, which impairs memory retrieval, and post-training administration of LY341495 can reduce HFD-induced reference memory impairment.Strawberry fruit has a short shelf life. If stored at ambient temperature only lasts 1 day, so it needs to be dried into a frozen product so that its shelf life is longer. Frozen products are favored by consumers because they still have properties like fresh fruit. This study was aimed at examining the physical and sensory characteristics of new frozen products from strawberries. The research sample was freeze-dried at 3 variations of the heating plate temperature were 40, 50, and 60 °C and 3 variations of the drying time were 24, 36, and 48 h. The research parameters observed were weight loss, water content, texture, color, aroma, and taste. The results showed that the freeze-vacuum drying process has a significant influence on the parameters of weight loss, moisture content, texture, and color of frozen strawberries, but does not influence significantly to aroma and taste. The highest weight loss and evaporation were obtained at 60 °C and 48 h of drying time. Frozen strawberries most preferred by panelists are those that are freeze-dried at 50 °C and a drying time of 36 h because they have aroma and flavor that seem fresh strawberries.Fuels have important effects on the quality parameters of engines such as noise pollution and vibration. Diesel fuel are used in wide range of applications especially in compression ignition engines. The objective of the present research is evaluation of the noise emitted from a single-cylinder diesel engine using magnetized biodiesel-diesel fuel blends. In general, samples were provided with different percentages of the biodiesel-diesel blends as diesel (100, 95, 90, and 80%) and biodiesel (0, 5, 10, and 20%) by applying magnetic field (0, 5300 and 7000 G) to fuel line known as DxByMz. The measurements were done on a power tiller engine at a 10 cm distance from driver ear with three replications. The statistical approach in time domain and signal processing in frequency domain were applied for data analysis. The results of the variance analysis approved significant differences between the studied fuel blends and magnetic levels at 1% probability level. The highest and lowest average value of sound pressure level was corresponded to D100B0M0 and D80B20M5300, respectively. link3 The results in frequency domain showed that the maximum sound pressure level values were in the frequency range of 31.5-200 Hz for all fuel blends and magnetic levels. The frequencies related to the maximum sound values varied by changing biodiesel percent and magnetic level.Digital signage is widely utilized in digital-out-of-home (DOOH) advertising for marketing and business. Recently, the combination of the digital camera and digital signage enables the advertiser to gather the audience demographic for audience measurement. Audience measurement is useful for the advertiser to understand the audience's behavior and improve their business strategies. When an audience is facing the digital display, the vision-based DOOH system will process the audience's face and broadcast a personalized advertisement. Most of the digital signage is available in an uncontrolled environment of public areas. Thus, it poses two main challenges for the vision-based DOOH system to track the audience's movement, which are multiple adjacent faces and occlusion by passer-by. In this paper, a new framework is proposed to combine the digital signage with a depth camera for tracking multi-face in the three-dimensional (3D) environment. Raltitrexed price proposed framework extracts the audience's face centroid position (x, y) and depth information (z) and plots into the aerial map to simulate the audience's movement that is corresponding to the real-world environment.